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Reporting Adverse Reactions to Appropriate Authorities Job Aid for Transfusion Service/Laboratory Blood Components (Red Blood Cells, Platelets, Plasma, Cryoprecipitate) Type of Adverse Recipient Reaction Minor allergic FNHTR not related to bacterial contamination Transfusion-associated circulatory overload Report to SK TTISS Program Yes Report to CBS Yes No No Report to Health Canada No (TACO) Delayed hemolytic reaction Hypotensive reaction Transfusion-associated dyspnea (TAD) Report if safety of blood has been compromised1 AND if criteria for serious adverse reaction is met Report to CBS and Health Canada if it is not clear whether the root cause of the adverse reaction is due to a regulated facility activity that affected the safety of the blood component or due to the quality of the blood component itself Any serious or unexpected adverse reaction Yes Yes associated with the quality of blood: Severe allergic/anaphylactic/anaphylactoid Immediately if Immediately if Acute hemolytic transfusion reaction there is a fatality there is a fatality TRALI and possible TRALI or any other or any other Suspected bacterial contamination of component serious or serious or Transfusion transmitted infections (TTI’s) unexpected unexpected adverse reaction2 Graft versus host disease (TA-GvHD) adverse reaction Post-transfusion purpura (PTP) Significant transfusion associated hyperkalemia (Include CBS Death linked to blood component quality TRALI Data Form, Any other serious or unexpected adverse reaction if applicable) where the facility is concerned the blood component is the cause (e.g. hemolysis of RBC’s) Any suspect E/A thought to have been carried out by CBS which compromised the safety of blood and led to an adverse reaction or has the potential to do so (e.g. mislabelled blood component by CBS – red cell phenotype) Any serious or unexpected adverse reaction where Yes No Yes the root cause analysis has established that the safety of the transfused blood was compromised Immediately if Within 24 hrs if there is a fatality3 during a regulated activity carried out by the facility there is a fatality - Hemolysis of RBC’s due to irradiation or or any other improper storage (overheating or freezing) serious or Within 15 days of Death linked to blood component safety unexpected being notified for Suspected bacterial contamination due to an E/A adverse reaction any other serious that occurred during a transformation or storage or unexpected adverse reaction3 activity carried out by the facility (e.g. due to washing, pooling, storage in malfunctioning fridge) - Mislabeled blood component by TSL (e.g. Final Report on ABO/D) completion of the - Any other E/A thought to have been carried out adverse reaction investigation3 by the facility during a regulated activity which compromised the safety of blood and led to an adverse reaction or has the potential to do so Immediately report any fatality or serious adverse event that meets the criteria of a transfusion associated critical incident to Facility Risk Management. SK Ministry of Health must be notified within 3 business days. Notes: 1 Safety of the transfused blood was compromised during a regulated activity carried out by the facility (e.g. transformation or storage activity). 2 CBS is required to report to Health Canada any fatality within 24 hrs and any serious or unexpected adverse reaction within 15 days of receiving the initial report of a serious adverse reaction from the TSL. 3 Reported by the Investigating Establishment. It is where the root cause of the serious or unexpected adverse reaction occurred that determines who must investigate and report to Health Canada. See HC’s Blood Regulations. Appendix # 12 Saskatchewan Transfusion Resource Manual Version February 28, 2017 Page 1 of 2 Adapted from Job Aid: Transfusion Reaction Reporting to External Agencies Job Aid for Hospital TMS; TR 0007JA Version 1.4; BC Provincial Blood Coordinating Office Reporting Adverse Reactions to Appropriate Authorities Job Aid for Transfusion Service/Laboratory Plasma Protein Products (Albumin, Immune Globulins, Hyperimmune Globulins, PCC’s, Coagulation Factor Concentrates, Fibrin Sealants, etc.) Type of Adverse Recipient Reaction Minor allergic FNHTR not related to bacterial Report to SK TTISS Program Yes Report to Plasma Protein Product Manufacturer No Report to Health Canada No1 contamination IVIG headache Hypotensive reaction Transfusion-associated circulatory overload (TACO) Yes Report if criteria for serious adverse reaction is met2 Transfusion-associated dyspnea (TAD) Voluntary reporting encouraged if criteria for serious adverse reaction is met1 Voluntary reporting encouraged1 Yes2 Severe allergic/anaphylactic/anaphylactoid Yes Acute hemolytic transfusion reaction Aseptic meningitis (IVIG-related) Immediately if there Immediately if there TRALI and possible TRALI is a fatality or any is a fatality or any Suspected bacterial contamination other serious or other serious or Transfusion transmitted infections (TTI’s) unexpected adverse unexpected adverse Death linked to product quality reaction reaction Any other serious or unexpected adverse reaction where the facility is concerned the plasma protein product is the cause (e.g. incorrect ABO - SD Plasma) Immediately report any fatality or serious adverse event that meets the criteria of a transfusion associated critical incident to Facility Risk Management. SK Ministry of Health must be notified within 3 business days. Notes: 1 Report lot-associated issues, particularly potential clusters of serious and non-serious reactions which could signal a problem with the plasma protein product to Health Canada. 2 The Product Manufacturer is required to report any fatality or any serious and unexpected adverse reaction to Health Canada after receiving the initial report from the TSL. Contact Information for Reporting Authorities SK TTISS Fax reports to your local SK TTISS designate; either SHR or RQHR SHR Fax: (306) 655-0987 RQHR Fax: (306) 766-4382 CBS Fax or email SK TAER form your local CBS Office Product Manufacturer Fax or email SK TAER form to the applicable plasma protein product manufacturer The relevant product manufacturer fax and phone numbers are available at https://www.blood.ca/ → Hospitals → Other Resources → Plasma Protein Products → Manufacturer Contact List Health Canada Fax ARR notifications and reports to: Adverse Recipient Reactions (ARR’s) Canada Vigilance Program Telephone: (613) 957-0337 Fax: (613) 957-0335 Health Canada Email or fax E/A notifications and reports to: Errors and Accidents (E/A’s) Regulatory Operations and Regions Branch (RORB) Email: [email protected] with the subject line “[Establishment Name] – Blood E/A Report” Fax: (613) 960-2156 When reporting to CBS, the Product Manufacturer and Health Canada, edit recipient identifiers on the SK TAER form so that only the recipient’s age, sex, unique identifier / identification number and date of transfusion/reaction are sent. Appendix # 12 Saskatchewan Transfusion Resource Manual Version February 28, 2017 Page 2 of 2 Adapted from Job Aid: Transfusion Reaction Reporting to External Agencies Job Aid for Hospital TMS; TR 0007JA Version 1.4; BC Provincial Blood Coordinating Office