N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.7

Current through Register Vol. 46, No. 45, November 2, 2024

Section 52-2.7 - Administration and direction

(a) Every tissue bank other than a tissue transplantation facility or limited tissue procurement service shall have a tissue bank director. The tissue bank director shall develop and implement policies and procedures for the operation of the bank, consistent with this Subpart and the Subparts for each category of tissue. If the tissue bank director is not a physician, a medical director who is a physician shall be retained.

(b) Except for transplantation facilities, insemination/implantation sites, and limited tissue procurement services, every tissue bank shall have a medical advisory committee, composed of persons with training and experience in tissue banking or a closely related field, as well as at least one member with infectious disease expertise, and with the qualifications specified in the Subpart(s) for each category of tissue, if any.

(c) Medical direction of a tissue bank, other than a tissue transplantation facility or limited tissue procurement service, shall be provided by a physician, designated as the medical director, in consultation with the medical advisory committee, if applicable.

(d) The tissue bank director, if one is required, in consultation with the medical director, if not the same person, and the medical advisory committee, if one is required, shall monitor the medical efficacy of the tissue banking program and shall, as a minimum, develop:

(1) medical criteria for allogeneic donor participation;

(2) quality control and quality assurance standards; and

(3) procedures to assure that tissues from allogeneic donors are distributed based on medical need and not preferentially distributed according to the donor's or recipient's membership in a category based on race, color, creed, ii national origin, marital status, social organization or income except if medically indicated.

(e) The tissue bank director shall be responsible for donor selection and the technical/ scientific operation of the bank, including recruitment of sufficient numbers, training, and supervision of all personnel performing tissue acquisition, processing, storage or distribution activities.

(f) The tissue bank director shall be responsible for ensuring that the tissue transplantation facility or insemination/implantation site performing each transplant, artificial insemination, transfer, or implantation is advised of the donor's applicable medical history and tissue processing methods used, so that recipient counseling may be provided if indicated.

(g) The medical director of each insemination/implantation site shall be responsible for ensuring that the individual performing each artificial insemination, transfer or implantation is advised of the donor's significant medical history.

(h) The tissue bank director, medical director and owner(s) shall be responsible for compliance with this Part.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.7