Transfusion Transmitted Injuries Surveillance System
Project Progress Report 2001-2002

Appendix 2: Minimum Data Elements for Reporting of Transfusion Related Adverse Events to Health Canada

Minimum Data Elements for Reporting of Transfusion Related Adverse Events to Blood Safety Surveillance and Health Care Acquired Infections Division of Health Canada²

Section 1: Recipient Identification

Age (year and month of birth)
Sex (male and female)
Case number (linked to provincial number for follow-up)

Section 3: Time and Place of Incident/Adverse Reaction

Date and time of reaction
Use of equipment (pumps, blood warmer, etc)

Section 4: Clinical Signs and Laboratory Results

Fever (temperature before and after), Hypotension/Hypertension (BP before and after), Oliguria, Diffuse Hemorrhage, Urticaria, Nausea/Vomiting, Jaundice, Tachycardia, Chills/Rigors, Shortness of Breath, Shock, Death, Other skin rash, Pain, Hemoglobinuria, Other

Bacterial Infection:
Blood Culture Recipient: Negative/Positive, Organism Identified
Blood Culture of Product: Negative/Positive, If positive, Lot #, Organism Identified

Section 5: Suspect Products

Transfused product code or name
Hospital modification code
Autologous unit
Expiry date of product
Date and time of transfusion

Section 7: Results of Investigation & Conclusion³

Severe Allergic Reactions, e.g., Anaphylactic/Anaphylactoid - Signs
   and Symptoms
ABO Incompatibility
Acute Haemolytic Reactions
Viral Infections (type)
Bacterial Infections
Other Infections
Transfusion Related Graft-Versus-Host Disease (TR-GVHD)
TRALI
Post Transfusion Purpura
Unknown⁴
Others (specify)³
Severity : (Death/Life-threatening/Long-term sequelae/Minor or no sequelae/
   Not determined)
Relationship to Transfusion: (definite, probable, possible and not determined)

Footnote

2. Version 2, April 23, 2003
3. All events listed in Section 7, with the exception of Unknown and Others, will be reported to the National level regardless of the severity of the outcome.
4. All Unknown and Other events will only be reported to the National level for Death, Life-threatening and Long-term sequelae (severe).

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