[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: 42CFR485.638]

[Page 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. 485.638  Conditions of participation: Clinical records.

    (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]