N.J. Admin. Code § 8:8-13.8

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:8-13.8 - Criteria for donor selection

(a) When establishing the suitability of HPC donors for collection, the criteria used for medical history; physical examinations; bleeding limitations and the applicable requirements as prescribed by 8:8-6.2 shall be followed and shall be consistent with FDA regulations.

(b) When selecting donors for suitability, the applicable requirements as prescribed by 8:8-6.3 shall be followed and shall be consistent with FDA regulations and AABB Standards.

(c) The recipient's physician shall write a request for collection and processing before HPC are collected.

(d) The licensee shall obtain an informed consent of the peripheral blood donor prior to collection.

(e) Informed consent for cord blood donors shall:

1. Be obtained from birth mother, preferably both parents and if applicable, the legal custodian(s), according to 8:8-6.4(a) and the AABB Standards;

2. Not be obtained during active labor or while the mother is under the influence of sedation;

3. Be obtained prior to collection in cases of in utero collection; and

4. Begin before collection and be completed within 48 hours of collection.

(f) The requirements for qualifying the peripheral blood donor shall include:

1. Physician's approval of donor suitability; and

2. Written approval by the Medical Director and the recipient's physician for any exceptions to the donor qualification process.

(g) The licensee shall provide medical provisions for care of donors in case of adverse events and for a licensed physician to supervise when drugs, growth factors, pharmacologic or biologic agents are administered to a donor of peripheral blood.

(h) Donor acceptance shall be at the discretion of the transplant physician based on the degrees of ABO and HLA incompatibility.

(i) The cord blood service shall establish criteria for accepting birth mothers of autologous and related allogeneic donors that are acceptable to the Department.

(j) Birth mothers shall qualify with the allogeneic donor suitability requirements.

N.J. Admin. Code § 8:8-13.8