A Risk Sciences International Case Study

Canadian Recipient Hemovigilance System Renewal Consensus Conference

Canada and its ten provinces and three territories

Client: Canada Blood Services

Listing of the client in no way affirms the client's support, sponsorship, or validation in any form of Risk Sciences International or the RSI staff member(s) who conducted this project during their stay with RSI or prior to joining the company. This case study is displayed for informative purposes only to demonstrate the capacity of RSI staff members. This case study reveals no proprietary information or information deemed sensitive.

Project description:

Canadian Recipient Hemovigilance System Renewal Consensus Conference

Following the planned closure of the Blood Safety Contribution Program (BSCP), support was needed to help define the structure, elements, and functions of a renewed national recipient hemovigilance system for Canada. The work centered on preparing the transfusion medicine community, federal and provincial/territorial partners, blood operators, and patient representatives to develop recommendations for a future system that could maintain national coordination, support blood and patient safety, and preserve trust in Canada’s blood system.

RSI was asked to support a broad consultation and consensus-building process leading to a national Consensus Conference. This included developing the evidence and discussion materials needed to help participants consider options for the future of adverse transfusion reaction and transfusion error surveillance, including the Transfusion-Transmitted Injury Surveillance System (TTISS) and the Transfusion Error Surveillance System (TESS). The project required analysis of the existing hemovigilance context, stakeholder perspectives, international comparators, and the development of options for governance, data reporting, system infrastructure, communication, education, collaboration, and cluster identification. A key objective was to equip participants with a shared understanding of the current system, the implications of losing national BSCP functions, and the practical choices involved in renewing a pan-Canadian program.

The Consensus Conference was designed to turn options for a renewed hemovigilance system into recommendations for federal, provincial, and territorial decision-makers. Participants in the Consensus Conference moved from shared evidence and diverse perspectives toward practical recommendations on national leadership, reporting requirements, data standards, analysis and sharing, communication, education, coordination, and mechanisms to identify clusters of transfusion-related events. This process reflected RSI’s CRAFT approach, the Collective Risk Action Framework and Toolkit, by convening participants around a complex risk issue that crossed jurisdictions, organizations, and areas of expertise. CRAFT is a process designed for complex risks that transcend traditional boundaries and require collaboration across stakeholders, jurisdictions and sectors, and served as a useful framework for the hemovigilance renewal project.

Start: 2025

End: 2026

Experts related to this case study

Greg Paoli

CEO, Principal Risk Scientist

Greg Paoli is the CEO and Principal Risk Scientist at Risk Sciences International (RSI), a firm he co-founded in 2006 following the integration of his earlier consultancy, Decisionalysis Risk Consultants, with the consulting activities of the McLaughlin Centre for Population...
Read More about Greg Paoli

Cemil ‘Jim’ Alyanak

Vice-President Communications and Strategic Initiatives

Cemil ‘Jim’ Alyanak joined Risk Sciences International (RSI) in 2018 and serves as Vice-President, Communications and Strategic Initiatives. In this senior leadership role, he leads RSI’s risk communications practice, drives cross-cutting initiatives, advances strategic in-house projects, and expands the company’s...
Read More about Cemil ‘Jim’ Alyanak

Anne Wiles

Senior Analyst

Dr. Anne Wiles joined Risk Sciences International (RSI) in 2008, where she currently serves as a Senior Analyst specializing in risk communication, perception, and governance. With a distinctive blend of expertise in language, regulation, and the use of science in...
Read More about Anne Wiles

Rosanna Wong

Risk Analyst

Rosanna Wong is a Junior Risk Analyst at Risk Sciences International (RSI), where she supports multidisciplinary projects at the intersection of climate resilience, food systems, and public safety. Since joining RSI in 2021, Rosanna has contributed to a broad range...
Read More about Rosanna Wong

Martin LeBlanc

Business Development

Since joining Risk Sciences International in 2019, Martin has served in Business Development, leading RSI’s business expansion efforts across Canadian and global markets. He is instrumental in identifying and qualifying opportunities, coordinating multidisciplinary proposal teams, developing project frameworks, and supporting contract negotiations. His...
Read More about Martin LeBlanc

Monique MacDonald

Office Administrator

Monique MacDonald is a seasoned Office Administrator with over thirty-five years of experience ensuring the smooth and efficient operation of office environments. She joined Risk Sciences International (RSI) in 2017, where she oversees the full range of internal operations and...
Read More about Monique MacDonald

More RSI Case Studies

RSI presents a very small selection of case studies to highlight some of its key work.

Assessing the Impact of Interstudy Variation in LOAELs on Findings of Low-Dose Additivity in In Vivo Studies of Mixtures

Demonstrating the safe use of chemical mixtures remains a critical challenge in toxicological science. In recent years, studies have suggested that chemicals can exhibit dose additivity—causing a combined effect—even when each chemical individually is below its effect threshold. This project...
Read More about Assessing the Impact of Interstudy Variation in LOAELs on Findings of Low-Dose Additivity in In Vivo Studies of Mixtures

Communication material on lithium in drinking water and health risks

To support public communication around emerging drinking water concerns, RSI was engaged to develop accessible, scientifically grounded materials on lithium exposure and its potential health effects. The work focused on equipping stakeholders with clear, credible information that could inform both...
Read More about Communication material on lithium in drinking water and health risks

Applying New Assessment Methods (NAMs) for Assessing Semi-Volatile Organic Compounds (SVOCs) in Indoor Residential Environments

Health Canada sought expert support in advancing its efforts to develop screening values for semi-volatile organic compounds (SVOCs) commonly found in residential indoor environments. Previous work on indoor air contaminants had focused on volatile organic compounds (VOCs), where screening values...
Read More about Applying New Assessment Methods (NAMs) for Assessing Semi-Volatile Organic Compounds (SVOCs) in Indoor Residential Environments

Age-Related Cognitive Decline: Systematic Review and Meta-Analysis

The College of Physicians & Surgeons of Alberta (CPSA) commissioned a systematic review and meta-analysis to support evidence-informed decision-making around age-related cognitive decline among practicing physicians. The initiative was led by CPSA’s Physician Health Monitoring Program (PHMP), which sought to...
Read More about Age-Related Cognitive Decline: Systematic Review and Meta-Analysis

Developing a Risk-Based Compliance Framework for Digital Service Delivery

The Financial Consumer Agency of Canada (FCAC) engaged Risk Sciences International to provide strategic advisory services aimed at enhancing its regulatory compliance model through risk-based methodologies. FCAC’s objective was to explore new approaches that would integrate digital tools and data-driven...
Read More about Developing a Risk-Based Compliance Framework for Digital Service Delivery

Update of WHO Guidance on Food Defense

To support international efforts in mitigating deliberate threats to the food system, the World Health Organization commissioned an update to its earlier guidance titled Terrorist Threats to Food. The revision aimed to broaden the original scope by addressing not only...
Read More about Update of WHO Guidance on Food Defense

Evaluation of Drug Recall Communication and Risk Determination Processes

In response to public and ministerial concerns about the timeliness and adequacy of information shared during a major prescription drug recall, Health Canada commissioned an independent review to assess its response to the event. The situation involved a recall of...
Read More about Evaluation of Drug Recall Communication and Risk Determination Processes

Institutional & communications assessment

In the mid-1990s the International Organization for Migration (IOM) faced one of the most pivotal moments in its history. Though it counted 76 member states, it remained outside the United Nations system, and its work was increasingly perceived to overlap...
Read More about Institutional & communications assessment

Risk-Based Decision-Making (RBDM) Support for Plasma Supply / Sufficiency

Facing renewed challenges in securing a reliable domestic plasma supply, Canadian Blood Services sought support to apply a Risk-Based Decision-Making (RBDM) framework. The objective was to assess the value and implications of expanding domestic plasma collection and processing capacity in...
Read More about Risk-Based Decision-Making (RBDM) Support for Plasma Supply / Sufficiency

EFSA Framework for Problem Formulation

To enhance the methodological rigour of its scientific assessments, EFSA sought to develop a standardised framework for problem formulation (PF) within its non-application scientific assessment protocols. The goal was to support the planning phase of these assessments by establishing a...
Read More about EFSA Framework for Problem Formulation

Technical Support for Risk-Based Decision Making (RBDM)

To enhance the oversight of cannabis production under its regulatory mandate, the Cannabis Directorate sought expert support in developing a risk-based decision-making framework tailored to its compliance and enforcement responsibilities. The directorate aimed to better assess and respond to non-conformance...
Read More about Technical Support for Risk-Based Decision Making (RBDM)

Finalization of Risk Assessment on Secure Opioid Dispensing Devices

To support decision-making around modifications to opioid agonist treatment delivery, a detailed risk assessment was requested to evaluate the integration of secure dispensing devices for direct patient access to hydromorphone. Building on a previously conducted preliminary assessment, the work required...
Read More about Finalization of Risk Assessment on Secure Opioid Dispensing Devices

Risk-Based Optimization of Enforcement Activities

A federal agency required scientific support to enhance the effectiveness of its environmental enforcement activities. This involved identifying and analyzing the risk factors—both environmental and human health-related—that contribute to the likelihood and impact of regulatory offences. The objective was to...
Read More about Risk-Based Optimization of Enforcement Activities

External Peer Consultation of the Inorganic – Late Biomonitoring Approach Draft Screening Assessment Report

To support the Chemicals Management Plan under the Canadian Environmental Protection Act (CEPA), Health Canada sought expert peer consultation for a draft screening assessment report (DSAR) evaluating 47 inorganic substances identified as priorities. The client required independent scientific and technical...
Read More about External Peer Consultation of the Inorganic – Late Biomonitoring Approach Draft Screening Assessment Report

Risk Assessment of the Impact of Lethality Standards on Salmonellosis from Ready-to-Eat (RTE) Meat and Poultry Products

To support regulatory decision-making, a comprehensive risk assessment was conducted to evaluate how varying lethality performance standards would impact the public health burden of salmonellosis associated with Ready-to-Eat (RTE) meat and poultry products. The primary objective was to quantify the...
Read More about Risk Assessment of the Impact of Lethality Standards on Salmonellosis from Ready-to-Eat (RTE) Meat and Poultry Products

Characterizing uncertainty in MAF values estimated using the KEMI MAF

The client sought to improve understanding of uncertainties surrounding the application of mixture assessment factors (MAFs) for aquatic receptors, specifically those estimated using the KEMI methodology. While the KEMI MAF approach is considered technically robust, its assumptions—particularly about chemical-specific controls,...
Read More about Characterizing uncertainty in MAF values estimated using the KEMI MAF

Food Inspection Scientific Analysis & Risk Modelling

In support of ongoing efforts to modernize Canada's food inspection system, a request was issued for scientific and analytical expertise to enhance two critical risk-based decision tools: the Establishment-based Risk Assessment (ERA) and Importer Risk Assessment (IRA) models. These models...
Read More about Food Inspection Scientific Analysis & Risk Modelling

Building an international alliance and campaign

UN-Habitat sought to establish a new global platform to bring coherence to international dialogue on sustainable urbanization. At the outset, this initiative had no name, no identity, and no governing structure, only the recognition that cities faced pressing challenges requiring...
Read More about Building an international alliance and campaign