Executive Summary - A Coordinated and Comprehensive Donation and Transplantation Strategy for Canada

A Report from the National Coordinating Committee for Organ and Tissue Donation and Transplantation to the Federal / Provincial / Territorial Advisory Committee on Health Services. The report describes recommendations for a coordinated and comprehensive organ and tissue donation, distribution and transplant system for Canada.

Introduction

After ten years of deliberations by various lobby groups, professional associations and governments, the shortage of organs and tissues remains an ongoing concern for Canadians in need of organ and tissue transplants. National donation rates lag behind countries which a decade ago had similar rates to Canada. Canada now has the dubious honour of having one of the lowest donation rates among developed countries.

Organ and tissue donation and transplantation is an important component of the health system that provides life saving and enhancing interventions to hundreds of Canadians annually. The absence of a coordinated and comprehensive approach to organ and tissue donation and transplantation is a serious concern. Without a coordinated and comprehensive approach, opportunities to enhance donation and transplantation will be lost. Many individuals with end stage organ failure will die without the opportunity of an enhanced quality of life.

The framework for a coordinated and comprehensive donation and transplant strategy proposed by the National Coordinating Committee is based on current evidence and best practices. It has been developed with input from a wide range of experts involved in the practice and administration of donation and transplantation programs. These representatives include government officials to front-line clinicians. The National Coordinating Committee strongly believes that if implemented, the proposed framework will enhance Canada's donation to a level that compares favorably with those of the United States and Spain. In so doing, Canadians will have better access to a basic health service that is effective in extending and improving quality of life, and, has been found to be cost effective compared to alternatives other than transplantation.

Process Employed

The NCC, with the involvement of a number of invited experts from across Canada, began working on the task in November 1998 following the appointment of the non-government co-chair. The majority of the work was accomplished through two workshops. The first was in Aylmer, Quebec in June 29-30, 1999 and the second in Montreal, Quebec on September 27 - 28 1999.

Considerations

The structure of Canada's Health System influenced the decisions of the NCC as it recognized the distinct roles of the FPT governments in the regulation, funding and delivery of health services. Because of the nature of donation and transplant practice where organs can be recovered in one province and then transplanted in a number of other jurisdictions, it was realized that a national strategy was required to ensure nation-wide coordination. This was thought to be essential to optimizing donation outcomes and the safety of organs and tissue being offered for transplantation. It would also ensure equity of allocation of organs through the monitoring and evaluation of sharing guidelines.

Background

In 1995, the Federal / Provincial / Territorial Ministers (FPT) of Health agreed to undertake a nation-wide study to identify problems impacting donation and transplantation in Canada. The findings of this study are described in the report, "Organ and Tissue Donation and Distribution in Canada (1996). The report identified thirteen strategies and 35 initiatives to enhance donation and transplant performance in Canada.

In 1997, the FPT Ministers of Health approved the proposed strategy and recommended a coordinating committee be convened to develop an implementation plan to address the 13 strategy elements. The Advisory Committee on Health Services (ACHS) proceeded to establish the National Coordinating Committee for Organ and Tissue Donation and Transplantation (NCC). The NCC was given a three-year mandate and a budget of $500,000 to complete the project.

In June 1999, the Conference of the Federal / Provincial / Territorial Deputy Ministers of Health, directed the NCC to bring forward an interim report to the Ministers that would include the following:

• A framework for action at the local, provincial / territorial and national levels which would result in a sustained systematic approach to increasing the rates of organ and tissue donation and transplantation in Canada
• A statement of principles to guide officials in preparing an organizational and financial plan for collaborative action to support donation and transplantation activities.
• A timeline for the submission for a detailed plan for approval.
• A goal expressed in organ donations per million population (DPMP) annually in Canada by the year 2005.

In September 1999, the Conference of Ministers of Health approved the framework for action submitted by the NCC, including the establishment of a Council, three Advisory Committees and Secretariat.

• The Ministers also supported the principles for success and goal of 25 DPMP by the year 2005.
• The Ministers directed ACHS to submit to the Deputy Ministers by November 1999 further information on the proposed structure and business case including the cost impact of insured services related to increased donation and transplantation and the potential cost savings that would be achieved from dialysis care.

In October 1999, ACHS agreed to undertake a provincial and territorial project to determine the costs related to transplantation and donation and determine the cost effectiveness / cost utility of transplantation versus dialysis intervention.

Recommendations

Building Blocks

The coordinated and comprehensive donation and transplant strategy for Canada is built on six building blocks. These six building blocks are considered critical to the over-all strategy and all need to be addressed for the desired targets to be realized. They also define the three levels of accountability and give direction to the provinces / territories to proceed to implement the strategy at both the provincial / territorial and regional / hospital levels.

Strategic Direction

To keep the strategy focused on the long term objectives, measurable goals, key success factors, performance measures and targets will be defined for the three levels of accountability: regional / hospital, provincial / territorial and nationally. A national target of 25 donors per million population (DPMP) by the year 2005 has been recommended - a target that also exists for the provinces / territories. Performance measures and targets will also be set by each province / territory to measure key outcomes related to donation, tissue banking and transplantation.

Processes

The core functions and support processes relate to the service delivery component and are a provincial / territorial responsibility. The core functions for organ donation, tissue banking and transplantation describe the critical steps where a direct service is provided. Policies, standards and guidelines must be developed to guide practitioners and provide practice and safety standards for each of these critical steps. This also ensures that performance can be measured, evaluated and reported.

Seven support processes are also described. They provide the necessary support services and quality framework for each step in the donation, tissue banking and transplant process.

People and Organization

Accountability relationships, communication flows and responsibilities for all levels of government, hospitals, service providers and the public are described. The Canadian Council for Donation and Transplantation, its Secretariat and the three Advisory Committees will serve as permanent structures to facilitate and support all levels of service delivery through the creation and maintenance of national practice and safety standards, standardizing data sets and facilitating reporting functions.

The formal relationship of the Council, its Advisory Committees and Secretariat to Health Canada needs to be defined by ACHS.

Legislation and Policies

Policies and guidelines of national concern will be drafted by the Council for approval by the Ministers of Health, based on the recommendations from the Advisory Committees and provinces / territories. Health Canada is in the process of developing safety standards for donation and transplantation. These will be referenced in the Food and Drugs Act.

Technology and Information Systems

An information system built on existing technology will be designed by the Council to link service providers and support overall data needs of the strategy. The provinces / territories will be responsible for entering data to support timely matching of organs and tissues with potential transplant recipients, and to evaluate donation and transplant outcomes. The Council will assist the provinces and territories to undertake performance monitoring, evaluation surveillance and quality assurance functions.

Physical Infrastructure

It is anticipated that Health Canada will support the operations of the Council, three Advisory Committees and Secretariat. The start up requirements for years one ($17.33M) and two ($16.03M) are slightly higher than the anticipated annual operating requirement of $14.78M.

Resource Impact

The resource impact for the provinces / territories will increase annually as the number of organ and tissue donors increases with a proportional increase in organ and tissue transplantation. The costs identified in year one, under provincial donor coordination, would primarily be associated with the hiring of new donor coordinators for all the facilities who will have designated Intensive care units where donation responsibilities will be part of the mandate. The costs in year two under information systems is the anticipated cost of implementing / linking service providers to the national database. This would include some capital outlay in regard to computer hardware, including notepads and communication modalities.

The remaining estimated costs are directed at the aforementioned support processes linked to donation, tissue banking and transplantation. These include resources to support staff education and training, public education and social marketing, development of policies, standards and guidelines, monitoring and evaluation of outcomes, surveillance, quality assurance functions and the overall coordination functions required through administration and operations. Funds have also been identified to support holistic programs / projects directed at disease prevention and health promotion that would either prevent the need for transplantation and others directed at health behaviors impacting graft survival.

Conclusions

The task of developing a strategy to enhance donation and transplantation in Canada has not been easy. The issues are complex and do not lend to an easy or simple solution. This reflects the fact that donation and transplant health care is complex, involving many people, professionals, services, functions and levels of government.

The members of the NCC have learned about the issues impacting donation and transplantation in Canada and have been guided by excellent advice from people with a wide variety of expertise. The proposed coordinated and comprehensive strategy reflects the understanding of the NCC as to the most responsible and effective way to address the health issues concerning Canada's low donation performance.