Transfusion Transmitted Injuries Surveillance System

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Transfusion Transmitted Injuries Surveillance System 2014 Saskatchewan TTISS Update NWGTTISS Meeting February 17, 2016 Elaine Blais, SHR/North SK Transfusion Safety Manager

Acknowledgments Dr. D. Ledingham, MSc, MD, FRCPC, Hematopathologist, Regina Qu'Appelle Health Region Aimee Beauchamp, Business Operations, Provincial Lead, BC Provincial Blood Coordinating Office Keely McBride & Samantha Cassie, Alberta Health 2

Overview 12 RHA s and 1 Health Authority are funded and responsible for providing care in Saskatchewan 2 tertiary centres (with reasonably balanced service portfolios) that transfuse ~ 70% of the RBCs and 90% platelets 6 regional hospitals that transfuse ~ 23% of the RBCs and 7% of platelets 75/75 facilities participate in TTISS reporting = 100% participation 3

SK TTISS Structure Lead Health Region role for the STTISS Project was transferred from the Regina Qu Appelle Health Region to the Saskatoon Health Region in 2014 Saskatoon Health Region became responsible for administration of the STTISS Project Regina Qu Appelle and Saskatoon Health Regions have independent responsibilities for monitoring and reporting adverse events and their outcomes within their jurisdiction to PHAC SHR Lead RHA RQHR Supporting RHA SHR/Northern RHA/facilities RQHR/Southern RHA/facilities 4

Provincial Transfusion Medicine Consultants Provide the medical director conclusion for the transfusion adverse events reported from the RHA/facilities they oversee SHR/Northern SK Transfusion Medicine Consultant position became vacant during 2014 The RQHR/Southern SK Transfusion Medicine Consultant reviewed all provincial transfusion reaction reports and supplied Transfusion Reaction Assessment Letters on a temporary basis 5

Accomplishments Implemented provincial transfusion adverse event report form Updated SK Bedside Transfusion Reaction Algorithm Provincial adoption of a transfusion specific identification band Began updating applicable guidelines within the SK Transfusion Resource Manual (version 2011) revisions still ongoing 6

Challenges Transition of lead health region role from RQHR to SHR SHR learning new SK TTISS responsibilities Separate collection/record management of transfusion reaction data by RQHR and SHR Manual collection of provincial surveillance data (excel spreadsheets) Validation & reconciliation of provincial adverse event data 7

Blood Components Transfused in the Last 5 Years 40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 2010 2011 2012 2013 2014 RBCs Plasma Platelets Cryoprecipitate 8

Transfusion Reactions Reported in the Last 5 Years 300 250 200 150 100 251 204 235 196 187 158 211 191 Total AE's Reported Possibly, Probably or Definitely Associated 50 0 2010 2011 2012 2013 2014 9

Transfusion Reactions Reported to PHAC N=211 Not Reported Reported Not Reported to PHAC Reported to PHAC 21% 79% 2014 10

Transfusion Reactions to Product Type N=211 9% Platelets 6% RBCs Platelets Plasma Plasma Albumin IVIG 2% 10% Albumin IVIG FEIBA RBCs 73% 2014 11

Transfusion Reactions by Type N=211 49% 2014 Febrile 18% Minor Allergic 8% TACO 2% 1% 1% 1% 1% 3% 9% Hypotensive 3% IVIG Headache No Transfusion Reaction No Transfusion Reaction Febrile Non-Hemolytic Minor Allergic Severe/Anaphylactic Incompatible Transfusion Acute Hemolytic Delayed Hemolytic Delayed Serological Bacterial Contamination TACO TAD TRALI Poss TRALI Hypotensive IVIg Headache Venous Thromboemboli Hypocalcemia/Citrate Toxicity Unknown Other 12

Relationship of the Adverse Event to the Transfusion N=211 11% Doubtful Not Reported/Documented 5% 2% Definite Definite Probable Possible Doubtful Ruled Out Not Determined Not Reported/Documented Possible 53% 29% Probable 2014 13

Severity of the Adverse Event to the Transfusion N=211 Grade 2 6% Grade 1 (non-severe) Grade 2 (severe) Grade 3 (life-threatening) Grade 4 (death) Not Determined Not Reported/Documented Grade 1 1% Not Determined 86% 7% Not Reported/Documented 2014 14

Outcome of the Reportable Adverse Event to the Transfusion N= 44 Death Major Minor Not Determined Not Documented 6% Not Documented 88% Minor 4% Death Unrelated x 1 Contributing x 1 2% Major 2014 15

Interesting Cases ABO hemolytic RBCs definite relationship Grade 2 (severe) minor or no sequelae AE occurred in small rural hospital. Rotational bench technologist (new grad) in a work alone situation on a Saturday. Sample mix-up > almost identical pt name > wrong patient sample used for pre-transfusion testing. Tech experienced interruptions during the crossmatch procedure. Multiple checkpoints for positive pt identification missed. O- patient received approximately ½ unit A+ RBCs. Early recognition & management of the transfusion reaction by the transfusionist(s) and attending physician greatly improved the patient s outcome. Hemolysis was noted on post-reaction workup, but patient experienced no permanent harm or disability per attending physician report. Remedial actions included review of existing procedures to confirm accuracy of instructions for positive patient identification and sample verification. Developed new procedures to identify critical stages in the transfusion/laboratory processes where interruptions in the work process would not be permitted (similar to nurses dispensing drugs). Adopted use of provincial transfusion specific identification system. 16

Interesting Cases Patient with history of anti-e received E positive RBCs possible relationship consequences not certain outcome of AE not certain An 74 yr old patient with cancer of the bowel 2 units RBC s ordered. No record of antibody in patient s health record or transfusion record. Patient did not present with an antibody card. Pre-transfusion test results negative antibody screen, RBC units compatible. AE occurred within 60 minutes from start time of transfusion > 45 ml transfused > s/s increased respirations. TSL reported AE to TM Medical Consultant but did not perform a full basic investigation. During review of the case, the TM Medical Consultant discovered a previously identified anti-e in the patient s electronic medical record. Conclusion unlikely transfusion reaction given that the patient had an underlying severe pneumonia. TM Medical Consultant recommended TSL to add anti-e to patient s health and transfusion records. Provincial issue with fragmented patient records that exist in multiple settings. Recommendation for TSL to investigate possibility of signing up for ehr Viewer which displays about 90% of all laboratory results processed in Saskatchewan. Need to determine if access is restricted to physicians/authorized health practitioners. To date, status of access is undetermined. 17

Interesting Cases Venous thromboembolism FEIBA probable relationship Grade 2 (severe) minor or no sequelae outcome A 84 year old patient taking dabigatran for atrial fibrillation presented to the ERD (tertiary hospital) with an acute bowel obstruction. FEIBA was used for emergency reversal of dabigatran for emergency surgery. The patient received a single preoperative dose of FEIBA and a second postoperative dose a few hours later. Developed symptoms of left arm DVT within 24 hours; heparin therapy was initiated. DVT ultrasound > affected were the internal jugular, subclavian and axillary veins > external jugular vein spared. Outcome patient regained function of left arm. Serious adverse drug reaction was reported to Health Canada's Canada Vigilance Adverse Reaction Monitoring Program. 18

Going Forward Standardize provincial data collection process Develop provincial and RHA/facility reporting back process Enhance value of provincial TTISS surveillance data Educate, educate, educate 19

Questions 20