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.
- 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.