By: Tara Luellen, VP of Lab Director Services, Lighthouse Lab Services
New York State recently proposed several amendments to regulations regarding laboratory directors (LDs), including moves that would impact the number of laboratories they can oversee and the frequency of their on-site presence.
We’ll take a closer look below at the changes and what they mean for lab directors overseeing New York-licensed labs if they go into effect later this year.
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). However, with the recent amendments to subdivision 58-1.2(b), LDs will now be able to serve at up to five clinical laboratories or blood banks, or any combination of the two. This aligns with the federal regulations under CLIA, which allow for a total of five laboratories to be overseen by an LD.
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On-site presence of LDs and sole assistant director
The amendments to subdivision 58-1.2(c) outline expectations for the on-site presence of the lab director and sole assistant director. While past regulations define “regular part-time hours” as a minimum of 20 hours per week on-site for LDs, the current proposed revisions go a step further to note that reduced on-site supervision by the LD may be approved in some cases. This provision allows for flexibility in LD on-site supervision, but the specific process for obtaining approval for reduced supervision is not outlined in the proposal.
Qualifying for reduced on-site supervision
Tara Luellen, VP of Lab Director Services, LLS
Currently, the process for qualifying for reduced lab director on-site frequency will be determined on a case-by-case basis. In our experience, CLEP representatives will weigh several factors, including NY sample volume, number of different specialties tested in-house, qualifications of other on-site staff, etc. to determine if reduced on-site involvement of the LD is appropriate.
Tara Luellen, VP of Lab Director Services at Lighthouse, says the current proposal stops short of specifying the exact process for how a lab or blood bank can qualify for this exception.
“Labs and blood banks wishing to apply for such a determination will need to contact the CLEP office directly to work with a representative,” Luellen recommends.
Current regulations still in effect
It’s important to note that the above outline concerns proposed changes, but the previous New York regulations concerning lab directors will remain in effect until these changes are approved.
- As of Jan. 24, 2023, the maximum number of labs that can be overseen by an LD is still two.
- Current regulations still require LDs to spend 20 hours per week on-site at each lab they direct.
The most recent proposal to update the regulations has received revisions, so the public comment period has been extended to June 21, 2023. If there is no opposition to the revised proposal, the updated regulations and amendments will go into effect sometime thereafter. Check back with us in late June for an update.
Next steps
If you need assistance interpreting these new regulations or are a lab director seeking new opportunities available under these proposed rules, don’t hesitate to reach out directly to our Lab Director Services Team for a free consultation.