Validation Guidelines, Quality Improvement and Regulatory Issues for Clinical Implementation
Kim Dickinson, MD, MBA, MPH
Anil Parwani, MD, PhD
As Digital Pathology is adopted in the routine laboratory practice, the necessary Quality Control and Quality Improvements parameters will need to be developed and standardized. The other disciplines in the laboratory environment have well established quality control measures. This session will discuss the development of quality measures within the guidelines of CLIA, CAP and other regulatory agencies. Three key aspects will be reviewed in this workshop: validation guidelines, quality improvement and regulatory issues. Discussion will also focus on CAP guidelines, inspection checklists and the recently released ATA Telepathology guidelines.
A. Primary Validation
- For both whole slide imaging
- Validating automated analysis for breast prognostics.
- Validating image analysis in a regulatory environment
- Development and application of algorithm
B. Quality Improvement & Control & Role of Digital Pathology
- Regulatory environment .eg. CLIA, FDA, CMS
- CAP guidelines
- ATA Telepathology guidelines
- Construction of a clear and broad validation plan
- Purpose, Responsibilities, Material and Equipment, Reagent, Sample Sources/Type, Sample Size, Method of Scoring, Validation Procedure, Validation Summary, Validation Summary, Validation Approval, and Supplemental data
- Scanner/instrument qualification:
- Definitions, Primary Site Validation, Material and Equipment, Validation Procedure, Scan Handling, and Scanner QC and calibration
- Algorithm validation:
- Definitions, Purpose, Responsibilities, Material and Equipment, Reagent, Sample Sources/Type, Sample Size, Method of Scoring, Validation Procedure, Validation Summary, Validation Summary, Validation Approval, and Supplemental data
- As you are working on your validations, begin to compile your training documents.
- Remember training for lab personnel and pathologist staff will be different