Lab Directors and assistant directors can now oversee up to five labs within or outside New York after the state recently approved a number of amendments to regulations regarding laboratory oversight. Additionally, requirements for a part-time director’s onsite presence have also been reduced to help allow for the oversight of more facilities.
Below is a complete breakdown of the changes effective May 24, 2023, for Lab Directors and facilities licensed by the State of New York. The full updated regulation is available to view here.
Maximum number of directorships raised to five
Previously, directors of New York-licensed laboratories were capped at overseeing two state-licensed facilities (a limited exception sometimes allowed oversight of a third). Under new rules, Lab Directors may now serve at up to five clinical laboratories or blood banks, or any combination of the two within or outside New York State. This aligns with the federal regulations under CLIA, which also allow for a total of five laboratories to be overseen by a single Lab Director.
Lowered requirements for on-site presence
Lab Directors and any sole assistant directors are now only required to be on site at their facilities on a regular, part-time basis of at least eight hours per week, according to the revised rules. This is a reduction of previous regulations stipulating Lab Directors must be on site at least 20 hours per week, made to allow for manageable oversight of the additional facilities that can now be assigned to a single director.
Keep in mind that attendance records documenting the lab director’s or sole assistant’s presence should be maintained. When not on site, the Lab Director must be accessible at all times through phone or two-way audio-visual communication to the lab’s staff and clients.
Requests to be on site for fewer than eight hours weekly will be considered by Clinical Laboratory Evaluation Program (CLEP) representatives pending a review of the number of testing categories a director oversees at a given lab, test volume, complexity of the testing, and the lab’s performance history. However, there is no explicit criteria outlining when such requests will be approved, meaning they will be determined on a case-by-case basis. Additionally, regulators can require lab directors to be on site more frequently based on inspection results or other factors.
Temporary absence stipulations
The updated regulations also stipulate that if a lab director or sole assistant director will be temporarily absent for more than 60 consecutive calendar days, the affected lab must make arrangements with state approval to acquire a new lab director or sole assistant who possesses a certificate of qualification in the appropriate testing categories.
Resignation, termination, death, or physical or mental incapacitation of lab’s director will result in the voiding of a lab’s permit within 60 calendar days of the event.
Next steps
If you need assistance interpreting these new regulations or are a lab director seeking new opportunities available under these updates, don’t hesitate to reach out directly to our Lab Director Services Team for a free consultation.