Transfusion Transmitted Injuries Surveillance System
Project Progress Report 2001-2002

2. Methodology

2.1 Transfusion Reaction Reporting

The mechanism of transfusion reaction reporting varies across the provinces.

2.1.1 British Columbia

The Provincial Blood Coordinating Office (PBCO), which coordinates the British Columbia (B.C.) Blood Surveillance project, the B.C. Adverse Event Reporting System (AERS), selected eight hospitals with six blood banks to participate in the ttiss project according to the 'specific monthly transfusion volumes of red blood cells, their commitment to quality improvement in transfusion and their willingness to participate in the development of a standardized reporting system'. These hospitals transfuse approximately 50% of blood products in the province. They worked with the PBCO to assess and redesign adverse reaction reporting, resulting in the establishment of a standard process for data collection and reporting. Forms and guidelines were developed and software made available for the collection and reporting of transfusion reactions to the PBCO. These are different from the ttiss form, User's Manual and database but compatible. Definitions of transfusion reactions were similar to those used by the other provinces. Seven hospitals/sites started reporting data on April 2001, and another one began in November 2001. Since this date, there has been ongoing rollout and reporting from facilities across the province.

Following a transfusion reaction, a team consisting of a nurse, a technologist and a pathologist worked together at each site to investigate and report the reaction to the PBCO. Transfusion reactions data were collected either through the manual reporting form or the electronic transmission of the data to the PBCO.

Manual reporting

Once a transfusion reaction was reported to the blood bank, the designated technologist conducted a preliminary review to ensure the form was complete and determined if the cases met ttiss requirements for reporting. For serious reactions, an investigation was performed, and when completed, the case was faxed to the PBCO for data entry into the PBCO master AERS system that was set up to export the cases to Health Canada.

Electronic reporting

For sites reporting electronically, all cases for which an investigation was completed were exported monthly to the PBCO on a diskette. These cases were then imported into the PBCO master system. The master AERS system at the PBCO contains only completed cases that have been investigated and validated.

Sites that reported adverse events of transfusion received, on a monthly basis, a summary of all reactions received at the PBCO and were asked to review them in order to ensure that no cases were missed. On a quarterly basis, a summary of all data submitted by the sites was once again sent back to them for review and reconciliation prior to exporting the cases in an encrypted text file to Health Canada.

2.1.2 Quebec

In Quebec, all 33 hospitals that were already participating in the Hemovigilance System participated in the 'Quebec Blood Surveillance Project' funded by Health Canada. These hospitals are served by 43 blood banks and transfuse about 80% of components in the province. All adverse transfusion reactions are reported to the Quebec Blood Secretariat since February 2000. Data reporting to Health Canada started in April 2002, with data collected since April 2001.

Manual reporting

At the beginning of Quebec's project, hospitals were reporting transfusion reactions manually. A standardized reporting form similar to the ttiss form was completed and signed by a transfusion safety officer. The diagnosis and association with transfusion were validated and signed by the hematologist in charge of the blood bank and the form was then sent to the Quebec Blood Secretariat where further validation was done by a provincial transfusion safety officer. The data were entered into a MS Access database and all serious adverse reactions were reviewed and validated by the project director.

Electronic reporting

An online reporting system, using the Lotus Notes messaging system, was implemented in health care facilities in April 2001 and most hospitals have been reporting online. A provincial transfusion safety officer reviewed submissions from hospitals on a daily basis and took steps to validate the data. As with the manual reporting, electronic forms for serious adverse events were reviewed and validated by the project director. Data on serious adverse events meeting ttiss requirements for reporting were extracted and an Excel file sent to Health Canada.

2.1.3 Nova Scotia

The Nova Scotia Blood Surveillance Project created and implemented a surveillance process for adverse reactions in eight hospitals/sites that transfuse approximately 52% of blood products in the province. Two sites started reporting transfusion data in June and October 2001, respectively, and another one in January 2002. The five remaining sites have reported transfusion reactions since mid June 2002.

The process of transfusion reaction reporting for each site was developed and implemented with a key laboratory partner, medical director and laboratory staff member. The implementation process involved education sessions on transfusion reactions to laboratory and nursing staff at each site.

Transfusion reaction information was sent by the blood bank laboratory staff to the project office by fax. The project coordinator who also functioned as a transfusion safety officer gathered the required information. Data were entered into a database at the project office after validation by the Blood Transfusion Service Medical Director and exported in an encrypted text file to Health Canada.

2.1.4 Prince Edward Island

The Prince Edward Island (P.E.I.) project on Transfusion Transmitted Injuries Surveillance was implemented province-wide through creation of a provincial Central Transfusion Registry that captures all transfusions and associated reactions. All seven P.E.I. hospitals participated in the surveillance project. Two blood banks, associated with these hospitals, provide 100% of blood products in the province.

When a transfusion reaction occurred, the hospitals filled out the ttiss form and initiated the investigation of the reaction. Forms were collected by a transfusion safety officer during quarterly on-site visits. The transfusion safety officer reviewed the forms and results of the investigation. The forms were submitted to the medical director for approval and validation of the diagnostic category and association with transfusion. The cases were then entered into the database installed by Health Canada and relevant data were exported to Health Canada, in a Microsoft Access Database (MDB) file.

2.2 Analyses

Data received from the provinces were compiled in a MS Access database, maintained in the TTI Section and exported to SPSS 10.0 for analysis. Descriptive analyses of the data reported were conducted, including number and proportion of each category of adverse events, their distribution by age and by sex, and their severity and relationship to transfusion. Suspected blood products implicated in these reactions were also analyzed. For the purpose of this analysis, only adverse events occurring during the period April 1, 2001 to June 30, 2002 were included.

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