CME – Laboratory Personnel Requirements

Number of Credits

3.0 CME




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 addresses the laboratory personnel requirements as stipulated by the CLIA ’88 regulations. Included in the discussion are the personnel requirements for waived laboratories, provider performed microscopy procedure (PPMP) laboratories, moderate complexity laboratories, and high complexity laboratories. The education and experience requirements necessary to qualify for each position, and the responsibilities of each position are explored. Personnel files, records, and licensure requirements are described. A discussion of personnel competency assessment is also included. This course also offers a Resource section with helpful web site links relating to personnel, and printable resources for your use.

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

  • Interpret and apply the personnel requirements addressed by the CLIA ’88 regulations
  • Locate the personnel requirements in the CLIA regulations
  • Apply the personnel requirements and responsibilities for a PPMP lab
  • Distinguish between the CLIA-required positions for a moderate complexity and a high complexity laboratory
  • Interpret the various pathways to qualify for each moderate complexity and high complexity position
  • Outline the responsibilities of each moderate complexity and high complexity position
  • Demonstrate the required contents of a personnel file
  • Predict when laboratory personnel must be licensed
  • Decide who has the responsibility to evaluate laboratory personnel and how often evaluations need to be conducted
  • Formulate ways to evaluate the competency of laboratory personnel

This course will take 3 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):

  • 3.00 Enduring Materials, Self-Study AAFP Elective Credit(s) – Laboratory Personnel Requirements

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.


  • Personnel Basics
  • Waived & PPMP
  • Graded Exam 1
  • Moderate Complexity
  • Graded Exam 2
  • High Complexity
  • Graded Exam 3
  • Records, Licensure & Competency
  • Graded Exam 4
  • Resources

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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.