The Biobanking Compliance Program (BCP) is responsible for the licensure of Embryo Storage Facilities (ESF) operating in New Jersey, in accordance with N.J.S.A. 26:2A-23 et seq. The program enforces compliance with the rules outlined in N.J.A.C. 8:77 to ensure safety and best practices in embryo storage facilities. It does so by evaluating facility adequacy, staff qualifications, equipment protection, record confidentiality, necessary accreditations, quality management programs, and internal audit reviews. The BCP conducts regular on-site inspections to evaluate and ensure compliance with these provisions.
Registration and Accreditation of Human Milk Banks (HMB)
The Biobanking Compliance Program (BCP) is responsible for the registration and accreditation of human milk banks (HMB) that operate or distribute in New Jersey, in accordance with N.J.S.A. 26:2A-17 et seq. The program enforces compliance with the rules outlined in N.J.A.C. 8:75, which set the standards for HMB services, including donor qualification, collection, processing, marketing, storage, and distribution of donor human milk. By conducting regular inspections and annual registration and accreditation assessments, the BCP monitors human milk banks' adherence to guidelines designed to protect public health and promote the safe operation of these facilities.
Enforce N.J.A.C. 8:77, which pertains to the licensure of embryo storage facilities, and N.J.A.C. 8:75, which covers the registration and accreditation of human milk banks.
Conduct Inspections, Assess Compliance, and Operations:
ESF: Perform on-site inspections of licensed embryo storage facilities (announced or unannounced) during normal operating hours to examine facilities, cryostorage equipment and alarm systems, personnel qualifications, emergency preparedness and recovery plans, quality management programs, reproductive tissue handling procedures, and all records and operational data. Inspections ensure compliance with N.J.S.A. 26:2A-23 et seq. and N.J.A.C. 8:77.
HMB: Perform on-site inspections of registered and accredited human milk banks at least once every five years (announced or unannounced) during normal operating hours, plus annual compliance assessments. Inspections examine facilities, equipment, personnel qualifications, donor screening and qualification procedures, collection, processing, storage, and distribution operations, quality management systems, and all records and operational data to ensure compliance with N.J.S.A. 26:2A-17 et seq. and N.J.A.C. 8:75.
Investigate Errors and Incidents:
Investigate errors and incidents that could negatively impact the viability, safety, or future use of the reproductive tissue, or affect the premises or operational continuity of the embryo storage facility.
Investigate errors and incidents that may present a threat to or compromise the public health and safety of human milk banks.
