Detailed information about the Clinical Laboratory Evaluation Program can be found in the CLEP Program Guide (July 2020).
Which facilities are required to obtain a clinical laboratory permit?
All clinical and forensic laboratories and blood banks located in or accepting specimens from New York State must hold a New York State Department of Health clinical laboratory permit.
Research testing is considered clinical if a patient-identified result is generated. This would include results used to make clinical decisions for patient management under an IRB-approved research protocol or clinical trial. Examples of testing performed for participant management include those that influence enrollment (exclusion or inclusion), safety or dosing.
Physician office laboratories (POLs) owned and/or operated by managed care organizations, hospitals or consulting firms, or POLs that perform testing on individuals other than their own patients must obtain a clinical laboratory permit to perform testing. Although POLs that are owned and operated by a licensed physician, osteopath, dentist, midwife, nurse practitioner or podiatrist who performs laboratory tests or procedures, personally or through his/her own employees, solely as an adjunct to treatment of his/her own patients are eligible for an exception to permit requirement, if the POL is owned and/or operated by managed care organization, hospitals or consulting firms, the patients are no longer patients of a private practice and an exception cannot be provided.
Which facilities do not require a clinical laboratory permit?
Any examination performed by a state or local government on materials derived from the human body for use in criminal proceedings or for investigative purposes is exempt from permit requirements. However, tests for these purposes that are referred must be sent to a laboratory holding a New York State clinical laboratory permit in the required permit category.
Laboratories operated by physicians, osteopaths, dentists, midwives, nurse practitioners or podiatrists performing testing only for their own patients are exempt from permit requirements; however, these facilities must obtain a CLIA number to operate in New York through the Physician Office Laboratory Evaluation Program (POLEP).
Facilities performing only those tests classified by federal CLIA regulations as waived and provider-performed microscopy procedures are exempt from clinical laboratory permit requirements, but must register as a Limited Service Laboratory.