CoP: Governing Body

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482.12 Standard: Governing Body

A-0043 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body.

Interpretive Guidelines §482.12
The hospital must have a governing body which is effective in carrying out its responsibilities for the conduct of the hospital. In the absence of an organized governing body, there must be written documentation that identifies the individual or individuals that are legally responsible for the conduct of the hospital operations.
If the hospital is part of a healthcare system that includes several separately certified hospitals, each with its own Medicare provider agreement and CMS Certification Number, the governing body of the healthcare system has the option to act as the governing body of each separately certified hospital, unless doing so would conflict with State law. A hospital system also has the option to form several governing bodies, each of which is responsible for several separately certified hospitals. For example, a health system operating hospitals in many States might choose to form regional sub-boards each responsible for the hospitals in its region, or a health system that has a mixture of types of hospitals may choose to form one sub-board responsible for its short-term acute care hospitals and another for its long term care hospitals.
When deciding whether or not to exercise the option to have a single governing body for multiple hospitals in the system, another factor for systems to consider might be Medicare payment requirements at §§412.22(e) - (h) applicable to certain types of hospitals, i.e., non-grandfathered Hospitals-within-Hospitals and Hospital Satellites. In such cases where the hospital system owns both the tenant and the host hospital, using a single governing body for both hospitals would jeopardize the payment status of a hospital that is being paid by Medicare under a payment system excluded from the Hospital Inpatient Prospective Payment System (IPPS). However, surveyors do not assess compliance with or enforce the Medicare payment regulations that govern Hospitals-within-Hospitals or Hospital Satellites.
The Medicare program offers hospital facilities considerable flexibility regarding how they choose to participate. Based on the geographic and other institutional limitations set out in the “provider-based” regulation at §413.65, which addresses provider-based status for hospital facilities in multiple locations, hospital governing bodies make business decisions about how they want to participate in Medicare, and they indicate on their Medicare enrollment application the choices they have made. It is not uncommon to find multiple hospital campuses with one owner located in the same geographic area enrolled in Medicare as one hospital. It is also not uncommon to see a hospital system choosing to enroll its various facilities as separately certified hospitals. Various factors enter into consideration when the governing body of a system makes these decisions.
For example, some governing bodies prefer to enroll various campuses as separate
hospitals, out of a concern that problems at one hospital’s campus might jeopardize the Medicare participation of the other campuses if they were a multi-campus hospital covered under one Medicare provider agreement. In other cases a governing body may see the benefits of integrating clinical services on multiple campuses into one integrated hospital. In still other cases, the deciding factor might be the implications for Medicare reimbursement of graduate medical education, the ease of adding satellite locations, etc.
CMS defers to the governing bodies of hospitals to weigh the pertinent factors and permissible options, and to make business decisions in their best interest when applying to participate in Medicare. CMS’s hospital certification decisions and issuance of a provider agreement and associated CCN follow from these business decisions by a hospital’s governing body. But once the “hospital,” with whatever component parts, has been certified, that hospital must independently demonstrate its compliance with the CoPs, independent of any other facility. (77 FR 29040, May 16, 2012)
If a hospital system has chosen to have a one body act as the governing body for multiple separately certified hospitals (i.e., a system governing body), this does not alter the fact that each hospital must independently demonstrate compliance with the CoPs. Examples of what this means include, but are not limited to, the following:
• Each separately certified hospital must be separately and independently assessed for its compliance with the CoPs, through either State Survey Agency or approved Medicare hospital accreditation program surveys. There is no survey of a hospital “system,” since the Medicare provider agreement and its terms are specific to each certified hospital.
• A system governing body may wish to adopt identical policies and procedures for many aspects of a hospital’s operations across all of its hospitals within the system. It has the flexibility to do so, but the documentation of such policies and procedures must be clear that the governing body has chosen to apply them to specifically named hospitals. Also, each hospital must be able to present for inspection the system governing body policies and procedures that clearly apply to that hospital. For example:
A document that says “XX Healthsystem has adopted the following policy” is not acceptable. Instead, the document must be more specific, such as, “XX Healthsystem adopts the following policy and procedure for Hospital A, Hospital B, and Hospital C.” Furthermore, the names of each hospital (Hospitals A, B, and C in this example) must correspond to the names used for their provider agreements. For example, if Hospital C is one Medicare-certified hospital with two inpatient campuses, one called “East” and one called “West,” it is not acceptable for the policy document to state, “XX Healthsystem adopts the following policy and procedure for Hospital A, Hospital B, and Hospital East and Hospital West.” It would be acceptable to state, “XX Healthsystem adopts the following policy and procedure for Hospital A, Hospital B, and Hospital C.”
It also is not acceptable for the policy document to state, “XX Healthsystem adopts the following policy and procedure for Hospital A, Hospital B, and Hospital East, but not Hospital West.” Since “Hospitals” East and West refer to separate campuses of Hospital C, which participates in Medicare as one multi-campus hospital, it is not appropriate to refer to these separate campuses of C as “hospitals,” since the XX Healthsystem made a business decision to enroll them as parts of one multi-campus hospital in Medicare. CMS recognizes that, depending on the particular policy topic, it may be acceptable to have policies that vary by type of unit/department within a hospital. The system governing body could achieve this as follows: “XX Healthsystem adopts the following policy and procedure requiring that a physician be on-site 24 hours per day, seven days per week on the inpatient campuses of Hospital A and Hospital B, but within Hospital C, only for the East inpatient campus.”
• Likewise, the minutes of the governing body must be written in such a manner so that it is clear when the governing body has taken actions that apply to a specific certified hospital.
• Departments of separately certified hospitals with one system governing body cannot be operationally integrated. For example, if a system has chosen to operate three separately certified hospitals in relatively close proximity to each other rather than to have them certified as one multi-campus hospital, then each hospital must have its own nursing service. It may not have one integrated nursing service with one Director of Nursing who manages one nursing staff for all three hospitals. The system cannot maintain one integrated schedule that assigns nursing staff among the different hospitals. The system also cannot move them back and forth between hospitals on an ad hoc, as needed basis, as if they were one hospital.
On the other hand, the policies and procedures the governing body has adopted for the nursing service in each hospital may be identical, so long as the services operate separately. It is also permissible for the same individual to be the Director of Nursing for each hospital, provided that he or she is able to carry out all of the duties of the position in each hospital, such as managing each hospital's separate nursing staff. It is also permissible for one nurse to work at multiple hospitals within the system, in the same way that a nurse may work for multiple hospitals that do not share ownership, but the nurse must have separate work schedules for each hospital. Such schedules cannot overlap.
• Likewise, although the system may choose to operate a quality assessment/performance improvement (QAPI) program at the system level which standardizes indicators measured across system hospitals, each separately-certified hospital in the system must have a QAPI program that is specific to that hospital. This is required not only to demonstrate compliance,
but also for the governing body to function effectively, since reviewing QAPI program results only at the system level would make it difficult for the governing body to identify and act upon problems that are localized to one hospital.
For example, the system may choose to use the same quality indicators or the same methodology to track adverse events across all system hospitals. But each certified hospital must have its own QAPI data with respect to these indicators and adverse events. If a system is tracking readmission rates across all of its hospitals, it must be able to separate out the hospital-specific results for the governing body’s review and possible action.
The governing body must be functioning effectively and holds the ultimate responsibility for the hospital’s compliance not only with the specific standards of the governing body CoP, but also with all of the CoPs. This is the case regardless of whether the regulatory text for a particular condition or standard within a condition specifically mentions responsibilities of the governing body. Substantial, i.e., condition-level, non-compliance with one of the other hospital CoPs may be an indicator that the governing body is not functioning effectively. However, it is not the policy of CMS that condition-level noncompliance with any other CoP automatically results in a condition-level citation of the governing body CoP. Surveyors must consider whether the manner and degree of the other deficiencies provide sufficient evidence to conclude that the governing body is not functioning effectively.

482.12(a) Standard: Medical Staff

A-0044 482.12(a) The governing body must ensure the medical staff requirements are met.

Interpretive Guidelines §482.12(a)
The governing body must ensure the medical staff requirements are met.

A-0045 482.12(a)(1) Determine, in accordance with State law, which categories of practitioners are eligible candidates for appointment to the medical staff.

Interpretive Guidelines §482.12(a)(1)
The governing body must determine, in accordance with State law, which categories of practitioners are eligible for appointment to the medical staff.

Physicians
The medical staff must, at a minimum, be composed of doctors of medicine or doctors of osteopathy. In addition, the medical staff may include other types of practitioners included in the definition of a physician in Section 1861(r) of the Social Security Act:
• Doctor of dental surgery or of dental medicine;
• Doctor of podiatric medicine;
• Doctor of optometry; and
• a Chiropractor.
In all cases, the practitioner included in the definition of a physician must be legally authorized to practice within the State where the hospital is located and providing services within their authorized scope of practice. In addition, in certain instances the Social Security Act and regulations attach further limitations as to the type of hospital services for which a practitioner may be considered to be a “physician.” See 42 CFR 482.12(c)(1) for more detail on these limitations.
The governing body has the flexibility, consistent with State law, to determine whether practitioners included in the definition of a physician other than a doctor of medicine or osteopathy are eligible for appointment to the medical staff.

"For Information Only – Not Required/ Not to be Cited"
--CMS expects that all physician practitioners granted privileges are also appointed as
members of the medical staff. However, if State law limits the composition of the hospital’s medical staff to certain categories of practitioners, e.g., only MDs or DOs, there is nothing in the CoPs that prohibits hospitals and their medical staffs from establishing certain practice privileges for other categories of physician practitioners excluded from medical staff membership under State law, or from granting those privileges to individual practitioners in those categories, as long as such privileges are recommended by the medical staff, approved by the governing body, and in accordance with State law. (79 FR 27114 - 27115, May 12, 2014)--

For physician practitioners granted privileges only, the hospital’s governing body and its medical staff must exercise oversight, such as through credentialing and competency review, of those other physician practitioners to whom it grants privileges, just as it would for those practitioners appointed to its medical staff.

Non-physician practitioners
Furthermore, the governing body has the authority, in accordance with State law, to grant medical staff privileges and membership to non-physician practitioners. The corresponding regulation at 42 CFR 482.22(a) allows hospitals and their medical staffs to take advantage of the expertise and skills of all types of practitioners who practice at the hospital when making decisions concerning medical staff privileges and membership. Granting medical staff privileges and membership to non-physician practitioners is an option available to the governing body; it is not a requirement.

"For Information Only – Not Required/ Not to be Cited"
--CMS expects that all practitioners granted privileges are also appointed as members of the medical staff. However, if State law limits the composition of the hospital’s medical staff to certain categories of practitioners, e.g., only physician practitioners, there is nothing in the CoPs that prohibits hospitals and their medical staffs from establishing certain practice privileges for those specific categories of non-physician practitioners excluded from medical staff membership under State law, or from granting those privileges to individual practitioners in those categories, as long as such privileges are recommended by the medical staff, approved by the governing body, and in accordance with State law. (79 FR 27114 - 27115, May 12, 2014)--

For non-physician practitioners granted privileges only, the hospital’s governing body and its medical staff must exercise oversight, such as through credentialing and competency review, of those non-physician practitioners to whom it grants privileges, just as it would for those practitioners appointed to its medical staff.
Practitioners are described in Section 1842(b)(18)(C) of the Act as any of the following:
• Physician assistant (as defined in Section 1861(aa)(5) of the Act);
• Nurse practitioner (as defined in Section 1861(aa)(5) of the Act);
• Clinical nurse specialist (as defined in Section 1861(aa)(5) of the Act);
• Certified registered nurse anesthetist (as defined in Section 1861(bb)(2) of the Act);
• Certified nurse-midwife (as defined in Section 1861(gg)(2) of the Act);
• Clinical social worker (as defined in Section 1861(hh)(1) of the Act;
• Clinical psychologist (as defined in 42 CFR 410.71 for purposes of Section 1861(ii) of the Act);
• Anesthesiologist’s Assistant (as defined at §410.69); or
• Registered dietician or nutrition professional.
Other types of licensed healthcare professionals have a more limited scope of practice and usually are not eligible for hospital medical staff privileges, unless their permitted scope of practice in their State makes them more comparable to the above listed types of non-physician practitioners. Some examples of types of such licensed healthcare professionals who might be eligible for medical staff privileges, depending on State law and medical staff bylaws, rules and regulations include, but are not limited to:
• Physical Therapist (as defined at §410.60 and §484.4);
• Occupational Therapist (as defined at §410.59 and §484.4); and
• Speech Language Therapist (as defined at §410.62 and §484.4).
Furthermore, some States have established a scope of practice for certain licensed pharmacists who are permitted to provide patient care, services that make them more like the above types of non-physician practitioners, including the monitoring and assessing of patients and ordering medications and laboratory tests. In such States, a hospital may grant medical staff privileges to such pharmacists and/or appoint them as members of the medical staff. There is no standard term for such pharmacists, although they are sometimes referred to as “clinical pharmacists.”
Practitioners may be granted active, courtesy, emergency, temporary, etc. membership or privileges in accordance with state law and as specified in the medical staff bylaws, rules, and regulations.

A-0046 482.12(a)(2) Appoint members of the medical staff after considering the recommendations of the existing members of the medical staff.

Interpretive Guidelines §482.12(a)(2)
The governing body determines whether to grant, deny, continue, revise, discontinue, limit, or revoke specified privileges, including medical staff membership, for a specific practitioner after considering the recommendation of the medical staff. In all instances, the governing body’s determination must be consistent with established hospital medical staff criteria, as well as with State and Federal law and regulations. Only the hospital’s governing body has the authority to grant a practitioner privileges to provide care in the hospital.

A-0047 482.12(a)(3) Assure that the medical staff has bylaws.

Interpretive Guidelines §482.12(a)(3)
The governing body must assure that the medical staff has bylaws and that those bylaws comply with State and Federal law and the requirements of the Medicare hospital Conditions of Participation.

A-0048 482.12(a)(4) Approve medical staff bylaws and other medical staff rules and regulations.

Interpretive Guidelines §482.12(a)(4)
The governing body decides whether or not to approve medical staff bylaws submitted by the medical staff. The medical staff bylaws and any revisions must be approved by the governing body before they are considered effective.

A-0049 482.12(a)(5) Ensure that the medical staff is accountable to the governing body for the quality of care provided to patients.

Interpretive Guidelines §482.12(a)(5)
The governing body must ensure that the medical staff as a group is accountable to the governing body for the quality of care provided to patients. The governing body is responsible for the conduct of the hospital and this conduct includes the quality of care provided to patients.
All hospital patients must be under the care of a practitioner who meets the criteria of 42 CFR 482.12(c)(1)and who has been granted medical staff privileges, or under the care of a practitioner who is directly under the supervision of a member of the medical staff. All patient care is provided by or in accordance with the orders of a practitioner who has been granted privileges in accordance with the criteria established by

A-0050 482.12(a)(6) Ensure the criteria for selection are individual character, competence, training, experience, and judgment.

Interpretive Guidelines §482.12(a)(6)
The governing body must assure that the medical staff bylaws describe the privileging process to be used by the hospital. The process articulated in the medical staff bylaws, rules, or regulations must include criteria for determining the privileges that may be granted to individual practitioners and a procedure for applying the criteria to individual practitioners that considers:
• Individual character;
• Individual competence;
• Individual training;
• Individual experience; and
• Individual judgment.
The governing body must ensure that the hospital’s bylaws governing medical staff membership or the granting of privileges

A-0051 482.12(a)(7) Ensure that under no circumstances is the accordance of staff membership or professional privileges in the hospital dependent solely upon certification, fellowship or membership in a specialty body or society.

Interpretive Guidelines §482.12(a)(7)
In making a judgment on medical staff membership, a hospital may not rely solely on the fact that a MD/DO is, or is not, board-certified. This does not mean that a hospital is prohibited from requiring board certification when considering a MD/DO for medical staff membership, but only that such certification must not be the only factor that the hospital considers. In addition to matters of board certification, a hospital must also consider other criteria such as training, character, competence and judgment. After analysis of all of the criteria, if all criteria are met except for board certification, the hospital has the discretion to decide not to select that individual to the medical staff.

A-0052 482.12(a)(8) Ensure that, when telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site hospital, the agreement is written and that it specifies that it is the responsibility of the governing body of the distant-site hospital to meet the requirements in paragraphs (a)(1) through (a)(7) of this section with regard to the distant –site hospital’s physicians and practitioners providing telemedicine services. The governing body of the hospital whose patients are receiving the telemedicine services may, in accordance with 482.22(a)(3) of this part, grant privileges based on its medical staff recommendations that rely on information provided by the distant-site hospital.

482.12(a)(9) Ensure that when telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site telemedicine entity, the written agreement specifies that the distant-site telemedicine entity is a contractor of services to the hospital and as such, in accordance with 482.12(e), furnishes the contracted services in a manner that permits the hospital to comply with all applicable conditions of participation for the contracted services, including, but not limited to, the requirements in paragraphs (a)(1) through (a)(7) of this section with regard to the distant-site telemedicine entity’s physicians and practitioners providing telemedicine services. The governing body of the hospital whose patients are receiving the telemedicine services may, in accordance with 482.22(a)(4) of this part, grant privileges to physicians and practitioners employed by the distant-site telemedicine entity based on such hospital’s medical staff recommendations; such staff recommendations may rely on information provided by the distant-site telemedicine entity.

Interpretive Guidelines §482.12(a)(8)&(a)(9)
“Telemedicine,” as the term is used in this regulation, means the provision of clinical services to patients by physicians and practitioners from a distance via electronic communications. The distant-site telemedicine physician or practitioner provides clinical services to the hospital patient either simultaneously, as is often the case with teleICU services, for example, or non-simultaneously, as may be the case with many teleradiology services. “Simultaneously” means that the clinical services (for example, assessment of the patient with a clinical plan for treatment, including any medical orders needed) are provided to the patient in “real time” by the telemedicine physician or practitioner, similar to the actions of an on-site physician or practitioner. “Non-simultaneously” means that, while the telemedicine physician or practitioner still provides clinical services to the patient upon a formal request from the patient’s attending physician, such services may involve after-the-fact interpretation of diagnostic tests in order to provide an assessment of the patient’s condition and do not necessarily require the telemedicine practitioner to directly assess the patient in “real time.” This would be similar to the services provided by an on-site radiologist who interprets a patient’s x-ray or CT scan and then communicates his or her assessment to the patient’s attending physician who then bases his or her diagnosis and treatment plan on these findings. (See 76 FR 25551-25552, May 5, 2011)
A hospital may make arrangements through written agreements either with a distant-site Medicare-participating hospital or a distant-site telemedicine entity for the provision of telemedicine services to the hospital’s patients by physicians or practitioners who have been granted privileges by the distant-site hospital or telemedicine entity. For the purposes of this rule, a distant-site telemedicine entity is defined as an entity that -- (1) provides telemedicine services; (2) is not a Medicare-participating hospital; and (3) provides contracted services in a manner that enables a hospital using its services to meet all applicable CoPs, particularly those requirements related to the credentialing and privileging of practitioners providing telemedicine services to the patients of a hospital. A distant-site telemedicine entity would include a distant-site hospital that does not participate in the Medicare program that is providing telemedicine services to a Medicare-participating hospital. (See 76 FR 25553, May 5, 2011)
If a hospital enters into an agreement for telemedicine services with a distant-site hospital or telemedicine entity, the agreement must be in writing. Furthermore, the written agreement must specify, in the case of a:
• Distant-site hospital, that it is the responsibility of the governing body of the distant-site hospital to satisfy the requirements of §§482.12(a)(1) through (a) (7) with respect to those physicians and practitioners at the distant-site hospital who furnish telemedicine services under the agreement. Since the distant-site hospital must also be a Medicare-participating hospital (see §482.22(a)(3)), it has an independent obligation to comply with these governing body requirements concerning medical staff membership and privileging. Nevertheless, the written agreement between the hospital and the distant-site hospital must explicitly include a provision addressing the distant-site hospital’s obligation to comply with these provisions.
• Distant-site telemedicine entity, that the written agreement specifies that they entity is a contractor providing telemedicine services to the hospital, and that, in accordance with the requirements governing services under arrangement at §482.12(e), the telemedicine entity furnishes the contracted telemedicine services in a manner that permits the hospital to comply with the Conditions of Participation, including, but not limited to, the governing body requirements of §§482.12(a)(1) through (a) (7) with respect to those physicians and practitioners at the distant-site telemedicine entity who furnish telemedicine services under the agreement.
There are additional requirements for the content of the written agreement, specified at
§482.22(a)(3) and §482.22(a)(4) under the medical staff Condition of Participation, which are discussed in the interpretive guidelines for those regulations.
The hospital’s governing body must grant privileges to each telemedicine physician or practitioner providing services at the hospital under an agreement with a distant-site hospital or telemedicine entity before they may provide telemedicine services. The scope of the privileges in the hospital must reflect the provision of the services via a telecommunications system. For example, a surgeon at a distant-site hospital may provide telemedicine consultation services at a hospital under agreement, but obviously would not be able to perform surgery by this means and must not have surgical privileges in the hospital as part of his/her telemedicine services privileges. If the surgeon also periodically performed surgery on-site at the hospital, then he or she would have to have privileges to do so, granted in the traditional manner provided for at §482.12(a)(1) through §482.12(a)(7) and §482.22(a)(1) and §482.22(a)(2).
In granting privileges to telemedicine physicians and practitioners, the hospital’s governing body has the option of considering hospital medical staff recommendations that rely, in accordance with §482.22(a)(3) and §482.22(a)(4), upon the credentialing and privileging decisions of the distant-site hospital or telemedicine entity. With respect to the decisions of a distant-site telemedicine entity, the regulation states that this streamlined privileging option is available to the hospital for physicians and practitioners “employed” by the distant-site telemedicine entity. We are interpreting “employed” in this context to mean “utilized by” the distant-site telemedicine entity to provide telemedicine services to the hospital under an agreement. Since it is common for telemedicine entities to contract with, rather than employ, the physicians and practitioners it utilizes to provide telemedicine services, it would not be reasonable or consistent with the regulatory intent to interpret “employed” to mean that the physicians or practitioners are employees of the distant-site telemedicine entity.
When the hospital’s governing body exercises the option to grant privileges based on its medical staff recommendations that rely upon the privileging decisions of a distant-site telemedicine hospital or entity, it may, but is not required to, maintain a separate file on each telemedicine physician and practitioner, or may instead have a file on all telemedicine physicians and practitioners providing services at the hospital under each agreement with a distant-site hospital or telemedicine entity, indicating which telemedicine services privileges the hospital has granted to each physician and practitioner on the list.
Relying upon the credentialing and privileging decisions of the distant-site hospital or telemedicine entity is an option available to the hospital’s governing body, not a requirement. A governing body may, if it so chooses, require its medical staff to independently review the credentials of and make privileging recommendations for each telemedicine physician and practitioner in accordance with §482.22(a)(1) and §482.22(a)(2), rather than permit its medical staff to rely upon the privileging decisions of the distant-site hospital or telemedicine entity. The agreement with the distant-site
hospital or telemedicine entity may not require the hospital to rely upon the distant-site organization’s privileging decisions.

A-0053 482.12(a)(10) Consult directly with the individual assigned the responsibility for the organization and conduct of the hospital’s medical staff, or his or her designee. At a minimum, this direct consultation must occur periodically throughout the fiscal or calendar year and include discussion of matters related to the quality of medical care provided to patients of the hospital. For a multi-hospital system using a single governing body, the single multi-hospital system governing body must consult directly with the individual responsible for the organized medical staff (or his or her designee) of each hospital within its system in addition to the other requirements of this paragraph (a).

Interpretive Guidelines §482.12(a)(10)
In accordance with §482.22(b)(3), there must be an individual member of the hospital’s medical staff who is assigned responsibility for the organization and conduct of the medical staff (for purposes of this guidance, the “leader” of the medical staff). §482.12(a)(10) requires that the governing body consult with this individual, or with someone the leader of the medical staff has designated.
“Direct consultation” means that the governing body, or a subcommittee of the governing body, meets with the leader(s) of the medical staff(s), or his/her designee(s) either face-to-face or via a telecommunications system permitting immediate, synchronous communication. (79 FR 27113, May 12, 2014)
This regulation does not preclude a hospital from having a member of the medical staff serve as a member of the hospital’s governing body. However, membership on the governing body by a medical staff member is not sufficient per se to satisfy the requirement for periodic consultation. In such a situation the hospital meets the consultation requirement only if the medical staff member serving on the governing body is the leader of the medical staff, or his or her designee, and only if such membership includes meeting with the board periodically throughout the fiscal or calendar year and discussing matters related to the quality of medical care provided to patients of the hospital. If there were a change in the medical staff leadership or his/her designee, and the bylaws governing terms and conditions of governing body membership did not allow for substitution of the new leader of the medical staff (or his or her designee) on the governing body, then the governing body would be expected to engage in direct consultation with the new leader of the medical staff, or his or her designee.
It should be noted that if a hospital chooses to have the leader of the medical staff, or his or her designee, serve on the governing body, there is nothing in the regulation which prohibits the hospital from also including other medical staff members on the governing body in addition to the leader of the medical staff, or his or her designee.
In the case of a multi-hospital system that has one single governing body, the governing body must consult with each separately certified hospital’s medical staff leader, or his/her designee. The consultations do not have to be separate. For example, the system governing body could periodically have a meeting that includes the leader of the medical staff, or his/her designee, from each hospital within the system, so long as there is discussion of matters related to the quality of medical care provided to the patients of each hospital.
If the medical staff members at separately certified hospitals in a multi-hospital system and the hospital system’s governing body also have opted to have a unified medical staff (see guidance for §482.22(b)(4)) for some or all of the hospitals in the system, then the governing body must consult with the leader of the unified medical staff or his/her designee. In this case, the leader of the unified medical staff, or the designee, as applicable, is expected to be aware of the concerns/views of members of the medical staff practicing at each separately certified hospital using the unified medical staff.
It is up to the governing body as to whether the leader of the medical staff must make the designation in writing when he or she chooses to designate another individual for these periodic consultations, or whether the leader of the medical staff may make informal, ad hoc designations. It is also up to the governing body as to whether it wishes to establish minimum advance notice of a designation from the leader of the medical staff to the governing body.
The requirement for the governing body to consult periodically throughout the year leaves some flexibility for the governing body to determine how often during the year its consultations with the leader of the medical staff or designee would occur, but it is expected that consultations occur at least twice during either a calendar or fiscal year. (“Fiscal year” refers to the Medicare cost-reporting year for the hospital; in the case of a hospital system with multiple, separately certified hospitals that have one single governing body and a unified medical staff, it is possible that individual hospitals have separate fiscal years. In this case, it would be more practical for the governing body to use a calendar year basis for determining the frequency of consultation.)
The governing body is expected to determine the number of consultations needed based on various factors specific to the hospital, or to each of the hospitals within a multi-hospital system. These factors include, but are not limited to, the scope and complexity of hospital services offered, specific patient populations served by a hospital, and any issues of patient safety and quality of care that a hospital’s quality assessment and performance improvement program might periodically identify as needing the attention of the governing body in consultation with its medical staff. The hospital must also provide evidence that the governing body is appropriately responsive to any periodic and/or urgent requests from the leader of the medical staff or designee for timely consultation on issues regarding the quality of medical care provided to patients of the hospital. (79 FR 27112, May 12, 2014).
The “year” referenced in the regulation may be either the calendar year or the hospital’s fiscal year, as identified on its Medicare cost report. It is up to the hospital which approach it will take, but it must document the approach selected and consistently apply it. For example, if a hospital chooses to use the calendar year, and had only one consultation during a calendar year, it could not then point out that it had had two meetings during the time period covered by its fiscal year.
The required consultation must include discussion of matters related to the quality of medical care provided to the hospital’s patients, or, in the case of a hospital system with one single governing body and a unified medical staff, the quality of medical care provided to each separately certified hospital’s patients.
The hospital’s governing body must adopt policies and procedures addressing how it implements the requirement for periodic, direct consultation with the leader of the medical staff, or the designee. The hospital must have evidence that the required consultations do take place, such as meeting agendas and lists of attendees, or minutes taken of the discussion, including who was present, etc., and that matters related to the quality of medical care provided to patients of the hospital were discussed.

A-0057 482.12(b) The governing body must appoint a chief executive officer who is responsible for managing the hospital.

Interpretive Guidelines §482.12(b)
The Governing Body must appoint one chief executive officer who is responsible for managing the entire hospital.

482.12(c) Standard: Care of Patients

A-0063 482.12(c) In accordance with hospital policy, the governing body must ensure that the following requirements are met:

No information available.

A-0064 482.12(c)(1) Every Medicare patient is under the care of:
(i) A doctor of medicine or osteopathy. (This provision is not to be construed to limit the authority of a doctor of medicine or osteopathy to delegate tasks to other qualified health care personnel to the extent recognized under State law or a State’s regulatory mechanism.);
(ii) A doctor of dental surgery or dental medicine who is legally authorized to practice dentistry by the State and who is acting within the scope of his or her license;
(iii) A doctor of podiatric medicine, but only with respect to functions which he or she is legally authorized by the State to perform;
(iv) A doctor of optometry who is legally authorized to practice optometry by the State in which he or she practices;
(v) A chiropractor who is licensed by the State or legally authorized to perform the services of a chiropractor, but only with respect to treatment by means of manual manipulation of the spine to correct a subluxation demonstrated by x-ray to exist; and
(vi) A clinical psychologist as defined in 410.71 of this chapter, but only with respect to clinical psychologist services as defined in 410.71 of this chapter and only to the extent permitted by State law.

Interpretive Guidelines §482.12(c)(1)
Practitioners other than doctors of medicine or osteopathy may join the medical staff if the practitioners are appropriately licensed and medical staff membership is in accordance with State law.
Every Medicare or Medicaid patient must be under the care of a licensed practitioner as defined in this requirement.

A-0065 482.12(c)(2) Patients are admitted to the hospital only on the recommendation of a licensed practitioner permitted by the State to admit patients to a hospital.

No information available.

A-0066 482.12(c)(2) If a Medicare patient is admitted by a practitioner not specified in paragraph (c)(1) of this section, that patient is under the care of a doctor of medicine or osteopathy.

Interpretive Guidelines §482.12(c)(2)
CMS hospital regulations do permit licensed practitioners (e.g., nurse practitioners, midwives, etc), as allowed by the State, to admit patients to a hospital, and CMS does not require these practitioners be employed by a MD/DO. However, CMS regulations do require that Medicare and Medicaid patients admitted by these practitioners be under the care of an MD/DO. Evidence of being under the care of an MD/DO must be in the patient’s medical record. If a hospital allows these practitioners to admit and care for patients, as allowed by State law, the governing body and medical staff would have to establish policies and bylaws to ensure that the requirements of 42 CFR §482 are met.
Midwife Patients
42 CFR 482.1(a)(5) states, "Section 1905(a) of the Act provides that 'medical assistance' (Medicaid) payments may be applied to various hospital services. Regulations interpreting those provisions specify that hospitals receiving payment under Medicaid must meet the requirements for participation in Medicare (except in the case of medical supervision of nurse midwife services. See §§440.10 and 440.165 of this chapter)."
Midwives are not specified at 42 CFR §482.12(c)(1).
Section 482.1(a)(5), when taken together with this requirement (42 CFR 482.12(c)(2)) means that in a State that permits midwives to admit patients (and in accordance with hospital policy and practitioner privileges), CMS requires ONLY Medicare patients of a midwife be under the care of a doctor of medicine or osteopathy. CMS DOES NOT require Medicaid or other non-Medicare patients admitted by a midwife to be under the care of a doctor of medicine or osteopathy.

A-0067 482.12(c)(3) A doctor of medicine or osteopathy is on duty or on call at all times.

No information available.

A-0068 482.12(c)(4) A doctor of medicine or osteopathy is responsible for the care of each Medicare patient with respect to any medical or psychiatric problem that--
(i) Is present on admission or develops during hospitalization; and
(ii) Is not specifically within the scope of practice of a doctor of dental surgery, dental medicine, podiatric medicine, or optometry; a chiropractor; or clinical psychologist, as that scope is:
(A) Defined by the medical staff;
(B) Permitted by State law; and
(C) Limited, under paragraph (c)(1)(v) of this section, with respect to chiropractors.

Interpretive Guidelines §482.12(c)(4)
CMS hospital regulations do permit licensed practitioners (i.e., doctors of dental surgery, dental medicine, podiatric medicine, or optometry; chiropractors; or clinical psychologists), as allowed by the State, to admit patients to a hospital. However, CMS does require that Medicare and Medicaid patients who are admitted by a doctor of dental surgery, dental medicine, podiatric medicine, or optometry; a chiropractor; or clinical psychologist be under the care of a MD/DO with respect to any medical or psychiatric problem that is present on admission or develops during hospitalization that is outside the scope of practice of the admitting practitioner. If a hospital allows a doctor of dental surgery, dental medicine, podiatric medicine, or optometry, a chiropractor or a clinical psychologist to admit and care for patients, as allowed by State law, the governing body and medical staff must establish policies and bylaws to ensure that the requirements of 42 CFR §482 are met. As applicable, the patient’s medical record must demonstrate MD/DO responsibility/care.

482.12(d) Standard: Institutional Plan and Budget

A-0073 482.12(d) The institution must have an overall institutional plan that meets the following conditions:
(1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles.
(2) The budget must include all anticipated income and expenses. This provision does not require that the budget identify item by item the components of each anticipated income or expense.
(3) The plan must provide for capital expenditures for at least a 3-year period, including the year in which the operating budget specified in paragraph (d)(2) of this section is applicable.
(4) The plan must include and identify in detail the objective of, and the anticipated sources of financing for, each anticipated capital expenditure in excess of $600,000 (or a lesser amount that is established, in accordance with section 1122(g)(1) of the Act, by the State in which the hospital is located) that relates to any of the following:
(i) Acquisition of land;
(ii) Improvement of land, buildings, and equipment; or
(iii) The replacement, modernization, and expansion of buildings and equipment.

No information available.

A-0074 482.12(d)(5) The plan must be submitted for review to the planning agency designated in accordance with section 1122(b) of the Act, or if an agency is not designated, to the appropriate health planning agency in the State. (See Part 100 of this title.)

No information available.

A-0075 482.12(d)(5) A capital expenditure is not subject to section 1122 review if 75 percent of the health care facility’s patients who are expected to use the service for which the capital expenditure is made are individuals enrolled in a health maintenance organization (HMO) or competitive medical plan (CMP) that meets the requirements of section 1876(b) of the Act, and if the Department determines that the capital expenditure is for services and facilities that are needed by the HMO or CMP in order to operate efficiently and economically and that are not otherwise readily accessible to the HMO or CMP because--
(i) The facilities do not provide common services at the same site;
(ii) The facilities are not available under a contract of reasonable duration;
(iii) Full and equal medical staff privileges in the facilities are not available;
(iv) Arrangements with these facilities are not administratively feasible; or
(v) The purchase of these services is more costly than if the HMO or CMP provided the services directly.

No information available.

A-0076 482.12(d)(6) The plan must be reviewed and updated annually Survey

No information available.

A-0077 482.12(d)(7) The plan must be prepared:
(i) Under the direction of the governing body; and
(ii) By a committee consisting of representatives of the governing body, the administrative staff, and the medical staff of the institution.

No information available.

482.12(e) Standard: Contracted Services

A-0083 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services.

Interpretive Guidelines §482.12(e)
The governing body has the responsibility for assuring that hospital services are provided in compliance with the Medicare Conditions of participation and according to acceptable standards of practice, irrespective of whether the services are provided directly by hospital employees or indirectly by contract. The governing body must take actions through the hospital’s QAPI program to: assess the services furnished directly by hospital staff and those services provided under contract, identify quality and performance problems, implement appropriate corrective or improvement activities, and to ensure the monitoring and sustainability of those corrective or improvement activities. See §482.21 QAPI.

A-0084 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner.

Interpretive Guidelines §482.12(e)(1)
Indirect arrangements may take into consideration services provided through formal contracts, joint ventures, informal agreements, shared services, or lease arrangements. The patient care services, and all other services, provided under contract are subject to the same hospital-wide quality assessment and performance improvement (QAPI) evaluation as other services provided directly by the hospital.

A-0085 482.12(e)(2) The hospital must maintain a list of all contracted services, including the scope and nature of the services provided.

No information available.

482.12(f) Standard: Emergency Services

A-0091 482.12(f) The hospital must ensure the emergency services requirements are met.

Interpretive Guidelines §482.12(f )
The hospital must ensure the emergency services requirements are met.

A-0092 482.12(f)(1) If emergency services are provided at the hospital, the hospital must comply with the requirements of 482.55.

No information available.

A-0093 482.12(f)(2) If emergency services are not provided at the hospital, the governing body must assure that the medical staff has written policies and procedures for appraisal of emergencies, initial treatment, and referral when appropriate.

Interpretive Guidelines §482.12(f)(2)
This requirement applies hospital-wide (all on-campus and off-campus locations) to hospitals that do not provide emergency services.
Hospitals without emergency departments must have appropriate policies and procedures in place for addressing individuals’ emergency care needs 24 hours per day and 7 days per week, including the following:
• Appraisal of Persons with Emergencies: A hospital must have medical staff policies and procedures for conducting appraisals of persons with emergencies. The policies and procedures must ensure that:
o As required by 42 CFR 482.23(b), an RN is immediately available, as needed, to provide bedside care to any patient and that,
o Among such RN(s) who are immediately available at all times, there must be an RN(s) who is/are qualified, through a combination of education, licensure, and training, to conduct an assessment that enables them to recognize the fact that a person has a need for emergency care.
The policies and procedures for appraisal should provide that the MD/DO (on-site or on-call) would directly provide appraisals of emergencies or provide medical direction of on-site staff conducting appraisals.
• Initial Treatment: A hospital must have medical staff policies and procedures for providing the initial treatment needed by persons with emergency conditions. Among the RN(s) who must be available at all times in a hospital as required by 42 CFR 482.23(b), there must be RN(s) who are qualified, through a combination of education, licensure, and training, to provide initial treatment to a person experiencing a medical emergency. The on-site or on-call physician could provide initial treatment directly or provide medical oversight and direction to other staff. This requirement, taken together with other hospital regulatory requirements, suggests that a prudent hospital would evaluate the patient population the hospital routinely cares for in order to anticipate potential emergency care scenarios and develop the policies, procedures, and staffing that would enable it to provide safe and adequate initial treatment of an emergency.
• Referral when Appropriate: A hospital must have medical staff policies and procedures to address situations in which a person’s emergency needs may exceed the hospital’s capabilities. The policies and procedures should be designed to enable hospital staff members who respond to emergencies to: (a) recognize when a person requires a referral or transfer, and (b) assure appropriate handling of the transfer. This includes arrangement for appropriate transport of the patient. Further, in accordance with the Discharge Planning CoP at 42 CFR 482.43(d), the hospital must transfer patients to appropriate facilities, i.e., those with the appropriate capabilities to handle the patient’s condition. The regulation also requires that necessary medical information be sent along with the patient being transferred. This enables the receiving hospital to treat the medical emergency more efficiently.
• Patient Transportation and Emergency Medical Services (EMS)
A hospital may arrange transportation of the referred patient by several methods, including using the hospital’s own ambulance service, the receiving hospital’s ambulance service, a contracted ambulance service, or, in extraordinary circumstances, alerting EMS via calling 9-1-1. There is no specific Medicare prohibition on a hospital with or without an emergency department calling 9-1-1 in order to obtain transport of a patient to another hospital. Use of 9-1-1 to obtain transport does not, however, relieve the hospital of its obligation to arrange for the patient’s transfer to an appropriate facility and to provide the necessary medical information along with the patient.
A hospital policy or practice that relies on calling 9-1-1 in order for EMS to substitute its emergency response capabilities for those the hospital is required to maintain, as described above, is not consistent with the Medicare CoPs. For example, a hospital may not rely upon 9-1-1 to provide appraisal and initial treatment of medical emergencies that occur at the hospital. Such policy or practice should be considered as condition-level non-compliance with the applicable CoP, 42 CFR 482.55 or 42 CFR 482.12(f).

A-0094 482.12(f)(3) If emergency services are provided at the hospital but are not provided at one or more off-campus departments of the hospital, the governing body of the hospital must assure that the medical staff has written policies and procedures in effect with respect to the off-campus department(s) for appraisal of emergencies and referral when appropriate.

Interpretive Guidelines §482.12(f)(3)
This requirement applies to any off-campus hospital department/location that does not qualify as a dedicated emergency department in accordance with 42 CFR 489.24(b) and is part of a hospital that provides emergency services. Such departments/locations must have and must implement medical staff policies and procedures for the appraisal of emergencies and referral when appropriate.
• Appraisal of Persons with Emergencies: A hospital must have medical staff policies and procedures for conducting appraisals of persons with emergencies at off-campus departments/locations that are not dedicated emergency departments. The policies and procedures must ensure that clinical personnel -- who are qualified, through a combination of education, licensure, and training, to conduct an assessment that enables them to recognize the fact that a person has a need for emergency care -- are available during all hours of operation at the off-campus department/location.
• Referral when Appropriate: A hospital must have medical staff policies and procedures to address situations in which a person’s emergency needs may exceed the capabilities of the off-campus departments/locations that are not dedicated emergency departments. The policies and procedures should be designed to enable staff members at such locations to: (a) recognize when a person requires a referral or transfer, and (b) assure appropriate handling of the transfer. This includes arrangement for appropriate transport of the patient along with the transfer of the patient’s medical information so that the receiving hospital may treat the medical emergency more efficiently.
• Initial Treatment: Although there is no specific regulatory requirement for such off-campus departments or locations to provide initial treatment of emergencies, nevertheless they are expected to provide treatment and stabilization consistent with the complexity of services, the type and qualifications of clinical staff, and the resources available at that location. This expectation is based on the requirements of the Outpatient Services CoP that hospital outpatient services meet the needs of the patients in accordance with acceptable standards of practice, outpatient services must be appropriately organized and integrated with inpatient services, and outpatient services must have appropriate professional and nonprofessional personnel available. For example, an off-campus cardiac rehabilitation clinic would be expected to have the appropriate qualified staff, equipment (such as a crash cart), and policies and procedures in place to appropriately provide appraisal, initial interventions, and referral of a patient who experiences a cardiac emergency.
• A hospital policy or practice that relies on calling 9-1-1 in order for EMS to substitute its emergency response capabilities for those the hospital is required to maintain at its off-campus departments/locations, as described above, is not consistent with the Medicare CoPs. However, given the more limited emergency capabilities that may be present in some off-campus departments or locations, calling 9-1-1 to respond to an emergency might be appropriate.
See the hospital emergency services CoP (42 CFR 482.55) for the emergency requirements for the hospital’s locations that provide emergency services.

CoP: Patient's Rights

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482.13 Patient's Rights

A-0115 482.13 A hospital must protect and promote each patient's rights.

Interpretive Guidelines §482.13
These requirements apply to all Medicare or Medicaid participating hospitals including short-term, acute care, surgical, specialty, psychiatric, rehabilitation, long-term, children's and cancer, whether or not they are accredited. This rule does not apply to critical access hospitals. (See Social Security Act (the Act) §1861(e).)
These requirements, as well as the other Conditions of Participation in 42 CFR 482, apply to all parts and locations (outpatient services, provider-based entities, inpatient services) of the Medicare participating hospital.

482.13(a) Standard: Notice of Rights

A-0117 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible.

Interpretive Guidelines §482.13(a)(1)
The hospital must inform each patient, or when appropriate, the patient’s representative as allowed by State law, of the patient’s rights. Whenever possible, this notice must be provided before providing or stopping care. All patients, inpatient or outpatient, must be informed of their rights as hospital patients. The patient’s rights include all of those discussed in this condition, as well as any other rights for which notice is required under State or Federal law or regulations for hospital patients. (See 42 CFR 482.11.) The patient’s rights should be provided and explained in a language or manner that the patient (or the patient’s representative) can understand. This is consistent with the guidance related to Title VI of the Civil Rights Act of 1964 issued by the Department of Health and Human Services - “Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons” (August 8, 2003, 68 FR 47311). In accordance with §482.11, hospitals are expected to comply with Title VI and may use this guidance to assist it in ensuring patient’s rights information is provided in a language and manner that the patient understands. Surveyors do not assess compliance with these requirements on limited English proficiency, but may refer concerns about possible noncompliance to the Office for Civil Rights in the applicable Department of Health and Human Services Regional Office.
Hospitals are expected to take reasonable steps to determine the patient’s wishes concerning designation of a representative. Unless prohibited by applicable State law:
• When a patient who is not incapacitated has designated, either orally to hospital staff or in writing, another individual to be his/her representative, the hospital must provide the designated individual with the required notice of patients’ rights in addition to the patient. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless expressly withdrawn, either orally or in writing, by the patient.
• In the case of a patient who is incapacitated, when an individual presents the hospital with an advance directive, medical power of attorney or similar document executed by the patient and designating an individual to make medical decisions for the patient when incapacitated, then the hospital must, when presented with the document, provide the required notice of its policies to the designated representative. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws the designation, either orally or in writing.
• When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no written advance directive on file or presented, and an individual asserts that he or she is the patient’s spouse, domestic partner (whether or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child), or other family member and thus is the patient’s representative, the hospital is expected to accept this assertion, without demanding supporting documentation, and provide the required notice to the individual, unless:
• More than one individual claims to be the patient’s representative. In such cases, it would be appropriate for the hospital to ask each individual for documentation supporting his/her claim to be the patient’s representative. The hospital should make its determination of who is the patient’s representative based upon the hospital’s determination of who the patient would most want to make decisions on his/her behalf. Examples of documentation a hospital might consider could include, but are not limited to, the following: proof of a legally recognized marriage, domestic partnership, or civil union; proof of a joint household; proof of shared or co-mingled finances; and any other documentation the hospital considers evidence of a special relationship that indicates familiarity with the patient’s preferences concerning medical treatment;
• Treating the individual as the patient’s representative without requesting supporting documentation would result in the hospital violating State law. State laws, including State regulations, may specify a procedure for determining who may be considered to be the incapacitated patient’s representative, and may specify when documentation is or is not required; or
• The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient’s spouse, domestic partner, parent or other family member.
Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual is the patient’s representative, given the critical role of the representative in exercising the patient’s rights.
A refusal by the hospital of an individual’s request to be treated as the patient’s representative, based on one of the above-specified familial relationships, must be documented in the patient’s medical record, along with the specific basis for the refusal.
In addition, according to the regulation at 42 CFR 489.27(a), (which cross references the regulation at 42 CFR 405.1205), each Medicare beneficiary who is an inpatient (or his/her representative) must be provided the standardized notice, “An Important Message from Medicare” (IM), within 2 days of admission. Medicare beneficiaries who have not been admitted (e.g., patients in observation status or receiving other care on an outpatient basis) are not required to receive the IM. The IM is a standardized, OMB-approved form and cannot be altered from its original format. The IM is to be signed and dated by the patient to acknowledge receipt. See Exhibit 16 for a copy of the IM. Furthermore, 42 CFR 405.1205(c) requires that hospitals present a copy of the signed IM in advance of the patient’s discharge, but not more than two calendar days before the patient’s discharge. In the case of short inpatient stays, however, where initial delivery of the IM is within 2 calendar days of the discharge, the second delivery of the IM is not required.
The hospital must establish and implement policies and procedures that effectively ensure that patients and/or their representatives have the information necessary to exercise their rights.

A-0118 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance.

Interpretive guidelines §482.13(a)(2)
The patient should have reasonable expectations of care and services and the facility should address those expectations in a timely, reasonable, and consistent manner. Although 482.13(a)(2)(ii) and (iii) address documentation of facility time frames for a response to a grievance, the expectation is that the facility will have a process to comply with a relatively minor request in a more timely manner than a written response. For example, a change in bedding, housekeeping of a room, and serving preferred food and beverage may be made relatively quickly and would not usually be considered a "grievance" and therefore would not require a written response.
The hospital must inform the patient and/or the patient's representative of the internal grievance process, including whom to contact to file a grievance (complaint). As part of its notification of patient rights, the hospital must provide the patient or the patient's representative a phone number and address for lodging a grievance with the State agency. The hospital must inform the patient that he/she may lodge a grievance with the State agency (the State agency that has licensure survey responsibility for the hospital) directly, regardless of whether he/she has first used the hospital's grievance process.
A “patient grievance” is a formal or informal written or verbal complaint that is made to the hospital by a patient, or the patient’s representative, regarding the patient's care (when the complaint is not resolved at the time of the complaint by staff present), abuse or neglect, issues related to the hospital's compliance with the CMS Hospital Conditions of Participation (CoPs), or a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489.
• "Staff present" includes any hospital staff present at the time of the complaint or who can quickly be at the patient's location (i.e., nursing, administration, nursing supervisors, patient advocates, etc.) to resolve the patient's complaint.
• If a patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution, then the complaint is a grievance for the purposes of these requirements. A complaint is considered resolved when the patient is satisfied with the actions taken on their behalf.
• Billing issues are not usually considered grievances for the purposes of these requirements. However, a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489 is considered a grievance.
• A written complaint is always considered a grievance. This includes written complaints from an inpatient, an outpatient, a released/discharged patient, or a patient’s representative regarding the patient care provided, abuse or neglect, or the hospital's compliance with CoPs. For the purposes of this requirement, an email or fax is considered "written."
• Information obtained from patient satisfaction surveys usually does not meet the definition of a grievance. If an identified patient writes or attaches a written complaint on the survey and requests resolution, then the complaint meets the definition of a grievance. If an identified patient writes or attaches a complaint to the survey but has not requested resolution, the hospital must treat this as a grievance if the hospital would usually treat such a complaint as a grievance.
• Patient complaints that are considered grievances also include situations where a patient or a patient's representative telephones the hospital with a complaint regarding the patient’s care or with an allegation of abuse or neglect, or failure of the hospital to comply with one or more CoPs, or other CMS requirements. Those post-hospital verbal communications regarding patient care that would routinely have been handled by staff present if the communication had occurred during the stay/visit are not required to be defined as a grievance.
• All verbal or written complaints regarding abuse, neglect, patient harm, or hospital compliance with CMS requirements are considered grievances for the purposes of these requirements.
• Whenever the patient or the patient's representative requests that his or her complaint be handled as a formal complaint or grievance or when the patient requests a response from the hospital, the complaint is considered a grievance and all the requirements apply.
• Data collected regarding patient grievances, as well as other complaints that are not defined as grievances (as determined by the hospital), must be incorporated in the hospital's Quality Assessment and Performance Improvement (QAPI) Program.

A-0119 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The hospital’s governing body must approve and be responsible for the effective operation of the grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee.

Interpretive guidelines §482.13(a)(2)
The hospital's grievance process must be approved by the governing body. The hospital's governing body is responsible for the effective operation of the grievance process. This includes the hospital's compliance with all of the CMS grievance process requirements. The hospital's governing body must review and resolve grievances, unless it delegates this responsibility in writing to a grievance committee. A committee is more than one person. The committee membership should have adequate numbers of qualified members to review and resolve the grievances the hospital receives (this includes providing written responses) in a manner that complies with the CMS grievance process requirements.

A-0120 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The hospital’s governing body must approve and be responsible for the effective operation of the grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. The grievance process must include a mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the appropriate Utilization and Quality Control Quality Improvement Organization. At a minimum:

Interpretive Guidelines §482.13(a)(2)
Quality Improvement Organizations (QIOs) are CMS contractors charged with reviewing the appropriateness and quality of care rendered to Medicare beneficiaries in the hospital setting. The QIOs are also tasked with reviewing utilization decisions. Part of this duty includes reviewing discontinuation of stay determinations based upon a beneficiary’s request. The regulations state the functions of the QIOs in order to make Medicare beneficiaries aware of the fact that if they have a complaint regarding quality of care, disagree with a coverage decision, or they wish to appeal a premature discharge, they may contact the QIO to lodge a complaint. The hospital is required to have procedures for referring Medicare beneficiary concerns to the QIOs; additionally, CMS expects coordination between the grievance process and existing grievance referral procedures so that beneficiary complaints are handled timely and referred to the QIO at the beneficiary’s request.
This regulation requires coordination between the hospital’s existing mechanisms for utilization review notice and referral to QIOs for Medicare beneficiary concerns (See 42 CFR Part 489.27). This requirement does not mandate that the hospital automatically refer each Medicare beneficiary’s grievance to the QIO; however, the hospital must inform all beneficiaries of this right, and comply with his or her request if the beneficiary asks for QIO review.
Medicare patients have the right to appeal a premature discharge (see Interpretive Guidelines for 42 CFR 482.13(a)). Pursuant to 42 CFR 412.42(c)(3), a hospital must provide a hospital-issued notice of non-coverage (HINN) to any fee-for-service beneficiary that expresses dissatisfaction with an impending hospital discharge. Medicare Advantage (MA) organizations are required to provide enrollees with a notice of non-coverage, known as the Notice of Discharge and Medicare Appeal Rights (NODMAR), only when a beneficiary disagrees with the discharge decision or when the MA organization (or hospital, if the MA organization has delegated to it the authority to make the discharge decision) is not discharging the enrollee, but no longer intends to cover the inpatient stay.

A-0121 482.13(a)(2)(i) The hospital must establish a clearly explained procedure for the submission of a patient’s written or verbal grievance to the hospital.

Interpretive Guidelines §482.13(a)(2)(i)
The hospital’s procedure for a patient or the patient’s representative to submit written or verbal grievances must be clearly explained. The patient or patient’s representative should be able to clearly understand the procedure.

A-0122 482.13(a)(2)(ii) The grievance process must specify time frames for review of the grievance and the provision of a response.

Interpretive Guidelines §482.13(a)(2)(ii)
The hospital must review, investigate, and resolve each patient’s grievance within a reasonable time frame. For example, grievances about situations that endanger the patient, such as neglect or abuse, should be reviewed immediately, given the seriousness of the allegations and the potential for harm to the patient(s). However, regardless of the nature of the grievance, the hospital should make sure that it is responding to the substance of each grievance while identifying, investigating, and resolving any deeper, systemic problems indicated by the grievance.
Document when a grievance is so complicated that it may require an extensive investigation. We recognize that staff scheduling as well as fluctuations in the numbers and complexity of grievances can affect the timeframes for the resolution of a grievance and the provision of a written response. On average, a time frame of 7 days for the provision of the response would be considered appropriate. We do not require that every grievance be resolved during the specified timeframe although most should be resolved. 42 CFR 482.13(a)(2)(iii) specifies information the hospital must include in their response.
If the grievance will not be resolved, or if the investigation is not or will not be completed within 7 days, the hospital should inform the patient or the patient's representative that the hospital is still working to resolve the grievance and that the hospital will follow-up with a written response within a stated number of days in accordance with the hospital's grievance policy. The hospital must attempt to resolve all grievances as soon as possible.

A-0123 482.13(a)(2)(iii) In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Interpretive Guidelines §482.13(a)(2)(iii)
The written notice of the hospital’s determination regarding the grievance must be communicated to the patient or the patient’s representative in a language and manner the patient or the patient’s legal representative understands.
The hospital may use additional tools to resolve a grievance, such as meeting with the patient and his family. The regulatory requirements for the grievance process are minimum standards, and do not inhibit the use of additional effective approaches in handling patient grievances. However, in all cases the hospital must provide a written notice (response) to each patient’s grievance(s). The written response must contain the elements listed in this requirement.
When a patient communicates a grievance to the hospital via email the hospital may provide its response via email pursuant to hospital policy. (Some hospitals have policies against communicating to patients over email.) If the patient requests a response via email, the hospital may respond via email. When the email response contains the information stated in this requirement, the email meets the requirement for a written response. The hospital must maintain evidence of its compliance with these requirements.
A grievance is considered resolved when the patient is satisfied with the actions taken on their behalf.
There may be situations where the hospital has taken appropriate and reasonable actions on the patient's behalf in order to resolve the patient's grievance and the patient or the patient's representative remains unsatisfied with the hospital's actions. In these situations, the hospital may consider the grievance closed for the purposes of these requirements. The hospital must maintain documentation of its efforts and demonstrate compliance with CMS requirements.
In its written response, the hospital is not required to include statements that could be used in a legal action against the hospital, but the hospital must provide adequate information to address each item stated in this requirement. The hospital is not required to provide an exhaustive explanation of every action the hospital has taken to investigate the grievance, resolve the grievance, or other actions taken by the hospital.

482.13(b) Standard: Exercise of Rights

A-0130 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care.

Interpretive Guidelines §482.13(b)(1)
This regulation requires the hospital to actively include the patient in the development, implementation and revision of his/her plan of care. It requires the hospital to plan the patient’s care, with patient participation, to meet the patient’s psychological and medical needs.
The patient’s (or patient’s representatives, as allowed by State law) right to participate in the development and implementation of his or her plan of care includes at a minimum, the right to: participate in the development and implementation of his/her inpatient treatment/care plan, outpatient treatment/care plan, participate in the development and implementation of his/her discharge plan, and participate in the development and implementation of his/her pain management plan.
Hospitals are expected to take reasonable steps to determine the patient’s wishes concerning designation of a representative to exercise the patient’s right to participate in the development and implementation of the patient’s plan of care. Unless prohibited by applicable State law:
• When a patient who is not incapacitated has designated, either orally to hospital staff or in writing, another individual to be his/her representative, the hospital must involve the designated representative in the development and implementation of the patient’s plan of care. The explicit designation of a representative by the patient takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless expressly withdrawn, either orally or in writing, by the patient.
• In the case of a patient who is incapacitated, when an individual presents the hospital with an advance directive, medical power of attorney or similar document executed by the patient and designating an individual to make medical decisions for the patient when incapacitated, the hospital, when presented with the document, must involve the designated representative in the development and implementation of the patient’s plan of care. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws the designation, either orally or in writing.
• When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no written advance directive on file or presented, and an individual asserts that he or she is the patient’s spouse, domestic partner (whether or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child) or other family member and thus is the patient’s representative, the hospital is expected to accept this assertion, without demanding supporting documentation, and must involve the individual as the patient’s representative in the development and implementation of the patient’s plan of care, unless:
• More than one individual claims to be the patient’s representative. In such cases, it would be appropriate for the hospital to ask each individual for documentation supporting his/her claim to be the patient’s representative. The hospital should make its determination of who is the patient’s representative based upon the hospital’s determination of who the patient would most want to make decisions on his/her behalf. Examples of documentation a hospital might consider could include, but are not limited to, the following: proof of a legally recognized marriage, domestic partnership, or civil union; proof of a joint household; proof of shared or co-mingled finances; and any other documentation the hospital considers evidence of a special relationship that indicates familiarity with the patient’s preferences concerning medical treatment;
• Treating the individual as the patient’s representative without requesting supporting documentation would result in the hospital violating State law. State laws, including State regulations, may specify a procedure for determining who may be considered to be the incapacitated patient’s representative, and may specify when documentation is or is not required; or
• The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient’s spouse, domestic partner, parent or other family member.
Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual is the patient’s representative, given the critical role of the representative in exercising the patient’s rights.
A refusal by the hospital of an individual’s request to be treated as the patient’s representative, based on one of the above-specified familial relationships, must be documented in the patient’s medical record, along with the specific basis for the refusal.

A-0131 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient's rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate.

Interpretive Guidelines §482.13(b)(2)
The right to make informed decisions means that the patient or patient’s representative is given the information needed in order to make "informed" decisions regarding his/her care.

Patient’s Representative:
A patient may wish to delegate his/her right to make informed decisions to another person (as allowed under State law).
Hospitals are expected to take reasonable steps to determine the patient’s wishes concerning designation of a representative. Unless prohibited by applicable State law:
• When a patient who is not incapacitated has designated, either orally to hospital staff or in writing, another individual to be his/her representative, the hospital must provide the designated individual with the information required to make an informed decision about the patient’s care. The hospital must also seek the written consent of the patient’s representative when informed consent is required for a care decision. The explicit designation of a representative by the patient takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless expressly withdrawn, either orally or in writing, by the patient.
• In the case of a patient who is incapacitated, when an individual presents the hospital with an advance directive, medical power of attorney or similar document executed by the patient and designating an individual to make medical decisions for the patient when incapacitated, the hospital must, when presented with the document, provide the designated individual the information required to make informed decisions about the patient’s care. The hospital must also seek the consent of the designated individual when informed consent is required for a care decision. The explicit designation of a representative takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws the designation, either orally or in writing.
• When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no written advance directive on file or presented, and an individual asserts that he or she is the patient’s spouse, domestic partner (whether
or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child), or other family member and thus is the patient’s representative, the hospital is expected to accept this assertion, without demanding supporting documentation, and provide the individual the information required to make informed decisions about the patient’s care. The hospital must also seek the consent of the individual when informed consent is required for a care decision. Hospitals are expected to treat the individual as the patient’s representative unless:
• More than one individual claims to be the patient’s representative. In such cases, it would be appropriate for the hospital to ask each individual for documentation supporting his/her claim to be the patient’s representative. The hospital should make its determination of who is the patient’s representative based upon the hospital’s determination of who the patient would most want to make decisions on his/her behalf. Examples of documentation a hospital might consider could include, but are not limited to, the following: proof of a legally recognized marriage, domestic partnership, or civil union; proof of a joint household; proof of shared or co-mingled finances; and any other documentation the hospital considers evidence of a special relationship that indicates familiarity with the patient’s preferences concerning medical treatment;
• Treating the individual as the patient’s representative without requesting supporting documentation would result in the hospital violating State law. State laws, including State regulations, may specify a procedure for determining who may be considered to be the incapacitated patient’s representative, and may specify when documentation is or is not required; or
• The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient’s spouse, domestic partner, parent or other family member.
Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual is the patient’s representative, given the critical role of the representative in exercising the patient’s rights.
A refusal by the hospital of an individual’s request to be treated as the patient’s representative, based on one of the above-specified familial relationships, must be documented in the patient’s medical record must, along with the specific basis for the refusal.

Informed Decisions
The right to make informed decisions regarding care presumes that the patient or the patient’s representative has been provided information about his/her health status, diagnosis, and prognosis. Furthermore, it includes the patient's or the patient’s representative’s participation in the development of his/her plan of care, including providing consent to, or refusal of, medical or surgical interventions, and in planning for care after discharge from the hospital. The patient or the patient's representative should receive adequate information, provided in a manner that the patient or the patient's representative can understand, to assure that the patient or the patient’s representative can effectively exercise the right to make informed decisions.
Hospitals must establish processes to assure that each patient or the patient's representative is given information on the patient's health status, diagnosis, and prognosis.
Giving informed consent to a treatment or a surgical procedure is one type of informed decision that a patient or patient's representative may need to make regarding the patient's plan of care. Hospitals must utilize an informed consent process that assures patients or their representatives are given the information and disclosures needed to make an informed decision about whether to consent to a procedure, intervention, or type of care that requires consent. See the guidelines for 42 CFR 482.51(b)(2) pertaining to surgical services informed consent and the guidelines for 42 CFR 482.24(c)(2)(v) pertaining to medical records for further detail.
Informed decisions related to care planning also extend to discharge planning for the patient's post-acute care. See the guidelines at 42 CFR 482.43(c) pertaining to discharge planning for discussion of pertinent requirements.
Hospitals must also establish policies and procedures that assure a patient's right to request or refuse treatment. Such policies should indicate how the patient's request will be addressed. However, hospitals are under no obligation to fulfill a patient's request for a treatment or service that the responsible practitioner has deemed medically unnecessary or even inappropriate.

Required Hospital Disclosures to Patients:

Physician Ownership
In addition, there are certain provisions of the Medicare provider agreement rules concerning disclosures that certain hospitals are required to make which are enforced under 42 CFR 482.13(b)(2):
• 42 CFR 489.3 defines a “physician-owned hospital” as any participating hospital in which a physician or immediate family member of a physician (as defined in §411.351) has an ownership or investment interest in the hospital, except for those satisfying an exception found at §411.356(a) or (b). Surveyors are not required to make an independent determination regarding whether a hospital meets the Medicare definition of “physician-owned,” but they must ask whether the hospital is physician-owned.
• 42 CFR 489.20(u)(1) requires that all physician-owned hospitals provide written notice to their patients at the beginning of each patient’s hospital inpatient stay or outpatient visit stating that the hospital is physician-owned, in order to assist the patient in making an informed decision about his or her care, in accordance with the requirements of §482.13(b)(2).
• A planned inpatient stay or outpatient visit which is subject to the notice requirement begins with the provision of a package of information regarding scheduled preadmission testing and registration for a planned hospital admission for inpatient care or for an outpatient service subject to notice. An unplanned inpatient stay or outpatient visit subject to the notice requirement begins at the earliest point at which the patient presents to the hospital.
• The notice must disclose, in a manner reasonably designed to be understood by all patients, that the hospital is physician-owned and that a list of owners or investors who are physicians or immediate family members of physicians is available upon request. If the patient (or someone on behalf of the patient) requests this list, the hospital must provide it at the time of the request.
• However, the notice requirement does not apply to any physician-owned hospital that does not have at least one referring physician (as defined at §411.351) who has an ownership or investment interest in the hospital or who has an immediate family member who has an ownership or investment interest in the hospital. In such cases, the hospital must sign an attestation statement that it has no referring physician with an ownership or investment interest or whose immediate family member has an ownership or investment interest in the hospital. The hospital must maintain this attestation in its records.
• 42 CFR 489.20(u)(2) provides that physician-owned hospitals must require each physician owner who is a member of the hospital’s medical staff to agree, as a condition of obtaining/retaining medical staff membership or admitting privileges, to disclose in writing to all patients they refer to the hospital their ownership or investment interest in that hospital or that of any immediate family member. The hospital must require that this disclosure be made at the time of the referral and the requirement should be reflected in the hospital’s policies and procedures governing privileges for physician owners.
• The hospital may exempt from this disclosure requirement any physician owner who does not refer any patients to the hospital.
• 42 CFR 489.12 permits CMS to refuse to enter into a provider agreement with a physician-owned hospital applicant that does not have procedures in place to notify patients of physician ownership in the hospital as required under §489.20(u).
• 42 CFR 489.53(c) permits CMS to terminate a provider agreement with a physician-owned hospital if the hospital fails to comply with the requirements at §489.20(u).

MD/DO 24/7 On-Site Presence
42 CFR 489.20(w) mandates that if there is no doctor of medicine or osteopathy present in the hospital 24 hours per day, seven days per week, the hospital must provide written notice of this to all inpatients at the beginning of a planned or unplanned inpatient stay, and to outpatients for certain types of planned or unplanned outpatient visits. The purpose of this requirement is to assist the patient in making an informed decision about his/her care, in accordance with 42 CFR 482.13(b)(2). Hospitals that have an MD/DO on-site 24/7 (including residents who are MDs or DOs) do not need to issue any disclosure notice about emergency services capability.
• The notice must be provided to all inpatients and to those outpatients who are under observation or who are having surgery or any other procedure using anesthesia.
• The notice must be provided at the beginning of the planned or unplanned inpatient stay, or outpatient visit subject to notice.
• A planned inpatient stay or outpatient visit which is subject to the notice requirement begins with the provision of a package of information regarding scheduled preadmission testing and registration for a planned hospital admission for inpatient care or for an outpatient service subject to notice. An unplanned inpatient stay or outpatient visit which is subject to the notice requirement begins at the earliest point at which the patient presents to the hospital.
• Individual notices are not required in the hospital’s dedicated emergency department (DED) (as that term is defined in 42 CFR 489.24(b)), but the DED must post a notice conspicuously, in a place or places likely to be noticed by all individuals entering the DED. The posted notice must state that the hospital does not have a doctor of medicine or a doctor of osteopathy present in the hospital 24 hours per day, 7 days per week, and must indicate how the hospital will meet the medical needs of any patient with an emergency medical condition, as defined in 42 CFR 489.24(b) [the EMTALA definition], at a time when there is no doctor of medicine or doctor of osteopathy present in the hospital. If an emergency department patient is determined to require admission, then the individual notice requirements of 42 CFR 489.20(w) would apply to that patient.
• Before admitting an inpatient or providing outpatient services requiring notice, the hospital must obtain a signed acknowledgement from the patient stating that he/she understands that a doctor of medicine or doctor of osteopathy may not be present at all times services are furnished to him/her.
• In the event of an unplanned surgery or inpatient admission to treat an emergency medical condition, it may in some cases be necessary in the interest of the patient’s safety to proceed with treatment before the required notice can be given and acknowledgement can be obtained. In such circumstances, the hospital must provide notice and obtain acknowledgement as soon as possible after the patient’s stay or visit begins.
• For a hospital that participates in Medicare with multiple campuses providing inpatient services (e.g., a main provider campus and separate satellite, remote, and/or provider-based locations) under one CMS Certification Number, a separate determination is made for each campus or satellite location with inpatient services as to whether the disclosure notice is required. For example, if a hospital has a main campus and a satellite location and a physician is present 24/7 on the main campus but not at the satellite location, the hospital is required to provide the disclosure notice only at the satellite location. No notice is required for patients presenting to the main provider campus in this case. In this same example, if the hospital also has a provider-based, off-campus ambulatory (i.e., same-day) surgery department, no notice is required at that off-campus surgery site, since the hospital’s main campus does have an MD/DO present 24/7.
• 42 CFR 489.53(c) permits CMS to terminate a provider agreement with a hospital if the hospital fails to comply with the requirements at §489.20(w) when it does not have an MD or DO on-site 24/ 7.

A-0132 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), 489.102 of this part (Requirements for providers), and 489.104 of this part (Effective dates).

Interpretive Guidelines §482.13(b)(3)
An advance directive is defined at §489.100 as “a written instruction, such as a living will or durable power of attorney for health care, recognized under State law (whether statutory or as recognized by the courts of the State), relating to the provision of health care when the individual is incapacitated.” The patient (inpatient or outpatient) has the right to formulate advance directives, and to have hospital staff implement and comply with their advance directive. The regulation at 42 CFR 489.102 specifies the rights of a patient (as permitted by State law) to make medical care decisions, including the right to accept or refuse medical or surgical treatment and the right to formulate, at the individual’s option, advance directives.
In the advance directive, the patient may provide guidance as to his/her wishes concerning provision of care in certain situations; alternatively the patient may delegate decision-making authority to another individual, as permitted by State law. (In addition, the patient may use the advance directive to designate a “support person,” as that term is used in §482.13(h), for purposes of exercising the patient’s visitation rights.) When a patient who is incapacitated has executed an advance directive designating a particular individual to make medical decisions for him/her when incapacitated, the hospital must, when presented with the document, provide the designated individual the information required to make informed decisions about the patient’s care. (See also the requirements at §482.13(b)(2).) The hospital must also seek the consent of the patient’s representative when informed consent is required for a care decision. The explicit designation of a representative in the patient’s advance directive takes precedence over any non-designated relationship and continues throughout the patient’s inpatient stay or, as applicable, outpatient visit, unless the patient ceases to be incapacitated and expressly withdraws the designation, either orally or in writing.

§489.102 also requires the hospital to:
• Provide written notice of its policies regarding the implementation of patients’ rights to make decisions concerning medical care, such as the right to formulate advance directives. If an individual is incapacitated or otherwise unable to communicate, the hospital may provide the advance directive information required under §489.102 to the individual’s “family or surrogate in the same manner that it issues other materials about policies and procedures to the family of the incapacitated individual or to a surrogate or other concerned persons in accordance with State law.”(§489.102(e)) The guidance concerning the regulation at §482.13(a)(1) governing notice to the patient or the patient’s representative of the patient’s rights applies to the required provision of notice concerning the hospital’s advance directive policies. Although both inpatients and outpatients have the same rights under §482.13(a)(1), §489.102(b)(1) requires that notice of the hospital’s advance directive policy be provided at the time an individual is admitted as an inpatient. However, in view of the broader notice requirements at §482.13(a)(1), the hospital should also provide the advance directive notice to outpatients (or their representatives) who are in the emergency department, who are in an observation status, or who are undergoing same-day surgery. The notice should be presented at the time of registration. Notice is not required for other outpatients, given that they are unlikely to become incapacitated.
• The notice must include a clear and precise statement of limitation if the hospital cannot implement an advance directive on the basis of conscience. At a minimum, a statement of limitation should:
• Clarify any differences between institution-wide conscience objections and those
that may be raised by individual physicians or other practitioners;
• Identify the State legal authority permitting such an objection; and
• Describe the range of medical conditions or procedures affected by the conscience objection.
It should be noted that this provision allowing for certain conscience objections to implementing an advance directive is narrowly focused on the directive’s content related to medical conditions or procedures. This provision would not allow a hospital or individual physician or practitioner to refuse to honor those portions of an advance directive that designate an individual as the patient’s representative and/or support person, given that such designation does not concern a medical condition or procedure.
Issuance of the written notice of the hospital’s advance directive policies to the patient or the patient’s representative must be documented in the patient’s medical record.
• Document in a prominent part of the patient’s medical record whether or not the patient has executed an advance directive;
• Not condition the provision of care or otherwise discriminate against an individual based on whether or not the individual has executed an advance directive;
• Ensure compliance with requirements of State law concerning advance directives and inform individuals that complaints concerning the advance directive requirements may be filed with the State survey and certification agency;
• Provide for the education of staff concerning its policies and procedures on advance directives. The right to formulate advance directives includes the right to formulate a psychiatric advance directive (as allowed by State law); and
• Provide community education regarding advance directives and the hospital must document its efforts.
A psychiatric advance directive is akin to a traditional advance directive for health care. This type of advance directive might be prepared by an individual who is concerned that at some time he or she may be subject to involuntary psychiatric commitment or treatment. The psychiatric advance directive may cover a range of subjects, and may name another person who is authorized to make decisions for the individual if he or she is determined to be legally incompetent to make his/her own choices. It may also provide the patient’s instructions about hospitalization, alternatives to hospitalization, the use of medications, types of therapies, and the patient’s wishes concerning restraint or seclusion. The patient may designate who should be notified upon his/her admission to the hospital, as well as who should not be permitted to visit him or her. State laws regarding the use of psychiatric advance directives vary.
In accordance with State law, a psychiatric advance directive should be accorded the same respect and consideration that a traditional advance directive for health care is given. Hospitals should carefully coordinate how the choices of a patient balance with the rights of other patients, staff, and individuals in the event that a dangerous situation arises.
However, even if State law has not explicitly spoken to the use of psychiatric advance directives, consideration should be given to them inasmuch as this regulation also supports the patient’s right to participate in the development and implementation of his or her plan of care. When the patient is, for whatever reason, unable to communicate his/her wishes, the preferences expressed in the psychiatric advance directive can give critical insight to the MD/DOs, nurses, and other staff as they develop a plan of care and treatment for the patient.

A-0133 482.13(b)(4) The patient has the right to have a family member or representative of his or her choice and his or her own physician notified promptly of his or her admission to the hospital.

Interpretive Guidelines §482.13(b)(4)

Identifying Who Is to Be Notified
For every inpatient admission, the hospital must ask the patient whether the hospital should notify a family member or representative about the admission. If the patient requests such notice and identifies the family member or representative to be notified, the hospital must provide such notice promptly to the designated individual. The explicit designation of a family member or representative by the patient takes precedence over any non-designated relationship.
The hospital must also ask the patient whether the hospital should notify his/her own physician. In the case of scheduled admissions, the patient’s own physician likely is already aware of the admission. However, if the patient requests notice to and identifies the physician, the hospital must provide such notice promptly to the designated physician, regardless of whether the admission was scheduled in advance or emergent.
When a patient is incapacitated or otherwise unable to communicate and to identify a family member or representative to be notified, the hospital must make reasonable efforts to identify and promptly notify a family member or patient’s representative. If an individual who has accompanied the patient to the hospital, or who comes to or contacts the hospital after the patient has been admitted, asserts that he or she is the patient’s spouse, domestic partner (whether or not formally established and including a same-sex domestic partner), parent (including someone who has stood in loco parentis for the patient who is a minor child), or other family member, the hospital is expected to accept this assertion, without demanding supporting documentation, and provide this individual information about the patient’s admission, unless:
• More than one individual claims to be the patient’s family member or representative. In such cases it would not be inappropriate for the hospital to ask
each individual for documentation supporting his/her claim to be the patient’s family member or representative. The hospital should make its determination of who is the patient’s representative based upon the hospital’s determination of who the patient would most want to make decisions on his/her behalf. Examples of documentation a hospital might consider could include, but are not limited to, the following: proof of a legally recognized marriage, domestic partnership, or civil union; proof of a joint household; proof of shared or co-mingled finances; and any other documentation the hospital considers evidence of a special relationship that indicates familiarity with the patient’s preferences concerning medical treatment ;
• Treating the individual as the patient’s family member or representative without requesting supporting documentation would result in the hospital violating State law. State laws, including State regulations, may specify a procedure for determining who may be considered to be the incapacitated patient’s family member or representative, and may specify when documentation is or is not required; or
• The hospital has reasonable cause to believe that the individual is falsely claiming to be the patient’s spouse, domestic partner, parent or other family member.
Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual should be notified as the patient’s family member or representative, given the critical role of the representative in exercising the patient’s rights. Hospitals may also choose to provide notice to more than one family member.
When a patient is incapacitated and the hospital is able through reasonable efforts to identify the patient’s own physician – e.g., through information obtained from a family member, or from review of prior admissions or outpatient encounters, or through access to the patient’s records in a regional system of electronic patient medical records in which the hospital participates – the hospital must promptly notify the patient’s physician of the admission.

Prompt Notice
The hospital must provide the required notice promptly. “Promptly” means as soon as possible after the physician’s or other qualified practitioner’s order to admit the patient has been given. Notice may be given orally in person, by telephone, by e-mail or other electronic means, or by other methods that achieve prompt notification. It is not acceptable for the hospital to send a letter by regular mail.

Medical Record Documentation
The hospital must document that the patient, unless incapacitated, was asked no later than the time of admission whether he or she wanted a family member/representative notified, the date, time and method of notification when the patient requested such, or whether the patient declined to have notice provided. If the patient was incapacitated at the time of admission, the medical record must indicate what steps were taken to identify and provide notice to a family member/representative and to the patient’s physician.

482.13(c) Standard: Privacy and Safety

A-0143 482.13(c)(1) The patient has the right to personal privacy.

Interpretive Guidelines §482.13(c)(1)
The underlying principle of this requirement is the patient’s basic right to respect, dignity, and comfort while in the hospital.

Physical Privacy
“The right to personal privacy” includes at a minimum, that patients have physical privacy to the extent consistent with their care needs during personal hygiene activities (e.g., toileting, bathing, dressing), during medical/nursing treatments, and when requested as appropriate.
People not involved in the care of the patient should not be present without his/her consent while he/she is being examined or treated. If an individual requires assistance during toileting, bathing, and other personal hygiene activities, staff should assist, giving utmost attention to the individual’s need for privacy. Privacy should be afforded when the MD/DO or other staff visits the patient to discuss clinical care issues or conduct any examination or treatment.
However, audio/video monitoring (does not include recording) of patients in medical-surgical or intensive-care type units would not be considered violating the patient’s privacy, as long as there exists a clinical need, the patient/patient’s representative is aware of the monitoring and the monitors or speakers are located so that the monitor screens are not readily visible or where speakers are not readily audible to visitors or the public. Video recording of patients undergoing medical treatment requires the consent of the patient or his/her representative.
A patient’s right to privacy may also be limited in situations where a person must be continuously observed to ensure his or her safety, such as when a patient is simultaneously restrained and in seclusion to manage violent or self-destructive behavior or when the patient is under suicide precautions.

Protecting Patient Personal Information
The right to personal privacy also includes limiting the release or disclosure of patient information. Patient information includes, but is not limited to, the patient’s presence or location in the hospital; demographic information the hospital has collected on the patient, such as name, age, address, income; or information on the patient’s medical condition. Such patient information may not be disclosed without informing the patient or the patient’s representative in advance of the disclosure and providing the patient or the patient’s representative an opportunity to agree, prohibit, or restrict the disclosure. Below is a summary of privacy issues that surveyors might encounter in hospital settings, and the related privacy requirements.

Permitted Disclosures:
A hospital is permitted to use and disclose patient information, without the patient’s authorization, in order to provide patient care and perform related administrative functions, such as payment and other hospital operations.
• Payment operations include hospital activities to obtain payment or be reimbursed for
the provision of health care to an individual.
• Hospital operations are administrative, financial, legal, and quality improvement activities of a hospital that are necessary to conduct business and to support the core functions of treatment and payment. These activities include, but are not limited to: quality assessment and improvement activities, case management and care coordination; competency assurance activities, conducting or arranging for medical reviews, audits, or legal services, including fraud and abuse detection and compliance programs; business planning, development, management, and administration and certain hospital-specific fundraising activities.
Hospitals must develop and implement policies and procedures that restrict access to and use of patient information based on the specific roles of the members of their workforce. These policies and procedures must identify the persons, or classes of persons, in the workforce who need access to protected health information to carry out their duties and the categories of protected health information to which access is needed.
One example of a permitted disclosure is a Facility Directory. It is common practice in many hospitals to maintain a directory of patient contact information. The hospital must inform the patient, or the patient’s representative, of the individual information that may be included in a directory and the persons to whom such information may be disclosed. The patient, or the patient’s representative, must be given the opportunity to restrict or prohibit any or all uses and disclosures. The hospital may rely on a patient’s/representative’s individual’s informal permission to list in its facility directory the patient’s name, general condition, religious affiliation, and location in the provider’s facility. The provider may then disclose the patient’s condition and location in the facility to anyone asking for the patient by name, and also may disclose religious affiliation to clergy. If the opportunity to prohibit or restrict uses and disclosures cannot be provided due to the patient’s incapacity or emergency treatment circumstance, and there is no patient representative available, the hospital may disclose patient information for the facility’s directory if such disclosure is in the patient’s best interest. The hospital must provide the patient or the patient’s representative an opportunity to prohibit or restrict disclosure as soon as it becomes practicable to do so. The hospital may use patient information to notify, or assist in the notification of, a family member, a personal representative of the patient, or another person responsible for the care of the patient of their location, general condition, or death. The hospital must have procedures in place, in accordance with State law, to provide appropriate information to patient families or others in those situations where the patient is unable to make their wishes known.

Incidental Uses and Disclosures May be Acceptable:
An incidental use or disclosure is a secondary use or disclosure of patient information that cannot reasonably be prevented, is limited in nature, and that occurs as a result of another use or disclosure that is permitted. Many customary health care communications and practices play an important role in ensuring the prompt delivery of effective care. Due to the nature of these communications and practices, as well as of the hospital environment, the potential exists for a patient’s information to be disclosed incidentally. For example, a hospital visitor may overhear a health care professional’s confidential conversation with another health care professional or the patient, or may glimpse a patient’s information on a sign-in sheet or nursing station whiteboard. The regulation protecting patient privacy does not impede these customary and essential communications and practices and, thus, a hospital is not required to eliminate all risk of incidental use or disclosure secondary to a permitted use or disclosure, so long as the hospital takes reasonable safeguards and discloses only the minimum amount of personally identifiable information necessary. For example, hospitals may:
• Use patient care signs (e.g. “falls risk” or “diabetic diet” ) displayed at the bedside or outside a patient room;
• Display patient names on the outside of patient charts; or
• Use “whiteboards” that list the patients present on a unit, in an operating room suite, etc.
Hospitals are expected to review their practices and determine what steps are reasonable to safeguard patient information while not impeding the delivery of safe patient care or incurring undue administrative or financial burden as a result of implementing privacy safeguards.
Examples of reasonable safeguards could include, but are not limited to:
• Requesting that waiting customers stand a few feet back from a counter used for patient registration;
• Use of dividers or curtains in areas where patient and physician or other hospital staff communications routinely occur;
• Health care staff speaking quietly when discussing a patient’s condition or treatment in a semi-private room;
• Utilizing passwords and other security measures on computers maintaining personally identifiable health information; or
• Limiting access to areas where white boards or x-ray light boards are in use, or posting the board on a wall not readily visible to the public, or limiting the information placed on the board.

A-0144 482.13(c)(2) The patient has the right to receive care in a safe setting.

Interpretive Guidelines §482.13(c)(2)
The intention of this requirement is to specify that each patient receives care in an environment that a reasonable person would consider to be safe. For example, hospital staff should follow current standards of practice for patient environmental safety, infection control, and security. The hospital must protect vulnerable patients, including newborns and children. Additionally, this standard is intended to provide protection for the patient’s emotional health and safety as well as his/her physical safety. Respect, dignity and comfort would also be components of an emotionally safe environment. In order to provide care in a safe setting, hospitals must identify patients at risk for intentional harm to self or others, identify environmental safety risks for such patients, and provide education and training for staff and volunteers.
Patients at risk of suicide (or other forms of self-harm) or exhibit violent behaviors toward others receive healthcare services in both inpatient and outpatient locations of hospitals. The focus for a ligature “resistant” or ligature “free” environment is that of psychiatric units of acute care hospitals and psychiatric hospitals and does not apply to non-psychiatric units of acute care hospitals that provide care to those at risk of harm to self or others, e.g. emergency departments, intensive care units, medical-surgical units, and other inpatient and outpatient locations. It is important to note that not all patients with psychiatric conditions or a history of a psychiatric condition are cared for in psychiatric hospitals or psychiatric units of acute care hospitals. Therefore, non-
psychiatric settings of all hospitals where patients with psychiatric conditions may be cared for must also identify patients at risk for intentional harm to self or others and mitigate environmental safety risks. Psychiatric patients requiring medical care in a non-psychiatric setting (medical inpatient units, ED, ICU, etc.) must be protected when demonstrating suicidal ideation or harm to others. The protection would be that of utilizing safety measures such as 1:1 monitoring with continuous visual observation, removal of sharp objects from the room/area, or removal of equipment that can be used as a weapon.
Although all risks cannot be eliminated, hospitals are expected to demonstrate how they identify patients at risk of self-harm or harm to others and steps they are taking to minimize those risks in accordance with nationally recognized standards and guidelines. The potential risks include but are not limited to those from ligatures, sharps, harmful substances, access to medications, breakable windows, accessible light fixtures, plastic bags (for suffocation), oxygen tubing, bell cords, etc.
Identifying Patients at Risk
There are numerous models and versions of patient risk assessment tools available to identify patients at risk for harm to self or others. No one size fits all tool is available. Therefore, the type of patient risk assessment tool used should be appropriate to the patient population, care setting and staff competency. All hospitals are expected to implement a patient risk assessment strategy, but it is up to the hospital to implement the appropriate strategies. For example, a patient risk assessment strategy in a post-partum unit would most likely not be the same risk assessment strategy utilized in the emergency department.
Environmental Safety Risks
Just as all hospitals must implement a patient risk assessment strategy, all hospitals must implement an environmental risk assessment strategy. Environmental risk assessment strategies may not be the same in all hospitals or hospital units. The hospital must implement environmental risk assessment strategies appropriate to the specific care environment and patient population. That does not mean that a unit which does not typically care for patients with psychiatric conditions is not expected to conduct environmental risk assessments. It means that the risk assessment must be appropriate to the unit and should consider the possibility that the unit may sometimes care for patients at risk for harm to self or others. While CMS does not require the use of an Environmental Risk Assessment Tool (e.g. the Veteran’s Administration Environmental Risk Assessment Tool), the use of such tools may be used as a way for the hospital to assess for safety risks in all patient care environments in order to minimize environmental risks and to document the assessment findings. Examples of Environmental Risk Assessment Tool content may include prompts for staff to assess items such as, but not limited to:
• Ligature risks include but are not limited to, hand rails, door knobs, door hinges, shower curtains, exposed plumbing/pipes, soap and paper towel
dispensers on walls, power cords on medical equipment or call bell cords, and light fixtures or projections from ceilings, etc.
• Unattended items such as utility or housekeeping carts that contain hazardous items (mops, brooms, cleaning agents, hand sanitizer, etc.)
• Unsafe items brought to patients by visitors in locked psychiatric units of hospitals and psychiatric hospitals.
• Windows that can be opened or broken
• Unprotected lighting fixtures
• Inadequate staffing levels to provide appropriate patient observation and monitoring
A ligature risk (point) is defined as anything which could be used to attach a cord, rope, or other material for the purpose of hanging or strangulation. Ligature points include shower rails, coat hooks, pipes, and radiators, bedsteads, window and door frames, ceiling fittings, handles, hinges and closures. (CQC Brief Guide: Ligature points – Review date: June 2017). The most common ligature points and ligatures are doors, hooks/handles, windows, and belts or sheets/towels. The use of shoelaces, doors, and windows increased over time. (Hunt et al 2012; Ligature points used by psych inpatients.)The presence of ligature risks in the physical environment of a psychiatric patient compromises the patient’s safety. This is particularly an issue for a patient with suicidal ideation. The hospital Patient’s Rights Condition of Participation (CoP) at § 482.13(c)(2) provides all patients with the right to care in a safe setting. Psychiatric patients receiving care and treatment in a hospital setting are particularly vulnerable. The presence of ligature risks in the psychiatric patient’s physical environment compromise their right to receive care in a safe setting. Safety risks in a psychiatric setting include but are not limited to furniture that can be easily moved or be thrown; sharp objects accessible by patients; areas out of the view of staff; access to plastic bags (for suffocation); oxygen tubing; equipment used for vital signs or IV Fluid administration; breakable windows; access to medications; access to harmful medications; accessible light fixtures; non-tamper proof screws; etc. The focus of this memo and the forthcoming guidance is care delivered in psychiatric units/hospitals and does not apply to other healthcare settings such as acute care hospitals. Psychiatric patients requiring medical care in a non-psychiatric setting (medical inpatient units, ED, ICU, etc.) must be protected when demonstrating suicidal ideation. The protection would be that of utilizing safety measures such as 1:1 monitoring with continuous visual observation, removal of sharp objects from the room/area, or removal of equipment that can be used as a weapon.
Hospital staff must be trained to identify environmental safety risks regardless of whether or not the hospital has chosen to implement the use of an environmental risk assessment tool to identify potential or actual risks in the patient care environment.
Education and Training
Hospitals must provide the appropriate level of education and training to staff regarding the identification of patients at risk of harm to self or others, the identification of environmental patient safety risk factors and mitigation strategies. Staff includes direct employees, volunteers, contractors, per diem staff and any other individuals providing clinical care under arrangement. Hospitals have the flexibility to tailor the training to the particular services staff provide and the patient populations they serve. Hospitals are expected to provide education and training to all new staff initially upon orientation and whenever policies and procedures change. However, CMS recommends initial training and then ongoing training at least every two years thereafter.
Correction of Environmental Risks
Regulations at §488.28 require that the deficiencies addressed in a PoC be corrected within 60 days from receipt of the deficiency report. Follow up surveys to verify correction of condition level deficiencies or the ability of the hospital to correct the ligature risk deficiencies, will be done according to the standards established by the surveying agency. The ability of facilities to comply with the limited number of days allotted for the correction of ligature risks has proven to be burdensome based on a number of variables, such as the severity and scope of the deficiencies, the need to obtain governing body approval, capital budget funding requirements, engage in competitive bidding, availability of the required materials, time for completion of repairs, and access to the unit/hospital areas. Ligature risks are not eligible for life safety code (LSC) waivers as they are not LSC deficiencies.
Cited ligature risks, that do not pose an immediate jeopardy situation or no longer pose an immediate jeopardy situation because the immediate threat to patient health and safety has been removed by the hospital, or has been mitigated through the implementation of appropriate interim patient safety measures, are expected to be corrected within the allotted number of days accorded by the CMS RO, SA or AO. Interim patient safety measures are expected to be implemented as part of an acceptable plan of correction to mitigate patient safety risks, as appropriate, until the ligature risks can be eliminated. Per § 488.28, the correction period begins the date the facility is notified of the deficiencies by the SA or AO. In cases where the SA or AO determine that it is not reasonable to expect compliance within the specified number of days, SA or AO may recommend additional time be granted by CMS in accordance with the regulations at § 488.28. The SAs and AOs do not have independent authority to grant additional time for the correction of deficiencies.
Interim patient safety measures to mitigate identified ligature or safety risks may include continuous visual observation or 1:1 observation in which a staff member is assigned to observe only one patient at all times, including while the patient sleeps, toilets or bathes, to prevent harm directed toward self or others as well as other alternative nursing protocols recommended by the National Psychiatric Nursing Association (NPNA) at http://www.apna.org/files/public/Councils/PsychiatricNursingAvailabilityTool_021216.p
df . The level of constant visual observation may be determined based on the type of identified risk. For example, a suicidal patient that is placed in a room with windows that may be opened or with breakable glass, would require constant 1:1 visual observation that would allow the staff member to immediately intervene should the patient attempt to jump or break through the window. Another interim safety measure may include locking rooms in which ligature risks have been identified to prevent patient access.
Hospital requests for the extension of timeframes for the correction of ligature risk deficiencies must include the hospital’s accepted PoC, mitigation plan, an evaluation of the effectiveness of the mitigation plan, and an update on the status of the PoC. The hospital request must also include a rationale for why it is not reasonable to meet the correction timeframe. Non-deemed hospitals submit the request electronically to the SA; deemed hospitals submit the request electronically to their AO. If the SA or AO rejects the request for an extended timeframe for correction, the submission is returned to the hospital with a rationale for denial. If the SA or AO supports the request, the submission is forwarded electronically to the appropriate RO or CO, as appropriate, with a recommendation of approval. For deemed facilities, the AO will also copy the appropriate RO. All request packages will be submitted electronically via designated RO and CO e-mailboxes.
For non-deemed hospitals, the RO will provide an electronic response to the hospital and copy the SA; for deemed hospitals, CO will provide a response and copy the AO and RO within ten working days. The facility is required to provide electronic progress reports to the SA or AO on a monthly basis that include, but are not limited to, copies of invoices, receipts, communications with vendors, etc. detailing ongoing progress correcting the ligature risks and other safety deficiencies. The facility is also required to provide ongoing electronic routine status updates on the effectiveness of mitigation strategies utilizing outcome and process measures to demonstrate the effectiveness of the plan. The SA and AO are required to monitor PoCs, progress reports and mitigation measures, on a monthly basis, and provide an updated report to CMS (RO or CO, as appropriate) on a monthly basis. The SAs and ROs may use the current process in place using the CMS form-539. AOs will provide reports in a format specified by CMS.

A-0145 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment.

Interpretive Guidelines §482.13(c)(3)
The intent of this requirement is to prohibit all forms of abuse, neglect (as a form of abuse) and harassment whether from staff, other patients or visitors. The hospital must ensure that patients are free from all forms of abuse, neglect, or harassment. The hospital must have mechanisms/methods in place that ensure patients are free of all forms of abuse, neglect, or harassment.
Abuse is defined as the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish. This includes staff neglect or indifference to infliction of injury or intimidation of one patient by another. Neglect, for the purpose of this requirement, is considered a form of abuse and is defined as the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness.
The following components are suggested as necessary for effective abuse protection:
• Prevent. A critical part of this system is that there are adequate staff on duty, especially during the evening, nighttime, weekends and holiday shifts, to take care of the individual needs of all patients. (See information regarding meaning of adequate at those requirements that require the hospital to have adequate staff. Adequate staff would include that the hospital ensures that there are the number and types of qualified, trained, and experienced staff at the hospital and available to meet the care needs of every patient.)
• Screen. Persons with a record of abuse or neglect should not be hired or retained as employees.
• Identify. The hospital creates and maintains a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.
• Train. The hospital, during its orientation program, and through an ongoing training program, provides all employees with information regarding abuse and neglect, and related reporting requirements, including prevention, intervention, and detection.
• Protect. The hospital must protect patients from abuse during investigation of any allegations of abuse or neglect or harassment.
• Investigate. The hospital ensures, in a timely and thorough manner, objective investigation of all allegations of abuse, neglect or mistreatment.
• Report/Respond. The hospital must assure that any incidents of abuse, neglect or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with applicable local, State, or Federal law.
As a result of the implementation of this system, changes to the hospital’s policies and procedures should be made accordingly.

482.13(d) Standard: Confidentiality of Patient Records

A-0147 482.13(d)(1) The patient has the right to the confidentiality of his or her clinical records.

Interpretive Guidelines §482.13(d)(1)
The right to confidentiality of the patient’s medical record means the hospital must safeguard the contents of the medical record, whether it is in paper or electronic format, or a combination of the two, from unauthorized disclosure. Confidentiality applies wherever the record or portions thereof are stored, including but not limited to central records, patient care locations, radiology, laboratories, record storage areas, etc.
A hospital is permitted to disclose patient information, without a patient’s authorization, in order to provide patient care and perform related administrative functions, such as payment and other hospital operations.
• Payment operations include hospital activities to obtain payment or be reimbursed for the provision of health care to an individual.
• Hospital operations are administrative, financial, legal, and quality improvement activities of a hospital that are necessary to conduct business and to support the core functions of treatment and payment. These activities include, but are not limited to: quality assessment and improvement activities, case management and care coordination; competency assurance activities, conducting or arranging for medical reviews, audits, or legal services, including fraud and abuse detection and compliance programs; business planning, development, management, and administration and certain hospital-specific fundraising activities.
The hospital must develop policies and procedures that reasonably limit disclosures of information contained in the patient’s medical record to the minimum necessary, even when the disclosure is for treatment or payment purposes, or as otherwise required by State or Federal law.
When the minimum necessary standard is applied, a hospital may not disclose the entire medical record for a particular purpose, unless it can specifically justify that the whole record is the amount reasonably needed for the purpose.
A hospital may make an authorized disclosure of information from the medical record electronically, and may also share an electronic medical record system with other health care facilities, physicians and practitioners, so long as the system is designed and operated with safeguards that ensure that only authorized disclosures are made.
The hospital must obtain the patient’s, or the patient’s representative’s, written authorization for any disclosure of information in the medical record when the disclosure is not for treatment, payment or health care operations.

A-0148 482.13(d)(2) The patient has the right to access information contained in his or her clinical records within a reasonable time frame. The hospital must not frustrate the legitimate efforts of individuals to gain access to their own medical records and must actively seek to meet these requests as quickly as its record keeping system permits.

Interpretive Guidelines §482.13(d)(2)
The requirements of the Department of Health and Human Services with regard to the confidentiality rights of individuals are set forth in the Privacy Rule at 42 CFR 164.500 et seq., pursuant to §264 of the Health Insurance Portability and Accountability Act of 1996.” The regulation at 42 CFR 164.524 specifies that patients should be allowed to inspect and obtain a copy of health information about them that is held by providers; and that providers may not withhold information except under limited circumstances. These circumstances include:
• Psychotherapy notes;
• A correctional institution or a health care provider acting at the direction of a correctional institution may deny an inmate’s request for access, if providing such access would jeopardize the health or security of the individual, other inmates, or officers or employees of the correctional institution;
• The information is about another person (other than a health care provider) and the hospital determines that the patient inspection is reasonably likely to cause sufficient harm to that person to warrant withholding;
• A licensed health care professional has determined that the access requested is reasonably likely to endanger the life or physical safety of the individual or another person;
• The information contains data obtained under a promise of confidentiality (from someone other than a health care provider), and inspection could reasonably reveal the source;
• The information is collected in the course of research that includes treatment and the research is in progress, provided that the individual has agreed to the denial of access and the provider informs the individual that his or her right of access will be reinstated when the research is completed;
• The protected health information is subject to the Clinical Laboratory Improvements Amendments of 1988, 42 CFR 263a, to the extent that providing the requested access would be prohibited by law;
• The protected health information is exempt from the Clinical Laboratory Improvements Amendments of 1988, pursuant to 42 CFR 493.3(a)(2);
• The information is compiled in reasonable anticipation of, or for use in, a civil,
criminal or administrative action or proceeding; and
• The request is made by an individual’s personal representative (as allowed under state law) and a licensed health care professional has determined that access is reasonably likely to cause substantial harm to the individual or another person.
In general, each patient should be able to see and obtain a copy of his/her records. Record holders may not deny access except to a portion of the record that meets criteria specified above. In these cases, the record holder may decide to withhold portions of the record; however, to the extent possible, the patient should be given as much information as possible.
If the patient is incompetent, the patient record should be made available to his or her representative (as allowed under State law). Upon the patient’s request, other designated individuals may access the patient’s records.
The patient has the right to easily access his/her medical records. Reasonable cost-based fees may be imposed only to cover the cost of copying, postage, and/or preparing an explanation or summary of patient health information, as outlined in 42 CFR §164.524(c). The cost of duplicating a patient’s record must not create a barrier to the individual’s receiving his or her medical record.

482.13(e) Standard: Restraint or Seclusion

A-0154 482.13(e) All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time.

Interpretive Guidelines §482.13(e):
The intent of this standard is to identify patients’ basic rights, ensure patient safety, and eliminate the inappropriate use of restraint or seclusion. Each patient has the right to receive care in a safe setting. The safety of the patient, staff, or others is the basis for initiating and discontinuing the use of restraint or seclusion. Each patient has the right to be free from all forms of abuse and corporal punishment. Each patient has the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may not be used unless the use of restraint or seclusion is necessary to ensure the immediate physical safety of the patient, a staff member, or others. The use of restraint or seclusion must be discontinued as soon as possible based on an individualized patient assessment and re-evaluation. A violation of any of these patients’ rights constitutes an inappropriate use of restraint or seclusion and would be subject to a condition level deficiency.
The patient protections contained in this standard apply to all hospital patients when the use of restraint or seclusion becomes necessary, regardless of patient location. The requirements contained in this standard are not specific to any treatment setting within the hospital. They are not targeted only to patients on psychiatric units or those with behavioral/mental health care needs. Instead, the requirements are specific to the patient behavior that the restraint or seclusion intervention is being used to address.
In summary, these restraint and seclusion regulations apply to:
• All hospitals (acute care, long-term care, psychiatric, children's, and cancer);
• All locations within the hospital (including medical/surgical units, critical care units, forensic units, emergency department, psychiatric units, etc.); and
• All hospital patients, regardless of age, who are restrained or secluded (including both inpatients and outpatients).
The decision to use a restraint or seclusion is not driven by diagnosis, but by a comprehensive individual patient assessment. For a given patient at a particular point in time, this comprehensive individualized patient assessment is used to determine whether the use of less restrictive measures poses a greater risk than the risk of using a restraint or seclusion. The comprehensive assessment should include a physical assessment to identify medical problems that may be causing behavior changes in the patient. For example, temperature elevations, hypoxia, hypoglycemia, electrolyte imbalances, drug interactions, and drug side effects may cause confusion, agitation, and combative behaviors. Addressing these medical issues may eliminate or minimize the need for the use of restraints or seclusion.
Staff must assess and monitor a patient’s condition on an ongoing basis to ensure that the patient is released from restraint or seclusion at the earliest possible time. Restraint or seclusion may only be employed while the unsafe situation continues. Once the unsafe situation ends, the use of restraint or seclusion should be discontinued. However, the decision to discontinue the intervention should be based on the determination that the need for restraint or seclusion is no longer present, or that the patient’s needs can be addressed using less restrictive methods.

Hospital leadership is responsible for creating a culture that supports a patient’s right to be free from restraint or seclusion. Leadership must ensure that systems and processes are developed, implemented, and evaluated that support the patients’ rights addressed in this standard, and that eliminate the inappropriate use of restraint or seclusion. Through their QAPI program, hospital leadership should:
• Assess and monitor the use of restraint or seclusion in their facility;
• Implement actions to ensure that restraint or seclusion is used only to ensure the physical safety of the patient, staff and others; and
• Ensure that the hospital complies with the requirements set forth in this standard as well as those set forth by State law and hospital policy when the use of restraint or seclusion is necessary.
Patients have a right to receive safe care in a safe environment. However, the use of restraint is inherently risky. When the use of restraint is necessary, the least restrictive method must be used to ensure a patient’s safety. The use of restraint for the management of patient behavior should not be considered a routine part of care.
The use of restraints for the prevention of falls should not be considered a routine part of a falls prevention program. Although restraints have been traditionally used as a falls prevention approach, they have major, serious drawbacks and can contribute to serious injuries. There is no evidence that the use of physical restraint, (including, but not limited to, raised side rails) will prevent or reduce falls. Additionally, falls that occur while a person is physically restrained often result in more severe injuries.1

--FOOTNOTES: 1- American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. Guideline for the prevention of falls in older persons. Journal of the American Geriatrics Society. 49(5):664-72, 2001 May.
- Neufeld RR, Libow LS, Foley WJ, Dunbar JM, Cohen C, Breuer B. Restraint reduction reduces serious injuries among nursing home residents. J Am Geriatr Soc 1999; 47:1202-1207.--
In fact in some instances reducing the use of physical restraints may actually decrease the risk of falling.2
Consider, for example, a patient who is displaying symptoms of Sundowner’s Syndrome, a syndrome in which a patient's dementia becomes more apparent at the end of the day than at the beginning of the day. The patient is not acting out or behaving in a violent or self-destructive manner. However, the patient has an unsteady gait and continues to get out of bed even after staff has tried alternatives to keep the patient from getting out of bed. There is nothing inherently dangerous about a patient being able to walk or wander, even at night. Under the provisions of this regulation, the rationale that the patient should be restrained because he “might” fall does not constitute an adequate basis for using a restraint for the purposes of this regulation. When assessing a patient’s risk for falls and planning care for the patient, staff should consider whether the patient has a medical condition or symptom that indicates a current need for a protective intervention to prevent the patient from walking or getting out of bed. A history of falling without a current clinical basis for a restraint intervention is inadequate to demonstrate the need for restraint. It is important to note that the regulation specifically states that convenience is not an acceptable reason to restrain a patient. In addition, a restraint must not serve as a substitute for the adequate staffing needed to monitor patients.
An individualized patient assessment is critical. In this example, an assessment should minimally address the following questions:
• Are there safety interventions or precautions (other than restraint) that can be taken to reduce the risk of the patient slipping, tripping, or falling if the patient gets out of bed?
• Is there a way to enable the patient to safely ambulate?
• Is there some assistive device that will improve the patient’s ability to self ambulate?
• Is a medication or a reversible condition causing the unsteady gait?
• Would the patient be content to walk with a staff person?
• Could the patient be brought closer to the nurse’s station where he or she could be supervised?
--Footnotes:
- Si M, Neufeld RR, Dunbar J. Removal of bedrails on a short-term nursing home rehabilitation unit. Gerontologist 1999; 39:611-614.
- Hanger HC, Ball MC, Wood LA. An analysis of falls in the hospital: can we do without bedrails? J Am Geriatr Soc 1999; 47:529-531.
- Tinetti ME, Liu YB, Ginter S. Mechanical restraint use and fall related injuries among residents of skilled nursing facilities. Ann Intern Med 1992; 116:369-374.
- Capezuti E, Evans L, Strumpf N, Maislin G. Physical restraint use and falls in nursing home residents. J Am Geriatr Soc 1996; 44:627-633.
- Capezuti E, Strumpf NE, Evans LK, Grisso JA, Maislin G. The relationship between physical restraint removal and falls and injuries among nursing home residents. J Gerontol A Biol Sci Med Sci 1998; 53:M47-M52.
2University of California at San Francisco (UCSF)-Stanford University Evidence-based Practice Center Subchapter 26.2. Interventions that Decrease the Use of Physical Restraints” of the Evidence Report/Technology Assessment, No. 43 entitled, “Making Health Care Safer: A Critical Analysis of Patient Safety Practices.” The full report can be accessed at: http://www.ahrq.gov/qual/errorsix.htm --

If an assessment reveals a medical condition or symptom that indicates the need for an intervention to protect the patient from harm, the regulation requires the hospital to use the least restrictive intervention that will effectively protect the patient from harm. Upon making this determination, the hospital may consider the use of a restraint; however, that consideration should weigh the risks of using a restraint (which are widely documented in research) against the risks presented by the patient’s behavior. If the hospital chooses to use the restraint, it must meet the requirements contained in this standard.
In addition, a request from a patient or family member for the application of a restraint, which they would consider to be beneficial, is not a sufficient basis for the use of a restraint intervention. A patient or family member request for a restraint intervention, such as a vest restraint or raising all four side rails, to keep the patient from getting out of bed or falling should prompt a patient and situational assessment to determine whether such a restraint intervention is needed. If a need for restraint is confirmed, the practitioner must then determine the type of restraint intervention that will meet the patient's needs with the least risk and most benefit to the patient. If restraint (as defined by the regulation) is used, then the requirements of the regulation must be met.
Patient care staff must demonstrate through their documentation in the patient’s medical record that the restraint intervention used is the least restrictive intervention that protects the patient’s safety, and that the use of restraint is based on individual assessments of the patient. The assessments and documentation of those assessments must be ongoing in order to demonstrate a continued need for restraint. Documentation by the physician or other staff once a day may not be adequate to support that the restraint intervention needs to continue and may not comply with the requirement to end the restraint as soon as possible. A patient’s clinical needs often change over time.
CMS does not consider the use of weapons in the application of restraint or seclusion as a safe, appropriate health care intervention. For the purposes of this regulation, the term “weapon” includes, but is not limited to, pepper spray, mace, nightsticks, tazers, cattle prods, stun guns, and pistols. Security staff may carry weapons as allowed by hospital policy, and State and Federal law. However, the use of weapons by security staff is considered a law enforcement action, not a health care intervention. CMS does not support the use of weapons by any hospital staff as a means of subduing a patient in order to place that patient in restraint or seclusion. If a weapon is used by security or law enforcement personnel on a person in a hospital (patient, staff, or visitor) to protect people or hospital property from harm, we would expect the situation to be handled as a criminal activity and the perpetrator be placed in the custody of local law enforcement.
The use of handcuffs, manacles, shackles, other chain-type restraint devices, or other restrictive devices applied by non-hospital employed or contracted law enforcement officials for custody, detention, and public safety reasons are not governed by this rule. The use of such devices are considered law enforcement restraint devices and would not be considered safe, appropriate health care restraint interventions for use by hospital staff to restrain patients. The law enforcement officers who maintain custody and direct supervision of their prisoner (the hospital’s patient) are responsible for the use, application, and monitoring of these restrictive devices in accordance with Federal and State law. However, the hospital is still responsible for an appropriate patient assessment and the provision of safe, appropriate care to its patient (the law enforcement officer’s prisoner).

A-0159 482.13(e) (1) Definitions. (i) A restraint is:
(A) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely; or

Interpretive Guidelines §482.13(e)(1)(i)(A)
This restraint definition applies to all uses of restraint in all hospital care settings. Under this definition, commonly used hospital devices and other practices could meet the definition of a restraint, such as:
• Tucking a patient’s sheets in so tightly that the patient cannot move;
• Use of a “net bed” or an “enclosed bed” that prevents the patient from freely exiting the bed. EXCEPTION: Placement of a toddler in an "enclosed" or "domed" crib;
• Use of "Freedom" splints that immobilize a patient's limb;
• Using side rails to prevent a patient from voluntarily getting out of bed; or
• Geri chairs or recliners, only if the patient cannot easily remove the restraint appliance and get out of the chair on his or her own.
NOTE: Generally, if a patient can easily remove a device, the device would not be considered a restraint. In this context, “easily remove” means that the manual method, device, material, or equipment can be removed intentionally by the patient in the same manner as it was applied by the staff (e.g., side rails are put down, not climbed over; buckles are intentionally unbuckled; ties or knots are intentionally untied; etc.) considering the patient’s physical condition and ability to accomplish objective (e.g., transfer to a chair, get to the bathroom in time).

A-0160 482.13(e)(1) (I) A restraint is:
(B) A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.

Interpretive Guidelines §482.13(e)(1)(i)(B)
Drugs or medications that are used as part of a patient's standard medical or psychiatric treatment, and are administered within the standard dosage for the patient’s condition, would not be subject to the requirements of standard (e). These regulations are not intended to interfere with the clinical treatment of patients who are suffering from serious mental illness and who need therapeutic doses of medication to improve their level of functioning so that they can more actively participate in their treatment. Similarly, these regulations are not intended to interfere with appropriate doses of sleeping medication prescribed for patients with insomnia, anti-anxiety medication prescribed to calm a patient who is anxious, or analgesics prescribed for pain management. The regulatory language is intended to provide flexibility and recognize the variations in patient conditions.
Whether or not an order for a drug or medication is PRN (Latin abbreviation for pro re nata - as needed; as circumstances require) or a standing-order does not determine whether or not the use of that drug or medication is considered a restraint. The use of PRN or standing-order drugs or medications is only prohibited if the drug or medication meets the definition of a drug or medication used as a restraint.
Criteria used to determine whether the use of a drug or medication, or combination of drugs or medications is a standard treatment or dosage for the patient's condition includes all of the following:
• The drug or medication is used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer for the indications that it is manufactured and labeled to address, including listed dosage parameters;
• The use of the drug or medication follows national practice standards established or recognized by the medical community, or professional medical associations or organizations; and,
• The use of the drug or medication to treat a specific patient’s clinical condition is based on that patient's symptoms, overall clinical situation, and on the physician's or other licensed independent practitioner’s (LIP) knowledge of that patient's expected and actual response to the medication.
Another component of “standard treatment or dosage” for a drug or medication is the expectation that the standard use of a drug or medication to treat the patient's condition enables the patient to more effectively or appropriately function in the world around them than would be possible without the use of the drug or medication. If the overall effect of a drug or medication, or combination of drugs or medications, is to reduce the patient's
ability to effectively or appropriately interact with the world around the patient, then the drug or medication is not being used as a standard treatment or dosage for the patient's condition.
As with any use of restraint or seclusion, staff must conduct a comprehensive patient assessment to determine the need for other types of interventions before using a drug or medication as a restraint. For example, a patient may be agitated due to pain, an adverse reaction to an existing drug or medication, or other unmet care need or concern.
There are situations where the use of a drug or medication is clearly outside the standard for a patient or a situation, or a medication is not medically necessary but is used for patient discipline or staff convenience (neither of which is permitted by the regulation).
• EXAMPLE 1: A patient has Sundowner's Syndrome, a syndrome in which a patient's dementia becomes more apparent at the end of the day rather than at the beginning of the day. The patient may become agitated, angry, or anxious at sundown. This may lead to wandering, pacing the floors, or other nervous behaviors. The staff finds the patient’s behavior bothersome, and asks the physician to order a high dose of a sedative to “knock out” the patient and keep him in bed. The patient has no medical symptoms or condition that indicates the need for a sedative. In this case, for this patient, the sedative is being used inappropriately as a restraint for staff convenience. Such use is not permitted by the regulation.
A drug or medication that is not being used as a standard treatment for the patient’s medical or psychiatric condition, and that results in restricting the patient’s freedom of movement would be a drug used as a restraint.
In addition, the regulation does not permit a drug or medication to be used to restrain the patient for staff convenience, to coerce or discipline the patient, or as a method of retaliation. While drugs or medications can be a beneficial part of a carefully constructed, individualized treatment plan for the patient, drug and medication use should be based on the assessed needs of the individual patient, and the effects of drugs and medications on the patient should be carefully monitored.
• EXAMPLE 2: A patient is in a detoxification program. The patient becomes violent and aggressive. Staff administers a PRN medication ordered by the patient’s physician or other LIP to address these types of outbursts. The use of the medication enables the patient to better interact with others or function more effectively. In this case, the medication used for this patient is not considered a “drug used as a restraint.” The availability of a PRN medication to manage outbursts of specific behaviors, such as aggressive, violent behavior is standard for this patient’s medical condition (i.e., drug or alcohol withdrawal). Therefore, this patient’s medication does not meet the definition of “drug used as a restraint” since it is a standard treatment or dosage for the patient’s medical or psychiatric condition. The use of this medication for this patient is not affected by standard (e).
If a drug or medication is used as a standard treatment (as previously defined) to address the assessed symptoms and needs of a patient with a particular medical or psychiatric condition, its use is not subject to the requirements of this regulation. However, the patient would still need to receive assessments, monitoring, interventions, and care that are appropriate for that patient’s needs.
The regulation supports existing State laws that provide more vigorous promotion of the patient’s choice and rights. Therefore, when a State’s law prohibits the administration of drugs against the wishes of the patient without a court order, the State law applies.

A-0161 482.13(e)(1)(i)(C) A restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort).

Interpretive Guidelines §482.13(e)(1)(i)(C)
The devices and methods listed here would not be considered restraints, and, therefore, not subject to these requirements. These devices and methods are typically used in medical-surgical care.
Use of an IV arm board to stabilize an IV line is generally not considered a restraint. However, if the arm board is tied down (or otherwise attached to the bed), or the entire limb is immobilized such that the patient cannot access his or her body, the use of the arm board would be considered a restraint.
A mechanical support used to achieve proper body position, balance, or alignment so as to allow greater freedom of mobility than would be possible without the use of such a mechanical support is not considered a restraint. For example, some patients lack the ability to walk without the use of leg braces, or to sit upright without neck, head, or back braces.
A medically necessary positioning or securing device used to maintain the position, limit mobility, or temporarily immobilize the patient during medical, dental, diagnostic, or surgical procedures is not considered a restraint.
Recovery from anesthesia that occurs when the patient is in a critical care or postanesthesia care unit is considered part of the surgical procedure; therefore, medically necessary restraint use in this setting would not need to meet the requirements of the regulation. However, if the intervention is maintained when the patient is transferred to another unit, or recovers from the effects of the anesthesia (whichever occurs first), a restraint order would be necessary and the requirements of standard (e) would apply.
Many types of hand mitts would not be considered restraint. However, pinning or otherwise attaching those same mitts to bedding or using a wrist restraint in conjunction with the hand mitts would meet the definition of restraint and the requirements would apply. In addition, if the mitts are applied so tightly that the patient's hand or fingers are immobilized, this would be considered restraint and the requirements would apply. Likewise, if the mitts are so bulky that the patient's ability to use their hands is significantly reduced, this would be considered restraint and the requirements would apply.
NOTE: Because this definition of physical restraint does not name each device and situation that can be used to immobilize or reduce the ability of the patient to move his or her arms, legs, body or head freely, it promotes looking at each patient situation on a case-by-case basis.
In addition, if a patient can easily remove a device, the device would not be considered a restraint. In this context, “easily remove” means that the manual method, device, material, or equipment can be removed intentionally by the patient in the same manner as it was applied by the staff (e.g., side rails are put down, not climbed over; buckles are intentionally unbuckled; ties or knots are intentionally untied; etc.) considering the patient’s physical condition and ability to accomplish the objective (e.g., transfer to a chair, get to the bathroom in time).
Age or developmentally appropriate protective safety interventions (such as stroller safety belts, swing safety belts, high chair lap belts, raised crib rails, and crib covers) that a safety-conscious child care provider outside a health care setting would utilize to protect an infant, toddler, or preschool-aged child would not be considered restraint or seclusion for the purposes of this regulation. The use of these safety interventions needs to be
addressed in the hospital’s policies or procedures.

Physical Escort
A physical escort would include a “light” grasp to escort the patient to a desired location. If the patient can easily remove or escape the grasp, this would not be considered physical restraint. However, if the patient cannot easily remove or escape the grasp, this would be considered physical restraint and all the requirements would apply.

Physical holding
The regulation permits the physical holding of a patient for the purpose of conducting routine physical examinations or tests. However, patients do have the right to refuse treatment. See §482.13(b)(2). This includes the right to refuse physical examinations or tests. Holding a patient in a manner that restricts the patient's movement against the patient’s will is considered restraint. This includes holds that some member of the medical community may term “therapeutic holds.” Many deaths have occurred while employing these practices. Physically holding a patient can be just as restrictive, and just as dangerous, as restraining methods that involve devices. Physically holding a patient during a forced psychotropic medication procedure is considered a restraint and is not included in this exception.
For the purposes of this regulation, a staff member picking up, redirecting, or holding an infant, toddler, or preschool-aged child to comfort the patient is not considered restraint.

Physical Holding for Forced Medications
The application of force to physically hold a patient, in order to administer a medication against the patient’s wishes, is considered restraint. The patient has a right to be free of restraint and, in accordance with §482.13(b)(2), also has a right to refuse medications, unless a court has ordered medication treatment. A court order for medication treatment only removes the patient’s right to refuse the medication. Additionally, in accordance with State law, some patients may be medicated against their will in certain emergency circumstances. However, in both of these circumstances, health care staff is expected to use the least restrictive method of administering the medication to avoid or reduce the use of force, when possible. The use of force in order to medicate a patient, as with other restraint, must have a physician’s order prior to the application of the restraint (use of force). If physical holding for forced medication is necessary with a violent patient, the 1-hour face-to-face evaluation requirement would also apply.
In certain circumstances, a patient may consent to an injection or procedure, but may not be able to hold still for an injection, or cooperate with a procedure. In such circumstances, and at the patient’s request, staff may “hold” the patient in order to safely administer an injection (or obtain a blood sample, or insert an intravenous line, if applicable) or to conduct a procedure. This is not considered restraint.

Side rails
A restraint does not include methods that protect the patient from falling out of bed. Examples include raising the side rails when a patient is: on a stretcher, recovering from anesthesia, sedated, experiencing involuntary movement, or on certain types of therapeutic beds to prevent the patient from falling out of the bed. The use of side rails in these situations protects the patient from falling out of bed and, therefore, would not be subject to the requirements of standard (e).
However, side rails are frequently not used as a method to prevent the patient from falling out of bed, but instead, used to restrict the patient’s freedom to exit the bed. The use of side rails to prevent the patient from exiting the bed would be considered a restraint and would be subject to the requirements of standard (e). The use of side rails is inherently risky, particularly if the patient is elderly or disoriented. Frail elderly patients may be at risk for entrapment between the mattress or bed frame and the side rail. Disoriented patients may view a raised side rail as a barrier to climb over, may slide between raised, segmented side rails, or may scoot to the end of the bed to get around a raised side rail and exit the bed. When attempting to leave the bed by any of these routes, the patient is at risk for entrapment, entanglement, or falling from a greater height posed by the raised side rail, with a possibility for sustaining greater injury or death than if the patient had fallen from the height of a lowered bed without raised side rails. In short, the patient may have an increased risk for a fall or other injury by attempting to exit the bed with the side rails raised. The risk presented by side rail use should be weighed against the risk presented by the patient's behavior as ascertained through individualized assessment.
When the clinician raises all four side rails in order to restrain a patient, defined in this regulation as immobilizing or reducing the ability of a patient to move his or her arms, legs, body, or head freely to ensure the immediate physical safety of the patient, then the requirements of this rule apply. Raising fewer than four side rails when the bed has segmented side rails would not necessarily immobilize or reduce the ability of a patient to move freely as defined in the regulation. For example, if the side rails are segmented and all but one segment are raised to allow the patient to freely exit the bed, the side rail is not acting as a restraint and the requirements of this rule would not apply. Conversely, if a patient is not physically able to get out of bed regardless of whether the side rails are raised or not, raising all four side rails for this patient would not be considered restraint because the side rails have no impact on the patient’s freedom of movement. In this example, the use of all four side rails would not be considered restraint. Therefore, the requirements of this rule would not apply.
When a patient is on a bed that constantly moves to improve circulation or prevents skin breakdown, raised side rails are a safety intervention to prevent the patient from falling out of bed and are not viewed as restraint.
When a patient is placed on seizure precautions and all side rails are raised, the use of side rails would not be considered restraint. The use of padded side rails in this situation should protect the patient from harm; including falling out of bed should the patient have a seizure.
Placement in a crib with raised rails is an age-appropriate standard safety practice for every infant or toddler. Therefore, placement of an infant or toddler in the crib with raised rails would not be considered restraint.
If the patient is on a stretcher (a narrow, elevated, and highly mobile cart used to transport patients and to evaluate or treat patients), there is an increased risk of falling from a stretcher without raised side rails due to its narrow width, and mobility. In addition, because stretchers are elevated platforms, the risk of patient injury due to a fall is significant. Therefore, the use of raised side rails on stretchers is not considered restraint but a prudent safety intervention. Likewise, the use of a seat belt when transporting a patient in a wheelchair is not considered restraint.

A-0162 482.13(e)(1)(ii) Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior.

Interpretive Guidelines §482.13(e)(1)(ii)
Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.
Seclusion is not just confining a patient to an area, but involuntarily confining the patient alone in a room or area where the patient is physically prevented from leaving. If a patient is restricted to a room alone and staff are physically intervening to prevent the patient from leaving the room or giving the perception that threatens the patient with physical intervention if the patient attempts to leave the room, the room is considered locked, whether the door is actually locked or not. In this situation, the patient is being secluded.
A patient physically restrained alone in an unlocked room does not constitute seclusion.
Confinement on a locked unit or ward where the patient is with others does not constitute seclusion.
Timeout is not considered seclusion. Timeout is an intervention in which the patient consents to being alone in a designated area for an agreed upon timeframe from which the patient is not physically prevented from leaving. Therefore, the patient can leave the designated area when the patient chooses.

A-0164 482.13(e)(2) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient, a staff member, or others from harm.

Interpretive Guidelines §482.13(e)(2)
A comprehensive assessment of the patient must determine that the risks associated with the use of the restraint or seclusion is outweighed by the risk of not using the restraint or seclusion. Less restrictive interventions do not always need to be tried, but less restrictive interventions must be determined by staff to be ineffective to protect the patient or others from harm prior to the introduction of more restrictive measures. Alternatives attempted or the rationale for not using alternatives must be documented.
The underpinning of this regulation is the concept that safe patient care hinges on looking at the patient as an individual and assessing the patient’s condition, needs, strengths, weaknesses, and preferences. Such an approach relies on caregivers who are skilled in individualized assessment and in tailoring interventions to the individual patient’s needs after weighing factors such as the patient’s condition, behaviors, history, and environmental factors.
Resources are available to assist clinicians in identifying less restrictive interventions. For example, the American Psychiatric Association (APA), American Psychiatric Nurses Association (APNA), and the National Association of Psychiatric Health Systems (NAPHS), with support from the American Hospital Association (AHA), have sponsored the publication of a document entitled, “Learning from Each Other—Success Stories and Ideas for Reducing Restraint/Seclusion in Behavioral Health.” This document, published in 2003, was developed through dialogue with clinicians in the field and included extensive input from behavioral healthcare providers throughout the country who have been working to reduce the use of restraint and seclusion and to improve care within their facilities. To access this document and other useful resources, visit the web sites of the sponsoring organizations: http://www.naphs.org; http://www.psych.org; http://www.apna.org; http://www.aha.org.

A-0165 482.13(e)(3) The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the patient, a staff member, or others from harm.

Interpretive Guidelines §482.13(e)(3)
Resources are available to assist clinicians in identifying less restrictive restraint or seclusion interventions. For example, the American Psychiatric Association (APA), American Psychiatric Nurses Association (APNA), and the National Association of Psychiatric Health Systems (NAPHS), with support from the American Hospital Association (AHA), have sponsored the publication of a document entitled, “Learning from Each Other—Success Stories and Ideas for Reducing Restraint/Seclusion in Behavioral Health.” This document, published in 2003, was developed through dialogue with the field and extensive input from behavioral healthcare providers throughout the country who have been working to reduce the use of restraint and seclusion and to improve care within their facilities. To access this document and other useful resources, visit the web sites of the sponsoring organizations: http://www.naphs.org; http://www.psych.org; http://www.apna.org; http://www.aha.org

A-0166 482.13(e)(4) The use of restraint or seclusion must be:
(i) in accordance with a written modification to the patient's plan of care.

Interpretive Guidelines §482.13(e)(4)(i)
The use of restraint or seclusion (including drugs or medications used as restraint as well as physical restraint) must be documented in the patient’s plan of care or treatment plan. The use of restraint or seclusion constitutes a change in a patient’s plan of care.
The regulation does not require that a modification to the patient’s plan of care be made before initiating or obtaining an order for the use of restraint or seclusion. The use of a restraint or seclusion intervention should be reflected in the patient’s plan of care or treatment plan based on an assessment and evaluation of the patient. The plan of care or treatment plan should be reviewed and updated in writing within a timeframe specified by hospital policy.

A-0167 482.13(e)(4) The use of restraint or seclusion must be:
(ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law.

Interpretive Guidelines §482.13(e)(4)(ii)
Restraint or seclusion must be implemented appropriately and safely, and reflect hospital policy in accordance with State law.
The use of restraint or seclusion must never act as a barrier to the provision of other interventions to meet the patient’s needs.

A-0168 482.13(e)(5) The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §481.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law.

Interpretive Guidelines §482.13(e)(5)
Hospitals must have policies and procedures for the initiation of restraint or seclusion that identify the categories of LIPs that are permitted to order restraint or seclusion in that hospital, consistent with State law.
The regulation requires that a physician or other LIP responsible for the care of the patient to order restraint or seclusion prior to the application of restraint or seclusion. In some situations, however, the need for a restraint or seclusion intervention may occur so quickly that an order cannot be obtained prior to the application of restraint or seclusion. In these emergency application situations, the order must be obtained either during the emergency application of the restraint or seclusion, or immediately (within a few minutes) after the restraint or seclusion has been applied. The failure to immediately obtain an order is viewed as the application of restraint or seclusion without an order. The hospital should address this process in its restraint and seclusion policies and procedures. The policies and procedures should specify who can initiate the emergency application of restraint or seclusion prior to obtaining an order from a physician or other LIP.

Licensed Independent Practitioner (LIP)
For the purpose of ordering restraint or seclusion, an LIP is any practitioner permitted by State law and hospital policy as having the authority to independently order restraints or seclusion for patients.
A resident who is authorized by State law and the hospital’s residency program to practice as a physician can carry out functions reserved for a physician or LIP by the regulation. A medical school student holds no license, and his/her work is reviewed and must be countersigned by the attending physician; therefore, he or she is not licensed or independent. A medical school student is not an LIP.

Protocols
A protocol cannot serve as a substitute for obtaining a physician's or other LIP’s order prior to initiating each episode of restraint or seclusion use. If a hospital uses protocols that include the use of restraint or seclusion, a specific physician or LIP order is still required for each episode of restraint or seclusion use. The philosophy that serves as a foundation for the regulation is that restraint or seclusion use is an exceptional event, not a routine response to a certain patient condition or behavior. Each patient must be assessed, and interventions should be tailored to meet the individual patient’s needs. The
creation of a protocol can run counter to this philosophy if it sets up the expectation that restraint or seclusion will be used as a routine part of care. The use of restraint or seclusion is a last resort when less restrictive measures have been determined ineffective to ensure the safety of the patient, staff or others, should not be a standard response to a behavior or patient need.

A-0169 482.13(e)(6) Orders for the use of restraint or seclusion must never be written as a standing order or on an as needed basis (PRN).

Interpretive Guidelines §482.13(e)(6)
This regulation prohibits the use of standing or PRN (Latin abbreviation for pro re nata - as needed; as circumstances require) orders for the use of restraint or seclusion. The ongoing authorization of restraint or seclusion is not permitted. Each episode of restraint or seclusion must be initiated in accordance with the order of a physician or other LIP. If a patient was recently released from restraint or seclusion, and exhibits behavior that can only be handled through the reapplication of restraint or seclusion, a new order would be required. Staff cannot discontinue a restraint or seclusion intervention, and then re-start it under the same order. This would constitute a PRN order. A “trial release” constitutes a PRN use of restraint or seclusion, and, therefore, is not permitted by this regulation.
When a staff member ends an ordered restraint or seclusion intervention, the staff member has no authority to reinstitute the intervention without a new order. For example, a patient is released from restraint or seclusion based on the staff’s assessment of the patient’s condition. If this patient later exhibits behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others that can only be handled through the use of restraint or seclusion, a new order would be required.
NOTE: A temporary, directly-supervised release, however, that occurs for the purpose of caring for a patient's needs (e.g., toileting, feeding, or range of motion exercises) is not considered a discontinuation of the restraint or seclusion intervention. As long as the patient remains under direct staff supervision, the restraint is not considered to be discontinued because the staff member is present and is serving the same purpose as the restraint or seclusion.
The use of PRN orders for drugs or medications is only prohibited when a drug or medication is being used as a restraint. A drug or medication is deemed to be a restraint only if it is not a standard treatment or dosage for the patient’s condition, and the drug or medication is a restriction to manage the patient’s behavior or restricts the patient’s freedom of movement Using a drug to restrain the patient for staff convenience is expressly prohibited.
EXCEPTIONS
• Geri chair. If a patient requires the use of a Geri chair with the tray locked in place in order for the patient to safely be out of bed, a standing or PRN order is permitted. Given that a patient may be out of bed in a Geri chair several times a day, it is not necessary to obtain a new order each time.
• Raised side rails. If a patient's status requires that all bedrails be raised (restraint) while the patient is in bed, a standing or PRN order is permitted. It is not necessary to obtain a new order each time the patient is returned to bed after being out of bed.
• Repetitive self-mutilating behavior. If a patient is diagnosed with a chronic medical or psychiatric condition, such as Lesch-Nyham Syndrome, and the patient engages in repetitive self-mutilating behavior, a standing or PRN order for restraint to be applied in accordance with specific parameters established in the treatment plan would be permitted. Since the use of restraints to prevent self-injury is needed for these types of rare, severe, medical and psychiatric conditions, the specific requirements (1-hour face-to-face evaluation, time-limited orders, and evaluation every 24 hours before renewal of the order) for the management of violent or self- destructive behavior do not apply.

A-0170 482.13(e)(7) The attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion.

Interpretive Guidelines §482.13(e)(7)
The attending physician is the MD/DO who is responsible for the management and care of the patient. Hospital medical staff policies determine who is considered the attending physician. The intent of this requirement is to ensure that the physician who has overall responsibility and authority for the management and care of the patient is aware of the patient’s condition and is aware of the restraint or seclusion intervention. It is important to consult with the attending physician to promote continuity of care, to ensure patient safety, and to elicit information that might be relevant in choosing the most appropriate intervention for the patient. The attending physician may have information regarding the patient’s history that may have a significant impact on the selection of a restraint or seclusion intervention or an alternative intervention, and the subsequent course of treatment. Therefore, consultation should occur as soon as possible. Hospital policies and procedures should address the definition of “as soon as possible” based on the needs of their particular patient population(s). However, any established time frames must be consistent with “as soon as possible.”
The hospital CoPs do permit the patient to be under the care of a treating LIP other than a physician. Section 482.12(c)(1) requires every Medicare patient to be under the care of a doctor of medicine or osteopathy; or, within the scope of their respective licenses, a doctor of dental surgery or dental medicine, a doctor of podiatry, chiropractor, or clinical psychologist. The individual overseeing the patient’s care may be the attending physician or a health professional practicing with the delegated authority or supervision of a doctor of medicine or osteopathy as permitted by State law and hospital policy.
When the attending physician of record is unavailable, responsibility for the patient must be delegated to another physician, who would then be considered the attending physician.
This provision does not specify that consultation with the attending physician be face-to-face. The consultation can occur via telephone.

A-0171 482.13(e)(8) Unless superseded by State law that is more restrictive:
(i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours:
(A) 4 hours for adults 18 years of age or older;
(B) 2 hours for children and adolescents 9 to 17 years of age; or
(C) 1 hour for children under 9 years of age; and

Interpretive Guidelines §482.13(e)(8)(i)
Patients of all ages are vulnerable and at risk when restrained or secluded to manage violent or self-destructive behavior. Therefore, time limits have been established for each order for restraint or seclusion used to manage violent or self-destructive behavior. State law may require more restrictive time limits. These time limits do not apply to orders for restraint used to manage non-violent or non-self-destructive behavior. However, the requirement that restraint use be ended at the earliest possible time applies to all uses of restraint.
In the final rule on the use of restraint or seclusion, CMS did not include specific criteria for differentiating between emergency situations where the patient’s behavior is violent or self-destructive and jeopardizes the immediate physical safety of the patient, a staff member, or others, and non-emergency use of restraint. Clinicians are adept at identifying various behaviors and symptoms, and can readily recognize violent and self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. Asking clinicians to act based on an evaluation of the patient’s behavior is no different than relying on the clinical judgment that they use daily in assessing the needs of each patient and taking actions to meet those individual needs.
The regulation identifies maximum time limits on the length of each order for restraint or seclusion based on age. The physician or other LIP has the discretion to write the order for a shorter length of time. The length-of-order requirement identifies critical points at which there is mandatory contact with a physician or other LIP responsible for the care of the patient. In addition, the time limits do not dictate how long a patient should remain in restraint or seclusion. Staff is expected to continually assess and monitor the patient to ensure that the patient is released from restraint or seclusion at the earliest possible time. Restraint or seclusion may only be employed while the unsafe situation continues. Once the unsafe situation ends, the use of restraint or seclusion should be discontinued. The regulation explicitly states that the intervention must be discontinued at the earliest possible time, regardless of the length of time identified in the order. For example, if a patient’s behavior is no longer violent or self-destructive 20 minutes after the intervention is initiated, then the restraint or seclusion should be discontinued, even if the order was given for up to 4 hours. If restraint or seclusion is discontinued prior to the expiration of the original order, a new order must be obtained prior to reinitiating the use of restraint or seclusion.
At the end of the time frame, if the continued use of restraint or seclusion to manage violent or self-destructive behavior is deemed necessary based on an individualized patient assessment, another order is required. When the original order is about to expire, an RN must contact the physician or other LIP, report the results of his or her most recent assessment and request that the original order be renewed (not to exceed the time limits established in the regulation). Whether or not an onsite assessment is necessary prior to renewing the order is left to the discretion of the physician or other LIP in conjunction with a discussion with the RN who is over-seeing the care of the patient. Another 1-hour face-to-face patient evaluation (see §482.13(e)(12) and the related interpretive guidance) is not required when the original order is renewed.
The original restraint or seclusion order may only be renewed within the required time limits for up to a total of 24 hours. After the original order expires, a physician or other LIP must see and assess the patient before issuing a new order.
EXCEPTION: Repetitive self-mutilating behaviors – see interpretive guidance for §482.13(e)(6).

A-0172 482.13(e)(8) Unless superseded by State law that is more restrictive:
(ii) After 24 hours, before writing a new order for the use of restraint or seclusion for the management of violent or self-destructive behavior, a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §482.12(c) of this part and authorized to order restraint or seclusion by hospital policy in accordance with State law must see and assess the patient.

Interpretive Guidelines §482.13(e)(8)(ii)
At a minimum, if a patient remains in restraint or seclusion for the management of violent or self-destructive behavior 24 hours after the original order, the physician or other LIP must see the patient and conduct a face-to-face re-evaluation before writing a new order for the continued use of restraint or seclusion. Twenty-four hours of restraint or seclusion for the management of violent or self-destructive behavior is an extreme measure with the potential for serious harm to the patient.
State laws may be more restrictive and require the physician or other LIP to conduct a face-to-face re-evaluation within a shorter timeframe.
When the physician or other LIP renews an order or writes a new order authorizing the continued use of restraint or seclusion, there must be documentation in the patient’s medical record that describes the findings of the physician's or other LIP's re-evaluation supporting the continued use of restraint or seclusion.
EXCEPTION: Repetitive self-mutilating behaviors – see interpretive guidance for §482.13(e)(6).

A-0173 482.13(e)(8) Unless superseded by State law that is more restrictive:
(iii) Each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient may be renewed as authorized by hospital policy.

Interpretive Guidelines §482.13(e)(8)(iii)
Hospitals have the flexibility to determine time frames for the renewal of orders for restraint of the non-violent, non-self-destructive patient. These time frames should be addressed in hospital policies and procedures.

A-0174 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order.

Interpretive Guidelines §482.13(e)(9)
Restraint or seclusion may only be employed while the unsafe situation continues. Once the unsafe situation ends, the use of restraint or seclusion must be discontinued.
Staff members are expected to assess and monitor the patient’s condition on an ongoing basis to determine whether restraint or seclusion can safely be discontinued. The regulation requires that these interventions be ended as quickly as possible. However, the decision to discontinue the intervention should be based on the determination that the patient’s behavior is no longer a threat to self, staff members, or others. When the physician or LIP renews an order or writes a new order authorizing the continued use of restraint or seclusion, there must be documentation in the medical record that describes the patient’s clinical needs and supports the continued use of restraint or seclusion.
The hospital policies and procedures should address, at a minimum:
• Categories of staff that the hospital authorizes to discontinue restraint or seclusion in accordance with State law; and
• The circumstances under which restraint or seclusion is to be discontinued.

A-0175 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed independent practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy.

Interpretive Guidelines §482.13(e)(10)
Ongoing assessment and monitoring of the patient's condition by a physician, other LIP or trained staff is crucial for prevention of patient injury or death, as well as ensuring that the use of restraint or seclusion is discontinued at the earliest possible time. Hospital policies are expected to guide staff in determining appropriate intervals for assessment and monitoring based on the individual needs of the patient, the patient's condition, and the type of restraint or seclusion used. The selection of an intervention and determination of the necessary frequency of assessment and monitoring should be individualized, taking into consideration variables such as the patient’s condition, cognitive status, risks associated with the use of the chosen intervention, and other relevant factors. In some cases, checks every 15 minutes or vital signs taken every 2 hours may not be sufficient to ensure the patient’s safety. In others, it may be excessive or disruptive to patient care (e.g., it may be unnecessary to mandate that a patient with wrist restraints, and who is asleep, be checked every 15 minutes and awakened every 2 hours to take the patient’s vital signs). Similarly, depending on the patient’s needs and situational factors, the use of restraint or seclusion may require either periodic (e.g., every 15 minutes, every 30 minutes, etc.) or continual (i.e., moment to moment) monitoring and assessment.
Hospital policies should address: frequencies of monitoring and assessment; assessment content (e.g., vital signs, circulation, hydration needs, elimination needs, level of distress and agitation, mental status, cognitive functioning, skin integrity, etc.); providing for nutritional needs, range of motion exercises, and elimination needs; and mental status and neurological evaluations.
With the exception of the simultaneous use of restraint and seclusion, one-to-one observation with a staff member in constant attendance is not required by this regulation unless deemed necessary based on a practitioner’s clinical judgment. For example, placing staff at the bedside of a patient with wrist restraints may be unnecessary. However, for a more restrictive or risky intervention and/or a patient who is suicidal, self injurious, or combative, staff may determine that continual face-to-face monitoring is needed. The hospital is responsible for providing the level of monitoring and frequency of reassessment that will protect the patient's safety.
Hospitals have flexibility in determining which staff performs the patient assessment and monitoring. This determination must be in accordance with the practitioner’s scope of clinical practice and State law. For example, assessment and monitoring are activities within a registered nurse’s scope of practice. However, some trained, unlicensed staff may perform components of monitoring (e.g., checking the patient's vital signs, hydration and circulation; the patient’s level of distress and agitation; or skin integrity), and may also provide for general care needs (e.g., eating, hydration, toileting, and range of motion exercises). Section 482.13(f) requires that before applying restraints, implementing seclusion, or performing associated monitoring and care tasks, staff must be trained and able to demonstrate competency in the performance of these actions.

A-0176 482.13(e)(11) Physician and other licensed independent practitioner training requirements must be specified in hospital policy. At a minimum, physicians and other licensed independent practitioners authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion.

Interpretive Guidelines §482.13(e)(11)
At a minimum, physicians and other LIPs authorized to order restraint and seclusion must have a working knowledge of hospital policy regarding the use of restraint and seclusion.
Hospitals have the flexibility to identify training requirements above this minimum requirement based on the competency level of their physicians and other LIPs, and the needs of the patient population(s) that they serve. Physicians receive training in the assessment, monitoring, and evaluation of a patient’s condition as part of their medical school education. However, physicians generally do not receive training regarding application of restraint or implementation of seclusion as part of their basic education. Depending on the level and frequency of involvement that a physician or other LIP has in the performance of these activities, additional training may or may not be necessary to ensure the competency of these individuals in this area. The hospital is in the best position to determine if additional physician or other LIP training is necessary based on the model of care, level of physician competency, and the needs of the patient population(s) that the hospital serves.

A-0178 482.13(e)(12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1 hour after the initiation of the intervention:
(i) By a:
(A) Physician or other licensed independent practitioner; or
(B) Registered nurse or physician assistant who has been trained in accordance with the requirements specified in paragraph (f) of this section.

Interpretive Guidelines §482.13(e)(12)(i)
When restraint or seclusion is used to manage violent or self-destructive behavior, a physician or other LIP, or a registered nurse (RN) or physician assistant (PA) trained in accordance with the requirements specified under §482.13(f), must see the patient face-to-face within 1-hour after the initiation of the intervention. This requirement also applies when a drug or medication is used as a restraint to manage violent or self-destructive behavior.
The 1-hour face-to-face patient evaluation must be conducted in person by a physician or other LIP, or trained RN or PA. A telephone call or telemedicine methodology is not permitted.
If a patient’s violent or self-destructive behavior resolves and the restraint or seclusion intervention is discontinued before the practitioner arrives to perform the 1-hour face-to-face evaluation, the practitioner is still required to see the patient face-to-face and conduct the evaluation within 1 hour after the initiation of this intervention. The fact that the patient’s behavior warranted the use of a restraint or seclusion indicates a serious medical or psychological need for prompt evaluation of the patient behavior that led to the intervention. The evaluation would also determine whether there is a continued need for the intervention, factors that may have contributed to the violent or self-destructive behavior, and whether the intervention was appropriate to address the violent or self-destructive behavior.
EXCEPTION: Repetitive self-mutilating behaviors – see interpretive guidance for §482.13(e)(6).

A-0179 482.13(e)(12) The patient must be seen face-to-face within 1 hour after the initiation of the intervention:
(ii)To evaluate:
(A) The patient's immediate situation;
(B) The patient's reaction to the intervention;
(C) The patient's medical and behavioral condition; and
(D) The need to continue or terminate the restraint or seclusion.

Interpretive Guidelines §482.13(e)(12)(ii)
The 1-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice. An evaluation of the patient’s medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient’s history, drugs and medications, most recent lab results, etc. The purpose is to complete a comprehensive review of the patient’s condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient’s violent or self-destructive behavior.
Training for an RN or PA to conduct the 1-hour face-to-face evaluation would include all of the training requirements at §482.13(f) as well as content to evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition (documented training in conducting physical and behavioral assessment); and the need to continue or terminate the restraint or seclusion.

A-0180 482.13(e)(13) States are free to have requirements by statute or regulation that are more restrictive than those contained in paragraph (e)(12)(i) of this section.

Interpretive Guidelines §482.13(e)(13)
States are free to have requirements that are more restrictive regarding the types of practitioners who may conduct the 1-hour face-to-face evaluation. Generally, States may have more restrictive requirements as long as they do not conflict with Federal requirements.

A-0182 482.13(e)(14) If the face-to-face evaluation specified in paragraph (e)(12) of this section is conducted by a trained registered nurse or physician assistant, the trained registered nurse or physician assistant must consult the attending physician or other licensed independent practitioner who is responsible for the care of the patient as specified under 482.12(c) as soon as possible after the completion of the 1 hour face-to-face evaluation.

Interpretive Guidelines §482.13(e)(14)
When a trained RN or PA conducts the required face-to-face evaluation, he or she must consult the attending physician or other LIP responsible for the patient’s care as soon as possible after the completion of the evaluation. Hospital policy should address the expected time frame for and the components of the consultation with the attending physician or other LIP consistent with “as soon as possible.” This consultation should include, at a minimum, a discussion of the findings of the 1-hour face-to-face evaluation, the need for other interventions or treatments, and the need to continue or discontinue the use of restraint or seclusion. A consultation that is not conducted prior to a renewal of the order would not be consistent with the requirement, “as soon as possible.”

A-0183 482.13(e)(15) All requirements specified under this paragraph are applicable to the simultaneous use of restraint and seclusion. Simultaneous restraint and seclusion use is only permitted if the patient is continually monitored:
(i) Face-to-face by an assigned, trained staff member; or
(ii) By trained staff using both video and audio equipment. This monitoring must be in close proximity to the patient.

Interpretive Guidelines §482.13(e)(15)
When the simultaneous use of restraint and seclusion is employed, there must be adequate documentation that justifies the decision for simultaneous use as well as vigilance in continuously monitoring the patient so that the patient’s care needs are met.
All requirements specified under standard (e) apply to the simultaneous use of restraint and seclusion. The simultaneous use of restraint and seclusion is not permitted unless the patient is continually monitored by trained staff, either through face-to-face observation or through the use of both video and audio equipment. Monitoring with video and audio equipment further requires that staff perform the monitoring in close proximity to the patient. For the purposes of this requirement, “continually” means ongoing without interruption. The use of video and audio equipment does not eliminate the need for frequent monitoring and assessment of the patient.
An individual who is physically restrained alone in his or her room is not necessarily being simultaneously secluded. The individual’s privacy and dignity should be protected to the extent possible during any intervention. In fact, the purpose of restraining a patient alone in his or her room may be to promote privacy and dignity versus simultaneously using seclusion and restraint. While this distinction may be difficult to make, it is helpful to consider whether the patient would, in the absence of the physical restraint, be able to voluntarily leave the room. If so, then the patient is not also being secluded. However, if the physical restraint was removed and the patient was still unable to leave the room because the door was locked or staff were otherwise physically preventing the patient from doing so, then the patient is also being secluded.
Staff must take extra care to protect the safety of the patient when interventions that are more restrictive are used. Monitoring must be appropriate to the intervention chosen, so that the patient is protected from possible abuse, assault, or self injury during the intervention.

482.13(e)(16) - When restraint or seclusion is used, there must be documentation in the patient's medical record of the following:

A-0184 482.13(e)(16)(i) The 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior.

Interpretive Guidelines §482.13(e)(16)(i)
When restraint or seclusion is used to manage violent or self-destructive behavior, the 1 hour face-to-face medical and behavioral evaluation must be documented in the patient’s medical record.

A-0185 482.13(e)(16)(ii) A description of the patient's behavior and the intervention used.

Interpretive Guidelines §482.13(e)(16)(ii)
Documentation that must be included in the patient’s medical record when the patient is restrained or secluded includes a description of the patient’s behavior and the intervention used. The patient’s behavior should be documented in descriptive terms to evaluate the appropriateness of the interventions used. The documentation should include a detailed description of the patient’s physical and mental status assessments, and of any environmental factors (e.g., physical, milieu, activities, etc.) that may have contributed to the situation at the time of the intervention.

A-0186 482.13(e)(16)(iii) Alternatives or other less restrictive interventions attempted (as applicable).

Interpretive Guidelines §482.13(e)(16)(iii)
The use of restraint or seclusion must be selected only when less restrictive measures have been judged to be ineffective to protect the patient or others from harm. It is not always appropriate for less restrictive alternatives to be attempted prior to the use of restraint or seclusion. When a patient’s behavior presents an immediate and serious danger to his- or herself, or others, immediate action is needed. For example, when a patient physically attacks someone, immediate action is needed. While staff should be mindful of using the least intrusive intervention, it is critical that the intervention selected be effective in protecting the patient or others from harm.

A-0187 482.13(e)(16)(iv) The patient's condition or symptom(s) that warranted the use of the restraint or seclusion.

Interpretive Guidelines §482.13(e)(16)(iv)
A comprehensive, individualized patient assessment is necessary to identify the most appropriate intervention to effectively manage a patient’s condition or symptom(s). When using a restraint or seclusion intervention, the patient’s condition or symptom(s) must be identified and documented in the patient’s medical record.

A-0188 482.13(e)(16)(v) The patient's response to the intervention(s) used, including the rationale for continued use of the intervention.

No information available.

482.13(f) Standard: Restraint or Seclusion : Staff Training Requirements

A-0194 482.13(f) The patient has the right to safe implementation of restraint or seclusion by trained staff.

Interpretive Guidelines §482.13(f)
Without adequate staff training and competency, the direct care staff, patients, and others are placed at risk. Patients have a right to the safe application of restraint or seclusion by trained and competent staff. Staff training and education play a critical role in the reduction of restraint and seclusion use in a hospital.

A-0196 482.13(f)(1) Training Intervals Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion:
(i) Before performing any of the actions specified in this paragraph;
(ii) As part of orientation; and
(iii) Subsequently on a periodic basis consistent with hospital policy.

Interpretive Guidelines §482.13(f)(1)(i) - (iii)
All staff designated by the hospital as having direct patient care responsibilities, including contract or agency personnel, must demonstrate the competencies specified in standard (f) prior to participating in the application of restraints, implementation of seclusion, monitoring, assessment, or care of a patient in restraint or seclusion. These competencies must be demonstrated initially as part of orientation and subsequently on a periodic basis consistent with hospital policy. Hospitals have the flexibility to identify a time frame for ongoing training based on the level of staff competency, and the needs of the patient population(s) served.
Training for an RN or PA to conduct the 1-hour face-to-face evaluation would include all of the training requirements at §482.13(f) as well as content to evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition, and the need to continue or terminate the restraint or seclusion. An evaluation of the patient’s medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient’s history, medications, most recent lab results, etc. The purpose of the 1-hour face-to-face evaluation is to complete a comprehensive review of the patient’s condition and determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient’s violent or self-destructive behavior.
Once initial training takes place, training must be provided frequently enough to ensure that staff possesses the requisite knowledge and skills to safely care for restrained or secluded patients in accordance with the regulations. The results of skills and knowledge assessments, new equipment, or QAPI data may indicate a need for targeted training or more frequent or revised training.
Hospitals are required to have appropriately trained staff for the proper and safe use of seclusion and restraint interventions. It would not be appropriate for a hospital to routinely call upon a law enforcement agency or agencies as a means of applying restraint or initiating seclusion. If hospital security guards, or other non-healthcare staff, as part of hospital policy, may assist direct care staff, when requested, in the application of restraint or seclusion, the security guards, or other non-healthcare staff, are also expected to be trained and able to demonstrate competency in the safe application of restraint and seclusion (in accordance with §482.13(f)).

482.13(f)(2) Training Content: The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:

A-0199 482.13(f)(2)(i) Techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion.

Interpretive Guidelines §482.13(f)(2)(i)
The term “appropriate staff” includes all staff that apply restraint or seclusion, monitor, assess, or otherwise provide care for patients in restraint or seclusion.
All staff, including contract or agency personnel, designated by the hospital as having direct patient care responsibilities are required to receive training in the areas of clinical techniques used to identify patient and staff behaviors, events and environmental factors that may trigger circumstances that require the use of restraint or seclusion. This training should be targeted to the specific needs of the patient populations being served, and to the competency level of staff.
Staff needs to be able to employ a broad range of clinical interventions to maintain the safety of the patient and others. The hospital is expected to provide education and training at the appropriate level to the appropriate staff based upon the specific needs of the patient population being served. For example, staff routinely providing care for patients who exhibit violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others (such as in an emergency department or on a psychiatric unit) generally require more in-depth training in the areas included in the regulation than staff routinely providing medical/surgical care. Hospitals may develop and implement their own training programs or use an outside training program. However, standard (f) specifies that individuals providing staff training must be qualified as evidenced by education, training, and experience.
Hospitals have the flexibility to develop their own training program to meet the staff training requirements at §482.13(f) or purchase a training program from the outside. CMS does not specify that any particular outside vendor must be used to provide the required training. Each hospital must assess the learning needs and competency of their staff to determine how extensive periodic training and staff competency demonstration must be subsequent to initial training. The training program must be provided to all appropriate staff. Any person monitoring or providing care to a restrained patient must demonstrate the knowledge and abilities required by the regulations.
At a minimum, physicians and other LIPs authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint and seclusion. Hospitals have the flexibility to identify training requirements above this minimum based on the competency level of their physicians and other LIPs and the needs of the patient population that they serve.

A-0200 482.13(f)(2)(ii) The use of nonphysical intervention skills.

Interpretive Guidelines §482.13(f)(2)(ii)
Although we recognize that there may be circumstances in which the use of restraint or seclusion may be necessary to prevent a patient situation from escalating, staff often skillfully intervene with alternative techniques to redirect a patient, engage the patient in constructive discussion or activity, or otherwise help the patient maintain self-control and avert escalation.
The use of nonphysical intervention skills does not mean attempting a complex series of interventions or a lengthy checklist of steps to initiate before restraining or secluding a patient. Rather, a whole toolbox of possible interventions can be implemented during the course of a patient’s treatment based upon the assessment of an individual patient’s responses.

A-0201 482.13(f)(2)(iii) Choosing the least restrictive intervention based on an individualized assessment of the patient's medical, or behavioral status or condition.

Interpretive Guidelines §482.13(f)(2)(iii)
The underpinning of this regulation is the concept that safe patient care hinges on looking at the patient as an individual and assessing the patient’s condition, needs, strengths, weaknesses, and preferences. Such an approach relies on caregivers who are skilled in individualized assessment and in tailoring interventions to individual patient’s needs after weighing factors such as the patient’s condition, behaviors, history, and environmental factors.
Resources are available to assist clinicians in identifying less restrictive interventions. For example, the American Psychiatric Association (APA), American Psychiatric Nurses Association (APNA), and the National Association of Psychiatric Health Systems (NAPHS), with support from the American Hospital Association (AHA), have sponsored the publication of a document entitled, “Learning from Each Other—Success Stories and Ideas for Reducing Restraint/Seclusion in Behavioral Health.” This document, published in 2003, was developed through dialogue with the field and extensive input from behavioral healthcare providers throughout the country who have been working to reduce the use of restraint and seclusion, and to improve care within their facilities. To access this document and other useful resources, visit the web sites of the sponsoring organizations: http://www.naphs.org; http://www.psych.org; http://www.apna.org; http://www.aha.org

A-0202 482.13(f)(2)(iv) The safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia).

Interpretive Guidelines §482.13(f)(2)(iv)
Patients have a right to the safe application of restraint or seclusion by trained and competent staff.

A-0204 482.13(f)(2)(v) Clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary.

Interpretive Guidelines §482.13(f)(2)(v)
The use of restraint or seclusion must be ended at the earliest possible time regardless of the length of time identified in the order. Staff must be trained and demonstrate competency in their ability to identify specific patient behavioral changes that may indicate that restraint or seclusion is no longer necessary and can be safely discontinued.

A-0205 482.13(f)(2)(vi) Monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation.

Interpretive Guidelines §482.13(f)(2)(vi)
Staff must be trained and demonstrate competency in monitoring the physical and psychological well-being of a patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and as well as any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation.

A-0206 482.13(f)(2)(vii) The use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification.

Interpretive Guidelines §482.13(f)(2)(vii)
Hospitals are required to provide a safe environment for the patients in their care. When restraint or seclusion techniques are used, patients are placed at a higher risk for injuries or even death. Hospitals must require appropriate staff (all staff who apply restraint or seclusion, monitor, access or provide care for a patient in restraint or seclusion) to receive education and training in the use of first aid techniques as well as training and certification in the use of cardiopulmonary resuscitation.
Hospitals are not required to use any particular recognized first aid course. Additionally, such courses may not adequately address the immediate interventions, the “first aid”, that needs to be rendered to a restrained or secluded patient who is in distress or injured. The goal is for staff to be able to render the appropriate “first aid” required if a restrained or secluded patient is in distress or injured. For example, a patient is found hanging in a vest restraint, a restrained patient is choking on food, a secluded suicidal patient is found hanging, a secluded suicidal patient has cut himself, etc. Hospital staff need to assess their patient population and identify likely scenarios, develop a first aid training that addresses those scenarios, and provide that “first aid” training to all staff that care for restrained or secluded patients.

A-0207 482.13(f)(3) Trainer Requirements: Individuals providing staff training must be qualified as evidenced by education, training, and experience in techniques used to address patients' behaviors.

Interpretive Guidelines §482.13(f)(3)
There is no requirement that training be obtained from Federally-specified programs. Hospitals may develop and implement their own training programs or use an outside training program. However, individuals providing the training must be qualified as evidenced by education, training and experience in techniques used to address patients’ behaviors for the patient populations being served. Trainers should demonstrate a high level of knowledge regarding all the requirements of these regulations as well as the hospital’s policies and procedures that address these requirements.

A-0208 482.13(f)(4) Training Documentation: The hospital must document in the staff personnel records that the training and demonstration of competency were successfully completed.

Interpretive Guidelines §482.13(f)(4)
Staff personnel records must contain documentation that the training and demonstration of competency were successfully completed initially during orientation and on a periodic basis consistent with hospital policy.

482.13(g) Standard: Death Reporting Requirements: Hospitals must report deaths associated with the use of seclusion or restraint.

A-0213 482.13(g)(1) With the exception of deaths described under paragraph (g)(2) of this section, the hospital must report the following information to CMS by telephone, facsimile, or electronically, as determined by CMS, no later than the close of business on the next business day following knowledge of the patient’s death:
(i) Each death that occurs while a patient is in restraint or seclusion.
(ii) Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion.
(iii) Each death known to the hospital that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death, regardless of the type(s) of restraint used on the patient during this time. “Reasonable to assume” in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing or asphyxiation.
(2) The staff must document in the patient’s medical record the date and time the death was:
(i) Reported to CMS for deaths described in paragraph (g)(1) of this section; or….

Interpretive Guidelines §482.13(g)(1) & (3)(i)
The hospital must report to its CMS Regional Office each death that occurs:
• While a patient is in restraint or in seclusion, except when no seclusion has been used and the only restraint used was a soft, cloth-like two-point wrist restraints;
• Within 24 hours after the patient has been removed from restraint or seclusion, except when no seclusion has been used and the only restraint used was a soft, two-point wrist restraint; or,
• Within 1 week after use of restraint or seclusion where the death is known to the hospital and it is reasonable to assume that the use of restraint or seclusion contributed directly or indirectly to the patient’s death, regardless of the type(s) of restraint used on the patient during this time.
o “Reasonable to assume” applies only to those deaths that occur on days 2-7 after restraint or seclusion has been discontinued.
o This criterion applies regardless of the type of restraint that was used on the patient. In other words, it applies to all uses of restraint or seclusion where the patient has died on days 2-7 after the restraint or seclusion was discontinued, and it is reasonable to assume the use of the restraint or seclusion contributed to the patient’s death. In a case where only two-point soft wrist restraints were used and there was no seclusion, it may reasonably be presumed that the patient’s death was not caused by the use of restraints.
o In cases involving death within one week after use of restraint or seclusion where the intervention may have contributed to the patient’s death, it is possible that the patient’s death might occur outside the hospital and that the hospital might not learn of the patient’s death, or that there might be a delay in the hospital’s learning of the patient’s death.
See the guidance for §482.13(g)(2) for handling of deaths while a patient was in, or within 24 hours after removal of a soft, two-point wrist restraint, when no other restraint or seclusion was used.
The reports required under §482.13(g)(1) must be submitted to the CMS Regional Office by telephone, facsimile, or electronically, as determined by the Regional Office no later than close of the next business day following the day in which the hospital knows of the patient’s death. The report must include basic identifying information related to the hospital, the patient’s name, date of birth, date of death, name of attending physician/practitioner, primary diagnosis(es), cause of death (preliminary, in case a final, official cause of death is not yet available), and type(s) of restraint or seclusion used. CMS makes a standard form available for hospitals to use in submitting the required reports.
Hospitals must document in the patient’s medical record the date and time each reportable death associated with the use of restraint or seclusion was reported to the CMS Regional Office.
After reviewing the submitted information, the Regional Office will determine whether an on-site investigation of the circumstances surrounding the patient’s death is warranted and will direct the State Survey Agency to conduct a survey if applicable.

A-0214 482.13(g)(2) When no seclusion has been used and when the only restraints used on the patient are those applied exclusively to the patient’s wrist(s), and which are composed solely of soft, non-rigid, cloth-like materials, the hospital staff must record in an internal log or other system, the following information:
(i) Any death that occurs while a patient is in such restraints.
(ii) Any death that occurs within 24 hours after a patient has been removed from such restraints.
(3) The staff must document in the patient’s medical record the date and time the death was:
(ii) Recorded in the internal log or other system for deaths described in paragraph (g)(2) of this section.
(4) For deaths described in paragraph (g)(2) of this section, entries into the log or other system must be documented as follows:
(i) Each entry must be made not later than seven days after the date of death of the patient.
(ii) Each entry must document the patient’s name, date of birth, date of death, name of attending physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §482.12(c), medical record number, and primary diagnosis(es).
(iii) The information must be made available in either written or electronic form to CMS immediately upon request.

Interpretive Guidelines §482.13(g)(2), (3)(ii), & (4)
Hospitals must maintain an internal log or other type of tracking system for recording information on each death that occurs:
• While a patient is in only 2-point soft, cloth-like non-rigid wrist restraints and there is no use of seclusion; and
• Within 24 hours of the patient being removed from 2-point soft, cloth-like non-rigid wrist restraints where there was no use of any other type of restraint or seclusion.
Use of the log or tracking system is limited only to patient deaths meeting one of these two criteria. Examples of patient deaths associated with restraints that must still be reported to CMS include:
• Deaths occurring during or within 24 hours of discontinuation of 2-point soft, cloth-like non-rigid wrist restraints used in combination with any other restraint device or with seclusion; or
• Deaths associated with the use of other types of wrist restraints, such as 2-point rigid or leather wrist restraints.
These cases would not be included in this internal log or tracking system and would require reporting the death to CMS using telephone, fax, or electronically.
The two-point soft wrist restraint death report must be entered into the internal log or tracking system within 7 days of the patient’s death.
The death report log or tracking system entry must include:
• The patient’s name;
• Patient’s date of birth;
• Patient’s date of death;
• Name of the attending physician or other licensed independent practitioner who is responsible for the care or the patient;
• Patient’s medical record number; and
• Primary diagnosis(es).
Depending on the size and nature of the patient population the hospital serves and the types of services it provides, there will likely be variations in the frequency of restraint use as well as in the incidence of patient deaths. Surveyors should adjust their expectations for the volume of log or tracking system entries accordingly. For example, hospitals with intensive care units might be more likely to use both soft, 2-point wrist restraints and to have seriously ill patients who die as a result of their disease while such restraints are being used or within 24 hours after their discontinuance. On the other hand, a rehabilitation hospital would be expected to use such restraints less frequently, and to have patients who die less frequently while hospitalized.
The log or tracking system must be available in written, i.e., hard copy, or electronic form immediately upon CMS’s request. CMS will specify the form in which the information is to be provided. Generally CMS would request access to the log or tracking system during an on-site survey by CMS staff or State surveyors acting on CMS’s behalf when assessing compliance with restraint/seclusion requirements. However, CMS may also request that a copy of portions or the entire log or tracking system be provided, even though no survey is in progress. Accreditation organizations conducting hospital inspections in accordance with a CMS-approved Medicare hospital accreditation program are also entitled to immediate access to the log or tracking system.
The hospital is not required to make the contents of the log or tracking system available to any other outside parties, unless required to do so under other Federal or State law.
The hospital must document in the patient’s medical record the date and time the death report entry was made into the log or tracking system.

482.13(h) Standard: Patient Visitation Rights

A-0215 482.13(h) A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation.

Interpretive Guidelines, §482.13(h)
Visitation plays an important role in the care of hospital patients. An article published in 2004 in the Journal of the American Medical Association (Berwick, D.M., and Kotagal, M.: “Restricted visiting hours in ICUs: time to change.” JAMA. 2004; Vol. 292, pp. 736-737) discusses the health and safety benefits of open visitation for patients, families, and intensive care unit (ICU) staff and debunks some of the myths surrounding the issue (physiologic stress for the patient; barriers to provision of care; exhaustion of family and friends). The article ultimately concluded that “available evidence indicates that hazards and problems regarding open visitation are generally overstated and manageable,” and that such visitation policies “do not harm patients but rather may help them by providing a support system and shaping a more familiar environment” as they “engender trust in families, creating a better working relationship between hospital staff and family members.” Hospitals that unnecessarily restrict patient visitation often miss an opportunity to gain valuable patient information from those who may know the patient best with respect to the patient’s medical history, conditions, medications, and allergies, particularly if the patient has difficulties with recall or articulation, or is totally unable to recall or articulate this vital personal information. Many times visitors who may know the patient best act as an intermediary for the patient, helping to communicate the patient’s needs to hospital staff.
Although visitation policies are generally considered to relate to visitors of inpatients, “visitors” also play a role for outpatients who wish to have a support person present during their outpatient visit. For example, a same-day surgery patient may wish to have a support person present during the pre-operative patient preparation or post-operative recovery. Or an outpatient clinic patient may wish to have a support person present during his or her examination by a physician. Accordingly, hospital visitation policies must address both the inpatient and outpatient settings.
Hospitals are required to develop and implement written policies and procedures that address the patient’s right to have visitors. If the hospital’s policy establishes restrictions or limitations on visitation, such restrictions/limitations must be clinically necessary or reasonable. Furthermore, the hospital’s policy must include the reasons for any restrictions/limitations. The right of a patient to have visitors may be limited or restricted when visitation would interfere with the care of the patient and/or the care of other patients. The regulation permits hospitals some flexibility, so that health care professionals may exercise their best clinical judgment when determining when visitation is, and is not, appropriate. Best clinical judgment takes into account all aspects of patient health and safety, including the benefits of visitation on a patient’s care as well as potential negative impacts that visitors may have on other patients in the hospital.
Broad examples of circumstances reasonably related to the care of the patient and/or the care of other patients that could provide a basis for a hospital to impose restrictions or limitations on visitors might include (but are not limited to) when:
• there may be infection control issues;
• visitation may interfere with the care of other patients;
• the hospital is aware that there is an existing court order restricting contact;
• visitors engage in disruptive, threatening, or violent behavior of any kind;
• the patient or patient’s roommate(s) need rest or privacy;
• in the case of an inpatient substance abuse treatment program, there are protocols limiting visitation; and
• the patient is undergoing care interventions. However, while there may be valid reasons for limiting visitation during a care intervention, we encourage hospitals to try to accommodate the needs of any patient who requests that at least one visitor be allowed to remain in the room to provide support and comfort at such times.
It may also be reasonable to limit the number of visitors for any one patient during a specific period of time, as well as to establish minimum age requirements for child visitors. However, when a hospital adopts policies that limit or restrict patients’ visitation rights, the burden of proof is upon the hospital to demonstrate that the visitation restriction is reasonably necessary to provide safe care.
Hospitals are expected to provide a clear explanation in their written policy of the clinical rationale for any visitation restrictions or limitations reflected in that policy. Hospitals are not required, however, to delineate each specific clinical reason for policies limiting or restricting visitation, given that it is not possible to anticipate every instance that may give rise to a clinically appropriate rationale for a restriction or limitation. If visitation policies differ by type of unit, e.g., separate policies for intensive care units, or for newborn nurseries, the hospital policy must address the clinical rationale for this differentiation explicitly.
The hospital’s policies and procedures are expected to address how hospital staff who play a role in facilitating or controlling visitor access to patients will be trained to assure appropriate implementation of the visitation policies and procedures and avoidance of unnecessary restrictions or limitations on patients’ visitation rights.

A-0216 482.13(h)(1) Inform each patient (or support person, where appropriate) of his or her visitation rights, including any clinical restriction or limitation on such rights, when he or she is informed of his or her other rights under this section.
(2) Inform each patient (or support person, where appropriate) of the right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time.

Interpretive Guidelines §482.13(h)(1)&(2)
Hospitals are required to inform each patient (or the patient’s support person, where appropriate) of his/her visitation rights. A patient’s “support person” does not necessarily have to be the same person as the patient’s representative who is legally responsible for making medical decisions on the patient’s behalf. A support person could be a family member, friend, or other individual who supports the patient during the course of the hospital stay. Not only may the support person visit the patient, but he or she may also exercise a patient’s visitation rights on behalf of the patient with respect to other visitors when the patient is unable to do so. Hospitals must accept a patient’s designation, orally or in writing, of an individual as the patient’s support person.
When a patient is incapacitated or otherwise unable to communicate his or her wishes and an individual provides an advance directive designating an individual as the patient’s support person (it is not necessary for the document to use this exact term), the hospital must accept this designation, provide the required notice of the patient’s visitation rights, and allow the individual to exercise the patient’s visitation rights on the patient’s behalf.
When a patient is incapacitated or otherwise unable to communicate his or her wishes, there is no advance directive designating a representative on file, and no one has presented an advance directive designating himself or herself as the patient’s representative, but an individual asserts that he or she, as the patient’s spouse, domestic partner (including a same-sex domestic partner), parent or other family member, friend, or otherwise, is the patient’s support person, the hospital is expected to accept this assertion, without demanding supporting documentation, provide the required notice of the patient’s visitation rights, and allow the individual to exercise the patient’s visitation rights on the patient’s behalf. However, if more than one individual claims to be the patient’s support person, it would not be inappropriate for the hospital to ask each individual for documentation supporting his/her claim to be the patient’s support person.
• Hospitals are expected to adopt policies and procedures that facilitate expeditious and non-discriminatory resolution of disputes about whether an individual is the patient’s support person, given the critical role of the support person in exercising the patient’s visitation rights.
• A refusal by the hospital of an individual’s request to be treated as the patient’s support person with respect to visitation rights must be documented in the patient’s medical record, along with the specific basis for the refusal.
Consistent with the patients’ rights notice requirements under the regulation at §482.13(a)(1), the required notice of the patient’s visitation rights must be provided, whenever possible, before the hospital provides or stops care. The notice to the patient, or to the patient’s support person, where appropriate, must be in writing. If the patient also has a representative who is different from the support person, the representative must also be provided information on the patient’s visitation rights, in addition to the support person, if applicable. In the event that a patient has both a representative and a support person who are not the same individual, and they disagree on who should be allowed to visit the patient, the hospital must defer to the decisions of the patient’s representative.
As the individual responsible for making decisions on the patient’s behalf, the patient’s representative has the authority to exercise a patient’s right to designate and deny visitors just as the patient would if he or she were capable of doing so. The designation of, and exercise of authority by, the patient’s representative is governed by State law, including statutory and case law. Many State courts have addressed the concept of substituted judgment, whereby the patient’s representative is expected to make medical decisions based on the patient’s values and interests, rather than the representative’s own values and interests. State courts have also developed a body of closely related law around the matter of a representative acting in the patient’s best interest. Such case law regarding substituted judgment and best interest may be a resource for hospitals on how to address such conflict situations as they establish visitation policies and procedures. Hospitals may also choose to utilize their own social work and pastoral counseling resources to resolve such conflicts to assure the patient’s well-being.
The required visitation rights notice must address any clinically necessary or reasonable limitations or restrictions imposed by hospital policy on visitation rights, providing the clinical reasons for such limitations/restrictions, including how they are aimed at protecting the health and safety of all patients. The information must be sufficiently detailed to allow a patient (or the patient’s support person) to determine what the visitation hours are and what restrictions, if any, apply to that patient’s visitation rights.
The notice must also inform the patient (or the patient’s support person, where appropriate) of the patient’s right to:
• Consent to receive visitors he or she has designated, either orally or in writing, including but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend;
• Receive the visitors he or she has designated, including but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend; and
• Withdraw or deny his/her consent to receive specific visitors, either orally or in writing.
The medical record must contain documentation that the required notice was provided to the patient or, if appropriate, the patient’s support person.

A-0217 482.13(h)(3) Not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, or disability.
(4) Ensure that all visitors enjoy full and equal visitation privileges consistent with patient preferences.

Interpretive Guidelines §482.13(h)(3)&(4)
The hospital’s visitation policies and procedures may not use the race, color, national origin, religion, sex, gender identity, sexual orientation, or disability of either the patient (or the patient’s support person ore representative, where appropriate) or the patient’s visitors (including individuals seeking to visit the patient) as a basis for limiting, restricting, or otherwise denying visitation privileges.
The hospital’s policies and procedures must ensure that all visitors (including individuals seeking to visit the patient) enjoy full and equal visitation privileges, consistent with the preferences the patient (or, where appropriate, the patient’s support person) has expressed concerning visitors. In other words, it is permissible for the patient (or the patient’s support person, where appropriate) to limit the visiting privileges of his/her visitors, including providing for more limited visiting privileges for some visitors than those for others. But it is not permissible for the hospital, on its own, to differentiate among visitors without any clinically necessary or reasonable basis. This includes visitors designated by the patient who have characteristics not addressed specifically in §482.13(h)(3), when those characteristics do not reasonably relate to a clinically reasonable basis for limiting or denying visitation. For example, it would not be appropriate to prohibit a designated visitor based on that individual’s style of dress, unless there was a clinically reasonable basis for doing so.
The hospital is responsible for ensuring that hospital staff treat all individuals seeking to visit patients equally, consistent with the preferences of the patient (or, where appropriate, the patient’s support person) and do not use the race, color, national origin, religion, sex, gender identity, sexual orientation, or disability of either the patient(or the patient’s support person or representative, where appropriate) or the patient’s visitors (including individuals seeking to visit the patient) as a basis for limiting, restricting, or otherwise denying visitation privileges. Hospitals are expected to educate all staff who play a role in facilitating or controlling visitors on the hospital’s visitation policies and procedures, and are responsible for ensuring that staff implement the hospital’s policies correctly. Hospitals are urged to develop culturally competent training programs designed to address the range of patients served by the hospital.

CoP: Quality Assessment and Performance Improvement Program

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482.21 Quality Assessment and Performance Improvement Program

A-0263 482.21 The hospital must develop, implement, and maintain an effective, ongoing, hospital- wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS.

No information available.

A-0273 482.21(a), 482.21(b)(1), 482.21(b)(2)(i), & 482.21(b)(3) Data Collection & Analysis
482.21(a) Standard: Program Scope
(1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes;
(2) The hospital must measure, analyze, and track quality indicators…and other aspects of performance that assess processes of care, hospital service and operations.

482.21(b) Standard: Program Data.
(1) The program must incorporate quality indicator data including patient care data, and other relevant data, for example, information submitted to, or received from, the hospital’s Quality Improvement Organization.
(2) The hospital must use the data collected to:
(i) Monitor the effectiveness and safety of services and quality of care; and…
(3) The frequency and detail of data collection must be specified by the hospital’s governing body.

No information available.

A-0283 482.21(b)(2)(ii), 482.21(c)(1) & 482.21 (c)(3) Quality Improvement Activities
482.21(b)(2) Standard: Program Data
The hospital must use the data collected to:
(ii) Identify opportunities for improvement and changes that will lead to improvement.
482.21(c) Standard: Program Activities
(1) The hospital must set priorities for its performance improvement activities that
(i) Focus on high-risk, high-volume, or problem-prone areas;
(ii) Consider the incidence, prevalence, and severity of problems in those areas; and
(iii) Affect health outcomes, patient safety, and quality of care.
(3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained.

No information available.

A-0286 482.21(a)(1), 482.21(a)(2), 482.21(c)(2), & 482.21(e)(3) Patient Safety, Medical Errors & Adverse Events
482.21(a) Standard: Program Scope.
(1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will … identify and reduce medical errors.
(2) The hospital must measure, analyze, and track…adverse patient events….

482.21(c) Standard: Program Activities…
(2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital.

482.21(e) Standard: Executive Responsibilities. The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:…
(3) That clear expectations for safety are established.

No information available.

A-0297 482.21(d) As part of its quality assessment and performance improvement program, the hospital must conduct performance improvement projects.
(1) The number and scope of distinct improvement projects conducted annually must be proportional to the scope and complexity of the hospital’s services and operations.
(2) A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes.
(3) The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.
(4) A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort.

No information available.

A-0308 482.21 The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement) The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS.

No information available.

482.31(e) Executive Responsibilities

A-0309 482.21(e) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:
(1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained.
(2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated.
(5) That the determination of the number of distinct improvement projects is conducted annually.

No information available.

A-0315 482.21(e) The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:
(4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital’s performance and reducing risk to patients.

No information available.

CoP: Medical Staff

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482.22 Medical Staff

A-0338 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital.

Interpretive Guidelines §482.22
The hospital must have one medical staff for the entire hospital (including all campuses, provider-based locations, satellites, remote locations, etc.). For example, a multi-campus hospital may not have a separately organized medical staff for each campus. On the other hand, in the case of a hospital system, it is permissible for the system to have a unified and integrated medical staff (hereafter referred to as a “unified medical staff”) for multiple, separately certified hospitals. The medical staff must be organized and integrated as one body that operates under one set of bylaws approved by the governing body. These medical staff bylaws must apply equally to all practitioners within each category of practitioners at all locations of the hospital and to the care provided at all locations of the hospital. The medical staff is responsible for the quality of medical care provided to patients by the hospital.

482.22(a) Standard: Eligibility and Process for Appointment to Medical Staff

A-0339 482.22(a) The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope-of-practice laws, the medical staff may also include other categories of physicians (as listed at 482.12(c)(1)) and non- physician practitioners who are determined to be eligible for appointment by the governing body.

Interpretive Guidelines §482.22(a)
The hospital’s governing body has the responsibility, consistent with State law, including scope-of-practice laws, to determine which types/categories of physicians and, if it so chooses, non-physician practitioners or other licensed healthcare professionals (collectively referred to in this guidance as “practitioners”) may be privileged to provide care to hospital patients. All practitioners who require privileges in order to furnish care to hospital patients must be evaluated under the hospital’s medical staff privileging system before the hospital’s governing body may grant them privileges. All practitioners granted medical staff privileges must function under the bylaws, regulations and rules of the hospital’s medical staff. The privileges granted to an individual practitioner must be consistent with State scope-of-practice laws.

Physicians:
The medical staff must at a minimum be composed of doctors of medicine or doctors of osteopathy. In addition, the medical staff may include other types of practitioners included in the definition in Section 1861(r) of the Social Security Act of a “physician:”
• Doctor of dental surgery or of dental medicine;
• Doctor of podiatric medicine;
• Doctor of optometry; and a
• Chiropractor.
In all cases, the practitioner included in the definition of a physician must be legally authorized to practice within the State where the hospital is located and providing services within their authorized scope of practice. In addition, in certain instances the Social Security Act and regulations attach further limitations as to the type of hospital services for which a practitioner may be considered to be a “physician.” See §482.12(c)(1) for more detail on these limitations.
The governing body has the flexibility to determine, consistent with State law, whether practitioners included in the definition of a physician, other than doctors of medicine or osteopathy, are eligible for appointment to the medical staff.

"For Information Only – Not Required/ Not to be Cited"
--CMS expects that all physician practitioners granted privileges are also appointed as members of the medical staff. However, if State law limits the composition of the hospital’s medical staff to certain categories of practitioners, e.g., only MDs or DOs, there is nothing in the CoPs that prohibits hospitals and their medical staffs from establishing certain practice privileges for other categories of physician practitioners excluded from medical staff membership under State law, or from granting those privileges to individual practitioners in those categories, as long as such privileges are recommended by the medical staff, approved by the governing body, and in accordance with State law. (79 FR 27114 - 27115, May 12, 2014)--

For physician practitioners granted privileges only, the hospital’s governing body and its medical staff must exercise oversight, such as through credentialing and competency review, of those other physician practitioners to whom it grants privileges, just as it would for those practitioners appointed to its medical staff.

Non-physician practitioners
Furthermore, the governing body has the authority, in accordance with State law, to grant medical staff privileges and membership to non-physician practitioners. The regulation allows hospitals and their medical staffs to take advantage of the expertise and skills of all types of practitioners who practice at the hospital when making recommendations and decisions concerning medical staff privileges and membership.

"For Information Only – Not Required/ Not to be Cited"
--CMS expects that all practitioners granted privileges are also appointed as members of the medical staff. However, if State law limits the composition of the hospital’s medical staff to certain categories of practitioners, e.g., only physician practitioners, there is nothing in the CoPs that prohibits hospitals and their medical staffs from establishing certain practice privileges for those specific categories of non-physician practitioners excluded from medical staff membership under State law, or from granting those privileges to individual practitioners in those categories, as long as such privileges are recommended by the medical staff, approved by the governing body, and in accordance with State law. (79 FR 27114 - 27115, May 12, 2014)--

For non-physician practitioners granted privileges only, the hospital’s governing body and its medical staff must exercise oversight, such as through credentialing and competency review, of those non-physician practitioners to whom it grants privileges, just as it would for those practitioners appointed to its medical staff.

Practitioners are described in Section 1842(b)(18)(C) of the Act as any of the following:
• Physician assistant (as defined in Section 1861(aa)(5) of the Act);
• Nurse practitioner (as defined in Section 1861(aa)(5) of the Act);
• Clinical nurse specialist (as defined in Section 1861(aa)(5) of the Act);
• Certified registered nurse anesthetist (as defined in Section 1861(bb)(2) of the Act);
• Certified nurse-midwife (as defined in Section 1861(gg)(2) of the Act);
• Clinical social worker (as defined in Section 1861(hh)(1) of the Act);
• Clinical psychologist (as defined in 42 CFR 410.71 for purposes of Section 1861(ii) of the Act);
• Anesthesiologist’s Assistant (as defined in §410.69); or
• Registered dietician or nutrition professional.
Other types of licensed healthcare professionals have a more limited scope of practice and usually are not eligible for hospital medical staff privileges, unless their permitted scope of practice in their State makes them more comparable to the above types of non-physician practitioners. Some examples of types of such licensed healthcare professionals who might be eligible for medical staff privileges depending on State law and medical staff bylaws, rules and regulations include, but are not limited to:
• Physical Therapist (as defined at §410.60 and §484.4);
• Occupational Therapist (as defined at §410.59 and §484.4); and
• Speech Language Therapist (as defined at §410.62 and §484.4).
Furthermore, some States have established a scope of practice for certain licensed pharmacists who are permitted to provide patient care services that make them more like the above types of non-physician practitioners, including the monitoring and assessing of patients and ordering medications and laboratory tests. In such States, a hospital may grant medical staff privileges to such pharmacists and/or appoint them as members of the medical staff. There is no standard term for such pharmacists, although they are sometimes referred to as “clinical pharmacists.”
Practitioners may be granted active, courtesy, emergency, temporary, etc. membership or privileges in accordance with state law and as specified in the medical staff bylaws, rules, and regulations.

A-0340 482.22(a)(1) - The medical staff must periodically conduct appraisals of its members.

Interpretive Guidelines §482.22(a)(1)
The medical staff must at regular intervals appraise the qualifications of all practitioners appointed to the medical staff/granted medical staff privileges. In the absence of a State law that establishes a timeframe for periodic reappraisal, a hospital’s medical staff must conduct a periodic appraisal of each practitioner. CMS recommends that an appraisal be conducted at least every 24 months for each practitioner.
The purpose of the appraisal is for the medical staff to determine the suitability of continuing the medical staff membership or privileges of each individual practitioner, to determine if that individual practitioner’s membership or privileges should be continued, discontinued, revised, or otherwise changed.
The medical staff appraisal procedures must evaluate each individual practitioner’s qualifications and demonstrated competencies to perform each task or activity within the applicable scope of practice or privileges for that type of practitioner for which he/she has been granted privileges. Components of practitioner qualifications and demonstrated competencies would include at least: current work practice, special training, quality of specific work, patient outcomes, education, maintenance of continuing education, adherence to medical staff rules, certifications, appropriate licensure, and currency of compliance with licensure requirements.
In addition to the periodic appraisal of members, any procedure/task/activity/privilege requested by a practitioner that goes beyond the specified list of privileges for that particular category of practitioner requires an appraisal by the medical staff and approval by the governing body. The appraisal must consider evidence of qualifications and competencies specific to the nature of the request. It must also consider whether the activity/task/procedure is one that the hospital can support when it is conducted within the hospital. Privileges cannot be granted for tasks/procedures/activities that are not conducted within the hospital, regardless of the individual practitioner’s ability to perform them.
After the medical staff conducts its reappraisal of individual members, the medical staff makes recommendations to the governing body to continue, revise, discontinue, limit, or revoke some or all of the practitioner’s privileges, and the governing body takes final appropriate action.
A separate credentials file must be maintained for each medical staff member. The hospital must ensure that the practitioner and appropriate hospital patient care areas/departments are informed of the privileges granted to the practitioner, as well as of any revisions or revocations of the practitioner’s privileges. Furthermore, whenever a practitioner’s privileges are limited, revoked, or in any way constrained, the hospital must, in accordance with State and/or Federal laws or regulations, report those constraints to the appropriate State and Federal authorities, registries, and/or data bases, such as the National Practitioner Data Bank.

A-0341 482.22(a)(2) - The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidates in accordance with State law, including scope-of-practice laws, and the medical staff bylaws, rules, and regulations. A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section.

Interpretive Guidelines §482.22(a)(2)
There must be a mechanism established to examine credentials of individual prospective members (new appointments or reappointments) by the medical staff. The individual’s credentials to be examined must include at least:
• A request for clinical privileges;
• Evidence of current licensure;
• Evidence of training and professional education;
• Documented experience; and
• Supporting references of competence.
The medical staff may not make its recommendation solely on the basis of the presence or absence of board certification, but must consider all of the elements above. However, this does not mean that the medical staff is prohibited from requiring in its bylaws board certification when considering a MD/DO for medical staff membership or privileges; only that such certification may not be the only factor that the medical staff considers.
The medical staff makes recommendations to the governing body for each candidate for medical staff membership/privileges that are specific to type of appointment and extent of the individual practitioner’s specific clinical privileges, and then the governing body takes final appropriate action.
Each practitioner who is a member of the medical staff or who holds medical staff privileges is subject to the medical staff’s bylaws, rules, and regulations, in addition to all the requirements of the Medical Staff Condition of Participation. The medical staff and the governing body must enforce its medical staff requirements and take appropriate actions when individual members or other practitioners with privileges do not adhere to the medical staff’s bylaws, regulations, and rules. They must likewise afford all members/practitioners who hold privileges the protections and due process rights provided for in the bylaws, rules and regulations.
A separate credentials file must be maintained for each individual medical staff member or applicant. The hospital must ensure that the practitioner and appropriate hospital patient care areas/departments are informed of the privileges granted to the practitioner.

A-0342 482.22(a)(3) When telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site hospital, the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the distant-site hospital when making recommendations on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital’s governing body ensures, through its written agreement with the distant-site hospital, that all of the following provisions are met:
(i) The distant-site hospital providing the telemedicine services is a Medicare-participating hospital.
(ii) The individual distant-site physician or practitioner is privileged at the distant-site hospital providing the telemedicine services, which provides a current list of the distant-site physician’s or practitioner’s privileges at the distant-site hospital.
(iii) The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the hospital whose patients are receiving the telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician’s or practitioner’s performance of these privileges and sends the distant- site hospital such performance information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant- site physician or practitioner to the hospital’s patients and all complaints the hospital has received about the distant-site physician or practitioner.

Interpretive guidelines §482.22(a)(3)
The hospital’s governing body has the option, when considering granting privileges to telemedicine physicians and practitioners, to have the hospital’s medical staff rely upon the credentialing and privileging decisions of the distant-site hospital for these physicians and practitioners. This process would be in lieu of the traditional process required under §482.22(a)(1) and §482.22(a)(2), whereby the hospital’s medical staff conducts its own review of each telemedicine physician’s or practitioner’s credentials and makes a recommendation based on that individualized review.
In order to exercise this alternative credentialing and privileging option, the hospital’s governing body must ensure through its written agreement with the distant-site hospital that all of the following requirements are met:
• The distant-site hospital participates in the Medicare program. If the distant-site hospital’s participation in Medicare is terminated, either voluntarily or involuntarily, at any time during the agreement, then, as of the effective date of the termination, the hospital may no longer receive telemedicine services under the agreement;
• The distant-site hospital provides to the hospital a list of all its physicians and practitioners covered by the agreement, including their privileges at the distant-site hospital. The list may not include any physician or practitioner who does not hold privileges at the distant-site hospital. The list must be current, so the agreement must address how the distant-site hospital will keep the list current;
• Each physician or practitioner who provides telemedicine services to the hospital’s patients under the agreement holds a license issued or recognized by the State where the hospital (not the distant-site hospital) is located. States may have varying requirements as to whether they will recognize an out-of-state license for purposes of practicing within their State, and they may also vary as to whether they establish different standards for telemedicine services. The licensure requirements governing in the State where the hospital whose patients are receiving the telemedicine services is located must be satisfied, whatever they may be; and
• The hospital has evidence that it reviews the telemedicine services provided to its patients and provides feedback based on this review to the distant-site hospital for the latter’s use in its periodic appraisal of each physician and practitioner providing telemedicine services under the agreement. At a minimum, the hospital must review and send information to the distant-site hospital on all adverse events that result from a physician or practitioner’s provision of telemedicine services under the agreement and on all complaints it has received about a telemedicine physician or practitioner covered by the agreement.

A-0343 482.22(a)(4) When telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site telemedicine entity, the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the distant- site telemedicine entity when making recommendations on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital’s governing body ensures, through its written agreement with the distant- site telemedicine entity, that the distant-site telemedicine entity furnishes services that, in accordance with §482.12(e), permit the hospital to comply with all applicable conditions of participation for the contracted services. The hospital’s governing body must also ensure, through its written agreement with the distant-site telemedicine entity, that all of the following provisions are met:
(i) The distant-site telemedicine entity’s medical staff credentialing and privileging process and standards at least meet the standards at §482.12(a)(1) through (a)(7) and §482.22(a)(1) through (a)(2).
(ii) The individual distant-site physician or practitioner is privileged at the distant- site telemedicine entity providing the telemedicine services, which provides the hospital with a current list of the distant-site physician’s or practitioner’s privileges at the distant-site telemedicine entity.
(iii) The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the hospital whose patients are receiving such telemedicine services is located.
(iv) With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician’s or practitioner’s performance of these privileges and sends the distant-site telemedicine entity such performance information for use in the periodic appraisal of the distant- site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital’s patients, and all complaints the hospital has received about the distant-site physician or practitioner.

Interpretive guidelines §482.22(a)(4)
For the purposes of this rule, a distant-site telemedicine entity is defined as an entity that -- (1) provides telemedicine services; (2) is not a Medicare-participating hospital; and (3) provides contracted services in a manner that enables a hospital using its services to meet all applicable Conditions of Participation, particularly those requirements related to the credentialing and privileging of practitioners providing telemedicine services to the patients of a hospital. A distant-site telemedicine entity would include a distant-site hospital that does not participate in the Medicare program that is providing telemedicine services to a Medicare-participating hospital. (See 76 FR 25553, May 5, 2011)
The hospital’s governing body has the option, when considering granting privileges to telemedicine physicians and practitioners, to have the hospital’s medical staff rely upon the credentialing and privileging decisions of the distant-site telemedicine entity for these physicians and practitioners. This process would be in lieu of the traditional process required under §482.22(a)(1) and §482.22(a)(2), whereby the medical staff conducts its own review of each telemedicine physician’s or practitioner’s credentials and makes a recommendation based on that individualized review.
In order to exercise this alternative credentialing and privileging option, the hospital’s governing body must ensure that its written agreement with the distant-site hospital enables the hospital, as required under the regulation at §482.12(e) governing services provided under arrangement, to comply with all applicable hospital Conditions of Participation. In particular, the written agreement between the hospital and the distant-site telemedicine entity must ensure that all of the following requirements are met:
• The distant-site telemedicine entity utilizes a medical staff credentialing and privileging process and standards that at least meets the standards for the medical staff of a hospital established at §482.12(a)(1) through (a)(7) and §482.22(a)(1) through (a)(2);
• The distant-site telemedicine entity provides a list to the hospital of all physicians and practitioners covered by the agreement, including their privileges at the distant-site telemedicine entity. The list may not include any physician or practitioner who does not hold privileges at the distant-site telemedicine entity. The list must be current, so the agreement must address how the distant-site telemedicine entity will keep the list current;
• Each physician or practitioner who provides telemedicine services to the hospital’s patients under the agreement holds a license issued or recognized by the State where the hospital is located. States may have varying requirements as to whether they will recognize an out-of-state license for purposes of practicing within their State, and they may also vary as to whether they establish different standards for telemedicine services. The licensure requirements governing in the State where the hospital whose patients are receiving the telemedicine services is located must be satisfied, whatever they may be; and
• The hospital has evidence that it reviews the telemedicine services provided to its patients and provides a written copy of this review to the distant-site telemedicine entity for the latter’s use in its periodic appraisal of the physicians and practitioners providing telemedicine services under the agreement. At a minimum, the hospital must review and send information to the distant-site telemedicine entity on all adverse events that result from a physician or practitioner’s provision of telemedicine services and on all complaints it has received about a telemedicine physician or practitioner.

482.22(b) Standard: Medical Staff Organization and Accountability

A-0347 482.22(b) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients.
(1) The medical staff must be organized in a manner approved by the governing body.
(2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy.
(3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following:
(i) An individual doctor of medicine or osteopathy.
(ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located.
(iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located.

Interpretive Guidelines §482.22(b)(1) – (3)
The conditions of participation create a system of checks and balances within an overall framework of collaboration between the governing body and the medical staff (and, to a certain degree, also between an individual practitioner and the hospital’s medical staff and governing body). Each has its own areas of authority. The medical staff has oversight of all practitioners practicing in the hospital through processes such as peer review and making recommendations concerning privileging and re-privileging. The governing body has the authority to establish the categories of healthcare professionals (regardless of the terms used to describe those categories) who are eligible for privileges and medical staff appointment. However, the governing body must rely on the medical staff to apply the criteria for privileging and appointment to those eligible candidates and to make their recommendations before the governing body makes a final decision to appoint or not appoint a practitioner to the medical staff. (77 FR 29042 May 16, 2012).
If the hospital uses a unified medical staff that it shares with other hospitals that are part of a multi-hospital system, this does not change the requirement for the medical staff to be well organized and accountable to the system’s governing body for the quality of care in each separately certified hospital.

Leadership of the medical staff
The members of the hospital’s medical staff must select, in accordance with the medical staff bylaws, rules or regulations approved by the governing body, a single individual to lead the medical staff and be responsible for the organization and conduct of the medical staff. This individual must be a doctor of medicine or osteopathy, or, if permitted by State law where the hospital is located, a doctor of dental surgery, dental medicine, or podiatric medicine. Removal of the leader of the medical staff may only occur in accordance with medical staff bylaws, rules or regulations.
If the hospital uses a unified medical staff, only one individual may be responsible for the organization and conduct of the unified medical staff; that individual may or may not hold privileges and practice at the hospital being surveyed. When the individual does not
practice at the hospital being surveyed and it is necessary to interview this individual as part of a survey, a telephone interview must be arranged.

Executive Committee
The medical staff bylaws, rules and regulations may provide for the members of the medical staff to select a smaller executive committee to which it delegates many of the functions of the medical staff, in order to increase the efficiency of its operations. If the medical staff has an executive committee, the majority of the voting members must be doctors of medicine (MDs) or osteopathy (DOs).

"For Information Only – Not Required/ Not to be Cited"
--A hospital is not required to have an executive committee. However, use of an executive committee may facilitate efficient and effective functioning of the medical staff in hospitals systems that use a unified medical staff, particularly if the executive committee includes members from each hospital that shares the unified medical staff.--

Accountability of the medical staff
The medical staff must be accountable to the hospital’s governing body for the quality of medical care provided to the patients. The medical staff demonstrates its accountability through its exercise of its duties related to appointment of members of the medical staff, its conduct of reappraisals, including peer reviews, its approval of policies and procedures as required under other conditions of participation and its leadership participation in the organization and implementation of the hospital’s quality assessment and performance improvement program required in accordance with §482.21.
If the hospital uses a unified medical staff, the medical staff continues to be accountable for the quality of care in each separately certified hospital that uses the unified medical staff.

A-0348 482.22(b)(4) - If a hospital is part of a hospital system consisting of multiple separately certified hospitals and the system elects to have a unified and integrated medical staff for its member hospitals, after determining that such a decision is in accordance with all applicable State and local laws, each separately certified hospital must demonstrate that:….

Interpretive Guidelines §482.22(b)(4)
A hospital that is part of a system consisting of multiple separately certified hospitals may use a single unified and integrated medical staff (hereafter referred to as a “unified medical staff”) that is shared with one or more of the other hospitals in the system. In other words, as long as the requirements of §482.22(b)(4) are met, it is not necessary for each separately-certified hospital within the system to have its own distinct medical staff organization and structure, including hospital-specific medical staff bylaws, rules and requirements, hospital-specific medical staff leadership, hospital-specific credentialing and peer review, etc. Instead, it may use one medical staff organization and structure for multiple hospitals, so long as all of the requirements of this section are met. However, separately certified hospitals which share a single unified and integrated medical staff must also share a system governing body, in accordance with the provisions of §482.12, since only one governing body may carry out the governing body’s medical staff responsibilities for a unified medical staff.
Note that a multi-campus hospital that has several inpatient campuses that are provider-based, remote locations of the hospital is not a multi-hospital system. A multi-campus hospital is one certified hospital, not several separately certified hospitals. A multi-campus hospital may not have separate medical staffs at each campus, since each hospital must have no more than one medical staff. A multi-campus hospital with one medical staff separate from that of other certified hospitals is not employing a unified medical staff as that term is used in this regulation. However, a multi-campus hospital that is part of a hospital system consisting of multiple separately certified hospitals may share a unified medical staff with other separately certified hospitals within the system.
It should also be noted that a hospital system that includes certain types of hospitals, i.e., Hospitals-within-Hospitals or Hospital Satellites, that are being paid under a Medicare payment system other than the Hospital Inpatient Prospective Payment System (IPPS) might jeopardize the Medicare payment status of those excluded hospitals if it owns both the tenant and host hospitals and uses a unified medical staff for both. This is the case even if the requirements of §482.22(b)(4) are met. However, surveyors do not assess compliance with or enforce the Medicare payment regulations that govern Hospitals-within-
Hospitals or Hospital Satellites.
When granting practitioners privileges to provide patient care, a hospital’s governing body must specify those hospitals in the system where the privileges apply, since, in addition to the qualifications of individual practitioners, the services provided at each hospital must be considered when granting privileges. For example, psychiatric hospitals do not offer surgical services, labor and delivery services, nuclear medicine, etc., so it would not be appropriate for practitioners practicing in these areas to hold privileges at psychiatric hospitals in a multi-hospital system that uses a unified medical staff. Likewise if a multi-hospital system covers a wide geographic area, many of its practitioners may have no interest in practicing on site at hospitals that are distant from their usual practice location(s). In addition, in order for the acceptance or opt-out provisions of §482.22(b)(4)(i) and (ii) to be workable, privileges must be granted on a hospital-specific basis to practitioners who actually practice or are likely to practice at the hospital.
The governing body in a multi-hospital system must elect to exercise this option. Since a number of hospital systems interpreted the Medical Staff CoP to permit a unified and integrated medical staff prior to publication of the final rule at §482.22(b)(4) on May 12, 2014 or its effective date on July 11, 2014, the existence of a unified medical staff prior to July 11, 2014 is considered evidence of the hospital’s governing body’s election of this option.
• This does not relieve the governing body of the responsibility to conduct a review of all applicable State and local laws, including regulations, and make a determination that use of a unified medical staff that is shared by multiple hospitals does not conflict with those laws. The hospital must maintain documentation of this determination by its governing body.
• Nor does it relieve the governing body of the obligation to inform the medical staff of the right to vote to opt out of a unified medical staff arrangement. (See discussion of §482.22(b)(4)(ii), which requires notification of all members of this right. Failure to comply would be cited under the tag for §482.22(b)(4)(ii).)
If a hospital is part of a multi-hospital system that wishes to establish a unified medical staff for some or all of its separately certified hospitals after the July 11, 2014 effective date of the final rule at §482.22(b)(4), then the hospital’s system governing body must document in writing its decision to elect to use the unified medical staff option, conditioned upon acceptance of a unified medical staff by the hospital’s medical staff in accordance with §482.22(b)(4)(i).The governing body must also document its determination that such election does not conflict with State or local laws, including regulations.
Surveyors are not expected, as part of their assessment of compliance with the Medicare CoPs, to evaluate whether the governing body’s determination of compliance with State and local law is accurate. This would be handled by the appropriate State or local authorities, or, if the State Survey Agency is the appropriate authority, under its State licensure or other authority and not as part of a Federal survey.

A-0349 482.22(b)(4)(i) The medical staff members of each separately certified hospital in the system (that is, all medical staff members who hold specific privileges to practice at that hospital) have voted by majority, in accordance with medical staff bylaws, either to accept a unified and integrated medical staff structure or to opt out of such a structure and to maintain a separate and distinct medical staff for their respective hospital;

Interpretive Guidelines §482.22(b)(4)(i)
The decision for a particular certified hospital in a multi-hospital system to use a unified medical staff is a joint one arrived at by the:
• Election of the unified medical staff option by the hospital’s governing body; and
• Acceptance by a majority of the medical staff members who hold privileges to practice at that particular hospital, voting in accordance with the medical staff bylaws.
The medical staff of each hospital also has the option to opt out of an existing unified medical staff, when a majority of the medical staff members who hold privileges to practice at that particular hospital, voting in accordance with the medical staff bylaws, vote to do so.
For purposes of voting on whether to accept or opt out of a unified medical staff, the term “privileges to practice at that particular hospital” is interpreted to mean only those practitioners who hold privileges to practice on-site at the hospital. Practitioners who hold only telemedicine privileges at a hospital are not to be included when identifying which practitioners are eligible to vote nor what constitutes a majority of the practitioners holding privileges at the hospital.
A hospital that is part of a hospital system is expected to have medical staff bylaws, rules and requirements that address the regulatory requirements of §482.22(b)(4)(i) – (iv) related to using a unified medical staff, including the processes under the bylaws for voting to accept or opt out of a unified medical staff. This is the case even if the hospital currently does not use a unified medical staff.
If the hospital uses a unified medical staff, depending on State law requirements, the unified medical staff bylaws, rules and requirements required at §482.22(b)(4)(ii) may substitute for hospital-specific medical staff bylaws, rules and requirements. However, CMS recognizes that the process of amending bylaws can be a lengthy one. Hospitals that were part of a hospital system using a unified medical staff as of July 11, 2014 are expected to have initiated the process before December 31, 2014 to effect the necessary amendments, even if the process is not completed until after that date. Likewise, when a
hospital is acquired by a system but maintains separate participation in Medicare, if the hospital’s governing body elects to use a unified medical staff and the medical staff accepts such election, the hospital is expected to initiate the necessary changes to its medical staff bylaws, rules and requirements no later than six months after the effective date of its acquisition.
In establishing medical staff bylaws governing medical staff voting on the questions of acceptance of, or opting out of, a unified medical staff, the medical staff and the governing body, which must approve the revised bylaws in accordance with §482.12(a)(4), have the flexibility to determine the details of the voting process, such as how an acceptance or opt-out vote can be requested; whether all categories of members holding privileges to practice on-site at the hospital are afforded medical staff voting rights; whether voting will be in writing and open or by secret ballot, etc. However, a hospital may not set up bylaws that unduly restrict the rights of medical staff members when voting on the issue of accepting or opting out of a unified medical staff structure. For example:
Hospitals may not establish different criteria as to which categories of medical staff members have voting rights with respect to a vote to accept or opt out of a unified medical staff than are used for other amendments to the medical staff’s bylaws, except as required under the regulation at §482.22(b)(4) that only members holding privileges to practice at the hospital may vote. (See also the discussion below concerning delegation of authority to the medical staff executive committee.)
Hospitals may not require as a condition for holding an opt-out vote that there be a petition signed by the same number of voting members as would be required for a successful vote to opt out.
Hospitals may require for a successful acceptance or opt-out vote a “supermajority”, that is, a majority that is greater than a simple majority of more than fifty percent of the medical staff members with voting rights holding privileges to practice at the hospital, so long as the same type of supermajority is otherwise generally required to amend the medical staff’s bylaws, rules and requirements.
In the case where a hospital system has a unified medical staff and members of the staff at a hospital in the system exercise their right to hold a vote on the question of opting out, the hospital may not permit delegation of an opt-out decision to the unified medical staff’s executive committee. This is the case even when the executive committee is otherwise delegated authority to amend unified medical staff bylaws, rules and requirements that it recommends for approval to the governing body. In cases where the bylaws permit such delegation to the unified medical staff’s executive committee for other purposes, a “majority” for purposes of conducting a vote on whether to opt out of a unified medical staff consists of a simple majority, that is, any number which is greater than fifty percent, of the medical staff members practicing at the hospital who have voting privileges.
o On the other hand, in the case where a hospital that is part of a hospital system but has a separate medical staff is holding a vote on whether to accept participating in a unified medical staff, a hospital may permit a vote by members of the hospital’s medical staff executive committee only, if this is consistent with the hospital’s medical staff bylaws governing amendments in effect at the time of the vote.
A hospital may establish a minimum interval between acceptance or opt-out votes, such as not permitting a vote more than once every two years. However, a minimum interval between votes longer than two years might unduly restrain the rights of the members of the medical staff and would not be permissible.
It is not expected that the medical staff bylaws, rules and requirements that were in effect as of July 11, 2014 would address the issue of a unified medical staff, nor the process of voting by medical staff members at each hospital to accept or opt out of a unified medical staff. Although it is expected that the medical staff bylaws, rules and requirements of hospitals that are part of a hospital system will be amended in a timely fashion as discussed above, this does not mean that a vote to accept or opt out of a unified medical staff may not take place prior to enactment of such amendments.
Voting is governed by the hospital’s medical staff bylaws in effect at the time of the vote, except that only voting members of the medical staff who hold privileges to practice on-site at that hospital may participate in the vote. With respect to what constitutes a “majority,” the provisions of the bylaws governing voting rights and voting procedures at the time of the vote apply. However, as discussed above, in the case of a vote to opt-out of a unified medical staff, the vote may not be delegated to the executive committee of the unified medical staff.
Since a number of hospital systems interpreted the Medical Staff CoP to permit a unified medical staff prior to publication of the final rule at §482.22(b)(4) on May 12, 2014 or its effective date of July 11, 2014, in the case of a hospital’s use of a unified medical staff which began prior to the latter date, it is not necessary for the hospital to hold a vote among the members of the medical staff who hold privileges at that hospital to determine whether the majority accepts the continued use of a unified medical staff. However, the governing body is expected to formally notify the medical staff practicing at each hospital of its preference to continue using a unified medical staff arrangement, as well as of the right of the medical staff holding privileges at each hospital to vote to opt out of the unified medical staff.
If the system governing body of a hospital that is part of the multi-hospital system but which has a separate medical staff elects after July 11, 2014 to create a system unified medical staff structure and/or to include the hospital’s medical staff in an already existing unified medical staff structure, the hospital must arrange for a vote by medical staff members, in accordance with the medical staff bylaws, on whether or not to accept use of a unified medical staff for their hospital. The hospital may not use a unified medical staff unless a majority of its medical staff members holding voting rights vote, in accordance with the hospital’s medical staff bylaws, to accept a unified medical staff.
Even if a majority of a hospital’s medical staff has voted to use a unified medical staff in the past, the members of the unified medical staff with voting rights and holding privileges to practice on-site at that hospital still retain the right to hold a vote to opt out of the unified medical staff structure at a future date. If a majority of the staff with voting rights and holding privileges at that hospital vote, in accordance with the unified medical staff’s bylaws, to opt out, then the hospital must establish a separate medical staff.

A-0350 482.22(b)(4)(ii) The unified and integrated medical staff has bylaws, rules, and requirements that describe its processes for self-governance, appointment, credentialing, privileging, and oversight, as well as its peer review policies and due process rights guarantees, and which include a process for the members of the medical staff of each separately certified hospital (that is, all medical staff members who hold specific privileges to practice at that hospital) to be advised of their rights to opt out of the unified and integrated medical staff structure after a majority vote by the members to maintain a separate and distinct medical staff for their hospital;

Interpretive Guidelines §482.22(b)(4)(ii)
A hospital that uses a unified medical staff must ensure that the unified medical staff has one set of bylaws, rules and requirements that describe the medical staff’s processes for self-governance, appointment, credentialing, privileging, oversight, peer review, and due process rights guarantees. Consistent with the requirements for a system governing body in §482.12, the documentation of the bylaws, rules and requirements that apply to the unified medical staff must identify each separately certified hospital that has elected to use a unified medical staff and which, therefore, is covered by the unified medical staff bylaws, rules and regulations. Depending on State law requirements, the unified medical staff bylaws, rules and requirements may be in addition to or instead of hospital-specific medical staff bylaws, rules and requirements. The unified medical staff’s bylaws, rules and requirements must not conflict with any of the specific requirements for medical staff found elsewhere in §482.12 or §482.22, or under any other hospital CoPs which assign responsibilities to the hospital’s medical staff.
The unified medical staff’s bylaws, rules and requirements addressing its self-governance processes must provide for a process by which members of the unified medical staff holding privileges to practice on site at each separately certified hospital are advised that they have the right to vote on whether to opt out of participation in the unified medical staff, and that if a majority vote to opt out, then the hospital must establish a separate medical staff. At a minimum, the hospital must advise medical staff members in writing of their right to vote by majority to opt out when medical staff membership is first granted, and when it is renewed.
The bylaws must address the process by which a vote to opt out of the unified medical staff is conducted. In establishing the unified medical staff bylaws governing opting out, the unified medical staff, and the system governing body, which must approve the medical staff’s bylaws, rules or regulations in accordance with §482.12(a)(4), have the flexibility to determine the details of the voting process, such as how an acceptance or opt-out vote can be requested; whether all categories of members holding privileges to practice on-site at the hospital are afforded medical staff voting rights; whether voting will be in writing and open or by secret ballot, etc. However, the unified medical staff and system governing body may not set up bylaws that unduly restrict the rights of medical staff members at each separately certified hospital to vote whether to accept or opt out of a unified medical staff structure. For example:
The bylaws, rules and requirements may not establish different criteria as to which categories of medical staff members have voting rights with respect to a vote to accept or opt out of a unified medical staff than are used for any other type of voting the medical staff engages in, except as required under the regulation at §482.22(b)(4) that only members holding privileges to practice at the hospital may vote. (See also the discussion below concerning delegation of authority to the medical staff executive committee.)
The bylaws, rules and requirements may not require as a condition for holding an opt-out vote that there be a petition signed by the same number of voting members as would be required for a successful vote to opt out.
The bylaws, rules and requirements may require for a successful acceptance or opt-out vote a “super-majority,” that is, a majority that is greater than a simple majority of more than fifty percent of the medical staff members with voting rights holding privileges to practice at the hospital, so long as the same type of supermajority is otherwise required to amend the unified medical staff’s bylaws, rules and requirements.
In the case where a hospital system has a unified medical staff and members of the staff at a hospital in the system exercise their right to hold a vote on the question of opting out, the unified medical staff bylaws may not permit delegation of an opt-out decision to the unified medical staff’s executive committee. This is the case even when the executive committee is otherwise delegated authority to amend unified medical staff bylaws, rules and requirements that it recommends for approval to the governing body. In cases where the bylaws permit such delegation to the unified medical staff’s executive committee for other purposes, a “majority” for purposes of conducting a vote on whether to opt out of a unified medical staff consists of a simple majority, that is, any number which is greater than fifty percent of the medical staff members practicing at the hospital who have voting privileges.
The bylaws, rules and requirements may establish a minimum interval between acceptance or opt-out votes, such as not permitting a vote more than once every two years. However, minimum interval between votes longer than two years might unduly restrain the rights of the members of the medical staff and would not be permissible.

A-0351 482.22(b)(4)(iii) The unified and integrated medical staff is established in a manner that takes into account each member hospital’s unique circumstances and any significant differences in patient populations and services offered in each hospital;

Interpretive Guidelines §482.22(b)(4)(iii)
The separately certified hospitals belonging to a multi-hospital system and using a single unified medical staff may be very different from each other, presenting different needs and challenges for the medical staff. As a result, the unified medical staff is expected to take these differences into account rather than using a one-size-fits-all approach for all of its policies and procedures. For example, a multi-hospital system may:
• Consist of a mixture of different types of hospitals, such as short-term acute care hospitals, psychiatric hospitals, rehabilitation hospitals, children’s hospitals, and long-term care hospitals. As a result, they would offer different types of services to different patient populations. This could have implications for medical staff functions such as the periodic review of credentials and privileges and ongoing peer review of the quality of medical care. It could also have implications for other responsibilities the medical staff has under various CoPs. For example, the medical staff has a key role in the development and oversight of the use of standing orders/protocols, but these orders/protocols may need to be specific to each hospital, reflecting the types of services a hospital offers and its patient population;
Consist of hospitals that differ in size, ranging from comparatively small hospitals in rural areas, or which provide specialized rehabilitation or long term care hospital services, to very large short term acute care service hospitals. Such differences could have implications for various medical staff requirements, such as on-call requirements.
Consist of hospitals that differ as to whether they are teaching hospitals or not, which would have implications for policies concerning the roles and supervision of residents.
Consist of hospitals that are located in different states which have different licensure requirements affecting the organization and composition of the medical staff. For example, in one state it might be permissible for non-physician practitioners to be members of the medical staff, while in another the medical staff is limited to physicians.
On the other hand, a multi-hospital system may have a conscious strategy of having hospitals that are very similar to each other in terms of size, services, patient populations served, and type of location. In this case, the unified medical staff would have fewer challenges in addressing the needs of each hospital, and might have more policies that are uniform across the medical staff.
In all cases the hospital’s leadership and the medical staff leadership must be able to explain how the way in which the unified medical staff is organized and functions takes account of and responds to the unique circumstances of the hospital that is being surveyed.

A-0352 482.22(b)(4)(iv) The unified and integrated medical staff establishes and implements policies and procedures to ensure that the needs and concerns expressed by members of the medical staff, at each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated medical staff has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed.

Interpretive Guidelines §482.22(b)(4)(iv)
The hospital’s unified medical staff must have written policies and procedures that address how it considers and addresses needs and concerns expressed by members who practice at the hospital. This provision is not about an individual medical staff member’s concerns with privileges granted or not granted to him/her, peer review results, due process issues, etc., since these matters are addressed under the requirements at §482.22(a) and (c) as well as §482.22(b)(4)(ii). Instead, this provision addresses a requirement for the unified medical staff to consider and address concerns that practitioners have concerning their own hospital’s needs. For example, physicians practicing in a children’s hospital may have concerns about having protocols for medication administration that reflect specific pediatric patient concerns, or physicians practicing in a small rural hospital may have concerns about how to get timely telemedicine consults from their colleagues in urban areas.
The medical staff has flexibility in establishing its written policies and procedures for addressing these local concerns, but at a minimum they must cover the following:
A process by which members who practice at a hospital can raise their local concerns and needs with the unified medical staff’s leadership;
How members are informed of the process by which they can raise their local concerns and needs;
A process for referring the concerns and needs raised to the appropriate committee or other group within the medical staff for due consideration; and
Documentation of the outcome of the medical staff’s review of the concerns and needs raised.

482.22(c) Standard: Medical Staff Bylaws

A-0353 482.22(c) The medical staff must adopt and enforce bylaws to carry out its responsibilities. The bylaws must:

Interpretive Guidelines §482.22(c)
The medical staff must regulate itself by bylaws that are consistent with the requirements of this and other CoPs that mention medical staff bylaws, as well as State laws. The bylaws must be enforced and revised as necessary.

A-0354 482.22(c)(1) Be approved by the governing body.

Interpretive Guidelines §482.22(c)(1)
Medical staff bylaws and any revisions of those bylaws must be submitted to the governing body for approval. The governing body has the authority to approve or disapprove bylaws suggested by the medical staff. The bylaws and any revisions must be approved by the governing body before they are considered effective.

A-0355 482.22(c)(2) Include a statement of the duties and privileges of each category of medical staff (e.g., active, courtesy, etc.)

Interpretive Guidelines §482.22(c)(2)
The medical staff bylaws must state the duties and scope of medical staff privileges each category of practitioner may be granted. Specific privileges for each category must clearly and completely list the specific privileges or limitations for that category of practitioner. The specific privileges must reflect activities that the majority of practitioners in that category can perform competently and that the hospital can support.
Although the medical staff bylaws must address the duties and scope for each category of practitioner, this does not mean that each individual practitioner within the category may automatically be granted the full range of privileges. It cannot be assumed that every practitioner can perform every task/activity/privilege that is specified for the applicable category of practitioner. The individual practitioner’s ability to perform each task/activity/privilege must be individually assessed.

A-0356 482.22(c)(3) Describe the organization of the medical staff.

Interpretive Guidelines §482.22(c)(3)
The medical staff bylaws must describe the organizational structure of the medical staff, and lay out the rules and regulations of the medical staff to make clear what are acceptable standards of patient care for all diagnostic, medical, surgical, and rehabilitative services.

A-0357 482.22(c)(4) Describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body.

Interpretive Guidelines §482.22(c)(4)
The medical staff bylaws must describe the qualifications to be met by a candidate for medical staff membership/privileges in order for the medical staff to recommend the candidate be approved by the governing body. The bylaws must describe the privileging process to be used in the hospital. The process articulated in the medical staff bylaws must include criteria for determining the privileges that may be granted to individual practitioners and a procedure for applying the criteria to individual practitioners that considers:
• Individual character;
• Individual competence;
• Individual training;
• Individual experience; and
• Individual judgment.
The medical staff may not rely solely on the fact that a MD/DO is, or is not, board-certified in making a judgment on medical staff membership. This does not mean that the medical staff is prohibited from requiring board certification when considering a MD/DO for medical staff membership; only that such certification is not the only factor that the hospital considers. After analysis of all of the criteria, if all criteria are met except for board certification, the medical staff has the discretion to not recommend that individual for medical staff membership/privileges.
The bylaws must apply equally to all practitioners in each professional category of practitioners.
The medical staff then recommends individual candidates that meet those requirements to the governing body for appointment to the medical staff.

A-0358 482.22(c)(5) Include a requirement that: (i) A medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The medical history and physical examination must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.

Interpretive Guidelines §482.22(c)(5)(i)
The purpose of a medical history and physical examination (H&P) is to determine whether there is anything in the patient's overall condition that would affect the planned course of the patient's treatment, such as a medication allergy, or a new or existing co-morbid condition that requires additional interventions to reduce risk to the patient.
The Medical Staff bylaws must include a requirement that an H&P be completed and documented for each patient no more than 30 days prior to or 24 hours after hospital admission or registration, but prior to surgery or a procedure requiring anesthesia services. The H&P may be handwritten or transcribed, but always must be placed within the patient’s medical record within 24 hours of admission or registration, or prior to surgery or a procedure requiring anesthesia services, whichever comes first.
An H&P is required prior to surgery and prior to procedures requiring anesthesia services, regardless of whether care is being provided on an inpatient or outpatient basis. (71 FR 68676) An H&P that is completed within 24 hours of the patient’s admission or registration, but after the surgical procedure, procedure requiring anesthesia, or other procedure requiring an H&P would not be in compliance with this requirement.
The medical history and physical examination must be completed and documented by a physician (as defined in section 1861(r) of the Act), oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.
Section 1861(r) defines a physician as a:
• Doctor of medicine or osteopathy;
• Doctor of dental surgery or of dental medicine;
• Doctor of podiatric medicine;
• Doctor of optometry; or a
• Chiropractor.
In all cases the practitioners included in the definition of a physician must be legally authorized to practice within the State where the hospital is located and providing services within their authorized scope of practice. In addition, in certain instances the Social Security Act attaches further limitations as to the type of hospital services for which a practitioner is considered to be a “physician.” For example, a chiropractor is considered a physician only with respect to treatment by means of manual manipulation of the spine (to correct a subluxation).
Other qualified licensed individuals are those licensed practitioners who are authorized in accordance with their State scope of practice laws or regulations to perform an H&P and who are also formally authorized by the hospital to conduct an H&P. Other qualified licensed practitioners could include nurse practitioners and physician assistants.
More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When performance, documentation, and authentication are split among qualified practitioners, the practitioner who authenticates the H&P will be held responsible for its contents. (71 FR 68675)
A hospital may adopt a policy allowing submission of an H&P prior to the patient’s hospital admission or registration by a physician who may not be a member of the hospital's medical staff or who does not have admitting privileges at that hospital, or by a qualified licensed individual who does not practice at that hospital but is acting within his/her scope of practice under State law or regulations. Generally, this occurs where the H&P is completed in advance by the patient’s primary care practitioner. (71 FR 68675)
When the H&P is conducted within 30 days before admission or registration, an update must be completed and documented by a licensed practitioner who is credentialed and privileged by the hospital’s medical staff to perform an H&P. (71 FR 68675) (See discussion of H&P update requirements at 42 CFR 482.22(c)(5)(ii).)
Surveyors should cite noncompliance with the requirements of 42 CFR
482.22(c)(5) for failure by the hospital to comply with any of this standard's components.

A-0359 482.22(c)(5) Include a requirement that: (ii) An updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration. The updated examination of the patient, including any changes in the patient's condition, must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.

Interpretive Guidelines 482.22(c)(5)(ii)
The Medical Staff bylaws must include a requirement that when a medical history and physical examination has been completed within 30 days before admission or registration, an updated medical record entry must be completed and documented in the patient's medical record within 24 hours after admission or registration. The examination must be conducted by a licensed practitioner who is credentialed and privileged by the hospital’s medical staff to perform an H&P. In all cases, the update must take place prior to surgery or a procedure requiring anesthesia services. The update note must document an examination for any changes in the patient's condition since the patient's H&P was performed that might be significant for the planned course of treatment. The physician or qualified licensed individual uses his/her clinical judgment, based upon his/her assessment of the patient’s condition and co-morbidities, if any, in relation to the patient’s planned course of treatment to decide the extent of the update assessment needed as well as the information to be included in the update note in the patient’s medical record.
If, upon examination, the licensed practitioner finds no change in the patient's condition since the H&P was completed, he/she may indicate in the patient's medical record that the H&P was reviewed, the patient was examined, and that "no change" has occurred in the patient's condition since the H&P was completed (71 FR 68676). Any changes in the patient’s condition must be documented by the practitioner in the update note and placed in the patient’s medical record within 24 hours of admission or registration, but prior to surgery or a procedure requirement anesthesia services. Additionally, if the practitioner finds that the H&P done before admission is incomplete, inaccurate, or otherwise unacceptable, the practitioner reviewing the H&P, examining the patient, and completing the update may disregard the existing H&P, and conduct and document in the medical record a new H&P within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia.

A-0363 482.22(c)(6) Include criteria for determining the privileges to be granted to individual practitioners and a procedure for applying the criteria to individuals requesting privileges. For distant-site physicians and practitioners requesting privileges to furnish telemedicine services under an agreement with the hospital, the criteria for determining privileges and the procedure for applying the criteria are also subject to the requirements in §482.12(a)(8) and (a)(9), and §482.22(a)(3) and (a)(4).

Interpretive Guidelines §482.22(c)(6)
All patient care is provided by or in accordance with the orders of a physician or practitioner who meets the medical staff criteria and procedures for the privileges granted, who has been granted privileges in accordance with those criteria by the governing body, and who is working within the scope of those granted privileges.
Privileges are granted by the hospital’s governing body to individual practitioners based on the medical staff’s review of that individual practitioner’s qualifications and the medical staff’s recommendations for that individual practitioner to the governing body. However, in the case of telemedicine physicians and practitioners providing telemedicine services under an agreement, the governing body has the option of having the medical staff rely upon the credentialing and privileging decisions of the distant-site hospital or telemedicine entity with which the hospital has entered into an agreement. When the governing body has exercised this option, the medical staff’s bylaws must include a provision allowing the medical staff to rely upon the credentialing and privileging decisions of a distant-site hospital or telemedicine entity when that distant-site hospital or entity is required under the terms of its agreement with the hospital to employ a credentialing and privileging process that conforms to the provisions of §482.12(a)(8) and (a)(9), and §482.22(a)(3) and (a)(4).

A-0364 482.22(d) The medical staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. The mechanism for documenting permission to perform an autopsy must be defined. There must be a system for notifying the medical staff, and specifically the attending practitioner, when an autopsy is being performed.

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CoP: Nursing Services

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482.23 Nursing Services

A-0385 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse.

Interpretive Guidelines §482.23
The hospital must have an organized nursing service and must provide on premise nursing services 24 hours a day, 7 days a week with at least 1 registered nurse (RN) furnishing or supervising the service 24 hours a day, 7 days a week (Exception: small rural hospitals operating under a waiver as discussed in §482.23(b)(1)).
The Social Security Act (SSA) at §1861(b) states that nursing services must be furnished to inpatients and furnished by the hospital. The SSA at §1861(e) further requires that the hospital have a RN on duty at all times (except small rural hospitals operating under
a nursing waiver).
The nursing service must be a well-organized service of the hospital and under the direction of a registered nurse.
The nursing service must be integrated into the hospital-wide QAPI program.

482.23(a) Standard: Organization

A-0386 482.23(a) The hospital must have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care. The director of the nursing service must be a licensed registered nurse. He or she is responsible for the operation of the service, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.

Interpretive Guidelines §482.23(a)
The hospital may have only one nursing service hospital-wide and the single nursing service must be under the direction of one RN.
The director of the nursing service must be a currently licensed RN and he/she is responsible for the operation of the nursing service. The operation of the nursing service would include the quality of the patient care provided by the nursing service.
The director of the nursing service must determine and provide the types and numbers of nursing care personnel necessary to provide nursing care to all areas of the hospital.
The organization will include various configurations of the following hospital personnel as determined necessary by the hospital and the Director of Nursing:
• Assistant/Associate Director(s);
• Supervisors/Coordinators;
• Head Nurses/Nurse Managers;
• Staff Nurses;
• Unit Secretaries/Clerks;
• Nurses Aide/Orderlies.

482.23(b) Standard: Staffing and Delivery of Care

A-0392 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for bedside care of any patient.

Interpretive Guidelines §482.23(b)
The nursing service must ensure that patient needs are met by ongoing assessments of patients’ needs and provides nursing staff to meet those needs. There must be sufficient numbers, types and qualifications of supervisory and staff nursing personnel to respond to the appropriate nursing needs and care of the patient population of each department or nursing unit.
There must be a RN physically present on the premises and on duty at all times. Every inpatient unit/department/location within the hospital-wide nursing service must have adequate numbers of RNs physically present at each location to ensure the immediate availability of a RN for the bedside care of any patient.
A RN would not be considered immediately available if the RN were working on more than one unit, building, floor in a building, or provider (distinct part SNF, RHC, excluded unit, etc.) at the same time.
Staffing schedules must be reviewed and revised as necessary to meet the patient care needs and to make adjustments for nursing staff absenteeism.

A-0393 482.23(b)(1) The hospital must provide 24-hour nursing services furnished or supervised by a registered nurse, and have a licensed practical nurse or registered nurse on duty at all times, except for rural hospitals that have in effect a 24-hour nursing waiver granted under 488.54(c)of this chapter.

Interpretive Guidelines §482.23(b)(1)
The hospital must provide nursing services 24 hours a day, 7 days a week. An LPN can provide nursing services if an RN, who is immediately available for the bedside care of those patients, supervises that care.

EXCEPTION: Section 488.54(c) sets forth certain conditions under which rural hospitals of 50 beds or fewer may be granted a temporary waiver of the 24-hour registered nurse requirement by the regional office.
Rural is defined as all areas not delineated as “urbanized” areas by the Census Bureau, in the most recent census. Temporary is defined as a one year period or less and the waiver cannot be renewed.

A-0394 482.23(b)(2) The nursing service must have a procedure to ensure that hospital nursing personnel for whom licensure is required have valid and current licensure.

Interpretive Guidelines §482.23(b)(2)
The hospital’s procedure must ensure that all nursing personnel have valid and current licensure that complies with State licensure laws. Furthermore, the Condition of Participation (CoP) Compliance with Federal, State and local laws (42 CFR 482.11) requires the hospital to assure that personnel meet applicable standards (such as continuing education, certification or training) required by State or local law.

A-0395 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient.

Interpretive Guidelines §482.23(b)(3)
A RN must supervise the nursing care for each patient. A RN must evaluate the care for each patient upon admission and when appropriate on an ongoing basis in accordance with accepted standards of nursing practice and hospital policy. Evaluation would include assessing the patient’s care needs, patient’s health status/conditioning, as well as the patient’s response to interventions.

A-0396 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient. The nursing care plan may be part of an interdisciplinary care plan.

Interpretive Guidelines §482.23(b)(4)
Nursing care planning starts upon admission. It includes planning the patient’s care while in the hospital as well as planning for discharge to meet post-hospital needs. A nursing care plan is based on assessing the patient’s nursing care needs (not solely those needs related to the admitting diagnosis). The assessment considers the patient’s treatment goals and, as appropriate, physiological and psychosocial factors and patient discharge planning. The plan develops appropriate nursing interventions in response to the identified nursing care needs. The nursing care plan is kept current by ongoing assessments of the patient’s needs and of the patient’s response to interventions, and updating or revising the patient’s nursing care plan in response to assessments. The nursing care plan is part of the patient’s medical record and must comply with the medical records requirements at §482.24.
Hospitals have the flexibility of developing the nursing care plan as part of a larger, coordinated interdisciplinary plan of care. This method may serve to promote communication among disciplines and reinforce an integrated, multi-faceted approach to a patient’s care, resulting in better patient outcomes. The interdisciplinary plan of care does not minimize or eliminate the need for a nursing care plan. It does, however, serve to promote the collaboration between members of the patient’s health care team.
The required documentation for the nursing component of an interdisciplinary care plan remains the same. For other components, the hospital should follow the current documentation policies that it uses to document services provided by other disciplines, such as services provided by physical therapists, occupational therapists, speech-language pathologists, and others. Documentation should follow the standards of practice for those disciplines in addition to any specific requirements that the hospital might want to establish. The documentation must also comply with the requirements of the medical records requirement at §482.24. (77 FR 29049, May 16, 2012)

A-0397 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available.

Interpretive Guidelines §482.23(b)(5)
A RN must make all patient care assignments. The director of the nursing service and the hospital are to ensure that nursing personnel with the appropriate education, experience, licensure, competence and specialized qualifications are assigned to provide nursing care for each patient in accordance with the individual needs of each patient.

A-0398 482.23(b)(6) Non-employee licensed nurses who are working in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel which occur within the responsibility of the nursing services.

Interpretive Guidelines §482.23(b)(6)
The hospital must ensure that there are adequate numbers of clinical nursing personnel to meet its patients nursing care needs. In order to meet their patient’s needs the hospital may supplement their hospital employed licensed nurses with volunteer and or contract non-employee licensed nurses.
The hospital and the director of the nursing service are responsible for the clinical activities of all nursing personnel. This would include the clinical activities of all non-employee nursing personnel (contract or volunteer).
Non-employee licensed nurses who are working at the hospital must adhere to the policies and procedures of the hospital. The hospital and the director of the nursing service are responsible for ensuring that non-employee nursing personnel know the hospital’s policies and procedures in order to adhere to those policies and procedures.
The hospital and the director of the nursing service ensure that each non-employee nursing care staff person is adequately supervised and that their clinical activities are evaluated. This supervision and evaluation of the clinical activities of each non-employee nursing staff person must be conducted by an appropriately qualified hospital-employed RN.

482.23(c) Standard: Preparation and Administration of Drugs.

A-0405 482.23(c)(1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under 482.12(c), and accepted standards of practice.
(i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under 482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations….
(2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures.

Interpretive Guidelines §§482.23(c)(1), (c)(1)(i) and (c)(2)
According to the Institute of Medicine of the National Academies, medication errors are among the most common medical errors, harming at least 1.5 million people each year.3 It has been estimated that drug-related adverse outcomes were noted in nearly 1.9 million inpatient hospital stays (4.7 percent of all stays), and 838,000 treat-and-release ED visits (0.8 percent of all visits).4 Although technological advances in electronic order entry, medication administration, and electronic medical records hold a great deal of promise for decreasing medication errors, there are a multitude of human and environmental factors that will impact their success. The increasing complexity of medical care and patient acuity present significant challenges that require an approach to medication administration that takes advantage of available technology while recognizing that it must be integrated into the medication administration work processes in a manner that meets the needs of patients and promotes their safety.
The regulations at §482.23(c) and §482.23(c)(1) promote safety in the preparation and administration of drugs and biologicals to hospital patients by requiring preparation and administration in accordance with:
-- Footnotes:3Institute of Medicine. Preventing Medication Errors. Washington DC: The National Academies Press, 2007.
4Lucado, Jennifer, et al, Medication-Related Adverse Outcomes in U.S. Hospitals and Emergency Departments. Statistical Brief #109, April, 2011. Healthcare Cost and Utilization Project, Agency For Healthcare Research and Quality, Rockville, MD.--
• Federal and State law;
• Accepted standards of practice;
• Orders of the practitioner(s) responsible for the patient’s care, as specified under §482.12(c) or of another practitioner as permitted under State law, hospital policy and medical staff bylaws, rules and regulations; and
• Medical staff-approved policies and procedures.

Federal and State Law
Federal law regulates the approval and classification of drugs and biologicals. Individual States establish laws and regulations which specify the scope of practice for various types of licensed healthcare professionals, including which medications they may prescribe and administer, including controlled substances.

Accepted Standards of Practice
Hospital policies and procedures for the preparation and administration of all drugs and biologicals must not only comply with all applicable Federal and State laws, but also must be consistent with accepted standards of practice based on guidelines or recommendations issued by nationally recognized organizations with expertise in medication preparation and administration. Examples of such organizations include, but are not limited to:
• American Society of Health-System Pharmacists (http://www.ashp.org/default.aspx)
• Infusion Nurses Society (http://www.ins1.org)
• Institute for Safe Medication Practices (www.ismp.org)
• National Coordinating Council for Medication Error Reporting and Prevention (www.nccmerp.org)
• U.S Pharmacopeia (www.usp.org)

Orders of an authorized practitioner
Drugs must be administered in response to an order from a practitioner, or on the basis of a standing order which is appropriately authenticated subsequently by a practitioner. (See §482.23(c)(1) (ii) concerning standing orders.) Generally, the ordering practitioner is the practitioner(s) responsible for the care of the patient in accordance with §482.12(c). However, other practitioners not specified under §482.12(c) may write orders for the preparation and administration of drugs and biologicals, if they are acting in accordance with State law, including scope of practice laws, hospital policies and procedures, and medical staff bylaws, rules and regulations. This includes practitioners ordering outpatient services who do not have privileges in the hospital but who are permitted under their State scope of practice and authorized by hospital and medical staff policy to order outpatient services.
In accordance with standard practice, all practitioner orders for the administration of drugs and biologicals must include at least the following:
• Name of the patient;
• Age and weight of the patient, to facilitate dose calculation when applicable. Policies and procedures must address weight-based dosing for pediatric patients as well as in other circumstances identified in the hospital’s policies. (Note that dose calculations are based on metric weight (kg, or g for newborns). If a hospital permits practitioners to record weight in either pounds or using metric weight, the opportunity for error increases, since some orders would require conversion while others would not. Accordingly, hospitals must specify a uniform approach to be used by prescribing practitioners. For example, a hospital could require all prescribers to use pounds or ounces and have the electronic ordering system or the pharmacy convert to metric);
• Date and time of the order;
• Drug name;
• Dose, frequency, and route;
• Dose calculation requirements, when applicable;
• Exact strength or concentration, when applicable;
• Quantity and/or duration, when applicable;
• Specific instructions for use, when applicable; and;
• Name of the prescriber.

Medical Staff Approved Policies and Procedures
The hospital’s medical staff must approve policies and procedures for medication administration, consistent with the requirements of Federal and State law and accepted standards of practice. It is recommended that the medical staff consult with nurses, pharmacists, Quality Assessment and Performance Improvement program staff, and others in developing these policies and procedures. The adopted policies and procedures must address key issues related to medication administration, which include but are not limited to:

Personnel authorized to administer medication
§482.23(c)(2) requires that all drugs and biologicals are administered by, or under the supervision of, nursing or other personnel, in accordance with Federal or State law and approved medical staff policies and procedures. State law requirements include licensure requirements. Policies and procedures must identify categories of licensed personnel and the types of medications they are permitted to administer, in accordance with state laws. The policies and procedures must also address education and training for all personnel administering drugs and biologicals.
Medication administration education and training is typically included in hospital orientation or other continuing education for nursing staff and other authorized healthcare personnel. Training or continuing education topics regarding medication administration may include but are not limited to the following:
• Safe handling and preparation of authorized medications;
• Knowledge of the indications, side effects, drug interactions, compatibility, and dose limits of administered medications;
• Equipment, devices, special procedures, and/or techniques required for medication administration;
Policies and procedures must address the required components of the training and if the training provided during hospital orientation imparts sufficient education or whether ongoing in-services or continuing education will be required to demonstrate competence.

Basic safe practices for medication administration
The hospital’s policies and procedures must reflect accepted standards of practice that require the following be confirmed prior to each administration of medication (often referred to as the “five rights” of medication administration practice):
• Right patient: the patient’s identity— acceptable patient identifiers include, but are not limited to: the patient’s full name; an identification number assigned by the hospital; or date of birth. Identifiers must be confirmed by patient wrist band, patient identification card, patient statement (when possible) or other means outlined in the hospital’s policy. The patient’s identification must be confirmed to be in agreement with the medication administration record and medication labeling prior to medication administration to ensure that the medication is being given to the correct patient.
• Right medication: the correct medication, to ensure that the medication being given to the patient matches that prescribed for the patient and that the patient does not have a documented allergy to it;
• Right dose: the correct dose, to ensure that the dosage of the medication matches the prescribed dose, and that the prescription itself does not reflect an unsafe dosage level (i.e., a dose that is too high or too low);
• Right route: the correct route, to ensure that the method of administration – orally, intramuscular, intravenous, etc., is the appropriate one for that particular medication and patient; and
• Right time: the appropriate time, to ensure adherence to the prescribed frequency and time of administration.
NOTE: the “5 rights” focus specifically on the process of administering medications. The medication process is generally recognized as consisting of five stages: ordering/prescribing; transcribing and verifying; dispensing and delivering; administering; and monitoring/reporting. Errors may occur in other components of the process, even when there is strict adherence to the “5 rights” of medication administration, for example when there has been a prescribing or a dispensing error. Hospitals are also expected to comply with requirements under the Pharmaceutical Services CoP at §482.25 and the patient safety requirements under the Quality Assessment and Performance Improvement CoP at §482.21, using a comprehensive systems approach to all components of the medication process.

"For Information – Not Required/Not to be Cited"
--Recent literature* identifies up to nine “rights” of medication administration including:
 Right patient
 Right drug
 Right route
 Right time
 Right dose
 Right documentation
 Right action (appropriate reason)
 Right form
 Right response
However, other sources refer to 8 or 10 “rights, and some of these topics, such as right action, appear to involve prescribing and/or dispensing. Accordingly, there does not (yet) appear to be consensus about expanding beyond the 5 “rights.”
*Reference: Elliott, M. and Lis, Y. (2010). The Nine Rights of Medication Administration: An Overview. British Journal of Nursing, Vol. 19, 5, 300-305.--

Hospitals are encouraged to promote a culture in which it is not only acceptable, but also strongly encouraged, for staff to bring to the attention of the prescribing practitioner questions or concerns they have regarding medication orders. Any questions about orders for drugs or biologicals are expected to be resolved promptly, whether they arise prior to the preparation, dispensing, or administration of the medication.
Hospitals must also ensure staff adherence to accepted standards of practice required to prevent healthcare-associated infections related to medication preparation and/or administration. Adherence to these standards is assessed under the infection control CoP at 42 CFR 482.42, and details about the required practices are found in the Hospital Infection Control Worksheet.
Compounded sterile preparations (CSPs) may also be a source of healthcare-associated infection if proper precautions are not followed. The applicable standards of practice for safe sterile compounding are, at a minimum, the standards published in The United States Pharmacopeia National Formulary Chapter <797> (“Pharmaceutical Compounding – Sterile Preparations”) and other relevant USP/NF Chapters (USP <797>). (See the guidance for §482.25(b)(1) for more information on the role of USP/NF standards and for discussion of the term “compounding.”) Hospitals must ensure that they meet all currently accepted standards for safe preparation and administration for CSPs, whether they are the type of CSP that must be compounded in an aseptic pharmacy location that meets USP <797> standards for low, medium or high-level risk CSPs or are “immediate-use CSPs” prepared outside of the pharmacy.
Nurses commonly prepare sterile medications that are categorized by USP <797> as “immediate-use CSPs,” which are needed for immediate or emergency use for a particular patient and are not to be stored for anticipated needs. The following USP <797> standards apply when preparing an immediate-use CSP:
• Preparation of an immediate-use CSP must only involve “simple transfer of not more than three commercially manufactured…sterile nonhazardous products from the manufacturer’s original containers and not more than two entries into any one container or package (e.g. bag, vial) of sterile infusion solution or administration container/device;”
• “Administration begins not later than one hour following the start of the preparation of the CSP (if not, the CSP must be appropriately discarded);”
• Meticulous aseptic technique must be followed during all phases of preparation. If the CSP is not administered to the patient as soon as it is ready, “the finished CSP is under continuous supervision to minimize the potential for contact with non-sterile surfaces…,” contamination and/or confusion with other CSPs; and
• “Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer…,” the CSP must be labeled with at least:
• Patient identification information;
• The names and amounts of all ingredients;
• The name or initials of the person who prepared it; and
• The exact one hour “beyond use date” (see below).
A drug or biological is outdated after its expiration date, which is set by the manufacturer based on stability testing under specified conditions as part of the U.S. Food and Drug Administration’s (FDA) approval process. It should be noted that a drug or biological may become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s approved labeling.
A drug or biological is also outdated after its “beyond-use date” (BUD), which may be reached before the expiration date, but never later. The BUD is the date and time after which the medication must not be used, stored or transported. The BUD takes into account the specific conditions and potential for deterioration and microbial growth that may occur during or after the original container is opened, while preparing the medication for dispensing and administration, and/or during the compounding process if it is a compounded medication.
The BUD is to be based on information provided by the manufacturer, whenever such information is available. The hospital must maintain and implement policies and procedures that provide clear and consistent direction to pharmacy staff regarding how to determine a BUD when complete BUD information is not available from the manufacturer. The policies and procedures must be based on accepted professional principles which are equivalent to, or more stringent than, those described in the USP/NF (USP).5
According to Chapters <795> and <797> of the USP, the BUD must be safe for patients, and determined conservatively. The section in USP <797> entitled “Determining Beyond-Use Dates,” which addresses sterile compounding, notes that “the truly valid evidence for predicting beyond-use dating can be obtained only through product-specific experimental studies.” It provides an example of testing considered more appropriate for certain types of CSPs such as “CSPs with a narrow therapeutic index, where close monitoring or dose titration is required to ensure therapeutic effectiveness and to avoid toxicity….” It also provides examples of important issues that a pharmacist must be able to critically interpret and evaluate when consulting literature sources in the process of determining a BUD; and distinguishes between reviewing literature specific to a particular drug, composition, concentration of ingredients, fill volume, container, storage conditions and duration of use, etc., versus merely reviewing available publications or

-- Footnotes: 5 All references to “USP” herein are from: United States Pharmacopeial Convention. USP on Compounding: A Guide for the Compounding Practitioner. Current with USP 37-NF32 through First Supplement. Rockville, MD: United States Pharmacopeial Convention, 2014.--

tables. The former is the preferred approach, while the latter results in a “theoretical BUD,” which has an inherent likelihood of inaccuracy or error.

Timing of Medication Administration
Appropriate timing of medication administration must take into account the complex nature and variability among medications; the indications for which they are prescribed; the clinical situations in which they are administered; and the needs of the patients receiving them. The chemical properties, mechanism of action, or therapeutic goals of some medications require administration at the exact time prescribed, or within a narrow window of its prescribed scheduled time, to avoid compromising patient safety or achievement of the intended therapeutic effect. However, the therapeutic effect of many other medications is uncompromised by a much broader window of time for administration. Consequently, the application of a uniform required window of time before or after the scheduled time for the administration of all medications, without regard to their differences, could undermine the ability of nursing staff to prioritize nursing care activities appropriately. This could also result in staff work-arounds that jeopardize patient safety due to the imposition of unrealistic or unnecessary time constraints for medication administration. Instead, hospital policies and procedures must specifically address the timing of medication administration, based on the nature of the medication and its clinical application, to ensure safe and timely administration. The policies and procedures must address at least the following:
• Medications not eligible for scheduled dosing times;
• Medications eligible for scheduled dosing times;
• Administration of eligible medications outside of their scheduled dosing times and windows; and
• Evaluation of medication administration timing policies, including adherence to them.

Medications or categories of medication not eligible for scheduled dosing times
The policies and procedures must identify medications or categories of medication which are not eligible for scheduled dosing times, either in general or in specific clinical applications. These are medications that require exact or precise timing of administration, based on diagnosis type, treatment requirements, or therapeutic goals. The policies and procedures must reflect consideration of factors including, but not limited to, the pharmacokinetics of the prescribed medication; specific clinical applications; and patient risk factors. Examples of medications that hospitals may choose to identify as not eligible for scheduled dosing times may include, but are not limited to:
• Stat doses (immediate);
• First time or loading doses (initial large dose of a drug given to bring blood, tissue or fluid levels to an effective concentration quickly);
• One-time doses; doses specifically timed for procedures;
• Time-sequenced doses; doses timed for serum drug levels;
• Investigational drugs; or
• Drugs prescribed on an as needed basis (prn doses).
The policies and procedures must ensure timely administration of such medications. In addition they must specify if the policy for the administration of these medications will be applied hospital-wide or only for specific diagnosis types, hospital units or clinical situations.

Medications eligible for scheduled dosing times
Medications eligible for scheduled dosing times are those prescribed on a repeated cycle of frequency, such as once a day, BID (twice a day), TID (three times a day), hourly intervals (every 1, 2, 3 or more hours), etc. The goal of this scheduling is to achieve and maintain therapeutic blood levels of the prescribed medication over a period of time. Medication administration policies and procedures typically establish standardized dosing times for the administration of all ‘scheduled’ medications. For example, medications prescribed for BID (twice a day) administration might, under a given hospital’s policies and procedures, be scheduled to be administered at 8am and 8pm. Another hospital might choose to schedule BID medications at 7:30 am and 7:30 pm. Use of these standardized times facilitates the medication administration process, e.g., by providing to the hospital’s pharmacy that morning doses of all BID drugs must be dispensed and delivered to patient units in time for the scheduled administration. For the nursing staff, the scheduled administration time might prompt prioritization of additional activities that may be required, in the case of particular drugs, such as vital sign assessment or the collection and review of blood work, to ensure safe and timely medication administration.
Policies and procedures for medications eligible for scheduled dosing times must also address: first dose medications, including parameters within which nursing staff are allowed to use their own judgment regarding the timing of the first and subsequent doses, which may fall between scheduled dosing times; retiming of missed or omitted doses; medications that will not follow scheduled dosing times; and patient units that are not subject to following the scheduled dosing times.

Time-critical scheduled medications
Time-critical scheduled medications are those for which an early or late administration of greater than thirty minutes might cause harm or have significant, negative impact on the intended therapeutic or pharmacological effect. Accordingly, scheduled medications identified under the hospital’s policies and procedures as time-critical must be administered within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour.
It is possible for a given medication to be time- critical for some patients, due to diagnosis, clinical situation, various risk factors, or therapeutic intent, but not time-critical for other patients. Therefore, hospital policies and procedures must address the process for determining whether specific scheduled medications are always time-critical, or only under certain circumstances, and how staff involved in medication administration will know when a scheduled medication is time-critical. Examples of time-critical scheduled medications/medication types may include, but are not limited to:
• Antibiotics;
• Anticoagulants;
• Insulin;
• Anticonvulsants;
• Immunosuppressive agents;
• Pain medication (non-IV);
• Medications prescribed for administration within a specified period of time of the medication order;
• Medications that must be administered apart from other medications for optimal therapeutic effect; or
• Medications prescribed more frequently than every 4 hours.

Non-time-critical scheduled medications
Non-time critical scheduled medications are those for which a longer or shorter interval of time since the prior dose does not significantly change the medication’s therapeutic effect or otherwise cause harm. For such medications greater flexibility in the timing of their administration is permissible. Specifically:
• Medications prescribed for daily, weekly or monthly administration may be within 2 hours before or after the scheduled dosing time, for a total window that does not exceed 4 hours.
• Medications prescribed more frequently than daily but no more frequently than every 4 hours may be administered within 1 hour before or after the scheduled dosing time, for a total window that does not exceed 2 hours.

Missed or late administration of medications
The hospital’s policies and procedures must address the actions to be taken when medications eligible for scheduled dosing times are not administered within their permitted window of time. This includes doses which may have been missed due to the patient being temporarily away from the nursing unit, for example, for tests or procedures; patient refusal; patient inability to take the medication; problems related to medication availability; or other reasons that result in missed or late dose administration. Likewise, policies and procedures must also outline guidelines for the administration and timing of new medications which are initiated between standardized dosing times.
These policies and procedures must identify parameters within which nursing staff are allowed to use their own judgment regarding the rescheduling of missed or late doses and when notification of the physician or other practitioner responsible for the care of the patient is required prior doing so. In either case, the reporting of medication errors that are the result of missed or late dose administration must be reported to the attending physician in accordance with requirements at §482.25(b)(6). See interpretive guidance at §482.25(b)(6) for more details on internal reporting requirements

Evaluation of medication administration timing policies
Hospitals must periodically evaluate their medication administration timing policies, including staff adherence to the policies, to determine whether they assure safe and effective medication administration. Consistent with the QAPI requirements at 42 CFR 482.21(c)(2), medication errors related to the timing of medication administration must be tracked and analyzed to determine their causes. Based on the results of the evaluations of the policies and the medication administration errors, the medical staff must consider whether there is a need to revise the policies and procedures governing medication administration timing.

Assessment/Monitoring of Patients Receiving Medications
Observing the effects medications have on the patient is part of the multi-faceted medication administration process. Patients must be carefully monitored to determine whether the medication results in the therapeutically intended benefit, and to allow for early identification of adverse effects and timely initiation of appropriate corrective action. Depending on the medication and route/delivery mode, monitoring may need to include assessment of:
• Clinical and laboratory data to evaluate the efficacy of medication therapy, to anticipate or evaluate toxicity and adverse effects. For some medications,
including opioids, this may include clinical data such as respiratory status, blood pressure, and oxygenation and carbon dioxide levels;
• Physical signs and clinical symptoms relevant to the patient’s medication therapy, including but not limited to, somnolence, confusion, agitation, unsteady gait, pruritus, etc.
Certain types of medications are considered inherently high risk for adverse drug events. Although mistakes may or may not be more common with these drugs, the consequences of errors are often harmful, sometimes fatal, to patients. (See also the discussion of high-risk medications (typically referred to as “high-alert” medications) in the guidance for §482.25(a)(1))

"For Information – Not Required/Not to be Cited"
--The Institute for Safe Medication Practices (ISMP) makes available a list of high alert medications, which it defines as those medications that bear a heightened risk of causing significant patient harm when they are used in error. The current list may be found at: http://www.ismp.org/Tools/highAlertMedicationLists.asp--

In addition, certain factors place some patients at greater risk for adverse effects of medication. Factors including, but not limited to, age, altered liver and kidney function, a history of sleep apnea, patient weight (obesity may increase apnea or smaller patients may be more sensitive to dose levels of medications), asthma, history of smoking, drug-drug interactions, and first-time medication use may contribute to increased risk.
Consideration of patient risk factors as well as the risks inherent in a medication must be taken into account when determining the type and frequency of monitoring. Further, to enhance continuity of care/safe medication administration, it is essential to communicate all relevant information regarding patients’ medication risk factors and monitoring requirements during hand-offs of the patient to other clinical staff, such as when patients are transferred internally from one unit to another, during shift report at change of shift, etc. This would apply to hand-offs involving not only to nursing staff, but also to any other types of staff who administer medications, e.g., respiratory therapists.
Adverse patient reactions, such as anaphylaxis or opioid-induced respiratory depression, require timely and appropriate intervention, per established hospital protocols, and must also be reported immediately to the practitioner responsible for the care of the patient. (See the guidance for §482.23(c)(5) and §482.25(b)(6), concerning reporting of adverse medication-related events.)
An example of vigilant post-medication administration monitoring in the case of a high-alert medication where patient factors may increase risk would be regularly checking vital signs, oxygen level via pulse oximetry, and sedation levels of a post-surgical patient who is receiving pain medication via a patient controlled analgesia (PCA) pump. Narcotic medications, such as opioids, are often used to control pain but also have a sedating effect. Patients can become overly sedated and suffer respiratory depression or arrest, which can be fatal. Timely assessment and appropriate monitoring is essential in all hospital settings in which opioids are administered, to permit intervention to counteract respiratory depression should it occur. (See also the discussion of the requirements for intravenous medications at §482.23(c)(4)).
As part of the monitoring process, staff are expected to include the patient’s reports of his/her experience of the medication’s effects. Further, when monitoring requires awakening the patient in order to assess effects of the medications, the patient and/or the patient’s representative must be educated about this aspect of the monitoring process. In addition, hospitals are encouraged to educate the patient and his/her representative and/or family members about notifying nursing staff promptly when there is difficulty breathing or other changes that might be a reaction to medication.
Hospital policies and procedures are expected to address how the manner and frequency of monitoring, considering patient and drug risk factors, are determined, as well as the information to be communicated at shift changes, including the hospital’s requirements for the method(s) of communication.

Documentation
Note that documentation of medication administration is addressed in the Medical Records CoP, at §482.24(c), which specifies the required content of the medical record. Within this regulation §482.24(c)(vi) requires that the record contain: “All practitioners’ orders, nursing notes, reports of treatment, medication records, radiology, and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition.” Documentation is expected to occur after actual administration of the medication to the patient; advance documentation is not only inappropriate, but may result in medication errors. Proper documentation of medication administration actions taken and their outcomes is essential for planning and delivering future care of the patient. See the guidance for the various parts of §482.24(c) concerning documentation in the medical record. Deficiencies in documentation would be cited under the applicable Medical Records regulation.

A-0406 482.23(c)(1)(ii) Drugs and biologicals may be prepared and administered on the orders contained within pre-printed and electronic standing orders, order sets, and protocols for patient orders only if such orders meet the requirements of 482.24(c)(3).
482.23(c)(3) - With the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy after an assessment of contraindications, orders for drugs and biologicals must be documented and signed by a practitioner who is authorized to write orders in accordance with State law and hospital policy, and who is responsible for the care of the patient as specified under 482.12(c)
482.23(c)(3)(iii) - Orders for drugs and biologicals may be documented and signed by other practitioners not specified under 482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations.

Interpretive Guidelines §482.23(c)(1) (ii ),(c)(3) and (c)(3)(iii)
All orders for drugs and biologicals, with the exception of influenza and pneumococcal vaccines, must be documented and signed by a practitioner who is responsible for the care of the patient, as specified under §482.12(c), or who is another practitioner who is authorized by hospital policy and medical staff bylaws, rules and regulations, and who is acting in accordance with State law, including scope of practice laws.

Flu and pneumonia vaccines
Influenza and pneumococcal vaccines may be administered per physician-approved hospital policy, i.e., hospital policy approved by the physician members of the medical staff. There must be an assessment of contraindications prior to administration of the vaccine(s). There is no requirement for authentication by a practitioner when influenza and pneumococcal vaccines are administered to a patient in accordance with hospital policy and State law.

Standing orders
Nurses or other personnel authorized by hospital policy and in accordance with State law may administer drugs and biologicals in accordance with pre-printed and electronic standing orders, order sets, and protocols for patient orders, collectively referred to in this guidance as “standing orders,” to address well- defined clinical scenarios involving medication administration. The requirements governing the hospital’s development and use of standing orders are found at the Medical Records CoP, under §482.24(c)(3). For the nursing services requirement under§482.23(c)(1) (ii), compliance assessment focuses on whether nurses comply with the hospital’s established standing orders policies and procedures when administering drugs or biological in accordance with a standing order.

A-0407 482.23(c)(3)(i) If verbal orders are used, they are to be used infrequently.

Interpretive Guidelines §482.23(c)(3)(i)
Verbal orders, if used, must be used infrequently. This means that the use of verbal orders must not be a common practice. Verbal orders pose an increased risk of miscommunication that could contribute to a medication or other error, resulting in a patient adverse event. Verbal orders should be used only to meet the care needs of the patient when it is impossible or impractical for the ordering practitioner to write the order or enter it into an electronic prescribing system without delaying treatment. Verbal orders are not to be used for the convenience of the ordering practitioner. (71 FR 68679)
Hospitals are expected to develop appropriate policies and procedures that govern the use of verbal orders and minimize their use, such as policies which:
• Describe situations in which verbal orders may be used as well as limitations or prohibitions on their use;
• Provide a mechanism to establish the identity and authority of the practitioner issuing a verbal order;
• List the elements required for inclusion in the verbal order process;
● Establish protocols for clear and effective communication and verification of verbal orders.
The content of verbal orders must be clearly communicated. CMS expects nationally accepted read-back verification practice to be implemented for every verbal order. (71 FR 68680) As required by §482.24(b), all verbal orders must be promptly documented in the patient’s medical record by the individual receiving the order.

A-0408 482.23(c)(3)(ii) When verbal orders are used, they must only be accepted by persons who are authorized to do so by hospital policy and procedures consistent with Federal and State law.

Interpretive Guidelines §482.23(c)(3)(ii)
A verbal order for drugs and biologicals may only be accepted by an individual who is permitted by Federal and State law and hospital policy to accept verbal orders. Consistent with the requirements of §482.24(b), the person who received the verbal order must promptly document it in the medical record.

A-0409 482.23(c)(4) Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures.

Interpretative Guidelines §482.23(c)(4)
Intravenous (IV) medications and blood transfusions must be administered in accordance with State law and approved medical staff policies and procedures. Further, many of the medications included in the high-alert categories are administered intravenously. (See
also the discussion of high-risk/high-alert medications in the guidance for §482.25(b).) Hospital policies and procedures for blood transfusions and IV medications must be based on accepted standards of practice, and must address at least the following:

Vascular Access Route
Patients may require a form of vascular access to deliver blood or medications, either venous or arterial, based on the desired treatment plan. Safe administration of blood transfusions and IV medications includes the correct choice of vascular access. IV medications, such as fluids, antibiotics, and chemotherapy, may require specific types of access, such as peripheral or central catheters versus implanted port devices, based on the medication’s chemical properties or safety concerns. Hospital policies and procedures must address which medications can be given intravenously via what type of access.

Other Patient Safety Practices
In addition to the basic safe practices that apply to all medication administration (See the discussion of safe medication administration practices, and medication administration in general, at §482.23(c)), there are additional safe practices specific to IV medication administration that require consideration, including but not limited to, the following:
• Tracing invasive lines and tubes prior to administration to ensure the medication is to be administered via the proper route (for example, peripheral catheter versus epidural catheter connections);
• Avoiding forcing connections when the equipment offers clear resistance;
• Verifying proper programming of infusion devices (concentrations, flow rate, dose rate).

Patient Monitoring
As discussed in the medication administration guidance for §§482.23(c)(1), (c)(1)(i) and (c)(2), patients must be monitored for the effects of medications. To the extent that IV medications have a more rapid effect on the body, it is important that staff administering medications understand each medication and its monitoring requirements. Policies and procedures for IV medication administration must address appropriate IV medication monitoring requirements, including assessment of patients for risk factors that would influence the type and frequency of monitoring.
For example: a 50 year old patient with a history of renal failure is receiving IV vancomycin to treat a wound infection. The hospital policy for IV antibiotics, including vancomycin, requires the patient’s kidney function to be monitored daily with blood draws. Based on review of the lab results, a practitioner responsible for the care of the patient would be expected to determine on a timely basis whether or
not the antibiotic dose needs to be adjusted to protect kidney function or prevent drug toxicity while achieving the desired therapeutic effects. Staff administering the medication would be expected to review the lab results as well, and to raise with a practitioner responsible for the care of the patient any concerns they might have about whether an adjustment in the medication is needed.
Hospital policies and procedures related to monitoring patients receiving IV medications are expected to address, but are not limited to, the following:
• Monitoring for Fluid & Electrolyte Balance
Whenever IV medications and blood transfusions are administered, the patient may become at risk for fluid and electrolyte imbalance. Hospital policies and procedures must address monitoring and treatment for fluid and electrolyte imbalances that may occur with blood transfusions and IV medications.
• Monitoring Patients Receiving High-alert Medications, Including IV Opioids
Policies and procedures related to IV medication administration must address those medications the hospital has identified as high-alert medications and the monitoring requirements for patients receiving such drugs intravenously.

At a minimum, hospitals are expected to address monitoring for over-sedation and respiratory depression related to IV opioids for post-operative patients

Opioids are a class of medication used frequently in hospitals to treat pain. The sedating effects of opioids make it difficult at times to properly assess the patient’s level of sedation. It can be erroneously assumed that patients are asleep when they are actually exhibiting progressive symptoms of respiratory compromise - somnolence, decreased respiratory rate, and decrease in oxygen levels. These symptoms, if unrecognized, can progress to respiratory depression and even death.
Certain characteristics, in addition to those discussed in the medication administration guidance for §§482.23(c)(1), (c)(1)(i) and (c)(2), place patients receiving opioids at higher risk for oversedation and respiratory depression. These additional factors include, but are not limited to6:
• Snoring or history of sleep apnea
• No recent opioid use or first-time use of IV opioids
• Increased opioid dose requirement or opioid habituation
• Longer length of time receiving general anesthesia during surgery

--Footnotes: 6 Jarzyna D., Junquist C., Pasero C., et al. American Society for Pain Management Nursing - Guidelines on Monitoring for Opioid-Induced Sedation and Respiratory Depression. Pain Management Nursing, Vol 12, No. 3 (September), 2011: pp 118-145--

• Receiving other sedating drugs, such as benzodiazepines, antihistamines, sedatives, or other central nervous system depressants
• Preexisting pulmonary or cardiac disease
• Thoracic or other surgical incisions that may impair breathing

Of particular concern are patients receiving IV opioids post-operatively. The effects of IV opioids in post-operative patients must be monitored vigilantly via serial assessments of pain, respiratory status, and sedation levels.
Hospitals must have policies and procedures related to the use of high-alert medications, including IV opioids for post-operative patients. Policies and procedures must address, at a minimum, the process for patient risk assessment, including who conducts the assessments, and, based on the results of the assessment, monitoring frequency and duration, what is to be monitored, and monitoring methods. The policies and procedures must also address whether and under what circumstances practitioners prescribing IV opioids are allowed to establish protocols for IV opioid administration and monitoring that differ from the hospital-wide policies and procedures.
The frequency of the serial assessments and duration of the monitoring timeframe for post-operative patients receiving IV opioids must be determined based on at least the following considerations:
• Patient risk for adverse events;
• Opioid dosing frequency and IV delivery method. (push or patient-controlled analgesia (PCA));
• Duration of IV opioid therapy.
Regardless of the above factors, at a minimum monitoring must include the following:
• Vital signs (blood pressure, temperature, pulse, respiratory rate)
• Pain level;
• Respiratory status;
• Sedation level; sedation levels are important indicators for the clinical effects of opioids. Sedation is a useful assessment parameter to observe the effects of opioids since sedation typically precedes respiratory depression7. See the blue box below for information on sedation assessment methods.

-- Footnotes: 7 Institute for Safe Medication Practices (ISMP), Medication Safety Alert – Fatal PCA Adverse Events Continue to Happen…Better Patient Monitoring is Essential to Prevent Harm. May 30, 2013--

"For Information – Not Required/Not to be Cited"
--In addition to assessing risk for respiratory depression, the Institute for Safe Medication Practices recommends hospitals use a standard sedation scale when assessing patients receiving PCA. Scales such as the Richmond Agitation Sedation Scale, Pasero, Ramsey, or Glasgow Coma Scale are useful in assessing sedation.
Institute for Safe Medication Practices (ISMP), Medication Safety Alert – Fatal PCA Adverse Events Continue to Happen…Better Patient Monitoring is Essential to Prevent Harm. May 30, 2013--

In addition to vigilant nursing assessment at appropriate intervals, hospitals may choose to use technology to support effective monitoring of patients’ respiratory rate and oxygen levels.
For additional information regarding recommendations of expert organizations on post-operative opioid monitoring, including technology-supported monitoring, see blue boxes below. The practices described in the blue boxes below are not required under the regulations.
The assessment and monitoring process must be explained to the patient and/or the patient's representative, to communicate the rationale for vigilant monitoring, including that it might be necessary to awaken the patient in order to assess effects of the medications. In addition, hospitals are encouraged to educate the patient and his/her representative and/or family members about notifying nursing staff promptly when there is difficulty breathing or other changes that might be a reaction to medication.

"For Information – Not Required/Not to be Cited"
--Anesthesia Patient Safety Foundation
• APSF calls for every patient receiving postoperative opioid analgesics to be managed based on the following clinical considerations*:
• Individualize the dose and infusion rate of opioid while considering the unique aspects of each patient’s history and physical status.
• Make continuous monitoring of oxygenation (pulse oximetry) the routine rather than the exception.
• Assess the need for supplemental oxygen, especially if pulse oximetry or intermittent nurse assessment are the only methods of identifying progressive hypoventilation.
• When supplemental oxygen is indicated, monitoring of ventilation may warrant the use of technology designed to assess breathing or estimate arterial carbon dioxide concentrations. Continuous monitoring is most important for the highest risk patients, but depending on clinical judgment, should be applied to other patients.
APSF also has issued a video on opioid induced ventilatory impairment: http://apsf.org/resources_video4.php
*Stoelting, RK.,Weinger MB. Dangers of postoperative opioids: Is there a Cure? APSF Newsletter 2009;24:2.--

"For Information – Not Required/Not to be Cited"
--The Patient Safety Movement Foundation
PSMF recommends all patients receiving IV opioids have continuous measure-through motion and low perfusion pulse oximetry, and that patients on supplemental oxygen also have continuous respiration rate monitoring. It also calls for the monitoring system to be linked with a notification system to clinical staff who can respond immediately. It calls for an escalation protocol so that if a staff person does not acknowledge the alert in 60 seconds a second person will be notified.
The Patient Safety Movement Foundation - Actionable Patient Safety Solution (APSS) #1: Failure to Rescue: Post-Operative Respiratory Depression. January 13, 2013--

Adverse patient reactions require timely and appropriate intervention, per established protocols, and must also be reported immediately to the practitioner responsible for the care of the patient. (See the guidance for §482.23(c)(5) and §482.25(b)(6), concerning reporting of adverse medication-related events.)

Blood Components and Blood Administration Procedures
According to the U.S. Department of Health and Human Services, 13,785,000 units of whole blood and red blood cells were transfused in the United States in 20118. The collection, testing, preparation, and storage of blood and blood components are regulated by the Food and Drug Administration. However, administration of blood products via transfusion is governed by §482.23(c)(4). Blood transfusions can be life-saving. However, like IV medications, blood transfusions are not without risk of harm to patients. Transfusion reactions and/or errors can be fatal.
In addition to the safe practices and other safety considerations that apply to all IV medication administration, policies and procedures must address blood administration procedures that are consistent with accepted standards of transfusion practice, including but not limited to:
• Confirming the following prior to each blood transfusion:
• the patient’s identity
• verification of the right blood product for the right patient
The standard of practice calls for two qualified individuals, one of whom will be administering the transfusion, to perform the confirmation.
• Requirements for patient monitoring, including frequency and documentation of monitoring
• How to identify, treat, and report any adverse reactions the patient may experience during or related to transfusion.

Staff Training and Competencies
Intravenous (IV) medications and blood transfusions must be administered by qualified personnel, regardless of whether they are practitioners or non-practitioners. Generally IV medications and blood transfusions are administered to patients by registered nurses (RNs), consistent with State law governing scope of practice, and approved medical staff policies and procedures.

--Footnote: 8 The 2011 National Blood Collection and Utilization Survey Report. Retrieved September 27,2013 from http://www.hhs.gov/ash/bloodsafety/2011-nbcus.pdf--

Among other things, personnel must be able to demonstrate competency in venipuncture, in accordance with State law and hospital policy. If other types of vascular access are utilized, staff must have demonstrated competency in appropriate usage, care, and maintenance. Staff must also be trained in early detection of and timely intervention for IV opioid-induced over-sedation and respiratory depression.
Education and training regarding these procedures are typically included in the nurse’s hospital orientation. Nursing staff who receive training for intravenous medication administration and/or blood transfusion administration during hospital orientation or during other continuing education programs would meet the requirements of this regulation. Content of the training must address each required component of the approved medical staff policies and procedures.
Other non-practitioners, for example, licensed practical nurses or licensed vocational nurses, with demonstrated competence may also administer IV medications and blood transfusions if they are acting in accordance with State law, including scope of practice law, and the hospital’s approved medical staff policies and procedures. (77 FR 29050, May 16, 2012)
For non-practitioners, the appropriate competencies must be documented in the qualified staff person’s employee record.
All State law and scope of practice requirements must be met regarding the administration of intravenous medications and blood transfusions, as applicable.

A-0410 482.23(c)(5) There must be a hospital procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs.

Interpretive Guidelines §482.23(c)(5)
Adverse drug reactions and drug administration errors
There is a similar but more detailed and prescriptive requirement concerning internal hospital reporting of adverse drug reactions, drug administration errors and incompatibilities under the Pharmaceutical Services CoP at §482.25(b)(6). Therefore, it is not necessary for hospitals to establish a different procedure in the case of adverse drug reactions and drug administration errors for such events when nurses administer drugs or transfusions. Consult the guidance for §482.25(b)(6) to see what must be reported, to whom, and in what timeframe. Failure to make required reports concerning adverse drug reactions and errors in administration of drugs should be cited under §482.23(c)(5) when the drug was administered by a nurse, as well as under §482.25(b)(6).
Transfusion reactions
Transfusion reactions can occur during or after a blood transfusion. A patient’s immune system recognizes the foreign blood product and attempts to destroy the transfused cells. Incompatible blood products are typically the cause of transfusion reactions. Symptoms may include back pain, bloody urine, hives, chills, fainting, dizziness, fever, flank pain, and skin flushing. More serious complications may include acute kidney failure, anemia, respiratory distress, shock and even death.
Transfusion reactions are serious and can be life-threatening. The hospital must have policies and procedures in place for the internal reporting of transfusion reactions. The policies must include procedures for reporting transfusion reactions immediately to the practitioner responsible for the care of the patient. The transfusion reaction must also be reported to the hospital-wide quality assessment performance improvement program as an adverse event, in accordance with the QAPI CoP at 42 CFR 482.21(c)(2). The transfusion reaction must be documented in the patient’s medical record, including the prompt notification of the responsible practitioner.

A-0412 482.23(c)(6) The hospital may allow a patient (or his or her caregiver/support person where appropriate) to self -administer both hospital-issued medications and the patient’s own medications brought into the hospital, as defined and specified in the hospital’s policies and procedures.

(i) If the hospital allows a patient to self-administer specific hospital-issued medications, then the hospital must have policies and procedures in place to:
(A) Ensure that a practitioner responsible for the care of the patient has issued an order, consistent with hospital policy, permitting self-administration.
(B) Assess the capacity of the patient (or the patient’s caregiver/support person where appropriate) to self-administer the specified medication(s).
(C) Instruct the patient (or the patient’s support person where appropriate) in the safe and accurate administration of the specified medication(s).
(D) Address the security of the medication(s) for each patient.
(E) Document the administration of each medication, as reported by the patient (or the patient’s caregiver/support person where appropriate), in the patient’s medical record.

Interpretative Guidelines §482.23(c)(6)(i)
Hospitals have the option of establishing a program for self-administration by patients, or, when applicable, patient caregivers or support persons, of hospital-issued medications. The existence of this regulatory option does not mean that a hospital must offer medication self-administration programs or that a patient has a right to self-administer their medications.
A hospital program for patient self-administration of hospital-issued medications could be beneficial for the appropriate patients if the proper precautions are taken in designing and implementing such a program. Generally such a program would apply only to
inpatients, but there may be circumstances under which a hospital finds it appropriate to permit self-administration of hospital-issued medications by outpatients or their caregivers/support persons.
Among the potential benefits of medication self-administration, teaching patients or their caregivers/support persons adherence to the proper medication regimen could reduce hospital inpatient length of stay and also might have a positive effect on continued compliance with the regimen after discharge, potentially avoiding an emergency department visit or inpatient readmission secondary to post-hospital patient medication administration errors and noncompliance.
Hospitals have the discretion to establish policies providing for different levels of patient self-administration, and may make these levels across-the-board, patient-specific, or medication-specific. For example, a hospital may choose whether or not a nurse must be present to supervise the self-administration, and whether this supervision requirement could vary according to the type of medication or the capacity of the individual patient (or the patient’s caregiver/support person). A hospital may also determine through its policies and procedures whether supervision requirements must be addressed in the practitioner’s order or whether this may be left to the discretion of the nurse who assesses the patient. A hospital may choose to exclude certain medications from patient self-administration, for example, because they pose too great a medication security challenge, or because the manner in which they must be administered does not lend itself to safe self-administration. (77 FR 29052, May 16, 2012) It must be clear in the hospital’s policies and procedures whether it has established such a policy and what kind of limitations it has established for its program of patient self-administration of hospital-issued medications.
It is expected that the medical staff, nursing and pharmacy departments are to collaborate in developing policies and procedures governing self-administration of hospital-issued medications which are approved by the governing body.

Required elements of a self-administration program:
If the hospital chooses to develop programs for self-administration of hospital-issued medications by patients (and/or their caregiver/support persons), the following must be in place:
• An order allowing the patient to administer hospital-issued medications. The order must be consistent with the hospital’s policy concerning self-administration of hospital-issued medications and be written by a practitioner who is responsible for the care of the patient and who is authorized to order medications, in accordance with hospital policies and procedures, State law, including scope of practice laws, and medical staff by-laws, rules, and regulations.
• A documented assessment of the capacity of the patient (or their
caregiver/support person) to successfully administer medications for which self-administration has been authorized. Nurses are expected to exercise their clinical judgment and to inform the practitioner responsible for the care of the patient about any reservations the nurse might have about an individual patient’s (or caregiver/support person’s) capacity to safely self-administer medications. The assessment must be documented and must highlight the findings that are affirmative – i.e., support patient-self-administration – and negative – i.e., call into question patient self-administration. The nurse is also expected to document any discussions with the practitioner responsible for the care of the patient regarding the nurses’ concerns about patient’s (or caregiver/support person’s) capacity to safely self-administer medications. Hospitals may, as a matter of policy, permit a nurse to return to nurse administration for particular doses of a medication for which there is a self-administration order, without a discussion with the responsible practitioner if, based on the nurse’s assessment, the patient’s capacity has been temporarily diminished and there is no caregiver/support person who is assisting the patient with self-administration of medication. For example, a patient who has just had an invasive test or procedure may not be fully alert for a period thereafter, or the parent of a minor patient, who is administering medications to the patient may for whatever reasons not be available and a scheduled medication dose is close to being overdue.
• Instruction in self-administration. As part of the assessment of the patient’s self-administration capacity, nurses are expected to identify the patient’s (or the patient’s caregiver/support person’s) education and/or training needs. These needs may be related to type of medication, unique individual medication requirements, delivery route, dosage and scheduling, equipment (e.g. syringes, pill-cutters, measuring containers, etc.) intravenous access, potential adverse side effects and what to do if they occur, infection control measures, storage, medication disposal, among others. Education and training needs, and how they were addressed, must be documented in the medical record.
• Security of the self-administered medications. The security of a patient’s self-administered medications is extremely important, but does not lend itself well to a one-size-fits-all regulatory requirement. There are Federal and State laws, including the Pharmaceutical Services CoP, which require a higher level of security for certain medications (for example, controlled substances). Hospitals are expected to comply with these already-established requirements and laws, and generally should not include such medications as part of a patient self-administration program.
• Note that Patient-controlled Analgesia (PCA) pumps are a special variant of patient self-administration. Such pumps allow patients, within tightly controlled, pre-determined parameters with respect to dosage and minimum time intervals between doses, to release an intravenous dose of a controlled substance pain medication that has been pre-loaded into the PCA pump in a manner that prevents tampering by an unauthorized person. PCA pumps are considered secure despite their use of controlled substances.
PCA pumps allow for the self-administration of intravenous (IV) medications to patients. See the interpretive guidelines for §482.23(c)(4) concerning assessment and monitoring requirements for post-surgical patients receiving IV opioids, including via patient-controlled analgesia (PCA) pumps, in and out of the post-anesthesia care and intensive care units.
Hospitals are also free to exclude other medications besides controlled substances from their patient self-administered medication programs when the hospital has concerns over its capacity to address the safety and security of these other medications for patients.
A hospital may choose to have a policy where it maintains a list of medications that it excludes from self-administration entirely, due to security concerns. It may choose to have a policy that addresses the security of a particular medication on a patient-by-patient basis. Or it may establish a policy that is a combination of both of these approaches to medication security. (77 FR 29052, May 16, 2012)
• Documentation of medication administration. Under the regulation, a nurse must document the self-administration of a medication. In cases where the nurse directly supervised the self-administration, the nurse is expected to indicate that the medication administration was observed and confirmed. On the other hand, where direct nurse supervision is not required, the nurse is required to document only what the patient, or the patient’s caregiver/support person, reports to the nurse as to the time and amount of medication administered. Nurses are expected to assess whether the reports of the patient or patient’s caregiver/support person indicate, with respect to timing and dosage, that the patient is receiving the medication as ordered.

A-0413 482.23(c)(6)(ii) If the hospital allows a patient to self-administer his or her own specific medications brought into the hospital, then the hospital must have policies and procedures in place to:
(A) Ensure that a practitioner responsible for the care of the patient has issued an order, consistent with hospital policy, permitting self-administration of medications the patient brought into the hospital.
(B) Assess the capacity of the patient (or the patient’s caregiver/support person where appropriate) to self-administer the specified medication(s) and also determine if the patient (or the patient’s caregiver/supplier person where appropriate) needs instruction in the safe and accurate administration of the specified medication(s).
(C) Identify the specified medication(s) and visually evaluate the medication(s) for integrity.
(D) Address the security of the medication(s) for each patient.
(E) Document the administration of each medication, as reported by the patient (or the patient’s caregiver/support person where appropriate), in the patient’s medical record.

Interpretative Guidelines §482.23(c)(6)(ii)
Hospitals have the option of establishing a program for self-administration by patients, or, when applicable, patient caregivers or support persons, of medications the patient brings himself or herself to the hospital. The existence of this regulatory option does not mean that a hospital must offer medication self-administration programs or that a patient has a right to retain and self-administer medications they bring with them from home.
A hospital program for patient self-administration of medications the patient brings from home could be beneficial for the appropriate patients if the proper precautions are taken in designing and implementing such a program. Generally such a program would apply only to inpatients, but there may be circumstances under which a hospital finds it appropriate to permit self-administration of medications that outpatients or their caregivers/support persons bring with them.
Among the potential benefits of permitting self-administration of medications the patient brings from home is that problems are avoided related to the hospital’s formulary not including a particular medication that a patient needs to continue to take during his/her hospital stay, and the patient prefer to avoid medication substitution. The hospital also gains an opportunity to identify suboptimal patient medication administration techniques for these drugs and to provide instruction designed to ensure that the patient is administering his/her medications properly.
Hospitals have the discretion to establish policies providing for different levels of patient self-administration, and may make these levels across-the-board, patient-specific, or medication-specific. For example, a hospital may choose whether or not a nurse must be present to supervise the self-administration, and whether this supervision requirement could vary according to the type of medication or the capacity of the individual patient (or the patient’s caregiver/support person). A hospital may also determine through its policies and procedures whether supervision requirements must be addressed in the practitioner’s order or whether this may be left to the discretion of the nurse who assesses the patient. A hospital may choose to exclude certain medications from patient self-administration, for example, because they pose too great a medication security challenge. It must be clear in the hospital’s policies and procedures whether it has established such a policy and what kind of limitations it has established for its program of patient self-administration of medications the patient brings from home.
It is expected that the medical staff, nursing and pharmacy departments are to collaborate in developing policies and procedures for self-administration of medications the patient brings from home which are approved by the governing body.

Required elements of a self-administration program:
If the hospital chooses to develop programs for self-administration of medications brought from home by patients (and/or their caregiver/support persons), the following must be in place:
• An order allowing the patient to administer medications brought from home. The order must be consistent with the hospital’s policy concerning self-administration of medications brought from home and be written by a practitioner who is responsible for the care of the patient and who is authorized to order medications, in accordance with hospital policies and procedures, State law, including scope of practice laws, and
medical staff by-laws, rules, and regulations.
• A documented assessment of the capacity of the patient (or their caregiver/support person) to successfully administer the medication(s) specified in the order, including a determination whether the patient (or their caregiver/support person) needs instruction in the safe and accurate administration of the specified medication(s). Nurses are expected to exercise their clinical judgment and to inform the practitioner responsible for the care of the patient about any reservations the nurse might have about an individual patient’s (or caregiver/support person’s) capacity to safely self-administer medications. The assessment must be documented and must highlight the findings that are affirmative – i.e., support patient-self-administration – and negative – i.e., call into question patient self-administration. The nurse is also expected to document any discussions with the practitioner responsible for the care of the patient regarding the nurses’ concerns about patient’s (or caregiver/support person’s) capacity to safely self-administer medications. (77 FR 29052, May 16, 2012)
Hospitals may, as a matter of policy, permit a nurse to return to nurse administration for particular doses of a medication for which there is a self-administration order, without a discussion with the responsible practitioner if, based on the nurse’s assessment, the patient’s capacity has been temporarily diminished and there is no caregiver/support person who is assisting the patient with self-administration of medication. For example, a patient who has just had an invasive test or procedure may not be fully alert for a period thereafter, or the parent of a minor patient, who is administering medications to the patient may for whatever reasons not be available and a scheduled medication dose is close to being overdue.
As part of the assessment of the patient’s self-administration capacity, nurses are expected to identify whether the patient (or the patient’s caregiver/support person) needs instruction in the safe and accurate administration of the specified medication(s). Even though the patient has been taking the medication at home, the patient (or the patient’s caregiver/support person) may not be using optimal administration techniques. Patient needs may be related to type of medication, unique individual medication requirements, delivery route, dosage and scheduling, equipment (e.g. syringes, pill-cutters, measuring containers, etc.) intravenous access, potential adverse side effects and what to do if they occur, infection control measures, storage, medication disposal, among others. Education and training needs identified, and how they were addressed, must be documented in the medical record.
• Identification/visual evaluation for integrity. Hospitals must have policies and procedures addressing how they will identify the medications the patient has brought from home. Identification is important because the label on the patient’s medication container may not accurately reflect the contents. Further, the medication might have expired or have not been stored correctly in the patient’s home, requiring hospitals to at least conduct a visual inspection to see if the medication appears to have retained its integrity. It is recognized that a visual inspection for integrity may not be definitive, but the regulation does not require use of more complex methods.
• Security of the self-administered medications. The security of a patient’s self-administered medications is extremely important, but does not lend itself well to a one-size-fits-all regulatory requirement. There are Federal and State laws, including the Pharmaceutical Services CoP, which require a higher level of security for certain medications (for example, controlled substances). Hospitals are expected to comply with these already-established requirements and laws, and generally should not include such medications as part of a patient self-administration program.
Hospitals are also free to exclude other medications besides controlled substances from their patient self-administered medication programs when the hospital has concerns over its capacity to address the security of these other medications for patients.
A hospital may choose to have a policy where it maintains a list of medications brought from home that it excludes from self-administration entirely, due to security concerns. It may choose to have a policy that addresses the security of a particular medication on a patient-by-patient basis. Or it may establish a policy that is a combination of both of these approaches to medication security.
• Documentation of medication administration. Under the regulation, a nurse must document the self-administration of a medication. In cases where the nurse directly supervised the self-administration, the nurse is expected to indicate that the medication administration was observed and confirmed. On the other hand, where direct nurse supervision is not required, the nurse is required to document only what the patient, or the patient’s caregiver/support person, reports to the nurse as to the time and amount of medication administered. Nurses are expected to assess whether the reports of the patient or patient’s caregiver/support person indicate, with respect to timing and dosage, that the patient is receiving the medication as ordered.

CoP Medical Record Services

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482.24 Medical Record Services

A-0431 482.24 The hospital must have a medical record service that has administrative responsibility for medical records. A medical record must be maintained for every individual evaluated or treated in the hospital.

Interpretive Guidelines §482.24
The term “hospital” includes all locations of the hospital.
The hospital must have one unified medical record service that has administrative responsibility for all medical records, both inpatient and out patient records. The hospital must create and maintain a medical record for every individual, both inpatient and out patient evaluated or treated in the hospital.
The term “medical records” includes at least written documents, computerized electronic information, radiology film and scans, laboratory reports and pathology slides, videos, audio recordings, and other forms of information regarding the condition of a patient.

A-0432 482.24(a) The organization of the medical record service must be appropriate to the scope and complexity of the services performed. The hospital must employ adequate personnel to ensure prompt completion, filing, and retrieval of records.

Interpretive Guidelines §482.24(a)
The medical records service must be organized, equipped, and staffed in accordance with the scope and complexity of the hospital’s services and in such a manner as to comply with the requirements of this regulation and other Federal and State laws and regulations.
There must be an established medical record system that is organized and employs adequate personnel to ensure prompt:
• Completion of medical records;
• Filing of medical records; and
• Retrieval of medical records.
The term “employs adequate personnel” includes:
• That medical record personnel are employees of the hospital;
• That the hospital employs an adequate number of medical record personnel, employs adequate types of medical record personnel, and employs personnel who possess adequate education, skills, qualifications and experience to ensure the hospital complies with requirements of this regulation and other Federal and State laws and regulations.

482.24(b) Standard: Form and Retention of Record

A-0438 The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries.

Interpretive Guidelines §482.24(b)
The hospital must maintain a medical record for each inpatient and outpatient evaluated or treated in any part or location of the hospital.
All medical records must be accurately written. The hospital must ensure that all medical records accurately and completely document all orders, test results, evaluations, care plans, treatments, interventions, care provided and the patient’s response to those treatments, interventions and care.
All medical records must be promptly completed. Every medical record must be complete with all documentation of orders, diagnosis, evaluations, treatments, test results, care plans, discharge plans, consents, interventions, discharge summary, and care provided along with the patient’s response to those treatments, interventions, and care. The record must be completed promptly after discharge in accordance with State law and hospital policy but no later than 30 days after discharge.
The medical record must be properly filed and retained. The hospital must have a medical record system that ensures the prompt retrieval of any medical record, of any patient evaluated or treated at any location of the hospital within the past 5 years. [ §482.24(b)(1) addresses the 5 year medical record retention requirement]
The medical record must be accessible. The hospital must have a medical record system that allows the medical record of any patient, inpatient or outpatient, evaluated and/or treated at any location of the hospital within the past 5 years to be accessible by appropriate staff, 24 hours a day, 7 days a week, whenever that medical record may be needed.
Medical records must be properly stored in secure locations where they are protected from fire, water damage and other threats.
Medical information such as consultations, orders, practitioner notes, x-ray interpretations, lab test results, diagnostic test results, patient assessments and other patient information must be accurately written, promptly completed and properly filed in the patients’ medical record, and accessible to the physicians or other care providers when needed for use in making assessments of the patient’s condition, decisions on the provision of care to the patient, and in planning the patient’s care. This requirement applies to the medical records of current inpatients and outpatients of the hospital.
The hospital must have a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. The medical record system must correctly identify the author of every medical record entry and must protect the security of all medical record entries. The medial record system must ensure that medical record entries are not lost, stolen, destroyed, altered, or reproduced in an unauthorized manner. Locations where medical records are stored or maintained must ensure the integrity, security and protection of the records. These requirements apply to both manual and electronic medical record systems.

A-0439 482.24(b)(1) Medical records must be retained in their original or legally reproduced form for a period of at least 5 years.

Interpretive Guidelines §482.24(b)(1)
Medical records are retained in their original or legally reproduced form in hard copy, microfilm, computer memory, or other electronic storage media. The hospital must be able to promptly retrieve the complete medical record of every individual evaluated or treated in any part or location of the hospital within the last 5 years.
In accordance with Federal and State law and regulations, certain medical records may have retention requirements that exceed 5 years (for example: FDA, OSHA, EPA).

A-0440 482.24(b)(2) The hospital must have a system of coding and indexing medical records. The system must allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies.

No information available.

A-0441 482.24(b)(3) The hospital must have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals, and the hospital must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records must be released by the hospital only in accordance with Federal or State laws, court orders, or subpoenas.

Interpretive Guidelines §482.24(b)(3)

Release of Information from or Copies of Records:
The hospital must have a procedure to ensure the confidentiality of each patient’s medical record, whether it is in paper or electronic format, or a combination of the two, from unauthorized disclosure. Confidentiality applies wherever the record or portions thereof are stored, including but not limited to central records, patient care locations, radiology, laboratories, record storage areas, etc.
A hospital is permitted to disclose medical record information, without a patient’s authorization, in order to provide patient care and perform related administrative functions, such as payment and other hospital operations.
• Payment operations include hospital activities to obtain payment or be reimbursed for the provision of health care to an individual.
• Health care operations are administrative, financial, legal, and quality improvement activities of a hospital that are necessary to conduct business and to support the core functions of treatment and payment. These activities include, but are not limited to: quality assessment and improvement activities, case management and care coordination; competency assurance activities, conducting or arranging for medical reviews, audits, or legal services, including fraud and abuse detection and compliance programs; business planning, development, management, and administration and certain hospital-specific fundraising activities.
The hospital must develop policies and procedures that reasonably limit disclosures of information contained in the patient’s medical record to the minimum disclosure necessary, except when the disclosure is for treatment or payment purposes, or as otherwise required by State or Federal law.
When the minimum necessary standard is applied, a hospital may not disclose the entire medical record for a particular purpose, unless it can specifically justify that the whole record is the disclosure amount reasonably required for the purpose.
A hospital may disclose information from the medical record electronically, and may also share an electronic medical record system with other health care facilities, physicians and practitioners, so long as the system is designed and operated with safeguards that ensure that only authorized disclosures are made.
The hospital must obtain written authorization from the patient or the patient’s representative for any other disclosure of medical record information.

Preventing Unauthorized Access
The hospital must ensure that unauthorized individuals cannot gain access to patient records. This applies to records in electronic as well as hard copy formats. Patient records must be secure at all times and in all locations. This includes open patient records for patients who are currently inpatients in the hospital and outpatients in outpatient clinics. For hard copy records, techniques such as locked cabinets or file rooms and limiting access to keys or pass codes may be employed. For electronic records technical safeguards, such as business rules that limit access based on need to know, passwords, or other control mechanisms must be in place. When disposing of copies of medical records, physical safeguards might include first shredding documents containing confidential information, taking appropriate steps to erase information from media used to store electronic records, etc.

Release of Original Records
The hospital must not release the original of a medical record that exists in a hard copy, paper version only, unless it is required to do so in response to a court order, a subpoena, or Federal or State laws. For electronic records, the hospital must ensure that the media or other mechanism by which the records are stored electronically is not removed in such a way that all or part of the record is deleted from the hospital’s medical record system. The hospital must have policies and procedures that address how it assures that retains its “original” medical records, unless their release is mandated by law/court order/subpoena.

482.24(c) Standard: Content of Record

A-0449 482.24(c) The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services.

Interpretive Guidelines §482.24(c)
The medical record must contain information such as notes, documentation, records, reports, recordings, test results, assessments etc. to:
• Justify admission;
• Justify continued hospitalization;
• Support the diagnosis;
• Describe the patient’s progress;
• Describe the patient’s response to medications; and
• Describe the patient’s response to services such as interventions, care, treatments, etc.
The medical record must contain complete information/documentation regarding evaluations, interventions, care provided, services, care plans, discharge plans, and the patient’s response to those activities.
Patient medical record information, such as, laboratory reports, test results, consults, assessments, radiology reports, dictated notes, etc. must be promptly filed in the patient’s medical record in order to be available to the physician and other care providers to use in making assessments of the patient’s condition, to justify continued hospitalization, to support the diagnosis, to describe the patient’s progress, and to describe the patient’s response to medications, interventions, and services, in planning the patient’s care, and in making decisions on the provision of care to the patient.

A-0450 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures.

Interpretive Guidelines §482.24(c)(1)
All entries in the medical record must be legible. Orders, progress notes, nursing notes, or other entries in the medical record that are not legible may be misread or misinterpreted and may lead to medical errors or other adverse patient events.
All entries in the medical record must be complete. A medical record is considered complete if it contains sufficient information to identify the patient; support the diagnosis/condition; justify the care, treatment, and services; document the course and results of care, treatment, and services; and promote continuity of care among providers. With these criteria in mind, an individual entry into the medical record must contain sufficient information on the matter that is the subject of the entry to permit the medical record to satisfy the completeness standard.
All entries in the medical record must be dated, timed, and authenticated, in written or electronic form, by the person responsible for providing or evaluating the service provided.
• The time and date of each entry (orders, reports, notes, etc.) must be accurately documented. Timing establishes when an order was given, when an activity happened or when an activity is to take place. Timing and dating entries is
necessary for patient safety and quality of care. Timing and dating of entries establishes a baseline for future actions or assessments and establishes a timeline of events. Many patient interventions or assessments are based on time intervals or timelines of various signs, symptoms, or events. (71 FR 68687)
• The hospital must have a method to establish the identity of the author of each entry. This would include verification of the author of faxed orders/entries or computer entries.
• The hospital must have a method to require that each author takes a specific action to verify that the entry being authenticated is his/her entry or that he/she is responsible for the entry, and that the entry is accurate.
The requirements for dating and timing do not apply to orders or prescriptions that are generated outside of the hospital until they are presented to the hospital at the time of service. Once the hospital begins processing such an order or prescription, it is responsible for ensuring that the implementation of the order or prescription by the hospital is promptly dated, and timed in the patient’s medical record.
When a practitioner is using a preprinted order set, the ordering practitioner may be in compliance with the requirement at §482.24(c)(1) to date, time, and authenticate an order if the practitioner accomplishes the following:
• Last page: Sign, date, and time the last page of the orders, with the last page also identifying the total number of pages in the order set.
• Pages with Internal Selections: Sign or initial any other (internal) pages of the order set where selections or changes have been made.
o The practitioner should initial/sign the top or bottom of the pertinent page(s);and
o The practitioner should also initial each place in the preprinted order set where changes, such as additions, deletions, or strike-outs of components that do not apply, have been made.
• It is not necessary to initial every preprinted box that is checked to indicate selection of an order option, so long as there are no changes made to the option(s) selected.
In the case of a pre-established electronic order set, the same principles would apply, so that the practitioner would date, time and authenticate the final order that resulted from the electronic selection/annotation process, with the exception that pages with internal changes would not need to be initialed or signed if they are part of an integrated single electronic document.
Authentication of medical record entries may include written signatures, initials, computer key, or other code. For authentication, in written or electronic form, a method must be established to identify the author. When rubber stamps or electronic authorizations are used for authentication, the hospital must have policies and procedures to ensure that such stamps or authorizations are used only by the individuals whose signature they represent. There shall be no delegation of stamps or authentication codes to another individual. It should be noted that some insurers and other payers may have a policy prohibiting the use of rubber stamps as a means of authenticating the medical records that support a claim for payment. Medicare payment policy, for example, no longer permits such use of rubber stamps. Thus, while the use of a rubber stamp for signature authentication is not prohibited under the CoPs and analysis of the rubber stamp method per se is not an element of the survey process, hospitals may wish to eliminate their usage in order to avoid denial of claims for payment.
Where an electronic medical record is in use, the hospital must demonstrate how it prevents alterations of record entries after they have been authenticated. Information needed to review an electronic medical record, including pertinent codes and security features, must be readily available to surveyors to permit their review of sampled medical records while on-site in the hospital.
When State law and/or hospital policy requires that entries in the medical record made by residents or non-physicians be countersigned by supervisory or attending medical staff members, then the medical staff rules and regulations must address counter-signature requirements and processes.
A system of auto-authentication in which a physician or other practitioner authenticates an entry that he or she cannot review, e.g., because it has not yet been transcribed, or the electronic entry cannot be displayed, is not consistent with these requirements. There must be a method of determining that the practitioner did, in fact, authenticate the entry after it was created. In addition, failure to disapprove an entry within a specific time period is not acceptable as authentication.
The practitioner must separately date and time his/her signature authenticating an entry, even though there may already be a date and time on the document, since the latter may not reflect when the entry was authenticated. For certain electronically-generated documents, where the date and time that the physician reviewed the electronic transcription is automatically printed on the document, the requirements of this section would be satisfied. However, if the electronically-generated document only prints the date and time that an event occurred (e.g., EKG printouts, lab results, etc.) and does not print the date and time that the practitioner actually reviewed the document, then the practitioner must either authenticate, date, and time this document itself or incorporate an acknowledgment that the document was reviewed into another document (such as the H&P, a progress note, etc.), which would then be authenticated, dated, and timed by the practitioner.

A-0454 482.24(c)(2) All orders, including verbal orders, must be dated, timed, and authenticated promptly by the ordering practitioner or by another practitioner who is responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.

Interpretive Guidelines §482.24(c)(2)
The hospital must ensure that all orders, including verbal orders, are dated, timed, and authenticated promptly. The Merriam-Webster online dictionary defines “prompt” as performed readily or immediately.
Verbal orders are orders for medications, treatments, interventions or other patient care that are transmitted as oral, spoken communications between senders and receivers, delivered either face-to-face or via telephone.
The receiver of a verbal order must date, time, and sign the verbal order in accordance with hospital policy. CMS expects hospital policies and procedures for verbal orders to include a read-back and verification process.
The prescribing practitioner must verify, sign, date and time the order as soon as possible after issuing the order, in accordance with hospital policy, and State and Federal requirements.
Authentication of a verbal order may be written, electronic, or faxed. The hospital must have a method for establishing the identity of the practitioner who has given a verbal order, including verification of the author of faxed verbal orders or computer entries.
In some instances, the ordering practitioner may not be able to authenticate his or her order, including a verbal order (e.g., the ordering practitioner gives a verbal order which is written and transcribed, and then is “off duty” for the weekend or an extended period of time). In such cases it is acceptable for another practitioner who is responsible for the patient’s care to authenticate the order, including a verbal order, of the ordering practitioner as long as it is permitted under State law, hospital policies and medical staff bylaws, rules, and regulations. Hospitals may choose in their policies to restrict which practitioners it would authorize to authenticate another practitioner’s orders. For example, a hospital could choose to restrict authentication of orders for pediatric patients to practitioners who are privileged to provide pediatric care. (77 FR 29053, May 16, 2012)
• All practitioners responsible for the patient’s care are expected to have knowledge of the patient’s hospital course, medical plan of care, condition, and current status.
• When a practitioner other than the ordering practitioner authenticates an order, that practitioner assumes responsibility for the order as being complete, accurate and final.
• A qualified non-physician practitioner, such as a physician assistant (PA) or nurse practitioner (NP), who is responsible for the care of the patient may authenticate a physician’s or other qualified non-physician practitioner’s order only if the order is within his/her scope of practice.
If State law requires that the ordering practitioner authenticate his/her own orders, or his/her own verbal orders, then a practitioner other than the prescribing practitioner would not be permitted to authenticate the verbal order in that State.
(71 FR 68682 and 77 FR 29053, May 16, 2012)

NOTE CONCERNING VERBAL ORDERS FOR LABORATORY TESTS:
The requirement to authenticate promptly a verbal order applies to verbal orders associated with both inpatients and outpatients. It is possible that a hospital verbal order for a laboratory test could be authenticated in compliance with the Clinical Laboratory Improvement Amendment (CLIA) regulatory standard of authentication, i.e., within 30 days, but nonetheless be out of compliance with the hospital Medical Records Services requirement for prompt authentication of all orders, including verbal orders. Because CLIA laboratories – even if physically situated in a hospital – are surveyed for compliance only with CLIA regulations, the laboratory would not be cited for a deficiency by a CLIA survey team. However, hospital surveyors conducting a survey would cite the hospital’s inpatient or outpatient recordkeeping for deficiencies under the Medical Record Services CoP if the lab order originated for a patient during a hospital inpatient stay or hospital outpatient clinic visit and the order was not authenticated promptly.

A-0457 482.24(c)(3) Hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient orders only if the hospital:
(i) Establishes that such orders and protocols have been reviewed and approved by the medical staff and the hospital’s nursing and pharmacy leadership;
(ii) Demonstrates that such orders and protocols are consistent with nationally recognized and evidence-based guidelines;
(iii) Ensures that the periodic and regular review of such orders and protocols is conducted by the medical staff and the hospital’s nursing and pharmacy leadership to determine the continuing usefulness and safety of the orders and protocols; and
(iv) Ensures that such orders and protocols are dated, timed, and authenticated promptly in the patient’s medical record by the ordering practitioner or another practitioner responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.

Interpretive Guidelines §482.24(c)(3)

What is covered by this regulation?
There is no standard definition of a “standing order” in the hospital community at large (77 FR 29055, May 16, 2012), but the terms “pre-printed standing orders,” “electronic standing orders,” “order sets,” and “protocols for patient orders” are various ways in which the term “standing orders” has been applied. For purposes of brevity, in our guidance we generally use the term “standing order(s)” to refer interchangeably to pre-printed and electronic standing orders, order sets, and protocols. However, we note that the lack of a standard definition for these terms and their interchangeable and indistinct use by hospitals and health care professionals may result in confusion regarding what is or is not subject to the requirements of §482.24(c)(3), particularly with respect to “order sets.”
• Not all pre-printed and electronic order sets are considered a type of “standing order” covered by this regulation. Where the order sets consist solely of menus of treatment or care options designed to facilitate the creation of a patient-specific set of orders by a physician or other qualified practitioner authorized to write orders, and none of the treatment choices and actions can be initiated by non-practitioner clinical staff before the physician or other qualified practitioner actually creates the patient-specific order(s), such menus would not be considered “standing orders” covered by this regulation. We note in such cases the menus provide a convenient and efficient method for the physician/practitioner to create an order, but the availability of such menu options does not create an “order set” that is a “standing order” subject to the requirements of this regulation. The physician/practitioner may, based on his/her professional judgment, choose to: use the available menu options to create an order; not use the menu options and instead create an order from scratch; or modify the available menu options to create the order. In each case the physician/practitioner exercises his privileges to prescribe specific diagnosis and/or treatment activities that are to be implemented for a patient.
• On the other hand, in cases where hospital policy permits treatment to be initiated, by a nurse, for example, without a prior specific order from the treating physician/practitioner, this policy and practice must meet the requirements of this regulation for review of standing orders, regardless of whether it is called a standing order, a protocol, an order set, or something else. Such treatment is typically initiated when a patient’s condition meets certain pre-defined clinical criteria. For example, standing orders may be initiated as part of an emergency response or as part of an evidence-based treatment regimen where it is not practical for a nurse to obtain either a written, authenticated order or a verbal order from a physician or other qualified practitioner prior to the provision of care.
• Hybrids, where a component for non-practitioner-initiated treatment is embedded within a menu of options for the physician or other qualified practitioner, still require compliance with the requirements for a standing order for that component. For example, if an order set includes a protocol for nurse-initiated potassium replacement, that protocol must be reviewed under the requirements of this regulation before it may become part of a menu of treatment options from which a physician or other qualified practitioner would select treatments for a particular patient.

Requirements for “Standing Orders”
Hospitals have the flexibility to use standing orders to expedite the delivery of patient care in well-defined clinical scenarios for which there is evidence supporting the application of standardized treatments or interventions.
Appropriate use of standing orders can contribute to patient safety and quality of care by promoting consistency of care, based on objective evidence, when orders
may be initiated as part of an emergency response or as part of an evidence-based treatment regimen where it is not practicable for a nurse or other non-practitioner to obtain a verbal or authenticated written order from a physician or other practitioner responsible for the care of the patient prior to the provision of care.
In all cases, implementation of a standing order must be medically appropriate for the patient to whom the order is applied.
Much of the evidence on the effectiveness of standing orders in hospitals has been narrowly focused on aspects of their use by Rapid Response Teams addressing inpatient emergencies. However, standing orders may also be appropriate in other clinical circumstances, including, but not limited to:
• Protocols for triaging and initiating required screening examinations and stabilizing treatment for emergency department patients presenting with symptoms suggestive of acute asthma, myocardial infarction, stroke, etc. (This does not relieve a hospital of its obligations under the Emergency Medical Treatment and Labor Act (EMTALA) to have qualified medical personnel complete required screening and, when applicable, stabilizing treatment in a timely manner.)
• Post-operative recovery areas.
• Timely provision of immunizations, such as certain immunizations for newborns, for which there are clearly established and nationally recognized guidelines.

Standing orders may not be used in clinical situations where they are specifically prohibited under Federal or State law. For example, the hospital patient’s rights regulation at §482.13(e)(6) specifically prohibits the use of standing orders for restraint or seclusion of hospital patients.

When deciding whether to use standing orders, hospitals should also be aware that, although use of standing orders is permitted under the hospital Conditions of Participation, some insurers, including Medicare, may not pay for the services provided because of the use of standing orders. (77 FR 29056)

Minimum requirements for standing orders. Hospitals may employ standing orders only if the following requirements are met for each standing order for a particular well-defined clinical scenario:
• Each standing order must be reviewed and approved by the hospital’s medical staff and nursing and pharmacy leadership before it may be used in the clinical setting. The regulation requires a multi-disciplinary collaborative effort in establishing the protocols associated with each standing order.
• The hospital’s policies and procedures for standing orders must address the process by which a standing order is developed; approved; monitored; initiated by authorized staff; and subsequently authenticated by physicians or other practitioners responsible for the care of the patient.
• For each approved standing order, there must be specific criteria clearly identified in the protocol for the order for a nurse or other authorized personnel to initiate the execution of a particular standing order, for example, the specific clinical situations, patient conditions, or diagnoses by which initiation of the order would be justified. Under no circumstances may a hospital use standing orders in a manner that requires any staff not authorized to write patient orders to make clinical decisions outside of their scope of practice in order to initiate such orders.
Since residents are physicians, this regulation does not require specific criteria for a resident to initiate the execution of a particular standing order. However, there may be State laws governing the practice of residents in hospitals that are more restrictive; if so, the hospital is expected to comply with the State law. Likewise, the hospital may choose through its policies and medical staff bylaws, rules and regulations to restrict the role of residents with respect to standing orders.
• Policies and procedures should also address the instructions that the medical, nursing, and other applicable professional staff receive on the conditions and criteria for using standing orders as well as any individual staff responsibilities associated with the initiation and execution of standing orders. An order that has been initiated for a specific patient must be added to the patient’s medical record at the time of initiation, or as soon as possible thereafter.
• Likewise, standing order policies and procedures must specify the process whereby the physician or other practitioner responsible for the care of the patient acknowledges and authenticates the initiation of all standing orders after the fact, with the exception of influenza and pneumococcal vaccines, which do not require such authentication in accordance with § 482.23(c)(2).
(76 FR 65896, October 24, 2011 & 77 FR 29056, May 16, 2012)
• The hospital must be able to document that the standing order is consistent with nationally recognized and evidence-based guidelines. This does not mean that there must be a template standing order available in national guidelines which the hospital copies, but rather that the content of each standing order in the hospital must be consistent with nationally recognized, evidence-based guidelines for providing care. The burden of proof is on the hospital to show that there is a sound basis for the standing order.
• Each standing order must be subject to periodic and regular review by the medical staff and the hospital’s nursing and pharmacy leadership, to determine the continuing usefulness and safety of the orders and protocols. At a minimum, an annual review of each standing order would satisfy this requirement. However, the hospital’s policies and procedures must also address a process for the identification and timely completion of any requisite updates, corrections, modifications, or revisions based on changes in nationally recognized, evidence-based guidelines. The review may be prepared by the hospital’s QAPI program, so long as the medical staff and nursing and pharmacy leadership read, review, and, as applicable, act upon the final report. Among other things, reviews are expected to consider:
• Whether the standing order’s protocol continues to be consistent with the latest standards of practice reflected in nationally recognized, evidence-based guidelines;
• Whether there have been any preventable adverse patient events resulting from the use of the standing order, and if so, whether changes in the order would reduce the likelihood of future similar adverse events. Note that the review would not be expected to address adverse events that are a likely outcome of the course of patient’s disease or injury, even if the order was applied to that patient, unless there is concern that use of the standing order exacerbated the patient’s condition; and
• Whether a standing order has been initiated and executed in a manner consistent with the order’s protocol, and if not, whether the protocol needs revision and/or staff need more training in the correct procedures.
• An order that has been initiated for a specific patient must be added to the patient’s medical record at the time of initiation, or as soon as possible thereafter. The hospital must ensure each standing order that has been executed is dated, timed, and authenticated promptly in the patient’s medical record by the ordering practitioner or another practitioner responsible for the care of the patient. Another practitioner who is responsible for the care of the patient may date, time and authenticate the standing order instead of the ordering practitioner, but only if the other practitioner is acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules and regulations.
The hospital’s standing orders policies and procedures must specify the process whereby the responsible practitioner, or another authorized practitioner, acknowledges and authenticates the initiation of each standing order after the fact, with the exception of standing orders for influenza and pneumococcal vaccines, which do not require such authentication. Further, the responsible practitioner must be able to modify, cancel, void or decline to authenticate orders that were not medically necessary in a particular situation. The medical record must reflect the physician’s actions to modify, cancel, void or refusal to authenticate a standing order that the physician determined was not medically necessary. (76 FR 65896, October 24, 2011)

482.24(c)(4) All records must document the following, as appropriate:

A-0458 482.24(c)(4)(I)(A) A medical history and physical examination completed and documented no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The medical history and physical examination must be placed in the patient’s medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

Interpretive Guidelines §482.24(c)(4)(i)(A)
The medical record must include documentation that a medical history and physical examination (H&P) was completed and documented for each patient no more than 30 days prior to hospital admission or registration, or 24 hours after hospital admission or registration, but in all cases prior to surgery or a procedure requiring anesthesia services.
The purpose of an H&P is to determine whether there is anything in the patient's overall condition that would affect the planned course of the patient's treatment, such as an allergy to a medication that must be avoided, or a co-morbidity that requires certain additional interventions to reduce risk to the patient.
The H&P documentation must be placed in the medical record within 24 hours of admission or registration, but in all cases prior to surgery or a procedure requiring anesthesia services, including all inpatient, outpatient, or same-day surgeries or procedures. (71 FR 68676) The H&P may be handwritten or transcribed. An H&P that is completed within 24 hours of the patient’s admission or registration, but after surgery or a procedure requiring anesthesia would not be in compliance.

A-0461482.24(c)(4)(I)(B) An updated examination of the patient, including any changes in the patient’s condition, when the medical history and physical examination are completed within 30 days before admission or registration. Documentation of the updated examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

Interpretive Guidelines §482.24(c)(4)(i)(B)
When an H&P is completed within the 30 days before admission or registration, the hospital must ensure that an updated medical record entry documenting an examination for any changes in the patient's condition is placed in the patient's medical record within 24 hours after admission or registration, but, in all cases involving surgery or a procedure requiring anesthesia services, prior to the surgery or procedure.
The update note must document an examination for any changes in the patient's condition since the time that the patient's H&P was performed that might be significant for the planned course of treatment. The physician, oromaxillofacial surgeon, or qualified licensed individual uses his/her clinical judgment, based upon his/her assessment of the patient’s condition and co-morbidities, if any, in relation to the patient’s planned course of treatment to decide the extent of the update assessment needed as well as the information to be included in the update note in the patient’s medical record.
If, upon examination, the licensed practitioner finds no change in the patient's condition since the H&P was completed, he/she may indicate in the patient's medical record that the H&P was reviewed, the patient was examined, and that "no change" has occurred in the patient's condition since the H&P was completed. (71 FR 68676) Such statements in the medical record would meet the requirement for documenting the H&P update.
Any changes in the patient’s condition must be documented by the practitioner in the update note and placed in the patient’s medical record within 24 hours of admission or registration, but prior to surgery or a procedure requirement anesthesia services. Additionally, if the practitioner finds that the H&P done before admission is incomplete, inaccurate, or otherwise unacceptable, the practitioner reviewing the H&P, examining the patient, and completing the update may disregard the existing H&P, and conduct and document in the medical record a new H&P within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia.

A-0463 482.24(c)(4)(ii) Admitting diagnosis.

Interpretive Guidelines §482.24(c)(4)(ii)
All inpatient medical records must contain the admitting diagnosis.

A-0464 482.24(c)(4)(iii) Results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient.

Interpretive Guidelines §482.24(c)(4)(iii)
All patient records, both inpatient and outpatient, must contain the results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient. This information must be promptly filed in the patient’s medical record in order to be available to the physician or other care providers to use in making assessments of the patient’s condition, to justify treatment or continued hospitalization, to support or revise the patient’s diagnosis, to support or revise the plan of care, to describe the patient’s progress and to describe the patient’s response to medications, treatments, and services.

A-0465 482.24(c)(4)(iv) Documentation of complications, hospital acquired infections, and unfavorable reactions to drugs and anesthesia.

Interpretive Guidelines §482.24(c)(4)(iv)
All patient medical records, both inpatient and outpatient, must document:
• Complication;
• Hospital-acquired infections;
• Unfavorable reactions to drugs; and
• Unfavorable reactions to anesthesia.

A-0466 482.24(c)(4)(v) Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent.

Interpretive Guidelines §482.24(c)(4)(v)
Informed consent is discussed in three locations in the CMS Hospital CoPs. See also the guidelines for 42 CFR 482.13(b)(2) pertaining to patients' rights, and the guidelines for 42 CFR 482.51(b)(2), pertaining to surgical services.
The medical record must contain a document recording the patient’s informed consent for
those procedures and treatments that have been specified as requiring informed consent. Medical staff policies should address which procedures and treatments require written informed consent. There may also be applicable Federal or State law requiring informed consent. The informed consent form contained in the medical record should provide evidence that it was properly executed.

Informed Consent Forms
A properly executed informed consent form should reflect the patient consent process. Except as specified for emergency situations in the hospital’s informed consent policies, all inpatient and outpatient medical records must contain a properly executed informed consent form prior to conducting any procedure or other type of treatment that requires informed consent. An informed consent form, in order to be properly executed, must be consistent with hospital policies as well as applicable State and Federal law or regulation. A properly executed informed consent form contains the following minimum elements:
• Name of the hospital where the procedure or other type of medical treatment is to take place;
• Name of the specific procedure, or other type of medical treatment for which consent is being given;
• Name of the responsible practitioner who is performing the procedure or administering the medical treatment;
• Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative therapies, was explained to the patient or the patient’s legal representative; (Material risks could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but high degree of severity. Hospitals are free to delegate to the responsible practitioner, who uses the available clinical evidence as informed by the practitioner’s professional judgment, the determination of which material risks, benefits and alternatives will be discussed with the patient.)
• Signature of the patient or the patient’s legal representative; and
• Date and time the informed consent form is signed by the patient or the patient’s legal representative.
If there is applicable State law governing the content of the informed consent form, then the hospital’s form must comply with those requirements.
A well-designed informed consent form might also include the following additional information:
• Name of the practitioner who conducted the informed consent discussion with the patient or the patient’s representative.
• Date, time, and signature of the person witnessing the patient or the patient’s legal representative signing the consent form.
• Indication or listing of the material risks of the procedure or treatment that were discussed with the patient or the patient’s representative;
• Statement, if applicable, that physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, in accordance with the hospital’s policies and, in the case of residents, based on their skill set and under the supervision of the responsible practitioner.
• Statement, if applicable, that qualified medical practitioners who are not physicians who will perform important parts of the surgery or administration of anesthesia will be performing only tasks that are within their scope of practice, as determined under State law and regulation, and for which they have been granted privileges by the hospital.

A-0467 482.24(c)(4)(vi) All practitioners’ orders, nursing notes, reports of treatment, medication records, radiology, and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition.

Interpretive Guidelines §482.24(c)(4)(vi)
The requirement means that the stated information is necessary to monitor the patient’s condition and that this and other necessary information must be in the patient’s medical record. In order for necessary information to be used it must be promptly filed in the medical record so that health care staff involved in the patient’s care can access/retrieve this information in order to monitor the patient’s condition and provide appropriate care.
The medical record must contain:
• All practitioner’s orders (properly authenticated);
• All nursing notes (including nursing care plans);
• All reports of treatment (including complications and hospital-acquired infections);
• All medication records (including unfavorable reactions to drugs);
• All radiology reports;
• All laboratory reports;
• All vital signs; and
• All other information necessary to monitor the patient’s condition.

A-0468 482.24(c)(4)(vii) Discharge summary with outcome of hospitalization, disposition of case, and provisions for follow-up care.

Interpretive Guidelines §482.24(c)(4)(vii)
All patient medical records must contain a discharge summary. A discharge summary discusses the outcome of the hospitalization, the disposition of the patient, and provisions for follow-up care. Follow-up care provisions include any post hospital appointments, how post hospital patient care needs are to be met, and any plans for post-hospital care by providers such as home health, hospice, nursing homes, or assisted living.
The MD/DO or other qualified practitioner with admitting privileges in accordance with State law and hospital policy, who admitted the patient is responsible for the patient during the patient’s stay in the hospital. This responsibility would include developing and entering the discharge summary.
Other MD/DOs who work with the patient’s MD/DO and who are covering for the patient’s MD/DO and who are knowledgeable about the patient’s condition, the patient’s care during the hospitalization, and the patient’s discharge plans may write the discharge summary at the responsible MD/DO’s request.
In accordance with hospital policy, and 42 CFR Part 482.12(c)(1)(i) the MD/DO may delegate writing the discharge summary to other qualified health care personnel such as nurse practitioners and MD/DO assistants to the extent recognized under State law or a State’s regulatory mechanism.
Whether delegated or non-delegated, we would expect the person who writes the discharge summary to authenticate, date, and time their entry and additionally for delegated discharge summaries we would expect the MD/DO responsible for the patient during his/her hospital stay to co-authenticate and date the discharge summary to verify its content.
The discharge summary requirement would include outpatient records. For example:
• The outcome of the treatment, procedures, or surgery;
• The disposition of the case;
• Provisions for follow-up care for an outpatient surgery patient or an emergency
department patient who was not admitted or transferred to another hospital.

A-0469 482.24(c)(4)(viii) Final diagnosis with completion of medical records within 30 days following discharge.

Interpretive Guidelines §482.24(c)(4)(viii)
All medical records must contain a final diagnosis. All medical records must be complete within 30 days of discharge or outpatient care.

CoP: Pharmaceutical Services

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482.25 Pharmaceutical Services

A-0489 482.25 The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.

Interpretive Guidelines §482.25
A hospital must provide pharmaceutical services that meet the needs of its patients. The services must include either a pharmacy that is directed by a pharmacist, or, when appropriate, a drug storage area that is competently supervised. The hospital’s medical staff is responsible for developing pharmaceutical policies and procedures that minimize the potential for medication errors, but may delegate this function to the pharmaceutical service.
The manner or degree of noncompliance with the requirements of this Condition and its component standards must be evaluated to determine whether there is substantial noncompliance with the Condition, warranting a Condition-level citation.

A-0490 482.25 The hospital must have pharmaceutical services that meet the needs of the patients.

Interpretive Guidelines §482.25

What is included in pharmaceutical services?
Pharmaceutical services encompass the functions of procuring, storing, compounding, re-packaging, and dispensing all medications, biologicals, chemicals and medication-related devices within the hospital. They also include providing medication-related information to care professionals within the hospital, as well as direct provision of medication-related care.

Meeting patient needs
Hospitals must provide pharmaceutical services that meet the needs of their patients. The scope and complexity of pharmaceutical services available in the hospital must be consistent with the volume and types of patients the hospital serves. Except in unusual circumstances, the pharmaceutical service is expected to make available in a timely manner the volume and types of medications typically needed. These would be those medications typically prescribed by the hospital’s practitioners for hospital patients receiving inpatient services, surgical services, diagnostic services involving medications as a component of testing, and outpatient drug therapies administered while the patient is in the hospital.
Not every hospital is expected to offer the same level of pharmaceutical services. For example:
• It would not be uncommon for a psychiatric hospital to maintain a relatively limited pharmaceutical service, due to minimal need for compounding, and/or dispensing multiple types and forms of medications and biologicals.
• On the other hand, a short-term acute care hospital with a busy oncology outpatient service and other complex medical and surgical departments would be expected to provide a wider range of pharmaceutical services that are ready to be furnished when needed.

A-0491 482.25(a) The pharmacy or drug storage area must be administered in accordance with accepted professional principles.

Interpretive Guidelines §482.25(a)
Pharmaceutical services must be administered in accordance with accepted professional principles. Accepted professional principles includes compliance with applicable Federal and State laws, regulations, and guidelines governing pharmaceutical services, as well as, standards or recommendations promoted by nationally recognized professional organizations, such as those found in the U.S. Pharmacopeia/National Formulary (USP/NF).
The hospital’s pharmacy service must ensure safe and appropriate procurement, storage, preparation, dispensing, use, tracking and control, and disposal of medications and medication-related devices throughout the hospital, for both inpatient and outpatient services.
Hospitals may choose how to set up the pharmaceutical services utilizing various methods including, but not limited to:
• a unit dose system (i.e.; single unit package, dispensed in most ready to administer form possible),
• individual prescription (i.e.; instruction for a single patient, written by a medical practitioner for a medication or treatment),
• floor stock system (i.e.; storage of pharmaceutical and over-the-counter drugs on the patient care unit), or
• a combination of these systems, as long as they are properly stored.
However, hospitals with only a drug storage area must only use drugs that are pre-packaged and need no further preparation beyond that required at the point of care.
The hospital must develop, implement and periodically review and revise as needed policies and procedures governing provision of pharmaceutical services. The regulation makes the hospital’s medical staff responsible for the policies and procedures, but also permits the medical staff to delegate this function to the hospital’s pharmaceutical services. The policies and procedures must reflect accepted professional pharmacy principles, and the pharmacy director must be able to identify the source(s) used when developing and adopting the policies and procedures. There must also be a process to train staff on the applicable policies and procedures and to monitor their adherence.

Policies and Procedures for Minimizing Drug Errors
Medication errors are a substantial source of morbidity and mortality risk in the hospitalized setting. Therefore, hospitals must take steps to prevent, identify, and minimize these errors. These steps must be based on accepted professional principles. This includes not only ensuring that the pharmacy processes conform to of accepted standards of pharmacy practice but also proactively identifying and reviewing Adverse Drug Events (ADE) that occur. Pharmacies also need to be aware of external alerts to real or potential pharmacy-related problems in hospitals.
The pharmaceutical services policies and procedures must be designed to minimize drug errors and are expected to address:
• High-alert medications - are considered inherently high risk for adverse drug events. High alert drugs may include controlled medications, medications not on the approved FDA list, medications with a narrow therapeutic range, psychotherapeutic medications, look-alike/sound-alike medications and those new to the market or new to the hospital. Although mistakes may or may not be more common with these drugs, the consequences of errors are often harmful, sometimes fatal, to patients. Examples of ways to minimize high alert medication errors include, but are not
limited to, the following: dosing limits, administration guidelines, packaging, labeling and storage.
• Investigational medications - hospitals that conduct research involving investigational medications must have a policy and procedure in place to ensure that investigational medications are safely controlled and administered. Procedures for the use of investigational medications include, but are not limited to, the following: A written process for reviewing, approving, supervising and monitoring investigational medications specifying that when pharmacy services are provided, the pharmacy controls the storage, dispensing, labeling, and distribution of the investigational medication.
• Adherence to professional standards of practice for all compounding, packaging dispensing and drug disposal activities;
• Standardizing medication-related devices and equipment where feasible. For example, limit the types of general-purpose infusion pumps to one or two;
• Availability of up-to-date medication information and pharmacy expertise on-call when pharmacy does not operate 24 hours a day;
• Standardization of prescribing and communication practices to include:
o Avoidance of dangerous abbreviations;
o All elements of the order – dose, strength, units (metric), route, frequency, and rate;
o Alert systems for look-like and sound-alike drug names;
o Use of facility approved pre-printed order sheets whenever possible.
o Prohibition of orders to “resume previous orders;”
• Availability of patient-specific information to all individuals involved in provision of pharmaceutical services. The patient information must be sufficient to properly order, prepare, dispense, administer and monitor medications as appropriate;
• Identification of when weight-based dosing for pediatric populations is required; and
• A voluntary, non-punitive, reporting system to monitor and report adverse drug events (including medication errors and adverse drug reactions);
• Monitoring drug alerts and/or recalls. The hospital should have a means to incorporate external alerts and/or recommendations from national associations and
governmental agencies for review and facility policy and procedure revision consideration. National associations could include Institute for Safe Medications Practice and National Coordinating Council for Medication Error Reporting and Prevention. Governmental agencies may include: Food and Drug Administration, Med Watch Program; and
• The hospital’s pharmacy services must be integrated into its hospital-wide QAPI program and therefore, it is important to flag new types of mistakes and continually improve and refine policies and procedures as a result of analyses of errors and adverse events.

A-0492 482.25(a)(1) A full-time, part-time, or consulting pharmacist must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.

Interpretive Guidelines §482.25 and §482.25(a)(1)
Pharmaceutical services offered throughout the hospital must be under the direction of a pharmacist, who may be full-time, part-time, or consulting. This is required even in the case of a hospital that has a drug storage area instead of a pharmacy. The director must have documented training or expertise in hospital pharmacy practice and management. The hospital must have written criteria for the qualifications of the pharmacy director in accordance with the scope of services provided.
The extent of pharmaceutical services provided by the hospital determines whether a part-time director of the services is sufficient. Depending on the volume and complexity of the hospital’s services, oversight may not require full-time on-site management at the hospital’s pharmacy, but may be accomplished through regularly scheduled visits, and/or use of telecommunications in accordance with Federal and State law and accepted professional principles. If the hospital does not have a full-time pharmacist, it must be able to provide evidence of how a part-time or consulting pharmacist is able to perform all functions relating to developing, supervising and coordinating all pharmacy services activities.
In general, hospital pharmacies are staffed with registered pharmacists and pharmacy technicians who perform various functions, including, but not limited to, compounding, labeling, and dispensing of various drugs and biologicals.
There may be instances of small hospitals that do not have a pharmacy but utilize a drug storage area for dispensing pre-packaged drugs only. If the hospital has a drug storage area in lieu of a pharmacy, the day-to-day operations of pharmaceutical services must be under the supervision of an individual who, if not a pharmacist, nevertheless has documented competency to oversee compliance with all the pharmaceutical services regulatory requirements (e.g., security, access to locked areas, etc.). The hospital must establish in writing the qualifications of the drug storage area supervisor.
The job description or the written agreement for the responsibilities of the pharmacist director should be clearly defined and include development, supervision and coordination of all the activities of pharmacy services, including active leadership of those committees responsible for establishing medication-related policies and procedures.

A-0493 482.25(a)(2) The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.

Interpretive Guidelines §482.25(a)(2)
There must be sufficient personnel to respond to the pharmaceutical needs of the patient population being served.
The pharmaceutical services staff must be sufficient in types, numbers, and training to provide quality services, including 24 hour, 7-day emergency coverage, or there is an arrangement for emergency services, as determined by the needs of the patients and as specified by the medical staff.
The number of pharmacists and/or the number of hours of services provided by pharmacists at the hospital, or at each location of the hospital that provides pharmaceutical services, must meet and be in accordance with the needs of its patients and accepted professional principles (as previously defined), and reflect the scope and complexity of the hospital’s pharmaceutical services.
There must be sufficient numbers and types of personnel to provide accurate and timely medication delivery, ensure accurate and safe medication administration and to provide appropriate clinical services as well as the participation in continuous quality improvement programs that meet the needs of the patient population being served.

A-0494 482.25(a)(3) Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.

Interpretive Guidelines §482.25(a)(3)
Components of a record system to maintain current and accurate records of the receipt and disposition of scheduled drugs would include:
• Accountability procedures to ensure control of the distribution, use, and disposition of all scheduled drugs.
• Records of the receipt and disposition of all scheduled drugs must be current and must be accurate.
• Records trace the movement of scheduled drugs throughout the service.
• The pharmacist is responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and reconciled.
• The record system, delineated in policies and procedures, tracks movement of all scheduled drugs from the point of entry into the hospital to the point of departure either through administration to the patient, destruction or return to the manufacture. This system provides documentation on scheduled drugs in a readily retrievable manner to facilitate reconciliation of the receipt and disposition of all scheduled drugs.
• All drug records are in order and an account of all scheduled drugs is maintained and any discrepancies in count are reconciled promptly.
• The hospital system is capable of readily identifying loss or diversion of all controlled substances in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion?
• Facility policies and procedures should minimize scheduled drug diversion.

482.25(b) Standard: Delivery of Services

A-0500 482.25(b) In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.

Interpretive Guidelines §482.25(b)
Drugs and biologicals must be controlled and distributed in accordance with applicable Federal and State laws and regulations, and in accordance with applicable standards of practice. Applicable standards of practice include compliance with all Federal and State laws, regulations, and guidelines. The procedures established to prevent unauthorized usage and distribution must provide for an accounting of the receipt and disposition of drugs subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970.
Other sources of additional guidelines could include, but are not limited to: American Society of Health-System Pharmacists, American College of Clinical Pharmacy, American Pharmacists Association, United States Pharmacopeia, etc.

NOTE re: US Pharmacopeia/National Formulary (USP/NF)
According to the Federal Food, Drug and Cosmetic Act (FCDA), the official compendia of the United States for excipients, drug substances, and drug products is the USP/NF. It is published every year in November by the United States Pharmacopeial Convention (http://www.usp.org/) and includes two supplements published in February and June.
The USP is a not-for-profit, non-governmental organization that since 1820 has established quality standards for, among other things, drug substances, drug products and compounded preparations. Congress established a role for USP standards in the adulteration provision of the 1906 Food and Drug Act. That role was expanded in the modern Food, Drug and Cosmetic Act (FDCA) beginning in 1938, with a role for USP compendial standards for naming and identity; strength, quality, and purity; and packaging and labeling, in both the adulteration and misbranding provisions of FDCA. (See, for example, §501(b) of the FDCA regarding compendial standards for strength, quality and purity, §502(g) for compendial standards for packaging and labeling). Under the FDCA, a drug with a name recognized in the USP/NF must comply with compendial identity standards, or be deemed adulterated, or misbranded, or both. To avoid being deemed adulterated, such drugs must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs.

The hospital must have a process in place for medication orders to be received in the pharmacy and dispensed in a safe and timely manner. Safe dispensing of medications must be in accordance with accepted standards of practice and includes, but is not limited to, the following:
• Implementing systems such as dose limits, pre-printed orders, special labeling, or double checks to minimize adverse drug events, especially for high alert medications;
• Reviewing all medication orders (except in emergency situations) for appropriateness by a pharmacist before the first dose is dispensed. A process is established for resolving questions with the prescribing practitioner and the discussion and outcome are documented in the patient’s medical record or pharmacy copy of the prescriber’s order;
This review should include:
• Therapeutic appropriateness of a patient’s medication regimen;
• Therapeutic duplication in the patient’s medication regimen;
• Appropriateness of the drug, dose, frequency, and route of administration;

-- NOTE re: US Pharmacopeia/National Formulary (USP/NF)
According to the Federal Food, Drug and Cosmetic Act (FCDA), the official compendia of the United States for excipients, drug substances, and drug products is the USP/NF. It is published every year in November by the United States Pharmacopeial Convention (http://www.usp.org/) and includes two supplements published in February and June.
The USP is a not-for-profit, non-governmental organization that since 1820 has established quality standards for, among other things, drug substances, drug products and compounded preparations. Congress established a role for USP standards in the adulteration provision of the 1906 Food and Drug Act. That role was expanded in the modern Food, Drug and Cosmetic Act (FDCA) beginning in 1938, with a role for USP compendial standards for naming and identity; strength, quality, and purity; and packaging and labeling, in both the adulteration and misbranding provisions of FDCA. (See, for example, §501(b) of the FDCA regarding compendial standards for strength, quality and purity, §502(g) for compendial standards for packaging and labeling). Under the FDCA, a drug with a name recognized in the USP/NF must comply with compendial identity standards, or be deemed adulterated, or misbranded, or both. To avoid being deemed adulterated, such drugs must also comply with compendial standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs.--

• Real or potential medication-medication, medication-food, medication-laboratory test and medication-disease interactions;
• Real or potential allergies or sensitivities; and
• Other contraindications.
• Medications dispensed by the hospital are retrieved when recalled or discontinued by the manufacturer or the Food and Drug Administration (FDA) for safety reasons;
• Policies and procedures that address the use of medications brought into the hospital by patients or their families when self-administration of medications is permitted by hospital policy; and
• Having a system in place to reconcile medications that are not administered (e.g., left in the patient’s medication drawer) when the pharmacy inventories patient medications or restocks patient medications. For example, did the patient refuse the medication, was there a clinical or treatment reason the medication was not used, or was the medication not used due to an error?

Monitoring the Effects of Medications
The pharmaceutical service may be responsible for monitoring the effects of medication(s) specified per hospital policy to assure medication therapy is appropriate and minimizes the occurrence of adverse events. Typically this occurs with anticoagulant therapy and antibiotics prescribed for the pharmacy to establish or adjust the dosage (i.e.; “pharmacy to dose” order). In such cases, the pharmacy’s monitoring process includes:
• Clinical and laboratory data to evaluate the efficacy of medication therapy to anticipate or evaluate toxicity and adverse effects;
• Physical signs and clinical symptoms relevant to the patient’s medication therapy;
• Assessing the patient’s own perceptions about side effects, and, when appropriate, perceived efficacy.
(See also the Nursing CoP discussion regarding monitoring of patients at §482.23(c)(4)).

A-0501 482.25(b)(1) All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws.

Interpretive Guidelines §482.25(b)(1)
All pharmaceutical services involving compounding, packaging, or dispensing of drugs and biologicals, must be conducted by or under the supervision of a pharmacist and performed consistent with State and Federal laws. The hospital must adopt and implement written policies and procedures to ensure all medications are prepared by authorized personnel.

Compounded Preparations
Hospitals use many medications that need to be reconstituted, mixed or which otherwise may be considered “compounded” preparations. Some may be compounded in the hospital pharmacy and/or the hospital may obtain some or all from external sources. The external sources could include:
• Manufacturers;
• registered outsourcing facilities, and/or
• compounding pharmacies.
Regardless of the source, if accepted standards for safe compounding are not met, compounded medications may contain less or more than the intended dose and/or may be chemically or microbiologically contaminated, with potentially devastating or even lethal consequences for the patients who receive them.

Use of Registered Outsourcing Facilities
The Drug Quality and Security Act (DQSA), signed into law on November 27, 2013, contains provisions relating to the oversight of compounding of human drugs. The DQSA created a new section 503B in the FDCA under which a compounder may elect to become an “outsourcing facility.” The law defines an “outsourcing facility” as a facility at one geographic location or address that is engaged in the compounding of sterile drugs; has elected to register as an outsourcing facility; and complies with all of the requirements of section 503B of the FDCA. Facilities that elect to register as outsourcing facilities, per section 503B:
• Must comply with the FDA’s Current Good Manufacturing Practice (CGMP) requirements, which contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The CGMP requirements make sure that a product is safe for use, and that it has the ingredients and strength it claims to have. The FDA’s publishes the most current versions of its draft and final regulations and guidance related to compounding on its website: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm ;
• Will be inspected by FDA according to a risk-based schedule; and
• Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.
In a January 2014 letter to purchasers of compounded medications (available at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm380596.htm ), the Commissioner of the FDA encouraged the use of registered outsourcing facilities and noted that,“[a]s a purchaser of compounded drugs, you can play an important role in improving the quality of compounded drugs by requiring compounding pharmacies that supply drugs to your facility to register as outsourcing facilities. Once they register, you and the patients you serve can be assured that FDA will inspect these facilities on a risk-based schedule, hold them to CGMP requirements, monitor the adverse event reports they are required to submit to the agency, and require appropriate labeling.”
FDA has posted a list of Registered Human Drug Compounding Outsourcing Facilities, including the end date of the last FDA inspection related to compounding, whether investigators observed any significant objectionable conditions, and whether other FDA actions were taken based on the last inspection, at: http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/pharmacycompounding/ucm378645.htm
Note that these registered outsourcing facilities are also popularly referred to as “503B pharmacies.”

Use of Compounding Pharmacies
Compounding pharmacies, not registered as an outsourcing facility with the FDA, are popularly referred to as “503A pharmacies” and generally are subject to oversight only by their State pharmacy board. If a hospital obtains compounded medications from a compounding pharmacy rather than a manufacturer or a registered outsourcing facility, then the hospital must demonstrate how it assures that the compounded medications it receives under this arrangement have been prepared in accordance with accepted professional principles for compounded drugs as well as applicable State or Federal laws or regulations. For example, does the contract with the vendor include provisions:
• Ensuring that the hospital has access to quality assurance data verifying that the vendor is adhering to current USP <795> and <797> requirements, and can the hospital document that it obtains and reviews such data?
• Requiring the vendor to meet the requirements of Section 503A of the FDCA concerning pharmacy compounding of human drug products?

"For Information – Not Required/Not to be Cited"
--ASHP Research and Education FoundationTM “Outsourcing Sterile Products Preparation: Contractor Assessment Tool”
The ASHP Research and Education FoundationTM offers a tool that hospitals may find useful for assessing vendors that provide compounded sterile preparations. The tool can be found at:
http://www.ashpfoundation.org/MainMenuCategories/PracticeTools/SterileProductsTool.aspx and click on "Start using Sterile Products Outsourcing Tool now."--

Medications Compounded by the Hospital’s Pharmacy
Only the pharmacy compounds or admixes all sterile medications, intravenous admixtures, or other drugs except in emergencies or when not feasible (for example, when there is a need for emergency or immediate patient administration of a compounded sterile preparation). In addition, all compounding of medications used or dispensed by the hospital must be performed consistent with standards of practice equivalent to or more stringent than those described in the compounding-related chapters in the United States Pharmacopeia and the National Formulary (USP) published by the U.S. Pharmacopeial Convention, which are recognized as authoritative guidance regarding minimum standards of safe practice applicable to both sterile and non-sterile compounding.
The definition of compounding as that term is used in the USP is found in USP Chapter <795> (USP <795>):
“The preparation, mixing, assembling, altering, packaging and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice. Compounding includes the following:
• Preparation of drug dosage forms for both human and animal patients;
• Preparation of drugs or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns;
• Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients;
• Preparation of drugs or devices for the purposes of, or as incident to, research (clinical or academic), teaching or chemical analysis;
• Preparation of drugs and devices for prescriber’s office use where permitted by federal and state law.”
Compounded medications, whether non-sterile or sterile, may be subject to physical and chemical contamination and unintended variations in strength. Microbial contamination and bacterial endotoxins are particularly hazardous with respect to compounded medications that are intended to be sterile.
USP <797> outlines minimum standards of practice to be followed by all health care personnel in any setting when preparing, storing and transporting “compounded sterile preparations” (CSPs). Its stated objective is “to describe conditions and practices to prevent harm, including death, to patients that could result from…microbial contamination…excessive bacterial endotoxins…variability of intended strength of correct ingredients…unintended chemical and physical contaminants…and ingredients of inappropriate quality….” Contaminated CSPs are especially hazardous if administered into body cavities, the central nervous system, vascular system, eyes, joints, and/or used as baths for live organs and tissues. “All compounded dosage forms that must be sterile when they are administered to patients” are considered by USP <797> to be CSPs, including but not limited to:
• “Aqueous bronchial and nasal inhalations;
• Baths and soaks for live organs and tissues;
• Injections [and infusions];
• Irrigations for wounds and body cavities;
• Ophthalmic drops and ointments;
• Tissue implants.”
USP <797> specifies differing standards for the physical layout and structure of the locations in which compounding takes place as well as processes, precautions and quality assurance practices to be implemented during the preparation, transport and storage of CSPs. The standards differ in part based on the level of risk of microbial contamination of the CSP, and the risk level has implications for whether a CSP must be terminally sterilized before being dispensed and for how long a CSP may be stored before use. The risk categories and accompanying standards are based on specific criteria, including but not limited to, factors such as:
• The structural design, environmental controls, air quality levels (based on International Organization for Standardization (ISO) standards for particulate matter in air) and air flow patterns in and surrounding the environment to which the contents of the CSP as well as the surfaces of devices and containers for the preparation, transfer, sterilization and packaging of CSPs are exposed.
• The sterility of the original ingredients and/or device(s) used in compounding, the number of containers that need to be entered, how many times they need to be entered, the nature and complexity of the manipulations and length of time required to prepare the CSP.
• Whether compounding personnel are appropriately garbed and gloved.
• Whether multiple doses of sterile products are pooled to produce a CSP that will be administered on more than one occasion or to more than one patient.
The goal of the USP <797> standards is to prevent and/or minimize the risk of microbial contamination of CSPs, whether by direct contact, exposure to particles in air generated by personnel or objects, or other mechanisms. A major concern is preventing contamination of “critical sites,” which include “any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed or at risk of direct contact with air…moisture…or touch contamination.”
USP <797> describes two basic structural designs for the physical layout and environmental controls intended to minimize airborne contamination of critical sites during preparation of CSPs. The risk level of the CSPs a facility can produce depends, in part, on which USP <797> environmental quality and control/facility design standards the hospital (or its vendor) is able to meet (low-risk level, medium-risk level and high-risk level are discussed here; see §482.23(c) for a discussion of “immediate-use” CSPs):
• Some facilities may only prepare low-risk level nonhazardous and radiopharmaceutical CSPs pursuant to a physician order for a specific patient, and administration must commence within the lesser of 12 hours of preparation or as recommended in the manufacturer’s package insert. Such a facility would have a designated, demarcated room or space that is the “segregated compounding area (SCA),” which contains a device that provides unidirectional airflow of International Standards Organization (ISO) Class 5 air quality (quality class ranges from class 0, the most stringent, to class 9, the most relaxed). The SCA may not be in an area with unsealed openings/potential openings to high traffic locations, the outdoors and other proscribed environmental conditions, and the SCA area may not contain any materials or be the site of any activities unrelated to preparing low-risk CSPs.
• If a facility is preparing high- or medium-level risk CSPs or low-risk CSPs with a beyond-use date of greater than 12 hours, it must meet additional environmental design and monitoring/testing standards in the buffer and ante-areas.
• USP<797> contains separate standards for the safe compounding of hazardous medications (defined as “...if studies in animals or humans indicate that exposures to them have a potential for causing cancer, development or reproductive toxicity, or harm to organs…”), radiopharmaceuticals and allergen extracts.
In addition, USP <797> includes standards for various processes, precautions and quality assurance practices required and recommended for the safe preparation of all risk levels of CSPs. These address issues such as:
• The responsibilities of compounding personnel and their supervisors to implement and maintain proper procedures and quality assurance checks;
• Issues specific to “immediate use” CSPs; single- and multiple-dose containers; CSPs containing hazardous drugs; radiopharmaceuticals; allergen extracts; and automated compounding devices used for parenteral nutrition compounding;
• Methods for sterilization, depyrogenation and for verifying compounding accuracy and sterility;
• Specifications for environmental quality and control, including but not limited to;
• Specifications and related personnel training, including competency assessment and evaluation of skill in aseptically preparing CSPs using visual observation as well as bacterial sampling of glove fingertips and “media-fill testing” at specified intervals;
• Evaluation and monitoring/testing of the environment in which compounding takes place and, if applicable, the adjacent “ante-” and “buffer” areas, including facility layout, design, environmental controls, restricted access, air quality standards and testing, surface characteristics, furnishings, cleaning and disinfection procedures, and standards for personnel health, attire/cosmetics, cleansing/garbing/gloving, aseptic work practices, etc;
• Suggested standard operating procedures to protect the quality of the environment in which CSPs are prepared;
• Quality control related to ingredients, devices and equipment used in relation to CSPs;
• Quality checks to be performed before CSPs are dispensed or administered;
• Issues related to beyond-use dating and packaging, storage and transportation conditions for CSPs;
• Protecting dispensed and distributed CSPs;
• Patient education issues;
• Monitoring for and reporting adverse patient events related to CSPs;
• Requirements for a formal quality assurance program to be maintained by providers of CSPs.
"For Information – Not Required/Not to be Cited"
--USP <797> Appendices I and III-V contain summaries and assessment tools that hospitals may find helpful. However, there is no requirement to use specific forms or materials as long as the hospital and/or its external sources of CSPs are implementing plans, procedures, testing and documentation consistent with applicable standards for safe compounding. These USP <797> materials are referenced here only as examples:
• “Appendix I: Principal Competencies, Conditions, Practices, and Quality Assurances That Are Required…and Recommended in USP Chapter <797>”
• “Appendix III:“Sample Form for Assessing Hand Hygiene and Garbing Related Practices of Compounding Personnel”
• “Appendix IV:“ “Sample Form for Assessing Aseptic Technique and Related Practices of Compounding Personnel”
• “Appendix V:“ “Sample Form for Assessing Cleaning and Disinfection Procedures”--

Packaging and Labeling of Medications
Safe medication use includes proper packaging and labeling to reduce the risk of error. For individual drug containers: each floor stock drug container is expected to be labeled with the name and strength of the drug, lot and control number equivalent, and expiration date. Appropriate accessory and cautionary statements are included as well as the expiration date and/or, if applicable, a beyond-use date (BUD). It should be noted that, for multi-dose medication vials with antimicrobial preservatives which have been opened or entered (e.g., needle-punctured), the USP standard is that the BUD is 28 days, unless otherwise specified by the manufacturer. In addition, where applicable, each patient’s individual drug container is expected to be labeled with the patient’s full name and quantity of the drug dispensed.
If the unit dose system is utilized, each single unit dose package is expected to be labeled with the name and strength of the drug, lot and control number equivalent, expiration date and/or, if applicable, a BUD.

"For Information Only"
--Certain provisions of the FDCA address the labeling of prescription drugs generally (e.g., section 503(b)(2) of the FDCA). Section 503B of the FDCA includes labeling requirements for drugs compounded by registered outsourcing facilities (see section 503B(a)(10)). Although hospitals are expected to comply with these requirements, surveyors conducting a Medicare survey do not assess compliance with other Federal laws.--

Dispensing of Medications
Medications must be dispensed by the hospital in a manner that is safe and meets the needs of the patient:
• Quantities of medications are dispensed which minimize diversion and potential adverse events while meeting the needs of the patient;
• Medications are dispensed in a timely manner. The hospital must have a system that ensures that medication orders get to the pharmacy and medications get back to patients promptly;
• Whenever possible, medications are dispensed in the most ready to administer form available from the manufacturer or, if feasible, in unit dose that have been repackaged by the pharmacy;
• The hospital consistently uses the same dose packaging system, or, if a different system is used, provides education about the use of the dose packaging system;
• All concerns, issues or questions are clarified with the individual prescriber before dispensing; and
• Medications dispensed by the hospital are retrieved when recalled or discontinued by the manufacturer or the Food and Drug Administration (FDA) for safety reasons.
Medications must be available for administration to patients when needed, including when the pharmacy is not open. Methods to accomplish this when the pharmacy is not open could include, but are not limited to, one or more of the following: automated dispensing units outside the pharmacy, night cabinets, contracted services after hours via telepharmacy contracting, on-call pharmacists, etc.
• Automated Dispensing Cabinets (ADCs) for medications are a secure option for medication storage since they ensure locked storage of medications and allow for electronic tracking of controlled substances and other drugs. These cabinets often have embedded security features, such as login and password or biometric identification so that they can only by accessed by authorized personnel.
• Policies and procedures must address who can access medications during after-hours.

"For Information Only – Not Required/Not to be Cited"
--When utilizing automated dispensing cabinets (ADCs), the Institute for Safe Medication Practices recommendations include the following:
(See: http://www.ismp.org/Newsletters/acutecare/articles/20090212.asp and http://www.ismp.org/Tools/guidelines/ADC_Guidelines_Final.pdf )
Security processes are established to ensure adequate control of medications outside of the pharmacy and to reduce the potential for medication diversion from ADCs.
• Utilize biometric user identification or, at a minimum, change user passwords quarterly.
• Link the ADC to the pharmacy computer to allow for patient “profiling,” so that a pharmacist can review each medication order and screen it for safety before the drug is dispensed or accessed by the nurse or other healthcare professional.
• Limiting the availability of overrides to the ADC system.
• Limiting access to drugs based on the patients profile so to decrease medication selection errors.
• Store each medication and strength in an individual lidded ADC compartment
that opens only when the specific medication is selected.
• Document the destruction of medication waste at the time of removal of the medication whenever possible. Record this waste via the ADC, and match the administered dose with ordered dose. Have a process to routinely review/reconcile the documented medication waste.
• Return all medications to a common secure one-way return bin that is maintained by pharmacy, not to an individual pocket or bin within the ADC.--

A-0502 482.25(b)(2)(i) All drugs and biologicals must be kept in a secure area, and locked when appropriate.

Interpretive Guidelines §482.25(b)(2)(i)
A secure area means that drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Drugs and biologicals must not be stored in areas that are readily accessible to unauthorized persons. For example, if medications are kept in a private office, or other area where patients and visitors are not allowed without the supervision or presence of a health care professional (for example, ambulatory infusion), they are considered secure. Areas restricted to authorized personnel only would generally be considered “secure areas.” If there is evidence of tampering or diversion, or if medication security otherwise becomes a problem, the hospital is expected to evaluate its current medication control policies and procedures, and implement the necessary systems and processes to ensure that the problem is corrected, and that patient health and safety are maintained. (71 FR 68689)
All controlled substances must be locked. Hospitals are permitted flexibility in the storage of non-controlled drugs and biologicals when delivering care to patients, and in the safeguarding of drugs and biologicals to prevent tampering or diversion. An area in which staff are actively providing care to patients or preparing to receive patients, i.e., setting up for procedures before the arrival of a patient, would generally be considered a secure area. When a patient care area is not staffed, both controlled and non-controlled substances are expected to be locked.
Generally labor and delivery suites and critical care units are staffed and actively providing patient care around the clock, and, therefore, considered secure. However, hospital policies and procedures are expected to ensure that these areas are secure, with entry and exit limited to appropriate staff, patients and visitors.
The operating room suite is considered secure when the suite is staffed and staff are actively providing patient care. When the suite is not in use (e.g., weekends, holidays and after hours), it would not be considered secure. A hospital may choose to lock the entire suite, lock non-mobile carts containing drugs and biologicals, place mobile carts in a locked room, or otherwise lock drugs and biologicals in a secure area. If an individual operating room is not in use, the hospital is expected to lock non-mobile carts, and ensure mobile carts are in a locked room. (71 FR 68689)
This regulation gives hospitals the flexibility to integrate patient self-administration of non-controlled drugs and biologicals into their practices as appropriate. When a hospital allows a patient to self-administer selected drugs and biologicals, the hospital authorizes the patient to have access to these medications. This regulation is consistent with the current practice of giving patients access at the bedside to urgently needed medications, such as nitroglycerine tablets and inhalers. It supports the current practice of placing selected nonprescription medications at the bedside for the patient’s use, such as lotions and creams, and rewetting eye drops. Hospitals are expected to address patient self-administration of non-controlled drugs and biologicals in their policies and procedures (see self-administration discussion at §§482.23(c)(6)(i) and 482.23(c)(6)(ii)). This regulation supports hospital development, in collaboration with the medical staff and the nursing and pharmacy departments, of formal patient medication self-administration programs for select populations of patients, including hospital policies and procedures necessary to ensure patient safety and security of medications. The policies and procedures are expected to include measures to ensure the security of bedside drugs and biologicals. They are also expected to address both the competence of the patient to self-administer drugs and biologicals as well as patient education regarding self-administration of drugs and biologicals. (71 FR 68689)
Due to their mobility, mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts containing drugs or biologicals (hereafter, all referred to as “carts”) must be locked in a secure area when not in use. Hospital policies and procedures are expected to address the security and monitoring of carts, locked or unlocked, containing drugs and biologicals in all patient care areas to ensure their safe storage and to ensure patient safety. (71 FR 68689)
Medication automated distribution units with security features, such as logon and password or biometric identification, are considered to be locked, since they can only be accessed by authorized personnel who are permitted access to the medications. Such units must be stored in a secure area.

A-0503 482.25(b)(2)(ii) Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area.

Interpretive Guidelines §482.25(b)(2)(ii)
All Schedule II, III, IV, and V drugs must be kept locked within a secure area. A secure area means the drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Medication automated distribution units with logon and password/biometric identification are considered to be locked, since they can only be accessed by authorized personnel who are permitted access to Schedule II –V medications.
Mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts containing Schedule II, III, IV, and V drugs must be locked within a secure area.

A-0504 482.25(b)(2)(iii) Only authorized personnel may have access to locked areas.

Interpretive Guidelines §482.25(b)(2)(iii)
The hospital must assure that only authorized personnel may have access to locked areas where drugs and biologicals are stored.
A hospital has the flexibility to define which personnel have access to locked areas, based on the hospital’s needs as well as State and local law. For example, a hospital could include within its definition of “authorized personnel” ancillary support personnel, such as engineering, housekeeping staff, orderlies and security personnel as necessary to perform their assigned duties. The hospital’s policies and procedures must specifically address how “authorized personnel” are defined for purposes of this section. It is not necessary for the policy to name specific authorized individuals, but the policy should be clear in describing the categories of personnel who have authorized access, as well as whether there are different levels of access authorized in different areas of the hospital, or at different times of day, or for different classes of drugs and biologicals, etc.
The hospital’s policies and procedures must also address how it prevents unauthorized personnel from gaining access to locked areas where drugs and biologicals are stored. Whenever unauthorized personnel have access, or could gain access, to those locked areas, the hospital is not in compliance with this requirement and is expected to re-evaluate and tighten its security measures.

A-0505 482.25(b)(3) Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.

Interpretive Guidelines §482.25(b)(3)
The hospital must have a pharmacy labeling, inspection, and inventory management system that ensures that outdated, mislabeled, or otherwise unusable drugs and biologicals are not available for patient use. This would include drugs that are the subject of a manufacturer’s recall.
A drug or biological is outdated after its expiration date, which is set by the manufacturer based on stability testing under specified conditions as part of the FDA approval process. It should be noted that a drug or biological may become unusable prior to its expiration date if it has been subjected to conditions that are inconsistent with the manufacturer’s approved labeling.
A drug or biological is also outdated after its “beyond-use date” (BUD), which may be reached before the expiration date, but never later. The BUD takes into account the specific conditions and potential for deterioration and microbial growth that may occur during or after the original container is opened, while preparing the medication for dispensing and administration, and/or during the compounding process if it is a compounded medication.
The BUD is to be based on information provided by the manufacturer, whenever such information is available. The hospital must maintain and implement policies and procedures that provide clear and consistent direction to pharmacy staff regarding how to determine a BUD when complete BUD information is not available from the manufacturer. The policies and procedures must be based on accepted professional principles which are equivalent to, or more stringent than, those described in the United States Pharmacopeia-National Formulary (USP).9
According to Chapters <795> and <797> of the USP, the BUD must be safe for patients, and determined conservatively. The section in USP <797> entitled “Determining Beyond-Use Dates,” which addresses sterile compounding, notes that “the truly valid evidence for predicting beyond-use dating can be obtained only through product-specific experimental studies.” It provides an example of testing considered more appropriate for certain types of compounded sterile preparations (CSPs) such as “CSPs with a narrow therapeutic index, where close monitoring or dose titration is required to ensure therapeutic effectiveness and to avoid toxicity….” It also provides examples of important issues that a pharmacist must be able to critically interpret and evaluate when consulting literature sources in the process of determining a BUD; and distinguishes between reviewing literature specific to a particular drug, composition, concentration of ingredients, fill volume, container, storage conditions and duration of use, etc., versus merely reviewing available publications or tables. The former is the preferred approach, while the latter results in a “theoretical BUD,” which has an inherent likelihood of inaccuracy or error.
For individual drug containers: each floor stock drug container is expected to be labeled with the name and strength of the drug, lot and control number equivalent, and expiration date. Appropriate accessory and cautionary statements are included as well as the expiration date and/or, if applicable, a BUD. It should be noted that, for multi-dose medication vials with antimicrobial preservatives which have been opened or entered (e.g., needle-punctured), the USP standard is that the BUD is 28 days, unless otherwise specified by the manufacturer. In addition, where applicable, each patient’s individual drug container is expected to be labeled with the patient’s full name and quantity of the drug dispensed.
If the unit dose system is utilized, each single unit dose package is expected to be labeled with the name and strength of the drug, lot and control number equivalent, expiration date and/or, if applicable, a BUD.
--Footnote: 9All references to “USP” herein are from: United States Pharmacopeial Convention. USP on Compounding: A Guide for the Compounding Practitioner. Current with USP 37-NF32 through First Supplement. Rockville, MD: United States Pharmacopeial Convention, 2014.--

A-0506 482.25(b)(4) When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law.

Interpretive Guidelines §482.25(b)(4)
Routine after-hours access to the pharmacy by non-pharmacists for access to medication should be minimized and eliminated as much as possible. The use of well-designed night cabinets, after-hours medication carts, and other methods may preclude the need for non-pharmacist to enter the pharmacy. Policies and procedures should be consistent with Federal and State Law.
If an urgent or emergent patient need occurs, the hospital must be able to provide medications to the patients in its facility.
The hospital must have a process for providing medications to meet patient needs when the pharmacy is closed.
When non-pharmacist health care professionals are allowed by law and regulation to obtain medications after the pharmacy is closed, the following safeguards are applied:
• Access is limited to a set of medications that has been approved by the hospital. These medications can be stored in a night cabinet, automated storage and distribution device, or a limited section of the pharmacy.
• Only trained, designated prescribers and nurses are permitted access to medications.
• Quality control procedures (such as an independent second check by another individual or a secondary verification built into the system, such as bar coding) are in place to prevent medication retrieval errors.
• The hospital arranges for a qualified pharmacist to be available either on-call or at another location (for example, at another organization that has 24-hour pharmacy service) to answer questions or provides medications beyond those accessible to non-pharmacy staff.
• This process is evaluated on an on-going basis to determine the medications accessed routinely and the causes of accessing the pharmacy after hours.
• Changes are implemented as appropriate to reduce the amount of times non-pharmacist health care professionals are obtaining medications after the pharmacy is closed.

A-0507 482.25(b)(5) Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff.

Interpretive Guidelines §482.25(b)(5)
In accordance with accepted standards of practice, the medical staff, in coordination and consultation with the pharmacy service, determines and establishes the reasonable time to automatically stop orders for drugs and biologicals not specifically prescribed as to time or number of doses. The hospital must implement, monitor, and enforce this automatic stop system.
It is important to note that hospitals with an electronic health record (EHR) system may have time and dose parameters automatically built into computerized provider order entry (CPOE) screens. These may be part of the hospital’s plan for addressing automatic stop orders.

A-0508 482.25(b)(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’s quality assessment and performance improvement program.

Interpretive Guidelines §482.25(b)(6)
Hospitals are required to ensure that the attending physician is made immediately aware of drug administration errors, adverse drug reactions, and incompatibilities. When the attending physician is unavailable, the covering physician must be notified. When the covering physician must be notified, the patient’s attending physician must be notified as soon as he/she is available. In addition, when appropriate, such events must also be reported to the hospital-wide Quality Assessment and Performance Improvement (QAPI) program.
The hospital must adopt policies and procedures that identify the types of events that must be reported immediately to the attending physician, as well as those to be reported to the QAPI program.
• Drug administration error:
The National Coordinating Council Medication Error Reporting and Prevention definition of a medication error is “Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.” In the context of this regulation, however, “drug administration error” is limited to those errors in administration that actually reach the patient, i.e., a medication actually is administered to a patient when it should not be, or the wrong dose is administered, or the wrong root of administration is used, etc., or a medication that should have been administered to the patient has not been administered in a timely manner, as discussed in the medication administration standard at 42 CFR 482.23(c).
• Adverse drug reaction:
The American Society of Health-System Pharmacists (ASHP) defines an adverse drug reaction (ADR) as “Any unexpected, unintended, undesired, or excessive response to a drug that:
1. Requires discontinuing the drug (therapeutic or diagnostic)
2. Requires changing the drug therapy
3. Requires modifying the dose (except for minor dosage adjustments)
4. Necessitates admission to a hospital
5. Prolongs stay in a health care facility
6. Necessitates supportive treatment
7. Significantly complicates diagnosis
8. Negatively affects prognosis, or
9. Results in temporary or permanent harm, disability, or death.
Consistent with the definition, an allergic reaction (an immunologic hypersensitivity occurring as the result of unusual sensitivity to a drug) and an idiosyncratic reaction (an abnormal susceptibility to a drug that is peculiar to the individual) are also considered ADRs.”
• Drug incompatibilities
A drug incompatibility occurs when drugs interfere with one another chemically or physiologically. Drugs known to be incompatible must not be mixed, administered together, or administered within a timeframe where they will interfere with each other.
When IV medications are administered with known incompatibilities, an error has occurred and it needs to be reported to the attending physician immediately. Any unexpected reaction that occurs between IV medications not previously identified as incompatible also needs to be reported.
Hospitals can minimize the risk of administering incompatible medications by making available pertinent resources, such as drug incompatibility charts and online incompatibility references. The incompatibility information needs to be readily available to staff administering medications. The information needs to be kept up-to-date as the information is frequently updated by drug manufacturers.
The immediate reporting requirement applies to drug administration errors, adverse drug reactions or incompatibilities that have harmed or have the potential to harm the patient. If the outcome of the drug administration error is unknown, the physician must also be notified without delay.
Drug administration errors that result in no or insignificant harm to the patient must also be documented in the medical record but do not require immediate reporting to the attending physician. For example, if an analgesic dose is missed during the night shift, it can be reported first thing in the morning. Hospital staff is expected to use their clinical judgment, based on patient presentation and assessment in accordance with hospital policy and procedures, to determine whether immediate reporting is required.
On the other hand, for purposes of reporting to the hospital’s QAPI program, hospitals must, in accordance with the requirements of the QAPI CoP at 42 CFR 482.21(c)(2), track and report not only the errors that cause or risk harm to the patient, but also those which do not. Such “near misses” and suspected ADRs may reveal important information about systems vulnerabilities that the hospital should address in order to avoid events that result in harm.
Hospitals must establish policies and procedures for reporting of medication errors, ADRs, and incompatibilities, and ensure that staff is aware of the reporting process. For those events that require immediate reporting, the hospital’s policies must establish timeframes for reporting that are based on the clinical effect of the error on the patient.
To improve staff willingness to report medication error incidents, hospitals are encouraged to adopt a non-punitive approach that focuses on system issues rather than individual health care professionals. A non-punitive approach is likely to encourage reporting by those who otherwise may fear retribution or hospital disciplinary action.
In addition to employing broad definitions of medication errors and ADRs for QAPI tracking purposes and encouraging the reporting of medication errors, ADRs and drug incompatibilities, the hospital must take additional steps to identify these events as part of its QAPI program where medical errors and adverse patient events are measured, analyzed and tracked. Reliance solely on incident reporting fails to identify the majority of errors and adverse reactions. Proactive identification includes observation of medication passes, concurrent and retrospective review of a patient’s clinical records, ADR surveillance team, implementation of medication usage evaluations for high-alert drugs, and identification of indicator drugs that, when ordered, automatically generate a drug regimen review for a potential adverse drug event.
The hospital must have a method by which to measure the effectiveness of its systems for identifying and reporting to the QAPI program medication errors and ADRs. Such methods could include use of established benchmarks for the size and scope of services provided by the hospital, or studies on reporting rates published in peer-reviewed journals. Hospitals are encouraged, and may be required by State law, to participate in statewide and national reporting of drug administration errors, adverse drug reactions, and incompatibilities. National organizations include, but are not limited to, the Food and Drug Administration’s (FDA) MedWatch Reporting Program and the Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program.

A-0509 482.25(b)(7) Abuses and losses of controlled substances must be reported, in accordance with applicable Federal and State laws, to the individual responsible for the pharmaceutical service, and to the chief executive officer, as appropriate.

No information available

A-0510 482.25(b)(8) Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff.

Interpretive Guidelines §482.25(b)(8)
The pharmacy must be a resource for medication-related information to the hospital’s health-care practitioners and other health care personnel to optimize therapeutic outcomes and minimize adverse drug events. Information must be available concerning drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration. The pharmacy may also assist other health care professionals with the following medication-related functions:
• Collection and organization of patient-specific information (height, weight, allergies);
• Identification of the presence of medication-therapy problems, both potential and actual, such as drug-drug interactions, excessive doses;
• Identification and specification of pharmaco-therapeutic goals;
• Implementation of a monitoring plan in collaboration with the patient, if applicable, and other health-care professionals;
• Monitoring the effects of the pharmacotherapeutic regimen – could include adjusting doses based on lab values (i.e.: Coumadin dosing); or
• Redesigning the regimen and monitoring plan as indicated.
For example, practitioners may write an order for “pharmacy to dose” an antibiotic. The pharmacist would then take patient-specific information, review the patient’s current medication therapies for any problems, and then calculate the dose required to meet therapeutic goals.
Increasingly, as hospitals move to computerized physician-order entry (CPOE) of medication orders, much of this consultation function (e.g.; dosage, path of administration, drug-drug interactions and other contraindications, etc.) is built in to the electronic health record (EHR) system. However, the pharmacy service remains responsible for the provision of accurate, up-to-date information to meet the needs of the hospital’s practitioners, nursing staff and patients.
The hospital must also have immediately available sufficient up-to-date reference material on drug therapy, whether in electronic or hard copy format. A pharmacist also should be readily available by telephone or other means to respond to questions from practitioners and nursing personnel.

A-0511 482.25(b)(9) A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs.

Interpretive Guidelines §482.25(b)(9)
The medical staff must establish a formulary system. The formulary lists medications for dispensing or administration that the hospital maintains or that are readily available. In accordance with accepted standards of practice, the medical staff, in consultation with the pharmacy service, should develop written criteria for determining what medications are available for dispensing or administration. At a minimum, the criteria include the indication for use, effectiveness, risks (including propensity for medication errors, abuse potential, and sentinel events), and costs.
Processes and mechanisms should be established to monitor patient responses to a newly added medication before the medication is made available for dispensing or administration within the hospital.
Medications designated as available for dispensing or administration are reviewed periodically based on emerging safety and efficacy information.
The hospital should have processes to approve and procure medications that are not on the hospital’s medication list.
The hospital should have processes to address medication shortages and outages,
including the following:
• Communicating with appropriate prescribers and staff;
• Developing approved substitution protocols;
• Educating appropriate LIPs, appropriate health care professionals, and staff about these protocols; and
• Obtaining medications in the event of a disaster.

CoP: Radiologic Services

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482.26 Radiologic Services

A-0528 482.26 The hospital must maintain, or have available, diagnostic radiologic services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.

Interpretive Guidelines §482.26
Hospitals must offer diagnostic radiologic services and may also offer therapeutic radiologic services. No matter where they are furnished in the hospital (including all departments on all campuses and off-site locations) radiologic services must satisfy professionally approved standards for safety and personnel qualifications. Hospitals are expected to take a consistent approach in their policies and procedures for radiologic services safety and personnel qualifications throughout the hospital. This may be accomplished in several ways, including by having one organized radiologic service under the direction of the radiologist who supervises all ionizing radiology services (see §482.26(c)(1)), or by the governing body ensuring a uniform approach to radiologic services that are offered in multiple departments of the hospital. .
The elements of the Condition’s regulatory language (the Condition “stem” statement) are close, but not identical, to those found in the standards at §§482.26(a) and (b). We have, therefore, repeated elements of this Condition regulatory language in the Tags for both §§482.26(a) and (b), in order to permit citation of deficiencies that are specific to requirements found in the Condition stem statement at either the standard or condition level, as appropriate. The manner or degree of noncompliance with the requirements of this Condition and its component standards must be evaluated to determine whether there is substantial noncompliance with the Condition, warranting a Condition-level citation.

What is included in Radiologic Services?
Radiologic services encompass many different modalities used for the purpose of diagnostic or therapeutic medical imaging and radiation therapy. Each type of technology yields different information about the area of the body being studied or treated, related to possible disease, injury, or the effectiveness of medical treatment. All the modalities use some form of radiation, which is a term for energy waves or particles that pass through a medium, such as light or radio signals through the air. Some of these modalities (radiography, computed tomography, fluoroscopy) utilize ionizing radiation, which has enough energy to potentially cause damage to DNA, while others (ultrasound, magnetic resonance imaging) use other forms of non-ionizing radiation to view the human body in order to diagnose, monitor, or treat medical conditions.
Most of the definitions and terms referred to in this guidance are based on technical information available on the U.S. Food and Drug Administration’s (FDA) website, located at http://www.fda.gov/Radiation-EmittingProducts/default.htm or from the Radiologic Society of North America’s (RSNA) website, located at http://www.radiologyinfo.org .

Diagnostic & Therapeutic Radiologic Services
Diagnostic and therapeutic radiologic services may use the same modalities, but for different purposes. Diagnostic services are performed to determine a specific cause of the medical problem with which the patient presents (e.g., fractured bone, occluded artery, tumor), while therapeutic services are performed to treat a specific problem (e.g., stenting of an artery or embolization of a blood vessel, lithotripsy of a renal stone, external beam radiation therapy to a cancerous tumor). Regardless of the purpose of the radiologic services, the risks to the patient and staff, if applicable, depend on the modality used, the length of the study/procedure, the size of the patient, the specifics of the device being used, and other factors.

Modalities that use Ionizing Radiation
Radiography (X-rays) is a technique for generating and recording an x-ray pattern for the purpose of providing the user with a static image(s) after termination of the exposure. During a radiographic procedure, an x-ray beam is passed through the body. A portion of the x-ray is absorbed or scattered by the body’s internal structure and the remaining x-ray pattern is transmitted to a detector, so that an image may be recorded for later evaluation. The recording of the pattern may occur on film or through electronic means (digital). X-rays are used to diagnose or treat patients by displaying images of the internal structure(s) of the body to assess the presence or absence of disease, foreign objects, and structural damage or anomaly.
Some common examples include:
• Verification of correct placement of invasive catheters, tubes, or devices;
• Orthopedic evaluations for fractured or dislocated bones;
• Chest x-ray to identify common conditions, such as congestive heart failure or pneumonia;
• Evaluations of radio-opaque foreign bodies in soft tissues; and
• Mammography.
Dual-energy X-ray absorptiometry (DEXA) is a form of medical imaging that uses very small amounts of ionizing radiation to measure bone mineral density and determine an individual’s risk for bone fractures or establish the diagnosis of osteoporosis. The amount of radiation used is less than one-tenth the dose of a traditional chest X-ray and less than one day’s exposure to natural radiation.
Computed Tomography (CT) scanning, also called computerized axial tomography (CAT) scanning, is a medical imaging procedure that uses x-rays to show cross-sectional images of the body. A CT imaging system produces cross-sectional images or "slices" of areas of the body, like the slices in a loaf of bread. During a CT scan, a patient undergoes several consecutive and simultaneous X-rays that can be configured as a three dimensional reconstruction of the part of the body that is being imaged. Thus, a CT scan delivers more ionizing radiation to the patient than radiography. CTs are better able to distinguish between different types of tissues in the body than radiography and, given its ability to image large areas over a short period of time, CT offers significantly improved resolution of many different structures in a variety of spatial configurations. Often a CT scan will be performed using x-ray dye or contrast agent, which can be administered by mouth or by vein. This technique further helps to identify the intestines or vasculature, which can assist with the diagnosis of disease or injury.
Some common examples include:
• CT of the brain to distinguish between an ischemic or hemorrhagic stroke;
• CT of the abdomen and pelvis to evaluate for internal bleeding following trauma;
• CT of the chest to determine the presence of a pulmonary embolus; and
• CT of the aorta with intravenous contrast agent to determine a ruptured aneurysm.
Fluoroscopy is a type of medical imaging that shows a continuous x-ray image on a monitor, much like an x-ray movie. It is used to diagnose or treat patients by displaying the movement of a body part, or of an instrument or x-ray dye (contrast agent) through the body.
Fluoroscopy is used in many types of examinations and procedures. Some examples include:
• Barium upper GI (gastrointestinal) series and enemas (to view movement through the GI tract);
• Catheter insertion (to direct the placement of a catheter in a blood vessel);
• Orthopedic surgery (to view fracture treatments); and
• Angiography (to determine if there are blockages in arteries).
The amount of ionizing radiation that a patient and the medical staff receive during the procedure depends on the procedure’s length and complexity.

Radiation Therapy
Ionizing radiation can also be used for therapeutic purposes, in which the energy is utilized to directly kill cancerous cells.
External beam therapy (EBT) is a method to deliver a beam of high-energy x-rays to a patient’s tumor. The beam is generated outside the patient and is targeted at the tumor site. The goal is to deposit the energy to kill the cancer cells while sparing the normal tissue. EBT is often used to treat cancers of the breast, head and neck, prostate, lung, and brain. It also can be used to provide palliative care for painful sites of metastases to bone.
Brachytherapy is a type of radiation therapy in which radioactive material is placed directly inside or next to the tumor. This type of therapy allows for a higher dose of radiation to treat a smaller area and in a shorter time than with EBT. It can be either temporary, in which the radioactive material is placed inside or near a tumor for a specified amount of time, often via a catheter; or permanent, in which radioactive seeds or pellets are placed near or inside a tumor and left there permanently, eventually decaying so that the radioactivity diminishes to nothing. Brachytherapy is often used to treat solid tumors, including prostate, breast, and gallbladder cancer.

Radiologic Services modalities that do not use ionizing radiation
Ultrasound
Ultrasound imaging (sonography) uses high-frequency sound waves to view soft tissues, such as muscles and internal organs. Because ultrasound images are captured in real-time, they can show movement of the body's internal organs as well as blood flowing through blood vessels. This imaging modality has no documented evidence of dangers to the patient or staff administering it, however, caution about the frequency of use has been encouraged, particularly in the imaging of fetuses. Ultrasound imaging is used in many types of examinations and procedures. Some examples include:
• Doppler ultrasound (to visualize blood flow through a blood vessel);
• Echocardiogram (to view the heart);
• Fetal ultrasound (to view the fetus in pregnancy);
• Ultrasound-guided biopsies of suspicious masses;
• Doppler fetal heart rate monitors (to listen to the fetal heart beat); and
• Lithotripsy to break up kidney stones; this procedure uses high energy sound waves (shock waves), but there is minimal risk to the patient and staff from this form of energy. Pre- and post-procedure radiographs are taken of the patient, which confer the same risk as a standard X-ray of that part of the body.
Magnetic resonance imaging (MRI) is a medical imaging procedure that uses strong magnetic fields and radio waves to produce cross-sectional images of organs and internal structures in the body. Because the signal detected by an MRI machine varies depending on the water content and local magnetic properties of a particular area of the body, different tissues or substances can be distinguished from one another in the study image.
MRI can give different information about structures in the body than can be obtained using a standard x-ray, ultrasound, or computed tomography (CT) exam. For example, an MRI study of a joint can provide detailed images of ligaments and cartilage, which are not visible using other modalities. In some cases, an MRI contrast agent is given by vein to show internal structures or abnormalities more clearly.
In most MRI devices, an electric current is passed through coiled wires to create a temporary magnetic field in a patient’s body. (In open-MRI devices, permanent magnets are used.) Radio waves are sent from and received by a transmitter/receiver in the machine, and these signals are used to produce digital images of the area of interest.
MRI scans facilitate diagnosis or monitoring of treatments for a variety of medical conditions, including:
• Abnormalities of the brain and spinal cord;
• Tumors, cysts, and other abnormalities in various parts of the body;
• Injuries or abnormalities of the joints;
• Certain types of heart problems;
• Diseases of the liver and other abdominal organs;
• Causes of pelvic pain in women (e.g., fibroids, endometriosis); and
• Suspected uterine abnormalities in women undergoing evaluation for infertility.

482.26(a) Radiologic Services

A-0529 482.26(a) The hospital must maintain, or have available, radiologic services according to the needs of patients.

Interpretive Guidelines §482.26 (a)

Mandatory and Optional Radiologic Services
The hospital must maintain, or have available, diagnostic radiological services according to the needs of the volume and types of patients the hospital serves. “Maintain” in this context means furnishing radiologic services on-site, while having them available means providing access to radiologic services even when they are not furnished on-site. For example:
• It would not be uncommon for a psychiatric hospital to maintain on-site relatively limited or no radiologic services, while making more extensive diagnostic services available under arrangement, at a site outside the psychiatric hospital.
• On the other hand, a short-term acute care hospital with a busy emergency department that handles trauma, stroke, and other complex medical and surgical cases would be expected to maintain on-site a wider range of diagnostic radiologic services that are ready to be furnished when needed.
A hospital’s diagnostic radiologic services must be maintained or available at all times. Multi-campus hospitals must have diagnostic radiologic services that can be furnished when needed in a clinically appropriate timeframe for each location providing inpatient, same-day surgery, and emergency services. The scope and complexity of diagnostic radiological services maintained or available must be specified in writing, in order to demonstrate how the hospital meets the needs of its patients.
Therapeutic radiologic services are optional, but if they are offered, must also comply with the Radiologic Services requirements.
Radiological services may be provided by the hospital directly utilizing its own staff, or through a contractual arrangement. The hospital is responsible for ensuring that the services meet all the requirements of this regulation, regardless of whether they are provided directly or under arrangement. Diagnostic radiologic services provided under arrangement may be provided either on the hospital’s campus or in an adjacent or other nearby, readily accessible facility so long as the services, including those required on an urgent or emergent basis, can be furnished within clinically appropriate timeframes.
Increasingly, hospitals are also separating the performance of radiologic studies, which may be done on-site or at a readily accessible facility off the hospital’s campus, from the interpretation of the studies, which can be performed remotely by a teleradiology practitioner in a timely fashion. This practice is acceptable, so long as the teleradiology practitioner is privileged in accordance with the requirements of the Governing Body (§482.12) and Medical Staff (§482.22) CoPs.

482.26(b) Standard: Safety for Patients and Personnel

A-0535 482.26(b) The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.

Interpretive Guidelines §482.26(b)
The hospital must adopt and implement radiologic services policies and procedures that provide safety for affected patients and hospital personnel and which are consistent with accepted professional standards for radiologic services.

Ionizing Radiology Procedures
Radiologic services modalities that use ionizing radiation have increased the ability to detect disease or injury early enough for a medical problem to be managed, treated, or cured. When applied and performed appropriately, these radiologic studies or procedures can maintain or improve health and save lives.
X-ray energy used in radiologic services also has a potential to harm living tissue. The most significant risks are:
• Cataracts and skin damage, but only at very high levels of radiation exposure; and
• An increase in the possibility that a person exposed to x-ray energy will develop cancer later in life. The risk of developing cancer from radiologic services radiation exposure is generally very small, and it depends on at least three factors—the amount of the radiation dose, the age of the person exposed, and the sex of the person exposed:
• The lifetime risk of cancer increases the larger the dose and the more x-ray studies or procedures a patient undergoes;
• The lifetime risk of cancer is larger for a patient who received x-rays at a younger age than for one who receives them at an older age; and.
• Women are at a somewhat higher lifetime risk than men for developing radiation-associated cancer after receiving the same exposures at the same ages.

MRI:
MRIs are useful when a soft tissue injury or disease process is suspected and are generally considered at low risk of causing harm to patients or staff. However, they also are not entirely risk-free. Potential risks include projectile risk of magnetic objects being sucked into the main magnet, thermal injury and burns, adverse effects on devices and leads implanted in patients, and hearing damage.

Provision of services in accordance with professionally approved standards for safety
All radiological services provided by the hospital, including both diagnostic and, if offered, therapeutic services, must be provided in accordance with acceptable standards of practice, including standards for safety.
Professionally approved standards include maintaining compliance with applicable Federal and State laws and regulations governing radiological services, including, but not limited to, facility licensure and/or certification requirements.
Professionally approved standards also include the recommendations or guidelines promulgated by expert governmental agencies, such as the U.S. Food and Drug Administration, as well as those issued by nationally recognized professional organizations, such as the American Medical Association, American College of Radiology, Radiological Society of North America, The Alliance for Radiation Safety in Pediatric Imaging, American Society of Radiologic Technologists, the American College of Cardiology, the American College of Neurology, the American College of Physicians, etc.
Generally, there are different standards for different imaging modalities used to provide radiologic services; there may also be different standards for diagnostic versus therapeutic uses, as well as for pediatric versus adult patients, etc. For example, the American College of Radiology has separate diagnostic radiology guidance documents for general radiology, CT, MRI, and ultrasound, among others. The hospital must be able to document the source standards that form the basis for its policies and procedures for each of its radiologic services modalities and/or settings. For example, if one organization’s standards are used for mammography services, another’s for CT services, another’s for MRI, and another’s for pediatric X-rays, this must be clearly indicated.
In order to ensure safety and freedom from hazards, the hospital’s radiologic services policies and procedures must include, but are not limited to, provisions addressing the following:
• For ionizing radiation services, application of the fundamental principle of As Low as Reasonably Achievable or ALARA, which is defined by the U.S. Environmental Protection Agency (EPA) as “A principle of radiation protection philosophy that requires that exposures to ionizing radiation be kept as low as reasonably achievable, economic and social factors being taken into account. The protection from radiation exposure is ALARA when the expenditure of further resources would be unwarranted by the reduction in exposure that would be achieved.” (Federal Guidance Report No. 14, Radiation Protection Guidance for Diagnostic and Interventional X-ray Procedures, p. 100, November, 2014) Although CMS does not interpret or enforce EPA guidance, the ALARA principle is considered an accepted standard of practice for ionizing radiation services to which hospitals must adhere.
• Written protocols developed or approved by the radiologist responsible for the radiologic services, in conjunction with other qualified radiologic services personnel (e.g., a medical physicist, radiologic technologists, patient safety officers, etc.) designed to ensure that diagnostic studies and therapeutic procedures are routinely performed in a safe manner, utilizing parameters and specifications that are appropriate to the ordered study/procedure. The hospital must ensure that protocols for the various types of ionizing radiation diagnostic or therapeutic imaging modalities are designed to minimize the amount of radiation while maximizing the yield and producing diagnostically acceptable image quality. Existing protocols must be reviewed periodically and updated as needed. The rationale and details for changes to technical parameters must be documented.

"For Information Only – Not Required/Not to be Cited"
--Hospitals are encouraged to follow the recommendation in the EPA’s Guidance
Report No. 14 concerning patient radiation dosage. The report says “As the ICRP [International Commission on Radiological Protection] has stated, ‘Provided that the medical exposures of patients have been properly justified and that the associated doses are commensurate with the medical purpose, it is not appropriate to apply dose limits or dose constraints to the medical exposure of patients, because such limits or constraints would often do more harm than good’ (ICRP 2007b). While dose limits do not apply to medical exposures, radiation doses to patients should always be optimized. All responsible parties should always strive to minimize patient irradiation to the dose that is necessary to perform the procedure with adequate image quality. The recommendation against establishing absolute dose limits should not discourage a facility from implementing diagnostic reference levels for imaging and interventional procedures. Exceeding these levels should prompt a review of practice at the facility as a quality assurance measure. Dose notification and alert values for CT, notification levels for use during interventional procedures, and trigger levels for follow-up after interventional procedures are also appropriate QA measures [emphasis added]...(EPA Guidance Report No. 14, p.6)--

• Policies and protocols to identify patients at high risk for adverse events for whom the radiologic study or procedure might be contraindicated, e.g., pregnant women, individuals with known allergies to contrast agents, individuals with implanted devices, etc. Policies would address the steps to be taken, and by which personnel, if an order is written for a radiologic study or procedure for an individual identified in the radiologic services policies as potentially at high risk (e.g., notify the ordering physician, cancel the procedure personally, etc.).
• Specific requirements related to procedures to mitigate radiation hazards are discussed in the guidance for §482.26(b)(1).
• Procedures to address risks associated with modalities that do not use ionizing radiation. For example, with respect to MRI:
• Measures to prevent magnetic materials from being closer than is safe to the MRI suite, per nationally recognized guidelines;
• If equipment and supplies, such as fire extinguishers and oxygen tanks, are located in the MRI area, they are MR-safe, i.e., they are non-ferromagnetic;
• Provision of adequate and effective hearing protection to patients, staff and others who might be in the MRI suite while the scans are taking place; and
• Measures to reduce the risk of thermal injuries/burns during MRI. This would include, but is not limited to, screening patients to identify those who may have metallic tattoos or metal in them, proper patient positioning, ensuring implants are MR Conditional, checking for electrically conductive materials that might be in close proximity to the patient and taking the appropriate precautions, and instructing the patient to immediately report any burning sensations experienced during the scan.
• Training required by personnel permitted to enter areas where radiologic services are provided.
• Training and, as applicable, qualifications, required for personnel who perform diagnostic imaging studies or therapeutic procedures utilizing radiologic services equipment. This includes proper operation of equipment per manufacturer’s instructions and hospital policy.
• Areas where radiologic services are provided must be equipped with the necessary equipment or materials to immediately respond to potential adverse events. This could include, but is not limited to, things like a crash cart, emergency stop mechanisms, cleaning and decontamination agents if applicable, etc.

"For Information Only – Not Required/Not to be Cited"
--Hospitals are encouraged to also address the following in their Radiologic Services:
• Encouraging physicians and other practitioners with privileges to order radiologic studies or procedures that utilize ionizing radiation to consider both the benefits and risks of the procedures.
• Recording and tracking the dosing patients receive. There are several nationally recognized quality assurance programs designed to assist health care providers in developing and maintaining this data, including, but not limited to:
• The Alliance for Safety in Pediatric Imaging (www.Imagegently.org)
• The Conference of Radiation Control Program Directors
• The American College of Radiology data registry (http://nrdr.acr.org)
• The Nationwide Evaluation of X-ray Trends (NEXT program)
Further, although the EPA’s Guidance Report No. 14 was developed by an Interagency Working Group on Medical Radiation specifically to provide guidance to Federal facilities that use diagnostic and interventional X-ray equipment, it should also be useful to non-Federal medical facilities and hospitals are encouraged to review it. The Guidance Report addresses the following topics:
• Radiation Safety Standards and General Concerns
• Structural Shielding and Door Interlock Switches
• Requesting and Performing Studies Involving X-rays
• Technical Quality Assurance
• General Guidelines for Clinical Imaging, organized into separate sections for Medical and Dental, and further broken down by modality
• Imaging Informatics
• Recommendations for Facility Action--

Medical Physicists
According to the American Association of Physicists in Medicine, the practice of Medical Physics means the use of principles and accepted protocols of physics to ensure the correct quality, quantity, and placement of radiation during the performance of a radiological procedure. Hospitals are not required under the regulations to have a medical physicist on staff or under contract. However, since radiologic services are required to be free from hazards to patients and hospital personnel, hospitals must ensure that qualified personnel, whether or not they are medical physicists, develop and carry out protocols and test, calibrate, and maintain radiologic services equipment and that there is a reliable means to validate the results.

"For Information Only - Not Required/Not to be Cited"
--Definition of a Medical Physicist
An example of a definition of and qualifications for a medical physicist is provided by the American Association of Physicists in Medicine:
“For the purpose of providing clinical professional services, a Qualified Medical Physicist (QMP) is an individual who is competent to independently provide clinical professional services in one or more of the subfields1 of medical physics. The subfields of medical physics are:
• Therapeutic Medical Physics
• Diagnostic Medical Physics
• Nuclear Medicine Physics
• Medical Health Physics
…. A Qualified Medical Physicist meets each of the following credentials:
• Has earned a master’s and/or doctoral degree in physics, medical physics, biophysics, radiological physics, medical health physics, or equivalent disciplines from an accredited college or university; and
• Has been granted certification in the specific subfield(s) of medical physics with its associate medical health physics aspects by an appropriate national certifying body and abides by the certifying body’s requirements for continuing education.” http://www.aapm.org/org/default.asp--

"For Information Only - Not Required/Not to be Cited"
--The responsibilities of the medical physicist in a hospital may include:
• protection of the patient and others from potentially harmful or excessive radiation;
• establishment, with the approval of the Director of Radiologic Services, of adequate protocols to ensure accurate patient dosimetry;
• measurement and characterization of radiation;
• determination of delivered dose;
• promotion of procedures necessary to ensure image quality;
• development and direction of quality assurance programs; and assistance to other healthcare professionals in optimizing the balance between the beneficial and deleterious effects of radiation.
Hospitals are also encouraged to involve a medical physicist in the calibration of the radiologic services equipment and monitoring of radiation dosage exposures to staff.--

Consistent with the requirements under the Quality Assessment and Performance Improvement (QAPI) CoP at 42 CFR 482.21, the hospital must monitor the quality and safety of radiologic services.
Examples of indicators of potential quality and safety problems could include, but are not limited to:
• Improper patient preparation, such as inadequate intravenous access or lack of pre-medication, such that procedures must be cancelled or reordered;
• Repeats of the same studies in the hospital for the same patient within a short time span, which may be an indicator of poor image quality; or
• Diagnostic imaging studies or therapeutic procedures performed in a manner inconsistent with the applicable hospital written protocol.
Under the QAPI CoP, hospitals are required to undertake improvement activities in areas that represent high risk, high volume, or problem-prone areas. Problems identified in radiologic services may meet these criteria. In addition, adverse events related to radiologic services must be analyzed for their causes, and preventive actions must then be undertaken. Deficiencies identified related to tracking, analyzing, and addressing adverse event and quality indicator data and performance improvement activities must be cited under the applicable QAPI standards.

A-0536 482.26(b)(1) Proper safety precautions must be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities, as well as appropriate storage, use and disposal of radioactive materials.

Interpretive Guidelines §482.26(b)(1)
The hospital must adopt and implement written policies and procedures to ensure safety from radiation hazards. The policies and procedures must include, but are not limited to, consideration of the following:
• Clear and easily recognizable signage identifying hazardous radiation areas;
• Limitations on access to areas containing radiologic services equipment.
• Appropriate use of shielding, including:
• Types of personal protective shielding (e.g., lead aprons, lead gloves, protective eyewear, thyroid shields, portable individualized lead panels, stationary barriers) to be used, under what circumstances, for patients, including high-risk patients as identified in radiologic services policies and procedures, patient family members or support persons who may be needed to be with the patient during a study or procedure, and hospital personnel;
• Lead and concrete barriers built into the walls and other structures of the imaging areas;
• Identification and use of appropriate containers to be used for various radioactive materials, if applicable, when stored, in transport between locations within the hospital, in use, and during/after disposal.

"For Information Only - Not Required/ Not to be Cited"
--The Occupational Health and Safety Administration (OSHA) has requirements for protecting hospital staff from radiation exposure, some of which are summarized below:
• “For information about exposure limits see: 29 CFR 1910.1096, Ionizing Radiation Standard. The standard also requires:
• Each radiation area shall be conspicuously posted with a sign or signs bearing the radiation caution symbol, with the wording ‘Caution Radiation Area’ [29 CFR 1910.1096(e)(2)]”
This document also discusses other tools to prevent radiation exposure.
See: https://www.osha.gov/SLTC/etools/hospital/clinical/radiology/radiology.html#Radiation
As a reminder, although hospitals are required to comply with applicable OSHA requirements, surveyors conducting surveys on behalf of CMS do not interpret or assess compliance with the requirements of OSHA or other Federal Agencies. Surveyors do assess compliance with Medicare requirements that may overlap or duplicate OSHA requirements.--

A-0537 482.26(b)(2) Periodic inspection of equipment must be made and hazards identified must be properly corrected.

Interpretive Guidelines §482.26(b)(2)
The hospital must have policies and procedures in place to ensure that periodic inspections of radiology equipment are conducted, current and that problems identified are corrected in a timely manner. Equipment includes not only devices used to deliver diagnostic or therapeutic radiologic services, but also exposure meters, badges, or personal radiation monitoring devices used by staff, as well as equipment the hospital uses to inspect or calibrate devices used to deliver diagnostic or therapeutic radiologic services. The hospital must ensure that equipment is inspected in accordance with manufacturer’s instructions and Federal and State laws, regulations, and guidelines, and hospital policy, as applicable. Inspections and maintenance, including correction of identified hazards, must be performed by qualified employees (e.g., medical physicists, qualified biomedical technicians, etc.) or through contractual arrangements with vendors with appropriate expertise.
Hospitals must follow the manufacturer’s instructions as to how to inspect and maintain radiologic equipment. This includes acceptance testing (i.e., upon initial installation and after major upgrades) as well as ongoing inspection and maintenance. Documentation of preventive maintenance, quality control tests, service records, and major software/hardware upgrades must be maintained by the hospital and be readily available for inspection.
The hospital must also have a system in place, to identify and remedy equipment hazards in a timely manner. This system must include, but is not limited to: periodic and consistent calibration of equipment and, for equipment using ionizing radiation, monitoring of dosimetry parameters with phantoms to ensure that an accurate dose of radiation is delivered per the applicable protocol. In addition, hospitals must also have a system to track all modifications made to the equipment that would significantly impact the accuracy of the dosage delivered. Any adverse events related to over- or under-dosing must be identified and addressed.

"For Information Only - Not Required/Not to be Cited"
--Requirements for Manufacturers Re: Instructions that Must be Made Available
Below is an FDA summary of its requirements for manufacturers of x-ray systems to make available to purchasers and, upon request, to other parties, information related to maintenance of the following types of systems:
• For all diagnostic x-ray systems, manufacturers are required to provide to purchasers, and, upon request, to others at a cost not to exceed the cost of publication and distribution, manuals or instruction sheets that include technical and safety information (21 CFR 1020.30(h). This information must include a schedule of the maintenance necessary to keep the equipment in compliance with §§1020.30, 1020.31, 1020.32, and 1020.33 (21 CFR 1020.30(h)(1)(ii)). Manufacturers are also required to provide to assemblers, and, upon request, to others at a cost not to exceed the cost of publication and distribution, instructions for assembly, installation, adjustment, and testing of specified components of diagnostic x-ray systems adequate to ensure that the products will comply with applicable provisions of §§1020.30, 1020.31, 1020.32, and 1020.33, when assembled, installed, adjusted, and tested as directed (21 CFR 1020.30(g)).
• In addition to the requirements applicable to all diagnostic x-ray systems, there are also other requirements for specific systems:
• Manufacturers of fluoroscopic x-ray systems manufactured on or after June 10, 2006 are required to provide a schedule of maintenance for any system instrumentation associated with the display of air kerma information necessary to maintain the displays of air kerma rate and cumulative air kerma within the limits of allowed uncertainty specified by 21 CFR 1020.32(k)(6). And, if the capability for user calibration of the display is provided, adequate instructions for such calibration must be supplied (21 CFR 1020.30(h)(6)(i)).
• Manufacturers of computed tomography (CT) systems are required to provide a specific phantom or phantoms for quality assurance testing of specific system parameters on these systems (21 CFR 1020.33(d)(1)), and instructions on the use of the phantom(s), including a schedule of testing appropriate for the system and allowable variations for the indicated parameters (21 CFR 1020.33(d)(2)).
• Manufacturers of cabinet x-ray systems are required to provide purchasers, and others, upon request, at a cost not to exceed the cost of preparation and distribution, manuals and instructions. These documents must include, among other technical and safety information, a schedule of maintenance necessary to keep the system in compliance with 21 CFR 1020.40 (21 CFR 1020.40(c)(9)(i)). Cabinet x-ray systems that are intended to be assembled or installed by the purchaser must be accompanied by instructions for assembly, installation, adjustment and testing of the cabinet x-ray adequate to ensure that the system is in compliance with the applicable provisions of 21 CFR 1020.40 when assembled, installed, adjusted and tested as directed (21 CFR 1020.40(c)(9)(ii)).--

A-0538 482.26(b)(3) Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure.

Interpretive Guidelines §482.26(b)(3)
This requirement applies to radiologic services personnel, as well as other hospital employees who may be regularly exposed to radiation due to working near radiation sources. This could include certain nursing and maintenance staff. The types or locations of employees who require monitoring for radiation exposure must be identified in the policies and procedures for the radiologic services developed or approved by the radiologist who supervises the services, in conjunction with the appropriately qualified radiation safety personnel. The monitoring of staff exposure must be documented by qualified personnel.
Hospitals are expected to educate staff who are monitored for radiation exposure about the appropriate use of the monitoring meters or badges (or through use of a “personal radiation monitoring device,” which employs modern technology for the same measurement purpose). Hospitals must educate staff on the importance of tracking their radiation exposure over various timeframes, such as the most recent month and year, as well as their cumulative exposure through work. Staff also must be educated about the appropriate storage of the meters and/or badges as well as the procedures to follow if the exposure device exceeds cumulative dosage parameters specified per hospital policy. The hospital is expected to proactively monitor staff cumulative dosage and take appropriate steps if an individual staff member’s cumulative dosage level exceeds parameters specified per hospital policy.

"For Information Only – Not Required/Not to be Cited"
--The Occupational Safety and Health Administration (OSHA) has requirements for protecting hospital staff from radiation exposure, some of which are summarized below:
• “For information about exposure limits see: 29 CFR 1910.1096, Ionizing Radiation Standard. The standard also requires:
• …Every employer shall supply appropriate personnel monitoring equipment, such as film badges, pocket chambers, pocket dosimeters, or film rings, and shall require the use of such equipment [29 CFR 1910.1096(d)(2)]
• Employers shall maintain records of the radiation exposure of all employees for whom personnel monitoring is required under paragraph (d) of this section and advise each employee of his individual exposure at least yearly…
See: https://www.osha.gov/SLTC/etools/hospital/clinical/radiology/radiology.html#Radiation
As a reminder, although hospitals are required to comply with applicable OSHA requirements, surveyors conducting surveys on behalf of CMS do not interpret or assess compliance with the requirements of OSHA or other Federal Agencies. Surveyors do assess compliance with Medicare requirements that may overlap or duplicate OSHA requirements.--

A-0539 482.26(b)(4) Radiologic services must be provided only on the order of practitioners with clinical privileges or, consistent with State law, of other practitioners authorized by the medical staff and the governing body to order the services.

Interpretive Guidelines §482.26(b)(4)
The medical staff and the governing body determine the necessary qualifications and clinical privileges that practitioners must have to order diagnostic radiologic studies or therapeutic procedures.
For outpatient services, the governing body and medical staff may also authorize practitioners who do not have hospital privileges to order such studies or procedures, as permitted under State law. For example, a hospital may decide that it will routinely accept orders from physicians in the communities it services for outpatient diagnostic studies, regardless of whether those physicians have privileges to practice in the hospital. See the guidance for §482.54(c) for more information on requirements related to outpatient orders from practitioners who do not hold privileges to practice at the hospital.
The order must include information for the radiologic technologist about the study or procedure to be performed, and the technologist is expected to review this information prior to implementing the order.

"For Information Only – Not Required/Not to be Cited"
--Hospitals are strongly encouraged, but not required, to develop standard formats for practitioner’s orders for radiologic services that clearly document the diagnostic or therapeutic purpose of the study/procedure, as well as any other pertinent information that may lead to altering the dose of radiation, including, but not limited to:
• Indication (reason) for the study/procedure
• Previous imaging studies of the body part(s) under investigation;
• Additional relevant radiation exposure; and
• Previous adverse events (e.g., over- or underexposure of dosing, allergic reaction to contrast dye) during radiologic procedures.
In addition, hospitals are encouraged to adopt policies to ensure that the radiation technologist performing the study/procedure confirms the order with the ordering practitioner if there are any concerns about its appropriateness.--

482.26(c) Standard: Personnel

A-0546 482.26(c)(1) A qualified full-time, part-time or consulting radiologist must supervise the ionizing radiology services and must interpret only those radiologic tests that are determined by the medical staff to require a radiologist’s specialized knowledge. For purposes of this section, a radiologist is a doctor of medicine or osteopathy who is qualified by education and experience in radiology.

Interpretive Guidelines §482.26(c)(1)
The regulation defines a radiologist as a doctor of medicine (MD) or doctor of osteopathy (DO) who is qualified by education and experience in radiology. The medical staff must establish the specific criteria related to education and experience that must be met in order to be privileged as a radiologist in the hospital.
Ionizing radiologic services offered throughout the hospital must be under the supervision of a radiologist, who may be part-time, full-time, or consulting. This may be accomplished in several ways, including by having one organized radiologic service under the direction of the supervising radiologist, or by the governing body ensuring a uniform approach to ionizing radiologic services that are offered in multiple, separately organized departments of the hospital which collaborate with the supervising radiologist in developing their department-specific protocols for ensuring that these services are free from hazards for patients and personnel.
The supervising radiologist, including, if applicable, a consultant who provides such supervision, must be privileged as a radiologist at the hospital. The extent of radiologic services provided by the hospital determines whether the supervising radiologist must carry out these responsibilities full or part-time.
For diagnostic radiologic services using ionizing radiation, policies and procedures must, in addition to the requirements addressed in other portions of the radiologic services CoP, identify which types of radiologic tests require interpretation by a radiologist, as opposed to another type of practitioner holding privileges; the hospital’s medical staff must approve this policy.
When interpretation of radiologic tests (studies) is provided via telemedicine, the radiologist interpreting the radiological test must be licensed and/or meet the other applicable standards that are required by State or local laws in the state where the hospital (and, therefore, the patient) is located. The requirements concerning granting of privileges to teleradiologists are addressed in the medical staff (§482.22) and governing body (§482.12) Conditions of Participation.

A-0547 482.26(c)(2) Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures.

Interpretive Guidelines §482.26(c)(2)
The medical staff must develop policies, consistent with State law, that govern the designation of all personnel who are qualified to use the radiologic equipment and perform diagnostic or therapeutic studies or procedures. Qualifications must include appropriate training and demonstrated competence in the use of equipment and administration of procedures prior to being designated as qualified. Only designated individuals may use the equipment and perform studies or procedures.
The use of the radiologic equipment includes, but is not limited to, functions such as operating the equipment according to the manufacturer’s instructions and hospital policy, and interfacing with specialized technology as needed.
In addition to a radiologist, and although not specifically mentioned in the regulations, radiologic technologists are typically involved in the delivery of radiologic services in a hospital. Radiologic technologists are medical personnel who typically perform diagnostic imaging examinations and administer radiation therapy treatments, as permitted under State law. They are educated in anatomy, patient positioning, examination techniques, equipment protocols, radiation safety, radiation protection, and basic patient care. All radiologic technologists using radiologic equipment or performing studies/procedures must be designated to do so.
Personnel also need to know how to respond to adverse events that may occur during a radiologic study or procedure.
Hospitals are expected to regularly reassess staff competency and to provide periodic training needed to keep staff skills up-to-date. The hospital must document training completion dates and evidence of satisfactory competence. Staff that complete training but cannot demonstrate satisfactory competence must not be permitted to use radiologic equipment and/or administer procedures.

482.26(d) Standard: Records

A-0553 482.26(d) Records of radiologic services must be maintained.
(1) - The radiologist or other practitioner who performs radiology services must sign reports of his or her interpretations.
(2) - The hospital must maintain the following for at least 5 years:
(i) Copies of reports and printouts.
(ii) Films, scans, and other image records, as appropriate.

Interpretive Guidelines §482.26(d)
The hospital must maintain records for all radiologic procedures performed. At a minimum, the records must include the orders for the services, copies of reports and printouts, and any films, scans, digital or other image records, as appropriate.
Radiology films, image records, scans, digital files, reports, and printouts must be secure and properly stored for at least five years. If State law requires a longer period, the hospital must comply, but surveyors do not assess compliance with State law requirements as part of the Federal survey. Patient radiologic services records are considered patient medical records and the hospital must comply with the requirements of the medical records CoP (§482.24). All reports of studies must be signed by the radiologist or other authorized practitioner (in the case of studies not designated as requiring a radiologist to interpret them) who reads and evaluates the findings of the study. Acceptable forms of signature include paper signatures as well as electronic signatures.

CoP: Laboratory Services

Do you want to review "Laboratory Services" conditions?

482.27 Laboratory Services

A-0576 482.27 The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with Part 493 of this chapter.

Interpretive Guidelines §482.27
The hospital must maintain or have available laboratory services whenever its patients need those services. The hospital may make laboratory services available directly, through contractual agreements, or through a combination of direct and contractual services. The scope and complexity of the hospital laboratory service must be adequate to meet the needs of its patients. The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients at each campus or off-campus location of the hospital. All laboratory services, whether direct or contractual, whether conducted in a lab or in another location, must be provided in accordance with Clinical Laboratory Improvement Act (CLIA) requirements. Every hospital laboratory service must be operating under a current CLIA certificate appropriate to the level of services performed.
The hospital’s laboratory services, including any contracted services, must be integrated into its hospital-wide QAPI program.
Patient laboratory results and all other laboratory clinical patient records are considered patient medical records and the hospital must comply with the requirements of the Medical Records CoP.

482.27(a) Adequacy of Laboratory Services

A-0582 482.27(a) The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets requirements of Part 493 of this chapter.

Interpretive Guidelines §482.27(a)
The CLIA certification may be accomplished by having one certificate for the entire hospital’s laboratory services, by having one certificate for each laboratory, or by the hospital having a mixture. Whatever the arrangement, all laboratory services must be provided in accordance with CLIA requirements and under a current CLIA certificate, even when those laboratory services take place outside of a lab.

A-0583 482.27(a)(1) - Emergency laboratory services must be available 24 hours a day.

Interpretive Guidelines §482.27(a)(1)
The hospital must provide emergency laboratory services 24 hours a day, 7 days a week. These onsite emergency services may be provided directly by the hospital or through onsite contracted laboratory services. Emergency lab services include collection, processing, and provision of results to meet a patient's emergency laboratory needs.
In a hospital with multiple hospital campuses, these emergency laboratory services must be available onsite 24/7 at each campus.
The medical staff must determine which laboratory services are to be immediately available to meet the emergency laboratory needs of patients who may be currently at the hospital or those patients who may arrive at the hospital in an emergency condition. The emergency laboratory services (procedures, tests, personnel) available should reflect the scope and complexity of the hospital’s operation and be provided in accordance with Federal and State law, regulations and guidelines and acceptable standards of practice.
At a hospital with off-campus locations the medical staff must determine which, if any, laboratory services must be immediately available to meet the emergency laboratory needs of the patients who are likely to seek care at each off-campus location. The emergency laboratory services available must reflect the scope and complexity of the hospital's operations at the location and be provided in accordance with Federal and State law, regulations and guidelines and acceptable standards of practice. The services must be available during the hours of operation of that location.

A-0584 482.27(a)(2) - A written description of services provided must be available to the medical staff

No information available.

A-0585 482.27(a)(3) - The laboratory must make provision for proper receipt and reporting of tissue specimens

Interpretive Guidelines §482.27(a)(3)
The laboratory must have written instructions for the collection, preservation, transportation, receipt, and reporting of tissue specimen results.

A-0586 482.27(a)(4) - The medical staff and a pathologist must determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examinations

Interpretive Guidelines §482.27(a)(4)
Laboratory written policies, approved by the medical staff and a pathologist, must state which tissue specimens require a macroscopic examination and which tissue specimens require both macroscopic and microscopic examination.

482.27(b) Standard: - Potentially Infectious Blood and Blood Components

A-0592 482.27(b)
(1) Potentially human immunodeficiency virus (HIV) infectious blood and blood components. Potentially HIV infectious blood and blood components are prior collections from a donor –
(i) Who tested negative at the time of donation but tests reactive for evidence of HIV infection on a later donation;
(ii) Who tests positive on the supplemental (additional, more specific) test or other follow-up testing required by FDA; and
(iii) For whom the timing of seroconversion cannot be precisely estimated.
(2) Potentially hepatitis C virus (HCV) infectious blood and blood components. Potentially HCV infectious blood and blood components are the blood and blood components identified in 21 CFR 610.47.
(3) Services furnished by an outside blood collecting establishment. If a hospital regularly uses the services of an outside blood collecting establishment, it must have an agreement with the blood collecting establishment that governs the procurement, transfer, and availability of blood and blood components. The agreement must require that the blood collecting establishment notify the hospital --
(i) Within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection;
(ii) Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA;
(iii) Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available, as set forth at 21 CFR 610.48(b)(3).
(4) Quarantine of blood and blood components pending completion of testing. If the blood collecting establishment (either internal or under an agreement) notifies the hospital of the reactive HIV or HCV screening test results, the hospital must determine the disposition of the blood or blood component and
quarantine all blood and blood components from previous donations in inventory.
(i) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is negative, absent other informative test results, the hospital may release the blood and blood components from quarantine.
(ii) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is positive, the hospital must –
(A) Dispose of the blood and blood components; and
(B) Notify the transfusion recipients as set forth in paragraph (b)(6) of this section.
(iii) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is indeterminate, the hospital must destroy or label prior collections of blood or blood components held in quarantine as set forth at 21 CFR 610.46(b)(2), 610.47(b)(2), and 610.48(c)(2).
(5) Recordkeeping by the hospital. The hospital must maintain --
(i) Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and
(ii) A fully funded plan to transfer these records to another hospital or other entity if such hospital ceases operation for any reason.
(6) Patient notification. If the hospital has administered potentially HIV or HCV infectious blood or blood components (either directly through its own blood collecting establishment or under an agreement) or released such blood or blood components to another entity or appropriate individual, the hospital must take the following actions:
(i) Make reasonable attempts to notify the patient, or to notify the attending physician who ordered the blood or blood component and ask the physician to notify the patient, or other individual as permitted under paragraph (b)(10) of this section, that potentially HIV or HCV infectious blood or blood components were transfused to the patient and that there may be a need for HIV or HCV testing and counseling.
(ii) If the physician is unavailable or declines to make the notification, make reasonable attempts to give this notification to the patient, legal guardian or relative.
(iii) Document in the patient’s medical record the notification or attempts to give the required notification.
(7) Time frame for notification.
(i) For donors tested on or after February 20, 2008. For notifications resulting from donors tested on or after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47 the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HIV or HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification over a period of 12 weeks unless--
(A) The patient is located and notified; or
(B) The hospital is unable to locate the patient and documents in the patient’s medical record the extenuating circumstances beyond the hospital’s control that caused the notification timeframe to exceed 12 weeks.
(ii) For donors tested before February 20, 2008. For notifications from donors tested before February 20, 2008 as set forth at 21 CFR 610.48(b) and (c), the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification and must complete the actions within 1 year of the date on which the hospital received notification from the outside blood collecting establishment.
(8) Content of notification. The notification must include the following information:
(i) A basic explanation of the need for HIV or HCV testing and counseling.
(ii) Enough oral or written information so that an informed decision can be made about whether to obtain HIV or HCV testing and counseling.
(iii) A list of programs or places where the person can obtain HIV or HCV testing and counseling, including any requirements or restrictions the
program may impose.
(9) Policies and procedures. The hospital must establish policies and procedures for notification and documentation that conform to Federal, State, and local laws, including requirements for the confidentiality of medical records and other patient information.
(10) Notification to legal representative or relative. If the patient has been adjudged incompetent by a State court, the physician or hospital must notify a legal representative designated in accordance with State law. If the patient is competent, but State law permits a legal representative or relative to receive the information on the patient’s behalf, the physician or hospital must notify the patient or his or her legal representative or relative. For possible HIV infectious transfusion recipients that are deceased, the physician or hospital must inform the deceased patient’s legal representative or relative. If the patient is a minor, the parents or legal guardian must be notified.
(11) Applicability. HCV notification requirements resulting from donors tested before February 20, 2008, as set forth at 21 CFR 610.48 will expire on August 24, 2015.

Interpretive Guidelines §482.27(b)
This regulation requires the hospital to have a system in place to take appropriate action when notified that blood or blood components it received are at increased risk of transmitting HIV or HCV.

482.27(c) Standard: General blood safety issues

A-0593 482.27(c) For lookback activities only related to new blood safety issues that are identified after August 24, 2007, hospitals must comply with FDA regulations as they pertain to blood safety issues in the following areas:
(1) Appropriate testing and quarantining of infectious blood and blood components.
(2) Notification and counseling of recipients that may have received infectious blood and blood components.

No information available.

CoP: Food and Dietetic Services

Do you want to review "Food and Dietetic Services" conditions?

482.28 Food and Dietetic Services

A-0618 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietician who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment.

Interpretative Guidelines §482.28
The hospital’s food and dietetic services must be organized, directed and staffed in such a manner to ensure that the nutritional needs of the patients are met in accordance with practitioners’ orders and acceptable standards of practice.
The hospital should have written policies and procedures that address at least the following:
• Availability of a diet manual and therapeutic diet menus to meet patients’ nutritional needs;
• Frequency of meals served;
• System for diet ordering and patient trays delivery;
• Accommodation of non-routine occurrences (e.g., parenteral nutrition (tube feeding), total parenteral nutrition, peripheral parenteral nutrition, change in diet orders, early/late trays, nutritional supplements, etc);
• Integration of the food and dietetic service into the hospital-wide QAPI and Infection Control programs;
• Guidelines for acceptable hygiene practices of food service personnel; and
• Guidelines for kitchen sanitation.
The same standards apply whether the food and dietetic services are provided by the hospital directly, through a contractual agreement, or by off-site vendor.
The hospital must be in compliance with Federal and State licensure requirements for food and dietary personnel as well as food service standards, laws and regulations.

482.28(a) Standard: Organization

A-0619 482.28(a) The hospital must ensure that the specific food and dietetic services organization requirements are met.

Interpretive Guidelines §482.28(a):
The hospital must ensure that the specific food and dietetic services organization requirements are met.

A-0620 482.28(a)(1) The hospital must have a full-time employee who:
(i) Serves as director of the food and dietetic services;
(ii) Is responsible for daily management of the dietary services; and
(iii) Is qualified by experience or training.

Interpretive Guidelines §482.28(a)(1)
The service director must be a full-time employee who has been granted the authority and delegated responsibility by the hospital’s governing body and medical staff for the operation of the dietary services. This authority and delegated responsibility includes, the daily management of the service, implementing training programs for dietary staff, and assuring that established policies and procedures are maintained that address at least the following:
• Safety practices for food handling;
• Emergency food supplies;
• Orientation, work assignments, supervision of work and personnel performance;
• Menu planning, purchasing of foods and supplies, and retention of essential records (e.g., cost, menus, personnel, training records, QAPI reports, etc);
• Service QAPI program.
Additionally, the service director must demonstrate, through education, experience and/or specialized training, the qualifications necessary to manage the service, appropriate to the scope and complexity of the food service operations.

A-0621 482.28(a)(2) There must be a qualified dietitian, full-time, part-time or on a consultant basis.

Interpretive Guidelines §482.28(a)(2)
A qualified dietitian must supervise the nutritional aspects of patient care. Responsibilities of a hospital dietitian may include, but are not limited to:
• Approving patient menus and nutritional supplements;
• Patient, family, and caretaker dietary counseling;
• Performing and documenting nutritional assessments and evaluating patient tolerance to therapeutic diets when appropriate;
• Collaborating with other hospital services (e.g., medical staff, nursing services, pharmacy service, social work service, etc) to plan and implement patient care as necessary in meeting the nutritional needs of the patients;
• Maintaining pertinent patient data necessary to recommend, prescribe, or modify therapeutic diets as needed to meet the nutritional needs of the patients.
Qualification is determined on the basis of education, experience, specialized training, State licensure or registration when applicable, and maintaining professional standards of practice.
If the qualified dietitian does not work full-time, and when the dietitian is not available, the hospital must make adequate provisions for dietary consultation that meets the needs of the patients. The frequency of consultation depends on the total number of patients, their nutritional needs and the number of patients requiring therapeutic diets or other nutritional supplementation.

A-0622 482.28(a)(3) There must be administrative and technical personnel competent in their respective duties.

Interpretive Guidelines §482.28(a)(3)
Administrative and technical personnel must be competent in their assigned duties. This competency is demonstrated through education, experience and specialized training appropriate to the task(s) assigned. Personnel files should include documentation that the staff member(s) is competent in their respective duties.

A-0629 482.28(b)(1) Individual patient nutritional needs must be met in accordance with recognized dietary practices.

Interpretive Guidelines §482.28(b)(1)
Each hospital patient for whom the hospital is providing one or more meals or nutrition must have their nutritional needs met in a manner that is consistent with recognized dietary practices. Affected patients include all inpatients and those patients in outpatient status, including the provision of observation services, whose stay is sufficiently long that they must be fed. According to the U.S. Department of Agriculture’s (USDA) Food and Nutrition Center the nationally recognized source for recommended dietary intakes allowances is the Institute of Medicine Food and Nutrition Board’s Dietary Reference Intakes (DRIs), which are designed to provide recommended nutrient intakes for use in a variety of settings. The DRIs are a set of four reference values:
• Recommended Dietary Allowance (RDA) is the average daily dietary intake of a nutrient that is sufficient to meet the requirement of nearly all (97-98%) healthy persons.
• Adequate Intake (AI) for a nutrient is similar to the Estimated Safe and Adequate Daily Dietary Intakes (ESADDI) and is only established when an RDA cannot be determined. Therefore a nutrient either has an RDA or an AI. The AI is based on observed intakes of the nutrient by a group of healthy persons.
• Tolerable Upper Intake Level (UL) is the highest daily intake of a nutrient that is likely to pose no risks of toxicity for almost all individuals. As intake above the UL increases, risk increases.
• Estimated Average Requirement (EAR) is the amount of a nutrient that is estimated to meet the requirement of half of all healthy individuals in the population.
USDA provides access to an interactive DRI tool and DRI tables at http://fnic.nal.usda.gov/dietary-guidance/dietary-reference-intakes
Meeting individual patient nutritional needs may include the use of therapeutic diets. Therapeutic diets refer to a diet ordered as part of the patient’s treatment for a disease or clinical condition, to eliminate, decrease, or increase certain substances in the diet (e.g., sodium or potassium), or to provide mechanically altered food when indicated.
Patients must be assessed for their risk for nutritional deficiencies or need for therapeutic diets and/or other nutritional supplementation.
Examples of patients who may have specialized dietary needs and may require a more detailed nutritional assessment include, but are not limited to:
All patients requiring artificial nutrition by any means (i.e., enteral nutrition (tube feeding), total parenteral nutrition, or peripheral parenteral nutrition);
Patients whose medical condition, surgical intervention, or physical status interferes with their ability to ingest, digest or absorb nutrients;
Patients whose diagnosis or presenting signs/symptoms indicates a compromised nutritional status (e.g., anorexia nervosa, bulimia, electrolyte imbalances, dysphagia, malabsorption, end stage organ diseases, etc.);
Patients whose medical condition can be adversely affected by their nutritional intake (e.g., diabetes, congestive heart failure, patients taking certain medications, renal diseases, etc.).
Patients who refuse the food served should be offered substitutes that are of equal nutritional value in order to meet their basic nutritional needs.
The care plan for patients identified as having specialized nutritional needs must address those needs as well as monitoring of their dietary intake and nutritional status. The methods and frequency of monitoring could include one or more of the following, as well as other methods:
• Patient weight (BMI, unintended weight loss or gain)
• Intake and output
• Lab values

A-0630 482.28(b)(2) All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dietitians and nutrition professionals.

Interpretive Guidelines §482.28(b)(2)
Patient diets, including therapeutic diets, must be provided in accordance with orders from a practitioner responsible for the care of the patient, or by a qualified dietitian or qualified nutrition professional who is permitted to order diets under State law and authorized to do so by the medical staff.
Diets must be based on an assessment of the patient’s nutritional and therapeutic needs and documented in the patient’s medical record (including documentation about the patient’s tolerance to any therapeutic diet ordered).
The hospital’s governing body may choose, when permitted under State law and upon recommendation of the medical staff, to grant qualified dietitians or qualified nutrition professionals diet-ordering privileges. In many cases State law determines what criteria an individual must satisfy in order to be a “qualified dietician;” State law may define the term to mean a “registered dietician” registered with a private organization, such as the Commission on Dietetic Registration, or State law may impose different or additional requirements. Terms such as “nutritionists,” “nutrition professionals,” “certified clinical nutritionists,” and “certified nutrition specialists” are also used to refer to individuals who are not dieticians, but who may also be qualified under State law to order patient diets. It is the responsibility of the hospital to ensure that individuals are qualified under State law before appointing them to the medical staff or granting them privileges to order diets.
If the hospital chooses not to grant diet-ordering privileges to dietitians or other nutrition professionals, even when permitted under State law, the patient’s diet must be prescribed by a practitioner responsible for the patient’s care. In this situation, a dietitian or nutrition professional who does not have privileges to order diets may nevertheless assess a patient’s nutritional needs and provide recommendations or consultations for patients to a practitioner responsible for the care of the patient.

A-0631 482.28(b)(3) A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel.

Interpretive Guidelines §482.28(b)(3)
The therapeutic diet manual must be approved by the dietitian and the medical staff. The publication or revision date of the approved therapeutic diet manual must not be more than 5 years old. The therapeutic diet manual (or copies of it) must be available to all medical, nursing and food service personnel.

CoP: Utilization Review

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482.30 Utilization Review

A-0652 482.30 The hospital must have in effect a utilization review (UR) plan that provides for review of services furnished by the institution and by members of the medical staff to patients entitled to benefits under the Medicare and Medicaid programs.

Interpretive Guidelines §482.30
If the hospital does not satisfy one of the exception criteria at §482.30(a), it must have a UR plan in effect which provides for review of services provided to Medicare and Medicaid beneficiaries.

A-0653 482.30(a) The provisions of this section apply except in either of the following circumstances:
(1) A Utilization and Quality Control Quality Improvement Organization (QIO) has assumed binding review for the hospital.
(2) CMS has determined that the UR procedures established by the State under title XIX of the Act are superior to the procedures required in this section, and has required hospitals in that State to meet the UR plan requirements under 456.50 through 456.245 of this chapter.

Interpretive Guidelines §482.30(a)
The regulation permits two exceptions to the requirement for a hospital UR plan: (1) where the hospital has an agreement with a QIO under contract with the Secretary to assume binding review for the hospital or; (2) where CMS has determined that UR procedures established by the State under Medicaid are superior to the UR requirements for the Medicare program and has required hospitals in that State to meet the UR requirements for the Medicaid program at 42 CFR 456.50 through 456.245.
According to the regulation at 42 CFR 476.86(e), QIO review and monitoring activities fulfill the requirements for compliance activities of State Survey Agencies under §1861(k) of the Social Security Act (Act). The statutory requirements for utilization review at §1861(k) of the Act are reiterated in the UR CoP at 42 CFR 482.30. Therefore, a hospital meets the exception requirements of 42 CFR 482.30 if a QIO has assumed binding review for the hospital. (The hospital may not make requests for work to be performed by the QIO that goes beyond the scope of the QIO’s contract with the Secretary.)
The regulation at 42 CFR 489.20(e) requires a hospital to maintain an agreement with a QIO to review the admissions, quality, appropriateness, and diagnostic information related to inpatient services for Medicare patients, if there is a QIO with a contract with CMS in the area where the hospital is located.
CMS anticipates that most hospitals comply with the UR CoP by means of the QIO exception.
With regard to the second exception, CMS would have to determine that UR procedures established by a State under Medicaid are superior to the UR requirements for Medicare. Currently no UR plans established by a State under Medicaid have been approved as exceeding the requirements under Medicare and required for hospital compliance with the Medicare UR CoP within that State. In the event that CMS approves a State’s Medicaid UR process for compliance with the Medicare UR CoP, CMS will advise the affected State Survey Agency.

A-0654 482.30(b) A UR committee consisting of two or more practitioners must carry out the UR function. At least two of the members of the committee must be doctors of medicine or osteopathy. The other members may be any of the other types of practitioners specified in 482.12(c)(1).
(1) Except as specified in paragraphs (b)(2) and (3) of this section, the UR committee must be one of the following:
(i) A staff committee of the institution;
(ii) A group outside the institution--
(A) Established by the local medical society and some or all of the hospitals in the locality; or
(B) Established in a manner approved by CMS.
(2) If, because of the small size of the institution, it is impracticable to have a properly functioning staff committee, the UR committee must be established as specified in paragraph (b)(1)(ii) of this section.
(3) The committee or group’s reviews may not be conducted by any individual who--
(i) Has a direct financial interest (for example, an ownership interest) in that hospital; or
(ii) Was professionally involved in the care of the patient whose case is being reviewed.

No information available.

A-0655 482.30(c)(1) The UR plan must provide for review for Medicare and Medicaid patients with respect to the medical necessity of:
(i) Admissions to the institution;
(ii) The duration of stays; and
(iii) Professional services furnished including drugs and biologicals.
(2) Review of admissions may be performed before, at, or after hospital admission.
(3) Except as specified in paragraph (e) of this section, reviews may be conducted on a sample basis.
(4) Hospitals that are paid for inpatient hospital services under the prospective payment system set forth in Part 412 of this chapter must conduct review of duration of stays and review of professional services as follows:
(i) For duration of stays, these hospitals need review only cases that they reasonably assume to be outlier cases based on extended length of stay, as described in 412.80(a)(1)(i) of this chapter; and
(ii) For professional services, these hospitals need review only cases that they reasonably assume to be outlier cases based on extraordinarily high costs, as described in 412.80(a)(1)(ii) of this chapter.

Interpretive Guidelines §482.30(c)
Admissions may be reviewed before, during, or after hospital admission as stated in the hospital’s UR plan.
Reviews may be conducted on a sample basis, except for reviews of extended stay cases.
In an Inpatient Prospective Payment System (IPPS) hospital, to determine outlier review compliance, “reasonably assumes” is a good faith test. The question to ask is whether the hospital is reviewing outlier cases. In instances where there was no other review of outlier cases, the question is whether it was reasonable for the hospital not to have known that the cases were in fact outliers. Some medical judgment might be required to determine whether it is reasonable for the hospital to have assumed that a patient fell into a DRG other than the one eventually assigned by the intermediary. This would be an issue in long stay outlier cases where the hospital did not review because the hospital erroneously assumed that the patient was in a DRG under which the case would not have
been an outlier.

A-0656 482.30(d)(1) The determination that an admission or continued stay is not medically necessary
(i) May be made by one member of the UR committee if the practitioner or practitioners responsible for the care of the patient, as specified of 482.12(c), concur with the determination or fail to present their views when afforded the opportunity; and
(ii) Must be made by at least two members of the UR committee in all other cases.
(2) Before making a determination that an admission or continued stay is not medically necessary, the UR committee must consult the practitioner or practitioners responsible for the care of the patient, as specified in 482.12(c), and afford the practitioner or practitioners the opportunity to present their views.
(3) If the committee decides that admission to or continued stay in the hospital is not medically necessary, written notification must be given, no later than 2 days after the determination, to the hospital, the patient, and the practitioner or practitioners responsible for the care of the patient, as specified in 482.12(c);

Interpretive Guidelines §482.30(d)
When other than a doctor of medicine or osteopathy makes an initial finding that the written criteria for extended stay are not met, the case must be referred to the committee, or subgroup thereof which contains at least one physician. If the committee or subgroup agrees after reviewing the case that admissions, or extended stay is not medically necessary or appropriate, the attending physician is notified and allowed an opportunity to present his views and any additional information relating to the patient’s needs for admissions or extended stay. When a physician member of the committee performs the initial review instead of a non-physician reviewer, and he finds that admissions or extended stay is not necessary no referral to the committee or subgroup is necessary and he may notify the attending practitioner directly.
If the attending practitioner does not respond or does not contest the findings of the committee or subgroup or those of the physician who performed the initial review, then the findings are final.
If the attending physician contests the committee or subgroup findings, or if he presents additional information relating to the patient’s need for extended stay, at least one additional physician member of the committee must review the case. If the two physician members determine that the patient’s stay is not medically necessary or appropriate after considering all the evidence, their determination becomes final. Written notification of this decision must be sent to the attending physician, patient (or next of kin), facility administrator, and the single State agency (in the case of Medicaid) no later than 2 days after such final decision and in no event later than 3 working days after the end of the assigned extended stay period.
There are only 5 working days in a given week. Normally these days are Monday through Friday, however, the institution has the option to establish 5 other days as working days. When a holiday falls on a working day, that day is not counted as a working day.
In no case may a non-physician make a final determination that a patient’s stay is not medically necessary or appropriate.
If, after referral of a questioned case to the committee or subgroup thereof, the physician reviewer determines that an admission or extended stay is justified, the attending physician shall be so notified and an appropriate date for subsequent extended stay review will be selected and noted on the patient’s record.
Written notification of this final determination must be sent to the attending physician, the patient (or next of kin), the facility administrator and the single State agency (in the case of Medicaid) no later than 2 days after such final determination and in no event later than 3 working days after the end of the assigned extended stay period.
Where possible, the written notification should be received by all involved parties within the stated time period. Where appropriate and desired, verbal notification may precede written notification.

A-0657 482.30(e)(1) In hospitals that are not paid under the prospective payment system, the UR committee must make a periodic review, as specified in the UR plan, or each current inpatient receiving hospital services during a continuous period of extended duration.
The scheduling of the periodic reviews may:
(i) Be the same for all cases; or
(ii) Differ for different classes of cases.
(2) In hospitals paid under the prospective payment system, the UR committee must review all cases reasonably assumed by the hospital to be outlier cases because the extended length of stay exceeds the threshold criteria for the diagnosis, as described in 412.80(a)(1)(i). The hospital is not required to review
an extended stay that does not exceed the outlier threshold for the diagnosis.
(3) The UR committee must make the periodic review no later than 7 days after the day required in the UR plan.

No information available.

A-0658 482.30(f) The committee must review professional services provided, to determine medical necessity and to promote the most efficient use of available health facilities and services.

Interpretive Guidelines §482.30(f)
“Professional” services means the services provided by practitioners, including both physicians and non-physician practitioners.
The review includes medical necessity and efficient use of available health facilities and services. Examples of topics a committee may review are:
• Availability and use of necessary services - underused, overuse, appropriate use
• Timeliness of scheduling of services - operating room, diagnostic
• Therapeutic procedures

CoP Physical Environment

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482.41 Physical Environment

A-0700 482.41 The hospital must be constructed, arranged, and maintained to ensure the safety of the patient, and to provide facilities for diagnosis and treatment and for special hospital services appropriate to the needs of the community.

Interpretive Guidelines §482.41
This CoP applies to all locations of the hospital, all campuses, all satellites, all provider-based activities, and all inpatient and outpatient locations.
The hospital’s Facility Maintenance and hospital departments or services responsible for the hospital’s buildings and equipment (both facility equipment and patient care equipment) must be incorporated into the hospital’s QAPI program and be in compliance with the QAPI requirements.

482.41(a) Standard: Buildings

A-0701 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured.

Interpretive Guidelines §482.41(a)
The hospital must ensure that the condition of the physical plant and overall hospital environment is developed and maintained in a manner to ensure the safety and well-being of patients. This includes ensuring that routine and preventive maintenance and testing activities are performed as necessary, in accordance with Federal and State laws, regulations, and guidelines and manufacturer’s recommendations, by establishing maintenance schedules and conducting ongoing maintenance inspections to identify areas or equipment in need of repair. The routine and preventive maintenance and testing activities should be incorporated into the hospital’s QAPI plan.
The hospital must be constructed and maintained to ensure risks are minimized for patients as well as for employees and visitors. Hospitals are expected to demonstrate how they are addressing important safety features in accordance with nationally recognized standards. Although the following items are expected to be addressed when applicable, the list is not all-inclusive.
Accessibility
• The hospital must ensure all buildings at all locations of the certified hospital meet State and Federal accessibility standards (e.g. Office of Civil Rights requirements). The requirements apply to the interior and exterior of all buildings.
Age-related safety features
• Hospitals are expected to address safety hazards and risks related to age-related factors. Healthcare provided to neonatal, pediatric, and geriatric patients must be in accordance with nationally recognized standards. Age-related risks may include items such as security of inpatient and outpatient locations, access to medications, cleaning supplies and other hazardous materials, furniture and other medical equipment, and increased chance of falls.
Security
• To minimize the risk of unauthorized access to or inappropriate departure from secured healthcare units, hospitals must demonstrate security features in accordance with nationally recognized standards to ensure the safety of vulnerable patients. This includes, but is not limited to, patients such as newborn (e.g. infant abduction), pediatric, behavioral health, those with diminished capacity and dementia/Alzheimer’s.
Access to non-clinical rooms identified as hazardous locations must be secured to prevent patient and visitor entry. Examples include electrical rooms and heat, ventilation, air conditioning (HVAC) rooms.
Ligature risk
• The presence of unmitigated ligature risks in a psychiatric hospital or psychiatric unit of a hospital is an immediate jeopardy situation. Additionally, this also includes any location where patients at risk of suicide are identified. Ligature risk findings must be referred to the health and safety surveyors for further evaluation and possible citation under Patients’ Rights.
Weather-related exterior issues
• Although hospitals cannot address all weather-related issues, they are expected to address potential safety hazards specific to weather on both the exterior and interior locations in accordance of nationally recognized standards. Areas of risk include driveways, garages, entry points, walkways, etc.
Life Safety Code surveyors assess the use of power strips in healthcare facilities. However, the following guidance is provided as reference for healthcare surveyors as they survey physical environment along with other CoP requirements. Any observed power strip deficiencies should be conveyed to the LSC surveyors for citation.
If line-operated medical equipment is used in a patient care room/area, inside the patient care vicinity:
• UL power strips would have to be a permanent component of a rack-, table-, pedestal-, or cart-mounted & tested medical equipment assembly
• Power strips providing power to medical equipment in a patient care room/area must be UL 1363A or UL 60601-1
• Power strips cannot be used for non-medical equipment
If line-operated medical equipment is used in a patient care room/area, outside the patient care vicinity:
• UL power strips could be used for medical & non-medical equipment with
precautions as described in the memo
• Power strips providing power to medical equipment in a patient care room/area must be UL 1363A or UL 60601-1
• Power strips providing power to non-medical equipment in a patient care room/area must be UL 1363
If line-operated medical equipment is not used in a patient care room/area, inside and outside the patient care vicinity:
• UL power strips could be used with precautions
Power strips providing power to non-medical equipment in a patient care room/area must be UL 1363. In non-patient care areas/rooms, other UL strips could be used with the general precautions.

A-0702 482.41(a)(1) There must be emergency power and lighting in at least the operating, recovery, intensive care, and emergency rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and flashlights must be available.

Interpretive Guidelines §482.41(a)(1)
The hospital must comply with the applicable provisions of the Life Safety Code, National Fire Protection Amendments (NFPA) 101, 2000 Edition and applicable references, such as, NFPA-99: Health Care Facilities, for emergency lighting and emergency power.

A-703 482.41(a)(2) There must be facilities for emergency gas and water supply.

Interpretive Guidelines §482.41(a)(2)
The hospital must have a system to provide emergency gas and water as needed to provide care to inpatients and other persons who may come to the hospital in need of care. This includes making arrangements with local utility companies and others for the provision of emergency sources of water and gas. The hospital should consider nationally accepted references or calculations made by qualified staff when determining the need for at least water and gas. For example, one source for information on water is the Federal Emergency Management Agency (FEMA).
Emergency gas includes fuels such as propane, natural gas, fuel oil, liquefied natural gas, as well as any gases the hospital uses in the care of patients such as oxygen, nitrogen, nitrous oxide, etc.
The hospital should have a plan to protect these limited emergency supplies, and have a plan for prioritizing their use until adequate supplies are available. The plan should also address the event of a disruption in supply (e.g., disruption to the entire surrounding community).

482.41(b) Standard: Life Safety from Fire

A-0709 482.41(b) The hospital must ensure that the life safety from fire requirements are met.

No information available.

A-0710 482.41(b)(1) Except as otherwise provided in this section:
(i) The hospital must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association. The Director of the Office of the Federal Register has approved the NFPA 101®2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the Federal Register to announce the changes.
(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the LSC does not apply to hospitals.
(2) After consideration of State survey agency findings, CMS may waive specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon the facility, but only if the waiver does not adversely affect the health and safety of the patients.
(3) The provisions of the Life Safety Code do not apply in a State where CMS finds that a fire and safety code imposed by State law adequately protects patients
in hospitals.

Interpretive Guidelines §482.41(b)(1) –(3)
Medicare-participating hospitals, regardless of size or number of beds, must comply with the hospital/healthcare Life Safety Code requirements for all inpatient care locations. Hospital departments and locations such as emergency departments, outpatient care locations, etc. must comply with hospital/healthcare Life Safety Code Requirements. Additionally, the hospital must be in compliance with all applicable codes referenced in the Life Safety Code, such as, NFPA-99: Health Care Facilities.
Life Safety Code waivers may be recommended by the State survey agency but only CMS (at the Regional Office level) may grant those waivers for Medicare or Medicaid-participating hospitals.

A-0711 482.41(b)(4) Beginning March 13, 2006, a hospital must be in compliance with Chapter 19.2.9, Emergency Lighting.

Interpretive Guidelines §482.41(b)(4)
Beginning March 13, 2006, Medicare-participating hospitals must be in compliance with Chapter 19.2.9 of the 2000 Edition of NFPA 101. Hospitals have until that date to replace 1-hour batteries with 1-1/2 hour batteries in emergency lighting systems that use batteries as power sources. After March 13, 2006, a hospital with emergency lighting systems with less than 1-1/2 hour batteries will not be in compliance and will be cited.

A-0712 482.41(b)(5) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 does not apply to hospitals.

Interpretive Guidelines §482.41(b)(5)
Beginning March 13, 2006, Medicare-participating hospitals may not keep in service roller latches even when those roller latches are demonstrating the ability to keep the door closed against 5lbf. A hospital with doors in service that have roller latches, where positive latching is required, will not be in compliance and will be cited.

A-0713 482.41(b)(6) The hospital must have procedures for the proper routine storage and prompt disposal of trash.

Interpretive Guidelines §482.41(b)(6)
The term trash refers to common garbage as well as biohazardous waste. The storage and disposal of trash must be in accordance with Federal, State and local laws and regulations (i.e., EPA, OSHA, CDC, State environmental, health and safety regulations). The Conditions of Participation for Radiology and Nuclear Medicine Services address handling and storage of radioactive materials.

A-0714 482.41(b)(7) The hospital must have written fire control plans that contain provisions for prompt reporting of fires; extinguishing fires; protection of patients,
personnel and guests; evacuation; and cooperation with fire fighting authorities.

No information available.

A-0715 482.41(b)(8) The hospital must maintain written evidence of regular inspection and approval by State or local fire control agencies.

No information available.

A-0716 482.41(b)(9) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a hospital may install alcohol-based hand rub dispensers in its facility if:
(i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities;
(ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls;
(iii) The dispensers are installed in a manner that adequately protects against inappropriate access; and
(iv) The dispensers are installed in accordance with Chapter 18.3.2.7 or Chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00–1(101), issued by the Standards
Council of the National Fire Protection Association on April 15, 2004. The Director of the Office of the Federal Register has approved NFPA Temporary Interim Amendment 00–1(101) for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the amendment is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the Office of the Federal Register, 800 North Capitol Street NW., Suite 700, Washington, DC. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269.
(v) The dispensers are maintained in accordance with dispenser manufacturer guidelines.

Interpretive Guidelines, 482.41(b)(9):
CMS amended its regulations, following an NFPA LSC amendment to permit the installation of alcohol-based hand run (ABHR) dispensers in exit access corridors of health care facilities. Previously, ABHR dispensers had been permitted in patient rooms, but not in egress corridors, since they contain flammable materials and could block egress in a fire.
ABHR dispensers have become increasingly common as an infection control method. Healthcare-acquired infections are of increasing concern, and many such infections are transmitted because health care workers do not wash their hands or do so improperly or inadequately.
An important aspect of getting health care workers to use ABHR dispensers is their accessibility. The American Hospital Association commissioned a study to determine the safest method to place ABHR dispensers in egress corridors. As a result of this study, the LSC was amended to permit their use under certain conditions, and CMS has adopted this change in its regulations.
Regular maintenance is seen as a crucial step in making sure that dispensers neither leak nor the contents spill. Hospitals are expected to maintain ABHR dispensers in accordance with manufacturers’ guidelines. If the manufacturer does not have specific maintenance requirements, the facility is expected to develop its own policies and procedures to ensure that the dispensers neither leak nor the contents spill.

482.41(c) Standard: Facilities

A-0722 482.41(c) The hospital must maintain adequate facilities for its services.

Interpretive Guidelines §482.41(c)
Adequate facilities means the hospital has facilities that are:
• Designed and maintained in accordance with Federal, State and local laws, regulations and guidelines; and
• Designed and maintained to reflect the scope and complexity of the services it offers in accordance with accepted standards of practice.

A-0723 482.41(c)(1) Diagnostic and therapeutic facilities must be located for the safety of patients.

Interpretive Guidelines §482.41(c)(1)
Diagnostic and therapeutic facilities must be in rooms or areas specifically designed for the purpose intended.

A-0724 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.

Interpretive Guidelines §482.41(c)(2)

Facilities
The hospital must ensure that the condition of the physical plant and overall hospital environment is developed and maintained in a manner that provides an acceptable level of safety and well-being of patients, staff and visitors.

Supplies
The hospital must ensure that supplies are maintained to provide an acceptable level of safety and quality for patients. Among other things, this means that the hospital identifies the supplies required to meet its patients’ needs for both day-to-day operations as well as those supplies that are likely to be needed in likely emergency situations, such as mass casualty events resulting from natural disasters, mass trauma, disease outbreaks, etc. Further, the hospital must make adequate provisions to ensure the availability of those supplies when needed.
Supplies must be stored in such a manner to ensure their safety (protection against theft or damage, contamination, or deterioration), as well as that the storage practices do not violate fire codes or otherwise endanger patients (storage of flammables, blocking passageways, storage of contaminated or dangerous materials, safe storage practices for poisons, etc.).

Equipment
In order to ensure an acceptable level of safety and quality, the hospital must identify the equipment required to meet its patients’ needs for both day-to-day operations and in a likely emergency/disaster situation, such as mass casualty events resulting from natural disasters, mass trauma, disease outbreaks, internal disasters, etc. In addition, the hospital must make adequate provisions to ensure the availability and reliability of equipment needed for its operations and services. Equipment includes both facility equipment, which supports the physical environment of the hospital (e.g., elevators, generators, air handlers, medical gas systems, air compressors and vacuum systems, etc.) and medical equipment, which are devices intended to be used for diagnostic, therapeutic or monitoring care provided to a patient by the hospital (e.g., IV infusion equipment, ventilators, laboratory equipment, surgical devices, etc.).
All equipment must be inspected and tested for performance and safety before initial use
and after major repairs or upgrades.
All equipment must be inspected, tested, and maintained to ensure their safety, availability and reliability. Equipment maintenance activities may be conducted using hospital personnel, contracted services, or through a combination of hospital personnel and contracted services. Individual(s) responsible for overseeing the development, implementation, and management of equipment maintenance programs and activities must be qualified. The hospital maintains records of hospital personnel qualifications and is able to demonstrate how it assures all personnel, including contracted personnel, are qualified.
All equipment maintenance policies, procedures and programs, as well as specific equipment maintenance inventories, activities and schedules, fall under the purview of the hospital’s clinical maintenance personnel, safety department personnel or other personnel who have been assigned responsibility for equipment maintenance by hospital leadership.
Hospitals comply with this regulation when they follow the manufacturer-recommended maintenance activities and schedule. Hospitals may choose to perform maintenance more frequently than the manufacturer recommends, but must use the manufacturer-recommended maintenance activities in such cases. When equipment is maintained in accordance with the manufacturer’s recommendations, the hospital must maintain documentation of those recommendations and the hospital’s associated maintenance activity for the affected equipment.

Alternate Equipment Management (AEM) Program
A hospital may, under certain conditions, use equipment maintenance activities and frequencies that differ from those recommended by the manufacturer. Hospitals that choose to employ alternate maintenance activities and/or schedules must develop, implement, and maintain a documented AEM program to minimize risks to patients and others in the hospital associated with the use of facility or medical equipment. The AEM program must be based on generally accepted standards of practice for facility or medical equipment maintenance. An example of guidelines for a medical equipment medical equipment maintenance program may be found in the American National Standards Institute/ Association for the Advancement of Medical Instrumentation document: ANSI/AAMI EQ 56:1999/ (R) 2013, Recommended Practice for a Medical Equipment Management Program. Likewise, an example of guidelines for physical plant equipment may be found in the American Society for Healthcare Engineering (ASHE) 2009 document: Maintenance Management for Health Care Facilities. There may be similar documents issued by other nationally recognized organizations which hospitals might choose to reference.

Decision to Place Equipment in an AEM Program
The determination of whether it is safe to perform facility or medical equipment maintenance without following the equipment manufacturer recommendations must be made by qualified personnel, regardless of whether they are hospital employees or contractors.
In the case of medical equipment, a clinical or biomedical technician or engineer would be considered qualified. Highly specialized or complex equipment may require specialized knowledge or training in order for personnel to be considered qualified to make a decision to place such equipment in an AEM program.
In the case of facility equipment, a Healthcare Facility Management professional (facility manager, director of facilities, vice president of facilities) would be considered qualified.
The hospital must maintain records of the qualifications of hospital personnel who make decisions on placing equipment in an AEM program, and must be able to demonstrate how they assure contracted personnel making such decisions are qualified.
In determining whether or not to include equipment in an AEM program, and which maintenance strategies to use in developing maintenance activities and frequencies for particular equipment, the hospital must take into account the typical health and safety risks associated with the equipment’s use. Note that the risk may vary for the same type of equipment, depending on the patient care setting within the hospital where it is used.
A hospital is expected to identify any equipment in its AEM program which is “critical equipment,” i.e., biomedical or physical plant equipment for which there is a risk of serious injury or death to a patient or staff person should the equipment fail. Surveyors must focus their review of a hospital’s AEM program on critical equipment in that program and the hospital’s documentation of the factors and evidence it considered in developing an AEM strategy for that equipment.
Factors for a hospital to consider when evaluating the risks associated with a particular type of equipment include, but are not limited to:
• How the equipment is used and the likely consequences of equipment failure or malfunction - would failure or malfunction of the equipment hospital-wide or in a particular setting be likely to cause harm to a patient or a staff person?
• How serious is the harm likely to be? For example, a slightly miscalibrated scale in an adult internal medicine outpatient clinic might not present significant risk of harm. However, a miscalibrated scale in a neonatal intensive care unit could have very serious consequences for patient care.
• How widespread is the harm likely to be? For example, are many patients exposed to the equipment, resulting in harm due to failure impacting more patients or staff? If harm would be widespread, even if the harm to each affected individual is not serious, this would be a cause for concern.
• Information, if available, on the manufacturer’s equipment maintenance recommendations, including the rationale for the manufacturer’s recommendations;
• Maintenance requirements of the equipment:
• Are they simple or complex?
• Are the manufacturer’s instructions and procedures available in the hospital, and if so can the hospital explain how and why it is modifying the manufacturer’s instructions?
• If the manufacturer’s instructions are not available in the hospital, how does the hospital assess whether the AEM uses appropriate maintenance strategies?
• How readily can the hospital validate the effectiveness of AEM methods for particular equipment? For example, can the hospital explain how it ensures there is no reduction in the quality of the performance of biomedical equipment subjected to alternate maintenance methods?
• The timely availability of alternate devices or backup systems in the event of equipment failure or malfunction; and
• Incident history of identical or very similar equipment – is there documented evidence, based on the experience of the hospital (or its third party contractor), or on evidence publicly reported by credible sources outside the hospital, which:
• Provides the number, frequency and nature of previous failures and service requests?
• Indicates use of an AEM strategy does not result in degraded performance of the equipment?
Generally multiple factors must be considered, since different types of equipment present different combinations of severity of potential harm and likelihood of failure. The hospital is expected to be able to demonstrate to a surveyor the factors it considered in its risk assessment for equipment placed in its AEM program.

Equipment not Eligible for Placement in the AEM Program:
Some equipment may not be eligible for placement in the AEM program, for one or more of the following reasons:
• Other Federal law (for example, regulations promulgated by another Federal agency)
or State law may require that facility or medical equipment maintenance, inspection and testing be performed strictly in accordance with the manufacturer’s recommendations, or may establish other, more stringent maintenance requirements. In these instances, the hospital must comply with these other Federal or State requirements, but State Surveyors conducting Federal surveys assess compliance only with the hospital Conditions of Participation (CoPs).
• Other CoPs require adherence to manufacturer’s recommendations and/or set specific standards which preclude their inclusion in an AEM program. For example:
• The National Fire Protection Association Life Safety Code (LSC) requirements incorporated by reference at 42 CFR 482.41(b) has some provisions that are pertinent to equipment maintenance, and compliance with these requirements are assessed on Federal surveys. Further, §482.41(b)(9)(v) requires hospitals to adhere to the manufacturer’s maintenance guidelines for alcohol-based hand-rub dispensers. Compliance with these requirements is assessed on Federal surveys.
• Imaging/radiologic equipment, whether used for diagnostic or therapeutic purposes, is governed by 42 CFR 482.26(b)(2) and must be maintained per manufacturer’s recommendations.
• The equipment is a medical laser device. It should be noted that for medical lasers the U.S. Food and Drug Administration requires manufacturers to provide a schedule of maintenance and adequate instructions for service adjustments and service procedures to purchasers and, at cost, to any other parties requesting them.
• New equipment for which sufficient maintenance history, either based on the hospital’s own or its contractor’s records, or available publicly from nationally recognized sources, is not available to support a risk-based determination must not be immediately included in the AEM program. New equipment must be maintained in accordance with manufacturer recommendations until a sufficient amount of maintenance history has been acquired to determine whether the alteration of maintenance activities or frequencies would be safe. If a hospital later transitions the equipment to a risk-based maintenance regimen different than the manufacturers’ recommendations, the hospital must maintain evidence that it has first evaluated the maintenance track record, risks, and tested the alternate regimen.

Alternative Maintenance Frequencies or Activities
Maintenance strategies are various methodologies used for determining the most efficient and effective maintenance activities and frequencies. Manufacturers’ recommendations may be based on one or more such strategies. A hospital may also use one or more maintenance strategies for its AEM program in order to determine the appropriate maintenance, inspection, and testing activities and frequencies, based upon the nature of
the equipment and the level of risk it presents to patient or staff health and safety. The risk to patient health and safety that is considered in developing alternative maintenance strategies must be explained and documented in the AEM program.
In developing AEM maintenance strategies hospitals may rely upon information from a variety of sources, including, but not limited to: manufacturer recommendations and other materials, nationally recognized expert associations, and/or the hospital’s (or its third party contractor’s) own experience. Maintenance strategies may be applied to groups or to individual pieces of equipment.
The hospital is expected to adhere strictly to the AEM activities or strategies it has developed.

Background Information on Types of Maintenance Strategies
• Preventive Maintenance (Time-based Maintenance) – a maintenance strategy where maintenance activities are performed at scheduled time intervals to minimize equipment degradation and reduce instances where there is a loss of performance. Most preventive maintenance is “interval-based maintenance” performed at fixed time intervals (e.g., annual or semi-annual), but may also be “metered maintenance” performed according to metered usage of the equipment (e.g., hours of operation). In either case, the primary focus of preventive maintenance is reliability, not optimization of cost-effectiveness. Maintenance is performed systematically, regardless of whether or not it is needed at the time. Example: Replacing a battery every year, after a set number of uses or after running for a set number of hours, regardless.
• Predictive Maintenance (Condition-based Maintenance) – a maintenance strategy that involves periodic or continuous equipment condition monitoring to detect the onset of equipment degradation. This information is used to predict future maintenance requirements and to schedule maintenance at a time just before equipment experiences a loss of performance. Example: Replacing a battery one year after the manufacturer’s recommended replacement interval, based on historical monitoring that has determined the battery capacity does not tend to fall below the required performance threshold before this extended time.
• Reactive Maintenance (Corrective, Breakdown or Run-to-Failure Maintenance) – a maintenance strategy based upon a “run it until it breaks” philosophy, where maintenance or replacement is performed only after equipment fails or experiences a problem. This strategy may be acceptable for equipment that is disposable or low cost, and presents little or no risk to health and safety if it fails. Example: Replacing a battery after equipment failure when the equipment has little negative health and safety consequences associated with a failure and there is a replacement readily available in supply.
• Reliability-Centered Maintenance – a maintenance strategy that not only considers equipment condition, but also considers other factors unique to individual pieces of equipment, such as equipment function, consequences of equipment failure, and the operational environment. Maintenance is performed to optimize reliability and cost effectiveness. Example: Replacing a battery in an ambulance defibrillator more frequently than the same model used at a nursing station, since the one in the ambulance is used more frequently and is charged by an unstable power supply.

Maintenance Tools
Tools (e.g., hand tools, test equipment, software, etc.) necessary for performing equipment maintenance must be available and maintained to ensure that measurements are reliable. Tools used for maintenance are not required to be those specifically recommended by the manufacturer, but tools utilized must be capable of providing results equivalent to those required by the equipment manufacturer.

AEM Program Documentation
For each type of equipment subject to the AEM program, there must be documentation indicating:
• The pertinent types and level of risks to patient or staff health and safety;
• Alternate maintenance activities, and the maintenance strategy and any other rationale used to determine those activities; the differences from the manufacturer’s recommended maintenance activities are made explicit, unless the hospital is unable to obtain the manufacturer’s maintenance recommendations, due to the age of the equipment or the manufacturer’s restricting the availability of its recommendations;
• Alternate maintenance frequencies to be used, if any, and the maintenance strategy and any other rationale used to determine those frequencies. For equipment identified as presenting a very low risk to patient or staff safety, it could be acceptable to not set a particular frequency but instead indicate a less specific approach, for example, an interval range, such as “every 12 – 24 months.” It could also be acceptable to employ periodic “departmental sweeps” for such very low risk equipment, where equipment functioning is sampled and operators are polled about its functionality.
• The date when AEM program maintenance activities were performed and, if applicable, further actions required/taken; and
• Documentation of any equipment failures (not including failures due to operator error), including whether there was resulting harm to an individual. (Note: equipment failure that is due to operator error and which results in an adverse event or near miss must be documented in accordance with the QAPI CoP, as part of the hospital’s required tracking of patient safety-related incidents. However, there is no
requirement to include operator failures in equipment maintenance documentation.)
When the hospital has multiple identical equipment items, the documentation may be generic to that type of equipment, except that documentation of maintenance activities performed must be specific to each item of equipment.

Evaluating Safety and Effectiveness of the AEM Program
The hospital must have policies and procedures which address the effectiveness of its AEM program. In evaluating the effectiveness of the AEM program the hospital is expected to address factors including, but not limited to:
• How equipment is evaluated to ensure there is no degradation of performance, particularly for equipment where such degradation may not be readily apparent to staff using the equipment, e.g., miscalibration.
• How incidents of equipment malfunction are investigated, including:
• whether or not the malfunction could have been prevented, and what steps will be taken to prevent future malfunctions; and
• how a determination is made whether or not the malfunction resulted from the use of an AEM strategy;
• The process for the removal from service of equipment determined to be unsafe or no longer suitable for its intended application; and
• The use of performance data to determine if modifications in the AEM program procedures are required.

Equipment Inventory
All hospital facility and medical equipment, regardless of whether it is leased or owned, and regardless of whether it is maintained according to manufacturer recommendations or is in an AEM program, is expected to be listed in an inventory which includes a record of maintenance activities. For low cost/low risk equipment, such as housekeeping cleaning equipment, it is acceptable for the inventory to indicate under one item the number of such pieces of equipment in the hospital, e.g., “15 vacuum cleaners for cleaning patient rooms and common areas.”
If the hospital is using an AEM program, the equipment managed through that program must be readily separately identifiable as subject to AEM. Critical equipment, whether in an AEM program or not, must also be readily identified as such.
To facilitate effective management, a well-designed equipment inventory contains the
following information for all equipment included. However, hospitals have the flexibility to demonstrate how alternative means they use are effective in enabling them to manage their equipment.
• A unique identification number;
• The equipment manufacturer;
• The equipment model number;
• The equipment serial number;
• A description of the equipment;
• The location of the equipment (for equipment generally kept in a fixed location);
• The identity of the department considered to “own” the equipment;
• Identification of the service provider;
• The acceptance date; and
• Any additional information the hospital believes may be useful for proper management of the equipment.

A-0725 482.41(c)(3) The extent and complexity of facilities must be determined by the services offered.

Interpretive Guidelines §482.41(c)(3)
Physical facilities must be large enough, numerous enough, appropriately designed and equipped, and of appropriate complexity to provide the services offered in accordance with Federal and State laws, regulations and guidelines and accepted standards of practice for that location or service.

A-0726 482.41(c)(4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas.

Interpretive Guidelines §482.41(c)(4)
There must be proper ventilation in at least the following areas:
• Areas using ethylene oxide, nitrous oxide, guteraldehydes, xylene, pentamidine, or other potentially hazardous substances;
• Locations where oxygen is transferred from one container to another;
• Isolation rooms and reverse isolation rooms (both must be in compliance with Federal and State laws, regulations, and guidelines such as OSHA, CDC, NIH, etc.);
• Pharmaceutical preparation areas (hoods, cabinets, etc.);
• Laboratory locations; and
• Anesthetizing locations. According to NFPA 99, anesthetizing locations are “Any area of a facility that has been designated to be used for the administration of nonflammable inhalation anesthetic agents in the course of examination or treatment, including the use of such agents for relative analgesia.” NFPA 99 defines relative analgesia as “A state of sedation and partial block of pain perception produced in a patient by the inhalation of concentrations of nitrous oxide insufficient to produce loss of consciousness (conscious sedation).” (Note that this definition is applicable only for LSC purposes and does not supercede other guidance we have issued for other purposes concerning anesthesia and analgesia.)
There must be adequate lighting in all the patient care areas, and food and medication preparation areas. Temperature, humidity and airflow in anesthetizing locations must be maintained within acceptable standards to inhibit microbial growth, reduce risk of infection, control odor, and promote patient comfort. Hospitals must maintain relative humidity (RH) levels at 35 percent or greater in each anesthetizing location, unless the hospital elects to use the CMS categorical waiver, which permits it to maintain a RH of at least 20 percent (see Appendix I, Section II for additional information). Hospitals must maintain records that demonstrate they have achieved the required levels. Although not required, CMS recommends that hospitals maintain the upper range of RH at 60 percent or less, as excessive humidity is conducive to microbial growth and compromises the integrity of wrapped sterile instruments and supplies. Each operating room should have separate temperature control. Acceptable standards such as from the Association of Operating Room Nurses (AORN) or the Facilities Guidelines Institute (FGI) should be incorporated into hospital policy.
The hospital must ensure that an appropriate number of refrigerators and/or heating devices are provided and ensure that food and pharmaceuticals are stored properly and in accordance with nationally accepted guidelines (food) and manufacturer’s recommendations (pharmaceuticals).

CoP: Infection Control

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482.42 Infection Control

A-0747 482.42 The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases.

Interpretive Guidelines §482.42
This regulation requires the hospital to develop, implement, and maintain an active, hospital-wide program for the prevention, control, and investigation of infections and communicable diseases. The National Institute of Allergy and Infectious Diseases defines an infectious disease as a change from a state of health to a state in which part or all of a host’s body cannot function normally because of the presence of an infectious agent or its product. An infectious agent is defined by the NIAID as a living or quasi-living organism or particle that causes an infectious disease, and includes bacteria, viruses, fungi, protozoa, helminthes, and prions. NIAID defines a communicable disease as a disease associated with an agent that can be transmitted from one host to another. (NIAID website glossary)
According to the Centers for Disease Control and Prevention (CDC), healthcare-associated infections, i.e., infections that patients acquire during the course of receiving treatment for other conditions within a healthcare setting, are one of the top ten leading causes of death in the United States. The CDC estimates that there are 1.7 million healthcare-associated infections in American hospitals each year, with 99,000 associated deaths. (CDC website, Estimates of Healthcare-Associated Infections, date last modified May 30, 2007)
The hospital must provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases. All areas of the hospital must be clean and sanitary. This includes all hospital units, campuses and off-site locations. The infection prevention and control program must include appropriate monitoring of housekeeping, maintenance (including repair, renovation and construction activities), and other activities to ensure that the hospital maintains a sanitary environment. Examples of areas to monitor would include: food storage, preparation, serving and dish rooms, refrigerators, ice machines, air handlers, autoclave rooms, venting systems, inpatient rooms, treatment areas, labs, waste handling, surgical areas, supply storage, equipment cleaning, etc.
The hospital’s program for prevention, control and investigation of infections and communicable diseases should be conducted in accordance with nationally recognized infection control practices or guidelines, as well as applicable regulations of other federal or state agencies. Examples of organizations that promulgate nationally recognized infection and communicable disease control guidelines, and/or recommendations include: the Centers for Disease Control and Prevention (CDC), the Association for Professionals in Infection Control and Epidemiology (APIC), the Society for Healthcare Epidemiology of America (SHEA), and the Association of periOperative Registered Nurses (AORN). The U.S. Occupational Health and Safety Administration (OSHA) also issues federal regulations applicable to infection control practices.
In order to prevent, control and investigate infections and communicable diseases, the hospital’s program must include an active surveillance component that covers both hospital patients and personnel working in the hospital. Surveillance includes infection detection, data collection and analysis, monitoring, and evaluation of preventive interventions.
The hospital must conduct surveillance on a hospital-wide basis in order to identify infectious risks or communicable disease problems at any particular location. This does not imply “total hospital surveillance,” but it does mean that hospitals must have reliable sampling or other mechanisms in place to permit identifying and monitoring infections and communicable diseases occurring throughout the hospital’s various locations or departments. The hospital must document its surveillance activities, including the measures selected for monitoring, and collection and analysis methods. Surveillance activities should be conducted in accordance with recognized infection control surveillance practices, such as, for example, those utilized by the CDC’s National Healthcare Safety Net (NHSN).
The hospital must develop and implement appropriate infection control interventions to address issues identified through its detection activities, and then monitor the effectiveness of interventions through further data collection and analysis.
The hospital’s infection prevention and control program must be integrated into its hospital-wide Quality Assurance and Performance Improvement (QAPI) program. (See 42 CFR 482.42(b)(1).)

SPECIAL CHALLENGES IN INFECTION CONTROL

MULTI-DRUG RESISTANT ORGANISMS (MDROs)
According to the Centers for Disease Control’s (CDC) publication, Management of Multi-drug Resistant Organisms in Healthcare Settings 2006, http://www.cdc.gov/ncidod/dhqp/pdf/ar/mrdoGuideline2006.pdf, MDROs are microorganisms that are resistant to one or more antimicrobial agents. Options for treating patients with MDRO infections are very limited, resulting in increased mortality, as well as increased hospital length of stay and costs. During the last several decades the prevalence of MDROs in hospitals has increased steadily. Hospitals are encouraged to have mechanisms in place for the early identification of patients with targeted MDROs prevalent in their hospital and community, and for the prevention of transmission of such MDROs. When ongoing transmission of targeted MDROs in the hospital is identified, the infection prevention and control program should use this event to identify potential breaches in infection control practice.

AMBULATORY CARE
The ambulatory care setting, including emergency departments, presents unique
challenges for infection control, because: patients remain in common areas, often for prolonged periods of time, until they can be seen by a healthcare practitioner; examination or treatment rooms are turned around quickly with minimal cleaning; and infectious patients may not be recognized immediately. Furthermore, immuno-compromised patients may receive treatments in rooms among other patients who pose risks of infection.
The hospital’s infection prevention and control program should be designed with these ambulatory care setting challenges in mind. After assessing the likely level of risk in its various ambulatory care settings, including off-site settings, a hospital might identify particular settings, such as the emergency department, where it would be appropriate to employ measures for screening individuals with potentially contagious diseases during their initial patient encounter, and taking appropriate control measures for those individuals who may present risk for the transmission of infectious agents by the airborne or droplet route. Guidelines promulgated by the CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) are a resource for hospitals in developing their infection control program for ambulatory care. For example, when potentially infectious individuals are identified, prevention measures should include prompt physical separation wherever possible, implementation of respiratory hygiene/cough etiquette protocols, and/or appropriate isolation precautions based on the routes of transmission of the suspected infection.

COMMUNICABLE DISEASE OUTBREAKS
Community-wide outbreaks of communicable diseases (such as measles, SARS, or influenza) present many of the same issues and require many of the same considerations and strategies as other hospital infectious disease threats. If a communicable disease outbreak occurs, an understanding of the epidemiology, likely modes of transmission, and clinical course of the disease is essential for responding to and managing the event. Among the infection control issues that may need to be addressed are:
• Preventing transmission among patients, healthcare personnel, and visitors;
• Identifying persons who may be infected and exposed;
• Providing treatment or prophylaxis to large numbers of people; and
• Logistics issues (staff, medical supplies, resupply, continued operations, and capacity).
Pandemics, or very widespread and clinically serious outbreaks of an infection, present additional challenges due to the widespread effect on the availability of back-up resources that would typically be available to address an outbreak confined to a smaller geographic area. Additionally, the duration of a pandemic may present special challenges for staffing, supplies, resupply, etc. Hospitals should work with local, State, and Federal
public health agencies to identify likely communicable disease threats and develop appropriate preparedness and response strategies.

BIOTERRORISM
Healthcare facilities would confront a set of issues similar to naturally occurring communicable disease threats when dealing with a suspected bioterrorism event. The required response is likely to differ based on whether exposure is a result of a biological release or person-to-person transmission. A variety of sources offer guidance for the management of persons exposed to likely agents of bioterrorism, including Federal agency websites (e.g., http://www.ahrq.gov/prep; http://www.usamrid.army.mil/publications/index.html; http://www.bt.cdc.gov) Because of the many similarities between man-made and naturally occurring threats, an all-hazards approach to developing emergency response plans is preferred, and hospitals are encouraged to work with their State and local emergency response agencies to develop their plans.
The hospital must be in compliance with the Occupational Health and Safety Administration’s Bloodborne Pathogens regulation at 29 CFR 1910.1030.

482.42(a) Standard: Organization and Policies

A-0748 482.42(a) A person or persons must be designated as infection control officer or officers to develop and implement policies governing control of infections and communicable diseases….

Interpretive Guidelines §482.42(a)
Hospital infection control officers are often referred to as “hospital epidemiologists (HEs),” “infection control professionals (ICPs)” or “infection preventionists.” CDC has defined “infection control professional” as “a person whose primary training is in either nursing, medical technology, microbiology, or epidemiology and who has acquired specialized training in infection control.”
The hospital must designate in writing an individual or group of individuals as its infection control officer or officers. In designating infection control officers, hospitals should assure that the individuals so designated are qualified through education, training, experience, or certification (such as that offered by the Certification Board of Infection Control and Epidemiology Inc. (CBIC), or by the specialty boards in adult or pediatric infectious diseases offered for physicians by the American Board of Internal Medicine (for internists) and the American Board of Pediatrics (for pediatricians)). Infection control officers should maintain their qualifications through ongoing education and training, which can be demonstrated by participation in infection control courses, or in local and national meetings organized by recognized professional societies, such as APIC and SHEA.
CMS does not specify either the number of infection control officers to be designated or the number of infection control officer hours that must be devoted to the infection prevention and control programs. However, resources must be adequate to accomplish the tasks required for the infection control program. A prudent hospital would consider patient census, characteristics of the patient population, and complexity of the healthcare services it offers in determining the size and scope of the resources it commits to infection control. The CDC’s HICPAC as well as professional infection control organizations such as the APIC and the SHEA publish studies and recommendations on resource allocation that hospitals may find useful.
The infection control officer(s) must develop and implement policies governing the control of infections and communicable diseases. Infection control policies should address the roles and responsibilities for infection control within the hospital; how the various hospital committees and departments interface with the infection control program; and how to prevent infectious/communicable diseases; and how to report infectious/communicable diseases to the infection control program.

A-0749 482.42(a) The infection control officer or officers must develop a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

Interpretive Guidelines §482.42(a)
The infection control officer or officers must develop, implement and evaluate measures governing the identification, investigation, reporting, prevention and control of infections and communicable diseases within the hospital, including both healthcare–associated infections and community-acquired infections. Infection control policies should be specific to each department, service, and location, including off-site locations, and be evaluated and revised when indicated. The successful development, implementation and evaluation of a hospital-wide infection prevention and control program requires frequent collaboration with persons administratively and clinically responsible for inpatient and outpatient departments and services, as well as, non-patient-care support staff, such as maintenance and housekeeping staff.
Implicit in the infection control officer(s)’ responsibility for measures to identify, investigate, report, prevent and control infections and communicable diseases are the following activities:
• Maintenance of a sanitary hospital environment;
• Development and implementation of infection control measures related to hospital personnel; hospital staff, for infection control purposes, includes all hospital staff, contract workers (e.g., agency nurses, housekeeping staff, etc), and volunteers;
• Mitigation of risks associated with patient infections present upon admission:
• Mitigation of risks contributing to healthcare-associated infections:
• Active surveillance;
• Monitoring compliance with all policies, procedures, protocols and other infection control program requirements;
• Program evaluation and revision of the program, when indicated;
• Coordination as required by law with federal, state, and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism, and outbreaks;
• Complying with the reportable disease requirements of the local health authority;
For example, a hospital with a comprehensive hospital-wide infection control program should have and implement policies and procedures, based as much as possible on national guidelines that address the following:
• Maintenance of a sanitary physical environment:
° Ventilation and water quality control issues, including measures taken to maintain a safe environment during internal or external construction/renovation;
° Maintaining safe air handling systems in areas of special ventilation, such as operating rooms, intensive care units, and airborne infection isolation rooms;
° Techniques for food sanitation;
° Techniques for cleaning and disinfecting environmental surfaces, carpeting and furniture;
° Techniques for textiles reprocessing, storage and distribution;
° Techniques for disposal of regulated and non-regulated waste; and
° Techniques for pest control.
• Hospital staff-related measures:
° Measures – and authority - for evaluating hospital staff immunization status for designated infectious diseases, as recommended by the CDC and its Advisory Committee on Immunization Practices (ACIP);
° Policies articulating the authority and circumstances under which the hospital screens hospital staff for infections likely to cause significant infectious disease or other risk to the exposed individual, and for reportable diseases, as required under local, state, or federal public health authority;
° Policies articulating when infected hospital staff are restricted from providing direct patient care and/or are required to remain away from the healthcare facility entirely;
° New employee and regular update training in preventing and controlling healthcare-associated infections and methods to prevent exposure to and transmission of infections and communicable diseases;
° Measures to evaluate staff and volunteers exposed to patients with infections and communicable disease;
• Mitigation of risks associated with patient infections present upon admission:
° Measures for the early identification of patients who require isolation in accordance with CDC guidelines;
° Appropriate use of personal protective equipment including gowns, gloves, masks and eye protection devices;
° Use and techniques for “isolation” precautions as recommended by the CDC.
• Mitigation of risks contributing to healthcare-associated infections:
° Surgery-related infection risk mitigation measures:
• Implementing appropriate prophylaxis to prevent surgical site infection (SSI), such as a protocol to assure that antibiotic prophylaxis to prevent surgical site infection for appropriate procedures is administered at the appropriate time, done with an appropriate antibiotic, and discontinued appropriately after surgery;
• Addressing aseptic technique practices used in surgery and invasive procedures performed outside the operating room, including sterilization of
instruments;
° Other hospital healthcare-associated infection risk mitigation measures:
• Promotion of hand washing hygiene among staff and employees, including utilization of alcohol-based hand sanitizers;
• Measures specific to prevention of infections caused by organisms that are antibiotic-resistant;
• Measures specific to prevention of device-associated bloodstream infection (BSI), such as a protocol for reducing infections of central venous catheters specifying aseptic precautions for line insertions, care of inserted lines, and prompt removal when a line is no longer needed;
• Measures specific to prevention of other device-associated infections, e.g., those associated with ventilators, tube feeding, indwelling urinary catheters, etc.;
• Isolation procedures and requirements for highly immuno-suppressed patients who require a protective environment.
• Care techniques for tracheostomy care, respiratory therapy, burns and other situations that reduce a patient's resistance to infection;
• Requiring disinfectants, antiseptics, and germicides to be used in accordance with the manufacturers' instructions;
• Appropriate use of facility and medical equipment, including negative and positive pressure isolation room equipment, portable air filtration equipment, treatment booths and enclosed beds, UV lights, and other equipment used to control the spread of infectious agents;
• Adherence to nationally recognized infection prevention and control precautions, such as current CDC guidelines and recommendations, for infections/communicable diseases identified as present in the hospital; and
• Educating patients, visitors, caregivers, and staff, as appropriate, about infections and communicable diseases and methods to reduce transmission in the hospital and in the community;
• Active surveillance:
° The hospital is expected to identify and track infections and communicable diseases in any of the following categories occurring throughout the hospital, whether in patients or staff (patient care staff and non-patient care staff,
including employees, contract staff and volunteers). Hospitals are not required to organize their surveillance according to these categories. The categories are:
• Healthcare-associated infections selected by the hospital’s Infection Prevention and Control Program as part of a targeted surveillance strategy based on nationally recognized guidelines and periodic risk assessment;
• Patients or staff with identified communicable diseases that local, State, or Federal health agencies require be reported;
• Patients identified by laboratory culture as colonized or infected with multi-drug-resistant organisms (MDROs), as defined by the hospital’s Infection Prevention and Control Program;
• Patients who meet CDC criteria for requiring isolation precautions (other than “Standard Precautions” or a protective environment) during their hospitalization;
• Patients or staff with signs and symptoms that have been requested be reported or recorded by local, State, or Federal health agencies; and
• Staff or patients who are known or suspected to be infected with epidemiologically-significant pathogens that are identified by the hospital or local, State, or Federal health agencies.

"For Information – Not Required/Not to be Cited"
--Many hospitals are using automated surveillance technology (AST) or “data mining” for identification and control of hospital-acquired infections (HAI) and implementation of evidence-based infection control practices. Use of AST or similar technology is encouraged in hospitals, but is not required.--

• Provisions to monitor compliance with all policies, procedures, protocols and other infection control program requirements;
• Provision for program evaluation and revision of the program, when indicated;
• Policies and procedures developed in coordination with federal, state, and local emergency preparedness and health authorities to address communicable disease threats, bioterrorism, and outbreaks; and
• Procedures for meeting the reporting requirements of the local health authority.

482.42(b) Standard: Responsibilities of Chief Executive Officer, Medical Staff, and Director of Nursing Services

A-0756 482.42(b) The chief executive officer, the medical staff, and the director of nursing must:
(1) Ensure that the hospital-wide quality assessment and performance improvement (QAPI) program and training programs address problems identified by the infection control officer or officers; and
(2) Be responsible for the implementation of successful corrective action plans in
affected problem areas.

Interpretive Guidelines §482.42(b)
The chief executive officer (CEO), the medical staff and the director of nursing (DON) must ensure that the hospital-wide Quality Assessment and Performance Improvement (QAPI) program and staff in-service training programs address problems identified through the infection prevention and control program.
To reflect the importance of infection control the regulations specifically require that the hospital’s QAPI and training programs must be involved in addressing problems identified by the infection control program, and hold the CEO, medical staff and DON jointly responsible for linking the infection control program with the QAPI and training programs. Requirements for the hospital’s QAPI program are found at 42 CFR 482.21.
These hospital leaders are also held explicitly responsible for implementing successful corrective action plans. In order to accomplish this, hospital leaders must monitor adherence to corrective action plans, as well as assess the effectiveness of actions taken, with implementation of revised corrective actions as needed.
Education on the principles and practices for preventing transmission of infectious agents within the hospital should be provided to anyone who has an opportunity for contact with patients or medical equipment, e.g., nursing and medical staff; therapists and technicians, such as those involved in respiratory, physical, and occupational therapy and radiology and cardiology services; phlebotomists; housekeeping and maintenance staff; volunteers; and all students and trainees in healthcare professions.

CoP: Discharge Planning

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482.43 Discharge Planning

A-0799 482.43 The hospital must have in effect a discharge planning process that applies to all patients. The hospital’s policies and procedures must be specified in writing.

Interpretive Guidelines §482.43
Hospital discharge planning is a process that involves determining the appropriate post-hospital discharge destination for a patient; identifying what the patient requires for a smooth and safe transition from the hospital to his/her discharge destination; and beginning the process of meeting the patient’s identified post-discharge needs. Newer terminology, such as “transition planning” or “community care transitions” is preferred by some, since it moves away from a focus primarily on a patient’s hospital stay to consideration of transitions among the multiple types of patient care settings that may be involved at various points in the treatment of a given patient. This approach recognizes the shared responsibility of health care professionals and facilities as well as patients and their support persons throughout the continuum of care, and the need to foster better communication among the various groups. Much of the interpretive guidance for this CoP has been informed by newer research on care transitions, understood broadly. At the same time, the term “discharge planning” is used both in Section 1861(ee) of the Social Security Act as well as in §482.43. In this guidance, therefore, we continue to use the term “discharge planning.”
When the discharge planning process is well executed, and absent unavoidable complications or unrelated illness or injury, the patient continues to progress towards the goals of his/her plan of care after discharge. However, it is not uncommon in the current health care environment for patients to be discharged from inpatient hospital settings only to be readmitted within a short timeframe for a related condition. Some readmissions may not be avoidable. Some may be avoidable, but are due to factors beyond the control of the hospital that discharged the patient. On the other hand, a poor discharge planning process may slow or complicate the patient’s recovery, may lead to readmission to a hospital, or may even result in the patient’s death.
Jencks10 et al. analyzed Medicare claims data for a two-year period in an attempt to more accurately identify readmission (called “rehospitalization”) rates and associated costs. They found approximately 19.6% of Medicare fee-for-service beneficiaries were rehospitalized within 30 days of discharge and 34.0% within 60 days of discharge. 70.5% of those surgical patients subsequently readmitted within 30 days had a medical cause for the readmission. Only approximately 10% of rehospitalizations were estimated to have been planned.
Reducing the number of preventable hospital readmissions is a major priority for patient safety, and holding hospitals accountable for complying with the discharge planning CoP is one key element of an overall strategy for reducing readmissions.
With respect to the causes of the high rate of preventable readmissions, “Multiple factors contribute to the high level of hospital readmissions in the U.S…. They may result from poor quality care or from poor transitions between different providers and care settings. Such readmissions may occur if patients are discharged from hospitals or other health care settings prematurely; if they are discharged to inappropriate settings; or if they do not receive adequate information or resources to ensure a continued progression of services. System factors, such as poorly coordinated care and incomplete communication and information exchange between inpatient and community‐based providers, may also lead to unplanned readmissions.”11 The discharge planning CoP requirements address all of these factors. While hospitals are not solely responsible for the success of their patients’ post-hospital care transitions, under the discharge planning CoP hospitals are expected to employ a discharge planning process that improves the quality of care for patients and reduces the chances of readmission.

--Footnote:10 Jencks, F. J., Williams, M. V., Coleman, E. A. Rehospitalizations among Patients in the Medicare Fee-for-Service program. The New England Journal of Medicine 2009; 360;14: 1418-1428.--
"For Information – Not to be Cited under the CoP"
--These interpretive guidelines address hospital discharge requirements under the Medicare statute and regulations. However, hospitals should be aware that, as entities receiving Federal financial assistance (including Medicaid and Medicare payments) and public accommodations, they are subject to the requirements of Section 504 of the Rehabilitation Act and the Americans with Disabilities Act. These statutes and their implementing regulations require that covered entities administer their services, programs and activities in the most integrated setting appropriate to individuals with disabilities and prohibit covered entities from utilizing criteria or methods of administration that lead to discrimination. CMS does not interpret or enforce these requirements. However, hospitals should ensure that their discharge practices comply with applicable Federal civil rights laws and do not lead to needless segregation.--
The plain language of the regulation requires hospitals to have a discharge planning process in effect for “all” patients. However, the preamble to the adoption of this regulation on December 13, 1994 makes it clear that this “all patients” language was meant to distinguish the final rule from the proposed rule, which would have applied only to hospital inpatients who were Medicare beneficiaries. It was not intended to apply the discharge planning process to outpatients as well as inpatients. Specifically, the preamble stated, “Discharge planning presupposes hospital admission and section 9305(c) of OBRA ’86 specifically indicates that discharge planning follows hospitalization.” (59 FR at 64141, December 13, 1994). Accordingly, under the regulation, hospitals are required to have a discharge planning process that applies to all inpatients; discharge planning is not required for outpatients.

"For Information – Not Required/Not to be Cited"
--Hospitals might consider utilizing, on a voluntary basis, an abbreviated post-hospital planning process for certain categories of outpatients, such as patients discharged from observation services, from same day surgery (including invasive procedures – see the definition of surgery in the guidance for the surgical services CoP), and for certain categories of emergency department discharges. Given the increasing complexity of services offered in the outpatient setting, many of the same concerns for effective post-hospital care coordination arise as for inpatients.--

--Footnote: 11 Modifications to the Maryland Hospital Preventable Readmissions (MHPR) Draft Recommendations, Staff Report, Maryland Health Services Cost Review Commission, December 1, 2010, accessed via the agenda for the December 8, 2010 Commission meeting.--

The discharge planning CoP (and Section 1861(ee) of the Act on which the CoP is based) provides for a four-stage discharge planning process:
• Screening all inpatients to determine which ones are at risk of adverse health consequences post-discharge if they lack discharge planning;
• Evaluation of the post-discharge needs of inpatients identified in the first stage, or of inpatients who request an evaluation, or whose physician requests one;
• Development of a discharge plan if indicated by the evaluation or at the request of the patient’s physician; and
• Initiation of the implementation of the discharge plan prior to the discharge of an inpatient.
The hospital is required to specify in writing its discharge planning policies and procedures. The policies and procedures must address all of the requirements of 42 CFR 482.43(a) – 482.43(e). The hospital must take steps to assure that its discharge planning policies and procedures are implemented consistently.

"For Information – Not Required/Not to be Cited"
--It would be advisable for the hospital to develop its discharge planning policies and procedures with input from the hospital’s medical staff prior to review and approval by the governing body.
Hospitals are also encouraged to obtain input from:
• Other healthcare facilities and professionals who provide care to discharged patients, including but not limited to: nursing homes/skilled nursing facilities, home health agencies, primary care physicians and clinics, etc.; and
• Patients and patient advocacy groups.--
The discharge planning CoP specifically addresses the role of the patient, or the patient’s representative, by requiring the hospital to develop a discharge planning evaluation at the patient’s request, and to discuss the evaluation and plan with the patient. This is consistent with the regulations at 42 CFR 482.13(b)(1) & (2), that provide the patient has the right to participate in the development and implementation of his/her plan of care, and to make informed decisions regarding his/her care. Accordingly, hospitals must actively involve patients or their representatives throughout the discharge planning process. Further, the specific discharge planning evaluation requirement to assess a patient’s capability for post-discharge self-care requires the hospital, as needed, to actively solicit information not only from the patient or the patient’s representative, but also from family/friends/support persons.

"For Information – Not Required/Not to be Cited"
--If a patient exercises the right to refuse to participate in discharge planning or to implement a discharge plan, documentation of the refusal is recommended.--

A-0800 482.43(a) The hospital must identify at an early stage of hospitalization all patients who are likely to suffer adverse health consequences upon discharge if there is no adequate discharge planning.

Interpretive Guidelines §482.43(a)

"For Information – Not Required/Not to be Cited
--Given the high level of readmissions that hospitals experience, a hospital would be well advised to assume that every inpatient requires a discharge plan to reduce the risk of adverse health consequences post-discharge. Providing a discharge plan for every inpatient means the hospital avoids the problems that result if it utilizes a screening process that fails to predict adequately which patients need a discharge plan to avoid adverse consequences.
This does not mean that every discharge plan will be equally detailed or complex; some may be comparatively simple, for example, focusing on clear instructions for self-care for patients whose post-care needs may be readily met in their home environment. On the other hand,