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International Consensus Conference on Risk-Based Decision-Making for Blood Safety, 10/26-10/28/10

Announcement of Consensus Conference Outcome

An International Consensus Development Conference (CDC) on Risk-based Decision Making for Blood Safety was held in Toronto, Canada, October 26-28, 2010.  The conference was hosted by Canadian Blood Services, and organized by an international consortium of blood organizations consisting of AABB, America’s Blood Centers, American Red Cross, Australian Red Cross Blood Services, Blood Systems, Inc, European Blood Alliance, Héma-Québec and National Health Service Blood & Transplant (UK).   The goal of the conference was to design a framework that can guide decision-making for blood safety in various jurisdictions taking into account local laws and social values.   To accomplish this task, a 12-person consensus panel was struck, chaired by Prof. Janice Stein, Director of the Munk School of Global Studies at the University of Toronto, and populated by an international group representing expertise in various areas of risk management, transfusion medicine, recipient perspectives, communications, and public health policy.  Over 100 key opinion leaders from the international blood industry participated in this conference.

The panel was charged with addressing 5 questions:  (1) What are the key aspects and limitations of current decision making in blood safety?  (2) What are the best practices in decision making to be leveraged and in what manner should they be applied? (3) What benefits can be achieved in the development of a framework? (4) What are the components to be incorporated in the design of a framework and what does the framework look like? (5) What are the necessary next steps to agree upon and implement a risk based decision making framework for blood organizations?

To assist them in answering these questions, the panel listened to two days of presentations from experts in various areas including current blood safety management practices, the regulatory processes used for risk-based decision making, general risk management practices, risk communication and perception, risk management in other industries, ethics, policy development, and the role of media in risk communication.  There were multiple discussion sessions held throughout the conference during which the panel had an opportunity to engage speakers in discussion on the issues at hand, and the delegates also participated.

In the usual format of a CDC, an initial draft consensus statement was presented to the speakers and delegates on the third day of the conference addressing the 5 questions and making recommendations as to next steps.
In general, the panel found no current process for making risk-based decisions in either healthcare or other fields addressing life and health safety issues served as a complete model in the blood safety area. The panel instead recommended a series of specific elements that serve as a framework for any process looking at “vein-to-vein” risks from the blood donor to the recipient. 

Following a lively discussion and thoughtful feedback from the participants, the panel returned to the task of editing and finalizing the consensus statement.  The final document will be completed in a few weeks to be published in a timely manner in transfusion medicine journals. The hope is that governments and private standard-setting organizations—in conjunction with blood organizations, other medical stakeholders and blood consumer representatives—will incorporate the panel’s recommendations in their processes used to make risk-based decisions involving blood collection and transfusion.