• Recordkeeping Requirements

    CLIA Requirements for Keeping Records

    PT Record Retention Requirements

    LABORATORY RECORD PERIOD OF RETENTION
    Proficiency Testing Results (copies of what was submitted to the PT provider) 2 years
    Attestation Statement 2 years
    Proficiency Testing Evaluations 2 years
    All other PT related forms 2 years

    Test Record Retention Requirements

    LABORATORY RECORD PERIOD OF RETENTION
    Test Requisitions 2 years
    Test Records 2 years
    Immunohematology 5 years
    Test Reports 2 years
    Immunohematology 5 years

    Quality Control Record Retention Requirements

    LABORATORY RECORD PERIOD OF RETENTION
    Discontinued procedures 2 years
    Method Performance Specifications 2 years
    Equipment Maintenance and Function Checks 2 years
    Calibration and Calibration Verification 2 years
    Control Procedures (e.g., daily QC records) 2 years
    Remedial Action - errors in reported results (both the original and corrected report) 2 years