Does a CLIA waived lab need a medical director?

It needs a named laboratory director, but CMS says there are no federal education or experience qualifications for a Certificate of Waiver director. Some states set their own requirements.

Can a nurse practitioner be a CLIA lab director?

For a PPM lab, yes, if the state authorizes the nurse practitioner to practice independently (42 CFR 493.1357). For a Certificate of Waiver, there are no federal qualifications. A moderate or high complexity director, whatever their title, must meet one of the subpart M education, experience and CE routes.

What are the 20 CE hours for CLIA directors?

Since December 28, 2024, most moderate and high complexity director routes require at least 20 continuing education credit hours in laboratory practice covering the director responsibilities, obtained before qualifying. Directors who were qualified and serving on that date and have served continuously since are grandfathered.

How many CLIA labs can one director oversee?

No more than five for PPM, moderate complexity and high complexity labs. The federal rules set no matching cap for Certificate of Waiver labs, though the CMS-116 asks the director to list them.

CLIA Laboratory Director Requirements by Certificate Type

The CMS-116 asks every applicant for the director's name, phone and credentials, whatever certificate it requests. What the regulations require of that person depends entirely on the certificate. For a Certificate of Waiver, federal law sets no qualifications. For PPM, the director must be a qualifying practitioner. For moderate and high complexity testing, the director must meet the detailed standards in subpart M of 42 CFR Part 493, which were rewritten by the 2023 rule CMS-3326-F and took effect December 28, 2024.

A note before the details: some states add their own director rules or license lab directors. Each federal qualification section begins with the requirement to "possess a current license as a laboratory director issued by the State in which the laboratory is located, if such licensing is required." Check your state in the state requirements index.

Does a Certificate of Waiver lab need a qualified director?

It needs a director, but no federal qualifications. CMS's application page says a lab with a Certificate of Waiver "must have a laboratory director. There are no federal education or experience qualifications required for the laboratory director." Subpart M, the personnel subpart, is titled "Personnel for Nonwaived Testing" and does not reach waiver labs. The director's name still goes on the CMS-116 and on the certificate, and a change of director must be reported within 30 days (493.39(b)).

That director is still the person CMS associates with the lab. The CMS-116's Section X asks applicants to list "all other facilities, including Certificate of Waiver, for which the director is responsible."

Who can direct a PPM lab?

Under 42 CFR 493.1357, a PPM director must meet one of three tests: be a physician (an MD, DO or DPM licensed in the state, per 493.2); be a midlevel practitioner "authorized by a State to practice independently in the State in which the laboratory is located"; or be one of the other practitioners the rule names. The regulation defines midlevel practitioners as nurse midwives, nurse practitioners, nurse anesthetists, clinical nurse specialists and physician assistants licensed by the state.

A PPM director's duties are set out in 493.1359: direct "no more than five laboratories," make sure each PPM procedure is personally performed by a qualified practitioner, and evaluate and document each tester's competency at least twice in their first year and annually after that. See the PPM certificate.

What qualifies someone to direct moderate complexity testing?

42 CFR 493.1405(b) offers five routes. In plain terms:

Pathologist. An MD or DO 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.
Physician with lab experience. An MD, DO or DPM licensed in the state with at least 1 year directing or supervising nonwaived testing, and at least 20 CE credit hours in laboratory practice covering the director responsibilities in 493.1407.
Doctoral scientist. An earned doctoral degree in a chemical, biological, clinical or medical laboratory science or medical technology (or another doctorate plus 16 semester hours of qualifying doctoral coursework or a qualifying thesis), certification by an HHS-approved board, at least 1 year directing or supervising nonwaived testing, and 20 CE credit hours.
Master's degree. A qualifying master's degree or equivalent graduate coursework, at least 1 year of nonwaived lab training or experience, at least 1 year of supervisory nonwaived experience, and 20 CE credit hours.
Bachelor's degree. A qualifying bachelor's degree, or 120 semester hours with 48 hours of lab science or specified science coursework, at least 2 years of nonwaived lab training or experience, at least 2 years of supervisory nonwaived experience, and 20 CE credit hours.

The rule also grandfathers anyone who was "qualified and serving as a laboratory director of moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since" (493.1405(b)(6)).

And for high complexity testing?

42 CFR 493.1443(b) is narrower:

an MD or DO licensed in the state and board-certified in anatomic or clinical pathology, or both;
an MD, DO or DPM licensed in the state with at least 2 years directing or supervising high complexity testing and 20 CE credit hours; or
a qualifying doctoral degree holder certified by an HHS-approved board, with at least 2 years of lab training or experience and 2 years directing or supervising high complexity testing, plus 20 CE credit hours.

The same December 28, 2024 grandfather clause applies (493.1443(b)(4)), and oral pathology has its own board certification requirement (493.1443(b)(5)).

What changed in 2024?

CMS-3326-F made the personnel changes effective December 28, 2024, a year after publication. The main ones, from the rule and CMS's summary memo QSO-24-03-CLIA:

20 CE credit hours. Required on most nonwaived director routes. The new definition says CE credit hours mean CME or CEUs, "must cover the applicable laboratory director responsibilities and be obtained prior to qualifying as a laboratory director" (493.2).
On-site visits. Moderate and high complexity directors must be on-site at least once every 6 months, with at least 4 months between the two visits, and must document them (493.1407(c), 493.1445(c)). See the 2024 rule on director CE and on-site visits.
Doctoral degree defined. An earned post-baccalaureate degree with at least 3 years of graduate study, which for this purpose does not include MD, DO, DPM, DVM or honorary degrees (493.2).
Experience must come from a real lab. Director, supervisory and training experience must be obtained in a facility that meets the CLIA definition of a laboratory and is not excepted (493.2).

Can the director hand off the work?

Partly. A moderate complexity director "if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities" to people who meet those roles' qualifications (493.1407(a)). High complexity directors may do the same with the technical supervisor, clinical consultant, general supervisor and testing personnel roles (493.1445(a)). Delegating does not move the responsibility: "If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed" (493.1407(b), 493.1445(b)). The director's own list of duties is long, from making sure test methods are verified and quality control programs are maintained to keeping proficiency testing current and specifying each person's duties in writing (493.1407(e)). For PPM labs, the director must make sure each procedure is personally performed by a qualified practitioner and must evaluate competency directly (493.1359).

How many labs can one person direct?

Five, for PPM, moderate and high complexity labs (493.1359(a), 493.1407(d), 493.1445(d)). The CMS-116 instructions say "for a Certificate for PPM, Certificate of Compliance or Certificate of Accreditation, an individual can only serve as the director for no more than five certificates." There is no matching federal cap for Certificate of Waiver labs, which matters for groups that rely on one physician across many waived sites. See the five-lab limit for CLIA directors.

What proof goes with the application?

For PPM, Registration, Compliance and Accreditation applications, the CMS-116 instructions require proof of the director's qualifications: "Verification of State Licensure, as applicable," documentation such as a diploma or transcript, credentials such as board certification or CE hours, and laboratory experience. Anyone educated outside the United States needs an evaluation showing equivalency. "Failure to submit this information will delay the processing of your application." A director change at an existing lab follows the same rule; see changing your CLIA laboratory director.

Where does White Glove CLIA fit, and where does it not?

We assemble the director's qualification packet (license verifications, diplomas or transcripts, board certificates and CE records) and prepare the CMS-116 for the owner or director to review and sign. A PPM Certificate Application is $599 per site, the Nonwaived Certificate Application Packet is $1,499, and a CLIA Change Request for a new director is $149. We are not a laboratory director, do not supply one, and do not make the on-site visits or competency evaluations the rule assigns to the director. Choosing and qualifying the director stays with the lab.