Regulation of Laboratory Developed Tests

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Clinical Laboratory Reference System The Department of Health's Wadsworth Center is charged with oversight of clinical laboratories and blood banks operating in New York State. This oversight is carried out through the Clinical Laboratory Reference System. Reference system activities include: •on-site surveys of facilities •proficiency testing of laboratories •review of laboratory personnel •reviewing and approving laboratory-developed assays
Part 58-1.10(g) of 10 NYCRR Assay Approval All technical procedures employed in a laboratory shall be of proven reliability and generally accepted by leading authorities in the specialty of laboratory medicine and/or approved by the department.
Page 1 and 2: Regulation of Laboratory Developed
Page 3: Wadsworth Center Clinical Laborator
Page 7 and 8: Assay Approval In the past 10 years
Page 9 and 10: Scope of Reviews Comprehensive Test
Page 11 and 12: Scope of Reviews Molecular Microbio
Page 19 and 20: Inter-assay reproducibility Scope o
Page 21 and 22: Assay Verification Scope of Reviews

Regulation of Laboratory Developed Tests

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