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Method Validation Approval Checklist

Once the method evaluation is completed and reviewed, the laboratory manager and medical director should sign a coversheet documenting that all of the required evaluation parameters that have been completed.  An example is included below.

Assay:

Instrument:

Live Date: __________________________

The following parameters have been completed before the go-live date for this assay:

  • Clinical application
  • Accuracy
  • Precision
  • Linearity
  • Sensitivity
  • Interference
  • Method comparison
  • Quality control
  • Reference range/ unit of measure
  • Reportable range
  • LIS report format
  • Interface
  • Cost accounting-direct/indirect cost
  • CAP and/or TJC notification – add assay/analyte to activity menu
  • Proficiency survey ordered or Alternate Proficiency organized
  • CPT coding
  • Written procedure/s; approved by Medical Director
  • Staff training/competency; paperwork placed in personnel files

Complexity -Non-Waived or Waived

FDA status approved or on-approved

This validation study has been reviewed and the performance of the method is considered acceptable for patient testing.

Manager Signature______________________________________________ Date________________

Medical Director Signature_______________________________________ Date_________________

Intermittent Testing: Assay Name

PT or alternative assessment performed within 30 days prior to restarting patient testing

Method performance specifications verified, as applicable, within 30 days prior to restarting patient testing

Competency assessed for analysts within 12 months prior to restarting patient testing

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