CLIA ’88 Requirements for the Medical Laboratory

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 online educational activity has been designed to meet the needs of individuals in a clinical laboratory, including healthcare professionals working as medical laboratory staff in non-waived diagnostic laboratories, testing personnel, technical consultants, supervisors, and laboratory assistants.This course examines the CLIA requirements that apply to clinical laboratories in the United States and discusses ways to meet the requirements and document compliance. This course explains the following CLIA ’88-related topics: certification, test complexity, proficiency testing, personnel, quality systems, quality assessment, and compliance. The course includes links to additional resources.This course has been approved for P.A.C.E.® credit. At the conclusion of this course, the learner will be able to:

  • Interpret the intent of the CLIA regulations
  • Outline major events in CLIA history
  • Summarize who, what, and how CLIA regulates
  • Navigate the CLIA regulations in the Federal Register
  • Summarize the basic requirements for each type of CLIA certificate
  • Differentiate between waived, moderate complexity, and high complexity requirements
  • Apply steps towards CLIA compliance

This activity will take approximately 2 hours to complete and there are no prerequisites. A P.A.C.E. completion certificate will be issued upon successful completion of the course with a score of 80% or higher on the graded exams, and completion of the course evaluation.

Outline Module 1

  • Introduction
  • CLIA History
  • CLIA Regulations
  • Working with the Federal Register
  • Module 1 Graded Exam

Module 2

  • Introduction
  • Registering for CLIA
  • Achieving CLIA Compliance
  • Module 2 Graded Exam
  • Resources

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