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Clinical Laboratory Evaluation Program

The Clinical Laboratory Evaluation Program (CLEP) seeks to ensure the accuracy and reliability of results of laboratory tests on specimens obtained within the state through on-site inspections, proficiency testing and evaluation of the qualifications of personnel of state permit-holding clinical laboratories and blood banks. The proper performance of diagnostic laboratory tests is a matter of vital concern, affecting the public health, safety and welfare of all NYS residents. Clinical laboratories and blood banks provide essential public health services in aiding the medical practitioner by furnishing information invaluable in the diagnosis and treatment of disease. Substandard performance of such tests may and has contributed to erroneous diagnoses and/or the selection of inappropriate treatment protocols.

CLEP currently issues on an annual basis permits to approximately 1,000 laboratories, and approximately 900 patient service centers in NYS. In addition, CLEP certifies, on a biennial basis, approximately 3,100 certificates of qualification to individuals to serve as directors/assistant directors of these clinical laboratories and blood banks. The excellence of the center's Clinical Laboratory Evaluation Program has been acknowledged by the federal Centers for Medicare and Medicaid Services through their granting of exempt status from the federal Clinical Laboratory Improvement Amendments of 1988 for laboratories located in and holding NYS clinical laboratory permits.