Home / Guides / Record retention
CLIA record retention periods
Under 42 CFR 493.1105, a laboratory keeps most records for at least two years. The exceptions are pathology reports and histopathology slides (ten years), cytology slides (five years), blood bank records (the FDA periods) and studies that verified a test's performance (as long as the test is in use, and not less than two years).
These are federal minimums. State law, payers and accreditation organizations often require longer.
Reviewed 11 Nov 2026 against the sources linked below. General information, not regulatory or legal advice.
| Record | Keep for at least | 42 CFR |
|---|---|---|
| Test requisitions and authorizations Includes the chart or medical record entry if it is used as the requisition. | 2 years | 493.1105(a)(1) |
| Test procedures Keep the dates of first use and discontinuance with each procedure. | 2 years after the procedure is discontinued | 493.1105(a)(2) |
| Analytic systems records Quality control and patient test records, instrument printouts, and records of maintenance, function checks, calibration and calibration verification. | 2 years | 493.1105(a)(3) |
| Performance specification studies The verification or establishment study for each test system. | For as long as the test is in use, and not less than 2 years | 493.1105(a)(3)(i) |
| Immunohematology, blood and blood product, and transfusion records These follow the FDA periods, which are longer than two years. | As FDA requires in 21 CFR 606.160 | 493.1105(a)(3)(ii) |
| Proficiency testing records Include the attestation statements and the record of how each sample was handled and tested. | 2 years | 493.1105(a)(4) |
| Quality system assessment records Quality assessment reviews, findings and corrective action. | 2 years | 493.1105(a)(5) |
| Test reports Retain or be able to retrieve a copy of the original report, including final, preliminary and corrected reports. | 2 years after the date of reporting | 493.1105(a)(6) |
| Pathology test reports | 10 years after the date of reporting | 493.1105(a)(6)(ii) |
| Cytology slide preparations | 5 years from the date of examination | 493.1105(a)(7)(i)(A) |
| Histopathology slides | 10 years from the date of examination | 493.1105(a)(7)(i)(B) |
| Pathology specimen blocks | 2 years from the date of examination | 493.1105(a)(7)(ii) |
| Tissue remnants | Until a diagnosis is made on the specimen | 493.1105(a)(7)(iii) |
How long does CLIA require laboratory records to be kept?
Two years for most records: requisitions, quality control and patient test records, proficiency testing records, quality assessment records and test reports. Pathology reports and histopathology slides are kept ten years, cytology slides five years, and blood bank records follow the FDA periods in 21 CFR 606.160.
How long are competency assessment and personnel records kept?
42 CFR 493.1105 does not list them by name. Set the period in your own policy. Two years is the usual floor, and many laboratories keep them for as long as the person is employed, because a surveyor may ask how a current employee was trained and first assessed.
Can records be kept electronically or off site?
The retention rule does not say where or in what form records are kept. What matters is that they are complete, legible and can be produced when a surveyor asks. Note where each record lives. A binder index does that job.
What happens to records if the laboratory closes?
The laboratory must make provisions so that records and, where applicable, slides, blocks and tissue are kept and available for the full periods above.
Does my state require longer?
It may. State law, Medicare and Medicaid billing rules, payer contracts and accreditation standards often set longer periods than CLIA. Use the longest one that applies to you.
Keeping track of where things are
Surveyors do not only ask whether a record exists. They ask to see it. The IR-02 Survey Binder Index in the Inspection Readiness Kit lists each record type with its retention period, where it is kept and who owns it.
Sources
Summaries on this page are ours and are written for convenience. The regulation and the agency documents control.