2. Screening Process POLICY FOR THE DISTRIBUTION OF IGA-DEFICIENT PLASMA. 1. Scope

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1 POLICY FOR THE DISTRIBUTION OF IGA-DEFICIENT PLASMA 1. Scope The ARDP is responsible for identifying the locat ion(s) of IgA-deficient plasma and request shipment of such products to authorized requesting blood centers in the United States and internationally. This responsibility is carried out by ARDP staff in Philadelphia where a database of IgA-deficient blood donors is maintained. High sensitivity IgA testing is performed at this location by NRLBGS staff on samples from donors prior to the donor submissions to the ARDP to assure the IgA-deficiency (aiga) status of the donor, i.e., IgA < 0.05 mg/dl. 1,2 Also, the NRLBGS has the capability to perform sensitive IgA testing and IgA antibody testing for patients Screening Process Since IgA-deficient plasma is usually in extremely limited supply, the distribution through the ARDP is controlled by conducting an assessment of each request by ARDP staff. 2 The initial request is received by a technical ARDP staff member who will make a decision on distribution based upon the guidelines established by ARDP medical staff. At all times, the ARDP technical staff member shall have an ARDP medical staff member available to contact for consultation and review. If there are unresolved disputes, the matter will be forwarded to the ARDP medical staff. 3. Distribution Guidelines Distribution Guidelines in Tables 1 and 2 are based on the Distribution Policies in a subsequent section. In general, for non-emergency requests the policy provides for the release of IgA-deficient plasma only if anti-iga can be demonstrated in the patient serum. Clinical circumstances differ among patients and may require variance for the guidelines. 2 4 Patient care and safety should have the highest priority. For this reason, Emergency and Non-Emergency guidelines differ. In addition, differences in opinion of the requesting physician and these guidelines should not incur unwarranted delays in patient care. Some selected circumstances may require a short-term distribution of IgA-deficient plasma even when these guidelines are not met.

2 Table 1. Guidelines for the distribution of IgA deficient plasma in emergency situations (needed within 4 days*) History of reaction X X X X X X X X No history of reaction X X X No IgA level available X Routine IgA tests IgA deficient X X X X X X X Sensitive IgA tests no IgA X X X X X IgA present X X X No anti-iga performed X X X X X Anti-IgA present X X X Anti-IgA not present X X X Decision B,D A,C A,C A B B,C B A A,C A B Table 2. Guidelines for the distribution of IgA deficient plasma in non-emergency situations (not needed within 4 days*) History of reaction X X X X X X X X No history of reaction X X X No IgA level available X Routine IgA tests IgA deficient X X X X X X X Sensitive IgA tests no IgA X X X X X IgA present X X X No anti-iga performed X X X X X Anti-IgA present X X X Anti-IgA not present X X X Decision B,C B,C B,C A B B,C B A B,C A B * The 4 day time frame is intended to allow for the time required for rapid shipment of serum samples and high sensitivity IgA and anti-iga testing. Geographic and transportation circumstances may require more or less than 4 days for results. Each of the columns represents an individual requesting scenario. Decision Key A. Release IgA deficient plasma B. Do not release IgA deficient plasma C. Ask for a pretransfusion sample for IgA and anti- IgA studies D. Ask to have a routine IgA level performed locally Note: All disputes or differing opinions on the part of the requesting physician shall be referred to the ARDP physician on-call. 4. Distribution Policies

3 a. IgA-deficient plasma will be distributed for all patients that exhibit, or have exhibited, anti-iga. This includes patients that exhibit limited specificity as well as class specific antibody, and includes all patients whether, or not, they have experienced an IgA-related transfusion reaction. It may include some patients that have normal or low level IgA and exhibit limited specificity antibody. b. IgA-deficient plasma will be distributed for all Emergency Need patients that have no IgA detected on routine (low sensitivity) testing and/or high sensitivity testing and have not had antibody testing performed within the past 12 months. At the time of accepting the request, the ARDP staff will request shipment of a pretransfusion serum sample to be submitted for IgA studies by the NRLBGS. c. IgA-deficient plasma should not be distributed for Emergency or Non- Emergency patients that have experienced transfusion reactions but have not have had an IgA level performed. d. IgA-deficient plasma should not be distributed for Emergency or Non- Emergency patients that have demonstrated IgA to be present by low or high sensitivity testing but have not had IgA antibody studies performed. Under these circumstances, the finding of a limited specificity antibody as the cause for a transfusion reaction is exceedingly rare. 1 e. IgA-deficient plasma should not be distributed for Non-Emergency patients that have no IgA detected on routine (low sensitivity) testing and/or high sensitivity testing and have not had antibody testing performed within the past 12 months. At the time of the request the ARDP staff will request shipment of a pretransfusion sample for IgA antibody studies by the NRLBGS. f. Alternative products: Group A or group B plasma may be a necessary substitute for group O plasma for group O patients. Plasma collected from D positive donors may be a necessary substitute for D negative plasma for D negative patients. Group AB IgA-deficient plasma is usually in very short supply. g. Requests for anti-cmv sero-negative plasma will not be honored since non-cellular blood components are not known to transmit CMV infection. 5. Blood Components and Derivatives: Note: It is recognized that some IgA-deficient plasma products may contain antibodies to IgA. a. Frozen Plasma: Almost all IgA-deficient plasma available through the ARDP is Frozen Plasma, frozen within 24 hours of collection. However, because of local manufacturing policy, some plasma units may be frozen within 8 hours of collection and considered Fresh Frozen Plasma. In each case, adequate

4 amounts of labile coagulation factors can be expected to be present. Some blood centers may have collected the IgA-deficient plasma by apheresis and provide double unit volumes. In rare instances, the plasma units may not meet all FDA requirements or AABB Standards, i.e., outdated. Such units will be offered only when licensed plasma is not available. b. Red Blood Cells: IgA-deficient red blood cells can be prepared locally by routine red cell washing (3 liter wash), or the use of frozen-thawed-deglycerolized red cells. 5 For the rare circumstance when washed or frozen-thaweddeglycerolized red cells continue to elicit transfusion reactions, red cell units collected from IgAdeficient donors may be made available through the ARDP given adequate notice for donor recruitment, collection, and full processing. c. Platelet Concentrates: IgA-deficient platelets may be prepared locally by washing routinely available platelet concentrates. 6 If platelet concentrate washing capability is not available locally, or washed platelets continue to elicit transfusion reactions, apheresis single donor platelets collected from IgA-deficient donors may be made available through the ARDP, but in limited numbers. A few participating blood centers have some IgA-deficient donors in their apheresis program. However, adequate advance notice will be needed to recruit, collect, and fully process single donor platelets collected from IgA-deficient donors. d. Cryoprecipitated AHF: Generally, cryoprecipitated AHF is not available through the ARDP. Most clinical needs for IgA-deficient cryoprecipitated AHF may be managed with IgA-deficient FFP, or selected IgA-deficient derivatives. Some ARDP members have maintained small inventories of IgA-deficient cryoprecipitated AHF, but availability is not guaranteed. e. Immune Globulin (Intravenous and Intramuscular): Isoimmune gamma globulin containing only trace amounts of IgA has been made available by some manufacturers. These availabilities are subject to change. The requestor should contact the various manufacturers to determine availability, and check package inserts or Physician s Desk Reference (PDR) to determine IgA content. f. AHF Concentrate: Plasma derived AHF concentrate, generally, has small amounts of IgA. The recombinant form has albumin added. The requestor should check with the manufacturer regarding IgA content.

5 g. Human Albumin: 5% and 25% can be expected to have trace amounts of IgA. 6. References: 1. Sandler SG, Mallory D, Malamut D, and Eckrish R. IgA anaphylactic transfusion reactions. Transf Med Rev 1995;9: Flickinger C, Petrone T, and Church A. Review: american rare donor program. Immunohematol 2004;20: Vassallo RR. Review: IgA anaphylactic transfusion reactions. Part I. Laboratory diagnosis, incidence, and supply of IgA-deficient products. Immunohematol 2004;20: Sandler SG, and Zantek ND. Review: IgA anaphylactic reactions. Part II. Clinical diagnosis and bedside management. Immunohematol 2004;20: Toth CB, Kramer J, Pinter, Thek M and Szabo JE. IgA content of washed red blood cell concentrates. Vox Sang 1998;74:13-4. ( 6. Sloand EM, Fox SM, Banks SM and Klein HG. Preparation of IgAdeficient platelets. Transfusion 1990;30:322-6.