Longitud de fases a encañazón (EC 31) y antesis (EC 60)

and drive best practices. Transparency is predicated on the availability of data to assess performance and monitor compliance. It is therefore recommended that the accountability framework identify mandatory data reporting and review and system-wide audit capability as integral components of the integrated inter-provincial system.

In the proposed accountability framework, transparency of system performance is the key mechanism that drives accountability. Improved transparency at the program and system levels will enable evidence-based system evaluation and improvements. It will also increase trust by both the public and health care professionals. In addition to their roles in developing policies in transparent and collaborative ways, committees will ensure that information on the ODT system is available to the public in an understandable and easily accessible fashion. Canadian Blood Services will support the committees by developing and implementing mechanisms (such as websites) to allow easy public access to information. The public and patients will have the ability to provide input into policy and participate in the system through the committees. Public awareness and education of the system will be another mechanism used to improve transparency.

By themselves, however, these efforts will not be enough to ensure transparency. Two other key enablers have been identified as critical in improving transparency and driving accountability: mandatory data reporting and auditing.

Mandatory data reporting

The ODT community, as well as organizations involved in treatment of end-stage organ failure (ESOF), using technologies such as dialysis and mechanical heart devices, have consistently identified the need for timely, accurate and comprehensive data to evaluate system performance. The current environment is plagued by too many gaps that result in an incomplete view of system performance: not all the required information is collected, not all information is received or analyzed in a timely manner, there is little verification of the quality of the data, and data reporting is not conducted in a timely fashion. The current environment also suffers from the lack of a responsive, modern information-technology system to manage data. As a result, it is difficult to evaluate the system and make evidence-based improvements.

Given the essential role data plays in the system, it is recommended that data collection and reporting be mandated activities for all ODT organizations. It is also important that the system’s data-reporting structures support improvements to the continuum of care for patients with end-stage organ failure, given the tremendous impact this type of care places on the health care system. It is critical that organ transplantation data be linked to other data points along the continuum, from end-stage organ failure, through bridges (e.g., dialysis and artificial assist devices), and to transplantation outcomes. As such, it is also recommended that data reporting be mandated for ESOF programs.

Through the committee structure, Canadian Blood Services would work with the Canadian Institute for Health Information (CIHI), the Canadian Organ Replacement Register (CORR) and other key stakeholders to develop mandatory data-reporting requirements and processes for ODT organizations. (For more information, please see recommendation 10 on data management.)

Auditing

Given the recommendations for data reporting and policy and practice compliance, it is also recommended that auditing be a mandated activity in the inter-provincial ODT system. Independent auditing of ODT

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The following areas were noted as being required for inclusion in the scope of the proposed audits: • data provided to patient registries: Allocation and offer-acceptance decisions are based on data entered

into the patient registries. Given the criticality of this information, it is recommended that Canadian Blood Services perform regular auditing of data being provided to the registries.

• compliance with clinical policies: An independent peer group should audit transplant programs to ensure that clinical policies are being followed. For example, since allocation decisions are based on the assignment of urgency status for patients on waitlists, it is critical to verify that status levels are being properly applied. • supplemental data provided for information management: In addition to required registry data,

supplemental data may be required to be reported to Canadian Blood Services or CIHI for information management purposes. Periodic audits for reporting compliance and quality should be conducted by Canadian Blood Services.

• compliance with inter-provincial policies (non-clinical): Service-delivery organizations should be audited against compliance with inter-provincial policies. Canadian Blood Services should be responsible for these audits, given that the organization is not responsible for frontline service delivery (other than registries), and given its experience in performing audits of both its internal operations and of external suppliers in its blood, plasma and stem cell activities. Canadian Blood Services could also manage data-reporting audits. • registries audits: It is recommended that a regular independent audit be performed on Canadian Blood

Services’ operation of the registries to ensure that it is fulfilling its mandate and is responsive to the ODT community.

• death audits: It is recommended that audits of deaths be made at the case level (by hospitals and OPOs) and system level (by Canadian Blood Services) to ensure that all potential donors were identified and referred to OPOs.

Audit information would be submitted to the appropriate committees for review and recommended action. Where non-compliance with targets or policies is identified, the information would be made available to the programs involved. Performance and compliance would also be reported on a regular basis to the provincial and territorial governments. Each government would be required to act on non-compliance data with respect to the programs and organizations in their jurisdictions.

While the above audit areas have been identified as new requirements, it should be noted that several regulations and pieces of legislation for ODT have already effected positive change in the system, especially in defining the safety, ethical and legal frameworks in which to operate. The following organizations will continue to play an important role in driving system improvements:

• Health Canada regulates cells, tissues and organs, through the Safety of Human Cells, Tissues and Organs

for Transplantation Regulations with the objective of assuring that biologics available to Canadians are safe,

effective and of a high quality. Health Canada will continue to establish and maintain these regulations and audit for compliance.

• The Canadian Standards Association develops standards for cells, tissues and organs that are principally related to safety and effectiveness. Specific sections of these standards have been referenced by Health Canada’s Safety of Human Cells, Tissues and Organs for Transplantation Regulations.

• Accreditation Canada provides Canadian health care organizations with an external peer review process to assess and improve the services they provide to their patients and clients based on standards of excellence. Accreditation Canada has recently developed new standards for OTDT covering living donation, deceased donation and transplant services. The organization is also responsible for assessing accredited hospital against these standards.

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• Pubic Health Agency of Canada (PHAC) has developed and is piloting the Cell, Tissue and Organ Surveillance System to track adverse events related to transplantation.

• Provinces and territories will continue to maintain human tissue gift acts in their jurisdictions, which regulate specific practices related to OTDT, such as consent, determination of death, definition of death, privacy, non-commodification of organs and tissues, liability and mandatory referral. Where possible, these practices should be aligned to ensure they are not barriers to national leading practices to optimize donation and transplantation in Canada.

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