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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