CLIA Lab Director Requirements for Moderate and High Complexity Labs
A CLIA lab director must hold any state license required and meet a pathway in 42 CFR 493.1405 (moderate complexity) or 493.1443 (high complexity). Options include a board-certified pathologist, a physician with directing experience and CE, or a doctoral, master's or bachelor's degree with experience. One person may direct up to five labs.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice. Confirm against the current eCFR and CMS memos.
Key facts and official sources
Moderate complexity director qualifications: 42 CFR 493.1405. Responsibilities: 42 CFR 493.1407
High complexity director qualifications: 42 CFR 493.1443. Responsibilities: 42 CFR 493.1445
CMS enforcement discretion on certain personnel requirements, June 23, 2025: QSO-25-21-CLIA
What are the moderate complexity director pathways?
Under §493.1405(b), the director must meet one of these:
(b)(1) Pathologist: MD/DO licensed in the state and board certified in anatomic and/or clinical pathology (ABP or AOBP)
(b)(2) Physician: MD, DO or DPM licensed in the state, with at least 1 year directing or supervising nonwaived testing and at least 20 CE hours covering director responsibilities
(b)(3) Doctoral: Qualifying doctoral degree, 20 CE hours, current HHS-approved board certification, and at least 1 year directing or supervising nonwaived testing
(b)(4) Master's: Qualifying master's degree or equivalent, 1 year of lab training or experience, 1 year of supervisory experience in nonwaived testing, and 20 CE hours
(b)(5) Bachelor's: Qualifying bachelor's degree or equivalent, 2 years of lab training or experience, 2 years of supervisory experience in nonwaived testing, and 20 CE hours
(b)(6) Grandfathered: Qualified and serving as a moderate complexity director in a CLIA-certified lab on December 28, 2024, and serving continuously since then
Current CMS enforcement discretion (QSO-25-21-CLIA):
Physicians under (b)(2) may have either the 1 year of experience or the 20 CE hours.
The additional 20 CE hours under (b)(3)-(5) is not being enforced.
Check the memo for its exact scope.
What are the high complexity director pathways?
Under §493.1443(b):
(b)(1) Board-certified pathologist (ABP or AOBP).
(b)(2) Licensed MD, DO or DPM with at least 2 years directing or supervising high complexity testing and 20 CE hours.
(b)(3) Qualifying doctoral degree, HHS-approved board certification, 2 years of lab training or experience and 2 years directing or supervising high complexity testing, and 20 CE hours.
(b)(4) Grandfathered if serving continuously since December 28, 2024.
(b)(5) Oral pathology: certification by the American Board of Oral Pathology, the ABP or the AOBP.
QSO-25-21-CLIA also states that CMS will not enforce the additional 20 CE hours under (b)(2) and (b)(3).
What does the lab director have to do?
The director is responsible for the overall operation and administration of the lab and for compliance with CLIA. That includes:
Employing competent personnel.
Making sure the testing systems provide quality results across pre-analytic, analytic and post-analytic phases.
Making sure the lab enrolls in PT and that PT results are reviewed and acted on.
Making sure QC and quality assessment programs are in place.
Making sure every person's responsibilities are specified in writing.
The director may delegate duties to qualified staff, but remains responsible for them (§493.1407(b), §493.1445(b)).
How often must the director be on site?
Under the current rule, the director must be on site at least once every six months, with at least four months between the two minimum visits. Each visit must be documented with evidence of director activities (§493.1407(c), §493.1445(c)). The director must also remain accessible by phone or electronically as needed.
Proposed, not in effect: CMS-3478-P would rescind the onsite visit requirement and keep "accessible to the laboratory as needed."
How many labs can one director oversee?
No more than five (§493.1407(d), §493.1445(d)).
Why do surveyors cite lab director deficiencies?
The director is accountable for PT, QC, competency and personnel. When those fail, surveyors often cite the director condition as well; for moderate complexity labs that is tag D6000. In the 2026 proposed rule, CMS states that "laboratory director citations remain among the top ten condition-level deficiencies cited by laboratory surveyors."
Can you outsource the lab director role?
Yes. Many labs contract with a qualified director of record. The contract should define:
onsite visits and how they are documented
review duties
response times
delegation to the technical consultant or supervisor
Frequently asked questions
Can a nurse practitioner be a CLIA lab director?
There is no nurse practitioner pathway in §493.1405 or §493.1443. An NP would have to meet one of the listed degree, experience and CE pathways. Check your state's rules too.
Does the director have to be on site for every test?
No. The director must be accessible as needed and, under the current rule, on site at least twice a year as described above.
What documents prove director qualifications?
Diplomas or transcripts, licenses, board certifications, CE certificates and experience letters. Surveyors review these with Form CMS-209.
Do waived labs need a qualified director?
CLIA sets no personnel qualifications for Certificate of Waiver labs. Some states do.
Need a qualified lab director?
Sound Lab Consultants provides lab director of record and technical consultant services, director onsite visit documentation, and deficiency response for director tags.