US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1105: Retain records for the CLIA minimum periods: requisitions, procedures, analytic and quality control records, PT records, quality assessment records and test reports for two years, pathology reports and histopathology slides for ten years, cytology slides for five years, blocks for two years, tissue until diagnosis, with provisions made for retention if the laboratory closes

What does 1105 require?

The laboratory must retain test requisitions and authorisations (including a patient chart used as the requisition) for at least two years; each test procedure for two years after it is discontinued, with dates of first use and discontinuance; quality control, patient test and analytic systems records for two years, performance specification records for as long as the test system is used and at least two years, and immunohematology, blood product and transfusion records as 21 CFR 606.160 requires; proficiency testing records for two years; quality system assessment records for two years; a copy of the original, preliminary and corrected test reports retrievable for two years, immunohematology reports as 21 CFR 606.160(d) requires, and pathology test reports for ten years; cytology slides for five years from examination, histopathology slides for ten years, pathology specimen blocks for two years, and tissue remnants until a diagnosis is made. A laboratory that ceases operation must make provision for all records, slides, blocks and tissue to remain available for these periods.