Since December 28, 2024, directors of moderate and high complexity labs must be on-site at each lab at least once every six months, with at least four months between visits, and document what they did (42 CFR 493.1407(c), 493.1445(c)). Most qualification routes also require 20 CE hours obtained before directing. Waiver labs are not covered.
CMS-3326-F, the CLIA rule published December 28, 2023 at 88 FR 89976, rewrote much of subpart M, the personnel rules for nonwaived testing. Most of the fee changes took effect January 27, 2024. The personnel changes, including the two that most affect directors, were delayed a year and took effect December 28, 2024. CMS explained that the delay "reflects the timeframe that we believe the laboratories, accreditation organizations, exempt States, and surveyors will need to adopt and implement these revised regulations."
None of this applies to Certificate of Waiver labs, whose directors have no federal qualifications, or to the PPM director rules in 493.1359. It applies to directors of labs performing moderate or high complexity testing under a Registration, Compliance or Accreditation certificate.
What does the on-site visit rule require?
The text is identical for moderate complexity (42 CFR 493.1407(c)) and high complexity (493.1445(c)) directors. The laboratory director must:
- "Be onsite at least once every 6 months, with at least 4 months between the minimum two on-site visits. Laboratory directors may elect to be on-site more frequently and must continue to be accessible to the laboratory to provide telephone or electronic consultation as needed; and"
- "Provide documentation of these visits, including evidence of performing activities that are part of the laboratory director responsibilities."
Two visits a year, spaced at least four months apart, is the floor. A January visit followed by a March visit does not satisfy it, even though both fall within six months.
Can a director meet it with video visits?
No. A commenter on the proposed rule asked for "allowance for virtual visits as an option," along with a single annual visit for small labs. CMS finalized the provision "without modifications." Its response pointed to the recommendation of the Clinical Laboratory Improvement Advisory Committee that directors make "at least two (reasonably spaced) on-site visits to each laboratory they direct annually." Remote consultation is still expected between visits; it just does not replace them.
What counts as documentation?
CMS left the format to the director. The preamble says "the LD determines the type or process of documentation needed as evidence of performing visits," and gives examples: "sign in/sign out logs, meeting minutes/summary, notes of observations, and travel vouchers." The documentation must also show the director actually did director work on site, such as reviewing quality control and proficiency testing records, observing testing or meeting with the technical consultant. A sign-in sheet alone proves presence, not activity.
CMS also clarified scope: "The on-site visit requirement pertains to only one location site visit per CLIA certificate." Where a primary lab's certificate covers additional locations, the director decides whether those are included; a location with its own Compliance or Accreditation certificate gets its own visits.
Why did CMS add the rule?
Because the states and accreditation organizations were inconsistent. The preamble reports that only 10 of 54 states and territories, 3 of 7 accreditation organizations and 1 of 2 exempt states required director on-site visits. CMS estimated that in the 40 states, four territories and DC without such a rule, 25,867 Compliance and Accreditation labs "may not currently meet this requirement and may incur travel costs to comply with it."
What is the 20-hour CE requirement?
Most nonwaived director routes now require "at least 20 CE credit hours in laboratory practice that cover the laboratory director responsibilities" (493.1405(b)(2) through (5) for moderate complexity, 493.1443(b)(2) and (3) for high complexity). The routes for board-certified pathologists do not list it. The definition in 493.2 says CE credit hours mean "either continuing medical education (CME) or continuing education units (CEUs)," which "must cover the applicable laboratory director responsibilities and be obtained prior to qualifying as a laboratory director." That last clause matters: CE completed after someone starts directing does not retroactively qualify them.
Who is grandfathered?
Anyone "qualified and serving as a laboratory director of moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and [who has] done so continuously since December 28, 2024" is considered qualified (493.1405(b)(6)). The high complexity rule has the same clause (493.1443(b)(4)). Grandfathering covers qualifications, including the CE requirement. It does not exempt anyone from the on-site visit requirement, which is a responsibility, not a qualification. A director who stops serving and later returns should expect to meet the current routes.
How do the visits interact with the five-lab limit?
A director may direct no more than five moderate or high complexity labs (493.1407(d), 493.1445(d)). With two documented visits per certificate per year, a director at the cap owes at least ten on-site visits a year. For a group spread across states, that is real travel, and it is a reason to plan director coverage before opening a new nonwaived site. See the five-lab limit.
What should a lab do to stay ready for a survey?
- Keep a dated log of each director visit with what was reviewed, signed by the director.
- Calendar the next visit no sooner than four months and no later than six months after the last one.
- Keep the director's CE certificates and dates in the personnel file, showing they predate the start of the directorship (or the grandfather date).
- When the director changes, report it to the State Agency within 30 days with the new director's qualification documents. See changing your CLIA laboratory director.
Where can White Glove CLIA help?
We assemble director qualification packets, including CE records, for new nonwaived applications (the Nonwaived Certificate Application Packet is $1,499) and for director changes ($149 per CLIA Change Request); see pricing. The visits themselves, and the director duties they document, belong to the lab's director. We do not act as a laboratory director or supply one. For the full qualification routes, read laboratory director requirements by certificate type.
Common questions
- Can a CLIA lab director do the six-month visits virtually?
- No. CMS was asked to allow virtual visits and finalized the on-site requirement without that option. Directors must be physically on-site at least once every six months, with at least four months between visits, and remain available by phone or electronically in between.
- Does the six-month visit rule apply to Certificate of Waiver labs?
- No. The requirement is in the moderate and high complexity director responsibilities (42 CFR 493.1407 and 493.1445). Waiver labs have no federal director qualifications or visit rule.
- What documents prove a director visited the lab?
- CMS leaves the format to the director and gives examples: sign-in and sign-out logs, meeting minutes or summaries, notes of observations and travel vouchers. The records should show director activities, not just attendance.
- Do grandfathered directors need the 20 CE hours?
- Directors who were qualified and serving as of December 28, 2024 and have served continuously since are considered qualified under 493.1405(b)(6) and 493.1443(b)(4). The on-site visit duty still applies to them.
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