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  • NJ S976
  • 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 Over
(9/29/2016)
Passed
(11/14/2016)
Signed
(1/9/2017)
Dead/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, 2nd Reading in the Senate, 2nd Reading in the Senate to Concur with Assembly Amendments, Bills and Joint Resolutions Signed by the Governor, Health and Senior Services, Passed Assembly, Passed both Houses, Passed Senate
Approved P.L.2016, c.86.  (on 1/9/2017)
 
 
Date Chamber Action Description
1/9/2017 S Approved P.L.2016, c.86.
11/14/2016 S Passed Senate (Passed Both Houses) (35-0)
10/5/2016 S Received in the Senate, 2nd Reading on Concurrence
9/29/2016 A Passed by the Assembly (73-0-0)
9/29/2016 A Substituted for A2332 (3R)
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 Committee, 2nd Reading
2/22/2016 Assembly Health and Senior Services Hearing (10:00 2/22/2016 Committee Room 11, 4th Floor)
2/16/2016 A Received in the Assembly, Referred to Assembly Health and Senior Services Committee
2/11/2016 S Passed by the Senate (35-0)
2/4/2016 S Reported from Senate Committee, 2nd Reading
2/4/2016 S Introduced in the Senate, Referred to Senate Health, Human Services and Senior Citizens Committee
Date Motion Yea Nay Other
Detail 11/14/2016 Senate Floor: Amend 35 0 5
Detail 9/29/2016 Assembly Floor: Substitute For A2332 Aaa (Voice Vote) 0 0 0
Detail 9/29/2016 Assembly Floor: Third Reading - Final Passage 73 0 7
Detail 2/22/2016 Assembly Health and Senior Services Committee: Reported Favorably 13 0 0
Detail 2/11/2016 Senate Floor: Third Reading - Final Passage 35 0 5
Detail 2/4/2016 Senate Health, Human Services and Senior Citizens Committee: Reported Favorably 9 0 0