---------------------------- I would refer you to the CAP accreditation requirements in the lab general section: GEN.20377 Phase II N/A YES NO Are laboratory records and materials retained for an appropriate time? NOTE: The following records must be retained for at least 2 years: specimen requisitions (including the patient chart or medical record only if used as the requisition), patient test results and reports, instrument printouts, accession records, quality control records, instrument maintenance records, proficiency testing records, and quality management records. Specimens of serum, heparinized plasma, EDTA plasma, CSF, and body fluids (except urine) should be retained for 48 hours. (The 48 hour retention requirement does not apply to whole blood samples; for example, samples collected for blood gas testing.) Urine specimens should be retained for 24 hours; exceptions may be made at the discretion of the laboratory director. Blood films, permanently stained body fluid slides, and permanently stained microbiology slides prepared from clinical specimens (including blood culture bottles) should be retained for 7 days. Specimens must be kept under appropriate storage conditions. Laboratories may wish to retain instrument maintenance records for longer than the 2-year requirement (e.g., for the life of the instrument), to facilitate trouble-shooting. Records of method performance specifications must be retained while the method is in use, and for at least two years afterwards. For requirements on retaining records of changes to software, the test library, and major functions of laboratory information systems, please refer to the Hardware and Software section of the Laboratory Computer Services section of this checklist. More stringent requirements for certain laboratory records (e.g., in anatomic pathology, cytopathology, transfusion medicine) may be found in the discipline-specific checklists. For data directly transmitted from instruments to the laboratory computer system via an interface (on-line system), it is not necessary to retain paper worksheets, printouts, etc., so long as the computer retains the data for at least two years. Manual computer entry of patient result data from worksheets, print-outs, etc. requires retention of all worksheets, printouts, etc. for at least two years. For results that are manually entered into the computer from 1) observation of an electronic display, with no paper print-out available, or 2) manually performed test methods without worksheets, the two-year retention requirement applies to the data within the computer. In establishing retention requirements, care should be taken to comply with state and federal regulations. REFERENCES 1) College of American Pathologists. Guidelines for the retention of laboratory records and materials. Northfield, IL: CAP, current edition 2) Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1105]