The Clinical Laboratory Evaluation Program (CLEP) seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from New York State (NYS) 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, treatment, and prevention 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 clinical laboratories, and approximately 900 patient service centers in NYS. In addition, CLEP certifies, on a biennial basis, approximately 3,500 certificates of qualification to individuals who serve as directors/assistant directors of these clinical laboratories and blood banks. CLEP also registers approximately 5,000 limited service laboratories, locations that perform one or more waived tests and/or provider-performed microscopy procedures. Waived tests include test systems cleared by the Food and Drug Administration (FDA) for home use and those simple tests that have a low risk for erroneous test result that are approved for waiver under criteria from CLIA (Clinical Laboratory Improvement Amendments). The excellence of the center's Clinical Laboratory Evaluation Program has been acknowledged by CMS 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.
Clinical Laboratories are those facilities that perform testing on materials derived from the human body, for the purpose of obtaining information for the diagnosis, treatment or prevention of disease or the assessment of a health condition or for identification purposes. Testing includes procedures to determine, measure or describe the presence or absence of various substances, components or organisms in the human body. These tests may be designated as moderate, high and, potentially, waived complexity testing, as categorized by the FDA. All clinical laboratories are required to comply with the New York State Clinical Laboratory Standards of Practice and participate successfully in Proficiency Testing for certain tests. Laboratories must also comply with all Test Approval requirements.
Limited Service Laboratories are those facilities that are eligible to perform only those tests classified by CMS as waived and/or provider-performed microscopy procedures.