Critical Access Hospital Regulations

Survey Protocol, Regulations, and Interpretive
Guidelines for Critical Access Hospitals

Critical Access Hospitals must adhere to survey protocol, as well as regulations and interpretive guidelines as conditions of participation. Critical Access Hospitals (CAHs) are required to be in compliance with the federal requirements set forth in the Medicare Conditions of Participation (CoP) in order to receive Medicare/Medicaid payment. The goal of a CAH survey is to determine if the CAH is in compliance with the CoP set forth at 42 CFR Part 485 Subpart F. Certification of CAH compliance with the CoP is accomplished through observations, interviews, and document/record reviews. The survey process focuses on a CAH’s performance of organizational and patient-focused functions and processes. The CAH survey is the means used to assess compliance with federal health, safety, and quality standards that will assure that the beneficiary receives safe, quality care and services.

Conditions of participation, regulations, and guidelines for CAHs include:

  • Compliance with all federal, state, and local laws and regulations
  • Required CAH Disclosures to Patients:

    • Physician Ownership
    • 24/7 On-site Presence of Doctor of Medicine or Osteopathy
  • Compliance with Advance Directives Requirements
  • Licensure in accordance with applicable federal, state, and local laws and regulations
  • Staff of CAH must be licensed, certified, or registered in accordance with applicable federal, state, and local laws and regulations
  • Location (35+ mile drive from nearest hospital or CAH)
  • Patient referral and transfer
  • Agreements for credentialing and quality
  • Agreements for credentialing and privileging of telemedicine physicians and practitioners
  • Provision of 24-hours a day emergency care necessary to meet the needs of its inpatients and outpatients
  • Equipment, supplies, and medication used in treating emergency cases are kept at the CAH and are readily available for treating emergency cases
  • 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
  • Except as permitted for CAHs having distinct part units under §485.647, the CAH maintains no more than 25 inpatient beds (does not include stretchers, newborn bassinets, surgical recovery beds, examination tables, and other types -see full CAH Regulations for details). Inpatient beds may be used for either inpatient or swing-bed services.
  • The CAH provides acute inpatient care for a period that does not exceed, on an annual average basis, 96 hours per patient.
  • The CAH is constructed, arranged, and maintained to ensure access to and safety of patients, and provides adequate space for the provision of services.
  • The CAH has housekeeping and preventive maintenance programs to ensure that all essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition
  • The CAH assures the safety of patients in non-medical emergencies by 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
  • Except as otherwise provided in this section, the CAH must meet the applicable provisions of the 2000 edition of the Life Safety Code of the National Fire Protection Association
  • 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.
  • The CAH discloses the names and addresses of 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
  • 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.
  • A registered nurse, clinical nurse specialist, or licensed practical nurse is on duty whenever the CAH has one or more inpatients
  • The policies are developed with the advice of members of the CAH’s professional healthcare staff, including one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff under the provisions of §485.631(a)(1).
  • CAHs must comply with applicable state law that governs the qualifications, certification, or licensure of staff who dispense drugs and biologicals.
  • The CAH furnishes acute care inpatient services.
  • The CAH provides 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).
  • Radiology services furnished by the CAH are provided by personnel qualified under state law, and do not expose CAH patients or personnel to radiation hazards.
  • 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.
  • The CAH maintains a list of all services furnished under arrangements or agreements. The list describes the nature and scope of the services provided.
  • Nursing services must meet the needs of patients.
  • 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.
  • 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.
  • A nursing care plan must be developed and kept current for each inpatient.
  • The CAH maintains a clinical records system in accordance with written policies and procedures. The records are legible, complete, accurately documented, readily accessible, and systematically organized.
  • The CAH maintains the confidentiality of record information and provides safeguards against loss, destruction, or unauthorized use.
  • The patient’s written consent is required for release of information not required by law.
  • 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.
  • If a CAH provides surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the CAH. The provision of surgical services is an optional CAH service.
  • The CAH carries out or arranges for a periodic evaluation of its total program.
  • Incorporates 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.
  • Ensures, 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 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, and the number of beds used at any time for acute care inpatient services does not exceed 15 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 this section.

Resident Rights

The intent of this requirement is to assure that each resident knows his or her rights and responsibilities and that the facility communicates this information prior to or upon admission, during the resident’s stay, and when the facility’s rules changes. A facility must promote the exercise of rights for all residents, including those who face barriers such as communication problems, hearing problems and cognition limits. These rights include the resident’s right to:

  • Be informed about what rights and responsibilities the resident has.
  • Choose a MD/DO;
  • Participate in decisions about treatment and care planning;
  • Have privacy and confidentiality;
  • Work or not work;
  • Have privacy in sending and receiving mail;
  • Visit and be visited by others from outside the facility;
  • Retain and use personal possessions;
  • Share a room with a spouse.

The resident has a right to a dignified existence, self-determination, and communication with and access to persons and services inside and outside the facility. A facility must protect and promote the rights of each resident, including each of the following rights:

  1. The resident has the right to exercise his or her rights as a resident of the facility and as a citizen or resident of the United States.
  2. The resident has the right to be free of interference, coercion, discrimination, and reprisal from the facility in exercising his or her rights.
  3. In the case of a resident adjudged incompetent under the laws of a state by a court of competent jurisdiction, the rights of the resident are exercised by the person appointed under state law to act on the resident’s behalf.
  4. In the case of a resident who has not been adjudged incompetent by the state court, any legal-surrogate designated in accordance with state law may exercise the resident’s rights to the extent provided by state law.

The facility must inform the resident both orally and in writing in a language that the resident understands of his or her rights and all rules and regulations governing resident conduct and responsibilities during the stay in the facility. The facility must also provide the resident with the notice (if any) of the state developed under section 1919(e)(6) of the Act. Such notification must be made prior to or upon admission and during the resident’s stay. Receipt of such information, and any amendments to it, must be acknowledged in writing;

The resident or his or her legal representative has the right–

Upon an oral or written request, to access all records pertaining to himself or herself including current clinical records within 24 hours (excluding weekends and holidays); and

After receipt of his or her records for inspection, to purchase at a cost not to exceed the community standard photocopies of the records or any portions of them upon request and 2 working days advance notice to the facility.

The resident has the right to be fully informed in language that he or she can understand of his or her total health status, including but not limited to, his or her medical condition.

A CAH must have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the CAH may need to place on such rights and the reasons for the clinical restriction or limitation. A CAH must meet the following requirements:

  • Not restrict, limit, or otherwise deny visitation privileges on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, or disability.
  • Ensure that all visitors enjoy full and equal visitation privileges consistent with patient preferences.

Five Rights of Medication Administration

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

  1. Right patient: the patient’s identity— acceptable patient identifiers include, but are not limited to: the patient’s full name; an identification number assigned by the CAH; or date of birth. Identifiers must be confirmed by patient wrist band, patient identification card, patient statement (when possible) or other means outlined in the CAH’s policy. The patient’s identification must be confirmed to be in agreement with the medication administration record and medication labeling prior to medication administration to ensure that the medication is being given to the correct patient.
  2. Right medication: the correct medication, to ensure that the medication being given to the patient matches that prescribed for the patient and that the patient does not have a documented allergy to it;
  3. Right dose: the correct dose, to ensure that the dosage of the medication matches the prescribed dose, and that the prescription itself does not reflect an unsafe dosage level (i.e., a dose that is too high or too low);
  4. Right route: the correct route, to ensure that the method of administration – orally, intramuscular, intravenous, etc., is the appropriate one for that particular medication and patient; and
  5. Right time: the appropriate time, to ensure adherence to the prescribed frequency and time of administration.

Note that this abridged and truncated list of regulations is by no means complete or comprehensive in scope and should not be relied upon as an authoritative source. Please view the complete list of CAH Regulations here.