Verification of Performance Specifications

Number of Credits

2 P.A.C.E.®




Cynthia Cardelino, MLT(ASCP), MT(HEW)
Course Keywords: , ,

This course provides P.A.C.E.® credit only and is not for individuals that are eligible for CME credit (physicians, nurse practitioners, nurses). For CME credit, register for the course under the Laboratory Director CME Program category where the course is offered for CME credit.

Course Details:

This course will assist laboratories in understanding and meeting the requirements for verification of performance specifications that are part of the updated CLIA requirements of 2003. For many moderate complexity laboratories this requirement is new, and it has caused some anxiety. Performance specifications are defined and the CLIA requirements and their purpose is explained. To help you perform a verification study, appropriate sample selection is discussed and suggested procedures are provided with example data to demonstrate the process. The course includes printable worksheets and links to additional resources.

At the end of this course, the learner will be able to:

  • Define performance specifications
  • Define the CLIA requirements regarding performance specifications and the purpose of the requirements
  • Recognize when verification or establishment is required
  • Identify the performance specifications that need to be verified for FDA-approved tests
  • Identify the performance specifications that need to be established for tests that are not FDA-approved
  • List samples appropriate for the study
  • Recognize appropriate procedures for performing the study
  • Recognize methods for interpreting and determining the acceptability of the study

This course has been approved for P.A.C.E.® credit.

  • Introduction
  • The CLIA Requirements
  • Sample Selection
  • Accuracy and Precision
  • Reportable Range and Reference Range
  • Establishment of Performance Specifications
  • Graded Quiz
  • Resources

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