CLIA Personnel Qualifications by Role and Test Complexity

CLIA personnel rules depend on test complexity. Moderate complexity labs need a lab director, technical consultant, clinical consultant and testing personnel. High complexity labs need a director, technical supervisor, clinical consultant, general supervisor and testing personnel. Each role has degree, experience and licensing requirements in 42 CFR 493 Subpart M, last revised December 28, 2024.

Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice. Confirm against the current eCFR.

Key facts and official sources

  • Personnel requirements are in 42 CFR 493 Subpart M: §§493.1403–493.1425 for moderate complexity and §§493.1441–493.1495 for high complexity.

  • Every role requires a current state license where the state requires one.

  • People who were qualified and serving in a role on December 28, 2024, and have served continuously since, remain qualified for that role (for example §493.1405(b)(6), §493.1411(b)(7), §493.1489(b)(5)).

  • Surveyors use Form CMS-209, the Laboratory Personnel Report, to review who fills each role.

Which roles does my lab need?

  • Laboratory director

    • Moderate complexity: §493.1405

    • High complexity: §493.1443

  • Technical consultant

    • Moderate complexity: §493.1411

    • High complexity: not used

  • Technical supervisor

    • Moderate complexity: not used

    • High complexity: §493.1449 (specialty-specific)

  • Clinical consultant

    • Moderate complexity: §493.1417

    • High complexity: §493.1455

  • General supervisor

    • Moderate complexity: not used

    • High complexity: §493.1461

  • Testing personnel

    • Moderate complexity: §493.1423

    • High complexity: §493.1489

One qualified person can hold more than one role. For example, the director may also serve as the technical consultant if they meet that role's qualifications (§493.1407(a), §493.1411).

What are the moderate complexity pathways?

  • Lab director: Board-certified pathologist; physician with experience and CE; doctoral, master's or bachelor's degree routes with experience and CE. See lab director requirements

  • Technical consultant: Pathologist; MD/DO/DPM + 1 yr; doctoral or master's + 1 yr; bachelor's + 2 yrs; associate degree in MLT/MLS/CLS + 4 yrs of nonwaived experience in the specialty. See TC qualifications

  • Clinical consultant: Qualified as a director under §493.1405(b)(1)-(3), or a licensed MD, DO or DPM

  • Testing personnel: MD/DO; doctoral, master's, bachelor's or associate degree in a lab science, medical technology or nursing; qualifying military training; or a high school diploma with documented training that covers the skills listed in §493.1423(b)(6)

What are the high complexity pathways?

  • Lab director: Board-certified pathologist; physician with 2 yrs directing or supervising high complexity testing and 20 CE; doctoral degree with board certification, experience and CE

  • Technical supervisor: Set by specialty and subspecialty in §493.1449. A pathologist certified in both AP and CP covers most specialties. Other routes require experience in the specific specialty

  • General supervisor: Qualified as a director or technical supervisor; MD/DO/DPM or a doctoral, master's or bachelor's lab science degree + 1 yr high complexity experience; or high complexity testing personnel with an associate degree + 2 yrs

  • Testing personnel: MD/DO/DPM; doctoral, master's or bachelor's degree in a lab science or medical technology; associate degree in a lab science or MLT, or the defined equivalent with training; or qualifying military training. Nursing degrees are not listed by name. A nurse may still qualify through the coursework and training equivalency in §493.1489(b)(3)(ii)

What is Form CMS-209?

Form CMS-209, the Laboratory Personnel Report (CLIA), lists the people responsible for testing and the CLIA positions they hold. Surveyors use it to check that each required position is filled by a qualified person. Keep it current whenever staff change.

How do you document qualifications for a survey?

Keep a file for each person containing:

  • diploma or transcript (with a foreign degree equivalency evaluation if applicable)

  • state license, if required

  • board certification, if used

  • experience letters showing nonwaived or high complexity work

  • CE certificates, if used

  • training records and competency assessments

Missing transcripts and undocumented experience are common reasons a qualification can't be verified.

Frequently asked questions

Can one person fill multiple CLIA roles?

Yes, if they meet the qualifications for each role. The director remains responsible for any duties they delegate.

Can a nurse perform moderate complexity testing?

Yes. §493.1423 lists bachelor's and associate degrees in nursing as qualifying for moderate complexity testing personnel. For high complexity testing, §493.1489 does not list nursing degrees by name. A nurse would need to meet another pathway, such as the coursework and training equivalency in §493.1489(b)(3)(ii).

Do waived labs have personnel requirements?

CLIA sets no federal personnel qualifications for Certificate of Waiver labs. Some states and accreditors do.

Are current staff grandfathered after the 2024 changes?

Yes, if they were qualified and serving in that role on December 28, 2024, and have served continuously since.

Need a personnel file audit?

Sound Lab Consultants reviews personnel files against Subpart M, fills lab director and technical consultant roles, and prepares labs for surveys.

Book a free consultation