Title: Section 58-2.15 - Collection of blood components by apheresis
58-2.15 Collection of blood components by apheresis.
(a) Notwithstanding any requirements in this Subpart to the contrary for blood collection by means other than apheresis, blood banks collecting blood components by apheresis must 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 blood components for transfusion 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 be 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 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 donor shall be obtained in writing after a licensed physician, physician assistant, nurse practitioner or a registered nurse, explains the hazards of the procedure and 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.
(d) 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 two 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) All persons performing apheresis procedures shall have completed a training program in apheresis procedure techniques. 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; and
(iv) prevent, and when necessary, initially address adverse reactions.
(3) A physician, physician assistant, nurse practitioner or a registered nurse, 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 an apheresis procedure in order to supervise the care of donors.
(4) The blood bank shall establish, maintain and follow standard operating procedures policies and procedures for management of donor adverse reactions, including obtaining rapid emergency medical services, that include using 911, for donors when medically necessary.
(e) Volume and frequency of apheresis. All collections shall follow criteria for the F.D.A. approved or cleared apheresis device used. In addition, the following requirements shall apply to:
(i) donors shall donate plasma no more frequently than twice in seven days, with at least two days between donations; and
(ii) donors shall be weighed at the time of each donation.
(i) platelet, leukocyte, and granulocyte donors shall donate no more frequently than twice in seven days, with at least two days between donations. The total volume of plasma collected must not exceed the maximum for the instrument as cleared by F.D.A.;
(ii) double or triple platelet collections shall occur no more frequently than once in seven days;
(iii) donors may not donate more than 24 times in a twelve-month period;
(iv) cytapheresis shall not take place less than eight weeks after a whole blood donation, unless the apheresis instrument has an extracorporeal red cell volume less than 100 ml. When such an instrument is used, cytapheresis shall not take place less than two days after a whole blood donation; and
(v) if red cell loss during apheresis is greater than 200 ml, the next apheresis shall take place no sooner than eight weeks after the first.
(i) the blood bank shall collect a blood specimen from the donor before each plateletpheresis procedure to determine the donor’s platelet count. This platelet count, if available, shall be used in the qualification of the donor. If this platelet count is not available, the donor’s most recent platelet count may be used in the qualification of the donor, except in the case of triple platelet collections from first time donors. An acceptable platelet count is required for such donors prior to donation; and
(ii) the donor’s platelet count must be greater than 150,000 per ul. Donors with fewer than 150,000 per ul must be deferred until the platelet count is acceptable.
(4) 2-unit red cell apheresis donors
(i) a 2-unit red cell apheresis donor shall not donate blood or blood components for at least 16 weeks after the apheresis; and
(ii) the blood bank shall not collect a red cell volume expected to result in a donor hematocrit of 30% or lower, or hemoglobin less than 10 g/dl after volume replacement.
VOLUME A-1 (Title 10)