45:9-42.34 Rules, regulations; standards for operation of clinical laboratories.

9. The Public Health Council of the department shall promulgate rules and regulations for operation of clinical laboratories, including 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. Notwithstanding the use of quality control programs as described in subsection h. of this section and the recognition of waived tests as described in subsection i. of this section, the rules and regulations shall at least equal the standards set forth in federal rules and regulations promulgated pursuant to the "Clinical Laboratory Improvement Amendments of 1988," Pub.L.100-578 (42 U.S.C.s.263a). Any rules or regulations promulgated after the effective date of P.L.2016, c.86 that exceed those federal standards shall only be promulgated after a rulemaking process that includes notice and comment and a public hearing. 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 and maintenance procedures for the equipment and personnel essential to proper conduct and operation of a clinical laboratory, including standards for education, experience, and continuing education.

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. The reports shall not be construed as constituting a diagnosis nor shall any clinical laboratory making a 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. The 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 which shall not exceed the standards set forth in federal regulations promulgated pursuant to the "Clinical Laboratory Improvement Amendments of 1988," Pub.L.100-578 (42 U.S.C.s.263a), effective as of January 1, 2016, or as subsequently amended , including the following alternative quality control testing procedures approved by the federal Centers for Medicare and Medicaid Services:

(1) Individualized Quality Control Plans , as specified in Appendix C of the State Operations Manual; and

(2) 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.

i. Recognition of all waived tests and waivers under the "Clinical Laboratory Improvement Amendments of 1988," Pub.L.100-578 (42 U.S.C.s.263a) and all regulations adopted pursuant thereto (42 C.F.R. Part 493).

j. The use of waived tests by clinical laboratories, which shall not exceed the standards set forth in the federal rules and regulations promulgated pursuant to the "Clinical Laboratory Improvement Amendments of 1988," Pub.L.100-578 (42 U.S.C.s.263a), effective as of January 1, 2016, or as subsequently amended, unless expressly required under this Act or the Public Health Council determines that it is necessary to exceed those federal standards in order to protect the public health. Such determinations shall detail the council's justification for exceeding federal standards.

L.1975, c.166, s.9; amended 2016, c.86, s.7.