UKMC TRANSFUSION SERVICE PRODUCTS AND AVAILABILITY

Lexington, KY Page 1 of 13 Affected Sites: Enterprise X Chandler Good Samaritan I. PRINCIPLE: The University of Kentucky Hospital is dedicated to serve the patients with safe, high quality blood products and related laboratory services while meeting changing healthcare needs. II. INDICATIONS: Proper selection of blood components and derivatives is indicated by the patient s blood type, age and gender of the patient, urgency of the situation, and special product requirements as deemed necessary for certain patient populations. III. QUALITY ASSURANCE: All patient specimens shall be tested for ABO/Rh type and clinically significant antibodies. All donor red cell products are retyped to confirm ABO; and Rh typing is performed on donor red cell products labeled Rh negative. Red cell products are crossmatched to confirm compatibility. Plasma products are selected by ABO group and given when donor plasma is compatible with recipient red cells. Special transfusion requirements for select patient groups are added to the patient s Blood Bank history as attributes, e.g. LEUKRD, CMVNG,HLAPLT, IRRD, etc. and QA system checks are in place to prevent issue and transfusion of inappropriate products. IV. SPECIMENS: Patient specimens Donor segments V. SERVICES: ABO Group/Rh Type Antibody Screen

Lexington, KY Page 2 of 13 Type and Screen (ABO/Rh and Antibody Screen) Antibody Identification Compatibility Testing (Crossmatch) Antibody Titration Cord Blood Testing Direct Antiglobulin Test (DAT) Fetal Screen (Qualitative Screen for Fetal Rh Positive RBCs in Rh Negative Mother) RBC Phenotype (Red Cell Antigen Type) Rh Phenotype Rh Immune Globulin Testing/Evaluation Transfusion Reaction Investigation VI. RECORDS, FORMS: Blood Bank Requisition Blood Bank Transfusion Record VII. BLOOD COMPONENTS/DERIVATIVES: Red Blood Cells (RBC) Autologous Donations Directed Donations (Designated donation) Frozen, deglycerolized RBC Washed RBC Fresh Frozen Plasma (FFP) Fresh Frozen Plasma, Cryoprecipitate Reduced (Cryopoor plasma) Cryoprecipitate Single Donor Platelets by Apheresis Single Donor Platelets by Apheresis, volume reduced Granulocytes by Apheresis Rh Immune Globulin (RhIG) Leukoreduced Cellular Blood Components CMV Reduced Risk Cellular Blood Components Irradiated Cellular Blood Components Hemoglobin S Negative RBC

Lexington, KY Page 3 of 13 VIII. POLICY GUIDELINES: A. EXPECTED TURN AROUND TIME: Turn around time for services are from the time the blood sample or order (in the case that no sample is used for testing) is received in the Blood Bank. STAT: 1 hour Routine: 6 hours If stat and routine do not meet your needs, under the Special Instructions field of the Blood Bank Requisition in SCM you can place a time and date when the blood is needed within 3 days from the time the T&S specimen was drawn. Antibody ID: 3 days if complex Irradiation of cellular blood products takes approximately 30 minutes. Thawing of FFP and cryoprecipitate will take up to one hour. Washed RBC, deglycerolized RBC, RBC specially prepared for exchange transfusion, are processes performed at the Kentucky Blood Center and will take about 6 hours from the time of the order. Expected TAT for other special blood components, to include delivery times, will be communicated to the patient caregiver as with any delay or substitution in service. The Medical Director of the Blood Bank may be involved in this process. B. DESCRIPTION OF BLOOD COMPONENTS: 1. RED BLOOD CELLS: Preparation from Whole Blood: Red blood cells (RBC) are the component remaining after the plasma is removed from a unit of whole blood and replaced with red cell additive solution. Approximate volume: 300 ml Pretransfusion Testing: Red cell components must be crossmatched and must be ABO and Rh compatible (not necessarily identical) with the patient s blood type. For example, group O can be given to all ABO blood types (universal donor). Note: A specimen for a Type and Screen may be used to crossmatch blood from day 0 (day drawn) through midnight of day 3.

Lexington, KY Page 4 of 13 Major Indications: Symptomatic anemia (Hgb < 7g/dL resulting in mental status changes, new arrhythmia, EKG ST changes, angina, SOB with mild exertion, and tachycardia [not from hypovolemia] ). Action/Recipient Benefit: Increases oxygen-carrying capacity Not Indicated For: Pharmacologically treatable anemia; coagulation deficiency; volume expansion Rate of Infusion: As fast as patient can tolerate, but less than 4 hours Autologous Blood Donations/Transfusions For selected surgical procedures, some patients may donate their own blood prior to surgery and have it on reserve in the event transfusion may be needed. However, the additional costs associated with the collection of autologous units, along with the advancements in the safety of allogeneic blood, have altered the cost-effectiveness of preoperative autologous donations in low risk patients. The studies show 80% of patients undergoing orthopedic procedures were identified to be a low risk (<10%) for transfusion, so autologous blood would not be recommended. In addition, about 50-90% of autologous units collected for surgical procedures are unused and wasted. As with allogeneic blood, transfusion of preoperatively donated autologous blood carries the same risks associated with administrative errors or bacterial contamination. If preoperative autologous donation is necessary, the procedure requires the written order of the patient s attending physician or surgeon. Patients may donate their blood at Kentucky Blood Center. Make an appointment at the blood center by calling 859-276-2534 ext. 3714. The patient s physician must write a prescription for the number of red cell units needed and the anticipated date of surgery. Directed/Designated Donations/Transfusions Patients may wish to receive blood transfusions from individuals they select to donate specifically for them. The donor must be ABO/Rh compatible with the patient. The donated blood will not be available for transfusion until at least 48 hours after the time of donation. This procedure requires a written order from the patient s attending physician or surgeon. Call the Kentucky Blood Center to make an appointment 859-276-2534 ext. 3714. The patient s physician must write a prescription for the number of red cell units needed, the patient s name, the hospital, and the anticipated date of surgery.

Lexington, KY Page 5 of 13 NOTE: Units not transfused to the intended patient will be released to the general blood supply seven days after the intended day of use, unless the Blood Bank is otherwise notified to hold the unit(s). Frozen, Deglycerolized Washed RBC These RBC units are available for patients who have formed alloantibodies against very common red cell antigens. Rare donor red cells are stored frozen for this need. Preparation requires up to 6 hours for 2 units. These units expire after 24 hours and are usually not suitable for massive transfusion. In complex cases it may take several days for such RBC to be found and shipped here from another blood center for patient s use. Frozen, deglycerolized washed RBC may also be used to supplement liquid RBC during inadvertent surge periods of use. This product does not meet the definition of a leukoreduced blood product (< 5 x 10 6 white blood cells) Washed RBC Saline-washed RBCs are units of whole blood or RBCs that have been washed with at least 1 liter of saline manually or in an automated cell washer. These units have a hematocrit of 70% and have been depleted of 99% of the plasma proteins and 85% of the leukocytes. This product does not meet the definition of a leukoreduced blood product (< 5 x 10 6 white blood cells). RBC metabolites, cytokines that cause febrile reactions, and proteins that cause allergic and anaphylactic reactions are almost entirely removed. This product may be used in patients with antibodies to IgA or IgE immunoglobulins. Saline washed RBCs must be used within 24 hours after washing because of the potential for bacterial contamination. 2. FRESH FROZEN PLASMA (FFP) Preparation from Whole Blood: Fresh frozen plasma is prepared by separating the plasma from a unit of freshly drawn whole blood within eight hours and freezing it at -18 C. Approximate volume: 200 ml. Pretransfusion Testing: FFP may be given without a crossmatch and should be ABO compatible (not necessarily identical) with the recipient s red cells. The Fresh Frozen Plasma is thawed and prepared just before the time of scheduled transfusion. Note: Approximate thaw and preparation time is 1 hour. The thawed Fresh Frozen Plasma should be transfused within 4 hours of thawing but no more than 24 hours

Lexington, KY Page 6 of 13 after being thawed. Five day, thawed plasma, is immediately available for issue for most situations where FFP might be used. Major Indications: Congenital and Acquired Factor deficiencies, Liver disease, Warfarin therapy, exchange transfusion for TTP, and for INR 1.5. Action/Recipient Benefit: Source of the deficient or defective plasma proteins Not Indicated For: Volume replacement. Coagulopathy that can be more effectively treated with specific factor concentrate therapy. Rate of Infusion: As fast as patient can tolerate, but less than 4 hours 3. FRESH FROZEN PLASMA, CRYOPRECIPITATE REDUCED (Cryopoor Plasma) Preparation from FFP: Cryoprecipitate Reduced Plasma is prepared from FFP by thawing and centrifugation to remove the cryoprecipitate, yielding plasma that is deficient in Factor VIII, von Willebrand factor (vwf), fibrinogen, cryoglobulin, and fibronectin. The high molecular forms of vwf are removed. Pretransfusion Testing: It may be given without a crossmatch and should be ABO compatible (not necessarily identical) with recipient s red cells. The Cryoprecipitate Reduced Plasma is thawed and prepared just before the time of scheduled transfusion. Note: Approximate thaw and preparation time is 1 hour. The thawed Cryoprecipitate Reduced Plasma should be transfused within 4 hours of thawing, but no more than 24 hours after being thawed. Major Indications: TTP refractory to FFP Action/Recipient Benefit: May be used for provision of clotting factors except fibrinogen, Factor VIII and vwf. Not Indicated For: Volume replacement. Coagulopathy that can be more effectively treated with specific factor concentrate therapy. For provision of fibrinogen, Factor VIII or vwf. Rate of Infusion: As fast as patient can tolerate, but less than 4 hours 4. CRYOPRECIPITATED AHF (CRYO) Preparation from Plasma:

Lexington, KY Page 7 of 13 Cryoprecipitate is the cold insoluble portion of plasma that precipitates after fresh frozen plasma has been thawed between 1-6 C. Approximate volume is 15 ml. When ordered for transfusion, the Cryo is thawed at 30-37 C. Pretransfusion Testing: Cryoprecipitate is transfused without a crossmatch and all ABO groups are acceptable for adults. Cryoprecipitate for neonates should be ABO compatible with the recipient s red cells. The Cryoprecipitate is thawed and prepared just before the time of the scheduled transfusion. The usual dose for an adult patient is a 10 unit pool of individual cryoprecipitate. Note: Approximate thaw and preparation time is 1 hour. The thawed Cryoprecipitate should be transfused within 4 hours of pooling, but no more than 6 hours after being thawed. Major Indications: Hypofibrinogenemia (fibrinogen < 100mg/dL); bleeding or invasive procedures in patients with uremia and prolonged bleeding time; second line of therapy for von Willebrand s disease; Factor XIII deficiency, and replacement of fibronectin in burn patients. Action/Recipient Benefit: Provides fibrinogen, Factor VIII, vwf, Factor XIII, and fibronectin. Not Indicated For: Volume replacement. Coagulopathy that can be more effectively treated with specific factor concentrate therapy. Deficiency of any plasma protein other than those enriched in Cryoprecipitated AHF. Rate of Infusion: As fast as patient can tolerate, but less than 4 hours. 5. SINGLE DONOR PLATELETS BY APHERESIS Collection from Single Donor: Platelets collected by apheresis to contain at least 3 x 10 11 platelets. The apheresis collection process involves collecting whole blood into an apparatus, while platelets are extracted, and all other components are returned to the donor. Note: A single donor apheresis platelet product is equivalent to 4-6 platelet concentrates with the added advantages of reduced donor exposure and leukoreduction. Pretransfusion Testing: Platelet may be given without crossmatch. All ABO groups are acceptable, although ABO-identical platelets are preferred; components compatible with the recipient s red cells are recommended. Requests should be made at least 4 hours in advance for same day transfusion to assure platelet availability. Platelet transfusions should be monitored by both a pre-transfusion platelet count (within 24 hours) and by post-transfusion platelet counts at 1 hour and 24 hours.

Lexington, KY Page 8 of 13 Major Indications: Bleeding from thrombocytopenia or platelet function abnormality. Action/Recipient Benefit: Improves hemostasis Not Indicated For: Plasma coagulation deficits. Some conditions with rapid platelet destruction (e.g. ITP, TTP) unless life threatening hemorrhage Rate of Infusion: As fast as patient can tolerate, but less than 4 hours Single Donor Platelets, Volume Reduced This product can be used for neonates, children, and for those adult patients with heart failure. 6. PLATELET CONCENTRATE (WHOLE BLOOD DERIVED PLATELETS, RANDOM DONOR PLATELETS) Preparation from Whole Blood: (only available as a pooled product from 4-6 donors and leukoreduced by Acrodose System). A unit of platelets is a concentrate of platelets separated from a single unit of whole blood and suspended in approximately 50 ml of the original plasma. One unit of platelets should contain at least 5.5 x 10 10 platelets. One unit is expected to increase the count of a 70 kg adult by 5-10,000/µL and in an 18 kg child by 20,000/µL. The usual dose in an adult patient is a 6 unit pool of platelet concentrate. Pretransfusion Testing Platelets may be given without a crossmatch. All ABO groups are acceptable, although ABO-identical platelets are preferred; components compatible with the recipient s red cells are recommended. Random platelets are no longer available at UK, however, whole blood derived platelets utilizing the Acrodose platelet system is available upon request. These platelets are pooled, leukoreduced, and culture-base tested for bacteria. Requests should be made at least 1-2 days in advance to assure platelet availability. Platelet transfusions should be monitored by both pre-transfusion platelet count (within 24 hours) and a post-transfusion platelet count at 1 hour and 24 hours. Major Indications: Bleeding from thrombocytopenia or platelet function abnormality. Action/Recipient Benefit: Improves hemostasis Not Indicated For: plasma coagulation deficits. Some conditions with rapid platelet destruction (e.g.itp, TTP) unless life threatening hemorrhage. Those patients requiring leukoreduced platelets. Rate of Infusion: As fast as patient can tolerate, but less than 4 hours.

Lexington, KY Page 9 of 13 7. GRANULOCYTES BY APHERESIS Preparation by apheresis. The donor is given G-CSF and/or steroids usually the day before collection. Hetastarch, a RBC sedimenting agent, is used during the collection process. Pretransfusion Testing: Granulocytes should be given ABO/Rh compatible and a RBC crossmatch must be performed due to the significant RBC content of the product. Major Indications: Severe neutropenia associated with infection that has failed antibiotic therapy, and recovery of bone marrow is expected. Granulocytes are transfused daily until the patient's infection clears or until the neutrophil count exceeds 500/µl. Granulocyte preparations contain viable lymphocytes, and graft versus host disease (GVHD) can occur, so irradiation is performed to prevent GVHD in severely immunocompromised patients. Granulocyte recovery and survival are adversely affected by as little as 8-24 hours storage. Therefore, granulocytes are administered immediately after collection. If this is not possible, the cells are stored at room temperature, without agitation, for no more than 24 hours. Leukocyte reduction filters cannot be used when transfusing granulocytes. If CMV is a consideration, a CMV negative donor will be provided. 8. RH IMMUNE GLOBULIN RhIG is a concentrate of IgG anti-d administered to Rh Negative individuals to counteract the immunizing effects of Rh(D) positive red cells. A full dose of anti-d (300ug or 1500IU) is sufficient for exposure to 15mL of red cells or 30mL of whole blood. ACOG recommends antepartum RhIG prophylaxis at 28 weeks of gestation and within 72 hours of delivery. The half-life of an injected dose of RhIG, in the absence of significant fetal-maternal hemorrhage, is approximately 21 days. Postpartum dose evaluation should be performed on a blood sample drawn from the mother within 1 hour after delivery and evaluated for fetal-maternal hemorrhage to determine if more than one vial of RhIG are necessary. Major Indications: Obstetrical: Indicated in Rh Negative women not alloimmunized to Rh(D) at 28 weeks, post-partum (if infant is Rh Positive or undetermined), termination of pregnancy, ectopic pregnancy, amniocentesis, percutaneous umbilical blood sampling (PUBS), chorionic villus sampling, and other obstetrical complications e.g. abdominal trauma, abruptio placenta, placenta previa, threatened abortion, or death in utero.

Lexington, KY Page 10 of 13 Action/Recipient Benefit: Prevent alloimmunization to Rh(D) and Hemolytic Disease of the Newborn Not Indicated For: Individuals already alloimmunized to Rh(D), Rh Negative women of Rh Negative fetuses/infants, and individuals receiving massive transfusion of Rh Positive red cells. Rate of Infusion: RhIG found in 2 formulations: 1) for intramuscular (IM) injection only and 2) for intravenous (IV) administration. 9. LEUKOREDUCED CELLULAR BLOOD COMPONENTS (RBCS AND PLATELET PRODUCTS) Preparation: Leukocyte-reduced blood components are prepared by filtering with special leukocyte filters that remove white cells to < 5 x10 6 leukocytes. Filtration may be achieved either 1) soon after collection (prestorage) or 2) at the bedside (post-storage). Pre-storage leukocyte reduced blood products are available from the blood supplier. Leukoreduction filters are dispensed from the blood bank accompanying the blood component for bedside filtration (post-storage). Note: Post-storage leukoreduction is not as effective or efficient as pre-storage leukoreduction performed at the blood center. Leukoreduction is indicated for: the prevention of HLA alloimmunization in chronically transfused patients (e.g. Hem/Onc patients) and transplant patients (organ and BMT) the prevention of recurrent febrile nonhemolytic transfusion reactions (in patients with 2 or more documented febrile reactions). to provide CMV reduced risk blood products. Sometimes CMV seronegative units are used in combination with leukoerduction for severely immunosuppressed patients. reduction of transfusion associated immune modulation (TRIM), which is associated with increased infections after blood transfusions. NOT indicated for: Prevention of transfusion associated graft versus host disease (see Irradiate Blood Products guideline) Prevention of transmission of infectious agents other than CMV, e.g. HTLV- I/II, vcjd

Lexington, KY Page 11 of 13 C. SPECIAL TRANSFUSION REQUIREMENTS: 1. CMV REDUCED RISK CELLULAR BLOOD COMPONENTS CMV is a concern only in cellular blood products, all of which contain white blood cells. Therefore FFP and cryoprecipitate regardless of the CMV status are acceptable. Cellular blood products leukoreduced to levels less than 5x10 6 white cells/product are generally considered equivalent to units tested serologically as CMV (-). Providing cellular products in which testing is negative for CMV or that are leukoreduced are referred to as CMV reduced risk because even if both are done, there are failures. Therefore the term CMV safe is no longer used. CMVreduced risk blood components are indicated for: Cases where the CMV antibody status of the patient is unknown or untested and where primary infection of CMV is considered to be potentially debilitating or fatal. Premature sick neonates < 1200 grams; all NICU patients Patients being prepared for organ transplant and support post-transplant All intrauterine transfusions NOT indicated for: Seropositive immunocompromised patients Infants of seropositive mothers Seronegative recipients of BMT from seropositive donors 2. IRRADIATED CELLULAR BLOOD COMPONENTS Irradiation of blood components to prevent proliferation of viable transfused T- lymphocytes is accomplished by utilizing a minimum of 25Gy (2500 rads) dose of gamma radiation to the blood product. Because irradiation damages red cells and reduces the overall viability, the red cell product s expiration is 28 days from the date of irradiation or the original assigned outdate, whichever comes first. Irradiation is indicated for: patients at risk from transfusion associated GVHD fetuses receiving intrauterine or exchange transfusions

Lexington, KY Page 12 of 13 Hodgkins Lymphoma and other hematologic malignancies Some cell mediated immunodeficiencies Immunocompromised marrow or stem cell recipients Directed Donations: recipients of donor units from blood relatives Patients receiving cellular blood products while undergoing peripheral blood stem cell harvest HLA matched platelets NOT indicated for: HIV patients Malignant solid tumors Solid organ transplant recipients or potential recipients Surgical patients requiring transfusions Patients with hemoglobinopathies, hemophilia, thrombophilia Other acute or chronic anemias requiring transfusion support NOTE: FFP, cryoprecipitate, and coagulation factor concentrates do not need irradiation 3. HEMOGLOBIN S NEGATIVE RED CELLS Screening of donor blood for Sickle Cell will identify those with Sickle Trait of value to sick premature neonates and Sickle Cell disease patients. Hgb S Negative units are indicated for: Patients known to have sickle cell disease requiring red cell transfusions Neonatal ICU patients at risk for hypoxia Pediatric patients requiring red cell exchanges Patients on ECMO NOT indicated for: Transfusions to the general population

Lexington, KY Page 13 of 13 HISTORY BLOCK: Replaces: Changes- Significant: Changes- Minor: BB053.00 UKMC Transfusion Service Products and Availability None Changed to Lab Policy Enterprise format Added Acrodose System platelets as additional platelet product APPROVAL BLOCK: Written by: Leonard I. Boral Date: July 9, 2010 Revised by: Julie O Brien Date: June 20, 2013 Approved by: Date: Medical Director Approved by: Date: Chief Med Tech Approved by: Date: QA Coordinator Medical Director: Annual Review Date: Date version removed from manual: Date procedure retired: Approved by: CLIA Designated Director Date: