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CLIA Laboratory Record Retention Requirements
(As of 2013 and stated in The Code of Federal Regulations, CFR42 Part 430, Appendix C, Subpart J, §493.1105 Standard: Record Retention requirements)
Listed are the CLIA requirements for retaining patient and testing records, specimens, and slides. Use the information below as a guideline when establishing your laboratory’s policies and procedures for record retention.
Note: If your laboratory ceases operation, the laboratory must make provisions to ensure that all records and, as applicable, slides, blocks, and tissue are maintained and available for the time frames specified below.
Test Requisitions and Authorizations
Including patient’s chart or medical record if used as the test requisition or authorization
Specialty/Subspecialty - All
Retention Time - 2 years
Test Procedures
Including dates of initial use and discontinuance
Specialty/Subspecialty - All
Retention Time - 2 years after the procedure has been discontinued
Analytic Systems Records
Quality control and patient test records, including instrument printouts, if applicable
Analytical systems activities (Test systems, equipment, instruments, reagents, materials, and supplies; Establishment and verification of performance specifications; Maintenance and function checks; Calibration and calibration verification procedures; Control procedures; Comparison of test results; Corrective actions)
Specialty/Subspecialty - Immunohematology (Transfusion-Related Only)
Retention Time - As specified in FDA 21 CFR 606.160(b)(3)(ii), (b)(3)(v), & (d): 10 years (After processing records are completed or six months after the latest expiration date for the individual product, whichever is the later date. When there is no expiration date, records shall be retained indefinitely.)
Specialty/Subspecialty - All Others
Retention Time - 2 years
Proficiency Testing Records
Includes all information regarding the PT event: test records, signed attestation statements sent or transmitted to the PT providers, PT results and scores from the provider, documentation of review and records of any corrective actions
Specialty/Subspecialty - All
Retention Time - 2 years
Laboratory Quality System Assessment
Specialty/Subspecialty - All
Retention Time - 2 years
Test Reports
Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports)
Specialty/Subspecialty - Pathology Subspecialties & Immunohematology (Transfusion-Related Only)
Retention Time - 10 years
Specialty/Subspecialty - All Others
Retention Time - 2 years
Slides
Specialty/Subspecialty - Cytology
Retention Time - 5 years
State of Illinois – 450 ILLINOIS CLINICAL LABORATORIES CODE - Section 450.1155 - Cytology Slides showing malignancy or pre-malignancy conditions and, all abnormal slides and reports shall be stored for ten years from the date of examination.
Specialty/Subspecialty - Histopathology
Retention Time - 10 years
Specialty/Subspecialty - All Others
Retention Time - No Requirements
Specimen Blocks
Specialty/Subspecialty - Pathology
Retention Time - 2 years
Tissue Remnants
Specialty/Subspecialty - Pathology
Retention Time - Completion of Diagnosis