CLIA Lab Director and Consultant Personnel Solutions

Key facts and official sources

• Personnel rules: 42 CFR 493 Subpart M

• Directors: §493.1405 (moderate) and §493.1443 (high)

• Technical consultant: §493.1411

• Clinical consultant: §493.1417 and §493.1455

Laboratory director qualifications by complexity

All directors must hold any state director license the state requires.

• Moderate complexity (§493.1405): a licensed MD or DO board certified in anatomic and/or clinical pathology. Or a licensed MD, DO or DPM with at least 1 year directing or supervising nonwaived testing plus 20 CE hours covering director duties. Or a qualifying doctoral degree (PhD) with board certification or other experience pathways in the rule.

• High complexity (§493.1443): a licensed MD or DO board certified in anatomic and/or clinical pathology. Or a licensed MD, DO or DPM with at least 2 years directing or supervising high complexity testing plus 20 CE hours. Or a qualifying doctoral degree with board certification from an HHS-approved board, as the rule specifies.

Technical consultant (moderate complexity)

The §493.1411 pathways run from board-certified pathologists, through doctoral, master's and bachelor's degrees, to associate degrees with 4 years of experience. Experience must be in nonwaived testing in the specialty. See CLIA technical consultant.

Clinical consultant

A clinical consultant advises the lab's clients on diagnosis, treatment and patient care. The person must qualify as a lab director under the matching director section, or be a licensed MD, DO or DPM in the lab's state (§493.1417 moderate, §493.1455 high).

Personnel checklist

• Test menu mapped to complexity

• Director qualifies for the highest complexity tested

• Technical consultant or technical supervisor named for each specialty

• Clinical consultant named

• Diplomas, licenses, transcripts and CE on file

• CMS-116 and accreditor updated when personnel change

• Director duties delegated in writing

How SLC helps

SLC supplies qualified laboratory directors and technical and clinical consultants for CLIA labs nationwide, including New York Certificate of Qualification (CQ) directors. SLC also recruits qualified laboratory directors (MD, DO or PhD) and technical and clinical consultants for labs that want to hire directly. Related: Laboratory director services, CLIA personnel qualifications, Part-time CLIA laboratory director, Outsourced TC vs full-time hire.

FAQs

Can a PhD be a CLIA lab director? Yes, under the doctoral pathways in §493.1405(b)(3) and §493.1443(b)(3), which include board certification or experience requirements.

Can one person be director and technical consultant? Yes, if they meet both sets of qualifications.

Does the director need to be on site? For moderate complexity, §493.1407 requires an on-site visit at least once every 6 months, with at least 4 months between visits, and documented oversight. See director services.

How many labs can one director oversee? No more than five laboratories (§493.1407(d)).

What changed in Subpart M in 2024? CMS updated education and experience pathways effective December 28, 2024. See personnel rule changes.

Do waived labs need a qualified director? A waived lab names a director, but Subpart M director qualifications apply to nonwaived testing.

Work with Sound Lab Consultants

Sound Lab Consultants (SLC) is a clinical laboratory consulting company. It provides CLIA compliance, lab startup and licensing, quality management, laboratory director and consultant personnel, and deficiency resolution services to labs nationwide. SLC works with labs accredited by CAP, COLA and The Joint Commission and prepares them for those inspections. Mailing address: PO Box 2135, Chandler, AZ 85244.

Last reviewed Oct 2026 · Sound Lab Consultants CLIA team · General information, not legal advice.