Key Takeaways
- New York’s revised laboratory director qualification rules take effect Jan. 1, 2027, requiring an estimated 85 out of 665 labs to replace or restructure leadership.
- Doctoral-level scientists generally must now hold current board certification from an HHS-recognized body to serve as laboratory directors.
- Collecting stations (patient service centers) may now perform CLIA-waived testing if they obtain a limited service laboratory registration.
On Sept. 2, 2026, the New York State Department of Health amended regulations that affect clinical laboratories holding New York Clinical Laboratory Evaluation Program (CLEP) permits, including out-of-state labs. Two of the changes to New York’s laboratory regulatory framework are particularly noteworthy. First, New York revised its laboratory director qualification requirements, which the department estimates may require nearly 13% of laboratories to replace or restructure their current laboratory leadership by Jan. 1, 2027. Second, New York removed its longstanding prohibition on testing at collecting stations, allowing these locations to perform CLIA-waived testing if they obtain the appropriate limited service laboratory registration.
Lab Director Qualifications
New York is changing its laboratory director qualification rules to more closely align with CLIA requirements instead of its longstanding state-specific approach. Accordingly, some laboratory directors may need to transition or be replaced before Jan. 1, 2027, and some individuals who could have qualified as laboratory directors under the prior rules will no longer qualify for a new appointment.
New York has long required the laboratory director of every New York CLEP-permitted laboratory to hold a New York Certificate of Qualification (CQ). Under the prior rules, physicians and doctoral-level scientists could obtain a CQ through several pathways, including in some cases through education and lab experience. The new rules replace that framework with Laboratory Director Certificate of Qualification (LDCQ) requirements that more closely track CLIA’s requirements.
The practical effect depends on the director’s credentials. Physicians licensed in the jurisdiction in which they serve as laboratory director may still qualify without board certification if they satisfy the applicable experience and education requirements. Ph.D. and other doctoral-level scientists generally must now hold current certification from an HHS-recognized board (e.g., American Board of Bioanalysis, American Board of Clinical Chemistry), in addition to satisfying the applicable degree and experience requirements. The full qualification pathways are reflected in the new LDCQ application.
This affects existing labs in several ways:
- Existing directors who satisfy the new LDCQ requirements can stay in place. They should apply for the new LDCQ approximately 60 days before their legacy CQ expires;
- Existing directors who do not satisfy the new requirements can remain only through Dec. 31, 2026. Their laboratories must have a newly qualified director in place by Jan. 1, 2027. The Department of Health says it will notify affected directors and laboratories in early September; and
- The transition protection is tied to the director’s existing laboratory. A legacy CQ holder who does not meet the new requirements cannot simply move to another laboratory and rely on the transition period. Any new lab director appointment between now and Jan. 1, 2027, requires the individual to obtain the new LDCQ before serving in this role.
In its rulemaking, the Department of Health estimated that about 85 of the 665 New York-permitted laboratories had directors who would not satisfy the new requirements.
CLIA-Waived Testing at Collecting Stations
New York historically treated collecting stations, commonly referred to as patient service centers, primarily as locations for collecting and temporarily storing specimens before sending them to a clinical laboratory for testing. With limited exceptions, the prior regulations expressly prohibited testing at a collecting station. The principal exception permitted screening for glucose or ketones in connection with a glucose tolerance test.
The amended regulations remove that prohibition. A collecting station can now perform CLIA-waived testing if the location holds a valid limited service laboratory registration authorizing the testing. This creates a new option for laboratories operating patient service centers. Rather than limiting those locations to specimen collection, laboratories may use appropriately registered locations to perform waived tests on site and provide results without sending the specimen to the laboratory’s primary testing site. For patients, this may reduce turnaround time and improve access by allowing certain routine tests and results to be completed during the same visit.
The change does not convert a collecting station into a full-service clinical laboratory. Testing remains limited to CLIA-waived testing authorized under the location’s limited service laboratory registration, and the collecting station remains subject to New York’s requirements governing its operation.
For practices and investors in New York, McGuireWoods is available to advise clients seeking laboratory permits and exploring expanded testing capabilities. For further information on amendments to Subpart 58-1 and a new Subpart 58-6 of Title 10 and federal regulations, contact the authors.