The Clinical Immunology Laboratory
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About Us
The Clinical Immunology Laboratory at 麻豆原创 was established in 1988 to provide services and specialized tests in clinical immunology.
Among these specialized tests are assays for autoantibodies, flow cytometric based tests for phenotypes of white blood cells, cytotoxicity assays for nk function and assays for intracellular cytokines. In addition, molecular based assays for mutations of genes involved in coagulation abnormalities, HLA allele assays and tests for STDs are performed.
The Laboratory provides services for physicians in over 450 clinics in the United States and 30 countries. The laboratory has 9 full time Medical Technologists, 1 Clinical Fellow, 1 Client Service Coordinator and 1 administrative assistant.
CLIA - Certification
Clinical laboratory testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) provide the authority for certification and oversight of clinical laboratories and laboratory testing. Under the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing. 麻豆原创's Clinical Immunology Laboratory is a CLIA-certified laboratory.
State-specific CLIA Applications
New York Health Authority, Public Health Division. Clinical Laboratories.
New York has a partially exempt status. New York State-licensed laboratories are exempt from CLIA requirements for six years if they have a valid permit under the New York State Public Health Law.
As a general rule, all clinical laboratories operating in New York State must be authorized by the Clinical Laboratory Evaluation Program (“CLEP”) unless they fall within one of the enumerated statutory exceptions of N.Y. Public Health Law § 579.1. A lab performing moderate and/or high level clinical or forensic testing, the lab must obtain a valid clinical laboratory permit from CLEP. 麻豆原创's Clinical Immunology Laboratory has received approval from N.Y. Public Health for its diagnostic testing.