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Regulatory Affairs

Regulatory Affairs is responsible for development of regulations and enforcement actions for clinical laboratories, environmental laboratories, blood banks, tissue banks, blood and breath alcohol testing for vehicle and traffic enforcement, clinical laboratory anti-fraud and abuse activities, and facilities that utilize living animals.

The unit also supervises the Laboratory Investigative Unit, and reviews all allegations which might result in administrative, civil or criminal prosecution. The unit makes appropriate referrals to other agencies, directs the conduct of inspections and preparation of referrals to the Health Department's Division of Legal Affairs, and determines the appropriate priority of all active cases and assigns resources.

Regulatory Affairs maintains the intake system for all complaints received by the Wadsworth Center, assigns them to various programs for response and monitors the type and subject of the complaint for trends. Requests for information from the Wadsworth Center, including freedom of information requests, requests for results of clinical laboratory and environmental laboratory tests performed by the center, and subpoenas in various court actions, are processed by the office.

Laboratory Investigative Unit


The Laboratory Investigative Unit (LIU) is responsible for the field investigation of allegations of misconduct made against individuals or corporations related to the operation of clinical and environmental laboratories, physician office laboratories (POL), tissue and blood banks and animal research facilities located in, or accepting business from, New York State. Charges and draft denials letters are prepared for review by program staff and referral to the Health Department's Division of Legal Affairs.

LIU conducts joint investigations with and/or refers cases or information to other units or agencies as appropriate.

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