The First Independent Provincial OPO in China: The Shanxi Experience.

Abstract

BACKGROUND It has been a decade since China launched the national pilot program for voluntary deceased organ donation (OD). The Chinese reform of OD and organ transplantation has been successful, achieving 5818 deceased ODs in 2019.1,2 In 2013, the national health commission advocated the concept of developing organ procurement organizations (OPOs) to manage deceased ODs. Here, we present the pathway of establishing the first independent provincial OPO in China and emphasize on its exemplary role to advance OD in China. CURRENT PROGRESS OF DECEASED OD IN CHINA Per the Global Observatory on Organ Donation and Transplantation, deceased OD cases performed in China reached 5818 in 2019, accounting for 14.3% of the global deceased donation volume.3 As of May 2021, over 34 200 deceased ODs have been performed under the national program framework, and over 101 200 organs have been recovered.4 The Civil Code updated in 2020 mandates an opt-in system for organ and tissue donation.5 The number of deceased organ donors per million population (PMP) remained low (4.16) in 2019,3 suggesting room for improvement. Currently, there are over 130 hospital-based OPOs throughout China. Regulations on Donor Organ Procurement and Distribution issued in 2019 stipulate that provincial OPOs should be gradually established to achieve the final goal in attaining self-sufficiency.6 ORGANIZATIONAL STRUCTURE OF SHANXI OPO From 2015 to 2017, a group of medical staff located in transplant hospitals managed OD activities in Shanxi. In 2018, the Shanxi Provincial Organ Procurement and Allocation Center (Shanxi OPO) was founded under the supervision of the Shanxi Provincial Health Commission. The Shanxi OPO represents the first independent nonprofit provincial OPO in China, covering a donation service area of 37.29 million people and serving 6 transplant hospitals in the region. As one of the pilot provinces, Shanxi explored a feasible and up-to-date organ procurement structure, under which organ donation coordination, organ recovery and organ allocaton are managed uniformly within the province. In addition to OD, tissue donation and its specific implementation process had not been standardized yet. Hence, pushing the “tissue” part under the current OPO program appeared imperative. Within the past 2 y, an operational structure with 7 functional departments has been built in the Shanxi OPO (Figure 1). Medical facilities including donor intensive care units, surgical suites for organ procurement, and machines for organ perfusion have been installed at the OPO. An information center was established in 2020 to maximize the utilization of information technology, helping to coordinate teams, organ recoveries, and allocations. Accordingly, close communication with donor and transplantation hospitals has been established to emphasize on efficiency while assuring that practices comply with regulations and protocols. Moreover, a board of directors, an ethics committee, and a scientific committee have been established to supervise and guide OPO operations (Figure 1). Funding for Shanxi OPO is supported partly by the provincial government (for facilities), with procurement costs covered by the transplant centers based on a payment structure approved by the provincial health commission.FIGURE 1.: Organizational structure of Shanxi OPO. Shanxi OPO, Shanxi Provincial Organ Procurement and Allocation Center.OD Shanxi witnessed an increasing rate in ODs, from 35 cases (PMP: 0.9) to 94 (PMP: 2.5), reflecting a growth rate of 168%. Organs recovered increased from 100 to 271 (Figure 2). From 2015 to 2017 (before the establishment of Shanxi OPO), procurement was limited to livers, kidneys, and lungs. Since 2018, procurements have been extended to hearts and pancreata, enabling the certification of heart, lung, and pancreas transplantation programs in Shanxi Province by the national health commission. The model of independent OPOs will focus on maximizing the opportunities for OD and the number of organs recovered.FIGURE 2.: Number of deceased donor and organ recovered in Shanxi Province.OPO Performance Analysis Although the number of organs procured increased, the number of organs recovered per donor and the organ utilization rate of Shanxi OPO have remained stable during the last 5 y (Figure 3). This trend reveals relatively strict donor selection criteria with professional skills of organ variability assessment, donor management, organ procurement, and organ preservation retained from teams that have started to work with the OPO.FIGURE 3.: Average organ recovered per donor and utilization rate kidneys and livers in Shanxi Province (2015–2020).OPO Performance During Coronavirus Disease 2019 Compared with the previous year, 2020 witnessed a decline of 10% in deceased ODs nationwide.7 Following local epidemic prevention and control guidelines, OD and organ transplantation activities continued in Shanxi in 2020 with 94 organ donors, representing an increase of 5.6% compared with 2019. Development of the Tissue Donation Program Based on a well-defined workflow for OD, in addition to lessons learned from experiences in other countries, we felt that it was imperative to include tissue recovery in our donor program. Fifty-two out of the 58 OPOs in the United States perform tissue recoveries.8 The Quality in Organ Donation program9 hosted by the University of Oxford is providing additional guidelines. The board of directors has, therefore, proposed to establish a biobank to collect, preserve, and distribute tissue, blood, and urine samples to provide clinical and research support. Overall, we expect that those initiatives will pave the way for innovative developments in bioengineering in Shanxi Province. Pushing OD Toward Professionalism Nationwide Advancing professionalism in OD and procurement in China appears imperative. Indeed, the first academic society on organ and tissue donation in China initiated by Shanxi OPO has been established. This national society was founded by over 270 members from emergency and critical care medicine, neurology, OPOs, and transplant teams, in addition to ethical, legal, humanitarian, and social science experts and red cross representatives reflective of the multidisciplinary effort in OD. Moreover, the Shanxi OPO also established a scientific committee to advance OD, and this committee has already contributed with scientific publications. The committee also initiated a consensus meeting on effective communication with families of potential organ and tissue donors in April 2021. A meeting report by participating experts is forthcoming and will be distributed nationwide as a document of the best practice. CONCLUSIONS OD has gained worldwide recognition as a professional and multidisciplinary effort. Practically, the international community has broadly recognized the value of independent OPO models. The Shanxi OPO represents the first independent provincial OPO in China. Since its founding, operating structure and donation volume have improved steadily. The “Shanxi experience” has thus served as a reference model for other regions in China in support of the country’s effort in achieving self-sufficiency in OT. ACKNOWLEDGMENTS The authors would like to express special thanks to the Health Commission of Shanxi Province, China, and the Red Cross Society of Shanxi Province, China, for their administrative support in establishing the Shanxi OPO, in addition to their efforts supporting the cause of OD in the province. They would like to extend their sincere gratitude to Dr Stefan G. Tullius, Mr Howard Nathan, Dr Curie Ahn, and Dr Katayoun Najafizadeh for their revision of the article.