Title: Section 58-2.14 - Serial plasmapheresis
58-2.14 Serial plasmapheresis.
(a) The standards that apply to whole blood collection and processing shall apply to serial plasmapheresis except as otherwise specified. Whenever the plasma is not intended for transfusion, or for the preparation of fractions for transfusion, the criteria for donor selection may be limited to those designed for the safety of the donor. In such instances, the plasma unit shall be prominently labeled, "NOT FOR TRANSFUSION", or similar language.
(b) Direction. The director of a serial plasmapheresis program shall be a physician who must demonstrate satisfactory training in all aspects of hemapheresis, including a minimum of two years' experience.
(c) Informed consent.The consent of a prospective serial plasmapheresis donor shall be obtained in writing after a licensed physician explains the hazards of the procedure to the donor in such a manner that he/she is offered an opportunity to refuse consent. The 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. For example, in the case of immunization with human blood components, the donor shall be told specifically about the risk of viral hepatitis, as well as about the increased risk of receiving incompatible blood if he/she ever needs a transfusion. 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 on a form approved by the department.
(d) Donor qualification. A donor may not be accepted for serial plasmapheresis unless the criteria in section 58-2.2(b) and (c) of this Subpart, with the exception of sections 58-2.2(b)(5) and (7), and 58-2.2(c)(10) and (11), are met.
(e) Care of serial plasmapheresis donors. A qualified, licensed physician shall be available within fifteen minutes' travel time of the premises, at which serial plasmapheresis is performed, immediately available for personal or telephone consultation in the treatment of a donor who manifests an adverse reaction, and responsible for all phases of plasmapheresis conducted. A physician or a registered nurse designated by the medical director shall be available on the premises at all times. The floor supervisor shall be a registered nurse, physician assistant, or person with at least two years' experience performing plasmapheresis procedures, and shall have completed a plasmapheresis training program that includes documented satisfactory performance of donor plasmapheresis procedures. Persons performing manual plasmapheresis procedures shall be licensed practical nurses, registered nurses, clinical laboratory technologists, physician assistants, or persons with at least two years' experience performing manual plasmapheresis procedures. Persons performing automated plasmapheresis procedures shall be licensed practical nurses, registered nurses, clinical laboratory technologists, clinical laboratory technicians or physician assistants, or persons with at least six months' experience in collecting whole blood for transfusion. All persons performing plasmapheresis procedures shall have one year's experience performing plasmapheresis procedures or 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 an 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;
(4) prevent, and when necessary, initially address adverse reactions;
(5) develop the ability to work independently, utilizing the floor supervisor as a resource when necessary; and
(6) provide support to the donor while maintaining control of the operation of the instrument.
The director shall establish an agreement with an accredited hospital in the vicinity of the plasmapheresis center for the admission of donors who sustain adverse reactions and require hospital care.
(f) Laboratory testing. A serologic test for syphilis shall be performed within 24 hours on a specimen collected at the time of the first donation and at four-month intervals thereafter. A donor with a reactive serologic test for syphilis shall not be plasmapheresed again until the donor's serum is nonreactive in confirmatory testing, except that donors with reactive tests for syphilis may be plasmapheresed to obtain plasma to be used for manufacturing control serum for serologic tests for syphilis. Approved tests for HBsAg and antibodies to HCV, HIV-1 and HIV-2 shall be performed on the retained plasma or on a specimen obtained from the donor at the time of donation. If the plasma is intended for transfusion, all tests required in section 58-2.3(a) of this Subpart shall be performed.
(g) Return of red blood cells to donor. If it is not possible to return red blood cells to a plasmapheresis donor, or if whole blood is donated, the donor shall not be plasmapheresed again for eight weeks, unless the donor's extracorporeal red blood cell volume during the procedure is not expected to exceed 100 milliliters.
(h) Manual plasmapheresis procedures. Containers and anticoagulants shall meet the standards for whole blood. 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. Plasmapheresis shall be performed aseptically under conditions that avoid air embolism. During their separation, the red blood cells shall be maintained at a temperature not exceeding 37 degrees Celsius and under conditions known to assure the sterility and viability of these cells upon their return to the donor. The identity of the donor and the container shall be confirmed by at least two technical staff members prior to reinfusion of the red blood cells. Red blood cells shall be returned to the donor within two hours of the phlebotomy. If plasmapheresis is to be performed using equipment dissimilar to blood bags used for the collection of blood so that the standards for containers and anticoagulants for whole blood do not apply, specific approval from the department is required.
(i) Automated plasmapheresis procedures. Plasmapheresis shall be performed aseptically under conditions that avoid air embolism and maintain sterile technique. If plasmapheresis is to be performed using equipment dissimilar to blood bags used for the collection of blood so that the standards for containers and anticoagulants for whole blood do not apply, specific approval from the department is required.
(j) Records. All institutions performing plasmapheresis shall maintain records of all plasmaphereses performed, and the clinical and laboratory information pertinent thereto. These records shall include complete information on each donor, signed consent of the donor, his/her identification code, and the amount of plasma removed. When immunizations are performed, the antigen and the procedures employed shall be identified and recorded, and the donor shall give specific consent for the immunization. These records shall be available for inspection for at least seven years after each plasmapheresis.
VOLUME A-1 (Title 10)