Laboratory worker handling samples. Image by Michal Jarmoluk from Pixabay

Service Laboratory Registration

Providers who perform on-site laboratory testing must obtain prior approval from the NYS Department of Health
Service Laboratory Registration
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Overview

OASAS providers performing on-site laboratory testing or interested in performing on-site (e.g. fingerstick glucose, urine pregnancy, drugs of abuse, dipstick urinalysis, breath alcohol) must obtain approval from the Department of Health’s Clinical Laboratory Evaluation Program to be eligible to perform testing.

Available options for sites performing or interested in performing on-site laboratory testing are either a Limited Service Laboratory Registration certificate (for tests categorized by the Food and Drug Administration as waived or provider-performed microscopy procedures) or a NYS Clinical Laboratory permit (for tests categorized as moderate or high complexity) depending on the test device(s) used.

Penalties

  • Providers performing waived tests or provider-performed microscopy procedures without holding a valid Limited Service Laboratory Registration certificate shall be subject to a civil penalty  of up to five hundred dollars for each test performed, not to exceed two thousand dollars per day for each day tests are performed.
     
  • Providers performing moderate or high complexity testing without a valid New York State clinical laboratory permit are guilty of a misdemeanor, punishable by imprisonment for not more than one year, or by a fine of not more than two thousand dollars, or by both such fine and imprisonment. For any subsequent offense, the penalty shall be both such fine and imprisonment.

Contact Department of Health’s Clinical Laboratory Evaluation Program

Questions regarding obtaining approval to perform testing can be directed to the New York State Department of Health Wadsworth Center.

Contact us by phone:
Wadsworth Center  518-485-5378
Contact us by email: