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  • NJ A2332
  • Requires Public Health Council to promulgate rules and regulations for use of quality control programs in bio-analytical and clinical laboratories.
Introduced
(2/4/2016)
In Committee
(2/22/2016)
Crossed OverPassedSignedDead/Failed/Vetoed
2016-2017 Regular Session
This bill requires the Public Health Council to promulgate rules and regulations for the use of quality control programs in bio-analytical and clinical laboratories. Pursuant to current law, the council has promulgated and incorporated in the State Sanitary Code rules and regulations for the operation of bio-analytical and clinical laboratories; however, the council is not currently required to promulgate rules and regulations establishing standards for the use of quality control programs. The bill requires the council to include standards for the use of quality control programs in the State Sanitary Code, and provides that these standards are not to exceed the standards mandated under federal law. Additionally, the bill provides that the provisions of P.L.1953, c.420 (C.45:9-42.1 et seq.), the "Bio-analytical Laboratory and Laboratory Directors Act (1953)," and P.L.1975, c.166 (C.45:9-42.26 et seq.), the "New Jersey Clinical Laboratory Improvement Act," do not apply to bio-analytical and clinical laboratories that: (1) possess a federal certificate of waiver issued pursuant to the "Clinical Laboratory Improvement Amendments of 1988" (CLIA); and (2) perform waived tests authorized by the federal Food and Drug Administration or the federal Department of Health and Human Services. The bill additionally clarifies that the rules and regulations promulgated by the Public Health Council are to include standards for the recognition of waivers under CLIA and personnel qualifications and proficiency testing standards that do not exceed federal requirements. The bill revises the requirements concerning supervision of bio-analytical laboratories to require that the laboratory be under the overall management and direction of either a licensed physician or a licensed bio-analytical laboratory director who is accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed. The bill additionally removes certain provisions in current law concerning the requirements for licensure as a bio-analytical laboratory director which do not conform to current federal requirements.
2nd Reading in the Assembly, Health and Senior Services, Substituted by another Bill
Substituted by S976 (2R)  (on 9/29/2016)
 
 

Date Chamber Action Description
9/29/2016 A Substituted by S976 (2R)
9/15/2016 A Assembly Floor Amendment Passed (Johnson)
6/30/2016 A Assembly Floor Amendment Passed (Benson)
2/22/2016 A Reported out of Assembly Comm. with Amendments, 2nd Reading
2/22/2016 Assembly Health and Senior Services Hearing (10:00 2/22/2016 Committee Room 11, 4th Floor)
2/4/2016 A Introduced, Referred to Assembly Health and Senior Services Committee
Date Motion Yea Nay Other
Detail 2/22/2016 Assembly Health and Senior Services Committee: Reported with Amendments 13 0 0