TITLE CLIN_092 ADMINISTRATION OF BLOOD AND BLOOD COMPONENTS

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1 Policies and procedures are guidelines and are not a substitute for the exercise of individual judgment. If you are reading a printed copy of this policy, make sure it is the most current by checking the on-line version TITLE CLIN_092 ADMINISTRATION OF BLOOD AND BLOOD COMPONENTS APPLICABILITY EDWARD HOSPITAL POLICY STATEMENT(S) To outline a process to safely obtain and administer blood and blood components in accordance with applicable regulatory standards. DEFINITION(S) ATX Number a unique number (4 numbers and one letter) assigned to each patient who may require blood / blood component transfusion. Blood whole blood or packed red blood cells (PRBC) Blood Components Fresh Frozen Plasma (FFP), platelets or cryoprecipitate. PROCEDURE A. CONSENT 1. Consent is obtained for all transfusions, including autologous, with an initial order for a transfusion of blood or blood components. The written consent form is valid for the entire admission unless otherwise revoked by the patient. 2. In situations where an emergency transfusion is necessary, no written consent is required. 3. The doctor ordering the transfusion is responsible for obtaining informed consent from the patient prior to the event. Nursing obtains documentation on the consent form. 4. If the patient refuses to consent to the transfusion, the refusal is documented in the medical record. 5. See Exhibit A Informed Consent to Transfusion of Blood or Blood Components. B. ORDERING 1. Blood/blood components are ordered through the computer system. During computer downtime, a manual lab requisition is completed. 2. Utilize the appropriate blood transfusion focused order set (adult/pediatric/neonatal). Follow order set prompts to order type and screen, product preparation and product transfusion. 3. Enter the transfusion indication for each blood / blood product order. 4. Release the transfuse order and generate the blood release form from the electronic medical record (exception: OR uses a manual blood release form). a. Complete the form with the required information including the patient s ATX number, nurse spectralink number and tube station number. b. Send the form to blood bank to requisition the product for transfusion. c. NICU When the product is dispensed in multiple aliquots, reorder transfuse product using the Additional Aliquot Dispensed frequency. Release the additional transfuse order. C. SPECIMEN COLLECTION 1. Assign the patient an ATX number. The ATX number is placed on both the blood

2 sample and a green wristband on the patient by the individual who draws the blood. 2. If the patient is already wearing an ATX band call the blood bank to determine if a new specimen is needed. If so, the ATX number must be transcribed onto the new specimen label. D. ISSUING/RECEIVING/RETURNING 1. The blood bank technologist issues the blood/blood component. 2. Blood or blood components are issued for only one patient at a time. 3. Transport of blood and blood components. a. Adult/pediatric units are sent via the pneumatic tube system. NOTE: Certain irreplaceable units such as autologous, designated and washed cells are transported via a RN or designee and must be picked up from the blood bank. b. Neonatal units are transported via a RN or designee and must be picked up from the blood bank. c. Surgery units 1) CVOR units are transported via the pneumatic tube system and stored in a Blood Bank approved refrigerator. 2) Non-CVOR units are transported and stored in Blood Bank dispensed insulated coolers. 4. In cases of downtime or with massive transfusion when many units are needed at once, it is recommended to send a RN or designee to the Blood Bank. 5. The RN or designee is authorized to receive the blood/blood component from blood bank. 6. In the event the issued blood or blood component is returned to the blood bank, it may be accepted for reissue if returned within 30 minutes of the issue time. a. Exception: if the unit was stored in a monitored CVOR blood refrigerator or a container validated by the blood bank for temporary blood storage. E. EMERGENCY RELEASE PROTOCOL 1. This protocol is used in cases where the patient s medical condition warrants the risk of forgoing the usual pre-transfusion testing. It is initiated by the ordering physician and allows for the issue of units prior to completion of normally required compatibility testing. A blood specimen is collected from the patient as soon as possible using the usual collection and patient banding protocol (see specimen collection section). Testing of the patient s specimen is conducted after the fact and unusual findings are immediately reported to the caregiver. 2. A physician or RN places an Emergency Release (Emergency Released Blood Products (O neg) order in EPIC. The order provides legal documentation of the physician s agreement to transfuse red cell products prior to the completion of compatibility testing. In addition, the order set automatically generates an order for a Type and Screen test and two units of packed cells. F. MASSIVE TRANSFUSION PROTOCOL: 1. This protocol is used in adult patients whose anticipated blood loss will exceed one blood volume (10-12 units) in a 24 hour period. A physician or RN places an order for Massive Transfusion Protocol. The order provides legal documentation of the physician s agreement to transfuse red cell products prior to the completion of compatibility testing and automatically generates a Type and Screen test order. Once initiated, the protocol will continue until the blood bank is notified of termination by the attending physician. 2. The blood bank has primary responsibility for product order placement (in the blood

3 bank computer system) and preparation. Each cycle of blood product transfusion consists of 5 red cell and 5 FFP units. With alternating cycles, 1 platelet pheresis unit and 10 units of pooled cryoprecipitate is supplied. After each cycle is issued, the blood bank begins to prepare the subsequent cycle. The blood bank notifies the patient care team when the new cycle is ready for issue. Note that a rapid infusion device may be utilized for massive transfusion. 3. NOTE: In the case of massive transfusion, the Blood product administration module of EPIC is not used for the documentation of blood transfusion. Alternate documentation methods may be used and includes evidence of positive identification of the transfusion recipient and blood components, the identity of the transfusionist, the blood component and unit number transfused, date and time of transfusion, evidence of patient monitoring pre-transfusion, during and after transfusion, and any adverse effects. G. PROCEDURE FOR BLOOD ADMINISTRATION 1. Pre-transfusion Preparation of Patient, Equipment, And Product a. Verify physician order. b. Explain the procedure to the patient. Discuss the anticipated length of transfusion time, rationale for frequent vital signs and the importance of notifying an RN if signs/symptoms of reaction occur (such as itching, chills, headache, rash, dyspnea and chest pain). c. Obtain consent for transfusion of blood or blood components in all non-emergent situations. This consent identifies the risks and alternatives for transfusion of blood/blood components. For details see Exhibit A. d. Obtain baseline vital signs. e. Start the adult patient s IV with a minimum of 18 gauge IV access. Note that a smaller gauge may be used for select patients (Exhibit B) f. Neonates: Start the neonate s IV with a minimum 24 gauge catheter. g. Gather needed equipment: 1) Standard Blood Administration set: contains an integral filter and is acceptable for use with Whole Blood, Packed Red Cells, Fresh Frozen Plasma, Platelets and Cryoprecipitate Neonates: Standard bore extension set 2) 0.9% normal saline (NEVER mix any medication or solutions with blood or blood components). 3) Infusion Pump: Administer blood and blood products using an infusion pump. In certain predetermined areas (procedural areas) and in emergent situations, blood and blood products may be administered by gravity at the discretion of the RN. Neonates: a syringe pump is used for the administration of blood or blood products 4) Blood administration tubing (with integral blood filter) is changed every 4 hours or after two units are infused, whichever comes first. h. Prime the blood administration tubing with 0.9% normal saline and attach directly to the patient IV Neonates: prime the blood administration tubing with the blood or blood product. i. Check patency of the IV before sending for blood or blood components. Infuse 0.9% normal saline at a keep-vein-open rate. Neonates: the peripheral IV is saline-locked unless otherwise ordered by physician. j. Requisition product from the blood bank. See ordering section. k. Upon receipt, inspect the blood or blood component for any clots, gas bubbles, cloudiness or abnormal color. Return the blood / blood component to the blood bank if any abnormalities are noted during visual inspection.

4 2. Patient Identification and Blood / Blood Component Verification a. Verify Physician order with two registered nurses. b. Two registered nurses and/or physicians are required to confirm the identity of the patient and blood components directly at the bedside, unless in the operative setting or an emergency release. 1) Open the blood product administration module and scan the patient s wristband when prompted. Scan the barcodes on the blood product (unit number, product code, expiration date and blood type). Verify the information which appears in EPIC after scanning (click accept). Note that manual entry of data is allowable if the user enters an override reason for omitting the use of a bar code scanner. 2) If an error message appears upon scanning the product, verify that the documentation effort was attempted using the correct product request. Contact the blood bank for further investigation, if necessary. 3) In rare instances, it may be acceptable to administer an expired product. In these cases, the user must choose an override reason for the transfusion of expired product. 4) Review the following items in the blood administration flowsheet. Dual signoff with a second RN is required. a) unit number on the bag and on the compatibility label match b) all patient identifiers match the compatibility label c) the donor ABO/RH and patient ABO/Rh are compatible d) Additional RBC match result of compatible or incompatible is noted and entered into EPIC e) visual inspection of the unit is completed (and unit found suitable for use) f) ordered special processing requirement match the product label (stated attributes) 3. Infusion Process a. Invert the blood or blood component gently and thoroughly several times. b. Spike the blood bag and connect to the blood administration Y set. Be certain that the fluid level in the drip chamber covers the filter in the Y tubing. In the NICU and in infants up to 12 months of age outside of the NICU, blood is supplied from the Blood Bank in a prefiltered syringe. A syringe pump is used for infusion. c. Flow rate Adult: Adjust the flow rate to infuse 30 ml of blood for the first 15 minutes. Observe and monitor the patient closely for signs of transfusion reaction. In case of hemodynamic instability, blood can be administered at a rapid rate to treat or prevent shock. Child: Administer blood/blood products at rate on Exhibit D. Physician may write an order with rate if child s condition warrants. Neonate: Administer blood at rate ordered by physician. d. Complete the blood administration documentation flowsheet in the electronic medical record. e. An RN remains with the patient during the first 15 minutes of blood product infusion. f. Check vital signs within 15 minutes of infusion initiation and hourly thereafter until the transfusion is completed. Document vital signs on the blood administration documentation flowsheet. g. If there are no signs of transfusion reaction after the first 15 minutes of the

5 transfusion, adjust the rate according to the physician s order. Four hours is the MAXIMUM transfusion time for a unit of packed cells or whole blood. h. If a transfusion reaction should occur, STOP the transfusion immediately and follow the steps outlined in the section, Procedure for Transfusion Reactions. i. After completion of the transfusion, flush the tubing with normal saline and obtain vital signs. j. Place the blood or blood component bag and tubing in a red bag and dispose of them in a biohazard container on the nursing unit. k. Complete the blood administration documentation flowsheet in the electronic medical record. l. Change blood administration tubing every 4 hours or after two units are infused, whichever comes first. m. Change blood administration tubing when changing the type of product to be infused. n. Do not administer different blood products through the same infusion set or the same infusion site simultaneously. It is acceptable to infuse multiple blood products through different infusion lines simultaneously. 4. Protocol for Handling Suspected Transfusion Reactions a. There are a number of adverse effects of transfusion which include, but are not limited to: 1) Immediate or delayed hemolytic reactions 2) Febrile non-hemolytic reactions (mediated by white blood cells or cytokines) 3) Urticarial reactions 4) Circulatory overload 5) Anaphylactic/anaphylactoid reactions 6) Transfusion-related acute lung injury (TRALI), 7) Transfusion transmitted disease (bacterial, viral, parasitic). b. The Registered Nurse monitors and observes the patient for symptoms of reaction including: 1) Temperature elevation of one degree Centigrade or two degree Fahrenheit from pre-transfusion temperature. 2) Chills 3) Nausea and vomiting 4) Shortness of breath 5) Decrease in blood pressure 6) Shock 7) Feeling of constriction in chest 8) Severe pain in lower back 9) Change in color of urine 10) Urticaria or edema c. If any of the above symptoms appear, take these actions: 1) Stop the transfusion immediately. 2) Obtain and record the patient s vital signs. 3) Change the blood tubing and infuse a new bag of 0.9% normal saline at a keepvein-open rate. 4) Notify the physician to determine if the transfusion should be continued. d. If transfusion is discontinued per physician order, take these actions: 1) Check all the identifying names and numbers on the patient s identification band and unit label 2) Document the transfusion reaction including patient s symptoms and nursing

6 interventions related to transfusion reaction in the blood administration flowsheet suspected transfusion reaction group. 3) Notify the blood bank of the suspected reaction. 4) Enter a Blood Transfusion Reaction order set. This will prompt the collection of a post-reaction blood specimen for laboratory testing. 5) Send the blood / blood component bag, administration tubing and IV solutions to the lab in a red bag. Tubing is left in place, clamped and capped with dead end cap to prevent leakage. 5. Transporting Patients During Infusion of Blood and Blood Components a. During transport of the patient, an RN accompanies the patient to assess and monitor the blood transfusion. b. The RN stays with the patient until the patient is handed off directly to another RN at the intended destination. c. Certain ancillary areas have RNs who may be available to monitor patients receiving blood / blood components. Arrange for the necessary RN coverage prior to transporting the patient. 6. Specialized Blood Components by Patient Population a. Infants/neonates up to 12 months of age 1) All red blood cells are supplied as leukocyte-reduced and gamma-irradiated by default. Indications for red blood cell transfusion include: a) Symptomatic anemia with Hgb </= 10 b) Hgb </= 12 requiring ventilator support or major surgery c) Hgb </= 13 with cyanotic or persistent pulmonary hypertension d) Active bleeding 2) All platelets are supplied as an aliquot of a leukocyte-reduced, gamma-irradiated single donor (apheresis) unit. 3) Red blood cell and platelet aliquots are prepared in the Blood Bank as prefiltered syringe units, with the exception of red blood cell exchange and some intraoperative procedures where a bag of blood will be released. b. Pediatric patients (under the age of 18) 1) All red blood cells are supplied as leukocyte-reduced by default. 2) All platelets are supplied as an aliquot of leukocyte-reduced, single donor (apheresis) units. 3) Cellular transfusion products (red blood cells and platelets) are selectively gamma-irradiated. Pediatric patients that should receive gamma-irradiated products include: a) Patients with a history of cancer or chemotherapy. b) Patients with a history of organ/bone marrow/stem-cell transplant. c) Patients on immunosuppressive medication. d) Patients with congenital immune deficiencies. e) Patients with undiagnosed failure to thrive or undiagnosed chronic diarrhea, prior to exclusion of an underlying immune deficiency. c. Adult patients 1. All platelets are supplied as leukocyte-reduced, single-donor (apheresis) units 2. Patients undergoing coronary bypass surgery will receive leukocyte-reduced red blood cells by default. 3. In non-coronary bypass patients, cellular transfusion products (red blood cells and platelets) are selectively leukocyte-reduced and gamma-irradiated.

7 Policy No: CLIN_092 Previous Policy No.: CLN-B003, CLN-B004, CLN-B005, CLN-B006, ADM Policy Creation Date: 05/09/1997 Most Recent 01/18/2017 Review/Revised Date(s): Approved by: Policy Committee: 05/09/1997; 02/23/2000; 08/22/2001; 08/28/2003; 7/8/2004; 8/12/2004; 11/10/2005; 09/22/2006; 05/10/2007, 08/14/2008, 09/09/2010; 02/10/2011; 02/09/2012; 03/08/2012, 04/11/2013; 05/08/2014; 07/10/2014; 08/13/2015; 01/18/2017

8 EXHIBIT A EDWARD HOSPITAL INFORMED CONSENT TO TRANSFUSION FOR BLOOD OR BLOOD COMPONENTS In the course of your treatment, it may become necessary to administer a transfusion of blood or blood components. This form provides basic information concerning this procedure and, if signed by you, authorizes its performance by qualified medical personnel. DESCRIPTION OF PROCEDURE: Blood is introduced into one of your veins, commonly in the arm, using a sterilized disposable needle. The amount of blood transfused, and whether the transfusion will be of blood or blood components is a judgment the physician will make based on your particular needs. RISKS: The transfusion is a common procedure of low risk. MINOR AND TEMPORARY REACTIONS ARE NOT UNCOMMON, including a slight bruise, swelling or local reaction in the area where the needle pierces your skin, or a nonserious reaction to the transfused material itself, including headache, fever or a mild skin reaction, such as rash. Serious reactions are possible, though very unlikely and include severe allergic reaction (shock) and destruction (hemolysis) of transfused blood cells. Infectious diseases which are known to be transmitted by blood transfusion include CERTAIN TYPES OF VIRAL HEPATITIS, a viral infection of the liver, HUMAN IMMUNODEFICIENCY VIRUS (HIV-1,2) infection, a viral infection known to cause ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AS WELL AS CERTAIN OTHER BACTERIAL, VIRAL AND PARASITIC DISEASES. While a minimal risk of acquiring an infectious disease from transfused blood exists, in accordance with Federal and State law all due care has been taken in donor selection and testing to avoid transmission of disease. ALTERNATIVES: If loss of blood poses serious threats in the course of your treatment, THERE IS NO EFFECTIVE ALTERNATIVE TO BLOOD TRANSFUSION. However, if you have any further questions on this matter, your physician will fully explain the alternatives to you if it has not already been done. I,, have read/had read to me the above. I understand the matters bearing on the decision whether or not to authorize a transfusion of blood or blood components. I have no questions which have not been answered to my full satisfaction. I hereby consent to such transfusion as my physician may deem necessary or advisable in the course of my treatment. Date Signature of Patient, Parent or Legal Guardian (Circle One) Witness to Signature (title or relationship to patient)

9 EXHIBIT B PREFERRED ADULT IV ACCESS Blood Product and Category IV Access Red Blood Cells Rapid transfusions in adults 14-18G or Central Venous Access Devices Red Blood Cells Routine transfusions in adults 18-22G or Central Venous Access Devices Other Blood Products and Plasma Derivatives Any size adequate EXHIBIT C ADULT Blood Component Packed red blood cells (RBCs) Same RBC mass as whole blood but with 80% of the plasma removed Platelets Apheresis platelets contain the equivalent of 6-10 units of platelets harvested from a single donor. Fresh frozen plasma (FFP) plasma which has been Indications Symptomatic anemia with Hgb </= 7 Coronary syndrome with Hgb </= 8 Hgb<10 with sepsis, severe CAD or other cause of low O2 Platelet count </= 20 Platelet count </= 50 with surgery or bleeding Platelet count </=100,000 with brain or eye surgery Platelet function defect Reversal of coagulation defect Thrombotic Tubing/Infusion Rate Standard Y-type blood administration set (contains an integral filter) Set Infusion pump at 120ml to deliver 30ml for the first 15 minutes Standard Y-type blood administration set (contains an integral filter) Complete transfusion within minutes or at the fastest rate the patient can tolerate. Standard Y-type blood administration set (contains an Monitoring Nurse remains with the patient during the first 15 minutes of the transfusion. signs, 15 minutes after initiation, then hourly until completed Nurse remains with the patient during the first 15 minutes of the transfusion signs, 15 minutes after initiation, then hourly until completed Nurse remains with the patient during the first 15 minutes of the Nursing Considerations Infuse within 4 hours. Use only with normal saline solution. Keep in mind that largevolume transfusions of

10 separated from whole blood (through centrifugation and removal of supernatant plasma) within 8 hours of collection. The quick removal of plasma from the red cell mass and subsequent freezing preserves most of the clotting factors in the product. Albumin 5% (buffered saline); albumin 25% (salt-poor) A small plasma protein prepared by fractionating pooled plasma Cryoprecipitate is prepared from FFP units thawed at 1-6 degrees. The insoluble protein at this temperature is harvested and stored in a frozen state. The product contains a concentrate of fibrinogen, factor VIII:C, von Willebrand Thrombocytopenic Purpura (TTP), Hemolytic Uremic Syndrome (HUS), HELLP Syndrome Active bleed Disseminated intravascular coagulation (DIC), factor deficiency To replace volume lost because of shock from burns, trauma, surgery, or infections To treat hypoproteinemia (with or without edema) DIC Active bleed Fibrinogen < 150 Congenital coagulopathy integral filter) Complete transfusion within minutes or at the fastest rate the patient can tolerate. Use administration set supplied by manufacturer and set rate based on patient's condition and response. Standard Y-type blood administration set (contains an integral filter) transfusion signs, 15 minutes after initiation, then hourly until completed FFP may require correction for hypocalcemia because citric acid in FFP binds calcium. Once FFP is thawed, it can be stored at refrigerated temperatures for up to 24 hours. Keep in mind that albumin is contraindicated in severe anemia. Administer cautiously in cardiac and pulmonary disease because heart failure may result from circulatory overload. Keep in mind that cryoprecipitate must be administered within 4 hours of thawing. Once the product is thawed and pooled, it must remain a room temperature to prevent reprecipitation of the insoluble protein.

11 factor and factor XIII. EXHIBIT D CHILDREN Blood Product Indications Infusion Rate Monitoring Tubing FYI Packed Red Blood Cells (PRBC S) Y-set Blood tubing Hgb </= 8 with chronic anemia not responsive to medical therapy Hgb </= 10 and receiving chemotherapy or irradiation Hgb </= 13 with severe cardiopulmonary disease Active bleeding or active surgical blood loss 2.5ml/kg/hr for the first 15 minutes, if tolerated then 5ml/kg/hr, not to exceed 250ml/hr signs, at 15 minutes prior to increase, then hourly Hang within 30 minutes and completed within 4 hours of unit arrival Platelets Fresh Frozen Plasma (FFP) Albumin Complications of sickle cell or chronic transfusion regimen for hemoglobinopathy Stop and/or prevent bleeding in patients with decreased or dysfunctional platelets Bleeding prevention, Coumadin reversal, hemorrhagic clotting factor deficiencies Plasma volume expansion, replacement of Within one hour, no greater than 30ml/kg/hr No greater than 0.5ml/kg/min See formulary or physician order for rate signs, after infusion and 30 minutes post infusion signs, every 30min for one hour, then every hour until complete signs and infusion Y-set Blood tubing Y-set Blood tubing Non filtered, vented IV Do not refrigerate Once spiked must be finished within 4 hours, preferably within 1 hour Must be discarded 6 hours after

12 Cryoprecipitate albumin Fibrinogen deficiencies 5-15 minutes, slowly completion vital signs signs and infusion completion vital signs tubing Y-set Blood tubing, replace after 4 hours spiking bottle Keep room temperature and infuse within 4 hours Exhibit E Blood/Blood Component ABO / Rh Compatibility RED CELL (PACKED CELL) TRANSFUSION + = Compatible NC = Not Compatible PATIENT DONOR O+ A+ B+ AB+ O- A- B- AB- O NC NC NC NC A+ NC + NC + NC NC NC NC B+ NC NC + + NC NC NC NC AB+ NC NC NC + NC NC NC NC O A- NC + NC + NC + NC + B- NC NC + + NC NC + + AB- NC NC NC + NC NC NC + FFP TRANSFUSION (ADULT/PEDIATRIC) + = Compatible NC = Not Compatible PATIENT DONOR O+ A+ B+ AB+ O- A- B- AB- O+ + NC NC NC + NC NC NC A+ + + NC NC + + NC NC B+ + NC + NC + NC + NC AB

13 O- + NC NC NC + NC NC NC A- + + NC NC + + NC NC B- + NC + NC + NC + NC AB PLATELET TRANSFUSION SELECTION FOR ADULTS/PEDIATRICS For non-bleeding patients, ABO matched is given if possible. If the patient is actively bleeding, it is acceptable to give platelets of any ABO type. After three ABO off type platelets are given, the blood bank medical director must decide if additional off type platelets will be transfused. Avoid giving platelets from an Rh positive donor to an Rh negative recipient with childbearing potential. (Platelets are devoid of Rh (D) antigen but contaminating red cells in the product may cause sensitization). CRYOPRECIPITATE FOR ADULTS/PEDIATRICS All ABO groups and Rh types are acceptable. After several ABO off type pooled cryoprecipitate is administered, the blood bank medical director must decide if additional off type product will be transfused. INFANT TRANSFUSION BLOOD AND BLOOD PRODUCT SELECTION Most neonatal patients are transfused with O negative packed cell products which have been leukoreduced, irradiated, etc. If non O blood is transfused, refer to the adult guide for information regarding compatible blood types. Stricter matching applies to transfusions of non-red cell products. For neonates, it is important to transfuse Group AB or group identical products.

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