GUIDELINES FOR IDENTIFICATION AND INDICATION OF BLOOD COMPONENTS AND BLOOD PRODUCTS.

Transcription

1 GUIDELINES FOR IDENTIFICATION AND INDICATION OF BLOOD COMPONENTS AND BLOOD PRODUCTS. Hur sluta röka cold turkey

2 1. Policy Statement The Regional Health Authorities should develop policies that: 1.1 Provide knowledge of and proper identification of blood components and blood products that are made available in the Transfusion Medicine Laboratory. 1.2 Provide safe blood components and blood products that benefit the intended recipient. 2. Definitions 2.1 Autologus: refers to the collection of blood from an individual for the purpose of transfusion back to the individual at a later date. 2.2 Blood Component: a therapeutic component of blood intended for transfusion. 2.3 Blood Product: a therapeutic product derived from blood or plasma and produced by a manufacturing process. 2.4 Platelets: a blood component prepared by centrifugation of whole blood that consists of a suspension of platelets in plasma or an approved storage solution. 2.5 Red Blood Cells: a blood component prepared by centrifugation, sedimentation or cytapheresis of whole blood that concentrates red cells by removing most of the plasma. 2.6 Transfusion Medicine Laboratory: Hospital Blood Bank. 2.7 Whole Blood: unaltered, anticoagulated blood collected from a donor. Page 2 of 17

3 3. Quality Control 3.1 A quality process should be in place to monitor appropriate utilization of blood components and products. 3.2 Recipients of blood components and/or blood products shall be properly informed before receiving blood components and blood products. 3.3 Unequivocal identification of the recipient and the blood component and blood product shall be established throughout the transfusion. 3.4 Blood components and blood products shall be administered according to facility policy. 3.5 The Transfusion Medicine Laboratory shall refuse to process incomplete, incorrect and illegible requests for blood components and blood products. 3.6 Blood components and blood products shall not be administered beyond the expiry date without documented approval from the Transfusion Service Medical Director. 4. General Information Product inserts shall be referred to for administration details and all blood components and blood products shall be administered according to facility policy. 4.1 Whole Blood is a fluid that transports oxygen and nutrients throughout the body and takes away waste products. It increases oxygen carrying capacity and expands blood volume. Whole blood is generally not available and is only used to treat massive bleeds and for autologous and some directed donations. Most often whole blood is broken down into different blood components and then used for specific clinical indications. 4.2 The four main blood components derived from whole blood include red cells, platelets, plasma and white blood cells Page 3 of 17

4 4.3 Red blood cells transport oxygen from the tissues to the lungs to restore and maintain the oxygen carrying capacity of the human body and increase red cell mass The indication for transfusion includes decreased oxygen carrying capacity, acute blood loss, chronic anemia and perioperative management Red blood cells can be modified depending on the recipient s special requirements to include: Cytomegalovirus (CMV) Antibody Negative, Irradiated, Autologous, Phenotyped and/or Directed A typical unit of red blood cells has a volume of between ml. Red blood cells must be stored at 1-6 C in a temperature controlled refrigerator. The shelf life is 42 days unless otherwise stated and the expiration date of red blood cells is assigned by the blood supplier. Red blood cells must be ABO compatible. Rh negative recipients should receive Rh negative red cells except in special circumstances Modified red cells stored between 1-6 C have an expiry of 24 hours after preparation. Modified red cells stored between C must be transfused within 4 hours Standard blood filter tubing ( um) is required for administration of red blood cells. The transfusion of red blood cells should be initiated within 30 minutes from the time the blood is released from the Transfusion Medicine Laboratory. The recommended transfusion time is over 2 hours, unless otherwise stated but always within 4 hours of removal from a temperature controlled environment. 4.4 Platelets facilitate blood clotting at the site of injury to control or prevent bleeding. They are also significant in blood coagulation, wound healing and inflammation The indication for transfusion includes significant bleeding, deficient platelet count due to production failure and/or function and prophylactically for invasive procedures and the presence of risk factors for bleeding There are two basic types of platelet components: Pooled platelets Platelets apheresis Various types of platelet components are available depending on the recipient s special requirements which include: Irradiated, Page 4 of 17

5 Apheresis, HLA Match Apheresis, CMV antibody negative, Plasma reduced, IgA deficient and or Buffy Coat The usual platelet transfusion dose for an adult patient can be ordered as pooled platelets which usually contains four pooled units or apheresis platelets. Platelets must be stored at C under continuous gentle agitation. The shelf life of platelets is 5 days. The plasma in platelet concentrates should be ABO compatible with the recipient s red cells Standard blood filter tubing ( um) is required for administration of platelets. Platelets are usually administered by gravity as rapidly as possible. The transfusion of platelets should be initiated within 30 minutes from the time they are released from the Transfusion Medicine Laboratory. The recommended infusion time is 60 minutes per dose but always within 4hours of removal from a temperature controlled environment. 4.5 Plasma is the protein salt solution that red cells, white cells and platelets are suspended within. Plasma aids in fighting infections, maintaining blood pressure and immunity and supports clotting mechanisms Plasma is further processed into plasma components that include: Apheresis Fresh Frozen Plasma (FFPA), Frozen Plasma (FP), Cryoprecipitate and Cryosupernatant plasma FFPA is plasma collected by apheresis from the blood of an individual donor and placed at -18 C within eight hours of collection from a donor. It contains all the clotting factors necessary for hemostasis FP is plasma separated from the blood of an individual donor and placed at -18 C within twenty four hours of collection from the donor. It contains all clotting factors necessary for hemostasis but has slightly reduced Factor V and Factor VIII compared to levels in FFPA FFPA/FP is indicated for the treatment and prevention of major bleeding in patients undergoing invasive procedures that are deficient in plasma coagulation factors, as a volume replacement in massive transfusions and microvascular bleeding, and plasma exchange Page 5 of 17

6 and for the emergency reversal of warfarin therapy if the recipient is bleeding The shelf life of FFPA/FP when stored in a temperature range of -18 C or colder is 12 months. Prior to administration, FFPA/FP requires thawing and once thawed the shelf life is 24 hours for AFFP and 5 days for FP when stored between 1-6 C ABO compatibility must be confirmed with the recipient s blood type Transfuse thawed plasma immediately. Transfusion requires a standard blood filter administration set ( um). The infusion rate is as rapid as tolerated by the recipient and must be infused within 4 hours of removal from a temperature controlled environment Cryoprecipitate is a plasma component produced from frozen plasma which contains a specific amount of fibrinogen and von Willebrand s factor.it s primary function is for fibrinogen replacement Cryoprecipitate is indicated for the treatment of fibrinogen deficiency, Factor XIII supplementation and to control and prevent bleeding The shelf life of cryoprecipitate is 12 months when frozen at 18 C or colder. Once thawed, cryoprecipitate must be stored at room temperature and must be transfused within 4hours. ABO Compatibility is preferred Cryoprecipitate must be transfused using a filtered blood administration set ( microns). It can be infused as rapidly as tolerated by the recipient and within 4 hours of removal from a temperature controlled environment Cryosupernatant is plasma from which the cold insoluble precipitate has been removed Cryosupernatant plasma is indicated for the treatment of thrombotic thrombocytopenic Page 6 of 17

7 purpura (TTP) and haemolytic uremic syndrome as a plasma exchange agent The shelf life is 12 months when frozen at - 18 C. Once thawed it can be stored between 1-6 C for 24 hours or as per manufacturer. Cryosupernatant must be ABO compatible Transfusion requires a standard blood filter administration set ( um). The infusion rate is as rapid as tolerated by the recipient and must be infused within 4 hours of removal from a temperature controlled environment Plasma is processed into fractionated plasma protein products prepared from large pools of human plasma under manufacturing conditions and include: albumin, immune globulin, coagulation factors and prothrombin complex concentrates Albumin is a plasma protein that is used as a volume replacement solution for volume expansion Albumin is available in two concentrations: 5 %, which is isosmotic with plasma and used primarily for volume deficit and 25 % which is hyperoncotic and primarily used to restore and maintain blood volume in the presence of oncotic deficiency Albumin is indicated in the treatment of hypovolemic and hyproteinemic conditions including nonhemorrhagic shock, severe necrotizing pancreatitis, extensive burns, large volume paracentesis, plasma exchange and diarrhea. The choice of Albumin 5 % or 25 % is dependent on the clinical situation of the recipient, whether or not the recipient requires a higher colloid osmotic activity and/or therapeutic guidelines and recommendations Albumin 5 % and 25 % shall be stored at room temperature not exceeding 30 C and has a shelf life of between 2-5 years depending on the manufacturing process, with the expiry date being stated on the package. Once opened the albumin should be infused within 4 hours. Page 7 of 17

8 The infusion rate is adjusted according to recipient requirements, assessment and status and should not exceed 5ml/minute for 5 % albumin and 1-2 mls/minute when administering 25 % albumin. Albumin is administered intravenously and need not be administered via a filtered administration set Immmue Globulin is plasma that contains IgG antibodies. It is indicated in the treatment of individuals with antibody deficiency and certain infectious diseases, to prevent specific antibody production, inhibit inflammation and provide temporary immunity following exposure to an infection. The most common types of Immune Globulin are Rh (D) Immune Globulin (WinRho SDF), Hepatitis B Immune Globulin, Intravenous Immune Globulin (IVIG) and Subcutaneous Immune Globulin (SCIG) Rh (R) Immune Globulin (WinRho SDF) is human plasma that contains antibodies to the D antigen on red blood cells WinRho SDF prevents the development of Rh antibodies in Rh negative individuals when they have been stimulated by Rh positive cells. WinRho SDF is indicated for Rh negative mothers during pregnancy, after any obstetric event that might allow fetal cells to enter the mother s circulation and post-natally to prevent the development of anti-d and haemolytic disease of the newborn. It is also used in the treating Rh negative individuals who receive Rh positive blood and blood components and immune thrombocytopenia purpura (ITP) WinRho SDF is available in two forms, lypophilized or liquid form and should be stored at 2-8 C. The lypophilized form must be reconstituted as per product monograph. Once reconstituted, if not used immediately it can be stored at room temperature for 4 hours. Page 8 of 17

9 WinRho SDF is available in 600 IU, 1500 IU and 5000 IU vials of anti-d. WinRho SDF can be administered intramuscular (IM) or intravenously (IV). WinRho SDF must be administered intravenously for the treatment of ITP. WinRho SDF should be administered to Rh negative females within 72 hours after the delivery of a baby who is Rh positive or unknown Rh and any obstetric event that potentially exposes the Rh negative mother to the Rh positive antigen. Between weeks gestation all Rh-negative mothers should receive WinRho SDF, unless they have pre-existing immune anti- D and/or the father is of known Rh negative Status. Once reconstituted WinRho SDF must be administered within 4 hours Hepatitis B Immune Globulin (HBIG) contains antibodies to the Hepatitis B virus (HBV) which provide a passive immunization for the Hepatitis B Virus (HBV) HBIG is indicated as a prophylactic treatment for individuals who are exposed to the Hepatitis B surface antigen (HBsAG), infants born to mothers who are positive for the HBsAg and the prevention of hepatitis B following liver transplantation HBIG is available in liquid formulation in a 0.5 ml syringe and 1 and 5 ml dose vials. It is stored under refrigeration at 2-8 C. It is not to be used after the expiration date indicated on the label HBIG can be administered intramuscularly or intravenously depending on the product. Both HyperHep B S/D and HepaGam B can be administered via intramuscular injection. HepaGam B should only be administered intravenously for the liver transplantation indication.consult the product insert or monograph for dosing information. Page 9 of 17

10 Intravenous Immune Globulin (IVIG) contains a broad spectrum of IgG antibodies used to fight off infectious agents, such as viruses and bacteria. IVIG is available as different immune globulin intravenous products IVIG labelled indications include: Primary Immune Deficiency Syndromes, Allogeneic Bone Marrow Transplantation, Pediatric HIV Infection, Chronic Inflammatory Demyelinating Polyneuropathy, idiopathic Thrombocytopenic Purpura, B-Cell Chronic Lymphocytic Leukemia IVIG is available in 2.5g, 5g, 10g, 20g and 30g sizes. Storage varies depending on the product. Do not use the IVIG product after the expiry date, as indicated on the product label and carton. Dosing is dependent on the recipient s weight and clinical indication Subcutaneous Immune Globulin (SCIG) is used as an antibody replacement therapy. SCIG is available as different immune globulin subcutaneous products SCIG is indicated in the treatment of adults and pediatric persons with primary immune deficiencies including: Congenital Agammaglobulinaemia and Hypogammaglobulinaemia, Common Variable Immunodeficiency, X-linked Immunodeficiency, Severe Combined Immunodeficiency and Wiskott Aldrich Syndrome. Gamunex and IGIVnex are also indicated for Secondary Immune Deficiency Syndromes SCIG can be stored in a refrigerator at 2 to 8 C for 36 months. SCIG can also be stored at room temperature for 5 months, expiring 5 months from the date of removal from refrigeration or the original expiry date on the product which ever comes first. It is stable for the period indicated by the expiration date on the label. It is administered at room temperature C by Page 10 of 17

11 subcutaneous injection and can be administered via a pump or rapid push method Factor concentrates are clotting concentrates that affect hemostasis by correcting the underlying clotting defect Factor rviia contains recombinant coagulation factor VIIa. It is indicated in the prevention and treatment of a wide range of bleeding episodes. It is used in the treatment of patients with hemophilia A and B who have developed inhibitors to FVIII or FIX Factor rviia is available as NiaStase and NiaStaseRT in various sizes of single use vials and requires reconstitution as per the product monograph Prior to reconstitution NiaStase RT should be stored between 2 to 30 C and NiaStase should be stored under refrigeration between 2 to 8 C. Both products require protection from light and should not be frozen. After reconstitution only NiaStase RT can be stored at room temperature or refrigerated for up to three hours. Neither product should be stored in a syringe or used after the expiration date It is administered by intravenous bolus only and should be administered immediately after the start of a bleeding episode if possible. The initial recommended dose is 90 µg/kg for bleeding episodes and surgery. The dosage and duration may vary depending on the severity of bleeding, procedure or surgery Factor VIII/vWF is prepared from human plasma. Factor VIII/vWF is available as Humate-P and wilate. Humate-P is indicated for the treatment of hemophilia A and bleeding episodes in von Willebrand disease, whereas wilate is indicated for the treatment and prophylactically with hemophilia A and in the prevention and treatment of bleeding in minor surgical procedures Humate-P and wilate is available in various size single use vials and should be reconstituted Page 11 of 17

12 as per product monograph. Humate-P should be stored at room temperature up to 25 C for the period indicated by the expiry date on the product label. Wilate should be stored at 2-8 C for the period indicated by the expiry date on the product label or stored at room temperature up to 25 C for 6 months at which time it must be used or discarded FVIII/vWF products should be administered via intravenous infusion. Humate-P should be administered within 3 hours after reconstitution and wilate should be administered immediately after reconstitution. The treatment schedule and dosage (IU/Kg) vary depending on the type of bleeding and severity of factor deficiency Recombinant Factor VIII (rfviii) is available as several products; Helixate FS and Kogenate FS are manufactured by recombinant DNA technology, Advate is synthesized by genetically engineered Chinese hamster ovary cell line and these products do not contain human albumin. It is indicated for the treatment of hemophilia A, Factor VIII deficiency, bleeding in patients with inhibitors to FVIII and prophylactically to prevent the occurrence of spontaneous hemorrhagic episodes Recombinant Factor VIII are available in 250, 500, 1000, 2000 and 3000 IU vials and should be stored under refrigeration between 2 to 8 C until expiry as indicated on the product label. Helixate FS and Kogenate FS can be stored at room temperature up to 25 C for 12 months, once removed from refrigeration the expiry date will be 12 months or the expiry date on the product label, whichever is shorter. Advate can be stored at room temperature up to 28 C for 6 months not exceeding the expiry date on the product label The product should be reconstituted as per the product monograph. Recombinant Factor VIII can be administered via intravenous bolus in a Page 12 of 17

13 median of 5-10 minutes and must be administered within 3 hours after reconstitution or as a continuous intravenous infusion according to the product monograph. The treatment schedule and dosage vary depending on the type of bleeding and severity of factor deficiency Factor IX is available as several products; Immunine is a human plasma protein FIX product and BeneFIX is a recombinant FIX (rfix), which does not contain human protein It is indicated for the treatment of hemophilia B and factor IX deficiency. Factor IX is available in various size vials and should be stored under refrigeration between 2 to 8 C until expiry as indicated on the product label Reconstitute factor IX products as per the product monograph. Administer intravenously after reconstitution. The treatment schedule and dosage (IU/Kg) vary depending on the type of bleeding and severity Factor XIII is a blood coagulation factor that is derived from human plasma. It is available as Fibrogammin P through the special access program at Health Canada. It is indicated for deficiency of factor XIII, haemorrhagic diathesis, haemorrhages and in wound healing Fibrogammin P is available in 250 and 1250 IU vials. It should be stored at 2-8 C until expiry as indicated on the label of the product The product should be reconstituted as per the package insert. Once reconstituted fibrogammin P should be administered immediately, it is stable for 8 hours from the time of reconstitution if stored at 2-8 C The dose IU/ Kg and frequency of fibrogammin P are individual and depend on the clinical indication. It should be administered at room temperature, intravenously and should Page 13 of 17

14 not be infused at a rate greater than 4 ml per minute Prothrombin Complex Concentrates (PCC) are prepared from human plasma and contain Vitamin K dependent factors and anticoagulant factors to varying degrees. PCC are available as two products; octaplex and Beriplex P/N. PCC are indicated for rapid correction of prothrombin complex levels in major bleeding or emergency surgery PCC are available in 500 IU vials. They must be stored at room temperature at +2 to +25 C until expiry as indicated on the label The dose is dependent on the patient s International Normalized Ratio (INR) and facility therapeutic guidelines. PCC should be reconstituted as per the package insert. It must be administered intravenously under the supervision of qualified health professionals experienced in the use of anticoagulation agents and the management of coagulation disorders. The recommended maximal infusion rates according to the manufacture is 3 ml/min for octaplex and 8 ml/min for Beriplex. 4.6 White blood cells (granulocytes, macrophages and lymphocytes) protect against viruses and bacteria that cause infection Neupogen is a human granulocyte colony-stimulating factor (GCSF) manufactured by recombinant DNA Technology. The indication for white blood cell components, such GCSF includes neutropenia, infection for hours, insufficient marrow function and/or lack of responsiveness to appropriate antibiotics Neupogen is available in 300 mcg and 480 mcg single dose vials or prefilled syringes. It should be stored at 2-8 C. If left at room temperature for 24 hours or greater neupogen should be discarded Neupogen should be administered at room temperature intravenously or subcutaneously. Page 14 of 17

15 5. References 5.1 Baxter Corporation. Advate Product Monograph. Mississauga (ON): Baxter Corporation; Available from: Baxter Corporation. Immunine VH Product Monograph. Toronto (ON): Baxter Corporation; Available from: Baxter Corporation. Kogenate FS product Monograph. Toronto (ON): Baxter Corporation; Available from: Brecher, M. Technical manual. 15thed. Bethesda, Maryland: AABB; Callum JL, Pinkerton PH. Blood easy 2, blood transfusion, blood alternatives and transfusion reactions, a guide to transfusion medicine. 2 nd ed. Toronto (ON): Sunnybrook and Women s College Health Sciences Centre; Canadian Blood Services. Canadian blood services circular of information for the use of human blood components, red blood cells, leukocytes reduced (LR). Ottawa (ON): Canadian Blood Services; Canadian Blood Services. Canadian blood services circular of information for the use of human blood components, platelets. Ottawa (ON): Canadian Blood Services; Canadian Blood Services.Canadian standards services circular of information for the use of human blood components, plasma components. Ottawa (ON): Canadian Blood Services; Canadian Blood Services. FVIII/ vwf Products Comparison Table; Available from: PlasmaProducts 5.10 Canadian Blood Services. Plasma Protein Products Customer Table of Information; Available from: PlasmaProducts. Page 15 of 17

16 5.11 Canadian Society for Transfusion Medicine. CSTM standards for hospital transfusion services. Version 3. Ottawa: Canadian Society for Transfusion Medicine; Canadian Standards Association. Blood and blood components, Z Mississauga (ON): Canadian Standards Association; Cangene Corporation. WinRho SDF Product Monograph. Winnipeg (MB): Cangene Corporation; Available from Cangene Corporation. HepaGam B Product Monograph. Winnipeg (MB): Cangene Corporation; Available from Clarke G, Blajchman M. Clinical guide to transfusion. 4 th ed. Toronto (ON): Canadian Blood Services; CSL Behring Canada Inc. Beriplex P/N Product Monograph. Ottawa (ON): CSL Behring; Available from: CSL Behring Canada Inc. Fibrogammin P Company Core Data Sheet. Ottawa (ON): CSL Behring; Available from: CSL Behring Canada Inc. Helixate FS Product Monograph. Ottawa (ON): CSL Behring; Available from: CSL Behring Canada Inc. Humate-P Product Monograph. Ottawa (ON): CSL Behring; Available from: Manitoba Provincial Blood Programs Coordinating Office. Manitoba transfusion medicine best practice resource manual for nursing. Version 1.Winnipeg (MB): Manitoba Provincial Blood Programs Coordinating Office; June Mintz, P. Transfusion therapy, clinical principles and practice. 3 rd ed. Bethesda, Maryland: AABB Press; Novo Nordisk Canada Inc. NiaStase Product Monograph. Mississauga (ON). Novo Nordisk Canada Inc.; Available from: Novo Nordisk Canada Inc. NiaStase RT Product Monograph. Mississauga (ON). Novo Nordisk Canada Inc.; Available from: Page 16 of 17

17 5.24 Octapharma Canada, Inc. octaplex Product Monogragh.. Scarborough (ON). Octapharma Canada Inc.; Available from: Octapharma Canada, Inc. wilate Product Monograph. Scarborough (ON). Octapharma Canada Inc.; Available from: Pfizer Canada Inc. BeneFIX Product Monograph. Kirkland (Quebec). Pfizer Canada Inc.; Available from: Talecris Biotherapeutics Ltd. Albumin 25 % Solution,USP Product Monograph. Mississauga (ON). Talecris Biotherapeutics Ltd; Available from: Talecris Biotherapeutics Ltd. HyperHep B S/D Product Monograph. Mississauga (ON). Talecris Biotherapeutics Ltd; Available from: Talecris Biotherapeutics Ltd. Plasbumin -5 Product Monograph. Mississauga (ON). Talecris Biotherapeutics Ltd; Available from: Transfusion Ontario Program. About blood transfusion, information for nurses and other health care professionals. 2 nd ed. Ontario: Transfusion Ontario Program; Triulzi, D. Blood transfusion therapy, a physician s handbook. 8 th ed. Bethesda, Maryland: AABB; Page 17 of 17