Transfusion Transmitted Injuries Surveillance System
Project Progress Report 2001-2002

Appendix 3: Definitions

Adverse Event: An undesirable and unintended occurrence during or after the administration of blood, blood components, or plasma derivatives whether or not considered to be related to the administration of blood, blood components, or plasma derivatives.

Note: The following are considered to be adverse events:

1. Incident: An accident or error that could lead to an adverse outcome affecting:
    
   1. the safety, efficacy or quality of blood, blood components, or plasma derivatives; or
   2. the safety of recipients.

   Accident: An unexpected or unplanned event, not attributable to a deviation from standard operating procedures or applicable laws or regulations that could adversely affect:

   1. the safety, efficacy or quality of blood, blood components, or plasma derivatives; or
   2. 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:

   1. the safety, efficacy or quality of blood, blood components or plasma derivatives; or
   2. the safety of recipients.
       
2. Adverse Reaction: An undesirable and unintended response to the administration of blood, blood components, or plasma derivatives that is considered to be definitely, probably or possibly related to the administration of blood, blood component, or plasma derivatives.
    
3. Serious Adverse Event: An adverse event which:
   • requires in-patient hospitalization or prolongation of hospitalization directly attributable to the event,
   • results in persistent or significant disability or incapacity,
   • necessitates medical or surgical intervention to preclude permanent damage or impairment of a body function,
   • is life-threatening, or
   • results in death.
      
4. Unexpected Adverse Event: An adverse event that is not identified in nature, severity or frequency among the currently known adverse effects associated with the administration of blood, blood components, or plasma derivatives.

Relationship to transfusion

Definite

If a clinical and/or laboratory event occurred within a time period consistent with the administration of the blood product and was proven by investigation to have been caused by transfusion.

Bacterial contamination is considered “definite” if it meets ALL the following criteria:

1. The recipient must demonstrate any of the following signs and symptoms of sepsis during or within 4 hours of the transfusion (fever, rigors, tachycardia, drop or rise in systolic blood pressure by > 30 mmHg)
2. Positive blood product culture
3. Recipient blood culture growing the same organism as that recovered from the blood product.

Probable

If a clinical and/or laboratory event occurred within a time period consistent with the administration of the blood product and did not seem to be explainable by any other cause.

Bacterial contamination is considered “probable” if it meets the following criteria:

1. The recipient must demonstrate any of the following signs and symptoms of sepsis during or within 4 hours of the transfusion (fever, rigors, tachycardia, drop or rise in systolic blood pressure by > 30 mmHg)
2. Positive blood product culture.
   

Possible

If the clinical and/or laboratory event occurred within a time period consistent with the administration of the blood product but could be explained by a concurrent disease or by the administration of a drug or other agent.

Not determined

If it remains to be determined whether the event was related to the administration of the blood product and further information is forthcoming.

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