Q&A column

Editor: Frederick L. Kiechle, MD, PhD

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Q. I am a nurse in a cardiac cath lab that performs point-of-care testing, including for activated clotting time. At my hospital, the POC testing coordinator only allows other cath lab staff, usually nurses, to use POC testing equipment if they have a copy of their diploma. Can staff who have proof of licensure (such as from the American Registry of Radiologic Technologists) but do not have a copy of their diploma be authorized to use POC testing equipment?

A.Laboratory and nonlaboratory testing personnel (nurses, respiratory therapists, radiologic technologists, and medical assistants) must meet the qualifications appropriate for the complexity of testing performed. Nonlaboratory personnel licensure is not acceptable documentation to demonstrate compliance with CLIA regulations for laboratory testing. All nonlaboratory personnel performing nonwaived POC testing must have proof of academic achievement, such as a copy of their diploma, transcript, primary source verification report confirming credentials, or equivalency evaluation from a nationally recognized organization for personnel trained outside of the United States.

Per CAP laboratory general checklist requirement GEN.54750 Nonwaived Testing Personnel Qualifications, personnel performing moderate-complexity testing, including nonlaboratory personnel, must have a minimum of one of the following:

• an MD or DO degree with a current medical license.
• a doctoral degree in clinical laboratory science or in a chemical, physical, or biological science.
• a master’s or bachelor’s degree in medical technology, clinical laboratory science, or in a chemical, physical, or biological science.
• an associate’s degree in a chemical, physical, or biological science or in medical laboratory technology.
• a high school diploma or equivalent and record of having successfully completed U.S. military training of 50 or more weeks and served as a medical laboratory specialist.
• a high school diploma or equivalent and a record of appropriate training and experience, as defined in CLIA regulation 42 CFR §493.1423, Testing Personnel Qualifications.

The laboratory must have records demonstrating that personnel meet minimum qualifications before authorizing them to perform patient testing.

For more information on what must be included in personnel records, refer to laboratory general checklist requirement GEN.54400 Personnel Records.