CLIA Lab Director Requirements: Qualifications by Testing Complexity

Short answer

Under CLIA, the federal qualification rules for a laboratory director depend on the complexity of the testing. Moderate complexity directors are governed by 42 CFR 493.1405 and high complexity directors by 42 CFR 493.1443; both need a current state director licence where the state requires one, plus an accepted combination of degree, experience and 20 continuing education (CE) hours. CMS states that waived testing has no federal education or experience qualification for the director. Every director can delegate duties but stays responsible for them, and one person may direct no more than five laboratories.

This page summarises the regulation text current on 2026-11-01. It is general information, not legal or compliance advice; state rules can be stricter than the federal text.

Who counts as a CLIA laboratory director

The director is the individual the regulations hold responsible for the overall operation and administration of the laboratory, including employing personnel who are competent to perform test procedures, reporting results promptly, accurately and proficiently, and assuring compliance with the applicable regulations (42 CFR 493.1445 for high complexity; 493.1407 uses the same wording for moderate complexity). Both qualification standards also require that the person be eligible to be an operator of a laboratory under subpart R.

For how a laboratory obtains its certificate in the first place, see CLIA certification; for the certificate-number side, see CLIA number lookup.

Qualifications by complexity tier

Testing tier	Federal director qualification	Source
Waived	No federal education or experience qualification for the director; the laboratory needs a Certificate of Waiver and staff who follow the manufacturers’ instructions.	CMS, For Laboratory Directors
Provider-performed microscopy (PPM)	Listed by CMS as a separate category with its own standard (42 CFR 493.1357); not covered on this page.	CMS, For Laboratory Directors
Moderate complexity	Standard at 42 CFR 493.1405: state licence if required, then one of five qualification paths (below). The CE hours must cover the director responsibilities in 493.1407.	eCFR 493.1405
High complexity	Standard at 42 CFR 493.1443: state licence if required, then one of three qualification paths (below), with a separate certification route for oral pathology. The CE hours must cover the responsibilities in 493.1445.	eCFR 493.1443

Moderate complexity paths (42 CFR 493.1405)

• A doctor of medicine or osteopathy licensed in the state where the laboratory is located and certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology.
• A doctor of medicine, osteopathy or podiatric medicine licensed in that state, with at least 1 year directing or supervising nonwaived laboratory testing and at least 20 CE hours in laboratory practice.
• An earned doctoral degree (in a chemical, biological, clinical or medical laboratory science or medical technology, or a doctorate with specified coursework or an approved thesis or research project), at least 20 CE hours, certification by an HHS-approved board, and at least 1 year directing or supervising nonwaived testing.
• A master’s degree (or bachelor’s equivalency with specified graduate coursework), at least 1 year of laboratory training or experience in nonwaived testing, at least 1 year of supervisory experience in nonwaived testing, and at least 20 CE hours.
• A bachelor’s degree (or the specified semester-hour equivalent), at least 2 years of laboratory training or experience in nonwaived testing, at least 2 years of supervisory experience in nonwaived testing, and at least 20 CE hours.

High complexity paths (42 CFR 493.1443)

• A doctor of medicine or osteopathy licensed in the state and certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology.
• A doctor of medicine, osteopathy or podiatric medicine licensed in the state, with at least 2 years of experience directing or supervising high complexity testing and at least 20 CE hours.
• An earned doctoral degree (same degree options as above), certification by an HHS-approved board that is kept current, at least 2 years of laboratory training or experience, at least 2 years directing or supervising high complexity testing, and at least 20 CE hours.

Both sections also include a continuity provision: an individual qualified and serving as a director in a CLIA-certified laboratory as of December 28, 2024, and continuously since that date, is considered qualified. Both were last amended on December 28, 2023 (88 FR 90039 and 88 FR 90041). The notable difference between the tiers is the bachelor’s and master’s routes: the moderate complexity standard has them, while the high complexity standard has none.

What the director is responsible for, and what can be delegated

The responsibilities in 42 CFR 493.1445(e) include ensuring that testing systems cover the preanalytic, analytic and postanalytic phases, that the laboratory is enrolled in an HHS-approved proficiency testing program and that unsatisfactory results are followed by an approved corrective action plan, that quality control and quality assessment programs are maintained, and that personnel have the education, experience and training for the services offered and have shown they can perform testing reliably. The director must also specify in writing the responsibilities and duties of each consultant, supervisor and testing person, including which examinations each is authorised to perform and whether supervisor or director review is needed before results are reported.

Delegation works as follows. A qualified director may perform, or delegate to appropriately qualified personnel, the duties of the technical supervisor, clinical consultant, general supervisor and testing personnel in high complexity testing (493.1445(a)); in moderate complexity testing the delegated roles are technical consultant, clinical consultant and testing personnel (493.1407(a)). Under 493.1445(b), a director who reapportions responsibilities “remains responsible for ensuring that all duties are properly performed.”

Two further limits apply to the person, not the role: the director must be onsite at least once every 6 months, with at least 4 months between the two minimum visits, remain accessible for telephone or electronic consultation, and document the visits, including evidence of performing director activities; and each individual may direct no more than five laboratories (493.1445(c) and (d)).

CLIA personnel requirements beyond the director

The director is one of several personnel categories. The text of 493.1445(a) names the other roles for high complexity testing as technical supervisor, clinical consultant, general supervisor and testing personnel, with their qualifications set in 493.1447, 493.1453, 493.1459 and 493.1487. For moderate complexity testing the qualification sections named in 493.1407(a) are 493.1409 (technical consultant), 493.1415 (clinical consultant) and 493.1421 (testing personnel). For the wider requirements that come with high complexity testing, see CLIA high complexity testing requirements, and for the quality system side, CLIA quality control requirements.

How a laboratory’s director arrangement can be checked

The regulations make several director obligations documentable, which gives a practical checklist for anyone reviewing a laboratory’s compliance file, for example when a research group relies on a clinical or reference laboratory. Each item traces to the text above.

1. Tier match. Identify whether the tests performed are waived, moderate or high complexity, then apply the matching standard (493.1405 or 493.1443).
2. Licence. Where the state requires a director licence, the director must hold a current one issued by the state where the laboratory is located (493.1405(a), 493.1443(a)).
3. Qualification path and CE. Confirm which listed path applies and that the 20 CE hours cover the responsibilities in 493.1407 or 493.1445 as the tier requires.
4. Five-laboratory cap. The same individual may direct no more than five laboratories (493.1445(d)).
5. Onsite visit records. Visits at least once every 6 months, at least 4 months apart, with documentation (493.1445(c)).
6. Written delegation. The director’s written statement of each person’s duties and authorised examinations (493.1445(e)(15)).

CMS also publishes a page for laboratory directors that links to the HHS-approved certification boards and names the CDC Laboratory Director University as a training resource.

For how CLIA relates to the international laboratory standard, see ISO 15189 vs CLIA.

Common misunderstandings

• “Delegating the work delegates the responsibility.” It does not; 493.1445(b) keeps the director responsible.
• “The same qualifications apply at every tier.” The paths, required years of experience and CE reference differ between 493.1405 and 493.1443, and CMS describes no federal director qualification for waived testing.
• “A director never needs to visit.” The rule sets a minimum of two documented onsite visits a year with a gap of at least 4 months.
• “Federal rules are the whole picture.” The standards refer to state licensure where required, so state requirements can add to the federal ones.

Frequently asked questions

What are the CLIA lab director requirements?

They depend on test complexity: 42 CFR 493.1405 for moderate and 493.1443 for high complexity, each requiring a state licence where applicable and a qualifying degree, experience and 20 CE hours combination, or board certification as pathologist. CMS states waived testing has no federal director qualification.

What are the CLIA personnel requirements?

The regulations set separate qualification standards by role and tier. Roles named in the director sections are technical supervisor, clinical consultant, general supervisor and testing personnel (high complexity) and technical consultant, clinical consultant and testing personnel (moderate complexity).

How many laboratories can one CLIA director direct?

No more than five (42 CFR 493.1445(d)).

How often must a CLIA laboratory director be onsite?

At least once every 6 months, with at least 4 months between the two minimum visits, and the visits must be documented (42 CFR 493.1445(c)).

Can a director delegate duties?

Yes, to personnel meeting the relevant qualifications, but the director remains responsible for ensuring that all duties are properly performed (42 CFR 493.1445(b)).

Sources

• eCFR, 42 CFR 493.1405, Standard; Laboratory director qualifications (moderate complexity), https://www.ecfr.gov/current/title-42/part-493/section-493.1405, checked 2026-11-01.
• eCFR, 42 CFR 493.1443, Standard; Laboratory director qualifications (high complexity), https://www.ecfr.gov/current/title-42/part-493/section-493.1443, checked 2026-11-01.
• eCFR, 42 CFR 493.1445, Standard; Laboratory director responsibilities (high complexity), https://www.ecfr.gov/current/title-42/part-493/section-493.1445, checked 2026-11-01.
• eCFR, 42 CFR 493.1407, Standard; Laboratory director responsibilities (moderate complexity), https://www.ecfr.gov/current/title-42/part-493/section-493.1407, checked 2026-11-01.
• CMS, CLIA: For Laboratory Directors, https://www.cms.gov/medicare/health-safety-standards/clinical-laboratory-improvement-amendments-clia/laboratory-directors, checked 2026-11-01.