[Code of Federal Regulations]

[Title 42, Volume 3]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR485.635]



[Page 608-610]

 

                         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outdated, mislabeled, or otherwise unusable drugs are not available for 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.



[[Page 609]]



    (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 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.



[[Page 610]]



    (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]