March 28, 2022
Author(s): Justin D. Pfeiffer
New York’s Department of Health published proposed regulations changing the requirements governing clinical laboratories and blood banks—the public comment period is open.
After a long development cycle, the New York State Department of Health (“NYSDOH”) has published proposed regulations that would make significant changes to the requirements governing clinical laboratories and blood banks. If adopted in their current form, the new regulations would:
The new character and competence requirements would be a significant change to NYSDOH’s permitting process. However, NYSDOH said little about them in the regulatory paperwork, focusing more on the regulatory flexibilities that the regulations would provide.
Among other goals, NYSDOH stated that these regulations would enable the agency to more quickly issue limited permits in a public health emergency—in particular, by providing a process for issuing provisional permits in the category of virology, as well as “single use” permits to laboratories not currently licensed by NYSDOH.
The new regulations also appear aimed at addressing the current shortage of laboratory director candidates—in particular, by allowing assistant directors to be treated as laboratory directors for certain categories of testing (“sole assistant directors”), and by increasing the number of directorships that may be held from two to five. At the same time, the regulations specify new on-site presence requirements for laboratory directors and sole assistant directors. Similarly, the regulations would expand the pool of laboratory supervisor candidates, by expanding the eligibility criteria.
The comment period for the regulations expires on May 23, 2022.
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