§482.11 Condition of Participation: Compliance with Federal, State and Local Laws

§482.11(a) The hospital must be in compliance with applicable Federal laws related to the health and safety of patients.

§482.11(b) The hospital must be (1) Licensed; or (2) Approved as meeting standards for licensing established by the agency of the State or locality responsible for licensing hospitals.

§482.11(c) The hospital must assure that personnel are licensed or meet other applicable standards that are required by State or local laws.

§482.12 Condition of Participation: Governing Body

Verify that the hospital has an organized governing body or has written documentation that identifies the individual or individuals that are responsible for the conduct of the hospital operations.

If the hospital is part of a hospital system which uses one governing body for several of the hospital’s separately certified within the system: Review the governing body minutes to determine if it is clear which actions pertain to which hospitals.

If the hospital is part of a hospital system which uses one governing body for several of the hospital’s separately certified within the system: Select for review several policy and procedure documents adopted by the system governing body to determine if it is clear that they apply to the hospital being surveyed.

§482.12(a) Standard: Medical Staff.

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

§482.12(a)(2) The governing body must: Appoint members of the medical staff after considering the recommendations of the existing members of the medical staff;

§482.12(a)(3) The governing body must:Assure that the medical staff has bylaws

§482.12(a)(4) The governing body must: Approve medical staff bylaws and other medical staff rules and regulations;

§482.12(a)(5) The governing body must: Ensure that the medical staff is accountable to the governing body for the quality of care provided to patients;

§482.12(a)(6) The governing body must: Ensure the criteria for selection are individual character, competence, training, experience, and judgment;

§482.12(a)(7) The governing body must: 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.

§482.12(a)(8) The governing body must: 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) The governing body must: 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.

§482.12(a)(10) The governing body must: 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).

§482.12(b) Standard: Chief Executive Officer

The governing body must appoint a chief executive officer who is responsible for managing the hospital.

§482.12(c) Standard: Care of Patients

§482.12(c)(1) The governing body must ensure that: 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; (ii)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

§482.12(c)(2) The governing body must ensure that: Patients are admitted to the hospital only on the recommendation of a licensed practitioner permitted by the State to admit patients to a hospital. 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.

§482.12(c)(3) The governing body must ensure that: A doctor of medicine or osteopathy is on duty or on call at all times

§482.12(c)(4) The governing body must ensure that: 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

§482.12(d) Standard: Institutional Plan and Budget

§482.12(d)(1) The plan must include an annual operating budget that is prepared according to generally accepted accounting principles.

§482.12(d)(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.

§482.12(d)(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.

§482.12(d)(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

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.) 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.

§482.12(d)(6) The plan must be reviewed and updated annually

§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.

§482.12(e) Standard: Contracted Services

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

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

§482.12(f) Standard: Emergency Services

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).

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

§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.

§482.13 Condition of Participation: Patient's Rights

A hospital must protect and promote each patient’s rights.

§482.13(a) Standard: Notice of Rights

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

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

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

[The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The hospital’s governing body must approve and be responsible for the effective operation of the

grievance process, and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee.] The grievance process must include a mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the appropriate Utilization and Quality Control Quality Improvement Organization.

At a minimum: §482.13(a)(2)(i) The hospital must establish a clearly explained procedure for the submission of a patient’s written or verbal grievance to the hospital.

At a minimum: §482.13(a)(2)(ii) The grievance process must specify time frames for review of the grievance and the provision of a response.

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

§482.13(b) Standard: Exercise of Rights

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

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

§482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this

part (Requirements for providers), and §489.104 of this part (Effective dates).

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

§482.13(c) Standard: Privacy and Safety

In order to provide care in a safe setting, hospitals must identify patients at risk for intentional harm to self or others, identify environmental safety risks for such patients, and provide education and training for staff and volunteers. That includes: identifying patients at risk; environmental safety risks, education and training, and correction of environmental risks.

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

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

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

§482.13(d) Standard: Confidentiality of Patient Records

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

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

§482.13(e) Standard: Restraint or seclusion

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

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

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

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

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

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

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

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

§482.13(e)(4)(ii) -The use of restraint or seclusion must be implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law.§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §481.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law.

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

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

§482.13(e)(8) - Unless superseded by State law that is more restrictive -- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1 hour for children under 9 years of age;§482.13(e)(8)(ii) - After 24 hours, before writing a new order for the use of restraint or seclusion for the management of violent or self-destructive behavior, a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §482.12(c) of this part and authorized to order restraint or seclusion by hospital policy in accordance with State law must see and assess the patient.

§482.13(e)(8)(iii) - Each order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient may be renewed as authorized by hospital policy.

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

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

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

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

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

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

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

§482.13(e)(15) - All requirements specified under this paragraph are applicable to the simultaneous use of restraint and seclusion. Simultaneous restraint and seclusion use is only permitted if the patient is continually monitored – (i) Face-to-face by an assigned, trained staff member; or (ii) By trained staff using both video and audio equipment. This monitoring must be in close proximity to the patient.§482.13(e)(16) -When restraint or seclusion is used, there must be documentation in the patient's medical record of the following: (i) The 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior; (ii) - A description of the patient's behavior and the intervention used. (iii) - Alternatives or other less restrictive interventions attempted (as applicable). (iv) - The patient's condition or symptom(s) that warranted the use of the restraint or seclusion. (v) - The patient's response to the intervention(s) used, including the rationale for continued use of the intervention.

§482.13(f) Standard: Restraint or seclusion: Staff training

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

§482.13(f)(2) Training Content. - The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following: (i) Techniques to identify staff and patient behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion.

[The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:] §482.13(f)(2)(ii) - The use of nonphysical intervention skills.demonstrated knowledge based on the specific needs of the patient population in at least the following:] §482.13(f)(2)(iii) - Choosing the least restrictive intervention based on an individualized assessment of the patient's medical, or behavioral status or condition

[The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:] §482.13(f)(2)(iv) - The safe application and use of all types of restraint or seclusion used in the hospital, including training in how to recognize and respond to signs of physical and psychological distress (for example, positional asphyxia).

[The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:] §482.13(f)(2)(v) - Clinical identification of specific behavioral changes that indicate that restraint or seclusion is no longer necessary.

[The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:] §482.13(f)(2)(vi) - Monitoring the physical and psychological well-being of the patient who is restrained or secluded, including but not limited to, respiratory and circulatory status, skin integrity, vital signs, and any special requirements specified by hospital policy associated with the 1-hour face-to-face evaluation.

[The hospital must require appropriate staff to have education, training, and demonstrated knowledge based on the specific needs of the patient population in at least the following:] §482.13(f)(2)(vii) - The use of first aid techniques and certification in the use of cardiopulmonary resuscitation, including required periodic recertification.

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

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

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

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

(2) When no seclusion has been used and when the only restraints used on the patient are those applied exclusively to the patient’s wrist(s), and which are composed solely of soft, non-rigid, cloth-like materials, the hospital staff must record in an internal log or other system, the following information:

(i) Any death that occurs while a patient is in such restraints.

(ii) Any death that occurs within 24 hours after a patient has been removed from such restraints.

(3) [The staff must document in the patient’s medical record the date and time the death was:]

(ii) Recorded in the internal log or other system for deaths described in paragraph (g)(2) of this section.

(4) For deaths described in paragraph (g)(2) of this section, entries into the log or other system must be documented as follows:

(i) Each entry must be made not later than seven days after the date of death of the patient.

(ii) Each entry must document the patient’s name, date of birth, date of death, name of attending physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §482.12(c), medical record number, and primary diagnosis(es).

(iii) The information must be made available in either written or electronic form to CMS immediately upon request.

§482.13(h) Standard: Patient visitation rights.

A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation. A hospital must meet the following requirements: (1) Inform each patient (or support person, where appropriate) of his or her visitation rights, including any clinical restriction or limitation on such rights, when he or she is informed of his or her other rights under this section. (2) Inform each patient (or support person, where appropriate) of the right, subject to his or her consent, to receive the visitors whom he or she designates, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and his or her right to withdraw or deny such consent at any time.

§482.13(h) Standard: Patient visitation rights. A hospital must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital may need to place on such rights and the reasons for the clinical restriction or limitation. A hospital must meet the following requirements: (3) Not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, or disability. (4) Ensure that all visitors enjoy full and equal visitation privileges consistent with patient preferences.

§482.21 Condition of Participation: Quality Assessment and Performance Improvement Program

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

§482.21(a) Standard: Program Scope

(1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will improve health outcomes

2) The hospital must measure, analyze, and track quality indicators…and other aspects of performance that assess processes of care, hospital service and operations

The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will … identify and reduce medical errors.

The hospital must measure, analyze, and track…adverse patient events….

482.21(b) Standard: Program Data

(1) The program must incorporate quality indicator data including patient care data, and other relevant data, for example, information submitted to, or received from, the hospital’s Quality Improvement Organization

(2) The hospital must use the data collected to-- (i) Monitor the effectiveness and safety of services and quality of care; and (ii) Identify opportunities for improvement and changes that will lead to improvement.

(3) The frequency and detail of data collection must be specified by the hospital’s governing body.

§482.21(c) Standard: Program Activities

(1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care.

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

§482.21(d) Standard: Performance Improvement Projects.

(1) The number and scope of distinct improvement projects conducted annually must be proportional to the scope and complexity of the hospital’s services and operations.

(2) A hospital may, as one of its projects, develop and implement an information technology system explicitly designed to improve patient safety and quality of care. This project, in its initial stage of development, does not need to demonstrate measurable improvement in indicators related to health outcomes.

(3) The hospital must document what quality improvement projects are being conducted, the reasons for conducting these projects, and the measurable progress achieved on these projects.

(4) A hospital is not required to participate in a QIO cooperative project, but its own projects are required to be of comparable effort.

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

§482.21(e) Standard: Executive Responsibilities - The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following:

(1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained.

(2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated…

(4) That adequate resources are allocated for measuring, assessing, improving, and sustaining the hospital’s performance and reducing risk to patients.

(5) That the determination of the number of distinct improvement projects is conducted annually.

§482.22 Condition of Participation: Medical Staff

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

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

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

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

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

§482.22(a)(3) When telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site hospital, the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the distant-site hospital when making recommendations on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital’s governing body ensures, through its written agreement with the distant-site hospital, that all of the following provisions are met:

(i) The distant-site hospital providing the telemedicine services is a Medicare-participating hospital.

(ii) The individual distant-site physician or practitioner is privileged at the distant-site hospital providing the telemedicine services, which provides a current list of the distant-site physician’s or practitioner’s privileges at the distant-site hospital.(iii) The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the hospital whose patients are receiving the telemedicine services is located.

(iv) With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician’s or practitioner’s performance of these privileges and sends the distant-site hospital such performance information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital’s patients and all complaints the hospital has received about the distant-site physician or practitioner.

§482.22(a)(4) When telemedicine services are furnished to the hospital’s patients through an agreement with a distant-site telemedicine entity, the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the distant- site telemedicine entity when making recommendations on privileges for the individual distant-site physicians and practitioners providing such services, if the hospital’s governing body ensures, through its written agreement with the distant-site telemedicine entity, that the distant-site telemedicine entity furnishes services that, in accordance with §482.12(e), permit the hospital to comply with all applicable conditions of participation for the contracted services. The hospital’s governing body must also ensure, through its written agreement with the distant-site telemedicine entity, that all of the following provisions are met:

(i) The distant-site telemedicine entity’s medical staff credentialing and privileging process and standards at least meet the standards at §482.12(a)(1) through (a)(7) and §482.22(a)(1) through (a)(2).

(ii) The individual distant-site physician or practitioner is privileged at the distant-site telemedicine entity providing the telemedicine services, which provides the hospital with a current list of the distant-site physician’s or practitioner’s privileges at the distant-site telemedicine entity.

(iii) The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the hospital whose patients are receiving such telemedicine services is located.

(iv) With respect to a distant-site physician or practitioner, who holds current privileges at the hospital whose patients are receiving the telemedicine services, the hospital has evidence of an internal review of the distant-site physician’s or practitioner’s performance of these privileges and sends the distant-site telemedicine entity such performance information for use in the periodic appraisal of the distant-site physician or practitioner. At a minimum, this information must include all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital’s patients, and all complaints the hospital has received about the distant-site physician or practitioner

§482.22(b) Standard: Medical Staff Organization and Accountability

The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients.

(1) The medical staff must be organized in a manner approved by the governing body.

(2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy.

(3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located

§482.22(b)(4) - If a hospital is part of a hospital system consisting of multiple separately certified hospitals and the system elects to have a unified and integrated medical staff for its member hospitals, after determining that such a decision is in accordance with all applicable State and local laws, each separately certified hospital must demonstrate that:….(i) The medical staff members of each separately certified hospital in the system (that is, all medical staff members who hold specific privileges to practice at that hospital) have voted by majority, in accordance with medical staff bylaws, either to accept a unified and integrated medical staff structure or to opt out of such a structure and to maintain a separate and distinct medical staff for their respective hospital;

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

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

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

§482.22(c) Standard: Medical Staff Bylaws

The medical staff must adopt and enforce bylaws to carry out its responsibilities.

[The bylaws must:] §482.22(c)(1) - Be approved by the governing body.

[The bylaws must:]§482.22(c)(2) - Include a statement of the duties and privileges of each category of medical staff (e.g., active, courtesy, etc.)

[The bylaws must:] §482.22(c)(3) - Describe the organization of the medical staff.

[The bylaws must:] §482.22(c)(4) - Describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body.

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

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

§482.22(d) Standard: Autopsies

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

§482.23 Condition of Participation: Nursing Services

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

The nursing service must be integrated into the hospital-wide QAPI program.

§482.23(a) Standard: Organization

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.

The hospital may have only one nursing service hospital-wide and the single nursing service must be under the direction of one RN.

§482.23(b) Standard: Staffing and Delivery of Care

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

There must be a RN physically present on the premises and on duty at all times. Every inpatient unit/department/location within the hospital-wide nursing service must have adequate numbers of RNs physically present at each location to ensure the immediate availability of a RN for the bedside care of any patient.

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

§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.

§482.23(b)(3) - A registered nurse must supervise and evaluate the nursing care for each patient.§482.23(b)(4) - The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient. The nursing care plan may be part of an interdisciplinary care plan.

§482.23(b)(4)The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient. The nursing care plan may be part of an interdisciplinary care plan. Each care plan should include the following components:

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

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

The hospital and the director of the nursing service are responsible for the clinical activities of all nursing personnel. This would include the clinical activities of all non-employee nursing personnel (contract or volunteer).

The hospital and the director of the nursing service ensure that each non-employee nursing care staff person is adequately supervised and that their clinical activities are evaluated. This supervision and evaluation of the clinical activities of each non-employee nursing staff person must be conducted by an appropriately qualified hospital-employed RN.

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

(1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice

(i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations

(2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures

The hospital’s policies and procedures must reflect accepted standards of practice that require the following be confirmed prior to each administration of medication (often referred to as the “five rights” of medication administration practice):

482.23(c)(1) (ii)– Drugs and biologicals may be prepared and administered on the orders contained within pre-printed and electronic standing orders, order sets, and protocols for patient orders only if such orders meet the requirements of §482.24(c)(3)

Nurses commonly prepare sterile medications that are categorized by USP <797> as “immediate-use CSPs,” which are needed for immediate or emergency use for a particular patient and are not to be stored for anticipated needs. The following USP <797> standards apply when preparing an immediate-use CSP:

the CSP must be labeled with at least:

A drug or biological is also outdated after its “beyond-use date” (BUD), which may be reached before the expiration date, but never later. The BUD is the date and time after which the medication must not be used, stored or transported. The BUD takes into account the specific conditions and potential for deterioration and microbial growth that may occur during or after the original container is opened, while preparing the medication for dispensing and administration, and/or during the compounding process if it is a compounded medication.

Timing of Medication Administration - hospital policies and procedures must specifically address the timing of medication administration, based on the nature of the medication and its clinical application, to ensure safe and timely administration. The policies and procedures must address at least the following:
• Medications not eligible for scheduled dosing times;
• Medications eligible for scheduled dosing times;
• Administration of eligible medications outside of their scheduled dosing times and windows; and
• Evaluation of medication administration timing policies, including adherence to them.

Medications that hospitals may choose to identify as not eligible for scheduled dosing times may include, but are not limited to:
• Stat doses (immediate);
• First time or loading doses (initial large dose of a drug given to bring blood, tissue or fluid levels to an effective concentration quickly);
• One-time doses; doses specifically timed for procedures;
• Time-sequenced doses; doses timed for serum drug levels;
• Investigational drugs; or
• Drugs prescribed on an as needed basis (prn doses).

Policies and procedures for medications eligible for scheduled dosing times must also address: first dose medications, including parameters within which nursing staff are allowed to use their own judgment regarding the timing of the first and subsequent doses, which may fall between scheduled dosing times; retiming of missed or omitted doses; medications that will not follow scheduled dosing times; and patient units that are not subject to following the scheduled dosing times.

scheduled medications identified under the hospital’s policies and procedures as time-critical must be administered within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour. Examples of time-critical scheduled medications/medication types may include, but are not limited to:
• Antibiotics;
• Anticoagulants;
• Insulin;
• Anticonvulsants;
• Immunosuppressive agents;
• Pain medication (non-IV);
• Medications prescribed for administration within a specified period of time of the medication order;
• Medications that must be administered apart from other medications for optimal therapeutic effect; or
• Medications prescribed more frequently than every 4 hours.

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

Missed or late administration of medications - The hospital’s policies and procedures must address the actions to be taken when medications eligible for scheduled dosing times are not administered within their permitted window of time. This includes doses which may have been missed due to the patient being temporarily away from the nursing unit, for example, for tests or procedures; patient refusal; patient inability to take the medication; problems related to medication availability; or other reasons that result in missed or late dose administration.

Policies and procedures must also outline guidelines for the administration and timing of new medications which are initiated between standardized dosing times.

These policies and procedures must identify parameters within which nursing staff are allowed to use their own judgment regarding the rescheduling of missed or late doses and when notification of the physician or other practitioner responsible for the care of the patient is required prior doing so.

The reporting of medication errors that are the result of missed or late dose administration must be reported to the attending physician in accordance with requirements at §482.25(b)(6). See interpretive guidance at §482.25(b)(6) for more details on internal reporting requirements

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

Assessment/Monitoring of Patients Receiving Medications - Depending on the medication and route/delivery mode, monitoring may need to include assessment of:
• Clinical and laboratory data to evaluate the efficacy of medication therapy, to anticipate or evaluate toxicity and adverse effects. For some medications, including opioids, this may include clinical data such as respiratory status, blood pressure, and oxygenation and carbon dioxide levels;
• Physical signs and clinical symptoms relevant to the patient’s medication therapy, including but not limited to, somnolence, confusion, agitation, unsteady gait, pruritus, etc.

certain factors place some patients at greater risk for adverse effects of medication. Factors including, but not limited to, age, altered liver and kidney function, a history of sleep apnea, patient weight (obesity may increase apnea or smaller patients may be more sensitive to dose levels of medications), asthma, history of smoking, drug-drug interactions, and first-time medication use may contribute to increased risk.

Adverse patient reactions, such as anaphylaxis or opioid-induced respiratory depression, require timely and appropriate intervention, per established hospital protocols, and must also be reported immediately to the practitioner responsible for the care of the patient.

Hospital policies and procedures are expected to address how the manner and frequency of monitoring, considering patient and drug risk factors, are determined, as well as the information to be communicated at shift changes, including the hospital’s requirements for the method(s) of communication.

§482.23(c)(3) - With the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy after an assessment of contraindications, orders for drugs and biologicals must be documented and signed by a practitioner who is authorized to write orders in accordance with State law and hospital policy, and who is responsible for the care of the patient as specified under §482.12(c)…

§482.23(c)(3)(iii) Orders for drugs and biologicals may be documented and signed by other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations

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

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

§482.23(c)(4) - Blood transfusions and intravenous medications must be

administered in accordance with State law and approved medical staff policies and procedures.Hospital policies and procedures for blood transfusions and IV medications must be based on accepted standards of practice, and must address at least the following:Vascular Access Route, Other Patient Safety Practices, Patient Monitoring, Monitoring for Fluid & Electrolyte Balance, Monitoring Patients Receiving High-alert Medications, Including IV Opioids.

At a minimum, hospitals are expected to address monitoring for over-sedation and respiratory depression related to IV opioids for post-operative patients (• Snoring or history of sleep apnea, • No recent opioid use or first-time use of IV opioids, • Increased opioid dose requirement or opioid habituation, • Longer length of time receiving general anesthesia during surgery, • Receiving other sedating drugs, such as benzodiazepines, antihistamines, sedatives, or other central nervous system depressants, • Preexisting pulmonary or cardiac disease, and • Thoracic or other surgical incisions that may impair breathing.

Of particular concern are patients receiving IV opioids post-operatively. The effects of IV opioids in post-operative patients must be monitored vigilantly via serial assessments of pain, respiratory status, and sedation levels.

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

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

The hospital must have policies and procedures in place for the internal reporting of transfusion reactions. The policies must include procedures for reporting transfusion reactions immediately to the practitioner responsible for the care of the patient. The transfusion reaction must also be reported to the hospital-wide quality assessment performance improvement program as an adverse event, in accordance with the QAPI CoP at 42 CFR 482.21(c)(2). The transfusion reaction must be documented in the patient’s medical record, including the prompt notification of the responsible practitioner.

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

If the hospital allows a patient to self-administer specific hospital-issued medications, then the hospital must have policies and procedures in place to:

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

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

§482.24 Condition of Participation: Medical Record Services

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

§482.24(a) Standard: Organization and Staffing

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

§482.24(b) Standard: Form and Retention of Record

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

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

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

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

§482.24(c) Standard: Content of Record

The medical record must contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient’s progress and response to medications and services.

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

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

§482.24(c) (3) Hospitals may use pre-printed and electronic standing orders, order sets, and protocols for patient orders only if the hospital: (i) Establishes that such orders and protocols have been reviewed and approved by the medical staff and the hospital’s nursing and pharmacy leadership;

(ii) Demonstrates that such orders and protocols are consistent with nationally recognized and evidence-based guidelines;

(iii) Ensures that the periodic and regular review of such orders and protocols is conducted by the medical staff and the hospital’s nursing and pharmacy leadership to determine the continuing usefulness and safety of the orders and protocols; and

(iv) Ensures that such orders and protocols are dated, timed, and authenticated promptly in the patient’s medical record by the ordering practitioner or another practitioner responsible for the care of the patient only if such a practitioner is acting in accordance with State law, including scope-of-practice laws, hospital policies, and medical staff bylaws, rules, and regulations.

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

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

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

482.24(c)(4) - [All records must document the following, as appropriate: (i) Evidence of --] (B) An updated examination of the patient, including any changes in the patient’s condition, when the medical history and physical examination are completed within 30 days before admission or registration. Documentation of the updated examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.

[All records must document the following, as appropriate:] §482.24(c)(4)(ii) - Admitting diagnosis.

[All records must document the following, as appropriate:] §482.24(c)(4)(iii) - Results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient.

[All records must document the following, as appropriate:] §482.24(c)(4)(iv) - Documentation of complications, hospital acquired infections, and unfavorable reactions to drugs and anesthesia.

[All records must document the following, as appropriate:] §482.24(c)(4)(v) - Properly executed informed consent forms for procedures and treatments specified by the medical staff, or by Federal or State law if applicable, to require written patient consent.

[All records must document the following, as appropriate:] §482.24(c)(4)(vi) - All practitioners’ orders, nursing notes, reports of treatment, medication records, radiology, and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition.

[All records must document the following, as appropriate:] §482.24(c)(4)(vii) - Discharge summary with outcome of hospitalization, disposition of case, and provisions for follow-up care.

[All records must document the following, as appropriate:] §482.24(c)(4)(viii) - Final diagnosis with completion of medical records within 30 days following discharge.

§482.25 Condition of Participation: Pharmaceutical Services.

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

The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.]

The hospital…. must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision

§482.25(a) Standard: Pharmacy Management and Administration

The pharmacy or drug storage area must be administered in accordance with accepted professional principles.

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

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

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

§482.25(b) Standard: Delivery of Services

In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law.

The hospital must have a process in place for medication orders to be received in the pharmacy and dispensed in a safe and timely manner. Safe dispensing of medications must be in accordance with accepted standards of practice and includes, but is not limited to, the following:
This review should include:

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

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

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

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

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

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

§482.25(b)(5) - Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff.§482.25(b)(6) - Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’s quality assessment and performance improvement program .

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

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

§482.25(b)(9) - A formulary system must be established by the medical staff to

assure quality pharmaceuticals at reasonable costs.

§482.26 Condition of Participation: Radiologic Services

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

§482.26(a) Standard: Radiologic Services

The hospital must maintain, or have available, radiologic services according to the needs of the patients.

Mandatory and Optional Radiologic Services - The hospital must maintain, or have available, diagnostic radiological services according to the needs of the volume and types of patients the hospital serves. “Maintain” in this context means furnishing radiologic services on-site, while having them available means providing access to radiologic services even when they are not furnished on-site.

A hospital’s diagnostic radiologic services must be maintained or available at all times.

§482.26(b) Standard: Safety for Patients and Personnel

If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications.]

The radiologic services, particularly ionizing radiology procedures, must be free from hazards for patients and personnel.

Written protocols developed or approved by the radiologist responsible for the radiologic services, in conjunction with other qualified radiologic services personnel (e.g., a medical physicist, radiologic technologists, patient safety officers, etc.) designed to ensure that diagnostic studies and therapeutic procedures are routinely performed in a safe manner, utilizing parameters and specifications that are appropriate to the ordered study/procedure. The hospital must ensure that protocols for the various types of ionizing radiation diagnostic or therapeutic imaging modalities are designed to minimize the amount of radiation while maximizing the yield and producing diagnostically acceptable image quality. Existing protocols must be reviewed periodically and updated as needed. The rationale and details for changes to technical parameters must be documented.

Policies and protocols to identify patients at high risk for adverse events for whom the radiologic study or procedure might be contraindicated, e.g., pregnant women, individuals with known allergies to contrast agents, individuals with implanted devices, etc. Policies would address the steps to be taken, and by which personnel, if an order is written for a radiologic study or procedure for an individual identified in the radiologic services policies as potentially at high risk (e.g., notify the ordering physician, cancel the procedure personally, etc.).

Specific requirements related to procedures to mitigate radiation hazards are discussed in the guidance for §482.26(b)(1).

Procedures to address risks associated with modalities that do not use ionizing radiation.

Training required by personnel permitted to enter areas where radiologic services are provided.

Training and, as applicable, qualifications, required for personnel who perform diagnostic imaging studies or therapeutic procedures utilizing radiologic services equipment. This includes proper operation of equipment per manufacturer’s instructions and hospital policy.

Areas where radiologic services are provided must be equipped with the necessary equipment or materials to immediately respond to potential adverse events. This could include, but is not limited to, things like a crash cart, emergency stop mechanisms, cleaning and decontamination agents if applicable, etc.

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

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

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

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

§482.26(c) – Standard: Personnel

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

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

§482.26(d) Standard: Records

Records of radiologic services must be maintained.

(1) - The radiologist or other practitioner who performs radiology services must sign reports of his or her interpretations.

(2) - The hospital must maintain the following for at least 5 years: (i) Copies of reports and printouts. (ii) Films, scans, and other image records, as appropriate.

§482.27 Condition of Participation: Laboratory Services

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

§482.27(a) Standard: - Adequacy of Laboratory Services

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

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

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

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

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

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

Potentially human immunodeficiency virus (HIV) infectious blood and blood components. Potentially HIV infectious blood and blood components are prior collections from a donor – (i) Who tested negative at the time of donation but tests reactive for evidence of HIV infection on a later donation; (ii) Who tests positive on the supplemental (additional, more specific) test or other follow-up testing required by FDA; and (iii) For whom the timing of seroconversion cannot be precisely estimated.

(2) Potentially hepatitis C virus (HCV) infectious blood and blood components. Potentially HCV infectious blood and blood components are the blood and blood components identified in 21 CFR 610.47.

(3) Services furnished by an outside blood collecting establishment. If a hospital regularly uses the services of an outside blood collecting establishment, it must have an agreement with the blood collecting establishment that governs the procurement, transfer, and availability of blood and blood components. The agreement must require that the blood collecting establishment notify the hospital -- (i) Within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; (ii) Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA; (iii)Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available, as set forth at 21 CFR 610.48(b)(3).

(4) Quarantine of blood and blood components pending completion of testing. If the blood collecting establishment (either internal or under an agreement) notifies the hospital of the reactive HIV or HCV screening test results, the hospital must determine the disposition of the blood or blood component and quarantine all blood and blood components from previous donations in inventory.

(i) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is negative, absent other informative test results, the hospital may release the blood and blood components from quarantine. (ii) If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is positive, the hospital must – (A) Dispose of the blood and blood components; and (B) Notify the transfusion recipients as set forth in paragraph (b)(6) of this section. (iii)If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is indeterminate, the hospital must destroy or label prior collections of blood or blood components held in quarantine as set forth at 21 CFR 610.46(b)(2), 610.47(b)(2), and 610.48(c)(2).

(5) Recordkeeping by the hospital. The hospital must maintain -- (i) Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and (ii) A fully funded plan to transfer these records to another hospital or other entity if such hospital ceases operation for any reason.

(6) Patient notification. If the hospital has administered potentially HIV or HCV infectious blood or blood components (either directly through its own blood collecting establishment or under an agreement) or released such blood or blood components to another entity or appropriate individual, the hospital must take the following actions: (i) Make reasonable attempts to notify the patient, or to notify the attending physician who ordered the blood or blood component and ask the physician to notify the patient, or other individual as permitted under paragraph (b)(10) of this section, that potentially HIV or HCV infectious blood or blood components were transfused to the patient and that there may be a need for HIV or HCV testing and counseling. (ii) If the physician is unavailable or declines to make the notification, make reasonable attempts to give this notification to the patient, legal guardian or relative. (iii)Document in the patient’s medical record the notification or attempts to give the required notification.

(7) Time frame for notification. i) For donors tested on or after February 20, 2008. For notifications resulting from donors tested on or after February 20, 2008 as set forth at 21 CFR 610.46 and 21 CFR 610.47 the notification effort begins the blood collecting establishment notifies the hospital that it received potentially HIV or HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification over a period of 12 weeks unless-- (A) The patient is located and notified; or

B) The hospital is unable to locate the patient and documents in the patient’s medical record the extenuating circumstances beyond the hospital’s control that caused the notification timeframe to exceed 12 weeks. (ii) For donors tested before February 20, 2008. For notifications from donors tested before February 20, 2008 as set forth at 21 CFR 610.48(b) and (c), the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification and must complete the actions within 1 year of the date on which the hospital received notification from the outside blood collecting establishment.

(8) Content of notification. The notification must include the following information: (i) A basic explanation of the need for HIV or HCV testing and counseling. (ii) Enough oral or written information so that an informed decision can be made about whether to obtain HIV or HCV testing and counseling. (iii)A list of programs or places where the person can obtain HIV or HCV testing and counseling, including any requirements or restrictions the program may impose.

(9) Policies and procedures. The hospital must establish policies and procedures for notification and documentation that conform to Federal, State, and local laws, including requirements for the confidentiality of medical records and other patient information.

(10) Notification to legal representative or relative. If the patient has been adjudged incompetent by a State court, the physician or hospital must notify a legal representative designated in accordance with State law. If the patient is competent, but State law permits a legal representative or relative to receive the information on the patient’s behalf, the physician or hospital must notify the patient or his or her legal representative or relative. For possible HIV infectious transfusion recipients that are deceased, the physician or hospital must inform the deceased patient’s legal

representative or relative. If the patient is a minor, the parents or legal guardian must be notified.

(11) Applicability. HCV notification requirements resulting from donors tested before February 20, 2008, as set forth at 21 CFR 610.48 will expire on August 24, 2015.

§482.27(c) Standard: General blood safety issues.

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

§482.28 Condition of Participation: Food and Dietetic Services

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.

§482.28(a) Standard: Organization

The hospital must ensure that the specific food and dietetic services organization requirements are met.

§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.

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

A qualified dietitian must supervise the nutritional aspects of patient care. Responsibilities of a hospital dietitian may include, but are not limited to:

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

§482.28(b) Menus must meet the needs of patients.

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

§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.

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

§482.30 Condition of Participation: Utilization Review

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

§482.30(a) Standard: Applicability

The provisions of this section apply except in either of the following

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

§82.30(b) Standard: Composition of Utilization Review Committee

A UR committee consisting of two or more practitioners must carry out the UR function. At least two of the members of the committee must be doctors of medicine or osteopathy. The other members may be any of the other types of practitioners specified in §482.12(c)(1).

(1) Except as specified in paragraphs (b)(2) and (3) of this section, the UR committee must be one of the following: (i) A staff committee of the institution; (ii) A group outside the institution-- (A) Established by the local medical society and some or all of the hospitals in the locality; or (B) Established in a manner approved by CMS

.(2) If, because of the small size of the institution, it is impracticable to have a properly functioning staff committee, the UR committee must be established as specified in paragraph (b)(1)(ii) of this section.

(3) The committee or group’s reviews may not be conducted by any individual who-- (i) Has a direct financial interest (for example, an ownership interest) in that hospital; or (ii) Was professionally involved in the care of the patient whose case is being reviewed.

§482.30(c) Standard: Scope and Frequency of Review

(1) The UR plan must provide for review for Medicare and Medicaid patients with respect to the medical necessity of-- (i) Admissions to the institution; (ii) The duration of stays; and (iii) Professional services furnished including drugs and biologicals.

(2) Review of admissions may be performed before, at, or after hospital admission.

(3) Except as specified in paragraph (e) of this section, reviews may be conducted on a sample basis.

(4) Hospitals that are paid for inpatient hospital services under the prospective payment system set forth in Part 412 of this chapter must conduct review of duration of stays and review of professional services as follows: (i) For duration of stays, these hospitals need review only cases that they reasonably assume to be outlier cases based on extended length of stay, as described in §412.80(a)(1)(i) of this chapter; and (ii) For professional services, these hospitals need review only cases that they reasonably assume to be outlier cases based on extraordinarily high costs, as described in §412.80(a)(1)(ii) of this chapter.

§482.30(d) Standard: Determination Regarding Admissions or Continued Stays

(1) The determination that an admission or continued stay is not medically necessary- (i) May be made by one member of the UR committee if the practitioner or practitioners responsible for the care of the patient, as specified of §482.12(c), concur with the determination or fail to present their views when afforded the opportunity; and (ii) Must be made by at least two members of the UR committee in all other cases.

(2) Before making a determination that an admission or continued stay is not medically necessary, the UR committee must consult the practitioner or practitioners responsible for the care of the patient, as specified in §482.12(c), and afford the practitioner or practitioners the opportunity to present their views.(3) If the committee decides that admission to or continued stay in the hospital is not medically necessary, written notification must be given, no later than 2 days after the determination, to the hospital, the patient, and the practitioner or practitioners responsible for the care of the patient, as specified in §482.12(c);

§482.30(e) Standard: Extended Stay Review

(1) In hospitals that are not paid under the prospective payment system, the UR committee must make a periodic review, as specified in the UR plan, or each current inpatient receiving hospital services during a continuous period of extended duration. The scheduling of the periodic reviews may-- (i) Be the same for all cases; or (ii) Differ for different classes of cases.

(2) In hospitals paid under the prospective payment system, the UR committee must review all cases reasonably assumed by the hospital to be outlier cases because the extended length of stay exceeds the threshold criteria for the diagnosis, as described in §412.80(a)(1)(i). The hospital is not required to review an extended stay that does not exceed the outlier threshold for the diagnosis.

(3) The UR committee must make the periodic review no later than 7 days after the day required in the UR plan.

§482.30(f) Standard: Review of Professional Services

The committee must review professional services provided, to determine medical necessity and to promote the most efficient use of available health facilities and services.

§482.41 Condition of Participation: Physical Environment

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

§482.41(a) Standard: Buildings

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

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

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

§482.41(b) Standard: Life Safety from Fire

§482.41(b) (1) Except as otherwise provided in this section— (i) The hospital must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association. The Director of the Office of the Federal Register has approved the NFPA 101®2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html

Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the Federal Register to announce the changes.(ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the LSC does not apply to hospitals. (2) After consideration of State survey agency findings, CMS may waive specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon the facility, but only if the waiver does not adversely affect the health and safety of the patients.Beginning March 13, 2006, Medicare-participating hospitals may not keep in service roller latches even when those roller latches are demonstrating the ability to keep the door closed against 5lbf. A hospital with doors in service that have roller latches, where positive latching is required, will not be in compliance and will be cited.

The provisions of the Life Safety Code do not apply in a State where CMS finds that a fire and safety code imposed by State law adequately protects patients in hospitals.

§482.41(b)(5) - Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 does not apply to hospitals. (Determine if the hospital is utilizing roller latches on doors that require positive latches.)

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

§482.41(b)(7) - The hospital must have written fire control plans that contain

provisions for prompt reporting of fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities.

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

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

§482.41(c) Standard: Facilities

The hospital must maintain adequate facilities for its services.

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

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

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

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

§482.42 Condition of Participation: Infection Control

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

§482.42(a) Standard: Organization and Policies

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….

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

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

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

§482.43 Condition of Participation: Discharge Planning

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

§482.43(a) Standard: Identification of Patients in Need of Discharge Planning

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

§482.43(b) Standard: Discharge Planning Evaluation

(1) The hospital must provide a discharge planning evaluation to the patients identified in paragraph (a) of this section, and to other patients upon the patient’s request, the request of a person acting on the patient’s behalf, or the request of the physician.

(3) - The discharge planning evaluation must include an evaluation of the likelihood of a patient needing post-hospital services and of the availability of the services.

(4) - The discharge planning evaluation must include an evaluation of the likelihood of a patient’s capacity for self-care or of the possibility of the patient being cared for in the environment from which he or she entered the hospital.

§482.43(b)(2) - A registered nurse, social worker, or other appropriately qualified personnel must develop, or supervise the development of, the evaluation.

§482.43(b)(5) - The hospital personnel must complete the evaluation on a timely basis so that appropriate arrangements for post-hospital care are made before discharge, and to avoid unnecessary delays in discharge.

§482.43(b)(6) - The hospital … must discuss the results of the evaluation with the patient or individual acting on his or her behalf.

§482.43(b)(6) – [The hospital must] include the discharge planning evaluation in the patient’s medical record for use in establishing an appropriate discharge plan….

§482.43(c) Standard: Discharge Plan

(1) - A registered nurse, social worker, or other appropriately qualified personnel must develop, or supervise the development of, a discharge plan if the discharge planning evaluation indicates a need for a discharge plan.

§482.43(c)(2) In the absence of a finding by the hospital that a patient needs a discharge plan, the patient’s physician may request a discharge plan. In such a case, the hospital must develop a discharge plan for the patient.

§482.43(c)(3) - The hospital must arrange for the initial implementation of the patient’s discharge plan….

§482.43(c)(5) - As needed, the patient and family members or interested persons must be counseled to prepare them for post-hospital care.

§482.43(c)(4) - The hospital must reassess the patient’s discharge plan if there are factors that may affect continuing care needs or the appropriateness of the discharge plan.

§482.43(c)(6) - The hospital must include in the discharge plan a list of HHAs or SNFs that are available to the patient, that are participating in the Medicare program, and that serve the geographic area (as defined by the HHA) in which the patient resides, or in the case of a SNF, in the geographic area requested by the patient. HHAs must request to be listed by the hospital as available.

(i) - This list must only be presented to patients for whom home health care or post-hospital extended care services are indicated and appropriate as determined by the discharge planning evaluation.

(ii) - For patients enrolled in managed care organizations, the hospital must indicate the availability of home health and post-hospital extended care services through individuals and entities that have a contract with the managed care organizations.

(iii) The hospital must document in the patient's medical record that the list was presented to the patient or to the individual acting on the patient's behalf.

§482.43(c)(7) The hospital, as part of the discharge planning process, must inform the patient or the patient's family of their freedom to choose among participating Medicare providers of post-hospital care services and must, when possible, respect patient and family preferences when they are expressed. The hospital must not specify or otherwise limit the qualified providers that are available to the patient.§482.43(c)(8) The discharge plan must identify any HHA or SNF to which the patient is referred in which the hospital has a disclosable financial interest, as specified by the Secretary, and any HHA or SNF that has a disclosable financial interest in a hospital under Medicare. Financial interests that are disclosable under Medicare are determined in accordance with the provisions of Part 420, Subpart C, of this chapter.

§482.43(d) Standard: Transfer or Referral

The hospital must transfer or refer patients, along with necessary medical information, to appropriate facilities, agencies, or outpatient services, as needed, for follow-up or ancillary care.

§483.43(e) Standard: Reassessment

The hospital must reassess its discharge planning process on an on-going basis. The reassessment must include a review of discharge plans to ensure that they are responsive to discharge needs.

§482.45 Condition of Participation: Organ, Tissue and Eye Procurement

The hospital must ensure the specific organ, tissue, and eye procurement requirements are met.

The hospital must have and implement written protocols that:§482.45(a)(1) - Incorporate an agreement with an OPO designated under part 486 of this chapter, under which it must notify, in a timely manner, the OPO or a third party designated by the OPO of individuals whose death is imminent or who have died in the hospital. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO determines medical suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose;

§482.45(a)(2) - Incorporate an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such an agreement does not interfere with organ procurement;

§482.45(a)(3) - Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes, or to decline to donate.

§482.45(a)(3) - (Continued) The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation;

§482.45(a)(4) - Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors;

§482.45(a)(5) - Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues;

§482.45(a)(5) - (Continued) [Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on…] reviewing death records to improve identification of potential donors, and

§482.45(a)(5) - (Continued) [Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on…] maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.

§482.45(b) Standard: Organ Transplantation Responsibilities

(1) A hospital in which organ transplants are performed must be a member of the Organ Procurement and Transplantation Network (OPTN) established and operated in accordance with section 372 of the Public Health Service (PHS) Act (42 U.S.C. 274) and abide by its rules. The term “rules of the OPTN” means those rules provided for in regulations issued by the Secretary in accordance with section 372 of the PHS Act which are enforceable under 42 CFR 121.10. No hospital is considered to be out of compliance with section 1138(a)(1)(B) of the Act, or with the requirements of this paragraph, unless the Secretary has given the OPTN formal notice that he or she approves the decision to exclude the hospital from the OPTN and has notified the hospital in writing.

(2) For purposes of these standards, the term “organ” means a human kidney, liver, heart, lung, or pancreas.

(3) If a hospital performs any type of transplants, it must provide organ transplant related data, as requested by the OPTN, the Scientific Registry, and the OPOs. The hospital must also provide such data directly to the Department when requested by the Secretary.

§482.51 Condition of Participation: Surgical Services

If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered.

§482.51(a) Standard: Organization and Staffing

The organization of the surgical services must be appropriate to the scope of the services offered.

§482.51(a)(1) - The operating rooms must be supervised by an experienced registered nurse or a doctor of medicine or osteopathy.

§482.51(a)(2) - Licensed practical nurses (LPNs) and surgical technologists (operating room technicians) may serve as “scrub nurses” under the supervision of a registered nurse.

(Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08)

§482.51(a)(3) - Qualified registered nurses may perform circulating duties in the operating room. In accordance with applicable State laws and approved medical staff policies and procedures, LPNs and surgical technologists may assist in circulatory duties under the supervision of a qualified registered nurse who is immediately available to respond to emergencies.

§482.51(a)(4) - Surgical privileges must be delineated for all practitioners performing surgery in accordance with the competencies of each practitioner. The surgical service must maintain a roster of practitioners specifying the surgical privileges of each practitioner.

§482.51(b) Standard: Delivery of Service

Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care.

§482.51(b) (1) - Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies:

(i) A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration.

(ii) An updated examination of the patient, including any changes in the patient’s condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration.

§482.51(b)(2) - A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies.

§482.51(b)(4) - There must be adequate provisions for immediate post-operative care.

§482.51(b)(3) - The following equipment must be available to the operating room suites: call-in system, cardiac monitor, resuscitator, defibrillator, aspirator, and tracheotomy set.

Check to determine that the operating room suite has available the items listed:

§482.51(b)(4) - There must be adequate provisions for immediate post-operative care.

Depending on the type of anesthesia and length of surgery, the post-operative check before transferring the patient from the PACU includes, but is not limited to:

§482.51(b)(5) - The operating room register must be complete and up-to-date.

The register includes at least the following information: • Patient’s name; • Patient’s hospital identification number; • Date of the operation; • Inclusive or total time of the operation; • Name of the surgeon and any assistant(s); • Name of nursing personnel (scrub and circulating); • Type of anesthesia used and name of person administering it;

• Operation performed; • Pre and post-op diagnosis; and • Age of patient.

§482.51(b)(6) - An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon.

The operative report includes at least:• Name and hospital identification number of the patient; • Date and times of the surgery; • Name(s) of the surgeon(s) and assistants or other practitioners who performed surgical tasks (even when performing those tasks under supervision); • Pre-operative and post-operative diagnosis; • Name of the specific surgical procedure(s) performed; • Type of anesthesia administered;

• Complications, if any; • A description of techniques, findings, and tissues removed or altered; • Surgeons or practitioners name(s) and a description of the specific significant surgical tasks that were conducted by practitioners other than the primary surgeon/practitioner (significant surgical procedures include: opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues); and • Prosthetic devices, grafts, tissues, transplants, or devices implanted, if any.

§482.52 Condition of Participation: Anesthesia Services

If the hospital furnishes anesthesia services, they must be provided in a well-organized manner under the direction of a qualified doctor of medicine or osteopathy. The service is responsible for all anesthesia administered in the hospital.

The anesthesia services must be under the direction of one individual who is a qualified doctor of medicine (MD) or doctor of osteopathy (DO). Consistent with the requirement at §482.12(a)(4) for it to approve medical staff bylaws, rules and regulations, the hospital’s governing body approves, after considering the medical staff’s recommendations, medical staff rules and regulations establishing criteria for the qualifications for the director of the anesthesia services. Such criteria must be consistent with State laws and acceptable standards of practice.

§482.52(b) Standard: Delivery of Services

Anesthesia services must be consistent with needs and resources. Policies on anesthesia procedures must include the delineation of preanesthesia and postanesthesia responsibilities. The policies must ensure that the following are provided for each patient:

[The policies must ensure that the following are provided for each patient:]

§482.52(b) (1) - A pre-anesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, performed within 48 hours prior to surgery or a procedure requiring anesthesia services.

§482.52(b)(2) - An intraoperative anesthesia record.

[The policies must ensure that the following are provided for each patient:]

482.52(b)(3) - A postanesthesia evaluation completed and documented by an individual qualified to administer anesthesia, as specified in paragraph (a) of this section, no later than 48 hours after surgery or a procedure requiring anesthesia services. The postanesthesia evaluation for anesthesia recovery must be completed in accordance with State law and with hospital policies and procedures that have been approved by the medical staff and that reflect current standards of anesthesia care.

The elements of an adequate post-anesthesia evaluation should be clearly documented and conform to current standards of anesthesia care, including: • Respiratory function, including respiratory rate, airway patency, and oxygen saturation; • Cardiovascular function, including pulse rate and blood pressure; • Mental status; • Temperature; • Pain; • Nausea and vomiting; and • Postoperative hydration.

§482.52(a) Standard: Organization and Staffing

The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by --(1) A qualified anesthesiologist; (2) A doctor of medicine or osteopathy (other than an anesthesiologist); (3) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; (4) A certified registered nurse anesthetist (CRNA), as defined in §410.69(b) of this chapter, who, unless exempted in accordance with paragraph (c) of this section, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or (5) An anesthesiologist’s assistant, as defined in Sec. 410.69(b) of this chapter, who is under the supervision of an anesthesiologist who is immediately available if needed.

§482.52(c) Standard: State Exemption

(1) A hospital may be exempted from the requirement for MD/DO supervision of CRNAs as described in paragraph (a)(4) of this section, if the State in which the hospital is located submits a letter to CMS signed by the Governor, following consultation with the State’s Boards of Medicine and Nursing, requesting exemption from MD/DO supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State’s citizens to opt-out of the current MD/DO supervision requirement, and that the opt-out is consistent with State law.

(2) The request for exemption and recognition of State laws, and the withdrawal of the request may be submitted at any time, and are effective upon submission.

General anesthesia, regional anesthesia and monitored anesthesia, including deep sedation/analgesia, may only be administered by: • A qualified anesthesiologist; • An MD or DO (other than an anesthesiologist); • A dentist, oral surgeon or podiatrist who is qualified to administer anesthesia under State law; • A CRNA who is supervised by the operating practitioner or by an anesthesiologist who is immediately available if needed; or • An anesthesiologist’s assistant under the supervision of an anesthesiologist who is immediately available if needed.

§482.53 Condition of Participation: Nuclear Medicine Services

If the hospital provides nuclear medicine services, those services must meet the needs of the patients in accordance with acceptable standards of practice.

§482.53(a) Standard: Organization and Staffing

The organization of the nuclear medicine service must be appropriate to the scope and complexity of the services offered.

(1) There must be a director who is a doctor of medicine or osteopathy qualified in nuclear medicine.

(2) The qualifications, training, functions and responsibilities of the nuclear medicine personnel must be specified by the service director and approved by the medical staff.

§482.53(b) Standard: Delivery of Service

Radioactive materials must be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice.

§482.53(b)(2) There is proper storage and disposal of radioactive material.

§482.53(b)(1) In-house preparation of radio pharmaceuticals is by, or under the supervision of, an appropriately trained registered pharmacist or doctor of medicine or osteopathy.

§482.53(b)(2) - There is proper storage and disposal of radioactive material.

§482.53(b)(3) - If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirement for laboratory services specified in §482.27.

§482.53(c) Standard: Facilities

Equipment and supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for safe and efficient performance. The equipment must be-- (1) Maintained in safe operating condition; and (2) Inspected, tested and calibrated at least annually by qualified personnel.

§482.53(d) Standard: Records

The hospital must maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures.

(1)The hospital must maintain copies of nuclear medicine reports for at least 5 years.

(2)The practitioner approved by the medical staff to interpret diagnostic procedures must sign and date the interpretation of these tests.

§482.53(d)(3) The hospital must maintain records of the receipt and distribution of radio-pharmaceuticals.

The nuclear medicine records must specify the following:

§482.53(d)(4) Nuclear medicine services must be ordered only by practitioners whose scope of Federal or State licensure and whose defined staff privileges allow such referrals.

§482.54 Condition of Participation: Outpatient Services

If the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice.

§482.54(a) Standard: Organization

Outpatient services must be appropriately organized and integrated with inpatient services.

482.54(b) Standard: Personnel

The hospital must (1) assign one or more individuals to be responsible for outpatient services.

The hospital must (2) have appropriate professional and nonprofessional personnel available at each location where outpatient services are offered, based on the scope and complexity of outpatient services.

§482.54(c) Standard: Orders for Outpatient Services
Outpatient services must be ordered by a practitioner who meets the following conditions:

The above applies to the following:
(I) All practitioners who are appointed to the hospital's medical staff and who have been granted privileges to order the applicable outpatient services.
(ii) All practitioners not appointed to the medical staff, but who satisfy the above criteria for authorization by the medical staff and the hospital for ordering the applicable outpatient services for their patients.

§482.55 Condition of Participation: Emergency Services

The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice.

§482.55(a) Standard: Organization and Direction. If emergency services are provided at the hospital --

§482.55(a)(1) The services must be organized under the direction of a qualified member of the medical staff;

§482.55(a)(2) The services must be integrated with other departments of the hospital;

Emergency Services integration includes at a minimum: Coordination and communication between the Emergency Department and other hospital services and departments.

Emergency Services integration includes at a minimum: Physical access for emergency department patients to the services, equipment, personnel, and resources of other hospital departments/services.

Emergency Services integration includes at a minimum: the immediate availability of services, equipment, personnel, and resources of other hospital departments/services to emergency patients.

Emergency Services integration includes at a minimum: the provision of services, equipment, personnel and resources of other hospital departments/services to emergency department patients is within timeframes that protect the health and safe of patients and is within acceptable standards of practice.

This includes the length of time it takes to transport the emergency patient from the ED to another hospital department where needed interventions or diagnostic services will be rendered; and, the length of time it takes to deliver equipment or supplies, or for the staff from other departments to travel from their location to the emergency department in order to provide needed interventions, test, care or services.

§482.55(a)(3) The policies and procedures governing medical care provided in the emergency service or department are established by and are a continuing responsibility of the medical staff.

The hospital's medical staff must establish policies and procedures governing the medical care provided in the emergency service or emergency department.

The medical staff must have had ongoing/continuing assessment of the medical care provided in the emergency service or department.

Emergency service or emergency department policies must be current and revised as necessary based on the ongoing monitoring conducted by the medical staff and the emergency service or department QAPI activities.

§482.55(b) Standard: Personnel

The hospital must ensue the emergency services personnel requirements are met.

§482.55(b)(1) The emergency services must be supervised by a qualified member of the medical staff.

§482.55(b)(2) There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedure and needs anticipated by the facility.

§482.56 Condition of Participation: Rehabilitation Services

If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients.

The hospital's rehabilitation services must be integrated into its hospital-wide QAPI program.

§482.56(a) Standard: Organization and Staffing

The organization of the service must be appropriate to the scope of the services offered.

The scope of rehabilitation services offered by the hospital should be defined in written policies and procedures, and approved by the Medical staff.

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

§482.56(a)(2) Physical therapy, occupational therapy, or speech-language pathology or audiology services, if provided, must be provided by qualified physical therapists, physical therapist assistants, occupational therapists, occupational therapy assistants, speech-language pathologists, or audiologists as defined in part 484 of this chapter.

§482.56(b) Standard: 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.

§482.56(b)(1) All rehabilitation services orders must be documented in the patient’s medical record in accordance with the requirements at §482.24.

§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.

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.”

§482.57 Condition of Participation: Respiratory Services

The hospital must meet the needs of the patients in accordance with acceptable standards of practice. The following requirements apply if the hospital provides respiratory care services.

§482.57(a) Standard: Organization and Staffing

The organization of the respiratory care services must be appropriate to the scope and complexity of the services offered.

The scope of diagnostic and/or therapeutic respiratory services offered by the hospital should be defined in writing, and approved by the Medical staff.

§482.57(a)(1) - There must be a director of respiratory care services who is a doctor of medicine or osteopathy with the knowledge, experience and capabilities to supervise and administer the service properly. The director may serve on either a full-time or part-time basis.

§482.57(a)(2) - There must be adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with State law.

§482.57(b) Standard: Delivery of Services

Services must be delivered in accordance with medical staff directives.

There should be written policies for the delivery of respiratory care services that are developed and approved by the medical staff. Appropriate to the scope of services provided, the written policies should address at least the following: • Equipment assembly, operation, and preventive maintenance; • Safety practices, including infection control measures for equipment, sterile supplies, biohazardous waste, posting of signs, and gas line identification; • Handling, storage, and dispensing of therapeutic gases to both inpatients and outpatients; • Cardiopulmonary resuscitation; • Procedures to follow in the advent of adverse reactions to treatments or interventions; • Pulmonary function testing; • Therapeutic percussion and vibration; • Bronchopulmonary drainage; • Mechanical ventilatory and oxygenation support; • Aerosol, humidification, and therapeutic gas administration; • Storage, access, control, administration of medications and medication errors; and • Procedures for obtaining and analyzing blood samples (e.g., arterial blood gases).

§482.57(b)(1) - Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures must be designated in writing.

The hospital must have written policies to address, at a minimum: • Each type of respiratory care service provided by the hospital; • The qualifications, including job title, licensure consistent with State law, education, training and experience of personnel authorized to perform each type of respiratory care service and whether they may perform it without supervision; and • The type of personnel qualified to provide the direct supervision.

§482.57(b)(2) - If blood gases or other clinical laboratory tests are performed in the respiratory care unit, the unit must meet the applicable requirements for laboratory services specified in §482.27.

§482.57(b)(3) - 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.

§482.57(b)(4)- All respiratory care services orders must be documented in the patient’s medical record in accordance with the requirements at §482.24.

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.