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.

Nursing Services - 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.

Nursing Services - 482.23(b) Standard: Staffing and Delivery of Care

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.

Food and Dietetic Services - 482.28

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.

Food and Dietetic Services - 482.28(a) Standard: Organization

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-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.

Infection Control - 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.

Rehabilitative Services - 482.56(a) Standard: Organization and Staffing

A-1125 482.56(a)(1) - The director of the services must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services.

Interpretive Guidelines §482.56(a)(1)
Each service must be accountable to an individual that directs the overall hospital-wide operation of that service. An individual may serve as the director of a multi-service department or as director of single service departments.
The service director must demonstrate through education, experience, and/or specialized training that he/she has the necessary knowledge, experience and capabilities to properly supervise and administer the service(s).
The director may be part-time or full time. In all situations the director retains professional and administrative responsibility for personnel providing the service. If the director is part-time, the time spent directing the service should be appropriate to the scope of the services provided.

Rehabilitative Services - 482.56(b) Standard: Delivery of Services

A-1132 482.56(b) Delivery of Services
Services must only be provided under the orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under State law, and who is authorized by the hospital’s medical staff to order the services in accordance with hospital policies and procedures and State laws.

Interpretive Guidelines §482.56(b)
Rehabilitation services must be ordered by a qualified and licensed practitioner who is responsible for the care of the patient. The practitioner must have medical staff privileges to write orders for these services or, for outpatient services, if hospital policy permits acceptance of orders from outside practitioners, the practitioner’s order must meet the requirements at §482.54(c).
For practitioners who have medical staff privileges, such privileges must be granted in a manner consistent with the State’s scope of practice law, as well as with hospital policies and procedures governing rehabilitation services developed by the medical staff.
Practitioners who may be granted privileges to order rehabilitation services include physicians, and may also, in accordance with hospital policy, include Nurse Practitioners, Physicians’ Assistants, and Clinical Nurse Specialists as long as they meet the parameters of this requirement. Although the following licensed professionals are also considered “practitioners” in accordance with Section 1842(b)(18)(C) of the Social Security Act, they generally would not be considered responsible for the care of the patient with regard to rehabilitation services or qualified to order rehabilitation services: Certified registered nurse anesthetist (Section 1861(bb)(2) of the Act); Certified nurse-midwife (Section 1861(gg)(2) of the Act); Clinical social worker (Section 1861(hh)(1) of the Act); Clinical psychologist (for purposes of Section 1861(ii) of the Act and as defined at 42 CFR 410.71); or registered dietician or nutrition professional.

A-1134 482.56(b)(2) The provision of care and the personnel qualifications must be in accordance with national acceptable standards of practice and must also meet the requirements of §409.17 of this chapter.

Interpretive Guidelines §482.56(b)(2)
The provision of rehabilitation services care and development of the plan of care for rehabilitation services can be initiated only after the order is written for services by a qualified licensed practitioner responsible for the care of the patient. Physical therapy, occupational therapy, or speech-language pathology must be furnished under a plan of care. The regulation at 42 CFR 409.17 specifies the following rehabilitation services plan of care requirements:
Establishment of the plan: “The plan must be established before treatment begins by one of the following: (1) A physician. (2) A nurse practitioner, a clinical nurse specialist or a physician assistant. (3) The physical therapist furnishing the physical therapy services. (4) A speech-language pathologist furnishing the speech-language pathology services. (5) An occupational therapist furnishing the occupational therapy services.”
Content of the plan: “The plan: (1) Prescribes the type, amount, frequency, and duration of the physical therapy, occupational therapy, or speech-language pathology services to be furnished to the individual; and (2) Indicates the diagnosis and anticipated goals.”
Changes in the plan: “Any changes in the plan are implemented in accordance with hospital policies and procedures.”
Also in accordance with 42 CFR 409.17, rehabilitation services must be provided by qualified physical therapists, physical therapy assistants, occupational therapists, occupational therapy assistants, and/or speech-language pathologists who meet the personnel qualifications defined in 42 CFR 484.4. Hospitals must have policies and procedures consistent with State law.
Rehabilitation services must be provided according to national standards of practice as established by professional organizations such as, but not limited to, the American Physical Therapy Association, the American Occupational Therapy Association, and the American Speech-Language-Hearing Association.

B Tags - Psychiatric Hospitals Must:

B99 482.60(a) Be primarily engaged in providing, by or under the supervision of a doctor of medicine or osteopathy, psychiatric services for the diagnosis and treatment of mentally ill persons.

Guidance §482.60(a)
The hospital will be deemed to meet standard (a) if it meets standards (c) and (d).

B136 482.62 The hospital must have adequate numbers of qualified professional and supportive staff to evaluate patients, formulate written, individualized comprehensive treatment plans, provide active treatment measures and engage in discharge planning.

Guidance §482.62
The purpose of this Condition of Participation is to ensure that the psychiatric hospital is adequately staffed with qualified mental health professionals and supportive staff to carry out an intensive and comprehensive active treatment program and to protect and promote the physical and mental health of the patients.
Through observation, interview and record review determine if numbers and/or deployment of qualified staff is a concern. Review incident reports, medication error reports, patient and staff injury reports, for indications that staffing is an issue.
Adequate numbers are defined to mean the numbers, and deployment, of staff with qualifications to evaluate, plan, implement and document active treatment.
Do not look at numbers alone. The hospital is responsible for organizing its available staff and administrative duties along with patient appointments, treatment plan meetings, treatment sessions, activities, materials, equipment and patient assignments to wards and groups in such a way that results in patients achieving the maximum therapeutic benefit.

482.62(a) Standard: Personnel
482.62(a) The hospital must employ or undertake to provide adequate numbers of qualified professional, technical, and consultative personnel to:

B137 482.62(a)(1) Evaluate Patients

No information available.

B138 482.62(a)(2) Formulate written individualized, comprehensive treatment plans;

Guidance §482.62(a)(2)
Staffing must be sufficient so that members of the patient’s treatment team and others responsible for evaluation and assessment can contribute their respective data for consideration in the formulation of the treatment plan.

B139 482.62(a)(3) Provide active treatment measures;

Guidance §482.62(a)(3)
Active treatment occurs when the patient receives treatment interventions that are delivered under the direction of a physician, and which are specific to patient strengths, disabilities, and problems identified in the treatment plan. Treatment interventions and other services are furnished in accordance with accepted standards of professional practice. Although the active treatment process must be identifiable in documentation, it must be first and foremost observable and evident in daily practice.
Treatment interventions need to be individualized, in that the patient receives assistance with resolving or ameliorating the problems/circumstances that led to hospitalization. Expect to see treatment focused on the unique needs of individual patients. For example, several patients may be referred to “Anger Management Group,” but the focus of discussion and therapeutic intervention may differ depending on the individual patient’s particular issue regarding managing anger.
Whether structure must be imposed by staff or whether the patient can direct his or her own activities for periods of time (without staff supervision), is based on the patient’s ability to engage in constructive, appropriate behavior (without engaging in harm to self or others). Be certain that the patient’s time on the unit is maximized toward the further development of appropriate desired outcomes, including but not limited to leisure and recreation.

B140 482.62(a)(4) Engage in discharge planning;

Guidance §482.62(a)(4)
The patient together with all relevant professionals caring for the patient should be expected to participate in the discharge planning process. Staffing should be sufficient to facilitate this outcome, to the maximum extent possible.

482.62(b) Standard: Director of Inpatient Psychiatric Services; Medical Staff

B141 482.62(b) Inpatient psychiatric services must be under the supervision of a clinical director, service chief, or equivalent who is qualified to provide the leadership required for an intensive treatment program.

Guidance §482.62(b)
Inpatient psychiatric services include the following functions: admission interviews, assessments and evaluations; psychiatric and medical work-ups; treatment team leadership; medication management; on-call provision of emergency psychiatric and medical treatment; provision of individual, group and family therapies; provision of clinical supervision to other professionals and paraprofessionals; provision of medical and psychiatric educational workshops and conferences for all staff; and provision of consultation to staff for clinical and/or administrative matters.
The clinical director is ultimately responsible for the medical and psychiatric care that is provided to patients. The clinical director should ascertain that quality improvement programs are in place to monitor all areas of patient care, and should implement educational programs for all levels of staff.

B142 482.62(b) The number and qualifications of doctors of medicine and osteopathy must be adequate to provide essential psychiatric services.

Guidance §482.62(b)
The number of full-time, part-time and consulting staff, who are board certified within each category and their availability to the hospital must be adequate to provide psychiatric services, as described above. Adequacy is considered in light of the following:
1. Number of admissions, discharges and current patients by treatment units;
2. Size of the hospital;
3. Geographic proximity of the wards and units;
4. Organization and kinds of treatment services rendered to the patients;
5. Availability of the physician coverage on evening, nights and weekends;
6. Availability of physicians to participate in treatment planning;
7. Availability of psychiatrists to consult with non-psychiatric physicians about psychotropic medication regimens; and
8. Availability of physicians to consult with multi-disciplinary staff about treatment issues.

B143 482.62(b)(1) The clinical director, service chief or equivalent must meet the training and experience requirements for examination by the American Board of Psychiatry and Neurology, or the American Osteopathic Board of Neurology and Psychiatry.

Guidance §482.62(b)(1)
A physician is qualified to take the examinations for board certification upon successful completion of a psychiatric residency program approved by the American Board of Psychiatry and Neurology and/or the American Osteopathic Board of Psychiatry and Neurology.

B144 482.62(b)(2) The director must monitor and evaluate the quality and appropriateness of services and treatment provided by the medical staff.

Guidance §482.62(b)(2)
Services and treatment prescribed to patients must be in accordance with appropriate and acceptable standards of practice.
In states that allow psychologists to have admitting privileges, it is still the responsibility of the clinical director to oversee the quality of the patient’s treatment.

482.62(c) Standard Availability of Medical Personnel

B145 482.62(c) Doctors of medicine or osteopathy and other appropriate professional personnel must be available to provide necessary medical and surgical diagnostic and treatment services. If medical and surgical diagnostic services and treatment are not available within the institution, the institution must have an agreement with an outside source of these services to ensure that they are immediately available or a satisfactory agreement must be established for transferring patients to a general hospital that participates in the Medicare program.

Guidance §482.62(c)
Contracts or other arrangements with individuals and/or providers assure that medical and surgical services are available to meet the needs of the patients. Review the medical and surgical services provided by the hospital during the interview with the clinical director.
Discuss contract or arrangements with the clinical director for services provided off grounds.

482.62(d) Standard: Nursing Services

B146 482.62(d) The hospital or unit must have a qualified director of psychiatric nursing services. In addition to the director of nursing, there must be adequate numbers of registered nurses, licensed practical nurses, and mental health workers to provide nursing care necessary under each patient’s active treatment program and to maintain progress notes on each patient.

Guidance §482.62(d)
Psychiatric nursing functions may include the following: supervision of paraprofessional staff; assessment, planning, provision, and evaluation of psychiatric nursing care to patients; medication teaching; management of the therapeutic milieu; provision of mandatory and voluntary in-service training to all staff; and provision of specialized treatments and therapies, such as individual, group and family therapies, that require the clinical expertise of a professional psychiatric nurse.
Expect to see evidence of orientation programs as well as ongoing continuing education programs for Licensed Practical Nurses and mental health workers that stress individualized treatment interventions.
Determine that there is a qualified Director of Nursing (DON) providing the required leadership and supervision for the psychiatric nursing department.

B147 482.62(d)(1) The director of psychiatric nursing services must be a registered nurse who has a master’s degree in psychiatric or mental health nursing or its equivalent from a school of nursing accredited by the National League for Nursing, or be qualified by education and experience in the care of the mentally ill.

Guidance §482.62(d)(1)
During the interview with the DON, assess his/her educational background and psychiatric nursing and leadership skills. If the DON has less than a Master’s Degree in Psychiatric Nursing, expect to see evidence of experience and on-going training in psychiatric nursing. Documented consultation from a nurse with a Master’s in Psychiatric Nursing constitutes on-going training.

B148 482.62(d)(1) The director must demonstrate competence to participate in interdisciplinary formulation of individual treatment plans; to give skilled nursing care and therapy; and to direct, monitor, and evaluate the nursing care furnished

Guidance §482.62(d)(1)
Based on structured observations of the patients in the sample and other patients in the hospital, patient and staff interviews and medical record review, ascertain that nursing services are provided in accordance with safe, acceptable standards of nursing practice
Information obtained from the DON should include: implementation of continuous quality improvement programs; provision of orientation, in-service and continuing education programs for nursing personnel especially in the areas of psychiatric nursing, nursing process, prevention and management of violence, CPR and Universal Precautions.

B149 482.62(d)(2) The staffing pattern must ensure the availability of a registered nurse 24 hours each day.

No information available.

B150 482.62(d)(2) There must be adequate numbers of registered nurses, licensed practical nurses, and mental health workers to provide the nursing care necessary under each patient’s active treatment program.

Guidance §482.62(d)(2)
The evaluation of sufficient numbers and level of RNs, LPNs and mental health workers is based on the patient characteristics as seen in structured observations of patients in the sample and other patients in the hospital, patient interviews, and as evidenced in medical records and other data related to patients (e.g. incident reports, seclusion/restraint reports). Patient care assignments should be appropriate to the skills and qualifications of the nursing personnel providing patient care.
There should be evidence that all nursing personnel have education, experience and/or training in psychiatric care. Mental health workers spend the majority of their workday interacting with patients. Expect to see evidence that they are receiving on-going supervision and training. Mental health workers should be assigned patient care duties and therapeutic modalities that reflect their educational level, psychiatric training, and experience.

482.62(e) Standard Psychological Services

B151 482.62(e) The hospital must provide or have available psychological services to meet the needs of the patients.

Guidance §482.62(e)
Psychology services may include the following: diagnostic testing and diagnostic formulations on request from physicians; provision of individual, group and family therapies; participation in multi-disciplinary treatment conferences; and program development and evaluation.
The number of full-time, part-time and consulting psychologists must be adequate to provide necessary services to patients. Arrangements with outside resources must assure that necessary patient services will be provided.

482.62(f) Standard: Social Services

B152 482.62(f) There must be a director of social services who monitors and evaluates the quality and appropriateness of social services furnished.

Guidance §482.62(f)
Social work functions may include the following functions: Intake or admission screening, psychosocial assessment of a newly admitted patient; developing an update or detailed re-assessment of the patient; high-social risk case finding; contact with family and others significant in the patient’s life. Such functions may include patient and family education, support, and advocacy; providing coordination/liaison with community-based social and mental health agency(ies) regarding the pre-admission status of the patient; participating as a member of the treatment team in development of treatment planning and subsequent planned interventions (modalities). Such modalities may include supportive, individual, couple, family, or group therapy, aimed at meeting specified goals identified in the treatment plan.
Continuity of care is an important social work principle and may be demonstrated through case management and a major role in discharge planning. Activities, in conjunction with the patient wishes, may include contact with patient’s family, identifying and assisting in referral of the patient to community-based agency(ies) at the time of discharge. Finally, post-discharge follow-up may be done to assure that linkage of the patient with community resources has occurred to reduce re-hospitalization.
Determine who completed the assessment required by §482.61(a)(4) and initiated preliminary discharge planning. When staff other than a Social Worker perform these duties, the Director of Social Work or a Master’s level social worker (MSW) qualified supervisory staff member should be involved to oversee the quality and appropriateness of service provided.
Patient and staff interviews, structured observations and review of selected medical records yield the information necessary to determine how well social work has met the needs of the patients. The surveyor should evaluate these data to determine adequacy of qualified and support staff deployed to patient areas and their duties.
The social work policies for service provision to the patient should describe: the organizational structure of the department (program) and the range of services performed by the department.

B153 482.62(f) The services must be furnished in accordance with accepted standards of practice and established policies and procedures.

Guidance §482.62(f)
Accepted standards of practice are based on policy statements adopted by the National Association of Social Workers and a definition of social work practice in health care adapted by the Consortium of Health Care Social Work Organizations. Staff should adhere to the facility’s personnel requirements.

B154 482.62(f)(1) The director of the social work department or service must have a master’s degree from an accredited school of social work or must be qualified by education and experience in the social services needs of the mentally ill. If the director does not hold a master’s degree in social work, at least one staff member must have this qualification.

Guidance §482.62(f)(1)
The duties, functions, and responsibilities of the director of social services/social work should be clearly delineated and documented in the facility’s policies and procedures. If the director is not MSW qualified and at least one staff member is MSW qualified, verify the duties, functions, and responsibilities of the MSW.

B155 482.62(f)(2) Social service staff responsibilities must include, but are not limited to, participating in discharge, planning, arranging for follow-up care, and developing mechanisms for exchange of appropriate information with sources outside the hospital.

Guidance §482.62(f)(2)
Social work contact with the patient, family, and significant others should occur during, or as soon as possible, after the admission. High-risk case finding should result in significant data being available for early integration into the treatment plan and subsequent social work action as indicated. The treatment team should consider, for possible inclusion into the patient’s treatment plan, the anticipated social work role and expected interventions as recommended in the psychosocial assessment . Treatment and discharge planning activities, liaison/follow-up efforts should be based upon the goals, including discharge goals, and staff responsibilities specified in the treatment plan.

482.62(g) Standard: Therapeutic Activities

B156 482.62(g) The hospital must provide a therapeutic activities program.

Guidance §482.62(g)
A variety of therapeutic and rehabilitative activities are selectively used as therapeutic tools in providing active treatment to the psychiatric patients. Therapeutic activities focus upon the development and maintenance of adaptive skills that will improve the patient’s functioning. In contrast, leisure activities provide the patient with individualized opportunities to acquire knowledge, skills and attitudes about meaningful leisure involvement and experiences. A patient may need treatment and/or remediation of functional behavior(s) prior to leisure involvement. However, for some psychiatric patients the priority need may be for leisure education and activities.

B157 482.62(g)(1) The program must be appropriate to the needs and interests of patients and be directed toward restoring and maintaining optimal levels of physical and psychosocial functioning.

Guidance §482.62(g)(1)
The hospital is responsible for ensuring consistent availability and provision of individualized therapeutic activities and rehabilitative services based on patient needs.
The selection of individualized therapeutic and rehabilitative staff modalities should be based on patient need and goals set in the patient’s treatment plan. Rehabilitative services may include educational, occupational, recreational, physical, art, dance, music, and speech therapies and vocational rehabilitation evaluation and counseling. There are other disciplines that also serve paients. Consultants include but are not limited to the following: educational instructors, registered occupational therapist/certified occupational therapy assistant, certified therapeutic recreation specialist, certified therapeutic recreation assistant, speech-language pathologist has certificate of clinical competence, registered and certified music therapist, registered art therapist, and registered physical therapist. The qualified vocational specialist may perform duties of a rehabilitation counselor, vocational evaluator, or the work adjustment specialist.

B158 482.62(g)(2) The number of qualified therapists, support personnel, and consultants must be adequate to provide comprehensive therapeutic activities consistent with each patient’s active treatment program.

Guidance §482.62(g)(2)
Qualified staff should complete their respective discipline assessments for use in multidisciplinary treatment planning. Specific role(s) and modalities to be implemented by rehabilitative staff must be determined by goals set in the patient’s treatment plan.
Qualified therapists who provide clinical services and administrative staff should utilize established monitoring and evaluation mechanisms to conduct consistent timely review of the quality and appropriateness of therapeutic and rehabilitative services delivered to patients.

Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things, workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to determine if the use of such checklist is permissible in your workplace or jurisdiction.