Q. Why is only male plasma used to pool the buffy coat platelets?

A. Male plasma is used to reduce the risk of TRALI. TRALI (Transfusion Related Acute Lung Injury) is an adverse reaction to blood components that has been associated with antibodies to human leukocyte antigens (HLA). These types of antibodies are most common in females who have had multiple pregnancies.

Q. What platelet products are for pediatric use?

A. A small number of whole blood random donor platelets will be available as one blood centre (Regina) will continue to process single donor units of platelets using the platelet rich plasma method of production. Each blood centre will receive a minimal stock of these platelets as needed. In addition, apheresis platelet units and buffy coat pooled platelet units may be aliquoted into smaller volumes to provide several pediatric doses.

Q. Is Mannitol safe? It is associated with renal toxicity and fluctuations in cerebral blood flow? Has it been used elsewhere?

A. Mannitol is a chemical in the red cell additive SAGM (Saline-adenine-glucose-mannitol) used in the buffy coat production method. Clinical studies comparing red cells stored in various red cell additive solutions (including those containing mannitol), have shown no apparent detrimental effects in neonates receiving simple transfusions. For preterm infants with severe hepatic or renal insufficiency, however, removing the additive-containing plasma may be beneficial, particularly for patients receiving multiple transfusions or in an exchange transfusion. Additive solutions are used to extend the shelf life of red cells to 42 days.

Q. Are the buffy coat platelets leuko-reduced and if so, where in the process does the filtration take place?

A. Yes, the pooled buffy coat platelet product is leuko-reduced by filtration. The leuko-reduction filtration occurs after the four buffy coats are pooled with the plasma from one of the four donations. This pool is spun down and the resulting platelet rich plasma is expressed into the final component bag through the leuko-reduction filter.

Q. When will these new products be seen at the hospital?

A. As the implementation of this process has already rolled out across the Province and the Country, some hospitals (particularly larger sites) may have already received some of these products. The Ottawa blood centre implemented this production method on Sept 29th, 2008. Therefore, hospitals in the North Ontario and Nunavut region have begun receiving the new products since October 1st and more so as we deplete our inventory of the pre-Buffy coat implementation products.

Q. Is the frozen plasma leuko-reduced?

A. The frozen plasma produced by the buffy coat method is not leuko-reduced by filtration however, the method itself was initially used to prepare a product that was leuko-reduced by centrifugation. Therefore, there is some reduction of leukocytes in the product. Canadian standards require both red cell products and platelet products to be leukoreduced by filtration but not plasma products.

Q. Are platelets pooled by ABO group?

A. Canadian standards states that only units of the same ABO blood group should be used in the preparation of pooled platelets. To label a platelet pool as Rh negative, all four donor units included in the pool need to test Rh negative. To label a platelet pool as CMV seronegative, all four donor units need to test as CMV seronegative. As much as possible, Canadian Blood Services will attempt to prepare as many Rh negative pools as possible however, in order to ensure inclusion of as many units as possible and reduce wasting units, it may be necessary to mix Rh and label the product as Rh positive.

Q. In the presentation, the picture showing the buffy coat pooled product shows a little bag attached to the main pool bag. What is that for? Will that be attached when the product is received at the hospital?

A. The little pouch attached to the buffy coat pool product showing on slide #12 of the presentation is the sample pouch used to collect a sample of the pooled product to be used for bacterial testing. This sample is removed from the product 24 hours after the latest collection time of the four units within the pool and is inoculated into bacterial culture bottles. The platelet pool is then available for issue to the hospital. These bacterial cultures will be incubated for 6 days at CBS. If bacterial growth is detected at any time during this incubation, the hospital will be notified as soon as possible.

Q. When the physician orders 5 units of platelets, should the laboratory just issue one dose?

A. Physicians should be encouraged to change the wording of platelet orders to ordering one adult dose of platelets.

Q. Are the coagulation factors in frozen plasma (FP) the same as those in fresh frozen plasma (FFP)?

A. Studies have shown that the levels of some coagulation factors (FVIII) are only slightly lower in FP compared to FFP. However, these products can be considered to be clinically equivalent for most indications.

Q. Can females still donate platelets?

A. Yes, Canadian Blood Services encourages donors, both females and males to donate. To try to lower the risk of TRALI though, there is emphasis to try to provide any transfusable plasma containing product, where possible, to be from male donors.

Q. If there is a blood shortage, will Canadian Blood Services have to go back to the platelet rich plasma (PRP) method of producing platelets?

A. No, once the switchover to the buffy coat production method has occurred, Canadian Blood Services (with the exception of Regina which is not changing) will no longer produce blood components using the PRP method. The change in production method required changes to equipment, supplies and procedures therefore, the PRP method will no longer be an option. The move to the new production method will result in the ability to produce platelets from whole blood donations collected farther away from the blood centre, therefore, should result in more platelets being available.

Q. Are the new Macopharma and Baxter bags used for the red cells, plasma and platelets latex free?

A. Yes.

Q. Will there be more of a delay in the provision of platelets to hospitals as a result of the pooling?

A. No, there should not be increased delay. In addition, once the platelet pool is received at the hospital, it will be ready to issue as the hospital no longer has to perform pooling.

Q. Are the blood administration sets to be used the same for the buffy coat products as for products currently transfused?

A. Yes. Blood components should be transfused through a sterile administration set containing a standard pore size 170-260 micron filter to remove any clots or other debris. These sets should be changed according to your hospital policy or the manufacturer's instructions.

Q. During the process of the buffy coat production method, is the platelet poor plasma discarded?

A. Plasma not used in the pooling of the final buffy coat product (3 of the 4 donations used for the production of the platelet pool) is not discarded. The plasma from a male donor is further processed into frozen plasma and the plasma from a female donor is shipped to a manufacturing facility in the United States to be used for the production of plasma protein products such as Albumin and Intravenous Immune Globulin.

Q. Why is Héma-Québec not a part of this implementation?

A. Héma-Québec is a separate organization from Canadian Blood Services, providing blood components and products to hospitals in the Province of Québec. As such, occasionally, they will make operational decision on priorities that may differ from Canadian Blood Services. Héma-Québec decided to implement the new labeling standard ISBT 128 as a priority. At this time, they have not announced that they will change their production method to the buffy coat method.

Q. Is the question about a history of transfusion on the record of donation because the risk of TRALI is associated with a history of previous transfusions?

A. It is true that a history of previous transfusions has been associated with a higher incidence of producing anti-HLA antibodies, however, this is not the reason this question appears on the donation questionnaire.� The question about transfusion history relates to the fact that donors who have received a blood transfusion in the past 12 months are not eligible to donate to ensure that they are fully recovered from the reason they needed this medical treatment.

Q. How much additive is in the unit of red cells/Plt and is this accounted for in the total volume of the unit?

A. A unit of SAGM Red Blood Cells, LR contains 100mL of SAG-M additive solution which is accounted for in the total volume of the unit. CPD Platelets, Pooled, LR are produced from CPD Whole Blood collections.8 No additive solution is added to both CPD Platelets, Pooled, LR and Platelets Apheresis, LR.