Requirements for Instrument Validation

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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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Requirements for Instrument Validation

Methods introduced into a laboratory, including instruments, require validation prior to reporting test results. Compliance requirements, as outlined in the Code of Federal Regulations, are as follows from the "State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. "
The requirements of §493.1253 apply to each nonwaived test system (i.e., moderate and high complexity) introduced into the laboratory on or after April 24, 2003.
  • "A test system that is introduced into the laboratory for the first time to measure an analyte that the laboratory has not previously measured
  • A test system introduced for the first time into the laboratory for a test that the laboratory currently performs on an alternative test system (e.g., instrument A has been used to perform cholesterol testing, now instrument B will be used)
  • An analyte added to a test system that can measure multiple analytes that the laboratory has been using for patient testing but has not previously reported patient results for this particular analyte
  • A modification to a test system that the laboratory has been using for patient testing (e.g., the laboratory reduces the specimen and/or reagent volumes). When multiple instruments (including the same make and model, e.g., point-of-care instruments) are used to perform the same test, the laboratory must verify or establish, as applicable, performance specifications for each instrument."
The above requirements are defined for CLIA compliance and serve as the minimum requirements.
Additional studies may be required by the manufacturer, accreditation agencies, state or local laboratory regulations, or specific institution protocols. Manufacturer-defined validation requirements are performed in addition to the above CLIA outlined requirements and may not override or replace any of the CLIA requirements.