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Title: Section 58-2.14 - Collection of source plasma

Effective Date

09/09/2020

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 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 as required by Title 21 CFR Part 630. If the director is not the responsible physician, the responsible physician shall be  licensed in the state or jurisdiction where the blood bank is located and either hold a Certificate of Qualification in transfusion pursuant to Part 19 of this Title, or be board certified in clinical pathology or in clinical pathology/laboratory medicine. The director shall not delegate approval of new or revised standard operating procedure manuals or other procedural guides specific to the facility as required by section 58-2.8 of this Title.

(c) Informed consent.The consent of a prospective serial plasmapheresis donor shall be obtained in writing after a licensed physician, physician assistant, nurse practitioner or registered nurse, explains the hazards of the procedure to the donor in such a manner that he/she is offered an opportunity to refuse consent. The prospective donor shall be told of the risks of serial plasmapheresis, including the possibility of a hemolytic transfusion reaction if he/she is given someone else's red cells, risk of any medications or sedimenting agents to be used, and, if he/she is to be immunized or hyperimmunized, of the hazards involved. 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.

(d) Care of serial plasmapheresis donors. A physician, physician assistant, nurse practitioner or registered nurse shall be available on the premises whenever collections of source plasma are performed in order to supervise the care of plasma donors.  A blood bank collecting source plasma must establish, maintain and follow standard operating policies and procedures for management of donor adverse reactions, including obtaining rapid emergency medical services, such as using 911, 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.

Statutory Authority

Public Health Law, Section 3121(5)

Volume

VOLUME A-1 (Title 10)

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