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Transfusion Transmitted Injuries Surveillance System User's Manual

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2. Transfusion Transmitted Injuries Surveillance System Section 8 Comments a b c d e f 8 Comments Record any relevant remarks concerning the incident or the adverse reaction Attach another sheet of paper as required Last name Enter the last name of the reporting physician or designate First name Enter the first name of the reporting physician or designate Signature The reporting physician or designate should sign the form in this location Telephone number Enter the work telephone number including the area code and extension if applicable of the reporting physician or designate Date Enter the date ddmmmyyyy on which the reporting physician or designate completed the form Time Enter the time 00 00 to 23 59 at which the reporting physician or designate completed the form User s Manual m Version 3 0 49 Transfusion Transmitted Injuries Surveillance System 50 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 9 Comments Completed by Canadian Blood Services CBS a CBS Comments Enter comments on the case in the space provided b Last name Enter the last name of the CBS Medical Director c First name Enter the first name of the CBS Medical Director d Signature The CBS Medical Director should sign the form in this location e Telephone number Enter the work telephone number including the area code and ext
3. 35 Relationship of Adverse Event to IransfusiOfozs s xc Miss as 42 Severity of Adverse Event 44 Outcome of the Adverse Event 45 Hospital Procedure Involved 46 Equipment Supplies 47 Medical Follow Up 47 Blood Supplier Centre Manufacturer Notified 47 Status of Investigation 48 Section 8 Comments a 0 40554 Lowe e eae be Y 49 Section 9 Comments Completed by Canadian Blood Services CBS ue ee Aces ee Swe E ere 51 Appendices css a Ae oid au eh GE OS s ep A eR eee 53 Blood Component Names and Codes 54 Plasma Derivative Product Names and Codes 56 Serious Adverse Events Requested by CBS 57 Contact Lists osc rwn be ie RR RUE RR OS ORT e 58 vi User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Definitions Adverse Event An undesirable and unintended occurrence during or after the administration of blood blood components or blood products plasma derivatives whether or not considered to be related to the administration of these products Note The following are considered to be adverse events Incident An accident or error that could lead to an adverse outcome affecting a the safety efficacy or quality of blood blood components or blood products plasma derivatives or b the safety of recipients Accident An unexpected or unplanned ev
4. Blood Culture Results If a blood culture was performed on the recipient post transfusion indicate date ddmmmyyyy and time 00 00 to 23 59 the sample s was were obtained results of the recipient s culture enter the number of positive results if the testing identified an organism s enter the number of negative results of the recipient s culture and ifthe culture was positive specify the organism s identified genus species if known If a blood culture was performed on the product blood blood component or blood product plasma derivative indicate date ddmmmyyyy and time 00 00 to 23 59 the blood blood component or blood product plasma derivative was received by the Microbiology Laboratory results of the product culture enter the number of positive results if the testing identified an organism s enter the number of negative results of the blood blood component or blood product plasma derivative culture and if the culture was positive specify the organism s identified genus species if known Document the unit number of the blood blood component that was positive Document the lot number of the vial of blood product plasma derivative that was positive Additional information regarding bacterial infection can be found in Section 7 Relationship of Adverse Event to Transfusion of this manual User s Manual Version 3 0 27 Transfusion Transmitted
5. Injuries Surveillance System 28 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 5 Suspect Blood Blood Components or Blood Produets Plasma Derivatives All blood blood components or blood products plasma derivatives that might be related to the adverse transfusion must be identified The first blood blood component or blood product plasma derivative listed should be the one most likely associated with the reported adverse event If it is not possible to identify which blood blood component or blood product plasma derivative was related to the transfusion all products should be listed and a note made in the Comments in Section 5 to explain that no one product could be determined to be the likely cause of the reaction a Transfused blood blood components or blood products plasma derivatives Product code name Enter the numeric product code or the name of the blood component blood product plasma derivative related to the transfusion incident adverse reaction from the Blood Component Names and Codes or the Plasma Derived Product Names and Trade Names area in the Appendices Product modification If product modification occurred enter the specific code from the list below and indicate where the modification occurred hospital or supplier If it was an autologous donation or directed designated donation please specify in the Comments in Section 5 Please note Multiple
6. Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Hamilton 299 Main Street East Hamilton ON L8N 1H8 Tel 905 645 6555 Fax 905 540 5803 Blood Products Dist Tel 905 645 6558 Dr Morris Blajchman Med Dir Tel 905 525 9140 Ext 26276 Fax 905 527 4866 Ottawa 40 Concourse Gate Ottawa ON K2E 8A6 Tel 613 560 7440 Fax 613 560 7226 Blood Products Dist Tel 613 560 7212 Dr Peter Lesley Med Dir Tel 613 560 7209 Fax 613 560 7226 New Brunswick 405 University Avenue Saint ohn NB E2L 467 Tel 506 648 5012 Fax 506 648 5077 Blood Products Dist Tel 506 648 5055 Dr Karl Misik Med Dir Tel 709 758 8086 Fax 709 758 2441 User s Manual m Version 3 0 Halifax 1940 Gottingen Street Halifax NS B3J 3B7 Tel 902 474 8200 Fax 902 474 8206 Blood Products Dist Tel 902 474 8300 Dr Irene Sadek Med Cons Tel 902 474 8286 or 8211 Fax 902 474 8206 Newfoundland amp Labrador 7 Wicklow Street St John s NL A1B 3Z9 Tel 709 758 5300 Fax 709 758 5324 Blood Products Dist Tel 709 682 4267 Dr Karl Misik Med Dir Tel 709 758 8086 Fax 709 758 2441 65 Transfusion Transmitted Injuries Surveillance System H MA QU BEC Contact List http www hema quebec qc ca Service client le h pitaux H ma Qu bec 4045 chemin C te Vertu Ville Saint Laurent Qc H4R 2W7 Tel 514 832 5000 6909 Fax 514 904 2522 66 User s Manual m Version 3 0
7. and 6 of the Form for incidents that occurred and were noted before the start of the transfusion Complete All Sections of the Form for incidents that occurred were noted during or after the transfusion Adverse Reaction Select Adverse Reaction with an x or Y if the recipient experienced a reaction suspected to be related to the product Examples Urticaria Fever chills pain Hypotension hypertension Bacterial or viral infection Complete All Sections of the Form Product Transfused Select Yes with an x or 7 if the blood blood component or blood product plasma derivative was administered to the recipient Select No with an x or 7 if the blood blood component or blood product plasma derivative was not administered to the recipient Please note that for Adverse Reactions Yes should always be selected for Product Transfused In the database if Adverse Reaction is selected then Product Transfused will automatically be selected For Incident either Yes or No could be selected for Product Transfused User s Manual m Version 3 0 11 Transfusion Transmitted Injuries Surveillance System Facility Identification a Name of facility Enter the official name of the facility that reported the incident or adverse reaction e g hospital medical clinic public health department b Hospital Code Enter the hospital identification number assigned by the provincial territorial department o
8. plasma derivatives must be reported Provincial territorial blood offices blood supplier centres and manufacturers should be informed promptly of adverse events that may affect product safety and disposition in order that they can carry out the following i quarantine during investigation recall or destroy implicated associated products e g in case of suspected bacterial contamination ii update donor safety profile e g exclude defer or special code donors ii fulfil their regulatory requirements to report serious adverse reactions events to Health Canada s regulatory branch What Adverse Events are to be Reported to Provincial Territorial Blood Offices All relevant information data from the Canadian Transfusion Adverse Event Reporting Form is to be provided to provincial territorial blood offices for any adverse events incidents as per each Provincial Territorial agreement with their hospitals What Adverse Events Are To Be Reported to Canadian Blood Services HEMA QUEBEC All relevant information data from the Canadian Transfusion Adverse Event Reporting Form should be provided to Canadian Blood Services or HEMA QUEBEC in accordance with their guidelines Please refer to the appendix Serious Adverse Events Requested By CBS for a list of data elements that the Canadian Blood Services requires Canadian Blood Services and HEMA QUEBEC are required to report transfusion associated deaths to the Biologics and
9. s underlying condition TRALI Select TRALI with an x or Y if the recipient s condition meets the following definition of Transfusion Related Acute Lung Injury TRALI n patients with no evidence of Acute Lung Injury ALI prior to transfusion TRALI is diagnosed if New ALI is present Acute onset Hypoxemia gt PaO FiO lt 300 or gt Oxygen saturation is 90 on room air or gt Other clinical evidence Bilateral lung infiltrates on frontal chest x ray No evidence of circulatory overload 8 It occurs during or within 6 hours of completion of transfusion a There are no other risk factors for ALI Indicate the time to recovery in hours in the space provided User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System n Possible TRALI Select Possible TRALI with an x or Y if the recipient s condition meets the following definition In patients with no evidence of ALI prior to transfusion possible TRALI is diagnosed if 5 New ALI is present Acute onset Hypoxemia gt PaO FiO lt 300 or gt Oxygen saturation is lt 90 on room air or gt Other clinical evidence Bilateral lung infiltrates on frontal chest x ray No evidence of circulatory overload B It occurs during or within 6 hours of completion of transfusion 8 There are one or more risk factors for ALI Direct Lung Injury Aspiration Pneumonia Toxic inhalation Lung contusion Near dr
10. who have a history of febrile or allergic reactions in order to minimize their clinical symptoms Commonly used medications include antipyretics i e acetaminophen antihistamines i e diphenhydramine hydrochloride corticosteroids i e hydrocortisone prednisone solucortef etc Select Yes with an x or 7 if the recipient received medication s before the transfusion User s Manual m Version 3 0 19 Transfusion Transmitted Injuries Surveillance System b 20 Specify the drug dose route administered Select No with an x or if the recipient did not receive any medications before the transfusion Transfused under anesthesia Select General with an x or if the recipient was receiving a general anaesthetic at the time of the reaction Select Local regional with an x or if the recipient was receiving a local regional anaesthesia at the time of the reaction This category includes epidurals Select None with an x or if the recipient was not receiving anaesthesia at the time of the reaction Guidelines to identify a transfusion reaction in the anaesthetized patient The operating room is a unique environment therefore classic signs and symptoms of a transfusion reaction may not be identifiable When patients are anaesthetized symptoms may be masked by the room temperature muscular inactivity and an inability to communicate signs and symptoms In the anaesthetized pa
11. with an x or v if these were administered for the transfusion reaction e g Lasix If the diuretics administered were effective select Effective with an x or v N B This information is important particularly when TRALI is suspected User s Manual m Version 3 0 31 Transfusion Transmitted Injuries Surveillance System i j k 1 32 Vasopressors Select Vasopressors with an x or v if these were administered for the transfusion reaction e g epinephrine dopamine norepinephrine Antibiotics Select Antibiotics with an x or if these were administered for the transfusion reaction Supplementary O Select Supplementary O with an x or 7 if the recipient was given oxygen before transfusion and the concentration had to be increased or if oxygen administration became necessary for a recipient who had not previously required it Mechanical Ventilation Select Mechanical Ventilation with an x or Y if the recipient was given mechanical ventilation before transfusion and the concentration had to be increased or if mechanical ventilation administration became necessary for a recipient who had not previously required it If mechanical ventilation occurred indicate the duration in the space provided ICU Required Select ICU Required with an x or 7 if a transfusion reaction led to a substantial increase in the level of care or a transfer to an intensive care unit
12. Chest x ray Select Chest x ray with an x or Y if a chest x ray was performed on the recipient Blood Culture Select Blood Culture with an x or 7 if a blood culture was ordered for the recipient and samples were taken and sent to the laboratory User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System p Product Culture Select Product Culture with an x or if blood containers bags were sent for culture q Other Measures Taken Select Other Measures Taken with an x or Y if other types of medications or measures were used for the transfusion reaction Specify the medications or measures Example anxiolytics bronchodilators desferoxamine other User s Manual m Version 3 0 33 Transfusion Transmitted Injuries Surveillance System 34 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 7 Results of Investigation amp Conclusion a b c No Transfusion Reaction Select No Transfusion Reaction with an x or 7 if the investiga tion indicated the recipient did not experience a transfusion reaction Febrile Non Hemolytic Reaction Select Febrile Non Hemolytic Reaction with an x or v if the recipient experienced one or more of the following fever 238 C and a change of 21 C from pretransfusion value chills sensation of cold or rigors these symptoms may be accompanied by headache and
13. DEGLYCEROLIZED LRF 06270 RED BLOOD CELLS FROZEN LRF 04760 SAGM RBC LR 05760 SAGM RBC LR Irradiated 34761 SAGM RBC LR Divided 1 34762 SAGM RBC LR Divided 2 Platelets PED o 12700 CP2D PLATELETS LRF Buffy Coat Platelets Buffy Coat PLT 12091 CPD Platelets Pooled LR 12691 CPD Platelets Pooled LR Irradiated 12071 PLATELETS APHERESIS LRF Plasma 18230 FRESH FROZEN PLASMA CP2D LRF 191701 FRESH FROZEN PLASMA DIVIDED CP2D LRF 18872 PLASMA CP2D LRF AUTOLOGOUS ONLY 18770 FRESH FROZEN PLASMA CPDA 1 LRF 54 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System 191771 FRESH FROZEN PLASMA DIVIDED CPDA 1 LRF 18972 PLASMA CPDA 1 LRF AUTOLOGOUS ONLY 19800 RECOVERED PLASMA WITHIN 15 HOURS OF PHLEBOTOMY 19600 RECOVERED PLASMA 18872 077 CRYOSUPERNATANT PLASMA CP2D LRF COMBINATION LABEL 18211 FRESH FROZEN PLASMA APHERESIS 18161 CPD Frozen Plasma 18465 CPD Cryosupernatant Plasma 18210 ACD Fresh Frozen Plasma Apheresis Cryoprecipitate CRYO 19070 CRYOPRECIPITATED AHF CP2D LRF 10160 CPD Cryoprecipitate User s Manual Version 3 0 55 Transfusion Transmitted Injuries Surveillance System Plasma Derived Product Names and Codes Code Name IVIG RhIG A5 INTRAVENOUS IMMUNE GLOBULIN Rh IMMUNE GLOBULIN ALBUMIN 5 ALBUMIN 25 HIBIG HEPATITIS B IMMUNE GLOBULINE ISG IMMUNE
14. Doubtful with an x or v if the clinical or laboratory event occurred within a reasonable time period but the preponderance of data supports an alternative explanation Bacterial contamination is considered Doubtful if The blood blood component or blood product plasma derivative culture is positive for one pathogen and the recipient s blood culture is positive for a different pathogen or contaminations of the samples or laboratory specimen are suspected v Ruled out Select Ruled Out with an x or if the clinical and or laboratory event occurred within a time period inconsistent with the administration of the blood blood component or blood product plasma derivative Or if it occurred within a consistent time period and it was proven to have no relationship to the transfusion User s Manual m Version 3 0 43 Transfusion Transmitted Injuries Surveillance System vi Not Determined Select Not Determined with an x or 7 if it remains to be determined whether the event was related to the administration of the blood blood component or blood product plasma derivative and further information is forthcoming Severity of Adverse Event 44 Select one of the following i iii Grade 1 Non Severe Select Grade 1 Non Severe with an x or 7 if the recipient may require medical intervention e g symptomatic treatment but lack of such would not result in permanent damage or im
15. Genetic Therapies Directorate of Health Canada within 24 hours and all other serious adverse events within 15 days of receiving a report User s Manual m Version 3 0 5 Transfusion Transmitted Injuries Surveillance System Specific direction on reporting adverse events follows Canadian Blood Services Refer to the Circular of Information for the Use of Human Blood and Blood Components or contact your local Canadian Blood Services blood supplier centre www bloodservices ca Please refer to the CBS Contact List within the Appendices H MA QU BEC Refer to the Circular of Information for the Use of Labile Blood Products or contact your local HEMA QUEBEC blood supplier centre www hema quebec qc ca Please refer to the HEMA QUEBEC Contact List within the Appendices Please see the flowchart titled Guidelines for Hospitals to Report Adverse Events for Blood Blood Components to Provincial Territorial Blood Offices and Canadian Blood Services H ma Qu bec CBS HQ 6 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Guidelines for Hospitals to Report Adverse Events for Blood Blood Components to Provincial Territorial Blood Offices and Canadian Blood Services H ma Qu bec CBS HQ Initiate process for reporting Adverse Event for Blood Blood Component Complete Canadian Transfusion Adverse Event Reporting Form do not delay reporting to complete all fields Promptly report all serio
16. In the 1997 Report of the Commission of Inquiry on the Blood System in Canada Justice Krever emphasized the importance of surveillance and tracking of blood blood components or blood products plasma deri vatives referring to the concept of vein to vein management of blood In response to this report the federal government launched a series of initiatives and provided additional funds to improve the safety of Canada s blood system One such initiative is the Transfusion Transmitted Injuries Surveillance System TTISS TTISS is a national surveillance and monitoring system for reporting of adverse reactions to blood blood components or blood products plasma derivatives It provides data that will be used for managing the risks related to the transfusion of these products in Canada The Canadian Transfusion Adverse Event Reporting Form and User s Manual have been developed by a National Working Group consisting of representatives from the provinces territories manufacturers of blood components and Health Canada and Public Health Agency of Canada personnel This manual is to be used as a resource for completing the Canadian Transfusion Adverse Event Reporting Form or TTISS database User s Manual m Version 3 0 iii Transfusion Transmitted Injuries Surveillance System iv User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Table of Contents Definitlolse u4eiuedx Vln BAS har WSS GRE Ci REE 1 Informati
17. J P ute NE Agence de of Canada Aee E bes Transfusion Transmitted Injuries surveillance System User s Manual Version 3 0 Transfusion Transmitted Injuries Surveillance System User s Manual Version 3 0 To be used as a guide for completion of the Canadian Transfusion Adverse Event Reporting Form F100 V3 0E November 2007 November 2007 Our mission is to promote and protect the health of Canadians through leadership partnership innovation and action in public health Public Health Agency of Canada Published by authority of the Minister of Health Transfusion Transmitted Injuries Surveillance System User s Manual Version 3 0 is available on the Internet at the following address http www phac aspc gc ca hcai iamss tti it galement disponible en fran ais sous le titre Systeme de surveillance des incidents transfusionnels Guide de l utilisateur Version 3 0 Transfusion Transmitted Injuries Section Blood Safety Surveillance and Health Care Acquired Infections Division Centre for Infectious Disease Prevention and Control Public Health Agency of Canada This publication can be made available on request on diskette large print audio cassette and braille O Her Majesty the Queen in right of Canada represented by the Minister of Health 2007 Cat No H40 6 2007E 978 0 662 44215 8 PDF HP40 6 2007E PDF 978 0 662 44216 5 Transfusion Transmitted Injuries Surveillance System Preface
18. SERUM GLOBULIN RaBIG RABIES IMMUNE GLOBULIN TIG TETANUS IMMUNE GLOBULINE VZIG VARICELLA ZOSTER IMMUNE GLOBULIN Anti CMV Anti CMV CoagulationFactor CoagFa FVIIa FACTOR VIla CONCENTRATE FVIII FACTOR VIII CONCENTRATE FIX FACTOR IX CONCENTRATE F XI FACTOR XI CONCENTRATE FXII FACTOR XIII CONCENTRATE Qi 6 A1 P1 ALPHA I PROTEINASE INHIBITOR AICC ANTIINHIBITOR COAGULATION COMPLEX AT3 ANTITHROBIN III CIEI ESTERASE INHIBITOR FIB FIBRINOGEN FS FIBRIN SEALANT PRTC PROTEIN C SD SD PLASMA User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Serious Adverse Events Requested by CBS As outlined in the current Circular of Information Canadian Blood Services CBS requires notification of all serious adverse events that are possibly related to transfusion of blood and blood components manufactured by CBS The following adverse events related to blood and blood components should be promptly reported to CBS and any event that is related to a death or to suspected bacterial contamination of a product should be reported to Canadian Blood Services immediately i e within 24 hours i All deaths ii All serious reactions immediate threat and or major deterioration Major allergic anaphylactic reaction Acute hemolytic reaction Significant Hyperkalemia Delayed hemolytic reactions iii All of the following reactions regardless of their severity TRALI Gr
19. adeleine S waters Al Information Manager Health Surveillance Population Health Division Alberta Health and Wellness 10025 J asper Avenue 24th Floor Edmonton AB T6 2N3 780 415 2833 Fax 780 422 3671 Saskatchewan Judy Hoff TTISS Project LIS Specialist Tech II Transfusions Department Regina General Hospital 1440 14th Avenue Regina SK S4P 0W5 Office phone 306 766 4474 Office fax 306 766 4004 62 Manitoba Susan Turnbull Provincial Blood Programs Coordinating Office PBPCO Manitoba Health 3rd floor 300 Carlton Street Winnipeg MB R3B 3M9 204 788 6355 Fax 204 944 0669 Ontario 1 PRIMARY CONTACT Nancy Heddle MSc FCSMLS D McMaster Transfusion Research Program McMaster University 1200 Main Street W HSC 3N43 Hamilton ON L8N 3Z5 Phone 905 525 9140 ext 22126 Fax 905 524 2983 Email heddlen mcmaster ca Website www fhs mcmaster ca mtrp 2 SECONDARY CONTACT Blood Programs Coordinating Office Acute Services Division Ministry of Health and Long Term Care 5700 Yonge Street 4th Floor Toronto ON M2M 4K5 Phone 416 326 6478 Fax 416 326 6481 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Qu bec C line Poulin MSc Conseill re en h movigilance Direction de la pr vention clinique et de la biovigilance Direction g n rale de la Sant publique Minist re de la Sant et des Services Sociaux 1075 Chemin Sainte Foy 12
20. aft versus Host Disease Post transfusion purpura iv Allcases of suspected bacterial contamination and or any positive culture of a product Canadian Blood Services should be contacted for any suspicious case of bacterial contamination so that products related to the same donation be rapidly put in quarantine or recalled v All post transfusion infections i e hepatitis A parvovirus B19 malaria Chagas WNv etc vi Allreactions for which the product quality is doubtful vii All unusual reactions ex red eye syndrome severe hypotensive reactions viii Any other reaction with the potential for permanent disablement or loss of life Adverse events such as febrile nonhemolytic transfusion reactions allergic reactions and delayed serologic reactions would not normally require reporting but should not be excluded if the attending physician feels that the severity of the reaction warrants investigation by the Blood Supplier Centre User s Manual m Version 3 0 57 Transfusion Transmitted Injuries Surveillance System Contact Lists 1 Public Health Agency of Canada PHAC Transfusion Transmitted Injuries TTT Section Marketed Health Products Directorate Contact List for Provincial Territorial Blood Offices Local Contact List for Canadian Blood Services H MA QU BEC Contact List oF N 58 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Public Health Agency of Canada PHAC Tran
21. an x or Y if the recipient died Relationship of Transfusion to Recipient s Death Document the relationship of the transfusion to the recipient s death by selecting one of the following Definite Select Definite with an x or v if the recipient s death occurred within a time period consistent with the administration of the blood blood component or blood product plasma derivative and was proven by investigation to have been caused by transfusion Probable Select Probable with an x or v if the recipient s death occurred within a time frame consistent with the administration of the blood blood component or blood product plasma derivative and did not seem to be explainable by any other cause Possible Select Possible with an x or Y if the death occurred within a time period consistent with the administration of the blood blood component or blood product plasma derivative but could be explained by a concurrent disease or by the administration of a drug or other agent User s Manual m Version 3 0 45 Transfusion Transmitted Injuries Surveillance System iii Doubtful Select Doubtful with an x or if the death occurred within a reasonable time period in relation to the transfusion but the preponderance of data supports an alternative explanation Ruled Out Select Ruled Out with an x or v if the death occurred within a time period inconsistent with the ad
22. an incident occurred related to the product Examples Blood manufacturer ABO error Product checked in with wrong group Error in product selection and labelling Expired product was dispensed Incorrect product was ordered for patient Product did not meet transfusion requirements Incorrect product issued Product temperature was unacceptable o Product was not available Specify the details of the incident User s Manual m Version 3 0 d Transfusion Transmitted Injuries Surveillance System Equipment Related Incident Select Equipment Related Incident with an x or v if an incident occurred related to the equipment Examples Filter Pump Pressure device Blood warmer 9 Reinfusion device Specify the details of the incident Other Incident Select Other Incident with an x or 7 if there was any other type of incident related to the transfusion process Examples Defective reagents Discrepancy with computer history Equipment malfunction Incorrect IV fluid used to administer product Incorrect patient information on blood bank tag Incorrect product info entered Misinterpretation of results Patient info entered incorrectly into system Quality control not performed correctly 9 Rejected sample Specify the details of the incident Section 3b Premedication and Anesthesia a Premedication Medication is often administered to individuals
23. discharged and readmitted on the same day User s Manual m Version 3 0 3 Transfusion Transmitted Injuries Surveillance System What should I do after completion of this form When you have provided all the necessary information this form should be forwarded to the appropriate location in your institution or province territory by fax or mail or electronically If you are unaware of the process consult with the Manager Director of Transfusion Services at your institution What information is transferred to the provincial territorial level Certain information on the form as agreed to within each province territory is entered into a centralized provincial territorial database and is reviewed by the provincial territorial blood office responsible for overseeing this program See Guidelines for Hospitals to Report Adverse Events to Provincial Territorial Blood Offices and Canadian Blood Services HEMA QUEBEC Please refer to the appropriate Contact List within the Appendices What information is transferred to the federal level Some of this information of national significance will be electronically transferred to the Public Health Agency of Canada The information provided is non nominal data that has been negotiated with the provinces territories Patient anonymity is maintained in this process as no specific patient identifiers are transferred to the provincial territorial or federal level Additional information may have to be trans
24. ducts Plasma Derivatives to Manufacturers Initiate process for reporting Adverse Event for Blood Product Plasma Derivative Complete Canadian Transfusion Adverse Event Reporting Form Is this a Serious Adverse Event Manufacturer will report adverse event to Health Canada s regulatory branch Promptly report serious adverse event to Manufacturer While it is not mandatory hospitals may also report events to Health Canada Send copy of completed Canadian Transfusion Adverse Event Reporting Form as per Provincial Territorial surveillance protocol For a list of Adverse Drug Reaction Centres go to http www hc sc gc ca dhp mps medeff report declaration centres Non Nominal data are reported to the Public Health Agency of mou Canada Surveillance by Provincial Territorial Blood Offices User s Manual m Version 3 0 9 Transfusion Transmitted Injuries Surveillance System 10 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Instructions to Complete the Canadian Transfusion Adverse Event Reporting Form For database users only Record closed Select Record closed in the database if the record has been closed Category of Event Select ONLY one of the following categories a b c Incident Select Incident with an x or 7 if an accident or error occurred Additional details are provided in Section 3a Incident Information Complete Sections 1 3
25. e tage Qu bec QC G1S 2M1 Canada Office phone 418 266 6729 Office fax 418 266 7510 New Brunswick Dr Holy Akwar Communicable Disease Epidemiologist Office of the Chief Medical Officer of Health NB Department of Health P O Box 5100 Carleton Place Fredericton NB E3B 5G8 506 453 2323 Fax 506 453 8702 Nova Scotia Carol MacEachern Program Manager Nova Scotia Provincial Blood Coordinating Program Room 7 130 7th Floor Centennial Building 1278 Tower Road Halifax NS B3H 2Y9 Office phone 902 473 2121 Office fax 902 473 2249 User s Manual m Version 3 0 Prince Edward Island Dr Eaid Kahwash Hematopathologist Division Head PEI Transfusion Service Dept of Lab Medicine Queen Elizabeth Hospital Charlottetown PE C1A 8T5 Phone 902 894 2328 Fax 902 894 2415 Newfoundland and Labrador Marilyn Collins Provincial Blood Coordinating Office Department of Health and Community Services PO Box 8700 St John s NL A1B 4J 6 Office phone 709 729 5246 Office fax 709 729 4009 63 Transfusion Transmitted Injuries Surveillance System Local Contact List for Canadian Blood Services http www bloodservices ca British Columbia amp Yukon 4750 Oak Street Vancouver BC V6H 2N9 Tel 604 879 7551 Fax 604 875 8004 Blood Products Dist Tel 604 876 7219 or 604 879 1433 Dr Gershon Growe Med Cons Tel 604 707 3449 Fax 604 875 8004 Edmonton 8249 114th Stre
26. e nursery neuro medical burn unit ER Emergency and or Trauma areas MSW Allinpatient care areas within a facility i e medical ward surgical hematology OB Obstetrics including labour and delivery case room and birth centre OR Operating room including day surgery REC Recovery Room including post anesthesia recovery CHR Chronic Care refers to long term care facilities units OP Outpatient refers to ambulatory care areas medical day units essentially where outpatients would come to receive a transfusion during daylight working hours Date and time reported Enter the date and time the adverse event was reported ddmmmyyyy and 00 00 to 23 59 User s Manual m Version 3 0 17 Transfusion Transmitted Injuries Surveillance System Section 3a Incident Information a b 18 Patient Identification Incident Select Patient Identification Incident with an x or v if an incident occurred involving the identification of the patient during the collection of the sample for type cross processing in the blood bank or during administration Examples Order on wrong patient Sample labelled with incorrect patient name Wrong patient collected Paperwork and sample ID do not match Sample testing error Order for pickup on wrong patient Wrong blood to patient transfusion Specify the details of the incident Product Related Incident Select Product Related Incident with an x or v if
27. e we are pleased to inform you that we will gladly accept reports made on the Canadian Transfusion Adverse Event Reporting Form Health professionals may submit reports toll free to Health Canada at Tel 866 234 2345 Fax 866 678 6789 Your call will be directed to the appropriate Adverse Reaction Regional Centre The Canadian Adverse Drug Reaction Monitoring Program at the Marketed Health Products Directorate MHPD is responsible for the collection and assessment of adverse reactions that have been submitted by health care professionals or consumers either directly or through market authorization holders In Canada Health Canada has had a system to gather information on adverse reaction reports since 1965 Information on all reported adverse reactions is maintained in a computerized database This database is a major tool in the ongoing assessment of marketed therapeutic health products 60 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System The Marketed Health Products Directorate MHPD of Health Canada is responsible for coordination of consistency of post market surveillance and assessment of signals and safety trends concerning all marketed health products The MHPD works in close collaboration with other Directorates in the Health Products and Food Branch and with other involved Branches The MHPD conducts the following range of activities monitors and collects adverse reaction and medication incid
28. e reaction Temperature Before Indicate the recipient s temperature in Celsius before the start of transfusion After Indicate the highest recipient temperature in Celsius obtained during the transfusion or within 4 hours of its completion Pulse Indicate the recipient s pulse before and after the transfusion Respiration Indicate the recipient s respiration rate per minute before and after the transfusion Blood Pressure BP Before Indicate the recipient s systolic and diastolic BP in mm of Hg before the start of the transfusion After Indicate the lowest systolic and diastolic BP hypotension or highest systolic and diastolic BP hypertension experienced by the recipient during the transfusion or within 4 hours of its completion Chills rigors Select Chills rigors with an x or if the recipient experienced chills and or rigors during the transfusion or within 4 hours of its completion User s Manual Version 3 0 23 Transfusion Transmitted Injuries Surveillance System 8 h j k 1 24 Urticaria Select Urticaria with an x or if the recipient experienced raised red spots with or without pruritis or if the recipient experienced generalized pruritis even without redness during the transfusion or within 4 hours of its completion Other skin rash Select Other skin rash with an x or if the recipient experienced a non urticarial skin rash S
29. ension if applicable of the CBS Medical Director f Date Enter the date ddmmmyyyy on which the CBS Medical Director completed the form g Time Enter the time 00 00 to 23 59 at which the CBS Medical Director completed the form User s Manual m Version 3 0 51 Transfusion Transmitted Injuries Surveillance System 52 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Appendices Blood Component Names and Codes 54 Plasma Derivative Product Names and Codes 56 Serious Adverse Events Requested by CBS 57 Contact Lists 24 4 5 044 RR AUR ECRIRE BAe ER RASE 58 User s Manual m Version 3 0 53 Transfusion Transmitted Injuries Surveillance System Blood Component Names and Codes Code Name 00180 CP2D WHOLE BLOOD 01480 CPD2 WHOLE BLOOD LRF 01461 CP2D WHOLE BLOOD LOW VOLUME LRF 04380 CP2D RED BLOOD CELLS LRF 04361 CP2D RED BLOOD CELLS LOW VOLUME LRF 04730 AS 3 RED BLOOD CELLS LRF 043771 AS 3 RED BLOOD CELLS DIVIDED LRF 00160 CPDA 1 WHOLE BLOOD 01471 CPDA 1 WHOLE BLOOD ADJUSTED ANTICOAGULANT 01467 CPDA 1 WHOLE BLOOD LRF 043671 CPDA 1 RED BLOOD CELLS DIVIDED LRF 04360 CPDA 1 RED BLOOD CELLS LRF 04371 CPDA 1 RED BLOOD CELLS LOW VOLUME LRF AUTOLOGUS ONLY 04870 RED BLOOD CELLS WASHED LRF 06400 RED BLOOD CELLS DEGLYCEROLIZED 06470 RED BLOOD CELLS
30. ent not attributable to a deviation from standard operating procedures or applicable laws or regulations that could adversely affect a the safety efficacy or quality of blood blood components or blood products plasma derivatives or b the safety of recipients Error An unexpected unplanned deviation from standard operating procedures or applicable laws and regulations usually attributable to a human or system problem that could adversely affect a the safety efficacy or quality of blood blood components or blood products plasma derivatives or b the safety of recipients Adverse Reaction An undesirable and unintended response to the administration of blood blood components or blood products plasma derivatives that is considered to be definitely probably or possibly related to these products Serious Adverse Event An adverse event that requires in patient hospitalization or prolongation of hospitalization directly attributable to the event results in persistent or significant disability or incapacity User s Manual m Version 3 0 1 Transfusion Transmitted Injuries Surveillance System necessitates medical or surgical intervention to preclude permanent damage to or impairment of a body function is life threatening or results in death Unexpected Adverse Event An adverse event that is not identified in nature severity or frequency among the currently known adverse effects associated wi
31. ent data reviews and analyses marketed health product safety data conducts risk benefit assessments communicates product related risks to health care professionals and the public coordinates regulatory advertising activities develops post approval policy and conducts active surveillance and drug effectiveness projects Please be advised that the contact person for this initiative on post market surveillance of plasma derivatives is Dr Carole L gar Manager Clinical section for Biologicals and Biotechnology Products Marketed Biologicals Biotechnology and Natural Health Products Bureau telephone 613 946 6506 fax 613 954 2354 e mail address Carole Legare hc sc gc ca We look forward to continuing to participate in this important work Christopher Turner MD FRCPC Director General Marketed Health Products Directorate User s Manual m Version 3 0 61 Transfusion Transmitted Injuries Surveillance System Contact List for Provincial Territorial Blood Offices Northwest Territories Robin Greig Manager Diagnostic amp Therapeutic Services Stanton Territorial Health Authority 550 Byrne Road Yellowknife NWT X1A 2N1 867 669 4165 Fax 867 669 4141 British Columbia amp Yukon Patti Thorne Administrative Director Provincial Blood Coordinating Office St Paul s Hospital Hornby Site 1081 Burrard Street Vancouver BC V6Z 1Y6 Ph 604 682 2344 Ext 63149 Fax 604 806 8824 Alberta M
32. erial contamination User s Manual m Version 3 0 47 Transfusion Transmitted Injuries Surveillance System allincidents that could possibly be traced back to the product or blood supplier centre NOTE See Reporting Guidelines To Provincial Territorial Blood Offices and Canadian Blood Services H MA QU BEC or Reporting Guidelines to Manufacturers of Blood Products Plasma Derivatives Select Yes with an x or Y if Canadian Blood Services or H MA QU BEC was contacted for issues related to blood blood components or the manufacturer of the blood product plasma derivative was contacted for issues related to it following an adverse transfusion event Document the name of the person contacted as well as the date and time on which they were contacted OR Select No with an x or if the blood supplier centre manufacturer was not contacted Status of Investigation 48 The investigation is defined as an inquiry into the causes of the incident or adverse reaction within the hospital Select one of the following i In progress Select In Progress with an x or 7 if an investigation is in progress ii Concluded Select Concluded with an x or 7 if an investigation has been concluded iii Cannot be conducted Select Cannot be Conducted with an x or 7 if an investigation was not conducted Document the reason an investigation was not conducted User s Manual m Version 3 0
33. et Edmonton AB T6G 2R8 Tel 780 431 0202 Fax 780 431 0461 Blood Products Dist Tel 780 431 0777 Dr J udith Hannon Med Dir Tel 780 431 8714 Fax 780 431 8770 Calgary 737 13th Avenue SouthWest Calgary AB T2R 1 1 Tel 403 410 2650 Fax 403 410 2794 Blood Products Dist Tel 403 589 3399 Dr Dale Towns Med Dir Tel 403 410 2676 Fax 403 410 2799 Saskatchewan Saskatoon amp Regina 2571 Broad Street Regina SK S4P 3B4 Tel 306 347 1666 Fax 306 347 1603 Blood Products Dist Tel 306 536 8444 Dr Ted Alport Med Dir Tel 306 347 1652 Fax 306 347 1604 64 Winnipeg 111 William Avenue Winnipeg MB R3E 3R4 Tel 204 789 1000 Fax 204 775 9215 Blood Products Dist Tel 204 789 1034 or Pager 204 932 1750 Dr Debra Lane Med Dir Tel 204 789 1079 Fax 204 783 6780 Sudbury 235 Cedar Street Sudbury ON P3B 1M8 Tel 705 674 2636 Fax 705 674 7165 Blood Products Dist Tel 705 674 4123 Dr Peter Lesley Med Dir Tel 613 560 7209 Fax 613 560 7226 London 850 Commissioners Road East London ON N6C 2V5 Tel 519 690 3999 Fax 519 690 3960 Blood Products Dist Tel 519 681 6783 Dr Morris Blajchman Med Dir Tel 905 525 9140 Ext 26276 Fax 905 527 4866 Central Ontario 67 College Street Toronto ON M5G 2M1 Tel 416 974 9900 Fax 416 974 9851 Blood Products Dist Tel 416 379 0559 Dr Benjamin Saxon Tel 416 313 4560 Fax 416 974 9757 User s
34. ferred to meet Health Canada regulatory requirements For a copy of the data elements transferred to the Public Health Agency of Canada for surveillance purposes contact your provincial territorial blood office or the Public Health Agency of Canada Please refer to the appropriate Contact List within the Appendices What do I do if a matter requires urgent attention It is important to remember that timeliness of reporting adverse events may be life saving In the event of a matter that requires immediate attention e g suspicion of acute bacterial infection related to a blood component the Medical Director responsible for blood transfusion and if appropriate the local Canadian Blood Services H MA QU BEC blood supplier centre or manufacturer of the blood product plasma derivative should be informed immediately by telephone so that urgent measures may be taken This form should then be completed to document the event and sent to the appropriate location as described in the Guidelines to Report Adverse Events 4 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Guidelines for Hospitals to Report Adverse Events to Provincial Territorial Blood Offices and Canadian Blood Services HEMA QUEBEC Timely reporting of serious unexpected adverse reactions facilitates effective risk management and regulatory decision making All suspected serious adverse reactions to blood blood components or blood products
35. he need for transfusion This may be a clinical decision by the Blood Safety Officer and or the Blood Bank Director or the diagnosis could be obtained from the hospital admission discharge system Standardized List for the patient diagnosis category Hematology Bone Marrow Transplant Oncology Medical Surgical Obstetrics Gyne Perinatal Trauma Neonatal Other Clinical History Select Other Clinical History with an x or 7 when providing additional information history that may be relevant to the transfusion Describe any previous reactions to drugs or allergies or clinical reactions to blood blood components or blood products plasma derivatives User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 3 Date Time and Place of Incident Adverse Reaction a b c Date and time adverse event occurred Enter the date and time the adverse event occurred ddmmmyyyy and 00 00 to 23 59 Place adverse event occurred Enter the location where the adverse event occurred using the following categories In the event of both an incident and adverse reaction occurring enter the location where the adverse reaction occurred ICU Intensive Care Unit OR Operating Room ER Emergency REC Recovery Room MSW _ Medical Surgical Ward CHR Chronic Care OB Obstetrics OP e Outpatient Clinic ICU All intensive care units including i e neonatal special car
36. hortness of breath Select Shortness of breath with an x or 7 if the recipient experienced the new onset or significant worsening of shortness of breath or a significant increase in respiratory rate with or without hypoxemia during the transfusion or within 24 hours of its completion Hypoxemia Select Hypoxemia with an x or Y if the recipient experienced PaO FiO lt 300 mm Hg Or Oxygen saturation lt 90 on room air or Other clinical evidence of hypoxemia Indicate the recipient s oxygen saturation on the line provided to the right of O sat Nausea vomiting Select Nausea vomiting with an x or Y f the recipient experienced nausea or vomiting during the transfusion or within 4 hours of its completion Pain Select Pain with an x or 7 if the recipient experienced pain during the transfusion or within 4 hours of its completion Specify the site of the pain in the space provided Example headache dorso lumbar abdominal thoracic User s Manual m Version 3 0 p q Transfusion Transmitted Injuries Surveillance System Jaundice Select Jaundice with an x or v if the recipient experienced new onset or worsening of scleral icterus Enter the total and indirect bilirubin results if available in Section 4b Abnormal Tests Laboratory Results as well as the pre transfusion results if available Hemoglobinuria Select Hemoglobinuria with an x or 7 if the rec
37. ified and that represents something new and unexpected and is of clinical significance i e red eye syndrome Other Select Other with an x or 7 if the recipient experienced any other type of transfusion reaction Specify the diagnosis Examples severe electrolyte imbalance atypical pain syndrome etc Note Atypical pain syndrome is defined as pain not usually associated with receiving a blood transfusion User s Manual m Version 3 0 41 Transfusion Transmitted Injuries Surveillance System Relationship of Adverse Event to Transfusion 42 Select one of the following i Definite Select Definite with an x or Y if a clinical and or laboratory event occurred within a time period consistent with the adminis tration of the blood blood component or blood product plasma derivative and was proven by investigation to have been caused by transfusion Bacterial contamination is considered Definite if it meets ALL of the following criteria The same bacteria are found in the recipient and the blood blood component or blood product plasma derivative Contamination of the blood sample or laboratory contamination is not suspected Probable Select Probable with an x or Y if a clinical and or laboratory event occurred within a time period consistent with the adminis tration of the blood blood component or blood product plasma derivative and did not seem to be explainable by any
38. ipient s urine became dark or reddish and if a urinalysis showed hemoglobin with or without red blood cells Oliguria Select Oliguria with an x or 7 if the recipient experienced a new onset of decreased urinary output within 72 hours of the identi fication of the transfusion reaction 500 cc output per 24 hours Diffuse Hemorrhage Select Diffuse Hemorrhage with an x or if the recipient experienced diffuse uncontrollable bleeding at puncture sites or catheter sites including hematuria or surgical wounds or diffuse mucocutaneous bleeding during the transfusion or within 4 hours of its completion Shock Select Shock with an x or if with severe hypotension the recipient experienced a drop in cardiac output including tachycardia tachypnea cutaneous vasoconstriction pallor sweating oliguria agitation and or loss of consciousness that required fluid resuscitation with or without inotropic support and an unexpectedly higher level of care User s Manual m Version 3 0 25 Transfusion Transmitted Injuries Surveillance System r Other Select Other with an x or Y if the recipient experienced any other relevant signs and symptoms during the transfusion or within 4 hours of its completion Specify the other signs and symptoms Example diaphoresis diarrhea epistaxis bronchospasm itching hyperkalemia hypercalcemia disseminated intravascular coagulation o
39. m Version 3 0 f 8 h Transfusion Transmitted Injuries Surveillance System Delayed Serological Transfusion Reaction new alloantibodies Select Delayed Serological Transfusion Reaction new alloantibodies with an x or Y f the recipient developed new alloantibodies in the 28 days following a transfusion with or without positive Direct Antiglobulin Test DAT but no clinical or laboratory signs of hemolysis Specify the antibody associated with the reaction in the space provided Examples anti C anti E anti c anti e anti G anti C anti K1 anti K2 anti JK anti JK anti S anti s anti Vel anti Fy anti Fy gt anti Wr anti Wr anti M anti N anti P anti Les anti Le anti I HLA Bacterial Infection Select Bacterial Infection with an x or v if the recipient developed a bacterial infection following a transfusion in association with the positive identification of a pathogen not previously identified in the recipient Specify the type of infection Refer to Section 4 to obtain this information Viral Infection Select Viral Infection with an x or Y if the recipient developed a viral infection associated with a transfusion which has been verified by confirmatory tests Specify the type of infection Examples hepatitis B HBV hepatitis C HCV human immuno deficiency virus HIV human T cell lymphotropic virus type I HTLV I and type II HTLV II cytomegalovirus CMV a
40. ministration of the blood blood component or blood product plasma derivative or if it occurred within a consistent time period but was proven to have no relationship to the transfusion Not Determined Select Not Determined with an x or if it cannot be determined if the recipient s death was related to the transfusion Major or Long Term Sequelae Select major or long term sequelae with an x or v if the recipient developed either an infection with a persistent infectious agent HIV Hepatitis C Hepatitis B or a transfusion reaction with major or long term sequelae or the anticipation of difficulties with future transfusions e g development of antibodies to antigens present in more than 95 of donations Minor or No Sequelae Select Minor or No Sequelae with an x or 7 if the recipient had no sequelae or permanent disability from the reaction or developed antibodies to low or medium frequency antigens lt 95 Not Determined Select Not Determined with an x or Y if the outcome of the adverse event is not certain Hospital Procedure Involved This section is to be completed if a hospital procedure was implicated in the incident adverse reaction a 46 Describe Describe the procedure related to the error incident in the first column User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System b Action List the name of the individuals or organizatio
41. modifications may be entered e g CMV Pooled Product Modification Codes IRR Irradiated CMV_ Negative for anti CMV D Deglycerolized DV Divided LV Low volume PR Plasma reduced W Washed P _ Pooled di Thawed User s Manual Version 3 0 29 Transfusion Transmitted Injuries Surveillance System b c d e f 8 h 30 Group of unit Enter the ABO and Rh group indicated on the bag or the label on the bag Blood Supplier Centre Code formerly Blood Centre Code Enter the blood supplier centre code formerly the blood centre code indicated on the bag or container Please refer to your local Canadian Blood Services or HEMA QUEBEC codes Unit no or Lot no Enter the unit of the blood blood component or lot number of the vial of blood product plasma derivative indicated on the bag or container Expiry date ddmmmyyyy Enter the date of expiration indicated on the bag or container ddmmmyyyy If the product has been modified enter the expiry date of the modified product Amount administered Enter the Amount administered along with the Unit of measure Or Enter the estimated Fraction 1 4 1 2 4 4 4 that was administered Transfusion Started Enter the date ddmmmyyyy and time 00 00 to 23 59 the transfusion was started Transfusion Finished Enter the date ddmmmyyyy and time 00 00 to 23 59 the transfusion was completed or di
42. nausea during the transfusion or within four hours of its completion without any other cause such as hemolytic transfusion reaction bacterial contamination or underlying condition Allergic Reaction Minor Select Minor with an x or 7 if the recipient experienced a skin reaction characterized by a transient urticarial or other skin rash with pruritus associated with the transfusion This reaction may be associated with localized angioedema without respiratory distress Severe Anaphylactic Anaphylactoid Select Severe Anaphylactic Anaphylactoid with an x or v if the recipient in addition to mucocutaneous signs symptoms experiences airway compromise or severe hypotension requiring vasopressor treatment The respiratory signs symptoms may be laryngeal tightness in the throat dysphagia dysphoria hoarseness strider or pulmonary dyspnea cough wheezing bronchospasm hypoxemia Anaphylactic Shock Select Anaphylactic Shock with an x or Y if the recipient experiences in addition to the above mentioned profound hypotension with loss of consciousness circulatory collapse or death User s Manual m Version 3 0 35 Transfusion Transmitted Injuries Surveillance System d e 36 Incompatible Transfusion Select Unintentional with an x or Y if the recipient was unintentionally given an incompatible transfusion Select Intentional with an x or if the recipient was intentionally given an i
43. ncompatible transfusion Select ABO System with an x or 7 if the incompatibility of this transfusion was in the ABO system Specify the antibody or antibodies identified Examples anti A anti B If ABO is selected complete section 3a Incident Information to identify the errors if any that existed at the origin of the ABO incompatible transfusion Select Other System with an x or Y if the incompatibility of the transfusion was exclusive of the ABO system Specify the antibody or antibodies identified Examples anti C anti E anti c anti e anti K1 anti K2 anti JK anti JK anti S anti s anti Fy anti Fy gt anti M anti Le anti Le HLA Hemolytic Reaction Hemolytic reactions cause the destruction of red blood cells as evidenced by a drop in hemoglobin an increase in indirect bilirubin and in LDH Accompanying clinical signs and symptoms may occur such as fever back pain and dyspnea Acute Select Acute with an x or 7 if the recipient experienced a hemolytic reaction within 24 hours of the receipt of the transfusion Delayed Select Delayed with an x or Y if the recipient experienced a hemolytic reaction more than 24 hours and up to 1 month following the transfusion Indicate the cause of acute and delayed hemolysis such as the antibodies involved in hemolysis of immune origin ABO incompatibility equipment or processes involved in mechanical hemolysis User s Manual
44. nd Epstein Barr virus West Nile virus WNv other Indicate whether the donor is infected or uninfected or whether this information is unknown with an x or v Other Infection Select Other Infection with an x or v if the recipient developed another infection associated with a transfusion which has been verified by confirmatory tests Specify the type of infection Examples malaria P Falciparum P Vivax babesiosis Lyme disease syphilis toxoplasmosis Creutzfeldt Jakob Disease other User s Manual m Version 3 0 37 Transfusion Transmitted Injuries Surveillance System j k 1 m 38 Donor Select Infected with an x or 7 if the donor is infected Select Uninfected with an x or 7 if the donor is uninfected Select Unknown with an x or if this information is unknown Specify the type of infection TACO Select TACO with an x or if the recipient experienced Transfusion Associated Circulatory Overload TACO characterized by dyspnea cyanosis orthopnea hypertension or congestive heart failure during or within 6 hours of completion of a transfusion TAD Select TAD with an x or Y if the recipient experienced Transfusion Associated Dyspnea TAD which is characterized by respiratory distress within 24 hours of transfusion that does not meet the criteria of TRALI TACO or allergic reaction Respiratory distress should not be explained by the patient
45. ns notified of the situation administration attending physician transfusion medicine committee etc the date of contact and the corrective measures remedial actions taken if any Equipment Supplies This section is to be completed if equipment or supplies were implicated in the incident adverse reaction a Describe Describe the equipment or supplies implicated in the incident adverse reaction Include brand names lot and model numbers b Action List the individuals or organizations notified of the situation administration attending physician transfusion medicine committee biomedical engineering etc the date of contact and the actions taken Medical Follow up This section is completed when medical follow up is applicable for example when long term sequelae are present a Treatment or Preventative Measures Describe any treatment or preventive measures taken following the reaction Blood Supplier Centre Manufacturer Notified The blood supplier centre manufacturer of the blood blood component or blood product plasma derivative should be notified as soon as possible of the following all transfusion reactions suspected of resulting in death as a consequence of the transfusion all transfusion reactions suspected of resulting in serious morbidity defined as a life threatening reaction or a reaction resulting in long term sequelae all infections bacterial viral parasitic suspected bact
46. on About the Canadian Transfusion Adverse Event Reporting Form 3 Guidelines to Report Adverse Events Guidelines for Hospitals to Report Adverse Events to Provincial Territorial Blood Offices and Canadian Blood ServiceHEMA QUEBEC b Guidelines for Hospitals to Report Adverse Events to Manufacturers of Blood Products Plasma Derivatives 8 Instructions to Complete the Canadian Transfusion Adverse Event Reporting Form 11 Catesory of Event 44 ran pannie n emo Re E sme 4 11 Facility Identification sus sess t pr ER 12 Section 1 Recipient Identification 13 Section 2 Clinical History 15 Section 3 Date Time and Place of Incident Adverse R ACHOM serino nona ses se ue oq ues 17 Section 3a Incident Information 18 Section 3b Premedication and Anesthesia 19 Section 3c Report of Possible Transfusion Related Blood Borne Infection 21 Section 4 Clinical Signs and Laboratory Results 23 Section 4a Clinical Signs and Symptoms 23 Section 4b Abnormal Tests Laboratory Results 26 Section 5 Suspect Blood Blood Components or Blood Products Plasma Derivatives 29 Section6 Measures Taken 31 User s Manual m Version 3 0 v Transfusion Transmitted Injuries Surveillance System Section 7 Results of Investigation amp Conclusion
47. other cause Bacterial contamination is considered Probable if it meets the following criteria Positive blood blood component or blood product plasma derivative culture Contamination of the blood sample or laboratory contamination is not suspected The recipient presents signs and symptoms of sepsis nothing else explains it The recipient s blood culture was not done No specimen was available A blood culture was not ordered The recipient s blood culture is negative The recipient is already taking antibiotics User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System iii Possible Select Possible with an x or Y if the clinical and or laboratory event occurred within a time period consistent with the administration of the blood blood component or blood product plasma derivative but could also be explained by a concurrent disease or by the administration of a drug or other agent Bacterial contamination is considered Possible if it meets the following criteria The recipient s blood culture is positive Contamination of the blood sample or laboratory contamination is not suspected The recipient presents signs and symptoms of sepsis nothing else explains it A blood blood component or blood product plasma derivative culture was not done No specimen was available A blood culture was not ordered iv Doubtful Select
48. owning Indirect Lung Injury Severe sepsis Shock Multiple trauma Burn injury Acute pancreatitis Cardiopulmonary bypass Drug overdose Indicate the time to recovery in hours in the space provided Indicate the risk factors for ALI involved in the space provided User s Manual m Version 3 0 39 Transfusion Transmitted Injuries Surveillance System 0 P q r 40 Hypotensive Reaction Select Hypotensive Reaction with an x or 7 if the recipient experienced a drop in systolic blood pressure by 30 mm Hg and a systolic blood pressure below 80 mm Hg or shock during the transfusion or within 4 hours of its completion without any other explanation for hypotension such as bacterial infection bleeding or severe allergic reaction Select ACE Inhibitors with an x or Y if the recipient was on ACE inhibitors PTP Select PTP with an x or 7 if the recipient develops Post Transfusion Purpura PTP characterized by a sudden severe thrombocytopenia platelet count 10 000 L 5 12 days after a cellular blood component transfusion This condition is most often associated with the presence of antibodies directed against the Human Platelet Antigen HPA system in the patient s serum TA GVHD Select TA GVHD with an x or if the recipient develops Transfusion Associated Graft Versus Host Disease TA GVHD characterized by fever skin rash which often starts on the palms the soles of the feet and
49. pairment of a body function Grade 2 Severe Select Grade 2 Severe with an x or 7 if the recipient requires in patient hospitalization or prolongation of hospitalization directly attributable to the event the adverse event results in persistent or significant disability or incapacity or the adverse event necessitates medical or surgical intervention to preclude permanent damage or impairment of a body function Examples aseptic meningitis severe headache with neck stiffness but recipient s life not threatened hemolytic reaction fever low back pain laboratory signs of hemolysis but patient stable and life not threatened and major allergic generalized urticaria dyspnea but no important bronchospasm Grade 3 Life threatening Select Grade 3 Life threatening with an x or v if the recipient required major intervention following the transfusion vasopressors intubation transfer to intensive care User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System iv Grade 4 Death v Select Grade 4 Death with an x or if the recipient s death was suspected to be the consequence of a transfusion reaction Describe the circumstances of death Not determined Select Not determined with an x or 7 if the consequences of the transfusion reaction are not certain Outcome of Adverse Event Select one of the following i Death Select Death with
50. r Ministry of Health c City Enter the city of the facility d Province Enter the province of the facility 12 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 1 Recipient Identification a b c d e f Last name Enter the recipient s last name First name Enter the recipient s first name Health card number Enter the recipient s health card number Hospital card number Enter the recipient s provincial territorial hospital card number as applicable Date of birth Enter the recipient s date of birth ddmmmyyyy Sex Enter the recipient s sex Select Male with an x or Y if the recipient is male Select Female with an x or if the recipient is female Select Other with an x or 7 if the recipient is a transgender individual or any other classification not described by the other headings Select Unknown with an x or 7 if the recipient s sex information is not known User s Manual m Version 3 0 13 Transfusion Transmitted Injuries Surveillance System 14 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 2 Clinical History a Blood group Enter the recipient s ABO A or B or O or AB with an x or 7 and enter the recipient s Rh type Pos or Neg with an x or v b Pregnancies Miscarriages Select Yes lt 3 mo with an x or v if the recipient is p
51. r an actual acute or chronic effect from the transfusion itself An adverse event could result from an incident error or accident or reaction This form may be used within hospitals for the reporting of all adverse events Each institution is responsible for ensuring that a process is in place to notify the individual who will be completing the form Who can complete this form Any health care professional can report a transfusion related adverse event Sections 1 through 6 of the form can be completed by the nurse laboratory technologist or the individual in your institution with the responsibility for reporting documenting and investigating blood transfusion reactions Section 7 should be completed by the individual responsible for interpreting blood transfusion reaction investigations e g pathologist blood bank medical director Under what circumstances must I complete two 2 forms on the same patient If the patient has had more than one adverse event in separate transfusion episodes then the separate adverse event details should be completed on separate forms If a patient has had more than one adverse event in the same transfusion episode then all the adverse event details can be reported on the same form A transfusion episode is all blood blood components or blood products plasma derivatives received within a 24 hour period or blood component product received on different admissions even if
52. regnant or has been pregnant within the past 3 months And or Select Yes gt 3 mo with an x or Y if the recipient was pregnant over 3 months ago Or Select No with an x or 7 if the recipient has never been pregnant Or Select Unknown with an x or 7 if this information is unknown c Transfusions Select Yes lt 3 mo with an x or v if the recipient received a previous transfusion of a blood blood component or blood product plasma derivative within the past 3 months And or Select Yes gt 3 mo with an x or v if the recipient received a previous transfusion of a blood blood component or blood product plasma derivative more than 3 months ago Or Select No with an x or Y if the recipient had not previously received a transfusion Or Select Unknown with an x or 7 if this information is unknown User s Manual m Version 3 0 15 Transfusion Transmitted Injuries Surveillance System d e f 16 Immune compromised Select Yes with an x or Y if the recipient is immunodeficient is taking medication that can cause immunosuppression or has an immunosuppressive disease Describe the reason for the recipient being immune compromised Examples include transplantation chemotherapy leukemia hepatitis hypogammaglobulinemia or other Patient Diagnosis Category Enter the patient diagnosis category from the standardized list that is most likely related to t
53. scontinued Comments This area should be used to Document if no one product could be determined to be the likely cause of the reaction Document if it was an autologous donation or directed designated donation Document any abnormal findings e g discoloration temperatures presence of clots Document the trade name if the blood product plasma derivative was identified e g Gamunex User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 6 Measures Taken Select all that apply a b d f 8 h None Select None with an x or Y if the reaction required no particular measures Transfusion Stopped Select Transfusion Stopped with an x or 7 if the transfusion was discontinued Transfusion Restarted Select Transfusion Restarted with an x or v if the transfusion was restarted Antipyretics Select Antipyretics with an x or Y if these were administered for the transfusion reaction e g acetaminophen Analgesics Select Analgesics with an x or Y if these were administered for the transfusion reaction Antihistamines Select Antihistamines with an x or v if these were administered for the transfusion reaction e g Benadryl Steroids Select Steroids with an x or 7 if these were administered for the transfusion reaction e g Solumedrol Solucortef Diuretics Select Diuretics
54. sfusion Transmitted Injuries TTI Section http Www phac aspc gc ca hcai iamss tti it Email address TTI Section IT phac aspc gc ca User s Manual m Version 3 0 59 Transfusion Transmitted Injuries Surveillance System Marketed Health Products Directorate http www hc sc gc ca ahc asc branch dirgen hpfb dgpsa mhpd dpsc index e html Subject Guidelines for Hospitals to Report Adverse Events for Plasma Derivatives to Manufacturers Your experience with any problems associated with plasma derivatives is important to the Canadian Adverse Drug Reaction Monitoring Program CADRMP Adverse reaction information is used by Health Canada to help ensure the benefits of a health product continue to outweigh the risks to update the labelling and product information for a health product and to work with market authorization holders and other stakeholders to inform Canadians about adverse reactions While serious adverse events to plasma derivatives and those which may question the safety of these products should always be reported to the market authorization holder manufacturer who is in a position to take immediate action whether by putting a product in quarantine pulling a lot number from circulation etc CADRMP is interested in receiving copies of all these adverse reactions Our reporting form can be found at the following address http www hc sc gc ca dhp mps medeff report declaration form index e html However for your convenienc
55. th the administration of blood blood components or blood products plasma derivatives Blood Component A therapeutic component of blood intended for transfusion e g red cells granulocytes platelets cryoprecipitate plasma that can be prepared using the equipment and techniques available in a blood supplier centre e g by centrifugation filtration or freezing Blood Product Plasma Derivative A product derived from human or animal plasma by a fractionation process Note Examples of blood products plasma derivatives are human serum albumin solvent detergent products immunoglobulin preparations factor IX or factor VIII concentrate products Examples of related products are porcine factor VIII and coagulation factors produced using recombinant DNA Provincial Territorial Blood Office An office department established in each province or territory to manage the collection of data regarding adverse events related to transfusion 2 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Information About the Canadian Transfusion Adverse Event Reporting Form What tri ers completion of the Canadian Transfusion Adverse Event Reporting Form Any event that may result or has resulted in untoward consequences from blood blood components or blood products plasma derivatives should trigger the completion of this form This could consist of an event that places a patient at risk of poor outcome o
56. the ear lobes elevated liver enzymes ALT and AST alkaline phosphatase and bilirubin pancytopenia and diarrhea occurring 1 to 6 weeks following transfusion The reaction is very severe and results in death in over 90 of cases To prevent GVHD in Canada blood components are routinely irradiated for directed donor transfusions bone marrow transplant recipients newborns who have received in utero transfusions and or low birthweight newborns Transfusion associated GVHD is rare and most commonly occurs in immunocompromised recipients who do not receive irradiated blood components Hemochromatosis Select Hemochromatosis with an x or 7 if the recipient developed clinical or pathological evidence of hemochromatosis iron overload as a result of repeated red cell transfusions User s Manual m Version 3 0 s t u v Transfusion Transmitted Injuries Surveillance System Aseptic Meningitis Select Aseptic Meningitis with an x or if the recipient experienced headache with meningismus or a deterioration in mental status after receiving IVIG Recipient may also have fever nausea vomiting pharyngitis diarrhea and photophobia IVIg Headache Select IVIg Headache with an x or if the recipient develops a headache during or shortly after Intravenous Immunoglobulin IVIg administration Unknown Select Unknown with an x or if the recipient experienced a reaction that cannot be class
57. ther Clinical Information for TRALI s t u Chest X ray Results Select Bilateral Infiltrates with an x or Y if recipient had bilateral pulmonary infiltrates or white lungs or signs of bilateral pulmonary edema Select Other with an x or 7 if the recipients chest x ray shows other relevant signs and describe Evidence of Circulatory Overload Select Yes with an x or 7 if there is evidence of circulatory overload Explain in the space provided Select No with an x or 7 if there is no evidence of circulatory overload Explain in the space provided Hospital Sample Collection to be sent to blood supplier centre Call your local blood supplier centre to obtain the most up to date shipping and sample requirements for patient samples transfused unit s sample s when available and crossmatch testing samples time sensitive samples Section 4b Abnormal Tests Laboratory Results a 26 Name of Laboratory Tests This section reports on the results of laboratory tests related to the investigation of the adverse event Enter the Name of Laboratory Tests and enter the Date Specimen Taken ddmmmyyyy then select the Results with an x or 7 as positive negative elevated or decreased Example indirect bilirubin total bilirubin plasma hemoglobin creatinine haptoglobin LDH Coombs test DAT other User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System b
58. tient a transfusion reaction should be suspected if any one of the following occurs during or within 4 hours of receiving a transfusion Urticarial skin rash Unexplained increase in airway pressures Unexpected shock Unexpected death Hemoglobinuria A drop in hemoglobin in the absence of bleeding Unusual hemoglobin results with evidence of hemolysis Clinical evidence of disseminated intravascular coagulation User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 3e Report of Possible Transfusion Related Blood Borne Infection a Bacterial infection Select Bacterial infection with an x or 7 if a bacterial infection is suspected b Viral infection Select Viral infection with an x or 7 if a viral infection is suspected c Other infection Select Other infection with an x or 7 if another type of infection is suspected User s Manual m Version 3 0 21 Transfusion Transmitted Injuries Surveillance System 22 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Section 4 Clinical Signs and Laboratory Results Section 4a Clinical Signs and Symptoms NOTE These definitions are guidelines and should not preclude the use of clinical judgement a b c d e f No Clinical Sign Symptom Select None with an x or 7 if the recipient did not demonstrate any clinical signs symptoms of an advers
59. uidance for industry on reporting adverse reactions to marketed drugs to Health Canada at http www hc sc gc ca dhp mps medeff report declaration guide guide Idir indust e html Manufacturers of blood products plasma derivatives should receive reports of all unexpected or serious adverse events that require in patient hospitalization or prolongation of hospitalization directly attributable to the event or adverse reaction result in persistent or significant disability or incapacity necessitate medical or surgical intervention to preclude permanent damage or impairment of a body function are life threatening or result in death Please see the flowchart titled Guidelines for Hospitals to Report Adverse Events for Blood Products Plasma Derivatives to Manufacturers Note A hospital may also choose to use the Canadian Transfusion Adverse Event Reporting Form to report these events directly to CADRMP through the Regional Adverse Drug Reaction Centre Contact information for the manufacturers of blood products plasma derivatives can be found on the Canadian Blood Services website at the following address http www blood ca centreapps internet uw v502 mainengine nsf page E PlasmaProducts or in the yellow pages of the Compendium of Pharmaceuticals and Specialties 8 User s Manual m Version 3 0 Transfusion Transmitted Injuries Surveillance System Guidelines for Hospitals to Report Adverse Events for Blood Pro
60. us adverse If bacterial contamination is events with potential relation to suspected report to CBS HO product quality to CBS HQ within 24 hours by phone and fax Complete remaining fields on Canadian Transfusion Adverse Event Reporting Form Send copy of completed Canadian Transfusion Adverse Event Reporting Form to CBS HQ who will report to Health Canada s regulatory branch Send copy of completed Canadian Transfusion Adverse Event Reporting Form as per Provincial Territorial surveillance protocol Non Nominal data are reported to the Public Health Agency of Canada Surveillance by Provincial Territorial Blood Offices User s Manual m Version 3 0 7 Transfusion Transmitted Injuries Surveillance System Guidelines for Hospitals to Report Adverse Events to Manufacturers of Blood Products Plasma Derivatives What Adverse Events are to be Reported to Manufacturers of Blood Products Plasma Derivatives All relevant information data from the Canadian Transfusion Adverse Event Reporting Form concerning suspected serious adverse events is to be provided to manufacturers of blood products plasma derivatives to allow appropriate investigation assessment and action Manufacturers of blood products plasma derivatives are required to report suspected serious adverse reactions to the Canadian Adverse Drug Reaction Monitoring Program CADRMD Marketed Health Products Directorate within 15 days of receiving the report See the G

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