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