Transfusion Medicine Quality Manual Guidelines for Investigation of Adverse Transfusion Reactions

Transcription

1 Transfusion Medicine Quality Manual Transfusion Reactions

2 1. Policy Statements 1.1 All adverse reactions shall be immediately reported to the Transfusion Medicine (TM) Laboratory. 1.2 The TM Laboratory shall investigate all reports of adverse reactions. The investigation shall determine the probable cause and shall include appropriate laboratory tests. 1.3 Donor units and patient blood cultures shall be sent to the microbiology laboratory whenever there is investigation of suspected transfusion transmitted bacterial contamination. 1.4 The following tests shall be performed as soon as possible to rule out an Acute Hemolytic Transfusion Reaction: Clerical check; Visual inspection of post-transfusion specimen for hemolysis; Direct Antiglobulin Test, post-transfusion specimen; Regrouping of recipient s pre- and post-transfusion specimens, implicated blood component unit and other units transfused within 6 hours of the reaction (if available). 1.5 The anti-human globulin (AHG) reagent used for a Direct Antiglobulin Test shall contain antibodies to IgG and the C3 component of complement (polyspecific AHG). 1.6 The following tests shall be performed on pre and post transfusion samples, if pre-transfusion samples are available: Direct Antiglobulin Test on pre-transfusion specimen (if not performed during pre-transfusion testing) if post transfusion specimen is positive; Repeat Indirect Antiglobulin Test (Antibody Screen) on recipient s pre- and post-transfusion specimens; AHG crossmatch of implicated unit and other units transfused within 6 hours of the reaction (if available) using recipient s preand post-transfusion specimens Gram stain and culture of implicated unit(s) if required; Page 2 of 13

3 1.6.5 Blood cultures (from recipient prior to antibiotic therapy) if required; Urinalysis; and Additional testing as requested by physician. 1.7 Transfusion reactions due to plasma protein products are documented on an adverse events form and forwarded to the transfusion medicine laboratory. 1.8 Transfusion reactions with suspected hemolysis due to IVIG require the following tests to be performed on the post-transfusion sample: 2. Linkages ABO/RH testing; Indirect Antiglobulin test (IAT); Direct Antiglobulin test (DAT); Elution (if required). When testing the eluate ensure reagent A cells and B cells are included. This will identify passively acquired anti-a1 or anti-b as IVIG may contain blood group antibodies which cause a positive (DAT) and hemolysis; and Additional testing as requested by physician. Standard Operating Procedure for ABO Grouping Tube Method. Available at: Standard Operating Procedure for Rh Typing Tube Method. Available at: Standard Operating Procedure for Performing the Direct Antiglobulin Test. Available at: globulin_test_ver3.pdf Standard Operating Procedure for Indirect Antiglobulin Crossmatch. Available at: lin_(ahg)_crossmatch_ver2.pdf Standard Operating Procedure for Patient History Check. Available at: Page 3 of 13

4 Standard Operating Procedure for Patient Identification and Specimen Labeling. Available at: beling.pdf Guideline for investigation of suspected transfusion transmitted bacterial contamination. Available at: Reporting Adverse Transfusion Events. Available at: df Algorithm: Suspected Transfusion Reaction. Available at: usion_reactions.pdf Canadian Blood Services requisition for TRALI investigation. Available at: Canadian Blood Services requisition for Patient Request for IgA/Anti-IgA Testing. Available at: Canadian Blood Services requisition for Platelet Immunology. Available at: Immunology-Requisition.pdf 3. Scope 3.1 All transfusion medicine laboratory technologists. 3.2 Responsible Hematologist/Hematopathologist. 4. General Information 4.1 All adverse reactions must be documented. Serological investigation is not required in the following circumstances UNLESS ordered by the attending physician The only sign/symptom is a mild rash <2/3 of the body surface area, pruritus, urticaria, or flushing; OR Page 4 of 13

5 4.1.2 The only sign/symptom is a temperature 38 C and <39 C and >1 C above baseline. 4.2 Pink or red discoloration in the post-transfusion specimen but not in the pretransfusion specimen is suggestive of intravascular red cell destruction and release of free hemoglobin. 4.3 If post-transfusion specimen is not collected until 5-7 hours after an acute hemolytic episode, hemoglobin degradation products, especially bilirubin, may cause a yellow or brown discoloration of the plasma. Bilirubin may begin to rise as early as one hour post reaction, peak at 5-7 hours and disappear within 24 hours if liver function is normal. 4.4 If transfused incompatible red cells have been coated with antibody and not immediately destroyed, the post-transfusion reaction DAT will likely be positive, frequently with a mixed field agglutination pattern. If there is a delay in collection of the post reaction specimen and the transfused cells have been rapidly destroyed, the DAT may be negative. 4.5 Examination should be performed on the centrifuged supernatant fluid of a freshly collected urine specimen. In acute hemolytic transfusion reactions, free hemoglobin released from damaged cells can cross the renal glomeruli and enter the urine. If previously intact red cells in a specimen undergo invitro hemolysis during transportation or storage, misleading free hemoglobin may be present. 4.6 Suspect a faulty infusion device or the addition of an incompatible solution if blood in the administration tubing and/or the donor unit is hemolysed. For example, 5% dextrose in water will hemolyze red cells. 4.7 Suspect the use of an incompatible solution if the blood in the administration tubing is clotted. For example lactated Ringer's solution, can cause clots to form in blood. 4.8 Platelets, due to their storage temperature, are the most common blood component implicated in suspected bacterial contamination reactions. 4.9 Initiation of treatment for suspected bacterial contamination should be based on the patient s clinical presentation as a delay in treatment may result in severe morbidity or death. Page 5 of 13

6 5. Process 5.1 Quality Control All reagents are used and controlled according to the manufacturer s written instructions All reagent antisera and red cells are controlled each day of use All anti-sera must be visually inspected for contamination such as discoloration, cloudiness, turbidity and/or particulate matter All reagent red cells must be visually inspected for hemolysis and/or discoloration. 5.2 Procedure Collect post-transfusion specimens, as required: EDTA specimen; Urine; Specimens for other tests which may be requested by physician; A minimum of one set of blood cultures (aerobic and anaerobic bottles) should be collected if there is a combination of symptoms which include fever, tachycardia, hypotension, chills, rigors, nausea, vomiting, diarrhea, dyspnea, oliguria, other signs of shock or a high suspicion of bacterial contamination without sign/symptom presentation Obtain post- transfusion reaction specimens, facility adverse transfusion reaction reporting form, blood unit with compatibility tag attached, administration set and attached IV solutions, if available. If several units have been transfused in succession, all units given in the past six (6) hours will be investigated (if available) as a possible source of the reaction. In certain circumstances, such as a suspected delayed hemolytic transfusion reaction, the physician or designate may request additional donor unit testing Perform a clerical check: Check compatibility tag attached to donor unit for errors. Ensure the blood types of the recipient and donor unit are compatible and that the correct tag is attached to the correct donor unit. Page 6 of 13

7 Ensure that the recipient s name and unique identification number on the pre-transfusion specimen, requisition and worksheet match exactly with the name and unique identification number on the compatibility tag If a clerical error is discovered: Notify Transfusion Medicine Supervisor or designate, and the attending physician or designate; Initiate a search of records to determine if other patients are at risk due to error; and Review the recipient s transfusion history (if available) for previous adverse transfusion reaction Confirm proper labeling of the post-transfusion sample. The label on the post-transfusion specimen(s) must include recipient s name, unique identification number, the date/time of collection and the identity of the phlebotomist. Ensure the recipient s name and unique identification number on the post transfusion specimen(s) matches that on the adverse transfusion reaction reporting form Perform a visual check for hemolysis. Centrifuge post-transfusion blood specimen and visually compare the color of the plasma to pretransfusion specimen for evidence of hemolysis/ icterus. If hemolysis is observed in post-transfusion specimen, a second specimen should be obtained to confirm the hemolysis in the first specimen was not due to improper collection technique Perform Direct Antiglobulin Test (DAT) on post-transfusion EDTA specimen. If DAT on post-transfusion specimen is positive, test specimen using monospecific IgG and C3 reagents. If DAT is positive due to IgG and/or C3, perform elution Perform ABO/ Rh typing on pre and post-transfusion specimens. If post-transfusion ABO/ Rh typing differs from the pre-transfusion ABO/ Rh typing, notify Transfusion Medicine Supervisor or designate and the attending physician or designate. Initiate appropriate search to determine if another patient may be at risk Perform ABO/ Rh typing on donor unit(s). Notify blood supplier if discrepancy detected Perform DAT on pre-transfusion specimen if not performed during pre-transfusion testing. If DAT on pre-transfusion specimen is positive, test specimen using monospecific IgG and C3 reagents. If DAT is positive due to IgG and/or C3 and the recipient has been Page 7 of 13

8 transfused or pregnant within the past three months or the recipient s transfusion history is unknown, perform elution Perform an Indirect Antiglobulin Test (IAT) on pre and posttransfusion specimens using original pre-transfusion method If the post-transfusion IAT is positive, perform an antibody identification; If the pre-transfusion IAT is positive, perform an antibody identification ; and If an antibody identified, phenotype the transfused units for the corresponding antigen Perform an Anti Human Globulin (AHG) crossmatch on donor unit(s) using pre and post-transfusion specimens. The AHG crossmatch method must be used for transfusion reaction investigation regardless of original method, i.e. immediate spin, computer crossmatch or AHG If indicated, following completion of the investigation, forward the transfusion reaction donor unit(s) that have been transfused within four (4) hours of the end of transfusion, administration set(s) and attached IV solutions, if any, to the Microbiology / Bacteriology Laboratory for culture. If transport to the Microbiology/ Bacteriology Laboratory is delayed, refrigerate the donor unit(s), administration set and attached IV solutions, if any Enter results if the transfusion reaction investigation into the LIS as per facility policy Notify the attending physician/designate or nurse with results of serological investigation Document details of date, time and the name of the person notified. 5.3 Guidelines Refer to Public Health Agency of Canada link. 5.4 Materials Blood component unit which was implicated in adverse transfusion reaction, with the compatibility tag attached, the administration set (without needle) and the IVsolutions (if any). Page 8 of 13

9 5.4.2 All blood component units (if available) transfused within 6 hours of the reaction. If the units are not available, the testing may be performed on the corresponding segments retained by the TM lab Pre-transfusion specimen Post- transfusion reaction blood specimens (EDTA specimen, blood cultures, specimens for other tests requested by physician, correctly labelled First voided urine post adverse transfusion reaction, correctly labelled Blood banking reagents required for testing of specimens Facility adverse transfusion reaction reporting form or occurrence form (computer or paper). 6. Acronyms AHG ATR DAT IAT SOB TM Laboratory LIS ATR investigation profile Antihuman globulin Adverse transfusion reaction Direct antiglobulin test Indirect antiglobulin test Short of Breath Transfusion Medicine Laboratory Lab Information System Adverse transfusion reaction investigation profile. Tests as outlined in the procedure. 7. Definitions Antibody screen use of selected red cells with known antigen composition for the major blood groups to identify unexpected clinically significant allo-antibodies detected in plasma or serum Bilirubin a yellow bile pigment formed in blood from haemoglobin during normal and Page 9 of 13

10 Bronchospasm Crossmatch Cyanosis Diaphoresis Direct Antiglobulin Test Dyspnea Edema Elution Erythema Erythroderma Fever Hypertension Hypotension Hypoxemia Oliguria Orthopnea Post-transfusion testing abnormal destruction of erythrocytes by the reticuloendothelial system. contraction of smooth muscle in the walls of the bronchi and bronchioles, causing narrowing of the lumen a procedure to detect incompatibilities between a recipient and a donor prior to transfusion dark blue or purplish discolouration of the skin due to deficient oxygenation of the blood profound sweating a procedure used to detect in vivo sensitization of red blood cells and determine which protein is coating the red blood cells. shortness of breath (SOB) swelling the removal of antibodies absorbed onto the red cell surface for the purpose of antibody identification redness of the skin intense and widespread reddening of the skin an increase in temperature of > 1 C from pre-transfusion value and 38 C an increase of greater than or equal to 30mm Hg systolic drop in systolic BP of greater than or equal to 30 mmhg and systolic BP less than or equal to 80 mmhg. subnormal oxygenation of arterial blood, PaO 2 / FiO 2 less than 300mm Hg or O 2 saturation less than 90% on room air new onset decrease in urinary output within 72 hours of the identification of the adverse reaction (<500cc/ 24 hours) discomfort in breathing brought on or aggravated by lying flat testing performed after a transfusion to investigate a suspected adverse transfusion Page 10 of 13

11 Pruritis reaction itching Rigors generalized, involuntary shaking that occurs during a fever Shortness of Breath (SOB) a new onset or significant worsening of shortness of breath or a significant increase in respiratory rate, with or without hypoxemia Tachycardia increased heart rate greater than or equal to 120 beats/ minute or heart rate greater than or equal to 40 beats/ minute from baseline Tachypnea rapid breathing Urinalysis examination of urine collected after a suspected transfusion reaction for detection of free hemoglobin and/ or bilirubinuria Urticaria raised red spots with or without pruritis 8. Records Management 8.1 The transfusion medicine laboratory shall retain the recipient administration data file indefinitely. 8.2 All administration records in the recipient s medical chart shall be retained in accordance with the health care facility policy. 8.3 Temperature monitoring records for blood components and blood products shall be retained a minimum of five years. 8.4 The report of an adverse transfusion reaction shall be placed in the recipient s health record: The report of investigation of all serious adverse transfusion reactions shall be retained in the transfusion medicine laboratory indefinitely; and Recommendations pertaining to special blood component requirements or preparation requirements for subsequent transfusions shall be placed in the recipient s transfusion history 8.5 Each facility shall have a record system that ensures a copy of all information relating to the patient and the administered blood component or blood product forms a permanent record for the patient: Page 11 of 13

12 8.5.1 The record system shall be organized and maintained in such a way that it is possible to trace blood components or blood products from distributor to final disposition (i.e. transfusion, administration or destruction); and The records system shall also provide a means to locate and access all records in the facility related to a given product. 9.0 Key Words Adverse, Reaction, Transfusion Supporting Documents 10.1 Tables/Charts Table of Recommended Tests Page 12 of 13

13 References. Canadian Society for Transfusion Medicine. (2011). CSTM standards for hospital transfusion service. Version 3. Ottawa: Author. Health Canada. (2013). Blood regulations. Canadian Gazette, Part II, 147(22), pp AABB. (2014). Standards for blood banks and transfusion services (29 th ed.). AABB: Bethesda, Maryland. Canadian Standards Association. (2010). Blood and blood components, Z Mississauga, ON: Author Mazzei, C.A., Popovsky, M.A., & Kopko, P.M. (2014). In M. K. Fung, B. J. Grossman, C. D. Hillyer, & C. M. Westhoff (Eds.). Technical Manual (18 th ed.), Bethesda, MD: AABB Press. Callum, J., Lin, Y., Pinkerton, P.H., Karkouti, K., Pendergast, J.M., Robitaille, N Webert, K.E. (2011). Bloody easy 3. Toronto, ON: Ontario Regional Blood Coordinating Network. Stedman, T. (2006). Stedman's Medical Dictionary (28th ed.). Baltimore, US: Stegman Public Health Agency of Canada. (2008). Guideline for investigation of suspected transfusion transmitted bacterial contamination. Retrieved February , from Mazzei, C. A., Popovsky, M. A., & Kopko, P. M. (2014). Noninfectious Complications of Blood Transfusion. In M. K. Fung (Ed.), AABB (18th ed., pp ). Bethesda, MD: AABB Press CSL Behring Canada Incorporated. (2014) Hizentra: Product monograph. Retrieved from AABB Center for Patient Safety. (2012) Retrieved from: Patient-Safety-Flyer.pdf Page 13 of 13