42 C.F.R. §§ 482.25–482.57

§482.25. Condition of participation: Pharmaceutical services.

42 C.F.R. § 482.25

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

(a)

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

(1)

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

(2)

The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services, including emergency services.

(3)

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

(b)

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

(1)

All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed consistent with State and Federal laws.

(2)

(i)

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

(ii)

Drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 must be kept locked within a secure area.

(iii)

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Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.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

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

(5)

Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff.

(6)

Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital's quality assessment and performance improvement program.

(7)

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

(8)

Information relating to drug interactions and information of drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration must be available to the professional staff.

(9)

A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs.

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694, Nov. 27, 2006; 77 FR 29075, May 16, 2012]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986; 71 FR 68694, Nov. 27, 2006; 77 FR 29075, May 16, 2012]

§482.26. Condition of participation: Radiologic services.

42 C.F.R. § 482.26

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

(a)

Standard: Radiologic services. The hospital 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 precutions 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)

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

(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 his or her interpretations.

(2)

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

(i)

Copies of reports and printouts.

(ii)

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

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986]

§482.27. Condition of participation: Laboratory services.

42 C.F.R. § 482.27

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

(a)

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

(1)

Emergency laboratory services must be available 24 hours a day.

(2)

A written description of services provided must be available to the medical staff.

(3)

The laboratory must make provision for proper receipt and reporting of tissue specimens.

(4)

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

(b)

Standard: Potentially infectious blood and blood components—

(1)

Potentially human immunodeficiency virus (HIV) infectious blood and blood components. Potentially HIV infectious blood and blood components are prior collections from a donor—

(i)

Who tested negative at the time of donation but tests reactive for evidence of HIV infection on a later donation;

(ii)

Who tests positive on the supplemental (additional, more specific) test or other follow-up testing required by FDA; and

(iii)

For whom the timing of seroconversion cannot be precisely estimated.

(2)

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

(3)

Services furnished by an outside blood collecting establishment. If a hospital regularly uses the services of an outside blood collecting establishment, it must have an agreement with the blood collecting establishment that governs the procurement, transfer, and availability of blood and blood components. The agreement must require that the blood collecting establishment notify the hospital—

(i)

Within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection;

(ii)

Within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA; and

(iii)

Within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available.

(4)

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

(i)

If the blood collecting establishment notifies the hospital that the result of the supplemental (additional, more specific) test or other follow-up testing required by FDA is negative, absent other informative test results, the hospital may release the blood and blood components from quarantine.

(ii)

If the blood collecting establishment notifies the hospital that the result of the supplemental, (additional, more specific) test or other follow-up testing required by FDA is positive, the hospital must—

(A)

Dispose of the blood and blood components; and

(B)

Notify the transfusion beneficiaries as set forth in paragraph (b)(6) of this section.

(iii)

If the blood collecting establishment notifies the hospital that the result of the supplemental, (additional, more specific) test or other follow-up testing required by FDA is indeterminate, the hospital must destroy or label prior collections of blood or blood components held in quarantine as set forth at 21 CFR 610.46(b)(2) and 610.47(b)(2).

(5)

Recordkeeping by the hospital. The hospital must maintain—

(i)

Records of the source and disposition of all units of blood and blood components for at least 10 years from the date of disposition in a manner that permits prompt retrieval; and

(ii)

A fully funded plan to transfer these records to another hospital or other entity if such hospital ceases operation for any reason.

(6)

Patient notification. If the hospital has administered potentially HIV or HCV infectious blood or blood components (either directly through its own blood collecting establishment or under an agreement) or released such blood or blood components to another entity or individual, the hospital must take the following actions:

(i)

Make reasonable attempts to notify the patient, or to notify the attending physician or the physician who ordered the blood or blood component and ask the physician to notify the patient, or other individual as permitted under paragraph (b)(10) of this section, that potentially HIV or HCV infectious blood or blood components were transfused to the patient and that there may be a need for HIV or HCV testing and counseling.

(ii)

If the physician is unavailable or declines to make the notification, make reasonable attempts to give this notification to the patient, legal guardian, or relative.

(iii)

Document in the patient's medical record the notification or attempts to give the required notification.

(7)

Timeframe for notification— For donors tested on or after February 20, 2008. For notifications resulting from donors tested on or after February 20, 2008 as set forth at 21 CFR 610.46 and 610.47 the notification effort begins when the blood collecting establishment notifies the hospital that it received potentially HIV or HCV infectious blood and blood components. The hospital must make reasonable attempts to give notification over a period of 12 weeks unless—

(i)

The patient is located and notified; or

(ii)

The hospital is unable to locate the patient and documents in the patient's medical record the extenuating circumstances beyond the hospital's control that caused the notification timeframe to exceed 12 weeks.

(8)

Content of notification. The notification must include the following information:

(i)

A basic explanation of the need for HIV or HCV testing and counseling;

(ii)

Enough oral or written information so that an informed decision can be made about whether to obtain HIV or HCV testing and counseling; and

(iii)

A list of programs or places where the person can obtain HIV or HCV testing and counseling, including any requirements or restrictions the program may impose.

(9)

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

(10)

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

(c)

General blood safety issues. For lookback activities only related to new blood safety issues that are identified after August 24, 2007, hospitals must comply with FDA regulations as they pertain to blood safety issues in the following areas:

(1)

Appropriate testing and quarantining of infectious blood and blood components.

(2)

Notification and counseling of beneficiaries that may have received infectious blood and blood components.

Notes, amendments, and revision history

Amendments

[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996; 72 FR 48573, Aug. 24, 2007; 84 FR 51819, Sept. 30, 2019; 85 FR 72909, Nov. 16, 2020]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[57 FR 7136, Feb. 28, 1992, as amended at 61 FR 47433, Sept. 9, 1996; 72 FR 48573, Aug. 24, 2007; 84 FR 51819, Sept. 30, 2019; 85 FR 72909, Nov. 16, 2020]

§482.28. Condition of participation: Food and dietetic services.

42 C.F.R. § 482.28

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

(a)

Standard: Organization.

(1)

The hospital must have a full-time employee who—

(i)

Serves as director of the food and dietetic service;

(ii)

Is responsible for the daily management of the dietary services; and

(iii)

Is qualified by experience or training.

(2)

There must be a qualified dietitian, full-time, part-time, or on a consultant basis.

(3)

There must be administrative and technical personnel competent in their respective duties.

(b)

Standard: Diets. Menus must meet the needs of the patients.

(1)

Individual patient nutritional needs must be met in accordance with recognized dietary practices.

(2)

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

(3)

A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel.

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 79 FR 27154, May 12, 2014]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 79 FR 27154, May 12, 2014]

§482.30. Condition of participation: Utilization review.

42 C.F.R. § 482.30

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

(a)

Applicability. The provisions of this section apply except in either of the following circumstances:

(1)

A Utilization and Quality Control Quality Improvement Organization (QIO) has assumed binding review for the hospital.

(2)

CMS has determined that the UR procedures established by the State under title XIX of the Act are superior to the procedures required in this section, and has required hospitals in that State to meet the UR plan requirements under §§ 456.50 through 456.245 of this chapter.

(b)

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

(1)

Except as specified in paragraphs (b) (2) and (3) of this section, the UR committee must be one of the following:

(i)

A staff committee of the institution;

(ii)

A group outside the institution—

(A)

Established by the local medical society and some or all of the hospitals in the locality; or

(B)

Established in a manner approved by CMS.

(2)

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

(3)

The committee's or group's reviews may not be conducted by any individual who—

(i)

Has a direct financial interest (for example, an ownership interest) in that hospital; or

(ii)

Was professionally involved in the care of the patient whose case is being reviewed.

(c)

Standard: Scope and frequency of review.

(1)

The UR plan must provide for review for Medicare and Medicaid patients with respect to the medical necessity of—

(i)

Admissions to the institution;

(ii)

The duration of stays; and

(iii)

Professional services furnished, including drugs and biologicals.

(2)

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

(3)

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

(4)

Hospitals that are paid for inpatient hospital services under the prospective payment system set forth in part 412 of this chapter must conduct review of duration of stays and review of professional services as follows:

(i)

For duration of stays, these hospitals need review only cases that they reasonably assume to be outlier cases based on extended length of stay, as described in § 412.80(a)(1)(i) of this chapter; and

(ii)

For professional services, these hospitals need review only cases that they reasonably assume to be outlier cases based on extraordinarily high costs, as described in § 412.80(a)(1)(ii) of this chapter.

(d)

Standard: Determination regarding admissions or continued stays.

(1)

The determination that an admission or continued stay is not medically necessary—

(i)

May be made by one member of the UR committee if the practitioner or practitioners responsible for the care of the patient, as specified of § 482.12(c), concur with the determination or fail to present their views when afforded the opportunity; and

(ii)

Must be made by at least two members of the UR committee in all other cases.

(2)

Before making a determination that an admission or continued stay is not medically necessary, the UR committee must consult the practitioner or practitioners responsible for the care of the patient, as specified in § 482.12(c), and afford the practitioner or practitioners the opportunity to present their views.

(3)

If the committee decides that admission to or continued stay in the hospital is not medically necessary, written notification must be given, no later than 2 days after the determination, to the hospital, the patient, and the practitioner or practitioners responsible for the care of the patient, as specified in § 482.12(c);

(e)

Standard: Extended stay review.

(1)

In hospitals that are not paid under the prospective payment system, the UR committee must make a periodic review, as specified in the UR plan, of each current inpatient receiving hospital services during a continuous period of extended duration. The scheduling of the periodic reviews may—

(i)

Be the same for all cases; or

(ii)

Differ for different classes of cases.

(2)

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

(3)

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

(f)

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

Notes, amendments, and revision history

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

§482.41. Condition of participation: Physical environment.

42 C.F.R. § 482.41

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

(a)

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

(1)

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

(2)

There must be facilities for emergency gas and water supply.

(b)

Standard: Life safety from fire.

(1)

Except as otherwise provided in this section—

(i)

The hospital must meet the applicable provisions 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.) Outpatient surgical departments must meet the provisions applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served.

(ii)

Notwithstanding paragraph (b)(1)(i) of this section, corridor doors and doors to rooms containing flammable or combustible materials must be provided with positive latching hardware. Roller latches are prohibited on such doors.

(2)

In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon a hospital, 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 where CMS finds that a fire and safety code imposed by State law adequately protects patients in hospitals.

(4)

The hospital must have procedures for the proper routine storage and prompt disposal of trash.

(5)

The hospital must have written fire control plans that contain provisions for prompt reporting of fires; extinguishing fires; protection of patients, personnel and guests; evacuation; and cooperation with fire fighting authorities.

(6)

The hospital must maintain written evidence of regular inspection and approval by State or local fire control agencies.

(7)

A hospital may install alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access;

(8)

When a sprinkler system is shut down for more than 10 hours, the hospital 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.

(9)

Buildings must have an outside window or outside door in every sleeping room, and for any building constructed after July 5, 2016 the sill height must not exceed 36 inches above the floor. Windows in atrium walls are considered outside windows for the purposes of this requirement.

(i)

The sill height requirement does not apply to newborn nurseries and rooms intended for occupancy for less than 24 hours.

(ii)

The sill height in special nursing care areas of new occupancies must not exceed 60 inches.

(c)

Standard: Building safety. Except as otherwise provided in this section, the hospital must meet the applicable provisions and must proceed in accordance with 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 a hospital.

(2)

If application of the Health Care Facilities Code required under paragraph (c) of this section would result in unreasonable hardship for the hospital, 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.

(d)

Standard: Facilities. The hospital 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 pharmaceutical, food preparation, and other appropriate areas.

(e)

The standards incorporated by reference in this section are approved for incorporation by reference by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may inspect a copy at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. If any changes in this edition of the Code are incorporated by reference, CMS will publish a document in the Federal Register to announce the changes.

(1)

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

(i)

NFPA 99, Standards for Health Care Facilities Code of the National Fire Protection Association 99, 2012 edition, issued August 11, 2011.

(ii)

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

Amendments

[51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988; 68 FR 1386, Jan. 10, 2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238, Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR 26899, May 4, 2016; 81 FR 42548, June 30, 2016]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 53 FR 11509, Apr. 7, 1988; 68 FR 1386, Jan. 10, 2003; 69 FR 49267, Aug. 11, 2004; 70 FR 15238, Mar. 25, 2005; 71 FR 55340, Sept. 22, 2006; 81 FR 26899, May 4, 2016; 81 FR 42548, June 30, 2016]

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

42 C.F.R. § 482.42

The hospital must have active hospital-wide programs for the surveillance, prevention, and control of 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 hospital-wide quality assessment and performance improvement (QAPI) program.

(a)

Standard: Infection prevention and control program organization and policies. The hospital 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 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 hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings;

(3)

The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and 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 hospital services provided.

(b)

Standard: Antibiotic stewardship program organization and policies. The hospital 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 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 hospital-wide antibiotic stewardship program—

(i)

Demonstrates coordination among all components of the hospital 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 hospital; 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 hospital services provided.

(c)

Standard: Leadership responsibilities.

(1)

The governing body 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 hospital QAPI leadership.

(2)

The infection preventionist(s)/infection control professional(s) is responsible for—

(i)

The development and implementation of hospital-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 hospital's QAPI program on infection prevention and control issues.

(iv)

Competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the hospital, 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 hospital 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 hospital-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 with the hospital's infection prevention and control and QAPI programs, on antibiotic use issues.

(iv)

Competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the hospital, 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-hospital systems. If a hospital is part of a hospital system consisting of multiple separately certified hospitals using a system governing body that is legally responsible for the conduct of two or more hospitals, the system governing body can elect to have unified and integrated infection prevention and control and antibiotic stewardship programs for all of its member hospitals 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 hospitals meets all of the requirements of this section. Each separately certified hospital 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 hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital;

(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 hospitals, 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 hospitals 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 hospital 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 hospital staff.

(e)

Respiratory illness reporting—

(1)

Ongoing reporting. The hospital must electronically report information on acute respiratory illnesses, including influenza, SARS-CoV-2/COVID-19, and RSV.

(i)

The report must be in a standardized format and frequency specified by the Secretary.

(ii)

To the extent as required by the Secretary, this report must include all of the following data elements:

(A)

Confirmed infections for a limited set of respiratory illnesses, including but not limited to influenza, SARS-CoV-2/COVID-19, and RSV, among newly admitted and hospitalized patients.

(B)

Total bed census and capacity, including for critical hospital units and age groups.

(C)

Limited patient demographic information, including but not limited to age.

(2)

Public health emergency (PHE) reporting. In the event that the Secretary has declared a national, State, or local PHE for an acute infectious illness, the hospital must also electronically report the following data elements in a standardized format and frequency specified by the Secretary:

(i)

Supply inventory shortages.

(ii)

Staffing shortages.

(iii)

Relevant medical countermeasures and therapeutic inventories, usage, or both.

(iv)

Facility structure and operating status, including hospital/ED diversion status.

Notes, amendments, and revision history

Amendments

[84 FR 51820, Sept. 30, 2019, as amended at 85 FR 54872, Sept. 2, 2020; 85 FR 86303, Dec. 29, 2020; 86 FR 61619, Nov. 5, 2021; 87 FR 49409, Aug. 10, 2022; 87 FR 66575, Nov. 4, 2022; 88 FR 36510, June 5, 2023; 89 FR 69913, Aug. 28, 2024]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[84 FR 51820, Sept. 30, 2019, as amended at 85 FR 54872, Sept. 2, 2020; 85 FR 86303, Dec. 29, 2020; 86 FR 61619, Nov. 5, 2021; 87 FR 49409, Aug. 10, 2022; 87 FR 66575, Nov. 4, 2022; 88 FR 36510, June 5, 2023; 89 FR 69913, Aug. 28, 2024]

§482.43. Condition of participation: Discharge planning.

42 C.F.R. § 482.43

The hospital must have an effective discharge planning process that focuses on the patient's goals and treatment preferences and includes the patient and his or her 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 his or her treatment preferences, ensure an effective transition of the patient from hospital to post-discharge care, and reduce the factors leading to preventable hospital readmissions.

(a)

Standard: Discharge planning process. The hospital's discharge planning process must identify, at an early stage of hospitalization, 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-hospital 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 post-hospital services, including, but not limited to, hospice care services, post-hospital 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 hospital 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 must be developed by, or under the supervision of, a registered nurse, social worker, or other appropriately qualified personnel.

(6)

The hospital'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 hospital must assess its discharge planning process on a regular basis. The assessment must include ongoing, periodic review of a representative sample of discharge plans, including those patients who were readmitted within 30 days of a previous admission, to ensure that the plans are responsive to patient post-discharge needs.

(8)

The hospital 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, HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. The hospital 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 hospital 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.

(c)

Standard: Transfer protocols. Effective July 1, 2025, the hospital must have written policies and procedures for transferring patients under its care (inclusive of inpatient services) to the appropriate level of care (including to another hospital) as needed to meet the needs of the patient. The hospital must also provide annual training to relevant staff regarding the hospital policies and procedures for transferring patients under its care.

(d)

Standard: Requirements related to post-acute care services. For those patients discharged home and referred for HHA services, or for those patients transferred to a SNF for post-hospital extended care services, or transferred to an IRF or LTCH for specialized hospital services, the following requirements apply, in addition to those set out at paragraphs (a) and (b) of this section:

(1)

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

(i)

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

(ii)

For patients enrolled in managed care organizations, the hospital must make the patient aware of the need to verify with their managed care organization which practitioners, providers or certified suppliers are in the managed care organization's network. If the hospital has information on which practitioners, providers or certified supplies are in the network of the patient's managed care organization, it must share this with the patient or the patient's representative.

(iii)

The hospital must document in the patient's medical record that the list was presented to the patient or to the patient's representative.

(2)

The hospital, as part of the discharge planning process, must inform the patient or the patient's representative of their freedom to choose among participating Medicare providers and suppliers of post-discharge services and must, when possible, respect the patient's or the patient's representative's goals of care and treatment preferences, as well as other preferences they express. The hospital must not specify or otherwise limit the qualified providers or suppliers that are available to the patient.

(3)

The discharge plan must identify any HHA or SNF to which the patient is referred in which the hospital has a disclosable financial interest, as specified by the Secretary, and any HHA or SNF that has a disclosable financial interest in a hospital under Medicare. Financial interests that are disclosable under Medicare are determined in accordance with the provisions of part 420, subpart C, of this chapter.

Notes, amendments, and revision history

Amendments

[84 FR 51882, Sept. 30, 2019, as amended at 89 FR 94592, Nov. 27, 2024]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[84 FR 51882, Sept. 30, 2019, as amended at 89 FR 94592, Nov. 27, 2024]

§482.45. Condition of participation: Organ, tissue, and eye procurement.

42 C.F.R. § 482.45

(a)

Standard: Organ procurement responsibilities. The hospital must have and implement written protocols that:

(1)

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

(2)

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

(3)

Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its options to donate organs, tissues, or eyes or to decline to donate. The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. A designated requestor is an individual who has completed a course offered or approved by the OPO and designed in conjunction with the tissue and eye bank community in the methodology for approaching potential donor families and requesting organ or tissue donation;

(4)

Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors;

(5)

Ensure that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in educating staff on donation issues, reviewing death records to improve identification of potential donors, and maintaining potential donors while necessary testing and placement of potential donated organs, tissues, and eyes take place.

(b)

Standard: Organ transplantation responsibilities.

(1)

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

(2)

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

(3)

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

Notes, amendments, and revision history

Amendments

[63 FR 33875, June 22, 1998]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[63 FR 33875, June 22, 1998]

§482.51. Condition of participation: Surgical services.

42 C.F.R. § 482.51

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

(a)

Standard: Organization and staffing. The organization of the surgical services must be appropriate to the scope of the services offered.

(1)

The operating rooms must be supervised by an experienced registered nurse or a doctor of medicine or osteopathy.

(2)

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

(3)

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

(4)

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

(b)

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

(1)

Prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies—

(i)

A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, and except as provided under paragraph (b)(1)(iii) of this section.

(ii)

An updated examination of the patient, including any changes in the patient's condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under paragraph (b)(1)(iii) of this section.

(iii)

An assessment of the patient must be completed and documented after registration (in lieu of the requirements of paragraphs (b)(1)(i) and (ii) of this section) when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at § 482.22(c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services.

(2)

A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies.

(3)

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

(4)

There must be adequate provisions for immediate post-operative care.

(5)

The operating room register must be complete and up-to-date.

(6)

An operative report describing techniques, findings, and tissues removed or altered must be written or dictated immediately following surgery and signed by the surgeon.

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 72 FR 66933, Nov. 27, 2007; 84 FR 51821, Sept. 30, 2019]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 72 FR 66933, Nov. 27, 2007; 84 FR 51821, Sept. 30, 2019]

§482.52. Condition of participation: Anesthesia services.

42 C.F.R. § 482.52

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

(a)

Standard: Organization and staffing. The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by—

(1)

A qualified anesthesiologist;

(2)

A doctor of medicine or osteopathy (other than an anesthesiologist);

(3)

A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law;

(4)

A certified registered nurse anesthetist (CRNA), as defined in § 410.69(b) of this chapter, who, unless exempted in accordance with paragraph (c)of this section, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or

(5)

An anesthesiologist's assistant, as defined in § 410.69(b) of this chapter, who is under the supervision of an anesthesiologist who is immediately available if needed.

(b)

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

(1)

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

(2)

An intraoperative anesthesia record.

(3)

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

(c)

Standard: State exemption.

(1)

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

(2)

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

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 57 FR 33900, July 31, 1992; 66 FR 56769, Nov. 13, 2001; 71 FR 68694, Nov. 27, 2006; 72 FR 66934, Nov. 27, 2007]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 57 FR 33900, July 31, 1992; 66 FR 56769, Nov. 13, 2001; 71 FR 68694, Nov. 27, 2006; 72 FR 66934, Nov. 27, 2007]

§482.53. Condition of participation: Nuclear medicine services.

42 C.F.R. § 482.53

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

(a)

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

(1)

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

(2)

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

(b)

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

(1)

In-house preparation of radiopharmaceuticals is by, or under the supervision of, an appropriately trained registered pharmacist or a doctor of medicine or osteopathy.

(2)

There is proper storage and disposal of radioactive material.

(3)

If laboratory tests are performed in the nuclear medicine service, the service must meet the applicable requirement for laboratory services specified in § 482.27.

(c)

Standard: Facilities. Equipment and supplies must be appropriate for the types of nuclear medicine services offered and must be maintained for safe and efficient performance. The equipment must be—

(1)

Maintained in safe operating condition; and

(2)

Inspected, tested, and calibrated at least annually by qualified personnel.

(d)

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

(1)

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

(2)

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

(3)

The hospital must maintain records of the receipt and disposition of radiopharmaceuticals.

(4)

Nuclear medicine services must be ordered only by practitioner whose scope of Federal or State licensure and whose defined staff privileges allow such referrals.

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992; 79 FR 27154, May 12, 2014]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 57 FR 7136, Feb. 28, 1992; 79 FR 27154, May 12, 2014]

§482.54. Condition of participation: Outpatient services.

42 C.F.R. § 482.54

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

(a)

Standard: Organization. Outpatient services must be appropriately organized and integrated with inpatient services.

(b)

Standard: Personnel. The hospital 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.

(c)

Standard: Orders for outpatient services. Outpatient 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 he or she provides care to the patient.

(3)

Is acting within his or her 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 hospital's medical staff and who have been granted privileges to order the applicable outpatient services.

(ii)

All practitioners not appointed to the medical staff, but who satisfy the above criteria for authorization by the medical staff and the hospital for ordering the applicable outpatient services for their patients.

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 77 FR 29075, May 16, 2012; 79 FR 27154, May 12, 2014]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 77 FR 29075, May 16, 2012; 79 FR 27154, May 12, 2014]

§482.55. Condition of participation: Emergency services.

42 C.F.R. § 482.55

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

(a)

Standard: Organization and direction. If emergency services are provided at the hospital—

(1)

The services must be organized under the direction of a qualified member of the medical staff;

(2)

The services must be integrated with other departments of the hospital;

(3)

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

(b)

Standard: Personnel.

(1)

The emergency services must be supervised by a qualified member of the medical staff.

(2)

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: Emergency services readiness. Effective July 1, 2025, in accordance with the complexity and scope of services offered, there must be adequate provisions and protocols to meet the emergency needs of patients.

(1)

Protocols. Protocols must be consistent with nationally recognized and evidence-based guidelines for the care of patients with emergency conditions, including but not limited to patients with obstetrical emergencies, complications, and immediate post-delivery care.

(2)

Provisions. Provisions include equipment, supplies, and medication used in treating emergency cases. Such provisions must be kept at the hospital and be readily available for treating emergency cases to meet the needs of patients. The available provisions must include the following:

(i)

Drugs, blood and blood products, and biologicals commonly used in life-saving procedures;

(ii)

Equipment and supplies commonly used in life-saving procedures; and

(iii)

Each emergency services treatment area must have a call-in-system for each patient.

(3)

Staff training. Applicable staff, as identified by the hospital, must be trained annually on the protocols and provisions implemented pursuant to this section.

(i)

The governing body must identify and document which staff must complete such training.

(ii)

The hospital must document in the staff personnel records that the training was successfully completed.

(iii)

The hospital must be able to demonstrate staff knowledge on the topics implemented pursuant to this section.

(iv)

The hospital must use findings from its QAPI program, as required at § 482.21, to inform staff training needs and any additions, revisions, or updates to training topics on an ongoing basis.

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 89 FR 94592, Nov. 27, 2024]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 89 FR 94592, Nov. 27, 2024]

§482.56. Condition of participation: Rehabilitation services.

42 C.F.R. § 482.56

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

(a)

Standard: Organization and staffing. The organization of the service must be appropriate to the scope of the services offered.

(1)

The director of the services must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services.

(2)

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

(b)

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

(1)

All rehabilitation services orders must be documented in the patient's medical record in accordance with the requirements at § 482.24.

(2)

The provision of care and the personnel qualifications must be in accordance with national acceptable standards of practice and must also meet the requirements of § 409.17 of this chapter.

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986, as amended at 72 FR 66406, Nov. 27, 2007; 75 FR 50418, Aug. 16, 2010]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986, as amended at 72 FR 66406, Nov. 27, 2007; 75 FR 50418, Aug. 16, 2010]

§482.57. Condition of participation: Respiratory care services.

42 C.F.R. § 482.57

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

(a)

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

(1)

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

(2)

There must be adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with State law.

(b)

Standard: Delivery of Services. Services must be delivered in accordance with medical staff directives.

(1)

Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures must be designated in writing.

(2)

If blood gases or other laboratory tests are performed in the respiratory care unit, the unit must meet the applicable requirements for laboratory services specified in § 482.27.

(3)

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

(4)

All respiratory care services orders must be documented in the patient's medical record in accordance with the requirements at § 482.24.

Notes, amendments, and revision history

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 57 FR 7136, Feb. 28, 1992; 75 FR 50418, Aug. 16, 2010]

Authority

Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise noted.

Source

Source: 51 FR 22042, June 17, 1986, unless otherwise noted.

Amendments

[51 FR 22042, June 17, 1986; 51 FR 27848, Aug. 4, 1986, as amended at 57 FR 7136, Feb. 28, 1992; 75 FR 50418, Aug. 16, 2010]