General Policy Manual - CAP & CLIA Retention Requirements

LABORATORY OF PATHOLOGY ONLINE POLICY MANUAL

CAP & CLIA Retention Requirements

Each clinical section must have clearly defined and documented policies to ensure preservation of appropriate patient data, test requisition and authorizations, records, and materials which meet or exceed the CAP & CLIA retention guidelines. The following are minimum retention guidelines:

Test requisition and authorizations: at least 2 years
Test procedures: at least 2 years after a procedure is discontinued.
Quality control records, including instrument printouts: at least 2 years.
Records of test system performance specifications that the lab used to establish or verify performance specifications: for the period of time the lab uses the test system but no less than 2 years.
Proficiency test records (including records of test handling, processing, examination, results reporting, and signed attestation statements): no less than 2 years.
Laboratory quality systems assessment records: retain for 2 years.
Test reports: Retain or be able to retrieve a copy of the original report (including final, preliminary, supplemental, or corrected reports) after the date of reporting as follows: Surgical Pathology Reports: 10 years; Cytology Reports: 10 years; Non-Forensic Autopsy Reports: 10 years; Forensic Autopsy Reports: Indefinitely; Cytogenetics Reports or diagnostic images (digitized, prints or negatives): 20 years.
Cytology slides: 5 years; fine needle aspiration slides: 10 years from the exam date.
Histopathology slides: 10 years from the exam date.
Cytogenetics slides: permanently stained slides, 3 years; fluorochrome stained slides, at the discretion of the laboratory director.
Surgical Pathology/Histopathology specimens: Wet tissue, 2 weeks after final report; paraffin blocks, 10 years.
Non-Forensic Autopsy specimens: Wet tissue, 3 months after final report; paraffin blocks, 10 years.
Forensic Autopsy specimens: Wet stock tissue, 1 year; Paraffin blocks and dried blood stain or frozen tissues for DNA Analysis, indefinitely; Body fluids and tissues for toxicology, 1 year.
Cytogenetics specimens: Fixed cell pellet, 2 weeks after final report; wet specimen / tissue, until adequate metaphase cells are obtained.
Flow Cytometry dot plots and histograms: 10 years.
If the laboratory ceases operation, the lab must make provisions to ensure that all records and , as applicable, slides, blocks, and tissues are maintained and available for the minimum time frames specified in this section.