[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR485.635]

[Page 594-596]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS--Table of Contents
 
Subpart F--Conditions of Participation: Critical Access Hospitals (CAHs)
 
Sec. 485.635  Condition of participation: Provision of services.

    (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 
Sec. 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outdated,

[[Page 595]]

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 
Sec. 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 
Sec. 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 Sec. 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

[[Page 596]]

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]