The Fundamental Role of the Organ Donation Organization (ODO) in Risk Management: An Efficient System for Maximizing Patient Safety - The Transplant Quebec Experience

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Abstract

Introduction

The process of organ donation and donor evaluation is strictly regulated. Despite this, solid organ transplantation necessarily involves risk. Some risks are related to the surgical procedure, others to the quality of the organs, still others to the donor. Donor risks include the transmission of infection, malignancy or other illness. In Quebec, the Ministry of Health mandates Transplant Quebec, the ODO, to investigate donor related complications.

Methods

The events reported by the transplant programs from 2012‐2016 were reviewed according to Transplant Quebec’s standardized protocol. The Transplant Quebec audit protocol involves 3 components: systematic review of all donor charts for conformity with regulations, in-depth review of all incidents reported by the transplant programs and systematic follow-up of recipient outcomes.

Results

Over a 5-year year period, 48 reports were received, for 2296 transplants and 889 donors. Of these, 25% concerned infectious complications, 12.5% were related to malignancies, and 62.5% were related to other issues. In 2 cases (4.2%) the donor charts and structures communication between transplant programs and the ODO provided conclusive evidence that the outcome was donor-related. In a further 2 cases, the donor charts were missing key elements that prevented demonstration of a causal link, while in the remaining 44 cases (91.6%), the donor charts conclusively showed that the outcome of interest was not causally related to the donor. In 1 case an illness identified in the donor required follow-up and counselling of the donor family.

Conclusion

The Transplant Quebec model helps avoid major donor related complications and provides a systematic method to ensure conformity with regulations, to collect and analyze all donor-related complications and platform to share information between clinicians. Additionally, systematic review allows the identification of risks that may have repercussions for the donor family as well. Donor derived complications associated with organ transplantation are real although fortunately rare. Through a systematic approach, the ODO plays a fundamental role in ensuring recipient safety. The diligent reporting of potentially donor related outcomes by clinicians is critical to the success of the risk management system.

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