Title: Section 58-2.15 - Collection of blood components by apheresis
58-2.15 Collection of blood components by apheresis.
(a) Selection of donors. The standards that apply to whole blood donation shall apply in the selection and care of the donor for apheresis, unless otherwise specified.
(b) Informed consent. The consent of a prospective donor shall be obtained in writing after a qualified and specially trained individual explains the hazards of the procedure in such a manner that the donor is offered an opportunity to refuse consent. The donor shall be informed of the risks of apheresis and the risks of any sedimenting agents or medications to be used.
(c) Qualifications and care of the donor. (1) Only those persons may be accepted as blood donors for apheresis who are in good health as indicated by the qualifications of a whole blood donor specified in section 58-2.2 of this Subpart, with the following exceptions:
(i) Ingestion of aspirin-containing medications within three days of donation shall preclude donation of platelets.
(ii) Cytapheresis of donors who do not meet the requirements of this subsection shall be performed only if the harvested cells are expected to be of particular value to an intended recipient, and only if the supervising physician has confirmed in writing the particular value of these cells and has certified that the donor's health permits cytapheresis.
(iii) Medications or sedimenting agents to facilitate cytapheresis shall not be used in donors whose medical history suggests that these may exacerbate previous or intercurrent disease. Guidelines for use of such agents shall be established by the medical director.
(2) The medical director, who must demonstrate satisfactory training in all aspects of apheresis, including one year of experience, shall be responsible for all phases of apheresis conducted. Persons performing apheresis procedures shall be registered nurses, licensed practical nurses, clinical laboratory technologists, clinical laboratory technicians or physician assistants, or persons with at least six months' experience collecting blood for transfusion. All persons performing apheresis procedures shall have at least one year's experience performing apheresis procedures or shall have completed a training program in apheresis 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 apheresis operator must be able to:
(i) safely and effectively operate the cell separator systems in use at the facility;
(ii) harvest blood components which meet quality standards;
(iii) manage fluid volumes safely;
(iv) prevent, and when necessary, initially address adverse reactions;
(v) develop the ability to work independently, utilizing the floor supervisor as a resource when necessary; and
(vi) provide support to the donor while maintaining control of the operation of the instrument. (3) The floor supervisor shall be a: (i) registered nurse; (ii) physician assistant; (iii) person with at least two years' experience performing apheresis procedures; or (iv) person with at least one year of experience supervising allogeneic blood collection. (4) The floor supervisor shall have completed an apheresis training program that includes documented satisfactory performance of donor apheresis procedures. (5) A person specifically trained in recognizing and addressing reactions that may occur in association with the procedures being performed shall be immediately available on the premises at all times during an apheresis procedure. A qualified licensed physician shall be immediately available, at least for telephone consultation, during all procedures.
(d) Volume and frequency of apheresis. Extracorporeal blood volume shall not exceed 15 percent of the donor's estimated blood volume. No more than 12.0 liters of plasma shall be removed per year from a donor weighing 175 pounds or less, and no more than 14.4 liters shall be removed per year from a donor weighing more than 175 pounds. The interval between procedures shall be at least 48 hours. The above volume and frequency requirements may be waived upon written authorization of the supervising physician, provided the donor meets all other eligibility requirements. Red blood cells shall not exceed 300 milliliters per eight weeks, unless the following requirements are met: (1) for male donors, the donor's weight is at least 130 pounds; (2) for female allogeneic donors, the donor's weight is at least 150 pounds; (3) for female autogeneic donors, the donor's weight is at least 130 pounds; (4) the allogeneic donor's hemoglobin content is 12.5 grams per deciliter or greater, or hematocrit is 38 percent or greater, and the donor meets the hemoglobin/hematocrit and weight requirements for use of the apheresis device, as approved by the F.D.A.; (5) the autogeneic donor's hemoglobin content is 11.0 grams per deciliter or greater, or hematocrit is 33 percent or greater, and the donor meets the hemoglobin/hematocrit and weight requirements for use of the apheresis device, as approved by the F.D.A.; (6) the volume of packed red blood cells removed does not exceed 550 milliliters; and (7) the volume removed is replaced with at least 225 milliliters of normal saline. Following a red cell apheresis procedure in which red blood cell loss exceeds 300 milliliters, the allogeneic donor shall not donate whole blood or undergo another apheresis procedure for a minimum of 16 weeks. For autogeneic donors, frequency and volume to be removed shall be determined by the medical director of the blood bank in conformance with recommendations of the manufacturer of the apheresis device.
(e) Return of red blood cells to donor. If it is not possible to return red blood cells to a donor, or if whole blood is donated, the donor shall not undergo apheresis again for eight weeks, unless the donor's extracorporeal red blood cells volume during the procedure will not exceed 100 milliliters.
(f) Procedures for collection of blood components by apheresis and their processing.Such procedures shall follow a written protocol approved by the medical director. Containers and anticoagulants shall meet the standards for whole blood. Apheresis shall be performed aseptically under conditions that prevent air embolism, and assure sterility and viability of cells returned to the donor. (g) Required records.All facilities performing apheresis shall maintain records of all such procedures performed, and the clinical and laboratory information pertinent thereto. These records shall include complete information on the donor, volume of blood removed, anticoagulants used, duration of the procedure, volume of components obtained, medications and sedimenting agents used, including manufacturer, lot number, expiration date and amount administered, and any adverse reactions and their management. These records shall be available to the department for inspection for at least seven years after each procedure.
VOLUME A-1 (Title 10)