Provincial Reporting Process for Adverse Transfusion Reactions
Clinical Service Provider
Recognition of an adverse reaction or infection to Blood Component, Plasma Protein Product or an Error/Accident
contributing to an adverse or unexpected reaction to a blood component or plasma protein product.
(Note: Transfusion Transmitted Diseases (TTDs) may develop years after transfusion)
* “It’s the Law”
Defines which transfusion transmissible diseases
MUST be reported to Public Health Services.
http://novascotia.ca/dhw/cdpc/documents/06026_ItsTheLawPoster_En.pdf *
Report to BTS
BTS Responsibilities
Adverse Reaction to Plasma
Protein Product (PPP)
Adverse Reaction to a Blood
Component
Yes
Yes to
ALL
Immediately Report
to the NSPBCP
AND if due to
Product Quality or a
CBS activity ***
report to CBS as
well via the
Canadian
Transfusion Adverse
Event Reporting
Form (CTAER)
Fax COMPLETED
report within 48
hours of initial
report
No to
ANY
Immediately
Report to
NSPBCP via
Canadian
Transfusion
Adverse Event
Reporting Form
(CTAER)
Report to
NSPBCP via
Canadian
Transfusion
Adverse Event
Reporting
Form
(CTAER) at
month end
Phone and Fax Numbers:
NSPBCP: (P) 902-487-0504
(F) 902-422-0893
CBS:
(P) 902-480-5678
(F) 902-480-5677
Health
(P) 902-426-2160
Canada: (F) 902-426-6676



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Did the E/A
1. Occur during a regulated activity*?
2. Get identified after the blood was
distributed or transfused?
3. Have reasonable probability that it
could lead to a serious reaction?
Was the reaction
serious?
Was the reaction serious or unexpected** and/or
did the reaction occur due to:
1. The product quality or;
2. A CBS activity or;
3. An E/A of a regulated activity*
performed at the hospital
Error or Accident
No
Report to
NSPBCP via
Canadian
Transfusion
Adverse
Event
Reporting
Form
(CTAER) at
month end
Yes to
ALL
Telephone Health
Canada
Immediately
Report through the
Hospital Error
Reporting System
(SIMS/TESS)
And NSPBCP via
fax of the Health
Canada Blood Error
or Accident
Investigation
Preliminary Report
Form (FRM_0337)
No to
ANY
Report
through
Hospital
Error
Reporting
System
SIMS/TESS
* Regulated Activities include processing, transformation,
labeling, storing, record keeping, importing and distributing.
** Unexpected Reaction an adverse reaction that is not identified among the possible adverse reactions in either the circular of information or in any
other information provided to the recipient.
Serious Adverse Reaction
Requires in-patient hospitalization or prolongation of hospitalization directly attributable to the event; or
Necessitates medical or surgical intervention to preclude permanent damage or impairment of a body function; or
Is life-threatening; or
Results in death
Report ALL Serious Reactions to NSPBCP
*** Reactions relating to Product Quality reportable to CBS include, but are not limited to:
 TRALI
 Bacterial contamination
 Severe allergic or anaphylactic
 any other reaction which is thought to be related to the blood component
Provincial Reporting Process for Adverse Transfusion Reactions 1.3 November 2016
Provincial Reporting Process for Adverse Transfusion Reactions
NSPBCP Responsibilities
Adverse Reaction to Plasma
Protein Product (PPP)
Adverse Reaction to a Blood
Component
Did the reaction occur due to?
1. The product quality or;
2. A CBS activity or;
3. An E/A of a regulated activity*
performed at the hospital
Yes
Report to
Canada
Vigilance
Ottawa
within in
24 hours
and TTISS
E/A occurred during a regulated
activity, was identified after the blood
was distributed and/or transfused and
there is probability that the transfusion
could lead to a serious adverse
reaction?
No
Was the reaction
serious?
Yes
Report to Canada
Vigilance – Atlantic,
the manufacturer and
TTISS
Error or Accident
Report to TTISS
Report to
Inspectorate Halifax
by faxing Canadian
Blood Error or
Accident
Investigation
Preliminary Report
Form (FRM_0337)
No
Report to
Canada
Vigilance
Ottawa and
TTISS
NOTE: CBS to report to Canada Vigilance if
due to a CBS activity or Product Quality
Provincial Reporting Process for Adverse Transfusion Reactions 1.3 November 2016