42 C.F.R. §§ 485.510–485.544

§485.510. Condition of participation: Governing body and organizational structure of the REH

42 C.F.R. § 485.510

There must be an effective governing body, or responsible individual or individuals, that is legally responsible for the conduct of the REH. If an REH does not have an organized governing body, the person or persons legally responsible for the conduct of the REH must carry out the functions specified in this subpart that pertain to the governing body.

(a)

Standard: Medical staff. The governing body must:

(1)

Determine, in accordance with state law, which categories of practitioners are eligible candidates for appointment to the medical staff.

(2)

Appoint members of the medical staff after considering the recommendations of the existing members of the medical staff.

(3)

Ensure that the medical staff has bylaws.

(4)

Approve medical staff bylaws and other medical staff rules and regulations.

(5)

Ensure that the medical staff is accountable to the governing body for the quality of care provided to patients.

(6)

Ensure the criteria for selection are individual character, competence, training, experience, and judgment.

(i)

Members of the medical staff must be legally and professionally qualified for the positions to which they are appointed and for the performance of privileges granted. The REH grants privileges in accordance with recommendations from qualified medical personnel.

(ii)

Medical staff privileges must be periodically reappraised by the REH. The scope of procedures performed in the REH must be periodically reviewed and amended as appropriate.

(iii)

If the REH assigns patient care responsibilities to practitioners other than physicians, it must have established policies and procedures, approved by the governing body, for overseeing and evaluating their clinical activities.

(7)

Ensure that under no circumstances is the accordance of staff membership or professional privileges in the REH dependent solely upon certification, fellowship, or membership in a specialty body or society.

(8)

Ensure that, when telemedicine services are furnished to the REH'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 (7) of this section with regard to the distant-site hospital's physicians and practitioners providing telemedicine services. The governing body of the REH whose patients are receiving the telemedicine services may, in accordance with § 485.512(a)(3), grant privileges based on its medical staff recommendations that rely on information provided by the distant-site hospital.

(9)

Ensure that when telemedicine services are furnished to the REH'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 REH and as such, in accordance with paragraph (b) of this section, furnishes the contracted services in a manner that permits the REH to comply with all applicable conditions of participation for the contracted services, including, but not limited to, the requirements in paragraphs (a)(1) through (7) of this section with regard to the distant-site telemedicine entity's physicians and practitioners providing telemedicine services. The governing body of the REH whose patients are receiving the telemedicine services may, in accordance with § 485.512(a)(4), grant privileges to physicians and practitioners employed by the distant-site telemedicine entity based on such REH's medical staff recommendations; such staff recommendations may rely on information provided by the distant-site telemedicine entity.

(10)

Consult directly with the individual assigned the responsibility for the organization and conduct of the REH's medical staff, or their 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 REH. For a multi-facility system, including a multi-hospital or multi-REH system, using a single governing body, the single multi-facility or multi-REH system governing body must consult directly with the individual responsible for the organized medical staff (or their designee) of each hospital or REH within its system in addition to the other requirements of this paragraph (a).

(b)

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

(1)

The governing body must ensure that the services performed under a contract are provided in a safe and effective manner.

(2)

The REH must maintain a list of all contracted services, including the scope and nature of the services provided.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.512. Condition of participation: Medical staff.

42 C.F.R. § 485.512

The REH 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 REH.

(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) of this chapter and non-physician practitioners who are determined to be eligible for appointment by the governing body.

(1)

The medical staff must periodically conduct appraisals of its members.

(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 these 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.

(3)

When telemedicine services are furnished to the REH's patients through an agreement with a distant-site hospital, the governing body of the REH whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (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 REH'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 REH 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 REH whose patients are receiving the telemedicine services, the REH 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 REH's patients and all complaints the REH has received about the distant-site physician or practitioner.

(4)

When telemedicine services are furnished to the REH's patients through an agreement with a distant-site telemedicine entity, the governing body of the REH whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (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 REH'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 paragraph (d) of this section, permit the REH to comply with all applicable conditions of participation for the contracted services. The REH'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 § 485.510(a)(1) through (7) and paragraphs (a)(1) and (2) of this section.

(ii)

The individual distant-site physician or practitioner is privileged at the distant-site telemedicine entity providing the telemedicine services, which provides the REH 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 REH 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 REH whose patients are receiving the telemedicine services, the REH 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 REH's patients, and all complaints the REH has received about the distant-site physician or practitioner.

(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 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.

(4)

If an REH is part of a system consisting of multiple separately certified hospitals, critical access hospitals, and/or REHs, and the system elects to have a unified and integrated medical staff for its member hospitals, critical access hospitals, and/or REHs after determining that such a decision is in accordance with all applicable state and local laws, each separately certified REH must demonstrate that:

(i)

The medical staff members of each separately certified REH in the system (that is, all medical staff members who hold specific privileges to practice at that REH) 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 REH;

(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 REH (that is, all medical staff members who hold specific privileges to practice at that REH) 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 REH;

(iii)

The unified and integrated medical staff is established in a manner that takes into account each member REH's unique circumstances and any significant differences in patient populations and services offered in each hospital, critical access hospital (CAH), and REH; 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, CAHs, and REHs, 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, CAHs, and REHs are duly considered and addressed.

(c)

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

(1)

Be approved by the governing body.

(2)

Include a statement of the duties and privileges of each category of medical staff (for example, active, courtesy, etc.).

(3)

Describe the organization of the medical staff.

(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.

(5)

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 REH, the criteria for determining privileges and the procedure for applying the criteria are also subject to the requirements in § 485.510(a)(8) and (9) and paragraphs (a)(3) and (4) of this section.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.514. Condition of participation: Provision of services.

42 C.F.R. § 485.514

(a)

The REH's health care services must be furnished in accordance with appropriate written policies that are consistent with applicable state law.

(b)

The policies must be developed with the advice of members of the REH's professional health care staff, including one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff under the provisions of § 485.528(b)(1).

(c)

The policies must include the following:

(1)

A description of the services the REH furnishes, including those furnished through agreement or arrangement.

(2)

Policies and procedures for emergency medical services.

(3)

Guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the REH.

(4)

Policies and procedures that address the post-acute care needs of patients receiving services in the REH.

(d)

The policies must be reviewed at least biennially by the group of professional personnel required under paragraph (b) of this section and updated as necessary by the REH.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.516. Condition of participation: Emergency services.

42 C.F.R. § 485.516

The REH must provide the emergency care necessary to meet the needs of its patients in accordance with acceptable standards of practice.

(a)

Standard: Organization and direction. The emergency services of the REH must be—

(1)

Organized under the direction of a qualified member of the medical staff; and

(2)

Integrated with other departments of the REH.

(b)

Standard: Personnel. There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility.

(c)

Standard: Compliance with CAH requirements. The REH must meet the requirements specified in § 485.618, with respect to:

(1)

24-hour availability of emergency services (§ 485.618(a)).

(2)

Equipment, supplies, and medication (§ 485.618(b)).

(3)

Blood and blood products (§ 485.618(c)).

(4)

Personnel (§ 485.618(d)).

(5)

Coordination with emergency response systems (§ 485.618(e)).

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.518. Condition of participation: Laboratory services.

42 C.F.R. § 485.518

The REH must provide basic laboratory services essential to the immediate diagnosis and treatment of the patient consistent with nationally recognized standards of care for emergency services, patient population, and services offered. The REH must ensure that—

(a)

Laboratory services are available, either directly or through a contractual agreement with a certified laboratory that meets requirements of part 493 of this chapter.

(b)

Emergency laboratory services are available 24 hours a day.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.520. Condition of participation: Radiologic services.

42 C.F.R. § 485.520

The REH must maintain, or have available, diagnostic radiologic services. If therapeutic services are also provided, the therapeutic services, as well as the diagnostic services, must be furnished by the REH and provided by personnel qualified under state law. The REH must ensure that REH patients or personnel are not exposed to radiation hazards.

(a)

Standard: Radiologic services. The REH must maintain, or have available, radiologic services according to needs of the patients.

(b)

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

(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.

(2)

Periodic inspection of equipment must be made and hazards identified must be promptly corrected.

(3)

Radiation workers must be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure.

(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.

(c)

Standard: Personnel.

(1)

The REH must have a full-time, part-time, or consulting qualified radiologist, or other personnel qualified under State law, to interpret only those radiologic tests that are determined by the medical staff to require 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.

(2)

Only personnel designated as qualified by the medical staff may use the radiologic equipment and administer procedures.

(d)

Standard: Records. Records of radiologic services must be maintained.

(1)

The radiologist or other practitioner who performs radiology services must sign reports of their interpretations.

(2)

The REH must maintain the following for at least 5 years:

(i)

Copies of reports and printouts.

(ii)

Films, scans, and other image records, as appropriate.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.522. Condition of participation: Pharmaceutical services.

42 C.F.R. § 485.522

The REH must have pharmaceutical services that meet the needs of its patients. The REH must have a pharmacy or a drug storage area that is directed by a registered pharmacist or other qualified individual in accordance with state scope of practice laws. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the REH's registered pharmacist or other qualified individual.

(a)

Standard: Pharmacy management and administration. The pharmacy or drug storage area must be administered in accordance with accepted professional principles and in accordance with state and Federal laws.

(1)

A pharmacist or competent individual in accordance with state scope of practice laws must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. The pharmacist or competent individual in accordance with state law and scope of practice must be available for a sufficient time to provide oversight of the REH's pharmacy services based on the scope and complexity of the services offered at the REH.

(2)

The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services for the provision of all services provided by the REH.

(3)

Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.

(b)

Standard: Delivery of services. Drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and state law, to ensure patient safety.

(1)

All compounding, packaging, and dispensing of drugs must be done by a licensed pharmacist or a licensed physician, or under the supervision of a pharmacist or competent individual in accordance with state law and scope of practice and performed consistent with state and Federal laws.

(2)

All drugs and biologicals must be kept in a secure area, and locked when appropriate.

(i)

All drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. 801 et seq.) must be kept locked within a secure area.

(ii)

Only authorized personnel may have access to locked areas.

(3)

Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.

(4)

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.

(c)

Standard: Administration of drugs— . Drugs must be prepared and administered according to established policies and acceptable standards of practice.

(1)

Adverse reactions must be reported to the physician responsible for the patient and must be documented in the record.

(2)

Blood transfusions, blood products, and intravenous medications must be administered in accordance with state law and approved medical staff policies and procedures.

(3)

Orders given orally for drugs and biologicals must be followed by a written order, signed by the prescribing physician or other authorized prescriber.

(4)

There must be an REH procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.524. Condition of participation: Additional outpatient medical and health services.

42 C.F.R. § 485.524

If the REH provides outpatient medical and health services in addition to providing emergency services and observation care, the medical and health services must be appropriately organized and meet the needs of the patients in accordance with acceptable standards of practice.

(a)

Standard: Patient services. The REH may provide outpatient and medical health diagnostic and therapeutic items and services that are commonly furnished in a physician's office or at another entry point into the health care delivery system that include, but are not limited to, radiology, laboratory, outpatient rehabilitation, surgical, maternal health, and behavioral health services. If the REH provides outpatient and medical health diagnostic and therapeutic items and services, those items and services must align with the health needs of the community served by the REH. If the REH provides outpatient medical and health services in addition to providing emergency services, the REH must—

(1)

Provide items and services based on nationally recognized guidelines and standards of practice;

(2)

Have a system in place for referral from the REH to different levels of care, including follow-up care, as appropriate;

(3)

Have effective communication systems in place between the REH and the patient (or responsible individual) and their family, ensuring that the REH is responsive to their needs and preferences;

(4)

Have established relationships with hospitals that have the resources and capacity available to deliver care that is beyond the scope of care delivered at the REH; and

(5)

Have personnel providing these services who meet the requirements at paragraph (b) of this section.

(b)

Standard— Personnel for additional outpatient and medical health services. The REH must—

(1)

Assign one or more individuals to be responsible for outpatient services.

(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.

(3)

For any specialty services offered at the REH, have a doctor of medicine or osteopathy, nurse practitioner, clinical nurse specialist, or physician assistant providing services with experience and training in the specialty service area and in accordance with their scope of practice.

(c)

Standard— Orders for outpatient medical and health services. Outpatient medical and health services must be ordered by a practitioner who meets the following conditions:

(1)

Is responsible for the care of the patient.

(2)

Is licensed in the state where they provide care to the patient.

(3)

Is acting within their scope of practice under state law.

(4)

Is authorized in accordance with state law and policies adopted by the medical staff, and approved by the governing body, to order the applicable outpatient services. This applies to the following:

(i)

All practitioners who are appointed to the REH'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 requirements of paragraphs (c)(1) through (4) of this section for authorization by the medical staff and the REH for ordering the applicable outpatient services for their patients.

(d)

Standard: Surgical services. If the REH provides outpatient surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the REH in accordance with the designation requirements under paragraph (a) of this section.

(1)

Designation of qualified practitioners. The REH designates the practitioners who are allowed to perform surgery for REH patients, in accordance with its approved policies and procedures, and with state scope of practice laws. Surgery is performed only by—

(i)

A doctor of medicine or osteopathy, including an osteopathic practitioner recognized under section 1101(a)(7) of the Act;

(ii)

A doctor of dental surgery or dental medicine; or

(iii)

A doctor of podiatric medicine.

(2)

Anesthetic risk and evaluation.

(i)

A qualified practitioner, as specified in paragraph (a) of this section, must examine the patient immediately before surgery to evaluate the risk of the procedure to be performed.

(ii)

A qualified practitioner, as specified in paragraph (d)(3) of this section, must examine each patient before surgery to evaluate the risk of anesthesia.

(iii)

Before discharge from the REH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in paragraph (d)(3) of this section.

(3)

Administration of anesthesia. The REH designates the person who is allowed to administer anesthesia to REH patients in accordance with its approved policies and procedures and with state scope-of-practice laws.

(i)

Anesthesia must be administered by only—

(A)

A qualified anesthesiologist;

(B)

A doctor of medicine or osteopathy other than an anesthesiologist; including an osteopathic practitioner recognized under section 1101(a)(7) of the Act;

(C)

A doctor of dental surgery or dental medicine;

(D)

A doctor of podiatric medicine;

(E)

A certified registered nurse anesthetist (CRNA), as defined in § 410.69(b) of this chapter;

(F)

An anesthesiologist's assistant, as defined in § 410.69(b) of this chapter; or

(G)

A supervised trainee in an approved educational program, as described in § 413.85 or §§ 413.76 through 413.83 of this chapter.

(ii)

In those cases in which a CRNA administers the anesthesia, the anesthetist must be under the supervision of the operating practitioner except as provided in paragraph (e) of this section. An anesthesiologist's assistant who administers anesthesia must be under the supervision of an anesthesiologist.

(4)

Discharge. All patients are discharged in the company of a responsible adult, except those exempted by the practitioner who performed the surgical procedure.

(5)

Standard: State exemption.

(i)

An REH may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (d)(3) of this section, if the state in which the REH 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 physician supervision for CRNAs. The letter from the Governor must attest that they have consulted with the 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 physician supervision requirement, and that the opt-out is consistent with state law.

(ii)

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.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.526. Condition of participation: Infection prevention and control and antibiotic stewardship programs.

42 C.F.R. § 485.526

The REH must have active facility-wide programs for the surveillance, prevention, and control of healthcare-associated infections (HAIs) and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic-resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the facility-wide quality assessment and performance improvement (QAPI) program.

(a)

Standard: Infection prevention and control program organization and policies. The REH must demonstrate that:

(1)

An individual (or individuals), who is qualified through education, training, experience, or certification in infection prevention and control, is appointed by the governing body, or responsible individual, as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership;

(2)

The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the REH and between the REH and other health care settings;

(3)

The infection prevention and control program include surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; and

(4)

The infection prevention and control program reflects the scope and complexity of the services furnished by the REH.

(b)

Standard: Antibiotic stewardship program organization and policies. The REH must demonstrate that —

(1)

An individual (or individuals), who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship, is appointed by the governing body, or responsible individual, as the leader(s) of the antibiotic stewardship program and that the appointment is based on the recommendations of medical staff leadership and pharmacy leadership;

(2)

The facility-wide antibiotic stewardship program—

(i)

Demonstrates coordination among all components of the REH responsible for antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, nursing services, and pharmacy services;

(ii)

Documents the evidence-based use of antibiotics in all departments and services of the REH; and

(iii)

Documents any improvements, including sustained improvements, in proper antibiotic use;

(3)

The antibiotic stewardship program adheres to nationally recognized guidelines, as well as best practices, for improving antibiotic use; and

(4)

The antibiotic stewardship program reflects the scope and complexity of the services furnished by an REH.

(c)

Standard: Leadership responsibilities.

(1)

The governing body, or responsible individual, must ensure all of the following:

(i)

Systems are in place and operational for the tracking of all infection surveillance, prevention and control, and antibiotic use activities, in order to demonstrate the implementation, success, and sustainability of such activities.

(ii)

All HAIs and other infectious diseases identified by the infection prevention and control program as well as antibiotic use issues identified by the antibiotic stewardship program are addressed in collaboration with the REH's QAPI leadership.

(2)

The infection prevention and control professional(s) are responsible for—

(i)

The development and implementation of facility-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines.

(ii)

All documentation, written or electronic, of the infection prevention and control program and its surveillance, prevention, and control activities.

(iii)

Communication and collaboration with the REH's QAPI program on infection prevention and control issues.

(iv)

Competency-based training and education of REH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the REH, on the practical applications of infection prevention and control guidelines, policies and procedures.

(v)

The prevention and control of HAIs, including auditing of adherence to infection prevention and control policies and procedures by REH personnel.

(vi)

Communication and collaboration with the antibiotic stewardship program.

(3)

The leader(s) of the antibiotic stewardship program is responsible for—

(i)

The development and implementation of a facility-wide antibiotic stewardship program, based on nationally recognized guidelines, to monitor and improve the use of antibiotics.

(ii)

All documentation, written or electronic, of antibiotic stewardship program activities.

(iii)

Communication and collaboration with medical staff, nursing, and pharmacy leadership, as well as the REH's infection prevention and control and QAPI programs, on antibiotic use issues.

(iv)

Competency-based training and education of REH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the REH, on the practical applications of antibiotic stewardship guidelines, policies, and procedures.

(d)

Standard:Unified and integrated infection prevention and control and antibiotic stewardship programs for multi-facility systems. If a REH is part of a system consisting of multiple separately certified hospitals, CAHs, and/or REHs using a system governing body that is legally responsible for the conduct of two or more hospitals, CAHs, and/or REHs, the system governing body can elect to have unified and integrated infection prevention and control and antibiotic stewardship programs for all of its member facilities after determining that such a decision is in accordance with all applicable state and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified REHs meets all of the requirements of this section. Each separately certified REH subject to the system governing body must demonstrate that:

(1)

The unified and integrated infection prevention and control and antibiotic stewardship programs are established in a manner that takes into account each member REH's unique circumstances and any significant differences in patient populations and services offered in each REH;

(2)

The unified and integrated infection prevention and control and antibiotic stewardship programs establish and implement policies and procedures to ensure that the needs and concerns of each of its separately certified REHs, regardless of practice or location, are given due consideration;

(3)

The unified and integrated infection prevention and control and antibiotic stewardship programs have mechanisms in place to ensure that issues localized to particular REHs are duly considered and addressed; and

(4)

A qualified individual (or individuals) with expertise in infection prevention and control and in antibiotic stewardship has been designated at the REH as responsible for communicating with the unified infection prevention and control and antibiotic stewardship programs, for implementing and maintaining the policies and procedures governing infection prevention and control and antibiotic stewardship as directed by the unified infection prevention and control and antibiotic stewardship programs, and for providing education and training on the practical applications of infection prevention and control and antibiotic stewardship to REH staff.

(e)

COVID-19 and seasonal influenza reporting. Beginning at the conclusion of the COVID-19 Public Health Emergency, as defined in § 400.200 of this chapter, and continuing until April 30, 2024, except when the Secretary specifies an earlier end date for the requirements of this paragraph (e), the REH must electronically report information about COVID-19 and seasonal influenza in a standardized format specified by the Secretary.

(1)

Related to COVID-19, to the extent as required by the Secretary, this report must include the following data elements:

(i)

Suspected and confirmed COVID-19 infections among patients and staff.

(ii)

Total COVID-19 deaths among patients and staff.

(iii)

Personal protective equipment and testing supplies.

(iv)

Ventilator use, capacity, and supplies.

(v)

Total patient census and capacity.

(vi)

Staffing shortages.

(vii)

COVID-19 vaccine administration data of patients and staff.

(viii)

Relevant therapeutic inventories or usage, or both.

(2)

Related to seasonal influenza, to the extent as required by the Secretary, this report must include the following data elements:

(i)

Confirmed influenza infections among patients and staff.

(ii)

Total influenza deaths among patients and staff.

(iii)

Confirmed co-morbid influenza and COVID-19 infections among patients and staff.

(f)

Standard: Reporting of data related to viral and bacterial pathogens and infectious diseases of pandemic or epidemic potential. The REH must electronically report information on acute respiratory illness (including, but not limited to, seasonal influenza virus, influenza-like illness, and severe acute respiratory infection), SARS-CoV-2/COVID-19, and other viral and bacterial pathogens and infectious diseases of pandemic or epidemic potential only when the Secretary has declared a Public Health Emergency (PHE), as defined in § 400.200 of this chapter, directly related to such specific pathogens and infectious diseases. The requirements of this paragraph (f) will be applicable to local, state, regional, or national PHEs as declared by the Secretary.

(1)

The REH must electronically report information about the infectious disease pathogen, relevant to the declared PHE, in a standardized format specified by the Secretary. To the extent as required by the Secretary, this report must include, the following:

(i)

Suspected and confirmed infections of the relevant infectious disease pathogen among patients and staff.

(ii)

Total deaths attributed to the relevant infectious disease pathogen among patients and staff.

(iii)

Personal protective equipment and other relevant supplies in the REH.

(iv)

Capacity and supplies in the REH relevant to the immediate and long term treatment of the relevant infectious disease pathogen, such as ventilator and dialysis/continuous renal replacement therapy capacity and supplies.

(v)

Total patient census, capacity, and capability.

(vi)

Staffing shortages.

(vii)

Vaccine administration data of patients and staff for conditions monitored under this section and where a specific vaccine is applicable.

(viii)

Relevant therapeutic inventories or usage, or both.

(ix)

Isolation capacity, including airborne isolation capacity.

(x)

Key co-morbidities or exposure risk factors, or both, of patients being treated for the pathogen or disease of interest in this section that are captured with interoperable data standards and elements.

(2)

Unless the Secretary specifies an alternative format by which the REH must report these data elements, the REH must report the applicable infection (confirmed and suspected) and vaccination data in a format that provides person-level information, which must include medical record identifier, race, ethnicity, age, sex, residential county and zip code, and relevant comorbidities for affected patients. Facilities must not report any directly or potentially individually-identifiable information for affected patients (for example, name, social security number) that is not set out in this section or otherwise specified by the Secretary.

(3)

The REH must provide the information specified in this paragraph (f) on a daily basis, unless the Secretary specifies a lesser frequency, to the Centers for Disease Control and Prevention's (CDC) National Healthcare Safety Network or other CDC-supported surveillance systems as determined by the Secretary.

(g)

Standard: COVID-19 vaccination of REH staff. Until November 4, 2024, unless the Secretary specifies an earlier end date for the requirements of this paragraph (g), the REH must develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. For purposes of this section, staff are considered fully vaccinated if it has been 2 weeks or more since they completed a primary vaccination series for COVID-19. The completion of a primary vaccination series for COVID-19 is defined here as the administration of a single-dose vaccine, or the administration of all required doses of a multi-dose vaccine.

(1)

Regardless of clinical responsibility or patient contact, the policies and procedures must apply to the following REH staff, who provide any care, treatment, or other services for the REH and/or its patients:

(i)

REH employees;

(ii)

Licensed practitioners;

(iii)

Students, trainees, and volunteers; and

(iv)

Individuals who provide care, treatment, or other services for the REH and/or its patients, under contract or by other arrangement.

(2)

The policies and procedures of this section do not apply to the following REH staff—

(i)

Staff who exclusively provide telehealth or telemedicine services outside of the REH setting and who do not have any direct contact with patients and other staff specified in paragraph (f)(1) of this section; and

(ii)

Staff who provide support services for the REH that are performed exclusively outside of the REH setting and who do not have any direct contact with patients and other staff specified in paragraph (f)(1) of this section.

(3)

The policies and procedures must include, at a minimum, the following components:

(i)

A process for ensuring all staff specified in paragraph (f)(1) of this section (except for those staff who have pending requests for, or who have been granted, exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations) have received, at a minimum, a single-dose COVID-19 vaccine, or the first dose of the primary vaccination series for a multi-dose COVID-19 vaccine prior to staff providing any care, treatment, or other services for the REH and/or its patients;

(ii)

A process for ensuring that all staff specified in paragraph (f)(1) of this section are fully vaccinated for COVID-19, except for those staff who have been granted exemptions to the vaccination requirements of this section, or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations;

(iii)

A process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19, for all staff who are not fully vaccinated for COVID-19;

(iv)

A process for tracking and securely documenting the COVID-19 vaccination status of all staff specified in paragraph (f)(1) of this section;

(v)

A process for tracking and securely documenting the COVID-19 vaccination status of any staff who have obtained any booster doses as recommended by the CDC;

(vi)

A process by which staff may request an exemption from the staff COVID-19 vaccination requirements based on an applicable Federal law;

(vii)

A process for tracking and securely documenting information provided by those staff who have requested, and for whom the REH has granted, an exemption from the staff COVID-19 vaccination requirements based on recognized clinical contraindications or applicable Federal laws;

(viii)

A process for ensuring that all documentation, which confirms recognized clinical contraindications to COVID-19 vaccines and which supports staff requests for medical exemptions from vaccination, has been signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable state and local laws, and for further ensuring that such documentation contains:

(A)

All information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and

(B)

A statement by the authenticating practitioner recommending that the staff member be exempted from the REH's COVID-19 vaccination requirements for staff based on the recognized clinical contraindications;

(ix)

A process for ensuring the tracking and secure documentation of the vaccination status of staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations, including, but not limited to, individuals with acute illness secondary to COVID-19, and individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment; and

(x)

Contingency plans for staff who are not fully vaccinated for COVID-19.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.528. Condition of participation: Staffing and staff responsibilities.

42 C.F.R. § 485.528

(a)

Standard: Emergency department staffing. The emergency department of the REH must be staffed 24 hours a day, 7 days a week by an individual or individuals competent in the skills needed to address emergency medical care. This individual(s) must be able to receive patients and activate the appropriate medical resources to meet the care needed by the patient.

(b)

Standard: Staffing.

(1)

The REH must have a professional health care staff that includes one or more doctors of medicine or osteopathy, and may include one or more physician assistants, nurse practitioners, or clinical nurse specialists.

(2)

Any ancillary personnel are supervised by the professional staff.

(3)

The staff is sufficient to provide the services essential to the operation of the REH.

(4)

A registered nurse, clinical nurse specialist, or licensed practical nurse is on duty whenever the REH has one or more patients receiving emergency care or observation care.

(c)

Standard: Responsibilities of the doctor of medicine or osteopathy.

(1)

The doctor of medicine or osteopathy must —

(i)

Provide medical direction for the REH's health care activities and consultation for, and medical supervision of, the health care staff.

(ii)

In conjunction with the physician assistant and/or nurse practitioner member(s), participate in developing, executing, and periodically reviewing the REH's written policies governing the services it furnishes.

(iii)

In conjunction with the physician assistant and/or nurse practitioner members, periodically review the REH's patient records, provide medical orders, and provide medical care services to the patients of the REH.

(iv)

Periodically review and sign a sample of outpatient records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants only to the extent where state law requires record reviews or co-signatures, or both, by a collaborating physician.

(2)

A doctor of medicine or osteopathy must be present for sufficient periods of time to provide medical direction, consultation, and supervision for the services provided in the REH, and is available through direct radio or telephone communication or electronic communication for consultation, assistance with medical emergencies, or patient referral.

(d)

Standard: Physician assistant, nurse practitioner, and clinical nurse specialist responsibilities.

(1)

The physician assistant, the nurse practitioner, or clinical nurse specialist members of the REH's staff must —

(i)

Participate in the development, execution and periodic review of the written policies governing the services the REH furnishes; and

(ii)

Participate with a doctor of medicine or osteopathy in a periodic review of the patients' health records.

(2)

The physician assistant, nurse practitioner, or clinical nurse specialist performs the following functions to the extent they are not being performed by a doctor of medicine or osteopathy:

(i)

Provides services in accordance with the REH's policies.

(ii)

Arranges for, or refers patients to, needed services that cannot be furnished at the REH, and assures that adequate patient health records are maintained and transferred as required when patients are referred.

(3)

Whenever a patient is placed in observation care at the REH by a nurse practitioner, physician assistant, or clinical nurse specialist, a doctor of medicine or osteopathy on the staff of the REH is notified of the patient's status.

(e)

Standard: Periodic review of clinical privileges and performance. The REH requires that —

(1)

The quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialists, and physician assistants at the REH must be evaluated by a member of the REH staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under contract with the REH.

(2)

The quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the REH must be evaluated by one of the following —

(i)

One Quality Improvement Organization (QIO) or equivalent entity.

(ii)

In the case of distant-site physicians and practitioners providing telemedicine services to the REH's patient under an agreement between the REH and a distant-site hospital, the distant-site hospital; or

(iii)

In the case of distant-site physicians and practitioners providing telemedicine services to the REH's patients under a written agreement between the REH and a distant-site telemedicine entity, one Quality Improvement Organization (QIO) or equivalent entity.

(3)

The REH staff consider the findings of the evaluation and make the necessary changes as specified in paragraphs (b) through (d) of this section.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.530. Condition of participation: Nursing services.

42 C.F.R. § 485.530

The REH must have an organized nursing service that is available to provide 24-hour nursing services for the provision of patient care. The nursing services must be furnished and supervised by a registered nurse. Nursing services must meet the needs of patients.

(a)

Standard: Organization and staffing. Patient care responsibilities must be delineated for all nursing service personnel. Nursing services must be provided in accordance with recognized standards of practice.

(b)

Standard: Nursing leadership. The director of the nursing service must be a licensed registered nurse. The individual 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 REH.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.532. Condition of participation: Discharge planning.

42 C.F.R. § 485.532

An REH must have an effective discharge planning process that focuses on the patient's goals and treatment preferences and includes the patient and their caregivers/support person(s) as active partners in the discharge planning for post-discharge care. The discharge planning process and the discharge plan must be consistent with the patient's goals for care and their treatment preferences, ensure an effective transition of the patient from the REH to post-discharge care, and reduce the factors leading to preventable hospital admissions or readmissions.

(a)

Standard: Discharge planning process. The REH's discharge planning process must identify, at an early stage of the provision of services, those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge planning and must provide a discharge planning evaluation for those patients so identified as well as for other patients upon the request of the patient, patient's representative, or patient's physician.

(1)

Any discharge planning evaluation must be made on a timely basis to ensure that appropriate arrangements for post-REH care will be made before discharge and to avoid unnecessary delays in discharge.

(2)

A discharge planning evaluation must include an evaluation of a patient's likely need for appropriate services following those furnished by the REH, including, but not limited to, hospice care services, post-REH extended care services, home health services, and non-health care services and community-based care providers, and must also include a determination of the availability of the appropriate services as well as of the patient's access to those services.

(3)

The discharge planning evaluation must be included in the patient's medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient's representative).

(4)

Upon the request of a patient's physician, the REH must arrange for the development and initial implementation of a discharge plan for the patient.

(5)

Any discharge planning evaluation or discharge plan required under this paragraph (a) must be developed by, or under the supervision of, a registered nurse, social worker, or other appropriately qualified personnel.

(6)

The REH's discharge planning process must require regular re-evaluation of the patient's condition to identify changes that require modification of the discharge plan. The discharge plan must be updated, as needed, to reflect these changes.

(7)

The REH must assess its discharge planning process on a regular basis. The assessment must include ongoing periodic review of a representative sample of discharge plans.

(8)

The REH must assist patients, their families, or the patient's representative in selecting a post-acute care provider by using and sharing data that includes, but is not limited to, home health agency (HHA), skilled nursing facility (SNF), inpatient rehabilitation facility (IRF), or long term care hospital (LTCH) data on quality measures and data on resource use measures. The REH must ensure that the post-acute care data on quality measures and data on resource use measures is relevant and applicable to the patient's goals of care and treatment preferences.

(b)

Standard: Discharge of the patient and provision and transmission of the patient's necessary medical information. The REH must discharge the patient, and also transfer or refer the patient where applicable, along with all necessary medical information pertaining to the patient's current course of illness and treatment, post-discharge goals of care, and treatment preferences, at the time of discharge, to the appropriate post-acute care service providers and suppliers, facilities, agencies, and other outpatient service providers and practitioners responsible for the patient's follow-up or ancillary care.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.534. Condition of participation: Patient's rights.

42 C.F.R. § 485.534

An REH must protect and promote each patient's rights.

(a)

Standard: Notice of rights.

(1)

An REH 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.

(2)

The REH must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The REH's governing body or responsible individual 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:

(i)

The REH must establish a clearly explained procedure for the submission of a patient's written or verbal grievance to the REH.

(ii)

The grievance process must specify time frames for review of the grievance and the provision of a response.

(iii)

In its resolution of the grievance, the REH must provide the patient with written notice of its decision that contains the name of the REH 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.

(b)

Standard: Exercise of rights. The patient has the right to—

(1)

Participate in the development and implementation of their plan of care.

(2)

Make informed decisions regarding their care, including being informed of their health status, 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.

(3)

Formulate advance directives and to have REH staff and practitioners who provide care in the REH comply with these directives, in accordance with §§ 489.100, 489.102, and 489.104 of this chapter.

(c)

Standard: Privacy and safety. The patient has the right to—

(1)

Personal privacy.

(2)

Receive care in a safe setting.

(3)

Be free from all forms of abuse or harassment.

(d)

Standard: Confidentiality of patient records.

(1)

The patient has the right to the confidentiality of their medical records.

(2)

The patient has the right to access their medical records, including current medical records, upon an oral or written request.

(i)

The records must be provided in the form and format requested by the individual, if it is readily producible in such form and format. This includes in an electronic form or format when such medical records are maintained electronically or if not, in a readable hard copy form or such other form and format as agreed to by the facility and the individual.

(ii)

The records must be provided within a reasonable time frame. The REH 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.

(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.

(1)

(i)

A <I>restraint is</I>—

(A)

Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move their arms, legs, body, or head freely; or

(B)

A drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition.

(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, off of a stretcher, or out of a chair, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort).

(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.

(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.

(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.

(4)

The REH must have written policies and procedures regarding the use of restraint and seclusion that are consistent with current standards of practice.

(f)

Standard: Restraint or seclusion: Staff training requirements. The patient has the right to safe implementation of restraint or seclusion by trained staff.

(1)

The REH must provide patient-centered competency-based training and education of REH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the REH, on the use of restraint and seclusion.

(2)

The training must include alternatives to the use of restraint/seclusion.

(g)

Standard: Death reporting requirements. REHs must report deaths associated with the use of seclusion or restraint.

(1)

With the exception of deaths described under paragraph (g)(2) of this section, the REH must report the following information to CMS by telephone, facsimile, or electronically, as determined by CMS, no later than the close of business on the next business day following knowledge of the patient's death:

(i)

Each death that occurs while a patient is in restraint or seclusion.

(ii)

Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion.

(iii)

Each death known to the REH that occurs within 1 week after restraint or seclusion where it is reasonable to assume that use of restraint or placement in seclusion contributed directly or indirectly to a patient's death, regardless of the type(s) of restraint used on the patient during this time. “Reasonable to assume” in this context includes, but is not limited to, deaths related to restrictions of movement for prolonged periods of time, or death related to chest compression, restriction of breathing, or asphyxiation.

(2)

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 REH 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:

(i)

Reported to CMS for deaths described in paragraph (g)(1) of this section; or

(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 internal 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 practitioner who is responsible for the care of the patient, 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.

(h)

Standard: Patient visitation rights— . An REH 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 REH may need to place on such rights and the reasons for the clinical restriction or limitation. An REH must meet the following requirements:

(1)

Inform each patient (or support person, where appropriate) of their visitation rights, including any clinical restriction or limitation on such rights, when they are informed of their other rights under this section.

(2)

Inform each patient (or support person, where appropriate) of the right, subject to their consent, to receive the visitors whom they designate, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and their right to withdraw or deny such consent at any time.

(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.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.536. Condition of participation: Quality assessment and performance improvement program.

42 C.F.R. § 485.536

The REH must develop, implement, and maintain an effective, ongoing, REH-wide, data-driven quality assessment and performance improvement (QAPI) program. The REH's governing body must ensure that the program reflects the complexity of the REH's organization and services; involves all REH 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 REH must maintain and demonstrate evidence of its QAPI program for review by CMS.

(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 and identify and reduce medical errors.

(2)

The REH must measure, analyze, and track quality indicators, including adverse patient events, staffing, and other aspects of performance that assess processes of care including REH service and operations.

(b)

Standard: Program data collection and analysis. The program must incorporate quality indicator data including patient care data, and other relevant data, in order to achieve the goals of the QAPI program.

(c)

Standard: Program activities.

(1)

The REH 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 REH. An adverse patient event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof. Medical error means an error that occurs in the delivery of health care services.

(3)

The REH must take actions aimed at performance improvement and, after implementing those actions, the REH must measure its success, and track performance to ensure that improvements are sustained.

(d)

Standard: Executive responsibilities. The REH's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the REH), 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 REH-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety; and that all improvement actions are evaluated.

(3)

That clear expectations for safety are established.

(4)

That adequate resources are allocated for measuring, assessing, improving, and sustaining the REH's performance and reducing risk to patients.

(e)

Standard: Unified and integrated QAPI program for an REH in a multi-facility system— . If an REH is part of a system consisting of multiple separately certified hospitals, CAHs, and/or REHs using a system governing body that is legally responsible for the conduct of two or more hospitals, CAHs, and/or REHs, the system governing body can elect to have a unified and integrated QAPI program for all of its member facilities after determining that such a decision is in accordance with all applicable state and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified REHs meets all of the requirements of this section. Each separately certified REH subject to the system governing body must demonstrate that—

(1)

The unified and integrated QAPI program is established in a manner that takes into account each member REH's unique circumstances and any significant differences in patient populations and services offered in each REH; and

(2)

The unified and integrated QAPI program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified REHs, regardless of practice or location, are given due consideration, and that the unified and integrated QAPI program has mechanisms in place to ensure that issues localized to particular REHs are duly considered and addressed.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.538. Condition of participation: Agreements.

42 C.F.R. § 485.538

The REH must have in effect an agreement with at least one certified hospital that is a level I or level II trauma center for the referral and transfer of patients requiring emergency medical care beyond the capabilities of the REH that is—

(a)

Licensed as a hospital in a state that provides for the licensing of hospitals under state or applicable local law or approved by the agency of such state or locality responsible for licensing hospitals, as meeting standards established for licensing established by the agency of the state; and

(b)

Licensed or designated by the state or local government authority as level I or level II trauma center or is verified by the American College of Surgeons as a level I or level II trauma center.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.540. Condition of participation: Medical records.

42 C.F.R. § 485.540

(a)

Standard: Records system.

(1)

The REH must maintain a medical records system in accordance with written policies and procedures.

(2)

The records must be legible, complete, accurately documented, readily accessible, and systematically organized.

(3)

A designated member of the professional staff is responsible for maintaining the records and for ensuring that they are completely and accurately documented, readily accessible, and systematically organized.

(4)

For each patient receiving health care services, the REH must maintain a record that includes, as applicable—

(i)

Identification and social data, evidence of properly executed informed consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition, and instructions to the patient;

(ii)

Reports of physical examinations, diagnostic and laboratory test results, including clinical laboratory services, and consultative findings;

(iii)

All orders of doctors of medicine or osteopathy or other practitioners, reports of treatments and medications, nursing notes and documentation of complications, and other pertinent information necessary to monitor the patient's progress, such as temperature graphics, progress notes describing the patient's response to treatment; and

(iv)

Dated signatures of the doctor of medicine or osteopathy or other health care professional.

(b)

Standard: Protection of record information.

(1)

The REH must maintain the confidentiality of record information and provides safeguards against loss, destruction, or unauthorized use.

(2)

The REH must have written policies and procedures that govern the use and removal of records from the REH and the conditions for the release of information.

(3)

The patient's written consent is required for release of information not required by law.

(c)

Standard: Retention of records. The records must be retained for at least 5 years from date of last entry, and longer if required by state statute, or if the records may be needed in any pending proceeding.

(d)

Standard: Electronic notifications. If the REH utilizes an electronic medical records system or other electronic administrative system, which is conformant with the content exchange standard at 45 CFR 170.205(d)(2), then the REH must demonstrate that—

(1)

The system's notification capacity is fully operational and the REH uses it in accordance with all state and Federal statutes and regulations applicable to the REH's exchange of patient health information.

(2)

The system sends notifications that must include at least patient name, treating practitioner name, and sending institution name.

(3)

To the extent permissible under applicable Federal and state law and regulations, and not inconsistent with the patient's expressed privacy preferences, the system sends notifications directly, or through an intermediary that facilitates exchange of health information, at the time of the patient's registration in the REH's emergency department.

(4)

To the extent permissible under applicable Federal and state law and regulations, and not inconsistent with the patient's expressed privacy preferences, the system sends notifications directly, or through an intermediary that facilitates exchange of health information, either immediately prior to, or at the time the patient's discharge or transfer from the REH's emergency department.

(5)

The REH has made a reasonable effort to ensure that the system sends the notifications to all applicable post-acute care services providers and suppliers, as well as to any of the following practitioners and entities, which need to receive notification of the patient's status for treatment, care coordination, or quality improvement purposes:

(i)

The patient's established primary care practitioner;

(ii)

The patient's established primary care practice group or entity; or

(iii)

Other practitioner, or other practice group or entity, identified by the patient as the practitioner, or practice group or entity, primarily responsible for their care.

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

§485.542. Condition of participation: Emergency preparedness.

42 C.F.R. § 485.542

The REH must comply with all applicable Federal, state, and local emergency preparedness requirements. The REH must establish and maintain an emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements:

(a)

Emergency plan. The REH must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least every 2 years. The plan must do the following:

(1)

Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.

(2)

Include strategies for addressing emergency events identified by the risk assessment.

(3)

Address patient population, including, but not limited to, the type of services the REH has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.

(4)

Include a process for cooperation and collaboration with local, tribal, regional, state, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.

(b)

Policies and procedures. The REH must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:

(1)

The provision of subsistence needs for staff and patients, whether they evacuate or shelter in place, include, but are not limited to—

(i)

Food, water, medical, and pharmaceutical supplies;

(ii)

Alternate sources of energy to maintain—

(A)

Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions;

(B)

Emergency lighting;

(C)

Fire detection, extinguishing, and alarm systems; and

(D)

Sewage and waste disposal.

(2)

A system to track the location of on-duty staff and sheltered patients in the REH's care during an emergency. If on-duty staff or sheltered patients are relocated during the emergency, the REH must document the specific name and location of the receiving facility or other location.

(3)

Safe evacuation from the REH, which includes the following—

(i)

Consideration of care and treatment needs of evacuees.

(ii)

Staff responsibilities.

(iii)

Transportation.

(iv)

Identification of evacuation location(s).

(v)

Primary and alternate means of communication with external sources of assistance.

(4)

A means to shelter in place for patients, staff, and volunteers who remain in the REH.

(5)

A system of medical documentation that does the following—

(i)

Preserves patient information.

(ii)

Protects confidentiality of patient information.

(iii)

Secures and maintains the availability of records.

(6)

The use of volunteers in an emergency and other staffing strategies, including the process and role for integration of state and federally designated health care professionals to address surge needs during an emergency.

(7)

The role of the REH under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.

(c)

Communication plan. The REH must develop and maintain an emergency preparedness communication plan that complies with Federal, state, and local laws and must be reviewed and updated at least every 2 years. The communication plan must include all of the following:

(1)

Names and contact information for the following—

(i)

Staff.

(ii)

Entities providing services under arrangement.

(iii)

Patients' physicians.

(iv)

Volunteers.

(2)

Contact information for the following—

(i)

Federal, state, tribal, regional, and local emergency preparedness staff.

(ii)

Other sources of assistance.

(3)

Primary and alternate means for communicating with the following:

(i)

REH's staff.

(ii)

Federal, state, tribal, regional, and local emergency management agencies.

(4)

A method for sharing information and medical documentation for patients under the REH's care, as necessary, with other health care providers to maintain the continuity of care.

(5)

A means, in the event of an evacuation, to release patient information as permitted under 45 CFR 164.510(b)(1)(ii).

(6)

A means of providing information about the general condition and location of patients under the facility's care as permitted under 45 CFR 164.510(b)(4).

(7)

A means of providing information about the REH's needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.

(d)

Training and testing. The REH must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years.

(1)

Training program. The REH must do all of the following:

(i)

Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing on-site services under arrangement, and volunteers, consistent with their expected roles.

(ii)

Provide emergency preparedness training at least every 2 years.

(iii)

Maintain documentation of all emergency preparedness training.

(iv)

Demonstrate staff knowledge of emergency procedures.

(v)

If the emergency preparedness policies and procedures are significantly updated, the REH must conduct training on the updated policies and procedures.

(2)

Testing. The REH must conduct exercises to test the emergency plan at least annually. The REH must do the following:

(i)

Participate in a full-scale exercise that is community-based every 2 years.

(A)

When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or

(B)

If the REH experiences an actual natural or man-made emergency that requires activation of the emergency plan, the REH is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the emergency event.

(ii)

Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:

(A)

A second full-scale exercise that is community-based, or an individual, facility-based functional exercise; or

(B)

A mock disaster drill; or

(C)

A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.

(iii)

Analyze the REH's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the REH's emergency plan, as needed.

(e)

Emergency and standby power systems. The REH must implement emergency and standby power systems based on the emergency plan set forth in paragraph (a) of this section.

(1)

Emergency generator location. The generator must be located in accordance with the location requirements found in the Health Care Facilities Code (NFPA 99 and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5, and TIA 12-6), Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4), and NFPA 110, when a new structure is built or when an existing structure or building is renovated.

(2)

Emergency generator inspection and testing. The REH must implement emergency power system inspection and testing requirements found in the Health Care Facilities Code, NFPA 110, and the Life Safety Code.

(3)

Emergency generator fuel. REHs that maintain an onsite fuel source to power emergency generators must have a plan for how it will keep emergency power systems operational during the emergency, unless it evacuates.

(f)

Integrated healthcare systems. If an REH is part of a healthcare system consisting of multiple separately certified healthcare facilities that elects to have a unified and integrated emergency preparedness program, the REH may choose to participate in the healthcare system's coordinated emergency preparedness program. If elected, the unified and integrated emergency preparedness program must—

(1)

Demonstrate that each separately certified facility within the system actively participated in the development of the unified and integrated emergency preparedness program.

(2)

Be developed and maintained in a manner that takes into account each separately certified facility's unique circumstances, patient populations, and services offered.

(3)

Demonstrate that each separately certified facility is capable of actively using the unified and integrated emergency preparedness program and is in compliance.

(4)

Include a unified and integrated emergency plan that meets the requirements of paragraphs (a)(2), (3), and (4) of this section. The unified and integrated emergency plan must also be based on and include the following:

(i)

A documented community-based risk assessment, utilizing an all-hazards approach.

(ii)

A documented individual facility-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach.

(5)

Include integrated policies and procedures that meet the requirements set forth in paragraph (b) of this section, a coordinated communication plan and training and testing programs that meet the requirements of paragraphs (c) and (d) of this section, respectively.

(g)

Incorporation by reference. The material listed in this paragraph (g) is incorporated by reference into this section with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, CMS must publish a document in the Federal Register and the material must be available to the public. All approved material is available for inspection at CMS and the National Archives and Records Administration (NARA). Contact CMS at: CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD, email: [email protected] or call (410) 786-9465. For information on the availability of this material at NARA, email: [email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the following source(s) in this paragraph (g):

(1)

National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.

(i)

NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11, 2011.

(ii)

Technical interim amendment (TIA) 12-2 to NFPA 99, issued August 11, 2011.

(iii)

TIA 12-3 to NFPA 99, issued August 9, 2012.

(iv)

TIA 12-4 to NFPA 99, issued March 7, 2013.

(v)

TIA 12-5 to NFPA 99, issued August 1, 2013.

(vi)

TIA 12-6 to NFPA 99, issued March 3, 2014.

(vii)

NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011.

(viii)

TIA 12-1 to NFPA 101, issued August 11, 2011.

(ix)

TIA 12-2 to NFPA 101, issued October 30, 2012.

(x)

TIA 12-3 to NFPA 101, issued October 22, 2013.

(xi)

TIA 12-4 to NFPA 101, issued October 22, 2013.

(xii)

NFPA 110, Standard for Emergency and Standby Power Systems, 2010 edition, including TIAs to chapter 7, issued August 6, 2009.

(2)

[Reserved]

Notes, amendments, and revision history

Amendments

[87 FR 72293, Nov. 23, 2022; 88 FR 299, Jan. 4, 2023]

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.

Amendments

[87 FR 72293, Nov. 23, 2022; 88 FR 299, Jan. 4, 2023]

§485.544. Condition of participation: Physical environment.

42 C.F.R. § 485.544

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

(a)

Standard: Buildings. The condition of the physical plant and the overall REH environment must be developed and maintained in such a manner that the safety and well-being of patients are ensured.

(1)

There must be emergency power and lighting in at least the operating, recovery, and emergency rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and flashlights must be available.

(2)

There must be facilities for emergency gas and water supply.

(3)

The REH must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients.

(b)

Standard: Facilities. The REH must maintain adequate facilities for its services.

(1)

Diagnostic and therapeutic facilities must be located for the safety of patients.

(2)

Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.

(3)

The extent and complexity of facilities must be determined by the services offered.

(4)

There must be proper ventilation, light, and temperature controls in patient care, pharmaceutical, food preparation, and other appropriate areas.

(c)

Standard: Safety from fire.

(1)

Except as otherwise provided in this section, the REH must meet the provisions applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served, and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4).

(2)

In consideration of a recommendation by the state survey agency or accrediting organization or at the discretion of the Secretary, CMS may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon an REH, but only if the waiver will not adversely affect the health and safety of the patients.

(3)

The provisions of the Life Safety Code do not apply in a state if CMS finds that a fire and safety code imposed by state law adequately protects patients in an REH.

(4)

An REH may place alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access.

(5)

When a sprinkler system is shut down for more than 10 hours, the REH must—

(i)

Evacuate the building or portion of the building affected by the system outage until the system is back in service, or

(ii)

Establish a fire watch until the system is back in service.

(d)

Standard: Building safety. Except as otherwise provided in this section, the REH must meet the applicable provisions and must proceed in accordance with the 2012 edition of the Health Care Facilities Code (NFPA 99, and Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 12-4, TIA 12-5 and TIA 12-6).

(1)

Chapters 7, 8, 12, and 13 of the adopted Health Care Facilities Code do not apply to an REH.

(2)

If application of the Health Care Facilities Code required under paragraph (d) of this section would result in unreasonable hardship for the REH, CMS may waive specific provisions of the Health Care Facilities Code, but only if the waiver does not adversely affect the health and safety of patients.

(e)

Incorporation by reference. The material listed in this paragraph (e) is incorporated by reference into this section with the approval the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, CMS must publish a document in the Federal Register and the material must be available to the public. All approved material is available for inspection at CMS and the National Archives and Records Administration (NARA). Contact CMS at: CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD, email [email protected] or call (410) 786-9465. For information on the availability of this material at NARA, email [email protected] or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the following source(s) in this paragraph (e).

(1)

National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169, www.nfpa.org, 1.617.770.3000.

(i)

NFPA 99, Health Care Facilities Code, 2012 edition, issued August 11, 2011.

(ii)

Technical interim amendment (TIA) 12-2 to NFPA 99, issued August 11, 2011.

(iii)

TIA 12-3 to NFPA 99, issued August 9, 2012.

(iv)

TIA 12-4 to NFPA 99, issued March 7, 2013.

(v)

TIA 12-5 to NFPA 99, issued August 1, 2013.

(vi)

TIA 12-6 to NFPA 99, issued March 3, 2014.

(vii)

NFPA 101, Life Safety Code, 2012 edition, issued August 11, 2011;

(viii)

TIA 12-1 to NFPA 101, issued August 11, 2011.

(ix)

TIA 12-2 to NFPA 101, issued October 30, 2012.

(x)

TIA 12-3 to NFPA 101, issued October 22, 2013.

(xi)

TIA 12-4 to NFPA 101, issued October 22, 2013.

(2)

[Reserved]

Notes, amendments, and revision history

Source

Source: 87 FR 72293, Nov. 23, 2022, unless otherwise noted.

Authority

Authority: 42 U.S.C. 1302 and 1395(hh).

Source

Source: 48 FR 56293, Dec. 15, 1982, unless otherwise noted. Redesignated at 50 FR 33034, Aug. 16, 1985.