42 C.F.R. Subpart F—Conditions of Participation: Critical Access Hospitals (CAHs)
Title 42 - Public Health
Source: 58 FR 30671, May 26, 1993, unless otherwise noted.
(a) Statutory basis. This subpart is based on section 1820 of the Act which sets forth the conditions for designating certain hospitals as CAHs. (b) Scope. This subpart sets forth the conditions that a hospital must meet to be designated as a CAH. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997] As used in this subpart, unless the context indicates otherwise: Direct services means services provided by employed staff of the CAH, not services provided through arrangements or agreements. [59 FR 45403, Sept. 1, 1994, as amended at 62 FR 46037, Aug. 29, 1997] A rural health network is an organization that meets the following specifications: (a) It includes— (1) At least one hospital that the State has designated or plans to designate as a CAH; and (2) At least one hospital that furnishes acute care services. (b) The members of the organization have entered into agreements regarding— (1) Patient referral and transfer; (2) The development and use of communications systems, including, where feasible, telemetry systems and systems for electronic sharing of patient data; and (3) The provision of emergency and nonemergency transportation among members. (c) Each CAH has an agreement with respect to credentialing and quality assurance with at least— (1) One hospital that is a member of the network when applicable; (2) One QIO or equivalent entity; or (3) One other appropriate and qualified entity identified in the State rural health care plan. [58 FR 30671, May 26, 1993, as amended at 62 FR 46035, Aug. 29, 1997; 63 FR 26359, May 12, 1998] Staff that furnish services in a CAH must meet the applicable requirements of this section. (a) Clinical nurse specialist. A clinical nurse specialist must be a person who performs the services of a clinical nurse specialist as authorized by the State, in accordance with State law or the State regulatory mechanism provided by State law. (b) Nurse practitioner. A nurse practitioner must be a registered professional nurse who is currently licensed to practice in the State, who meets the State's requirements governing the qualification of nurse practitioners, and who meets one of the following conditions: (1) Is currently certified as a primary care nurse practitioner by the American Nurses' Association or by the National Board of Pediatric Nurse Practitioners and Associates. (2) Has successfully completed a 1 academic year program that— (i) Prepares registered nurses to perform an expanded role in the delivery of primary care; (ii) Includes at least 4 months (in the aggregate) of classroom instruction and a component of supervised clinical practice; and (iii) Awards a degree, diploma, or certificate to persons who successfully complete the program. (3) Has successfully completed a formal educational program (for preparing registered nurses to perform an expanded role in the delivery of primary care) that does not meet the requirements of paragraph (a)(2) of this section, and has been performing an expanded role in the delivery of primary care for a total of 12 months during the 18-month period immediately preceding June 25, 1993. (c) Physician assistant. A physician assistant must be a person who meets the applicable State requirements governing the qualifications for assistants to primary care physicians, and who meets at least one of the following conditions: (1) Is currently certified by the National Commission on Certification of Physician Assistants to assist primary care physicians. (2) Has satisfactorily completed a program for preparing physician assistants that— (i) Was at least one academic year in length; (ii) Consisted of supervised clinical practice and at least 4 months (in the aggregate) of classroom instruction directed toward preparing students to deliver health care; and (iii) Was accredited by the American Medical Association's Committee on Allied Health Education and Accreditation. (3) Has satisfactorily completed a formal educational program (for preparing physician assistants) that does not meet the requirements of paragraph (c)(2) of this section and has been assisting primary care physicians for a total of 12 months during the 18-month period immediately preceding June 25, 1993. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997] (a) Criteria for State designation. (1) A State that has established a Medicare rural hospital flexibility program described in section 1820(c) of the Act may designate one or more facilities as CAHs if each facility meets the CAH conditions of participation in this subpart F. (2) The State must not deny any hospital that is otherwise eligible for designation as a CAH under this paragraph (a) solely because the hospital has entered into an agreement under which the hospital may provide posthospital SNF care as described in §482.66 of this chapter. (b) Criteria for CMS certification. CMS certifies a facility as a CAH if— (1) The facility is designated as a CAH by the State in which it is located and has been surveyed by the State survey agency or by CMS and found to meet all conditions of participation in this Part and all other applicable requirements for participation in Part 489 of this chapter. (2) The facility is a medical assistance facility operating in Montana or a rural primary care hospital designated by CMS before August 5, 1997, and is otherwise eligible to be designated as a CAH by the State under the rules in this subpart. [62 FR 46036, Aug. 29, 1997, as amended at 63 FR 26359, May 12, 1998] The CAH and its staff are in compliance with applicable Federal, State and local laws and regulations. (a) Standard: Compliance with Federal laws and regulations. The CAH is in compliance with applicable Federal laws and regulations related to the health and safety of patients. (b) Standard: Compliance with State and local laws and regulations. All patient care services are furnished in accordance with applicable State and local laws and regulations. (c) Standard: Licensure of CAH. The CAH is licensed in accordance with applicable Federal, State and local laws and regulations. (d) Standard: Licensure, certification or registration of personnel. Staff of the CAH are licensed, certified, or registered in accordance with applicable Federal, State, and local laws and regulations. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997]
Link to an amendment published at 71 FR 48143, Aug. 18, 2006. (a) Standard: Status. The facility is— (1) A currently participating hospital that meets all conditions of participation set forth in this subpart; (2) A recently closed facility, provided that the facility— (i) Was a hospital that ceased operations on or after the date that is 10 years before November 29, 1999; and (ii) Meets the criteria for designation under this subpart as of the effective date of its designation; or (3) A health clinic or a health center (as defined by the State) that— (i) Is licensed by the State as a health clinic or a health center; (ii) Was a hospital that was downsized to a health clinic or a health center; and (iii) As of the effective date of its designation, meets the criteria for designation set forth in this subpart. (b) Standard: Location in a rural area or treatment as rural. The CAH meets the requirements of either paragraph (b)(1) or (b)(2) or (b)(3) of this section. (1) The CAH meets the following requirements: (i) The CAH is located outside any area that is a Metropolitan Statistical Area, as defined by the Office of Management and Budget, or that has been recognized as urban under §412.64(b), excluding paragraph (b)(3) of this chapter; (ii) The CAH has not been classified as an urban hospital for purposes of the standardized payment amount by CMS or the Medicare Geographic Classification Review Board under §412.230(e) of this chapter, and is not among a group of hospitals that have been redesignated to an adjacent urban area under §412.232 of this chapter. (2) The CAH is located within a Metropolitan Statistical Area, as defined by the Office of Management and Budget, but is being treated as being located in a rural area in accordance with §412.103 of this chapter. (3) Effective only for October 1, 2004 through September 30, 2006, the CAH does not meet the location requirements in either paragraph (b)(1) or (b)(2) of this section and is located in a county that, in FY 2004, was not part of a Metropolitan Statistical Area as defined by the Office of Management and Budget, but as of FY 2005 was included as part of such an MSA as a result of the most recent census data and implementation of the new MSA definitions announced by OMB on June 6, 2003. (c) Standard: Location relative to other facilities or necessary provider certification. The CAH is located more than a 35-mile drive (or, in the case of mountainous terrain or in areas with only secondary roads available, a 15-mile drive) from a hospital or another CAH, or before January 1, 2006, the CAH is certified by the State as being a necessary provider of health care services to residents in the area. A CAH that is designated as a necessary provider as of October 1, 2006, will maintain its necessary provider designation after January 1, 2006. (d) Standard: Relocation of CAHs with a necessary provider designation. A CAH that has a necessary provider designation from the State that was in effect prior to January 1, 2006, and relocates its facility after January 1, 2006, can continue to meet the location requirement of paragraph (c) of this section based on the necessary provider designation only if the relocated facility meets the requirements as specified in paragraph (d)(1) of this section. (1) If a necessary provider CAH relocates its facility and begins providing services in a new location, the CAH can continue to meet the location requirement of paragraph (c) of this section based on the necessary provider designation only if the CAH in its new location— (i) Serves at least 75 percent of the same service area that it served prior to its relocation; (ii) Provides at least 75 percent of the same services that it provided prior to the relocation; and (iii) Is staffed by 75 percent of the same staff (including medical staff, contracted staff, and employees) that were on staff at the original location. (2) If a CAH that has been designated as a necessary provider by the State begins providing services at another location after January 1, 2006, and does not meet the requirements in paragraph (d)(1) of this section, the action will be considered a cessation of business as described in §489.52(b)(3). [62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 66 FR 39938, Aug. 1, 2001; 69 FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7, 2004; 70 FR 47490, Aug. 12, 2005] Except for recently closed facilities as described in §485.610(a)(2), or health clinics or health centers as described in §485.610(a)(3), the facility is a hospital that has a provider agreement to participate in the Medicare program as a hospital at the time the hospital applies for designation as a CAH. [66 FR 32196, June 13, 2001] (a) Standard: Agreements with network hospitals. In the case of a CAH that is a member of a rural health network as defined in §485.603 of this chapter, the CAH has in effect an agreement with at least one hospital that is a member of the network for— (1) Patient referral and transfer; (2) The development and use of communications systems of the network, including the network's system for the electronic sharing of patient data, and telemetry and medical records, if the network has in operation such a system; and (3) The provision of emergency and nonemergency transportation between the facility and the hospital. (b) Standard: Agreements for credentialing and quality assurance. Each CAH that is a member of a rural health network shall have an agreement with respect to credentialing and quality assurance with at least— (1) One hospital that is a member of the network; (2) One QIO or equivalent entity; or (3) One other appropriate and qualified entity identified in the State rural health care plan. [62 FR 46036, Aug. 29, 1997] The CAH provides emergency care necessary to meet the needs of its inpatients and outpatients. (a) Standard: Availability. Emergency services are available on a 24-hours a day basis. (b) Standard: Equipment, supplies, and medication. Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases. The items available must include the following: (1) Drugs and biologicals commonly used in life-saving procedures, including analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrythmics, cardiac glycosides, antihypertensives, diuretics, and electrolytes and replacement solutions. (2) Equipment and supplies commonly used in life-saving procedures, including airways, endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters. (c) Standard: Blood and blood products. The facility provides, either directly or under arrangements, the following: (1) Services for the procurement, safekeeping, and transfusion of blood, including the availability of blood products needed for emergencies on a 24-hours a day basis. (2) Blood storage facilities that meet the requirements of 42 CFR part 493, subpart K, and are under the control and supervision of a pathologist or other qualified doctor of medicine or osteopathy. If blood banking services are provided under an arrangement, the arrangement is approved by the facility's medical staff and by the persons directly responsible for the operation of the facility. (d) Standard: Personnel. (1) Except as specified in paragraph (d)(2) of this section, there must be a doctor of medicine or osteopathy, a physician assistant, a nurse practitioner, or a clinical nurse specialist, with training or experience in emergency care on call and immediately available by telephone or radio contact, and available onsite within the following timeframes: (i) Within 30 minutes, on a 24-hour a day basis, if the CAH is located in an area other than an area described in paragraph (d)(1)(ii) of this section; or (ii) Within 60 minutes, on a 24-hour a day basis, if all of the following requirements are met: (A) The CAH is located in an area designated as a frontier area (that is, an area with fewer than six residents per square mile based on the latest population data published by the Bureau of the Census) or in an area that meets the criteria for a remote location adopted by the State in its rural health care plan, and approved by CMS, under section 1820(b) of the Act. (B) The State has determined, under criteria in its rural health care plan, that allowing an emergency response time longer than 30 minutes is the only feasible method of providing emergency care to residents of the area served by the CAH. (C) The State maintains documentation showing that the response time of up to 60 minutes at a particular CAH it designates is justified because other available alternatives would increase the time needed to stabilize a patient in an emergency. (2) A registered nurse satisfies the personnel requirement specified in paragraph (d)(1) of this section for a temporary period if— (i) The CAH has no greater than 10 beds; (ii) The CAH is located in an area designated as a frontier area or remote location as described in paragraph (d)(1)(ii)(A) of this section; (iii) The State in which the CAH is located submits a letter to CMS signed by the Governor, following consultation on the issue of using RNs on a temporary basis as part of their State rural healthcare plan with the State Boards of Medicine and Nursing, and in accordance with State law, requesting that a registered nurse with training and experience in emergency care be included in the list of personnel specified in paragraph (d)(1) of this section. 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 emergency services in the States. The letter from the Governor must also describe the circumstances and duration of the temporary request to include the registered nurses on the list of personnel specified in paragraph (d)(1) of this section; (iv) Once a Governor submits a letter, as specified in paragraph (d)(2)(iii) of this section, a CAH must submit documentation to the State survey agency demonstrating that it has been unable, due to the shortage of such personnel in the area, to provide adequate coverage as specified in this paragraph (d). (3) The request, as specified in paragraph(d)(2)(iii) of this section, and the withdrawal of the request, may be submitted to us at any time, and are effective upon submission. (e) Standard: Coordination with emergency response systems. The CAH must, in coordination with emergency response systems in the area, establish procedures under which a doctor of medicine or osteopathy is immediately available by telephone or radio contact on a 24-hours a day basis to receive emergency calls, provide information on treatment of emergency patients, and refer patients to the CAH or other appropriate locations for treatment. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 64 FR 41544, July 30, 1999; 67 FR 80041, Dec. 31, 2002; 69 FR 49271, Aug. 11, 2004] (a) Standard: Number of beds. Except as permitted for CAHs having distinct part units under §485.647, the CAH maintains no more than 25 inpatient beds after January 1, 2004, that can be used for either inpatient or swing-bed services. (b) Standard: Length of stay. The CAH provides acute inpatient care for a period that does not exceed, on an annual average basis, 96 hours per patient. [62 FR 46036, Aug. 29, 1997, as amended at 65 FR 47052, Aug. 1, 2000; 69 FR 49271, Aug. 11, 2004; 69 FR 60252, Oct. 7, 2004] (a) Standard: Construction. The CAH is constructed, arranged, and maintained to ensure access to and safety of patients, and provides adequate space for the provision of direct services. (b) Standard: Maintenance. The CAH has housekeeping and preventive maintenance programs to ensure that— (1) All essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition; (2) There is proper routine storage and prompt disposal of trash; (3) Drugs and biologicals are appropriately stored; (4) The premises are clean and orderly; and (5) There is proper ventilation, lighting, and temperature control in all pharmaceutical, patient care, and food preparation areas. (c) Standard: Emergency procedures. The CAH assures the safety of patients in non-medical emergencies by— (1) Training staff in handling emergencies, including prompt reporting of fires, extinguishing of fires, protection and, where necessary, evacuation of patients, personnel, and guests, and cooperation with fire fighting and disaster authorities; (2) Providing for emergency power and lighting in the emergency room and for battery lamps and flashlights in other areas; (3) Providing for an emergency fuel and water supply; and (4) Taking other appropriate measures that are consistent with the particular conditions of the area in which the CAH is located. (d) Standard: Life safety from fire. (1) Except as otherwise provided in this section— (i) The CAH must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association. The Director of the Office of the Federal Register has approved the NFPA 101® 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the (ii) Chapter 19.3.6.3.2, exception number 2 of the adopted edition of the Life Safety Code does not apply to a CAH. (2) If CMS finds that the State has a fire and safety code imposed by State law that adequately protects patients, CMS may allow the State survey agency to apply the State's fire and safety code instead of the LSC. (3) After consideration of State survey agency findings, CMS may waive specific provisions of the Life Safety Code that, if rigidly applied, would result in unreasonable hardship on the CAH, but only if the waiver does not adversely affect the health and safety of patients. (4) The CAH maintains written evidence of regular inspection and approval by State or local fire control agencies. (5) Beginning March 13, 2006, a critical access hospital must be in compliance with Chapter 9.2.9, Emergency Lighting. (6) Beginning March 13, 2006, Chapter 19.3.6.3.2, exception number 2 does not apply to critical access hospitals. (7) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, a critical access hospital may install alcohol-based hand rub dispensers in its facility if— (i) Use of alcohol-based hand rub dispensers does not conflict with any State or local codes that prohibit or otherwise restrict the placement of alcohol-based hand rub dispensers in health care facilities; (ii) The dispensers are installed in a manner that minimizes leaks and spills that could lead to falls; (iii) The dispensers are installed in a manner that adequately protects against access by vulnerable populations; and (iv) The dispensers are installed in accordance with chapter 18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety Code, as amended by NFPA Temporary Interim Amendment 00–1(101), issued by the Standards Council of the National Fire Protection Association on April 15, 2004. The Director of the Office of the Federal Register has approved NFPA Temporary Interim Amendment 00–1(101) for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the amendment is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the Office of the Federal Register, 800 North Capitol Street NW., Suite 700, Washington, DC. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any additional changes are made to this amendment, CMS will publish notice in the [58 FR 30671, May 26, 1993, as amended at 62 FR 46036, 46037, Aug. 29, 1997; 68 FR 1387, Jan. 10, 2003; 69 FR 49271, Aug. 11, 2004; 70 FR 15239, Mar. 25, 2005] (a) Standard: Governing body or responsible individual. The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH's total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. (b) Standard: Disclosure. The CAH discloses the names and addresses of— (1) Its owners, or those with a controlling interest in the CAH or in any subcontractor in which the CAH directly or indirectly has a 5 percent or more ownership interest, in accordance with subpart C of part 420 of this chapter; (2) The person principally responsible for the operation of the CAH; and (3) The person responsible for medical direction. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997] (a) Standard: Staffing—(1) The CAH has 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 CAH. (4) A doctor of medicine or osteopathy, nurse practitioner, clinical nurse specialist, or physician assistant is available to furnish patient care services at all times the CAH operates. (5) A registered nurse, clinical nurse specialist, or licensed practical nurse is on duty whenever the CAH has one or more inpatients. (b) Standard: Responsibilities of the doctor of medicine or osteopathy. (1) The doctor of medicine or osteopathy— (i) Provides medical direction for the CAH'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), participates in developing, executing, and periodically reviewing the CAH's written policies governing the services it furnishes. (iii) In conjunction with the physician assistant and/or nurse practitioner members, periodically reviews the CAH's patient records, provides medical orders, and provides medical care services to the patients of the CAH; and (iv) Periodically reviews and signs the records of all inpatients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants. (v) Periodically, but not less than every 2 weeks, reviews and signs a sample of outpatient records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants according to the policies of the CAH and according to current standards of practice where State law requires record reviews or co-signatures, or both, by a collaborating physician. (vi) Is not required to review and sign outpatient records of patients cared for by nurse practitioners, clinical nurse specialists, certified nurse midwives, or physician assistants where State law does not require record reviews or co-signatures, or both, by a collaborating physician. (2) A doctor of medicine or osteopathy is present for sufficient periods of time, at least once in every 2 week period (except in extraordinary circumstances) to provide the medical direction, medical care services, consultation, and supervision described in this paragraph, and is available through direct radio or telephone communication for consultation, assistance with medical emergencies, or patient referral. The extraordinary circumstances are documented in the records of the CAH. A site visit is not required if no patients have been treated since the latest site visit. (c) Standard: Physician assistant, nurse practitioner, and clinical nurse specialist responsibilities. (1) The physician assistant, the nurse practitioner, or clinical nurse specialist members of the CAH's staff— (i) Participate in the development, execution and periodic review of the written policies governing the services the CAH 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 CAH's policies. (ii) Arranges for, or refers patients to, needed services that cannot be furnished at the CAH, and assures that adequate patient health records are maintained and transferred as required when patients are referred. (3) Whenever a patient is admitted to the CAH by a nurse practitioner, physician assistant, or clinical nurse specialist, a doctor of medicine or osteopathy on the staff of the CAH is notified of the admission. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 70 FR 68728, Nov. 10, 2005] (a) Standard: Patient care policies. (1) The CAH's health care services are furnished in accordance with appropriate written policies that are consistent with applicable State law. (2) The policies are developed with the advice of a group of professional personnel that includes 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 §485.631(a)(1); at least one member is not a member of the CAH staff. (3) The policies include the following: (i) A description of the services the CAH furnishes directly and those furnished through agreement or arrangement. (ii) Policies and procedures for emergency medical services. (iii) 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 CAH. (iv) Rules for the storage, handling, dispensation, and administration of drugs and biologicals. These rules must provide that there is a drug storage area that is administered in accordance with accepted professional principles, that current and accurate records are kept of the receipt and disposition of all scheduled drugs, and that outdated, mislabeled, or otherwise unusable drugs are not available for patient use. (v) Procedures for reporting adverse drug reactions and errors in the administration of drugs. (vi) A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel. (vii) If the CAH furnishes inpatient services, procedures that ensure that the nutritional needs of inpatients are met in accordance with recognized dietary practices and the orders of the practitioner responsible for the care of the patients, and that the requirement of §483.25(i) is met with respect to inpatients receiving posthospital SNF care. (4) These policies are reviewed at least annually by the group of professional personnel required under paragraph (a)(2) of this section, and reviewed as necessary by the CAH. (b) Standard: Direct services—(1) General. The CAH staff furnishes, as direct services, those diagnostic and therapeutic services and supplies that are commonly furnished in a physician's office or at another entry point into the health care delivery system, such as a low intensity hospital outpatient department or emergency department. These direct services include medical history, physical examination, specimen collection, assessment of health status, and treatment for a variety of medical conditions. (2) Laboratory services. The CAH provides, as direct services, basic laboratory services essential to the immediate diagnosis and treatment of the patient that meet the standards imposed under section 353 of the Public Health Service Act (42 U.S.C. 236a). (See the laboratory requirements specified in part 493 of this chapter.) The services provided include: (i) Chemical examination of urine by stick or tablet method or both (including urine ketones); (ii) Hemoglobin or hematocrit; (iii) Blood glucose: (iv) Examination of stool specimens for occult blood; (v) Pregnancy tests; and (vi) Primary culturing for transmittal to a certified laboratory. (3) Radiology services. Radiology services furnished at the CAH are provided as direct services by staff qualified under State law, and do not expose CAH patients or staff to radiation hazards. (4) Emergency procedures. In accordance with the requirements of §485.618, the CAH provides as direct services medical emergency procedures as a first response to common life-threatening injuries and acute illness. (c) Standard: Services provided through agreements or arrangements. (1) The CAH has agreements or arrangements (as appropriate) with one or more providers or suppliers participating under Medicare to furnish other services to its patients, including— (i) Inpatient hospital care; (ii) Services of doctors of medicine or osteopathy; and (iii) Additional or specialized diagnostic and clinical laboratory services that are not available at the CAH. (iv) Food and other services to meet inpatients' nutritional needs to the extent these services are not provided directly by the CAH. (2) If the agreements or arrangements are not in writing, the CAH is able to present evidence that patients referred by the CAH are being accepted and treated. (3) The CAH maintains a list of all services furnished under arrangements or agreements. The list describes the nature and scope of the services provided. (4) The person principally responsible for the operation of the CAH under §485.627(b)(2) of this chapter is also responsible for the following: (i) Services furnished in the CAH whether or not they are furnished under arrangements or agreements. (ii) Ensuring that a contractor of services (including one for shared services and joint ventures) furnishes services that enable the CAH to comply with all applicable conditions of participation and standards for the contracted services. (d) Standard: Nursing services. Nursing services must meet the needs of patients. (1) A registered nurse must provide (or assign to other personnel) the nursing care of each patient, including patients at a SNF level of care in a swing-bed CAH. The care must be provided in accordance with the patient's needs and the specialized qualifications and competence of the staff available. (2) A registered nurse or, where permitted by State law, a physician assistant, must supervise and evaluate the nursing care for each patient, including patients at a SNF level of care in a swing-bed CAH. (3) All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. (4) A nursing care plan must be developed and kept current for each inpatient. [58 FR 30671, May 26, 1993; 58 FR 49935, Sept. 24, 1993, as amended at 59 FR 45403, Sept. 1, 1994; 62 FR 46037, Aug. 29, 1997] (a) Standard: Records system—(1) The CAH maintains a clinical records system in accordance with written policies and procedures. (2) The records are 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 CAH maintains 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 CAH maintains the confidentiality of record information and provides safeguards against loss, destruction, or unauthorized use. (2) Written policies and procedures govern the use and removal of records from the CAH 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 are retained for at least 6 years from date of last entry, and longer if required by State statute, or if the records may be needed in any pending proceeding. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997] Surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body of the CAH in accordance with the designation requirements under paragraph (a) of this section. (a) Designation of qualified practitioners. The CAH designates the practitioners who are allowed to perform surgery for CAH patients, in accordance with its approved policies and procedures, and with State scope of practice laws. Surgery is performed only by— (1) A doctor of medicine or osteopathy, including an osteopathic practitioner recognized under section 1101(a)(7) of the Act; (2) A doctor of dental surgery or dental medicine; or (3) A doctor of podiatric medicine. (b) Anesthetic risk and evaluation. (1) 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. (2) A qualified practitioner, as specified in paragraph (c) of this section, must examine each patient before surgery to evaluate the risk of anesthesia. (3) Before discharge from the CAH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in paragraph (c) of this section. (c) Administration of anesthesia. The CAH designates the person who is allowed to administer anesthesia to CAH patients in accordance with its approved policies and procedures and with State scope-of-practice laws. (1) Anesthesia must be administered by only— (i) A qualified anesthesiologist; (ii) A doctor of medicine or osteopathy other than an anesthesiologist; including an osteopathic practitioner recognized under section 1101(a)(7) of the Act; (iii) A doctor of dental surgery or dental medicine; (iv) A doctor of podiatric medicine; (v) A certified registered nurse anesthetist (CRNA), as defined in §410.69(b) of this chapter; (vi) An anesthesiologist's assistant, as defined in §410.69(b) of this chapter; or (vii) A supervised trainee in an approved educational program, as described in §§413.85 or 413.86 of this chapter. (2) 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. (d) Discharge. All patients are discharged in the company of a responsible adult, except those exempted by the practitioner who performed the surgical procedure. (e) Standard: State exemption. (1) A CAH may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (c)(2) of this section, if the State in which the CAH 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 he or she has 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. (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. [60 FR 45851, Sept. 1, 1995, as amended at 62 FR 46037, Aug. 29, 1997; 66 FR 39938, Aug. 1, 2001; 66 FR 56769, Nov. 13, 2001] (a) Standard: Periodic evaluation—(1) The CAH carries out or arranges for a periodic evaluation of its total program. The evaluation is done at least once a year and includes review of— (i) The utilization of CAH services, including at least the number of patients served and the volume of services; (ii) A representative sample of both active and closed clinical records; and (iii) The CAH's health care policies. (2) The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed. (b) Standard: Quality assurance. The CAH has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. The program requires that— (1) All patient care services and other services affecting patient health and safety, are evaluated; (2) Nosocomial infections and medication therapy are evaluated; (3) The quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialists, and physician assistants at the CAH are evaluated by a member of the CAH staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under contract with the CAH; (4) The quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH are evaluated by— (i) One hospital that is a member of the network, when applicable; (ii) One QIO or equivalent entity; or (iii) One other appropriate and qualified entity identified in the State rural health care plan; and (5)(i) The CAH staff considers the findings of the evaluations, including any findings or recommendations of the QIO, and takes corrective action if necessary. (ii) The CAH also takes appropriate remedial action to address deficiencies found through the quality assurance program. (iii) The CAH documents the outcome of all remedial action. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 63 FR 26359, May 12, 1998] The CAH must have and implement written protocols that: (a) 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 CAH. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the CAH, 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 CAH for this purpose; (b) 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; (c) Ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its option to either donate or not donate organs, tissues, or eyes. The individual designated by the CAH to initiate the request to the family must be 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; (d) Encourage discretion and sensitivity with respect to the circumstances, views, and beliefs of the families of potential donors; (e) Ensure that the CAH 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. (f) For purposes of these standards, the term “organ” means a human kidney, liver, heart, lung, pancreas, or intestines (or multivisceral organs). [65 FR 47110, Aug. 1, 2000, as amended at 66 FR 39938, Aug. 1, 2001] A CAH must meet the following requirements in order to be granted an approval from CMS to provided post-hospital SNF care, as specified in §409.30 of this chapter, and to be paid for SNF-level services, in accordance with paragraph (c) of this section. (a) Eligibility. A CAH must meet the following eligibility requirements: (1) The facility has been certified as a CAH by CMS under §485.606(b) of this subpart; and (2) The facility provides not more than 25 inpatient beds. Any bed of a unit of the facility that is licensed as a distinct-part SNF at the time the facility applies to the State for designation as a CAH is not counted under paragraph (a) of this section. (b) Facilities participating as rural primary care hospitals (RPCHs) on September 30, 1997. These facilities must meet the following requirements: (1) Notwithstanding paragraph (a) of this section, a CAH that participated in Medicare as a RPCH on September 30, 1997, and on that date had in effect an approval from CMS to use its inpatient facilities to provide post-hospital SNF care may continue in that status under the same terms, conditions and limitations that were applicable at the time those approvals were granted. (2) A CAH that was granted swing-bed approval under paragraph (b)(1) of this section may request that its application to be a CAH and swing-bed provider be reevaluated under paragraph (a) of this section. If this request is approved, the approval is effective not earlier than October 1, 1997. As of the date of approval, the CAH no longer has any status under paragraph (b)(1) of this section and may not request reinstatement under paragraph (b)(1) of this section. (c) Payment. Payment for inpatient RPCH services to a CAH that has qualified as a CAH under the provisions in paragraph (a) of this section is made in accordance with §413.70 of this chapter. Payment for post-hospital SNF-level of care services is made in accordance with the payment provisions in §413.114 of this chapter. (d) SNF services. The CAH is substantially in compliance with the following SNF requirements contained in subpart B of part 483 of this chapter: (1) Residents rights (§483.10(b)(3) through (b)(6), (d) (e), (h), (i), (j)(1)(vii) and (viii), (l), and (m) of this chapter). (2) Admission, transfer, and discharge rights (§483.12(a) of this chapter). (3) Resident behavior and facility practices (§483.13 of this chapter). (4) Patient activities (§483.15(f) of this chapter), except that the services may be directed either by a qualified professional meeting the requirements of §485.15(f)(2), or by an individual on the facility staff who is designated as the activities director and who serves in consultation with a therapeutic recreation specialist, occupational therapist, or other professional with experience or education in recreational therapy. (5) Social services (§483.15(g) of this chapter). (6) Comprehensive assessment, comprehensive care plan, and discharge planning (§483.20(b), (k), and (l) of this chapter, except that the CAH is not required to use the resident assessment instrument (RAI) specified by the State that is required under §483.20(b), or to comply with the requirements for frequency, scope, and number of assessments prescribed in §413.343(b) of this chapter). (7) Specialized rehabilitative services (§483.45 of this chapter). (8) Dental services (§483.55 of this chapter). (9) Nutrition (§483.25(i) of this chapter). [63 FR 26359, May 12, 1998 as amended at 64 FR 41544, July 30, 1999; 67 FR 50120, Aug. 1, 2002; 69 FR 49272, Aug. 11, 2004] (a) Conditions. (1) If a CAH provides inpatient psychiatric services in a distinct part unit, the services furnished by the distinct part unit must comply with the hospital requirements specified in Subparts A, B, C, and D of Part 482 of this subchapter, the common requirements of §412.25(a)(2) through (f) of Part 412 of this chapter for hospital units excluded from the prospective payment systems, and the additional requirements of §412.27 of Part 412 of this chapter for excluded psychiatric units. (2) If a CAH provides inpatient rehabilitation services in a distinct part unit, the services furnished by the distinct part unit must comply with the hospital requirements specified in Subparts A, B, C, and D of Part 482 of this subchapter, the common requirements of §412.25(a)(2) through (f) of Part 412 of this chapter for hospital units excluded from the prospective payments systems, and the additional requirements of §§412.29 and §412.30 of Part 412 of this chapter related specifically to rehabilitation units. (b) Eligibility requirements. (1) To be eligible to receive Medicare payments for psychiatric or rehabilitation services as a distinct part unit, the facility provides no more than 10 beds in the distinct part unit. (2) The beds in the distinct part are excluded from the 25 inpatient-bed count limit specified in §485.620(a). (3) The average annual 96-hour length of stay requirement specified under §485.620(b) does not apply to the 10 beds in the distinct part units specified in paragraph (b)(1) of this section, and admissions and days of inpatient care in the distinct part units are not taken into account in determining the CAH's compliance with the limits on the number of beds and length of stay in §485.620. [69 FR 49272, Aug. 11, 2004]
Title 42: Public Health
PART 485—CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
Subpart F—Conditions of Participation: Critical Access Hospitals (CAHs)
§ 485.601 Basis and scope.
§ 485.602 Definitions.
§ 485.603 Rural health network.
§ 485.604 Personnel qualifications.
§ 485.606 Designation and certification of CAHs.
§ 485.608 Condition of participation: Compliance with Federal, State, and local laws and regulations.
§ 485.610 Condition of participation: Status and location.
§ 485.612 Condition of participation: Compliance with hospital requirements at the time of application.
§ 485.616 Condition of participation: Agreements.
§ 485.618 Condition of participation: Emergency services.
§ 485.620 Condition of participation: Number of beds and length of stay.
§ 485.623 Condition of participation: Physical plant and environment.
§ 485.627 Condition of participation: Organizational structure.
§ 485.631 Condition of participation: Staffing and staff responsibilities.
§ 485.635 Condition of participation: Provision of services.
§ 485.638 Conditions of participation: Clinical records.
§ 485.639 Condition of participation: Surgical services.
§ 485.641 Condition of participation: Periodic evaluation and quality assurance review.
§ 485.643 Condition of participation: Organ, tissue, and eye procurement.
§ 485.645 Special requirements for CAH providers of long-term care services (“swing-beds”)
§ 485.647 Condition of participation: psychiatric and rehabilitation distinct part units.
