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

The laboratory must retain all collected data, calculations, and conclusions. All data, calculations, and conclusions are reviewed and approved by the laboratory director for compliance. The laboratory maintains these documents for the instrument's life plus a minimum of 2 years. If the state or local agencies or accreditation agencies require retention for a more extended period after retirement, the retention time will be the maximum required period.