[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

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

[CITE: 42CFR485.721]



[Page 634-635]

 

                         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 

 

   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



[[Page 635]]



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]