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CODE: B.1.3 HEALTH SERVICES NURSING PROCEDURE TITLE: BLOOD & BLOOD PRODUCTS - IV and IM ADMINISTRATION – A. B. C. D. Rh (D) IMMUNE GLOBULIN Prior to Obtaining Rh(D) Immune Globulin Obtaining Rh(D) Immune Globulin Administration of Rh(D) Immune Globulin Following Administration of Rh(D) Immune Globulin CATEGORY: RN – SNP – IV administration RN – General – IM administration LPN – General – IM administration PURPOSE IV or IM administration: Prevention of Rh alloimmunization by pregnancy or other obstetrical conditions, or transfusion. Suppresses the active antibody response and formation of anti-Rh (D) antibodies in a Rh (D) negative person exposed to Rh positive blood via transfusion of platelets. It may be considered if Rh positive RBC units have been administered to an Rh negative patient, in consultation with transfusion medicine or clinical hematology. IV administration only: Treatment of Immune Thrombocytopenic Purpura (ITP) in Rh positive patients with intact spleen. NURSING ALERT: The product is indicated in Rh -negative women: In pregnancy at 28 weeks gestation. Within 72 hours in the following situations: After delivery if the baby is Rh (D) positive or unknown, after spontaneous or induced abortion, amniocentesis, cordocentesis, chorion villus sampling, external version, ruptured tubal pregnancy, abdominal trauma, or transplacental bleeding. Administer as soon as possible in the case of maternal bleeding due to threatened abortion. If administered early in pregnancy, recommended to administer at 12 week intervals in order to maintain adequate levels of passively acquired anti-Rh. If more than 72 hours has elapsed, administer as soon as possible up to 28 days. Approved: Page 1 of 21 HEALTH SERVICES CODE B.1.3 NURSING ALERT CONT. Postpartum, dosage is determined by the Transfusion Department based on the quantification of feto-maternal haemorrhage. WinRho® SDF liquid contains maltose, which can give falsely high blood glucose levels in certain types of blood glucose test systems. When the interval between administration of Rh (D) immune globulin and MMR is less than 14 days serologic testing should be done 2 months later to assess the immune response and need for repeat MMR. EQUIPMENT 1. 2. 3. 4. 5. 6. A. 1. 2. 3. Group and Screen Physician order or Authorization for Anti-D Immunoglobulin for Antenatal Cases RQHR 013 (Appendix D) Consent/ Refusal for Administration of Blood/ Blood Components and/ Plasma Protein Products RQHR 1163 (Appendix A) or Consent to Diagnostic and Treatment Procedures RQHR 370 (Appendix B) or Consent to Diagnostic and Treatment Procedures Outpatient and Ambulatory (Appendix C) or Consent for administration of Blood/ Blood Components and/or Plasma Protein Products Wallet card (Appendix E) Rh (D) immune globulin from Transfusions Department Personal protective equipment (PPE) as appropriate Notification of Administration of Blood and/ or Blood Products RQHR 425 (Appendix F) IV administration: 1 - 6 mL syringe with blunt needle 2 -12 mL syringes with 5 mL of normal saline solution in each Alcohol swabs B. IM administration: 1. 1 – 6 mL syringe with appropriate needle for IM use (1” 25 gauge needle) 2. Alcohol and chlorhexidine swabs PROCEDURE A. Prior to Obtaining Rh (D) Immune Globulin 1. Verify physician’s order. NOTE: Fetal Assessment Unit utilizes the Authorization for Anti- D Immunglobulin for Antenatal Cases RQHR 013 (Appendix D) when obtaining physician’s order. Approved: April 1, 2015 Page 2 of 21 HEALTH SERVICES CODE B.1.3 2. Check chart for completed Consent/ Refusal for Administration of Blood/ Blood Components and/ or Plasma Protein Products RQHR 1163 (Appendix A) or other appropriate consent form. Consent is considered valid for the entire pregnancy and postpartum period. NURSING ALERT: Prophylaxis of Rh immunization: Do not administer to patients who are Rh (D) positive, Rh (D) negative women who are Rh sensitized (has developed anti Rh (D) antibodies), patients with a history of anaphylactic or other severe systemic reaction to immune globulins, patients who are hypersensitive to this drug or any ingredient in the formulation, or who are IgA deficient. Treatment of ITP: Do not administer to patients who are Rh (D) negative, splenectomized, patients with a history of anaphylactic or other severe reaction to immune globulins, patients who are hypersensitive to this drug or any ingredient in the formula, IgA deficient, elderly patients with underlying cardiac, renal, or hepatic co-morbidities, and/ or those with evidence of autoimmune haemolytic anemia (Evan’s Syndrome), Systemic Lupus Erythematosus (SLE) or anti-phospholipid antibody syndrome. Obtain physician order for CBC 8 hours following administration of IV dose. Monitor closely for 8 hours post administration for complaints of back pain, shaking, chills, fever or discoloured urine. If CBC report indicates hemoglobin is reduced by greater than 10g/L, notify transfusion department to investigate possible transfusion reaction. 3. Provide patient with hand out Rh (D) Immune Globin CEAC 1148 (Appendix G). 4. Inform patient of use and side effects. 5. Ask patient the following screening questions before giving this product. ▪ Have you had a splenectomy? ▪ Do you have any allergies? ▪ Was there a reaction to previous blood products or human globulin? ▪ Have you received any vaccines in the last three months? B. Obtaining Rh (D) Immune Globulin 1. Stamp blood requisition with patient’s addressograph. Include the required blood product on the requisition. 2. Present requisition to Transfusion Department. NOTE: Any RQHR employee certified to transport blood and blood products may obtain product from Transfusion Department. Volunteers are not regarded as RQHR employees. Approved: April 1, 2015 Page 3 of 21 HEALTH SERVICES CODE B.1.3 NURSING ALERT: All blood products must be CHECKED AT BEDSIDE BY TWO INDIVIDUALS from following designations: Registered nurse (RN) Registered psychiatric nurse (RPN) Licensed practical nurse (LPN) Nurse practitioner (NP) Medical doctor (MD) Perfusionist Nursing student – under supervision of instructor, RN/RPN/LPN Grad nurse (GN), Advanced Care Paramedic, or competent trained adult for home infusion) may check blood only if checking with an RN/RPN/LPN (see Policy 4.2.4 – Administration of blood products , in RQHR Policy Manual). NOTE: For areas that do not have two individuals of the above designations available, an identified and trained designate approved by the Transfusion Department may check blood with an RN. C. Administration of Rh (D) Immune Globulin 1. 2. Inspect the integrity of the product, including the physical appearance and expiration date. NOTE: Do not use solutions that appear cloudy or contain deposits. Do not use if expired. Contact Transfusions Department if any concerns. NOTE: Liquid Rh (D) immune globulin does not require reconstitution. Verify at the bedside by two individuals: 3. Client name MRN Date of birth against transfusion record Verbal validation Attach pink copy of transfusion tag to transfusion record. (Appendix H) IV ADMINISTRATION 1. Initiate IV access and saline lock if not already done. NOTE: If an IV is already in progress, stop infusion and flush with normal saline. 2. Obtain and document baseline vital signs (BP, HR, RR and Temp). 3. Administer and monitor as per product monogragh. Approved: April 1, 2015 Page 4 of 21 HEALTH SERVICES CODE B.1.3 4. Flush with normal saline after administering WinRho®SDF Liquid to ensure dose has been completely administered to patient. 5. Observe for adverse reaction for at least 20 minutes after administration. For treatment of ITP, observe patient for 8 hours following administration. See following nursing alert regarding side effects. IM ADMINISTRATION NOTE: Liquid Rh (D) immune globulin does not require reconstitution. 1. Administer and monitor as per product monograph. NOTE: The gluteal region should not be used as an injection site due to the risk of a sciatic nerve injury. 2. Administer solution when it has reached room temperature. Liquid Rh (D) immune globulin must be administered within 4 hours of issue. 3. Observe patient for adverse reaction for at least 20 minutes after administration. See following nursing alert regarding side effects. NURSING ALERT: IM Administration: Reactions to WinRho® SDF are rare in Rh- negative individuals. Side effects may include: Discomfort or slight swelling at injection site Slight elevation in temperature. IM and IV Administration: Adverse reactions are rare and include following signs and symptoms. If you observe any of these symptoms, notify MRP immediately. Complete Saskatchewan Hospitals Transfusion Adverse Events Form (Appendix H). This form can be obtained from the Transfusion Home page intranet site: http://rhdintranet/Transfusions/public/Forms/SK%20AE%20form.pdf Hives Rash Chest tightening Wheezing Shortness of breath Feeling light headed or dizzy when standing (sudden drop in blood pressure) For Treatment of ITP: Most commonly reported side effects include: Pain/swelling at injection site Headache Chills Fever Nausea and vomiting Arthralgia Approved: April 1, 2015 Page 5 of 21 HEALTH SERVICES CODE B.1.3 NURSING ALERT CONT. Adverse reactions are rare and include the following signs and symptoms. If you observe any of these symptoms, notify MRP immediately. Complete Saskatchewan Hospitals Transfusion Adverse Events Form (Appendix H). This form can be obtained from the Transfusion Home page intranet site: http://rhdintranet/Transfusions/public/Forms/SK%20AE%20form.pdf Back pain Discoloured or darkened urine Decreased urine production Jaundice Facial swelling Wheezing, chest pain, or shortness of breath Decrease in haemoglobin D. Following Administration of Rh (D) Immune Globulin 1. Document: 2. date and time product given product and lot# amount of Rh (D) immune globulin given site and route signature of nurse Complete Notification of Administration of Blood and/or Blood Products RQHR 425. Ensure that the patient signs it and receives the yellow copy of the form (Appendix F). NOTE: If MMR has been administered post partum, check with physician regarding the need for a requisition for rubella titer in 8 weeks’ time to determine rubella immune status. Approved: April 1, 2015 Page 6 of 21 HEALTH SERVICES CODE B.1.3 REFERENCES Product Insert: WinRho® SDF (July 28, 2010).. Rh (D) Immune Globulin (Human) for Injection. Cangene Corporation, Winnipeg, Canada. Public Health Agency of Canada (May 12, 2013) Canadian Immunization Guide. Retrieved from http://www.phac-aspc.gc/publicat/cat/cig-gci/p01-10-eng.php Rh Program of Nova Scotia on-line documents, accessed October 15, 2014: a. Guidelines for Perinatal Antibody Screening and WinRho Administration (http://rcp.nshealth.ca/sites/default/files/resourcesreports/RhGuidelines Mar 2010.pfd) b. How to Administer Rho (D) Immune Globulin (http://rcp.nshealth.ca/sites/default/files/resourcesreports/RhWinRhoInstructions Dec2011.pfd) Revised by: Date: Revised by: Date: Shirley Martin, CNE Mother Baby Unit, Wendy Williams, CNE PAC/DAS & Day Surgery Units, Judy Hoff, MLT Supervisor, Laboratory October 4, 2010 Jana Poitras, CNE Mother Baby Unit, Anita MacPherson, CNE 5E, Janelle Thomson, CNE Women’s Health Centre, Paula Van Vliet, Transfusion Safety Manager, Laboratory Services November 3, 2014 Approved by RQHR Procedure Committee: Date: Keywords: WinRho April 1, 2015 Regina Qu’Appelle Health Region Health Services Nursing Procedure Committee Approved: April 1, 2015 Page 7 of 21 APPENDIX A CONSENT/REFUSAL FOR ADMINISTRATION OF BLOOD/BLOOD COMPONENTS AND/OR PLASMA PROTEIN PRODUCTS CLIENT OR SUBSTITUTE DECISION MAKER I, _______________________________________________________GIVE CONSENT for administration of blood/ blood components Print name of client or decision maker) or ______________________________________________________ to __________________________________________________. (Specify blood products) (Print name of client) I have been advised of the nature, consequences, benefits, and material risks associated with the administration of blood products and have been advised of any reasonable alternatives that may be available for my (or the client’s) condition. I have been informed of the consequences of refusing the administration of blood products. I have had the opportunity to seek clarification and have had my questions answered. Signed: _______________________________________________________ (SIGNATURE OF CLIENT OR SUBSTITUTE DECISION MAKER) Date: _______________________________________ (DD/MM/YYYY) Telephone Permission Date: _____________________ Relationship to Client: __________________________________ Date: ________________________________________ Witness: _____________________________________________ (Competent Adult) REFUSAL OF BLOOD OR BLOOD PRODUCTS I DO NOT consent to the administration of blood or blood products to myself or ______________________________________________ (NAME OF CLIENT) Signed: __________________________________________________Date: _______________________________________________ (SIGNATURE OF CLIENT OR SUBSTITUTE DECISION MAKER) (DD/MM/YYYY) PHYSICIAN / AUTHORIZED NURSE PRACTITIONER (NP) The risks of administration of blood/blood components and/or plasma protein products (blood products) have been explained to the client or substitute decision maker. The nature, consequences, benefits, material risks, and the reasonable alternatives, including the consequence(s) of refusing the administration of blood products has been discussed with the client or substitute decision maker. INFORMATION PAMPHLET GIVEN TO CLIENT This consent will remain valid per course of treatment up to 1 year or upon hospitalization discharge. ______________________________________________ (PRINT NAME OF PHYSICIAN / AUTHORIZED NP) _____________________________________________________ (SIGNATURE OF PHYSICIAN / AUTHORIZED NP) PHYSICIAN FOR USE IN EMERGENCY SITUATIONS WHERE CAPACITY CANNOT BE DETERMINED AND INFORMED CONSENT CAN NOT BE OBTAINED (TRANSFUSION OF FULLY CROSSMATCHED DONOR RED BLOOD CELLS AND OTHER BLOOD PRODUCTS). I certify that any delay in administering this transfusion will seriously endanger the health or life of the patient. ____________________________________________ (SIGNATURE OF PHYSICIAN OR PHYSICIAN DESIGNATE) __________________________________________ (DD/MM/YYYY) USE OF UNCROSSMATCHED DONOR RED CELLS I am aware the risk of transfusion of uncrossmatched donor red blood cells is greater than the risk of fully crossmatched donor red blood cells. It is my clinical judgment, the risk of awaiting fully crossmatched donor red blood cells is greater than the risk of administering uncrossmatched donor red blood cells. Physician Signature: _______________________________ Date: _________________________ (STARS EVENT Number: ____________________________) CALL RGH TRANSFUSIONS (306)766-4474 AND FAX FORM TO (306)766-4004 WHEN UNCROSSMATCHED RBCs required. RQHR 1163 (03/14) White Copy- Chart Code: B.1.3 Date: October 2010, November 2014, April 2015 Yellow - Patient Page 8 of 21 Duration of Consent: For the purposes of transfusion medicine in Saskatchewan, the duration of consent is for either one admission or, if a patient suffers from a chronic condition, for one course of treatment within 12 months, so long as the patient’s condition or medical knowledge in general about the condition has not significantly changed. (Approved by the Senior Medical Officer Committee on May 11, 2011.) 1 List of products for which the Blood Products Consent form is required: Some Products must have approval by Transfusion Physician on Call . Require Blood Products Consent Red Blood Cells, Leukocyte Reduced (LR), including washed and irradiated RBC Platelets, including apheresis and buffy coatderived platelets (Pooled Platelets LR) Plasma components, including Apheresis Fresh Frozen Plasma, Frozen Plasma, Cryosupernatant Plasma, Cryopreciptiate, Solvent Detergent (S/D) Plasma Albumin Hyperimmune Globulins: Anti-D IG (WinRho SDF), Anti-VZIG, Anti-HBIG, IMIG, Anti-CMV IG, Hepatitis A Immune Globulin Immune Globulins, including intravenous (IVIG) and subcutaneous formulations C1-Esterase Inhibitor Prothrombin Complex Concentrates (octaplex, Beriplex) Factor Concentrates: Anti-Inhibitor Coagulant Complex (FEIBA NF) Antithrombin FVII Special Access FVIII/vWF (Humate-P, wilate) FIX FXI Special Access FXIII Special Access Fibrinogen Special Access Protein C Special Access Fibrin Sealants: Tisseel Evicel Artiss Do not require Blood Products Consent Factor Concentrates: rFVIIa (NiaStase RT) rFVIII (Advate, Helixate FS, Kogenate FS, Xyntha) rFIX (BeneFIX) For new or other products not listed, please contact Transfusions Department at 306-766-4474. RQHR 1163 (03/14) Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 9 of 21 APPENDIX B Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 10 of 21 Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 11 of 21 APPENDIX C Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 12 of 21 Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 13 of 21 APPENDIX D Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 14 of 21 APPENDIX E Consent for administration of Blood/Blood Components and/or Plasma Protein Products Name: ____________________________________________________ PHN: _____________________________________________________ Diagnosis: ______________________________________________________ Consent Obtained on (DD/MM/YYYY):_________________________ Consent will expire one year from date obtained. For the purposes of transfusion medicine in Saskatchewan, the duration of consent is for either one admission or, if a patient suffers from a chronic condition, for one course of treatment within 12 months, so long as the patient’s condition or medical knowledge in general about the condition has not significantly changed. (Approved by the Senior Medical Officer Committee on May 11, 2011.) Please show card to the medical/nursing staff upon admission to hospital. Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 15 of 21 APPENDIX F Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 16 of 21 APPENDIX G RH (D) Immune Globulin What is the (Rhesus factor) Rh factor? This is an antigen found on red blood cells. Those that have the Rh factor” have a positive (+) blood type and those that do not have a negative (-) blood type. Having “Rh negative” blood is not usually a problem. Approximately 15% of all people are Rh negative. If “Rh positive” blood is given to an “Rh negative” individual, the body may form antibodies against the Rh factor. If you are Rh(D) negative when you become pregnant and your fetus has blood that is “Rh positive”, your body may form antibodies against the positive Rh factor. These antibodies may cause serious problems in future pregnancies. Products made from human plasma may contain infectious agents such as viruses. The manufacturing process is designed to inactivate and eliminate possible infectious agents. How Can You Protect Yourself Against Developing These Antibodies? Rh Immune Globulin is given to prevent your body from developing harmful Rh antibodies. All women should be tested early in pregnancy to determine if they have a Rh negative blood type. Those women with an Rh negative blood type receive a dose of this product during pregnancy. They receive another dose after the pregnancy if the baby has a Rh positive blood type. If the pregnancy results in unexpected bleeding, miscarriage or abortion, this product is required. Individuals who are “Rh negative” and have been exposed to “Rh positive” blood may require this product. This product may be used to treat a number of blood disorders. Who Should not Receive This Product? People with a history of hypersensitivity to plasma products. People with known isolated immunoglobulin A (IgA) deficiencies. People with allergies to human globulin, polysorbate 80, glycine, Triton X-100, Tri-n-butyl phosphate. Your doctor, nurse, or midwife are aware of other medical conditions where Rh (D) immune globulin is not recommended. CEAC 1148 December 2012 Page 1 of 2 Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 17 of 21 Do Reactions Occur After Receiving This Product? Most people do not have a reaction. Mild reactions: - There may be swelling, soreness, and redness where the needle was given. Cold face cloths to the area reduce discomfort. - Fever may occur. If necessary, use acetaminophen to reduce fever. Moderate reactions (occasional) o Tingling sensation, abdominal or back pain, paleness, diarrhea, joint pain, muscle pain, high blood pressure, dizziness, sleeplessness, itchiness, rash, and sweating may occur. Severe reactions (rare) o Any medicine carries a small risk of a serious reaction o These reactions could include difficulty breathing, shock, or death. What Should I do After Receiving This Product? Canadian immunization guidelines recommend a 15 minute wait after any type of immunization. Seek medical attention if you become moderately or severely ill and inform them of the recent administration of this product. Tell your doctor, nurse, or midwife as soon as possible about any reaction. Before Giving This Product, Screening Includes the Following Questions: Have you had a splenectomy? Do you have any allergies? Have you had a reaction to previous blood products or human globulin? Have you received any vaccines in the last three months? For more information about this product call your doctor, nurse, or midwife. Page 2 of 2 Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 18 of 21 APPENDIX H Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 19 of 21 APPENDIX I Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 20 of 21 Code: B.1.3 Date: October 2010, November 2014, April 2015 Page 21 of 21