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
