Record Keeping for Instrument Validation Studies

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The page below is a sample from the LabCE course Hematology Instrument Validation/Calibration Verification Protocol. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Record Keeping for Instrument Validation Studies

All collected data, calculations, and conclusions must be retained by the laboratory. For compliance all data, calculations, and conclusions are reviewed and approved by the laboratory director. These documents are retained by the laboratory for the life of the instrument plus at a minimum of 2 years. If the state or local agencies or accreditation agencies require retention for a longer period of time after retirement, the retention time will be the maximum required period.