Bill Text: NJ S3065 | 2014-2015 | Regular Session | Amended
Bill Title: Requires Public Health Counsel to promulgate rules and regulations for use of quality control programs in bio-analytical and clinical laboratories.*
Spectrum: Partisan Bill (Democrat 2-0)
Status: (Introduced - Dead) 2016-01-11 - Substituted by A4652 (1R) [S3065 Detail]
Download: New_Jersey-2014-S3065-Amended.html
Sponsored by:
Senator ROBERT M. GORDON
District 38 (Bergen and Passaic)
SYNOPSIS
Requires Public Health Counsel to promulgate rules and regulations for use of quality control programs in bio-analytical and clinical laboratories.
CURRENT VERSION OF TEXT
As reported by the Senate Health, Human Services and Senior Citizens Committee on December 21, 2015, with amendments.
An Act concerning 1bio-analytical and1 clinical laboratories and amending 1P.L.1953, c.420 and1 P.L.1975, c.166.
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
11. Section 7 of P.L.1953, c.420 (C.45:9-42.7) is amended to read as follows:
7. a. Any person possessing the educational and experiential qualifications [hereinafter] set forth in federal regulations at 42 C.F.R. Part 493, subpart M, may apply for examination for a plenary license as a bio-analytical laboratory director. [The following qualifications as to education and experience are established as prerequisites for application for examination or licensure for a bio-analytical laboratory director's plenary license:
(1) A doctorate degree, plus not less than one year of experience, or
(2) A master's degree, plus not less than two years of experience, or
(3) A bachelor's degree, plus not less than three years of experience.
The above academic degrees shall be course-earned in the fields of chemistry, pharmacy or the biological sciences and awarded by an educational institution approved by the board. "Years of experience," as used in this section, means for plenary license applicants, years of general bio-analytical laboratory experience acceptable to the board.]
b. The board shall grant a plenary license to all applicants who meet the qualifications for licensure and satisfactorily complete the examination given by the board.
All examinations shall be written in the English language, but the board, in its discretion, may use supplementary oral and practical examinations of the whole class or of individual applicants. The scope of all examinations shall be such as to determine the competence of the applicant to perform and supervise [such] those tests which are within the scope of the director's plenary license and the clinical laboratory license under the "New Jersey Clinical Laboratory Improvement Act," P.L.1975, c.166 (C.45:9-42.26 et seq.).
c. The board shall grant a specialty license in one or more of the fields of toxicological chemistry, microbiology, cytogenetics, biochemical genetics, diagnostic laboratory immunology and clinical chemistry if the applicant is certified by a national accrediting board, which board requires a doctorate degree plus experience, such as but not limited to the American Board of Pathology, the American Osteopathic Board of Pathology, the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bio-analysis or the American Board of Medical Genetics, or any other national accrediting board recognized by the State Board of Medical Examiners.
The applicant for a specialty license must offer proof to the satisfaction of the State Board of Medical Examiners of one year's experience in the specialty, which one year's experience [must] shall be within three years next preceding the date of application for the specialty license.
The specialty license shall authorize the licensee to perform and supervise only those tests which are within the scope of the specialty.1
(cf: P.L.1991, c.236, s.1)
12. Section 18 of P.L.1953, c.420 (C.45:9-42.18) is amended to read as follows:
18. Each bio-analytical laboratory shall be under the [direct and constant supervision] overall management and direction of either:
(a) a person licensed to practice medicine and surgery in the State of New Jersey, or
(b) a licensed bio-analytical laboratory director, who shall be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed.1
(cf: P.L.1953, c.420, s.18)
13. Section 20 of P.L.1953, c.420 (C.45:9-42.20) is amended to read as follows:
20. The provisions of this act shall not affect:
a. Physicians or members of other professions who, in their private practices perform bio-analytical laboratory tests in their own offices or laboratories for their own patients pursuant to licenses respectively granted to them according to law.
b. Nonprofit research institutions.
c. Bio-analytical laboratories of hospitals, licensed by the [New Jersey Department of Institutions and Agencies] Department of Health, where the work is confined to regularly admitted patients or registered clinic patients of the hospital.
d. Bio-analytical laboratories operated by the United States Government, the [State] Department of Health, or any county or municipality of the State.
e. Bio-analytical laboratories possessing a federal certificate of waiver issued pursuant to the "Clinical Laboratory Improvement Amendments of 1988" (Public Law 100-578) 42 U.S.C. s.263a and any regulations adopted pursuant thereto that perform:
(1) waived tests authorized by the federal Food and Drug Administration; or
(2) waived tests authorized by the federal Department of Health and Human Services and listed in 42 C.F.R. s.493.15(c).1
(cf: P.L.1953, c.420, s.20)
14. Section 8 of P.L.1975, c.166 (C.45:9-42.33) is amended to read as follows:
8. The provisions of this act shall not apply to:
a. Clinical laboratories operated and maintained exclusively for research and teaching purposes, involving no patient or public health services whatsoever;
b. Clinical laboratories operated by the United States Government, or blood banks licensed under P.L.1963, c.33 (C.26:2A-2 et seq.);
c. Clinical laboratories specifically exempted from the provisions of this act by rules and regulations promulgated by the Public Health Council pursuant to section 9 of P.L.1975, c.166 (C.45:9-42.34); [or]
d. Clinical laboratories which are operated by the Department of Corrections, any county jail, any county probation department, or any drug or alcohol treatment center providing services to persons under the jurisdiction of any of these agencies or in a program of supervisory treatment pursuant to the provisions of N.J.S.2C:43-13 and which perform only urinalysis for screening purposes to detect the presence of alcohol or illegal substances. The Attorney General shall approve procedures, methods, and devices used by these agencies or centers in screening for alcohol or illegal substances; or
e. Clinical laboratories possessing a federal certificate of waiver issued pursuant to the "Clinical Laboratory Improvement Amendments of 1988" (Public Law 100-578) 42 U.S.C. s.263a and any regulations adopted pursuant thereto that perform:
(1) waived tests authorized by the federal Food and Drug Administration; or
(2) waived tests authorized by the federal Department of Health and Human Services and listed in 42 C.F.R. s.493.15(c).1
(cf: P.L.1991, c.26, s.1)
1[1.] 5.1 Section 9 of P.L.1975, c.166 (C.45:9-42.34) is amended to read as follows:
9. The Public Health Council of the department shall promulgate rules and regulations for operation of clinical laboratories 1[and] , including1 the use of quality control programs as described in subsection h. of this section, which shall be incorporated in and made a part of the State Sanitary Code. 1[Where feasible such] The1 rules and regulations shall 1[equal or] not1 exceed 1[minimum standards for laboratory certification contained in] the standards set forth in1 [Federal] federal rules and regulations promulgated pursuant to the 1["Clinical Laboratories Improvement Act of 1967" (Public Law 90-174) 42 U.S.C. 263a and the]1 "Clinical Laboratory Improvement Amendments of 1988" (Public Law 100-578) 42 U.S.C. 263a. The rules and regulations so promulgated shall include but shall not be limited to standards for:
a. Construction of new, or modification of existing clinical laboratories.
b. Sanitary and safe conditions within the clinical laboratory and its surroundings, including adequate working space, lighting, fire prevention, and safety measures.
c. Clinical laboratory equipment 1[,] and1 maintenance procedures for 1[such] the1 equipment 1[and personnel essential to proper conduct and operation of a clinical laboratory, including standards for education, experience, continuing education, and periodic proficiency testing for laboratory directors, supervisors, technicians, and other personnel which the department may deem necessary for adequate laboratory staffing]1.
d. The acceptance, collection, transportation, identification, and examination of clinical laboratory specimens and reporting of results by clinical laboratories.
e. Reporting by laboratories of diseases for the protection of the public health. The department shall furnish forms for this purpose. 1[Such] The1 reports shall not be construed as constituting a diagnosis nor shall any clinical laboratory making 1[such] a1 report be held liable under the laws of this State for having violated a trust or confidential relationship.
f. Submitting such reports concerning clinical laboratory operations as may be necessary to administer this act. Each laboratory shall maintain a manual of procedures followed in that laboratory, which shall be reviewed and updated annually. 1[Such] The1 manual shall also include, but not be limited to, a list of equipment used for each procedure.
g. Exemptions of specific types of clinical laboratories from the provisions of section 7 of P.L.1971, c.136 (C.26:2H-7).
h. The use of a quality control program by clinical laboratories that meets the 1[requirements of the] standards set forth in federal1 regulations promulgated pursuant to the "Clinical Laboratory Improvement Amendments 1of 19881 ," 1(Public Law 100-578) 42 U.S.C. 263a,1 effective as of January 1, 2014, including the following alternative quality control testing procedures approved by the federal Centers for Medicare and Medicaid Services:
(1) until December 31, 2015, equivalent quality control procedures as specified in Appendix C of the State Operations Manual adopted by the Centers for Medicare and Medicaid Services;
(2) starting on January 1, 2016, individualized quality control plans, as specified in Appendix C of the State Operations Manual; and
(3) any other equivalent quality control procedures subsequently approved by the Centers for Medicare and Medicaid Services and specified in Appendix C of the State Operations Manual.
1i. Recognition of waivers under the "Clinical Laboratory Improvement Amendments of 1988" (Public Law 100-578) 42 U.S.C. 263a and all regulations adopted pursuant thereto (42 C.F.R. Part 493).
j. Personnel qualifications and proficiency testing standards that do not exceed federal standards set forth in federal regulations at 42 C.F.R. Part 493, subpart M.1
(cf: P.L.1975, c.166, s.9)
16. Section 12 of P.L.1975, c.166 (C.45:9-42.37) is amended to read as follows:
12. The department shall establish and conduct a clinical laboratory evaluation program to:
a. Prescribe minimum standards of performance in the examination of specimens, which standards shall not 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. 263a;
b. Test the proficiency of clinical laboratories to determine if the minimum standards of performance established pursuant to P.L. , c. (pending before the Legislature as this bill) are being met; and
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.1
(cf: P.L.1975, c.166, s.12)
1[2.] 7.1 This act shall take effect immediately except that the Public Health Council may take any anticipatory administrative action in advance as shall be necessary for the implementation of this act.
