Download Blood Components (red blood cells, platelets, plasma)

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.
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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