Frequently Asked Questions

Is the BioPharma Diagnostics staff trained in Good Clinical Practice (GCP) and if so, how often? Could you provide a summary of required training for your staff?

Our training is based on College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) requirements rather than GCP, and all employees complete annual competency assessments with seven required elements:

  • Direct observation of test performance/employee duties, for example, specimen handling, processing, and testing
  • Direct observation of performance of instrument maintenance and function checks
  • Observation for compliance with safety protocols
  • Assessment and evaluation of problem-solving skills
  • Assessment of test performance
  • Monitoring, recording, and reporting of test results
  • Review of intermediate test results and work product records for compliance with SOPs and applicable work load limits

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