A4652

An Act concerning clinical laboratories and amending P.L.1975, c.166.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

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 and 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. Where feasible such rules and regulations shall equal or exceed minimum standards for laboratory certification contained in [Federal] federal rules and regulations promulgated pursuant to the "Clinical Laboratories Improvement Act of 1967" (Public Law 90-174) 42 U.S.C. 263a and the "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, maintenance procedures for such equipment 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.

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. Such reports shall not be construed as constituting a diagnosis nor shall any clinical laboratory making such 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. Such 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 requirements of the regulations promulgated pursuant to the "Clinical Laboratory Improvement Amendments," 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.

(cf: P.L.1975, c.166, s.9)

2. 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.

STATEMENT

This bill requires the Public Health Council to promulgate rules and regulations for the use of quality control programs in clinical laboratories.

Specifically, the bill amends section 9 of P.L.1975, c.166 (C.45:9-42.34) to require that the rules and regulations promulgated by the Public Health Council and incorporated in the State Sanitary Code include standards for the use of quality control programs by clinical laboratories.

Pursuant to law, the council has promulgated and incorporated in the State Sanitary Code, rules and regulations for the operation of clinical laboratories. Current law does not require the council to promulgate rules and regulations establishing standards for the use of quality control programs and to incorporate them into the State Sanitary Code.

The bill clarifies that the rules and regulations promulgated by the Public Health Council should also equal or exceed minimum standards for laboratory certification contained in the regulations promulgated pursuant to "Clinical Laboratory Improvement Amendments of 1988" (CLIA).

Currently, the rules and regulations for laboratory certification are required to equal or exceed the minimum standards contained in the "Clinical Laboratories Improvement Act of 1967." Current law does not require rules and regulations to also include the standards established under the CLIA, which mandate laboratories to establish quality testing procedures.

The bill requires that the rules and regulations promulgated by the Public Health Council consist of standards that meet the requirements of regulations promulgated pursuant to the CLIA, effective January 1, 2014. The rules and regulations would include the following alternative quality control testing procedures approved by the federal Centers for Medicare and Medicaid Services: 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; starting on January 1, 2016, individualized quality control plans, as specified in Appendix C of the State Operations Manual; and 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.