AGENCY: Department of Health and Human Services. Community Health and Well-Being. Division of Population Health.

SERIES: 81557
TITLE: Clinical laboratory files
DATES: 1986-
ARRANGEMENT: Alphabetical by laboratory

DESCRIPTION: This is the file of laboratories that test for biological, microbiological, serological, chemical, immunohematological, biophysical, cytological, and/or pathological materials in the state. Oversight of these laboratories is required by the Clinical Laboratories Improvement Act of 1967 (42 USC 263a) and by Medicare regulations. See 42 CFR 74, 42 CFR 405 Subpart M, and 21 CFR 600 Subpart C. These files includes Clinical Laboratory Survey Report, Medicare/Medicaid Certification and Transmittal, Statement of Deficiencies and Plan of Correction, Blood Bank Inspection Checklist and Report, Medicare/Medicaid Hospital Survey Report, Specimens Received Per Year, Laboratory Personnel Report, Licensure Recommendation-CLIA Laboratory, Summary of Deficiencies not Corrected, Post-Certification Revisit Report, Clinical Laboratory Survey Report, copy of license or certification, proficiency test results, correspondence, and Suggestions for Laboratory Improvement. Information includes the name and address of the lab; the Clinical Laboratories Improvement Act code number; the Medicare identification number; the type of tests performed by the lab; the names and titles of all personnel functioning as director, supervisor, technologist, or cytotechnologist; the date of the survey; the names and titles of the surveyors; and the items that were inspected and the results of the inspection.


Retain for 3 year(s)




Retention and disposition for this series were specifically approved by the State Records Committee.

APPROVED: 06/1987


Paper: Retain in Office for 2 years and then transfer to State Records Center. Retain in State Records Center for 1 year and then destroy.



Although several CFR sections discuss the requirement for these records, they do not specify the retention. In that case, the provision of the Paperwork Reduction Act of 1981 (5 CFR 1320) sets a three year retention for this record.