Frequently Asked Questions > Quality

Quality

Can I visit your facility for regular audits during the project?

BioPharma Diagnostics permits a site qualification visit, which includes a tour of our facility and review of standard operating procedures. However, we do not allow routine audit monitoring visits, where we would pull records for your specific study.


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

What is your quality system structure? What regulatory and accreditation requirements does BioPharma Diagnostics follow?

See Mayo Clinic Laboratories' Quality and Compliance section.