EXPERIMENTAL AND CLINICAL TRANSPLANTATION

Key words : Procurement and transplant system, Quality management, Quality performance, Reporting approach

Introduction
The Tuscany Region has a high annual number of donors of about 100 per million population (pmp). This is the highest rate in both Italy and among most European countries. The achievement and the establishment of these numbers in the past 10 years have been made possible by several factors, including the generosity of the Tuscany population and a stable procurement transplant system, based on a complex health care organization and dedicated stakeholders. Donor programs active in the Tuscany Region include donation after brain death (DBD) and donation after circulatory death (DCD) (both controlled and uncontrolled). Donations after circulatory death account for 10% of organ transplants in Tuscany since 2016 (when uncontrolled DCD was implemented), thus representing additive programs to DBD donors.^3-5 Solid-organ donation and transplant are both complex health care processes, requiring high-level coordination and collaboration between distinct stakeholders, frequently involved in a time-limited manner. Conceptual frameworks have been increasingly used in the assessment of health care systems. Assessing performance in such processes requires accurate system-wide analysis to identify areas in need of improvement.^6-8 The reporting of donation and transplant activities represents a strategy to improve performance in many European countries, as described previously.^8-11 In this investigation, we described the reporting and monitoring approach for the assessment of quality performance implemented in 2022 by the Tuscany Procurement and Transplant Center (Organizzazione Toscana Trapianti [OTT]). We also assessed whether this methodology affected donation and transplant activity in the Tuscany Region in 2024 (January to November). The goal was to maintain donation activity and increase transplant activity.

Materials and Methods
Italy has a population of 59.6 million. Health care is provided by the Italian National Health Service (Servizio Sanitario Nazionale), which established a tax-based universal health care system in 1978.¹² Organ procurement and transplant in Italy is coordinated by the National Transplant Network (Rete Nazionale Trapianti) and The National Transplant Center (Centro Nazionale Trapianti [CNT]), which is a technical and scientific organization within the Ministry of Health (Istituto Superiore di Sanita) that operates within the Italian National Health Service (Servizio Sanitario Nazionale). The Law of April 1, 1999, is the reference law. In Tuscany, procurement and transplant are coordinated by the OTT, whose role has been defined by Tuscany legislation.¹³ The OTT is a technical and scientific organization within the Tuscany Region Health Department. It has the responsibility of clinical governance of the Tuscany Procurement and Transplant System, and its main objective is the coordination of clinical care pathways for end-stage diseases; the procurement of organs, tissues, and cells; and transplant procedures. The Tuscany donation system is constituted by 43 procurement centers (among which are 3 teaching hospitals). Tuscany has the following solid-organ transplant centers: heart transplant center, lung transplant center, liver transplant center, 3 kidney transplant centers, and a pancreas transplant center. Tuscany has regional transplant programs for heart, lung, liver, kidney, and pancreas. Figure 1 shows the conceptual framework of the OTT, which was suited to the Tuscany context. The Tuscany Procurement and Transplant System is characterized by procurement activity of about 100 donors pmp/year since 2017, and transplant activity is about 80 pmp. Each health care organization has instrumental goals in responsiveness, equity, and efficiency. Since 2021, OTT has systematically implemented (for procurement and transplant activities) a reporting and monitoring system for quality performance management. This approach has aimed to maintain the high procurement activity of the Tuscany Region while improving transplant activity. The methodology mainly consists of an integrated reporting and monitoring system based on indicators. Indicators for organ and transplant systems were previously reported by the ODEQUS project and other previous work. Our system partially modified some of these indicators and introduced new indicators (Table 1, Table 2). Indicators are not themselves goals or punitive for the system. This is an essential concept that OTT communicated to transplant coordinators and transplant centers. Indicators should be measurable, feasible, relevant, and reliable. The Tuscany Reporting and Monitoring System was codified in a Regional Law (DGR 993/2024). Indicators have been grouped in clusters for organ procurement, tissue procurement, and transplant activities. Indicators are measured by OTT, who transmit them monthly to hospital management staff, transplant coordinators, and/or transplant centers. Donor electronic files provide data sources, which are recorded and collected in a regional dedicated software called eGIT. Each indicator is shown as an absolute value, but indicators are compared with absolute values recorded in the same period of the previous year. Because indicators need to be relevant and reliable, we introduced a double-check procedure. Reports produced by OTT are double-checked with those produced by CNT and with the annual reports by the Management and Health Laboratory in Pisa (Management e Sanità). In our opinion, the strength of this “double-checking procedure” is that these reports have different data sources. The data source is represented by data from the Transplant Informative System (Sistema Informativo Trapianti) for CNT and by the ICD code for the Management and Health Laboratory in Pisa.

Statistical analyses
We used the IBM SPSS version 20 statistical package (SPSS Inc) for data analyses. We reported categorical variables as frequencies and percentages.

Results
From January to November 30, 2024, 352 donors were assessed in Tuscany with a utilization rate of 92%. Donations after circulatory death accounted for 13.8% of all donors (Table 3). Donation activity in the Tuscany Region was 101.2 pmp, a value comparable to that observed in the same period of the previous year (103 pmp). Although the number of DBDs was reduced, DCDs increased (+13), which were mainly controlled DCDs. The number of actual donors and the utilization rate showed an increase compared with 2023. Concerning utilization rate, a 4% increase was observed in 2024 compared with 2023. Of note, 340 transplants were performed from regional donors, 37 more than the previous year. In detail, from regional donors, the following transplants were performed: 16 heart, 148 liver, 141 kidney, 32 lung, and 3 pancreas transplants. A reduction in the refusal rate was also observed. With regard to transplant activity, from January to November 2024, 336 transplants were performed by Tuscany transplant centers, an amount of 74 transplants more than performed in 2023. Transplant activity was therefore 91.3 pmp versus 80 pmp observed in the Tuscany Region in 2023. We observed an increase in liver transplants (159 vs 119 in 2023), kidney transplants (136 vs 107 in 2023), and lung transplants (39 vs 37 in 2023). Fourteen heart transplants and 3 pancreas transplants were also performed.

Discussion
The methodology of “a reporting and monitoring system” implemented by the Tuscany Regional Transplant Center was associated with the maintenance of a high donation activity (about 100 donors pmp) and an increase in transplant activity. This system proved to be effective and efficacious in monitoring quality performance of the solid-organ donation and transplant system in the Tuscany Region. This organ donation and transplant system includes indicators and reports for both donation and transplant activities, under the strong guidance and coordination of the Tuscany Regional Transplant Center, who guarantees integration of all levels. In our opinion, the main positive effects of this new methodology were as follows: the maintenance of donation activity, an increase in controlled DCDs, and an increase in transplant activity. First, with regard to maintenance of a quite high donation activity, in Tuscany, as in Italy and in other European countries, donors are characterized by a progressively advancing age and an increase in comorbidities.^16-18 In this context, solid-organ donation and transplant may be quite challenging. The use of a reporting and monitoring system, transmitted monthly by the Regional Transplant Center to Hospital Management staff and hospital transplant coordinators, helped them to identify specific areas of improvement in the single hospital. As a result, an increase in controlled DCD activity was observed, which was also the result of a regional network empowered by the Regional Transplant Center. This network uses normothermic regional perfusion mobile teams, which made controlled DCD processes feasible even in peripheral hospitals.⁵ Finally, an increase in transplant activity was observed in Tuscany after the implementation of our reporting and monitoring system, an increase detectable in almost all regional transplant centers. This phenomenon may be related to the increased number of controlled DCDs, as indicated by the increased number of transplants from regional donors. An advantage of our reporting and monitoring system is that data are systematically and periodically double-checked using reports from the National Transplant Center and the Management and Health Laboratory. This allowed the assessment of goodness of data and, consequently, a correct and useful interpretation of data. Recent evidence has underscored the potential role of quality standards and continual quality improvements in solid-organ transplant systems.^9-11 In the United Kingdom,¹⁰ hospitals provide detailed reports and updates on their activities on a regularly scheduled basis, and these are collated into an annual activity report by the National Health Service Blood and Transplant, which publishes benchmarking reports. This represents a system with sound governing structures and solid leadership. Because of geographic, legislative, and organizational differences among countries,^19,20 each solid-organ donation and transplant systems has to build and implement its own quality performance methodology, after a deep and comprehensive understanding of the donation and transplant panorama. For solid-organ transplant, more than 300 quality metrics have been reported in transplantation, but many lacked details on development and selection, were poorly defined, or had inconsistent definitions.¹¹ Similarly, indicators were proposed for solid-organ donation activities (ODEQUS), but scarce data are available on their implementation.

Limitations
Our “reporting and monitoring approach” was built and suited for the Tuscany solid-organ donation and transplant panorama. Therefore, indicators and their clusters cannot tout court be transferred to other countries and/or regions. On the other hand, our methodology may be useful, independent of geographic and organizational differences. Our methodology can be briefly summarized by these steps: (1) identification of relevant indicators relevant that are clinically significant for donation and transplant activities; (2) adoption of a systematic double-check approach, (3) elaboration of reports to be transmitted, at least monthly, to hospital management staff, transplant coordinators, and transplant centers, and (4) discussion, at least twice a year (and/or when needed), with management staff and transplant coordinators or transplant centers to identify specific areas for improvement.

Volume: 23 Issue: 4 April 2025

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