Written by
Laurie Bjerklie
Education Lead
In December 2023, the Centers for Medicare & Medicaid Services (CMS) introduced significant updates to the Clinical Laboratory Improvement Amendment (CLIA) personnel regulations, marking the first major revision since 1992. These changes, effective December 28, 2024, aim to modernize qualifications and responsibilities for laboratory personnel. Key updates will include:
A. Expanded Definitions
· Mid-Level Practitioner: The updated definition now includes nurse anesthetists and clinical nurse specialists, adding to the existing categories of nurse midwives, nurse practitioners, and physician assistants.
· Continuing Education (CE) Credit Hours: This new term covers both continuing medical education (CME) for physicians and broader CE for non-physician laboratory directors (LDs).
· Doctoral Degree: A “doctoral degree” under CLIA now requires at least three years of graduate study in a field related to clinical laboratory testing. Notably, MDs, DOs, and DPMs are categorized separately with specific requirements.
· Training and Experience: Laboratory training now must be completed in a CLIA-certified facility, excluding forensic and research labs that only report aggregate data.
· Experience Directing or Supervising: CLIA now mandates that supervisory experience also be obtained in a certified laboratory.
B. Degree Requirements:
· Physical Science Degrees: Degrees in physical sciences are no longer automatically acceptable for laboratory positions. Individuals with such degrees must now meet specific coursework requirements in biology and chemistry to qualify.
· Nursing Degrees: Degrees in nursing now qualify for moderate-complexity testing personnel roles, reflecting the growing role of nurses in point-of-care testing. Bachelor of Science in Nursing (BSN) degrees are not recognized for high-complexity testing roles. Nurses are also excluded from roles such as Laboratory Director or Technical Consultant.
· Additionally, respiratory therapists and cardiovascular technicians with relevant degrees can qualify for blood gas testing.
C. Laboratory Director Qualifications:
For laboratories performing moderate-complexity testing, LDs do not require a doctoral degree but must meet coursework requirements in relevant scientific fields. This update allows broader access for individuals with nontraditional degrees to serve as LDs.
New pathways allow individuals without a traditional degree in biological or laboratory sciences to qualify as LDs through additional coursework and a thesis or research project. All LDs must
complete 20 CE credit hours and be certified by a relevant board, with a minimum of one year of experience in nonwaived testing.
· Continuing Education: Previously, only continuing medical education (CME) credits were defined to meet the need for continuing education. This definition has been broadened to include continuing education (CE) credits for those Laboratory Directors who are not physicians. Prospective Laboratory Directors must complete at least 20 continuing education (CE) credit hours covering laboratory director responsibilities in addition to the existing experience requirements.
· Onsite Presence: Laboratory Directors are now required to be physically present at the laboratory at least twice annually, with a minimum of four months between visits. Documentation of these visits and related activities is mandatory.
· Responsibilities of PPM Laboratory Directors: Laboratory Directors overseeing Provider-Performed Microscopy (PPM) must ensure testing personnel (TP) maintain competency through direct observation, results monitoring, and problem-solving assessments. Semiannual performance evaluations are required in the first year, with annual reviews thereafter.
D. Technical Consultant (TC) Role:
· Associate Degree Pathway: Individuals with an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science, plus four years of laboratory training or experience, can now qualify as Technical Consultants in moderate-complexity laboratories.
· Competency Assessments: Qualified Technical Consultants are authorized to perform competency assessments for both moderate and high-complexity testing personnel.
· Technical Supervisor (TS) and General Supervisor (GS) Updates: Technical and general supervisors must now assess the competency of TPs regularly, including both semiannual and annual evaluations, a responsibility that previously was limited to annual evaluations.
E. Military Training Recognition:
· High-Complexity Testing: The rule permanently recognizes U.S. military medical laboratory training programs of at least 50 weeks and holds a military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician), allowing graduates to qualify for high-complexity testing roles.
F. Standardization of Nomenclature:
· Professional Titles: The regulations now incorporate the term "Medical Laboratory Science" alongside "Clinical Laboratory Science" and "Medical Technology," reflecting current professional nomenclature.
These updates are designed to align CLIA personnel standards with contemporary educational and professional practices, ensuring laboratory personnel are adequately qualified for their roles.
Notes: LD = laboratory director; TC = technical consultant; TP = testing personnel; GS = general supervisor; TS = technical supervisor; CA = competency assessment