CME – CLIA ’88 Requirements for the Medical Laboratory

Number of Credits




Cynthia Cardelino, MLT(ASCP), MT(HEW)

This course provides CME credit and is only for individuals that are eligible for CME credit (physicians, nurse practitioners, nurses). All others should register for the course under the Laboratory Training category where the course is offered for
P.A.C.E. credit.

Course Details:

This online educational activity has been designed to meet the needs of physicians operating an office laboratory; healthcare professionals working as medical laboratory staff in non-waived diagnostic laboratories, including testing personnel, technical consultants, supervisors, and laboratory directors.This course examines the CLIA requirements that apply to clinical laboratories 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 a glossary and links to additional resources.

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 course will take 2 hours to complete and there are no prerequisites. A credit certificate will be issued upon completion of the course evaluation and post-test with a score of 80% or better.

This CME activity has been designed to change learner competence and focuses on the American Board of Medical Specialties areas of patient care, practice-based learning and systems-based practice.

The AAFP has reviewed Laboratory Director CME Program, and deemed it acceptable for AAFP credit. Term of approval is from 10/01/2021 to 10/01/2022. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Credit approval includes the following session(s):

  • 2.00 Enduring Materials, Self-Study AAFP Elective Credit(s) – CLIA ’88 Requirements for the Medical Laboratory

AAFP Prescribed credit is accepted by the American Medical Association as equivalent to AMA PRA Category 1 Credit™ toward the AMA Physician’s Recognition Award.  When applying for the AMA PRA, Prescribed credit earned must be reported as Prescribed, not as Category 1.

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

Free, current version of Internet Explorer, Chrome, Firefox, or Safari. (Some older browsers could produce error messages or not display the content correctly.)

Free, current version of Adobe Reader.

It is the policy of the AAFP and LabUniversity that the faculty, authors, planners, and other persons who may influence content of this CME activity disclose all relevant financial relationships with commercial interests* in order to allow CME staff to identify and resolve any potential conflicts of interest. Faculty must also disclose any planned discussions of unlabeled/unapproved uses of drugs or devices during their presentation. For this educational activity all conflicts of interests have been resolved and detailed disclosures are listed below:

Author and Course Reviewer: Cynthia Cardelino, MLT(ASCP), MT(HEW)
No relevant financial relationships to disclose, No discussion of unlabeled/unapproved uses of drugs/devices during presentation.

* The ACCME defines a commercial interest as any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The ACCME does not consider providers of clinical service directly to patients to be commercial interests.

Share this course with your colleagues: