Table of Contents: Evaluation of the Blood Safety Contribution Program at the Public Health Agency of Canada 2008–09 to 2013–14

Prepared by
Evaluation Directorate
Health Canada and the Public Health Agency of Canada

March 2014

Executive summary

This evaluation covered the Blood Safety Contribution Program (BSCP) for the period from 2008-09 to 2013-14. The evaluation was undertaken in fulfillment of the requirements of the Financial Administration Act and the Treasury Board of Canada's Policy on Evaluation (2009).

Evaluation Purpose and Scope

The purpose of the evaluation was to assess the relevance and performance of the BSCP. It reviewed the activities led by the Centre for Communicable Diseases and Infection Control within the Infectious Disease Prevention and Control Branch, at the Public Health Agency of Canada. These activities primarily focussed on three surveillance systems: the Transfusion Transmitted Injuries Surveillance System (TTISS), the Transfusion Errors Surveillance System (TESS) and the Cells, Tissues and Organs Surveillance System (CTOSS). This evaluation did not assess activities undertaken by the provinces and territories and their participation in the BSCP.

Program Description

The BSCP supports the development and/or enhancement of provincial and territorial systems to monitor adverse events associated with the transfusion of blood, blood products and cell, organ and tissue transplantation. The recipients of BSCP funding include provincial and territorial governments, transfusion and/or transplantation centres and agencies and/or groups designated by provincial and territorial Ministries of Health to undertake surveillance for blood/tissue/organ associated adverse events, and Canadian not-for profit organizations that support transfusion adverse event surveillance activities in the provinces and territories. Recipients transfer information to the Public Health Agency of Canada. This information is cleansed, analysed and reported at a national-level is made available to recipients and other transfusion and transplantation system stakeholders. This information is used to identify injury and error trends and to benchmark provincial/territorial adverse events with the national-level data. The surveillance information has also contributed to the development of transfusion guidelines and practices (e.g., bacterial contamination).

CONCLUSIONS - RELEVANCE

Continued Need

There is a continued need for the Public Health Agency to monitor the number and rates of infection and injuries from transfusions and transplantations. The number of units of blood transfused has increased from 714K to 1.8M for the 2002 to 2011 time period. While infections due to transfusions have decreased, due to testing, screening and deferral policies, the risk to patients from transfusion and transplantation injuries and errors persists. It is not a risk free medical procedure. Emerging blood pathogens, rapid changes in technology and new blood products mean that the risks to patients from transfusions and transplantations remain ongoing.

Alignment with Government Priorities

While the surveillance of transfusion and transplantation is not explicitly mentioned as a priority for the Government of Canada, it is encompassed in the broader priority of blood system and patient safety. Examples of these broader priorities can be seen in the development of new blood regulations expected to come into effect October 2014, funding to the Canadian Blood Services for the development of a pan-Canadian Organ and Tissue Donation and Transplantation System and blood research and development grants. Funding has also been provided in the area of patient safety for adverse drug events

Alignment with Federal Roles and Responsibilities

The BSCP is aligned with the roles and responsibilities of the Public Health Agency in terms of its legislative and program authorities and corporate documents, such as the Surveillance Strategic Plan. Since the Krever Commission in 1996, other organizations such as the Canadian Blood Service (CBS), Hema-Québéc (HQ) and Health Canada have established roles in monitoring blood safety activities where corrective action has taken place based on product safety, quality and utilization. The Public Health Agency's unique role within the transfusion and transplantation system consists of a collaboration and coordination function with the provinces and territories to collect and report on national-level transfusion and transplantation adverse events as they relate to patient safety trends.

CONCLUSIONS – PERFORMANCE

Achievement of Expected Outcomes (Effectiveness)

A key output of the Program is the timely publication of national-level transfusion and transplantation data. National-level transfusing injury data has not been available since 2005. Other countries are able to publish transfusion surveillance data annually and with a one year lag time. Since 2005, provinces and territories, as well as federal departments, have not been able to utilize national-level data for trend analysis, benchmarking and to contribute to improvements in guidelines and patient safety. The TESS and CTOSS have remained as pilots and not moved to fully operating surveillance systems as originally outlined in program authorities.

Demonstration of Economy and Efficiency

Overall, the Program's activities were not efficient or economical. The program did not produce its reports with the funding it received or move the TESS or CTOSS beyond the pilot phase. Some efforts were made by the Public Health Agency to operate the Blood Safety Contribution Program more efficiently and economically. Specifically, a key activity where the Public Health Agency decided to be more efficient was in replacing bi-annual and annual face-to-face meetings of its various working groups with WebEx teleconference meetings. These had the unintended consequence of reducing the exchanges of transfusion and transplantation information that occur both formally and informally in a physical as opposed to a virtual environment. Stakeholders felt that this decision negatively impacted the effectiveness of these working groups.

Recommendations

Recommendation 1.

Develop a haemovigilance action plan which takes into consideration the current blood safety environment:

a risk assessment of the transfusion and transplantation surveillance environment;
a clear determination of stakeholder/user needs; and
the role of key players in monitoring transfusion and transplantation safety and where the Public Health Agency should concentrate their effort.

The environment has changed since the original program authorities, although there is a continued need for transfusion and transplantation surveillance activities. It is time for the Public Health Agency to review its haemovigilance activities in light of these changes, including those organizations who now have a role in the blood safety system. This will help the Public Health Agency assess where to focus efforts based on current risks in the environment. This action plan should also take into consideration corporate strategic direction for surveillance.

Recommendation 2.

Develop and publicize service standards for the timing of the release of national-level transfusion and transplantation surveillance reporting.

To ensure that national-level data is available to stakeholders when needed, the Public Health Agency should develop standards for publication of surveillance information to stakeholders and the broader blood safety community. This would help enhance predictability and ensure that timely information is available for analysis and possibly to develop guidelines and influence transfusion practices. The program could consider the reporting format that best meets stakeholder needs. The following are potential formats: short and full reports, shelf tables, pivot tables, or specific studies that are published in refereed journals. The type of format chosen will likely influence the level of effort needed and therefore the amount of time necessary for the production and posting of the transfusion and transplantation results.

Recommendation 3.

Review and clarify the goals and objectives of the National Working Group.

Various working groups were set up to collaborate on the development, conduct and improvement of the three surveillance systems. However, it appears as though the working groups provided those in the transfusion and transplantation community with a network and access to resources and information that they believed would otherwise not have occurred. Lately, this ability to exchange knowledge on transfusion practices has been limited due to changes in meeting format. To maximise knowledge exchange within the blood safety community, the goals and objectives of these working group should be reviewed and clarified.

List of Acronyms

ADM: Assistant Deputy Minister
ATE: Adverse Transfusion Event
BBPSP: Blood Borne Pathogens Surveillance Project
BSCP: Blood Safety Contribution Program
CBC: Canadian Blood Services
CMIRPS: Canadian Medication Incident Reporting and Prevention System
CSA: Canadian Standards Association
CTO: Cells, Tissues and Organs
CTOSS: Cells, Tissues and Organs Surveillance System
DG: Director General
FDA: Food and Drug Administration
HIV: Human Immunodeficiency Virus
HQ: Hema-Québéc
IVIG: Intravenous immunoglobulin
NAC: National Advisory Council
NWG: National Working Group
P/T: Provincial and territorial
PAA: Program Alignment Architecture
PHAC: Public Health Network
TACO: Transfusion-associated circulatory overload
TESS: Transfusion Errors Surveillance System
TRALI: Transfusion related acute lung injury
TRUST: Transfusion Registry for Utilization Surveillance and Tracking
TTISS: Transfusion Transmitted Injuries Surveillance System

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Table of Contents: Evaluation of the Blood Safety Contribution Program at the Public Health Agency of Canada 2008–09 to 2013–14