Sec. 58-2.14. Collection of source plasma

(a) Notwithstanding any requirements in this Subpart to the contrary for blood collection by means other than plasmapheresis, blood banks collecting, processing, and/or distributing source plasma, as defined in title 21 of the Code of Federal Regulations (CFR) part 640, shall comply with applicable requirements in title 21 CFR parts 630 and 640 and any additional requirements in this section.

(b) Direction.

The director of a blood bank collecting, processing, and/or distributing source plasma shall be a licensed physician who holds a Certificate of Qualification in Blood Banking Collection – Comprehensive pursuant to Part 19 of this Title. The director may serve as the responsible physician for the purposes of title 21 CFR part 630; however, if the director is not the responsible physician, the responsible physician shall be a physician licensed in New York State. Except for testing procedures for clinical testing, the director may delegate approval of new or revised standard operating procedure manuals or other procedural guides required by section 58-2.8 of this Subpart.

(c) Informed consent.

The consent of a prospective donor shall be obtained in writing. If the donor will be immunized with human blood components, the donor shall be informed of the risk of transfusion-transmitted infections and the increased risk of receiving incompatible blood in future transfusions. A prospective donor who is to be deliberately exposed to an antigen shall also be given a general description of the immunization program, including the nature of the material to be injected. All of this information shall also be given to each prospective donor in written form, and the donor's consent shall be signed and witnessed. The blood bank director or responsible physician shall approve information provided to the donor regarding risks or hazards of the procedure and such approval may not be delegated.

(d) Care of source plasma donors.

A responsible physician, physician substitute, or other person who is specifically trained in recognizing and addressing reactions that may occur in association with the procedures being performed, shall be immediately available on the premises during a plasmapheresis procedure. A blood bank collecting source plasma must establish, maintain and follow standard operating policies and procedures for management of donor adverse reactions that include using 9-1-1 or obtaining other rapid emergency medical services for donors when medically necessary.

(e) Personnel training.

All persons performing plasmapheresis procedures shall have completed a training program in plasmapheresis procedure technique. The training program must include training in donor screening, venipuncture techniques, instrument operation, prevention of and initially addressing donor reactions, and proper documentation of all completed procedures. At the end of the training program, each plasmapheresis operator must be able to:

(1) safely and effectively operate the cell separator systems in use at the facility;

(2) harvest plasma which meets quality standards;

(3) manage fluid volumes safely; and

(4) prevent, and when necessary, initially address adverse reactions.

(f) Manual plasmapheresis procedures.

Before the blood container is separated from the donor for processing, it shall bear two separate and independent means of identification to enable both the donor and the phlebotomist to determine without doubt that the contents originate from the donor. The identity of the donor and the container shall be confirmed by at least two staff members, trained in accordance with subdivision (e) of this section, prior to reinfusion of the red blood cells. Red blood cells shall be returned to the donor within two hours of the phlebotomy.