Regulatory change notice

New York clinical laboratory regulations changed on 2 September 2026

Part 19 was repealed. The single Certificate of Qualification is now two certificates. Nine sections of Subpart 58-1 were rewritten at the same time, including the entire record and specimen retention schedule. All of it is already in force.

Verified 3 September 2026 against the adopted rule text, with two points confirmed in writing by the Department on 4 September 2026 · Effective date 2 September 2026 · 10 NYCRR Subpart 58-1 (amended) and Subpart 58-6 (new)

Bronwyn Ramey, PhD, HCLD(ABB) — Phoenix Laboratory Consulting, LLC

The Department of Health adopted these rules without a single change from the proposed text. Every response in both Assessments of Public Comment reads “No changes to the proposed regulation.” If you read the proposals in January and assumed the final version would be softer, it is not.

One certificate became two

The legacy Certificate of Qualification no longer exists as a single credential.

Laboratory Director Certificate

Covers the laboratory as a whole and is no longer category-specific. Valid two years. Once you hold one, apply for the next term no later than 60 days before expiration. 58-6.2

Technical Director Certificate

Held per permit category, and a laboratory must now have one or more technical directors certified in every category on its permit. Valid two years. Once held, apply for the next term no later than 45 days before expiration — not 60. 58-6.4, 58-1.1(a)(1)(ii)

The regulation defines 26 technical director categories, each with its own training, experience and board-certification requirements. Only thirteen of those have a supplemental questionnaire posted, which is why the count on the forms page looks smaller than it is. 58-6.4(f)(1)–(26)

Dates that matter

The provision that is not on the website

The transition guidance describes one grandfather scenario. The regulation contains two, and the second is considerably harder.

58-6.2(e) — a legacy certificate holder who does not meet the new requirements but was serving as a laboratory director when the rule took effect may continue, but only at the laboratory where they were then employed, and only until 1 January 2027. Taking a director role at a different laboratory requires meeting the new requirements immediately.

58-6.2(f) — a legacy certificate holder who does not meet the new requirements and was not serving as a laboratory director on 2 September 2026 may not renew as a laboratory director at all. There is no transition period and no 1 January date.

Retention schedules were rewritten

Subpart 58-1.11 was realigned to federal requirements. Some periods fell sharply. Two rose. A partial view:

Paraffin blocks dropping from twenty years to two is the change most laboratories will not believe without the citation. It is 58-1.11(d)(ii). Note also that this is not a one-directional relaxation — two cytology retention periods increased, and the longest-applicable-period rule still governs where another State or federal requirement is longer.

Changes beyond the director roles

• Attendance records are now mandatory. The wording moved from “may be required” to “must be maintained, and made available to the department upon request,” for both laboratory and technical directors. Most laboratories do not keep these in a defensible form. 58-1.2(c), (l)
• The laboratory director must be licensed in the jurisdiction where the laboratory sits, if that jurisdiction requires licensure. New, and it applies to out-of-state laboratories holding a New York permit. 58-1.1(a)(1)(i)
• Both directors owe at least eight hours a week on site, at each laboratory. 58-1.2(c)(1) sets the floor for laboratory directors; 58-1.2(l)(1) repeats it word for word for technical directors. Either may request less, under (c)(2) and (l)(2), and the Department weighs the request against permit categories held, testing volume and complexity, and inspection and proficiency history. Either may be required to attend more often, under (c)(3) and (l)(3), where inspection or proficiency testing raises concerns or more than one complaint has been received. The two five-laboratory limits, however, count different things. Do not assume they are the same test. 58-1.2(b), (c), (k), (l)
• Collecting stations may now perform CLIA-waived testing, provided the location is separately registered as a limited service laboratory. Not permitted in a transfer station. “Temporary collecting station” is renamed “temporary testing station,” and mobile collecting stations are defined for the first time. 58-1.7
• Point-of-care testing at temporary sites is allowed for authorised Hospital at Home programmes and certified ambulance or ALS first-response agencies, under five specific conditions. 58-1.9
• Supervisor eligibility expanded to include certificate holders, histotechnologists and pathology assistants; the histotechnologist title was added to personnel qualifications, and the physical science degree was removed as a standalone route. 58-1.4, 58-1.5
• The cytotechnologist registry is gone and the workload standard is a flat 100 slides per workday. Proration survives: a cytotechnologist working part-time, or carrying duties other than slide examination, still has that limit reduced, now by one formula rather than three. Cytopathologist review, meanwhile, extends to reactive and reparative changes and any epithelial cell abnormality, a broader trigger than before. 58-1.12(b)(2), (b)(4)

What to do in the next thirty days

• Establish which of the four transition scenarios each of your certificate holders is in, starting with anyone not currently seated as a laboratory director.
• Confirm every permit category has a technical director certified in that category, and identify categories that are now uncovered.
• Start an attendance record for each director and technical director. Backdating is not available to you; beginning now is.
• Recheck the five-laboratory count for anyone directing across sites, using the correct denominator for each role.
• Do not destroy anything yet on the strength of a shortened retention period. Confirm no longer federal, accreditation or State requirement applies first.
• Diary every certificate's expiry date yourself. Nothing is mailed to you any more, and what you file next is a fresh application under Subpart 58-6 rather than a continuation of what you hold. The 60-day and 45-day windows apply from the cycle after that.

Answered by the Department

Two points could not be resolved from the published material, so I put them to the Clinical Laboratory Evaluation Program in writing. Beverly Rauch, Director of the Program, replied on 4 September 2026.

The technical director application fee is $150, the same as the laboratory director fee. It is set in statute rather than in the regulation, which is why no figure appears in Subpart 58-6.

The eight-hour-per-week floor binds laboratory directors. The definition sits at 58-1.2(c)(1), inside the laboratory director subdivision, where the amendments left it untouched; the identical wording at (l)(1) is the copy made for technical directors. A director serving the maximum five laboratories therefore owes forty hours a week on site unless the Department approves less under 58-1.2(c)(2). No form and no timetable for that request are published. Make it in writing, and address the three factors the paragraph names: (1) the number of permit categories for which the director is responsible; (2) the volume and complexity of testing at the laboratory; and (3) the laboratory's performance history at inspection and in proficiency testing.