Overview of Adverse Transfusion Reaction Reporting for Hospitals in Canada - Supplement: Contacts for National ATR Report Recipients and Provincial TTISS Personnel

For reporting the investigation of Adverse Transfusion Reactions (ATRs) under the Blood Regulations, any form can be used but must include all the required information as specified in the Blood Regulations and Blood Regulations Guidance Document. Please refer to your provincial TTISS or blood coordinating office to determine which form is accepted and recommended.

For general blood-related inquiries or for suspected lot-associated issues (such as potential clusters of serious and non-serious reactions), you may wish to notify canada.vigilance.blood-sang@hc-sc.gc.ca prior to sending the reporting form(s).
*Please do not send copies of completed reports containing patient information to this email address.

As per the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), which amended the Food and Drug Act, reporting is done directly to Health Canada – Canada Vigilance Program (CVP). To provide the greatest flexibility for hospitals, and to allow them to use their existing systems and processes, Health Canada is able to receive serious adverse drug reactions or medical device incident reports through a variety of submission methods such as fax, mail or the online reporting portal. Further details as to what products are subjected to these regulations can be found in the Overview document.

Hospitals must submit a report which includes all the required information as detailed in Health Canada – CVP’s Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals – Guidance document.

FAX or Mail appropriate form to:

Canada Vigilance Program
Health Products Surveillance and Epidemiology Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator: 1908C
Ottawa ON K1A 0K9
Fax 1-866-678-6789
E-mail: canadavigilance@hc-sc.gc.ca (Do not send reports via email, for inquiries only)

We encourage hospitals to contact the Canada Vigilance Program (canadavigilance@hc-sc.gc.ca) should they have any questions related to the mandatory reporting regulations.

Hospitals are also strongly encouraged to send a copy of the completed report to the manufacturer. If you wish to send a copy of the report to the manufacturer, you may download the Manufacturer Contact List at the website: https://www.blood.ca/en/hospitals/plasma-products.

For ATRs that occur as a result of blood component transfusion where there is concern related to product quality and safety, reports must be submitted by hospitals to their local blood operator distribution site (Canadian Blood Services (CBS) or Héma-Québec (HQ)). CBS and HQ report to the Health Canada – CVP.

Should the hospital transfusion medicine lab manipulate the blood components implicated in the ATR (e.g. pooling the blood component which causes a bacterial infection), the hospital reports directly to Health Canada – CVP. There may be some discussion about the ATR with CBS or HQ to review the cause of the bacterial infection and determine whose responsibility it is to report (CBS or HQ, or the hospital transfusion medicine laboratory).

Within Québec, HQ also requires they receive all blood product ATR reports from hospitals, in addition to the Health Canada – CVP. A report on implicated products must also be completed by transfusion safety staff for submission to the Québec Hemovigilance System REIAT (Rapport d’événement indésirable associé à la transfusion) database.

All ATRs are to be reported to the provincial/territorial TTISS Office, or the Institut national de santé publique du Québec (INSPQ) via the REIAT database in Québec. Some Canadian provinces may have an online database or provincial version of the ATR data submission form. Official paper versions of data collection documents for TTISS are:

• Provinces/Territories (except Québec): Canadian Transfusion Adverse Event Reporting Form (CTAERF)
• Québec: REIAT – Rapport d’événement indésirable associé à la transfusion.

Provinces and territories report aggregate de-identified data to the Public Health Agency of Canada as part of the National TTISS program. Each province/territory collects ATR data through various processes. Provincial/territorial contacts responsible for TTISS ATR data reporting are as follows:

1. British Columbia & Yukon
   Aimee Beauchamp
   Lead, Business Operations, BC Provincial Blood Coordinating Office
   BC Provincial Laboratory Medicine Services
   Provincial Health Services Authority
   Office: 1867 West Broadway, 3rd Floor, Vancouver, BC V6J 4W1
   Office Phone: 604-714-2871 (working remotely, please use email for contact)
   abeauchamp@pbco.ca | www.pbco.ca
    
2. Alberta
   Samantha Cassie
   Manager, Transfusion Medicine Services
   Divisional Services Branch, Pharmaceutical & Supplementary Benefits Division
   780-983-9811 (mobile)
   780-644-8969 (office)
   Samantha.Cassie@gov.ab.ca
   
   Henry Sintim
   Provincial TTISS Coordinator
   henry.sintim@gov.ab.ca
    
3. Saskatchewan
   Elaine Blais
   Manager, Transfusion Safety and Patient Blood Management, Clinical Excellence
   Saskatchewan Health Authority
   Cell: 306-441-7210
   elaine.blais@saskhealthauthority.ca
    
4. Manitoba
   Shana Chiborak
   Nurse Manager, Blood Management Service
   Shared Health Manitoba
   431-278-5196
   schiborak@sharedhealthmb.ca
   
   Brittani Rainkie
   Nurse Coordinator, Blood Management Service
   Shared Health Manitoba
   204-926-7006
   brainkie@hsc.mb.ca
    
5. Ontario
   Melanie St. John
   Provincial Coordinator
   McMaster Centre for Transfusion Research
   Stjohm1@mcmaster.ca
   Website: https:\\ttiss.mcmaster.ca
    
6. Québec
   Andréanne Trottier
   Conseillère en biovigilance
   Ministère de la Santé et de Services sociaux
   andreanne.trottier@msss.gouv.qc.ca
   1075, chemin Sainte-Foy, 9e étage, Québec (Québec) G1S 2M1
   Téléphone : 581-814-9100, poste 62553
   Website: https://www.msss.gouv.qc.ca/professionnels/soins-et-services/biovigilance/fonctionnement/
    
7. Nova Scotia
   Jennifer LeFrense
   Manager, Provincial Blood Coordinating Team
   jennifer.lefrense@nshealth.ca
   Website: http://www.cdha.nshealth.ca/nova-scotia-provincial-blood-coordinating-team
   
   Michael Farrell
   Utilization Management Coordinator
   Nova Scotia Provincial Blood Coordinating Team
   902-487-0508
   michael.farrell@nshealth.ca
    
8. New Brunswick
   Sophie Traer MacKinnon
   Health Care Consultant - NB Blood System Coordinator
   Conseillère en soins de santé - Coordinatrice du Système Sanguin du N.-B.
   Health Services Division/Division des services de santé
   Department of Health/Ministère de la Santé
   HSBC Place, 520 King Street
   Fredericton, New Brunswick E3B 6G3
   sophie.traermackinnon@gnb.ca
    
9. Newfoundland and Labrador
   Newfoundland and Labrador Provincial Blood Coordinating Program
   nlpbcp@gov.nl.ca
    
10. Prince Edward Island
    Ami MacQuarrie
    Medical Laboratory Specialist
    Queen Elizabeth Hospital
    PO Box 6600
    60 Riverside Dr.
    Charlottetown, PE C1A0E3
    Ph: 902 894 2329
    Email : anmacquarrie@ihis.org
     
11. Northwest Territories
    Amy Richardson | Technical Specialist Transfusion Medicine
    Northwest Territories Health and Social Services Authority - Stanton Territorial Hospital |
    L'Administration des Services de Santé et des Services Sociaux des Territoires du Nord-Ouest- Hôpital territorial Stanton
    548 Byrne Road, PO Box 10/548, chemin Byrne, C. P. 10
    Yellowknife NT X1A 2N1
    Phone | Tél. : 867-767-9300 ext 46465
    Fax | Téléc. : 867-669-4306
    Email | Courriel : Amy_Richardson@gov.nt.ca