Verification and Validation Testing of FDA-Approved Assays/Instruments in Clinical Microbiology(by CACMLE) (Online Course)

Susan Sharp, PhD, D(ABMM), F(AAM) and Yvette McCarter, PhD, D(ABMM)

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Continuing Education Credits

Objectives

  • Explain the verification testing required by CLIA that must be done prior to the implementation of a FDA-approved(-cleared) assay/instrument.
  • List ways to verify FDA-approved (-cleared) blood culture instrumentation in the microbiology laboratory.
  • Apply protocols for the validation of recently verified laboratory assays/instruments.

Course Outline

  • PowerPoint Slides
      • Verification and Validation Testing of FDA-Approved Assays/Instruments in Clinical Microbiology
      • Goal for Course
      • Course Overview
      • Slide 4
      • Susan E. Sharp, PhD, D(ABMM), F(AAM)
      • Verification Testing of FDA-Approved Assays/Instruments in Clinical Microbiology
      • Learning Objectives
      • Cumitech 31A
      • Verification of Unmodified FDA-Cleared Test
      • Verification Testing
      • Verification of Unmodified, FDA-Cleared Tests
      • Verification of Unmodified, FDA-Cleared Tests, cont.
      • FDA-Cleared Assay
      • In addition . . .
      • FDA-cleared assays
      • FDA-cleared assays, cont.
      • FDA-cleared assays - Microbial Identification Tests
      • FDA-cleared assays - Microbial Identification Tests
      • FDA-cleared assays - Microbial Identification Tests
      • FDA-cleared assays - Blood Culture Systems
      • FDA-Cleared Assays - Blood Culture Systems
      • FDA-Cleared Assays - Blood Culture Systems
      • FDA-Cleared Assays - Blood Culture Systems
      • FDA-Cleared Assays - Blood Culture Systems
      • FDA-Cleared Assays - Blood Culture Systems
      • FDA-Cleared Assays - Blood Culture Systems
      • Validation Testing of FDA-Approved Assays/Instruments in Clinical Microbiology
      • Validation
      • Validation Components
      • Validation Components, cont.
      • Personnel Training and Competency Assessment
      • Training Checklist
      • Competency Assessment
      • Competency Assessment - Test Systems
      • Elements of Competency Assessment
      • Elements of Competency Assessment, cont.
      • Competency Assessment - nonwaived & waived test systems
      • Competency Assessment - Molecular Test Systems
      • Competency Assessment - Remediation
      • Proficiency Testing
      • Proficiency Testing, cont.
      • Proficiency Testing - Analytes with no external PT
      • Proficiency Testing - COM.01400
      • Quality Control - Organisms/Analytes, FDA-approved Tests
      • Quality Control - Organisms/Analytes, MIC.63262
      • Quality Control - Organisms/Analytes, MIC.34120, Daily QC - Nonwaived tests
      • Comparison of Results of Multiple Methods/Testing Sites
      • Comparison of Results of Multiple Methods/Testing Sites. MIC.11027
      • Validation Components - Instrument Calibration & Use of Historial Lab Data
      • Validation Components - Confidentiality and Specimen ID
      • Validation Components - Complaint Investigations & Communication
      • Validation Frequency
      • Summary of Verification and Validation
      • Concluding Remarks



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Slide 32