[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR485.721]

[Page 613]
 
                         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 H--Conditions of Participation for Clinics, Rehabilitation 
Agencies, and Public Health Agencies as Providers of Outpatient Physical 
             Therapy and Speech-Language Pathology Services
 
Sec. 485.721  Condition of participation: Clinical records.

    The organization maintains clinical records on all patients in 
accordance with accepted professional standards, and practices. The 
clinical records are completely and accurately documented, readily 
accessible, and systematically organized to facilitate retrieving and 
compiling information.
    (a) Standard: Protection of clinical record information. The 
organization recognizes the confidentiality of clinical record 
information and provides safeguards against loss, destruction, or 
unauthorized use. Written procedures govern the use and removal of 
records and the conditions for release of information. The patient's 
written consent is required for release of information not authorized by 
law.
    (b) Standard: Content. The clinical record contains sufficient 
information to identify the patient clearly, to justify the 
diagnosis(es) and treatment, and to document the results accurately. All 
clinical records contain the following general categories of data:
    (1) Documented evidence of the assessment of the needs of the 
patient, of an appropriate plan of care, and of the care and services 
furnished.
    (2) Identification data and consent forms.
    (3) Medical history.
    (4) Report of physical examinations, if any.
    (5) Observations and progress notes.
    (6) Reports of treatments and clinical findings.
    (7) Discharge summary including final diagnosis(es) and prognosis.
    (c) Standard: Completion of records and centralization of reports. 
Current clinical records and those of discharged patients are completed 
promptly. All clinical information pertaining to a patient is 
centralized in the patient's clinical record. Each physician signs the 
entries that he or she makes in the clinical record.
    (d) Standard: Retention and preservation. Clinical records are 
retained for at least:
    (1) The period determined by the respective State statute, or the 
statute of limitations in the State; or
    (2) In the absence of a State statute--
    (i) Five years after the date of discharge; or
    (ii) In the case of a minor, 3 years after the patient becomes of 
age under State law or 5 years after the date of discharge, whichever is 
longer.
    (e) Standard: Indexes. Clinical records are indexed at least 
according to name of patient to facilitate acquisition of statistical 
medical information and retrieval of records for research or 
administrative action.
    (f) Standard: Location and facilities. The organization maintains 
adequate facilities and equipment, conveniently located, to provide 
efficient processing of clinical records (reviewing, indexing, filing, 
and prompt retrieval).

[41 FR 20865, May 21, 1976. Redesignated at 42 FR 52826, Sept. 30, 1977. 
Further redesignated and amended at 60 FR 2326-2328, Jan. 9, 1995]