Q&A column

Gwendolyn A. McMillin, PhD, DABCC(CC,TC)
Professor, Clinical Pathology
University of Utah
Medical Director, Clinical Toxicology
Scientific Director, Mass Spectrometry
ARUP Laboratories
Salt Lake City, Utah
Member, CAP Toxicology Committee

Q. Can laboratory managers and supervisors assess the competency of testing personnel if they do not perform the lab tests themselves?

A.Yes, as long as those responsible for competency assessments have the education and experience required to evaluate the complexity of the testing being assessed and are delegated to perform that duty. For high-complexity testing, this is someone who is qualified as a technical supervisor or general supervisor. For moderate-complexity testing, it is someone who is qualified as a technical consultant. Competency assessors must be knowledgeable about the test systems but are not required to undergo competency assessment themselves unless they are testing personnel for that system.

Most clinical laboratory specialties require a technical supervisor to have a minimum of a bachelor’s degree in a chemical, physical, or biological science or in medical technology, from an accredited institution, and at least four years of laboratory training and/or experience in high-complexity testing. The requirements for clinical cytogenetics, histocompatibility, molecular pathology, and transfusion medicine are more stringent and are provided in the CAP checklist related to the specific discipline. A general supervisor must have a minimum of an associate’s degree in a laboratory science or medical technology (or equivalent) and at least two years of training and/or experience in high-complexity testing. A technical consultant for moderate-complexity testing must have a minimum of a bachelor’s degree in a chemical, physical, biological, or clinical laboratory science or in medical technology and at least two years of training and/or experience in nonwaived testing. In all cases, the training and experience must be in the designated specialty or subspecialty area of service for which the individual is responsible.

Centers for Medicare and Medicaid Services. What Do I Need to Do to Assess Personnel Competency? November 2012. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIA_CompBrochure_508.pdf

College of American Pathologists. Laboratory general checklist. Oct. 24, 2022.

Sarah Fabian, MLS(ASCP)
Investigations Analyst
CAP Accreditation Programs
College of American Pathologists
Northfield, Ill.

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