45:9-42.37 Clinical laboratory evaluation program.

12. The department shall establish and conduct a clinical laboratory evaluation program to:

a. Prescribe minimum standards of performance in the examination of specimens, and any standards that would exceed the standards established under federal rules and regulations promulgated pursuant to the "Clinical Laboratories Improvement Amendments of 1988," Public Law 100-578 (42 U.S.C.s.263a) shall only be promulgated after a rulemaking process that includes notice and comment and a public hearing;

b. Test the proficiency of clinical laboratories to determine if the minimum standards of performance established pursuant to P.L.2016, c.86 are being met;

c. Develop and organize appropriate consultation and training activities in clinical laboratory procedures with the purpose of improving the quality of performance of clinical laboratories licensed by this act;

d. In lieu of routine on-site survey and inspection of any clinical laboratory to determine compliance with this Act, the department may instead formally recognize and rely upon the routine survey and inspection of clinical laboratories by any accreditation entity approved by the Centers for Medicare and Medicaid Services pursuant to the "Clinical Laboratories Improvement Amendments of 1988," Public Law 100-578 (42 U.S.C. s.263a), provided the department determines that the standards of the accreditation entity are equivalent to the department's standards for on-site survey and inspection; and

e. Nothing contained in this section shall be construed to limit the department's authority to rely upon the inspection and survey results of any accreditation entity approved by the Centers for Medicare & Medicaid Services pursuant to the "Clinical Laboratories Improvement Amendments of 1988," Pub.L.100-578 (42 U.S.C.s.263a), or conduct a complaint inspection of any laboratory at any time.

L.1975, c.166, s.12; amended 2016, c.86, s.8.