CLIA Changes Effective December 28, 2024

Significant changes relating to Laboratory Director qualifications will take effect by the end of this year. The Network is sharing this information to ensure that independent consultants are aware and can take appropriate measures to remain in compliance.

On December 28, 2023, the Centers for Medicare & Medicaid Services (CMS) published a final rule updating the Clinical Laboratory Improvement Amendments (CLIA) regulations. The rule addresses outdated provisions and incorporates new technological advancements. The changes focus on the qualifications and responsibilities of laboratory personnel, which will take effect on December 28, 2024.

Key Changes to CLIA Personnel Regulations:

1. Clarification on Acceptable Degrees:

• Degrees in physical science are now considered too broad and must be assessed for specific course credits in biology, chemistry, and related subjects.
• Degrees in chemical, biological, clinical, or medical laboratory science from accredited institutions are acceptable.
• Degrees in other fields will be assessed based on coursework, particularly in subjects relevant to laboratory work (e.g., biology, chemistry).
• For full details on coursework equivalencies, refer to 42 CFR Part 493 [CMS–3326–F].

2. Exclusion of Certain Doctoral Degrees:

• The new regulations clarify that Doctor of Medicine (MD), Doctor of Osteopathy (DO), Doctor of Podiatry, Doctor of Veterinary Medicine (DVM), and honorary degrees do not qualify as doctoral degrees for laboratory personnel.
• The Doctorate in Clinical Laboratory Science (DCLS) is now recognized as an acceptable doctoral degree.

3. Nursing Degrees No Longer Qualify for High Complexity Testing Personnel:

• A nursing degree is no longer an acceptable qualification to serve as personnel for high complexity testing. Nursing degrees will only be considered when specifically listed in regulatory qualifications for a particular position.

4. Laboratory Director Onsite Visits:

• Laboratory directors must be onsite at least twice a year, with no fewer than 4 months between visits.
• Documentation must be maintained to verify the director’s presence and their involvement in laboratory activities.

5. Continuing Education Requirements for Laboratory Directors:

• Laboratory Directors (for moderate or high complexity laboratories) must complete at least 20 CE credit hours covering laboratory director responsibilities.
• This is in addition to required years of experience in laboratory supervision. Physicians board-certified in anatomic or clinical pathology are exempt from this CE requirement.

6. Changes for Technical Consultant (TC) Qualifications:

• Individuals with an associate degree in medical laboratory science may now qualify as Technical Consultants (TC) in moderate complexity laboratories if they have at least 4 years of experience in nonwaived testing within the specialty or subspecialty areas.

7. Revised Qualifications for Technical Supervisor (TS) in Immunohematology:

• The qualifications for a Technical Supervisor (TS) in high complexity immunohematology laboratories are now aligned with those of other laboratory specialties.
• A minimum bachelor’s degree in a relevant scientific field and 4 years of training or experience in high complexity immunohematology testing are required.

8. Competency Assessment:

• The new rule allows individuals qualifying as Technical Consultants (with associate degrees and experience) to perform competency assessments for both moderate and high complexity testing.

9. Blood Gas Testing:

• CMS clarifies that a degree in respiratory therapy or cardiovascular technology is not equivalent to a biological or chemical science degree.
• However, individuals with a bachelor’s degree in respiratory therapy or cardiovascular technology and 2 years of experience in blood gas analysis may qualify as Technical Consultants (TC) for blood gas testing.

Note:

• Laboratory personnel currently employed in their roles as of December 28, 2024, will retain their qualifications as long as they remain continuously employed in those positions.

These changes, effective December 28, 2024, are aimed at modernizing the CLIA regulations. For more details, including the full text of the regulations, refer to the Federal Register entry: CMS–3326–F.