4. a. The department shall promulgate rules and regulations pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.) governing the storage and care of human eggs, pre-embryos, and embryos by an embryo storage facility in accordance with:
(1)Standards ISO 9001 and ISO 20387 of the International Organization for Standardization;
(2)standards for biorepositories established by the College of American Pathologists Biorepository Accreditation Program; and (3) the U.S. Food and Drug Administration guidance on Current Good Tissue Practices. b. The rules and regulations promulgated pursuant to this section shall promote safety and best practices among embryo storage facilities and, at a minimum: prescribe standards governing the operation, maintenance, and administrat
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4. a. The department shall promulgate rules and regulations pursuant to the "Administrative Procedure Act," P.L.1968, c.410 (C.52:14B-1 et seq.) governing the storage and care of human eggs, pre-embryos, and embryos by an embryo storage facility in accordance with: (1) Standards ISO 9001 and ISO 20387 of the International Organization for Standardization; (2) standards for biorepositories established by the College of American Pathologists Biorepository Accreditation Program; and (3) the U.S. Food and Drug Administration guidance on Current Good Tissue Practices. b. The rules and regulations promulgated pursuant to this section shall promote safety and best practices among embryo storage facilities and, at a minimum: prescribe standards governing the operation, maintenance, and administration of embryo storage facilities; the safety and adequacy of the physical plant or the facilities; compliance with State and local fire safety codes; the number of staff and the qualifications of each staff member; the protection and safety of the equipment used by embryo storage facilities to process and store human eggs, pre-embryos, and embryos; the maintenance and confidentiality of records and furnishing of required information; the maintenance of all appropriate accreditations and certifications; the establishment of a quality management program; and the review of the scope of internal audits. c. The department shall conduct an on-site facility inspection and shall evaluate the embryo storage facility to determine whether the facility complies with the provisions of this act. d. The department shall have the authority to inspect and examine the physical plant or facilities of an embryo storage facility and to inspect all documents, records, files, or other data maintained pursuant to this act during normal operating hours and without prior notice. e. The department shall request the appropriate State and local fire, health, and building officials to conduct examinations and inspections to determine compliance with State and local ordinances, codes, and regulations by an embryo storage facility. The inspections shall be conducted and the results reported to the department within 60 days after the request. f. If an embryo storage facility meets the requirements of this act and the rules and regulations promulgated hereunder, the department shall issue a license to the facility. A license shall be valid for a period of one year and may be renewed at the end of that period, subject to continued compliance with the provisions of this act. g. Nothing in this section shall be interpreted to permit the adoption of any code or standard which exceeds the standards established pursuant to the "State Uniform Construction Code Act," P.L.1975, c.217 (C.52:27D-119 et seq.). L.2019, c.268, s.4.