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The page below is a sample from the LabCE course Breast Cancer Predictive Markers. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Compliance Documentation

For accreditation compliance, the following records are needed for each newly validated assay:
  • Validation summary, which includes:
    • Tissue source
    • Type and method of fixation
    • Specificity and selectivity of the assay
    • Clinical use and application
    • Heat-induced epitope retrieval (HIER) treatment used
    • Time and temperature
    • Antibody clone and titer
    • Incubation time & temperature
    • Internal positive/negative controls utilized
  • Signature that documents pathologist review
  • Optimization and validation slides
  • Proficiency testing (PT) records (PT required for predictive marker testing)
  • Documentation of the review of control material and slide quality
  • Lot-to-lot records