Safety & Compliance

Safety and Compliance

  • Federal Quality Standards: Standardizes U.S. facility human specimen testing for accurate and timely results.
  • Certification Types: Requires renewal every two years for Waiver (COW), Microscopy (PPM), or Compliance/Accreditation certificates.
  • Test Complexity: Categorizes tests into waived, moderate, or high complexity based on FDA criteria.
  • Quality Control: Mandates daily QC sample analysis and data review for moderate- and high-complexity labs.
  • Proficiency Testing: Demands enrollment in approved programs to analyze blind samples and track corrective actions.
  • Personnel Qualifications: Sets education, training, and competency standards for directors, supervisors, and testing staff.
  • Quality Systems: Requires Standard Operating Procedures across pre-analytic, analytic, and post-analytic testing phases.
  • Instrument Maintenance: Tracks regular preventative maintenance, calibration, and function checks against manufacturer specs.
  • Compliance Inspections: Enforces routine surveys every two years by CMS or accrediting organizations for non-waived labs.
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