Article
Law 91 of April 1, 1999 marked a milestone for donation, retrieval, and transplant activities in Italy.
While a decisive first step for donations had been made with the 1993 law concerning the determination of death, both brain death and cardiac death, the 1999 law addressed all other necessary functions for managing the donation-retrieval-transplant event 1,2. It detailed these within the context of a single national network.
Article 1 established that organ and tissue transplant activities and their coordination constitute objectives of the National Health Service. The procedures for performing transplants are regulated in such a way as to ensure respect for transparency criteria and equal opportunities among citizens, providing access criteria to waiting lists determined by clinical and immunological parameters.
The various articles firstly deal with consent, then with donation and transplant activities, management of waiting lists, training of professional figures, and, for the first time, discuss coordination functions carried out at the individual hospital and regional levels, as well as by a national body called the Centro Nazionale Trapianti (CNT). Specifically, Article 8 described the Center’s functions, ranging from oversight of waiting lists and defining common criteria for inclusion on lists to identifying criteria for organ and tissue allocation, managing national programs, and handling relations with foreign organizations. It also provided guidelines on the appointment of the Director General and the members of the CNT. Article 9 established the Permanent Technical Committee for Transplants.
This represented a true revolution compared to the existing situation, where donation, retrieval, and transplant activities existed but with widely heterogeneous characteristics and quality levels nationally.
The history of the Centro Nazionale Trapianti begins here.
The first Director was not a manager from the Higher Institute of Health (Istituto Superiore di Sanità, ISS) but the Regional Coordinator from Emilia-Romagna, who had recently formulated a regional regulation partly taken up in the law and had implemented a regional coordination model 3. The physical structure, by law located at the ISS, did not yet exist. The initial office was a room with four desks in the ISS basement, and the computerized information system, which by law the CNT had to possess, had not yet come into existence.
Simultaneously with the CNT, the first Technical Committee for Transplants was appointed pursuant to Article 9 of the law, which had existed since 1994 as a National Committee chaired by an ISS manager and had established fundamental rules on pediatric activity, liver emergencies, and had conducted the first data collections. Another fundamental role was carried out by the Superior Health Council (Consiglio Superiore di Sanità, CSS), which, together with the Biomedical Engineering Laboratory of the ISS, evaluated authorizations granted to transplant centers, while since 1993 any intensive care unit could perform transplants and assessments. The roles existed, but everything else was missing.
However, the Center was operational from the outset 4.
The then Minister of Health, Rosi Bindi, in compliance with the law’s provisions regarding consent for organ and tissue donation, decided to distribute a sky-blue paper form, the so-called “donation card”, to Italians during the delivery of voter identification certificates for a referendum, providing them a formal way to express consent for donation. This widespread distribution created a kind of “awareness” that manifested in many ways. Some authoritative figures strongly advised the Director not to authorize the operation due to potential damages. Some believed it was some kind of “passport to the afterlife” in case of hospitalization and publicly tore it up. Numerous TV reports and interviews followed. Minister of Health Umberto Veronesi, newly appointed, publicly supported the initiative. The CNT, then composed of four precarious staff members, answered more than 1,000 calls daily for about ten days. This may now be defined as an extraordinary start of activities.
A second highly debated topic was the creation of the computerized network. The first core of the Transplant Information System (Sistema Informativo Trapianti, SIT) was launched in 2001 after prolonged difficulties. In 2002, waiting lists were uploaded into the SIT, and in 2003, thanks to strong determination by Minister of Health Girolamo Sirchia, data on transplant outcomes for all organs began to be collected. Italy was the first country to have a unified performance overview for all transplant centers, later published on the Ministry’s website. Needless to say, methodological and conceptual debates on the national introduction of outcome evaluation were lively 5,6.
Important decisions were made within the newly appointed Technical Committee. Until then, patients could freely register on multiple waiting lists at any Italian center. After a passionate and intense discussion (I still recall Franca Pellini, then President of the main association of hemodialysis patients) the majority decided that registrations should be limited to two centers for kidney transplantation, except in regions with fewer than five donors per million inhabitants, where registration was limited to one center for liver and heart transplants.
It is worth noting that the CNT was not only composed of the Director and staff, where offices and responsibilities were beginning to take shape, but also by representatives from the interregional centers. Their meetings were held monthly, and the first CNT members were Mimmo Adorno (OCST), Mario Scalamogna (NITp), Sergio Curtoni (AIRT), and for a shorter period, Ignazio Marino (Sicily).
Thanks to the 1999 law, the CNT was placed at the heart of an institutional network dedicated to transplants, composed not only of local, regional, and interregional coordinations but also the Ministry of Health – which the Director depended on – the ISS for administrative aspects, the Regions for topics discussed in the Health Commission and State-Regions Conference. Relations with Patient Associations were constantly maintained through the Committee. In August 2000 and again in September 2002, meetings were organized with donation and transplant coordinators from Italian hospitals. These occasions already highlighted the important role that nursing competencies played in the process, skillfully navigating between intensive care, operational coordination, and direct patient care. In line with this essential holistic vision, it was decided to integrate a nursing figure into the CNT staff, coming from a Regional Center that had first understood and institutionalized this strategic role.
From the start, it was clear to all that for organ transplants to develop significantly in Italy, the number of donors had to increase and, in particular, the great disparity between regions had to be eliminated, specifically the high number of unperformed brain death determinations due to organizational and clinical issues. The innovative figure of the “local coordinator,” derived from the Spanish system and strongly supported by some renowned figures in intensive care and donation in the early 2000s in our country, was still largely based on the voluntary work of mainly senior anesthetists-intensivists who, in regions with better results, had developed an interest and clinical expertise in donor management over the years. At the beginning, the system was notably heterogeneous: regions like Tuscany hired the national Spanish coordinator directly, immediately defining clear roles and professionalizing the function, whereas in other regions like Veneto, the coordinator role was symbolically assigned to all intensive care unit chiefs, and in others, no action was taken 7.
Thus, to achieve full implementation of Laws 578/93 and 91/99 by appointing coordinators in all donation hospitals, the CNT implemented a successful policy of recruitment, training, and retention, particularly of intensive care physicians and nurses. Over the years, this led not only to certification and professionalization of the coordinator role but also, at least in high-potential donation hospitals, to the establishment of dedicated teams for identifying potential donors and managing the entire donation process. These teams, composed of physicians, nurses, and psychologists, were full-time in a limited number of cases.
This was no easy task, due not only to personnel shortages but also to various issues involving relationships with colleagues within hospitals and task allocation. However, this would not have sufficed without the CNT’s articulated effort to engage and collaborate with scientific societies, especially anesthetists-intensivists, aimed at ensuring donation was finally perceived as a normal, important, and virtuous part of clinical care for critically ill patients in intensive care. This effort was facilitated by shared guidelines and sustained national and regional training involving the best Italian and Spanish experts. In doing so, the CNT contributed significantly to creating a new human and clinical-organizational community and network, with strong ties and daily interaction on the ground with all medical and nursing staff in critical care, regional centers, transplant units, and all hospital components involved in donation, beginning with hospital management.
It may seem surprising that in the first decade of the 2000s, the concept of brain death was far from universally accepted and that donation faced unexpected obstacles in many hospitals, with associations opposing “organ predation” being very active. Frequent threats, judicial initiatives against intensivists, and aggressive attacks on the emerging web – where the CNT was a constant target – were part of this turbulent period.
Thanks to these initiatives, ongoing discussions, and growing awareness within the network, activity increased, and Italy engaged increasingly on the international stage. The first European project, EURODONOR, coordinated by the CNT along with several foreign sector organizations, involved collecting data on donation and transplant activities. Beyond its formal content, the project was the first European initiative among national Competent Authorities and laid the foundations for transparency and mutual trust, essential for further cooperation in the sector. This was a historic moment, considering that in September of the same year, during the Italian Presidency of the European Union, the European Commission entrusted Italy with organizing the Conference on Quality and Safety in organ transplantation held in Venice. This conference laid the groundwork for the development of European standards, approved from 2004 onward for tissues and cells, and in 2010 for organs.
Regarding transplants, an important new initiative was the start of audit activities at transplant centers aimed at evaluating each center’s results not only in terms of organ and patient survival but also regarding the quality of the transplant process through assessment of organizational structures and professional decision-making pathways. This initiative marked an important milestone in the transparency process undertaken by the entire system. Thanks to mixed inspection teams composed of CNT staff and professionals active in centers other than the one inspected, a true professional network was created. Liver transplant centers were audited in 2003, kidney transplant centers in 2005, heart transplant centers in 2008, and beginning in 2006, the CNT applied the same methodology to regional and interregional coordination centers. In every transplant center, commissions verified and evaluated all management and clinical aspects, waiting lists, transplants, and follow-up (Tab. I). The certification process provided teams with solid arguments to engage their General and Medical Directorates. Transplant professionals worked together and shared responsibilities 8.
Another fundamental part of the activity consisted of “national programs,” i.e., operational programs agreed upon with involved professionals and approved by the CNT and the Committee, used in the daily network activities.
The two programs approved before 1999 concerned the choice of pediatric recipients nationally (i.e., among all potential pediatric recipients on the waiting list regardless of registration location) and national management of liver emergencies.
From 2002, these were supplemented by the “second opinion”. Thanks to the availability of experts in infectious diseases and pathology, all coordinations and transplant centers had access to a 24/7 expert providing real-time opinions on organ transplantability. The transplant center holding the organ retained freedom of choice but had technical support and formal responsibility backing their decision.
This innovative tool also led to active 24/7 CNT presence for coordinating the operation, introducing predefined risk levels known to patients for organ acceptance. At that point, no professional in the network faced the key decision of organ transplantability alone. The transplant network became truly operational.
Following the implementation of these protocols, all patients transplanted with organs presenting risk factors were monitored. Data collected showed the risks linked to using such organs were acceptable with appropriate surveillance and prophylaxis thereafter. Risk levels were defined with guidelines and later by ministerial decree 9.
Since then, several shared programs have been managed directly by the CNT. Until 2009, the list included:
- heart transplant in patients with urgent clinical conditions;
- split liver transplantation;
- urgent liver transplantation;
- kidney transplant in patients with difficult transplantability (highly immunized);
- transplantation with organs presenting risk factors;
- transplantation of organs in HIV-infected subjects;
- transplantation of organs in pediatric subjects;
- living donor liver transplantation;
- intestine and multivisceral transplantation.
It was not all simple. The importance and media impact of transplant activities have always been high.
We realized this during a serious crisis in Tuscany in 2007. Due to human error, a donor’s positive HIV test was not correctly recorded, resulting in HIV-positive organs being transplanted into kidney and liver recipients. I recall receiving the news late in the morning and quickly gathering support from the Minister and then Prime Minister. However, the next day saw a flash flood of TV reports, newspaper articles, interviews, and comments. The primary French evening news opened with the HIV-positive transplant story. We were asked to stop transplants in Tuscany, to place the CNT under special administration, and for me to resign immediately. Thanks to our communication service and expertise from national and international professionals, we took responsibility, understood where the error occurred, and refused to deny responsibility either regionally – thanks to the Tuscany Region – or nationally. Who could examine the network we ourselves had established in Italy? The World Health Organization (WHO). Their representatives came to Italy and reviewed the CNT thoroughly. Their judgment was praiseworthy with some valuable suggestions. We then created a nationwide traveling commission that inspected laboratories working for the CNT and helped reduce the risk of recurrence by implementing mandatory simple safety measures such as double signatures on reports and high visibility of positivity on results. Since then, no such report-related error has recurred. Indeed, we became a WHO reference center for safety.
Finally, in 2010, nearly twenty years after the 1993 law, the National Bioethics Committee (Comitato Nazionale di Bioetica, CNB) reaffirmed – after a lengthy and at times heated discussion and numerous hearings – the legitimacy and ethical value of donation following death determined by neurological and circulatory criteria. That same year, the CNT participated in the WHO Global Consultation, contributing in particular to defining the “critical pathways for organ donation”, which still defines the internationally used terminology for donation after brain death (DBD) or circulatory death (DCD). Moreover, regarding donor safety and suitability, the CNT and Italian experts by this time played an international role, promptly responding to new oncological and infectious challenges. For example, in 2012, faced with concerns about the frequent presence of multidrug-resistant bacteria in donors, the CNT launched a prospective multicenter study (DRiN) that improved knowledge and screening capabilities, facilitating intensivists’ work and cooperation with the infectious disease second opinion team.
Implementing a quality project related to the donation process was a strategic step to understand potentials and efficiency and compare them nationally and internationally. This began with the QuPIDO project, which, as the acronym suggests, developed in the most popular and well-equipped aperitif venues in Veneto and Bologna, combining neuro-intensive care knowledge with health economics, and ultimately approved by the Committee in the ISS’s “flowery hall”. The tool of the “registry of all deaths with acute brain injury in intensive care” (brain-injury registry) by coordinators from all hospitals, associated with quality indicators, allowed for an objective evaluation of each ward’s and hospital’s potential utilization – up to the inclusion of indicators (and therefore donation) in the Essential Levels of Care (LEA) that assess regional performance.
Also in 2010, a new Minister of Health was appointed. We had built a network, increased donations and transplants, and defined four levels of coordination (hospital, regional, interregional, and national). Yet, compared to the best European models, there was no unified operation between donor reporting and organ assignment. Daily management of individual donors, national programs – which by now appeared in all donations – and management of real-time connections between interregional centers were not homogeneous.
The Minister authorized us to present a new model to the regions based on a single national operating center, a unified information system, and direct representation of regions in the CNT – letting regions choose between operating through their own regional center or via a pre-existing interregional center under contractual agreements.
Regions in the NITp area chose to maintain interregional operations; regions in the AIRT and OCST areas abolished interregional functions, keeping operations at regional level. The choices of direct CNT representation and unified real-time operation (i.e., 24/7 IT connection on the donation-transplant event) were shared by all.
Theoretically, transplant Italy would no longer be tripartite thanks to unified operations. Practically, everything had to be built.
Key steps included:
- choosing a nursing team for operational management based on the Spanish ONT model and the single French operational center, giving the nursing manager responsibility and coordination roles;
- securing funding thanks to Law 99;
- reconstructing and converting a storage room within the ISS grounds into a 24/7 Operational Center;
- optimizing IT connectivity of pre-existing interregional systems and developing new functions for the CNT Information System.
Three intensive years of uninterrupted work followed. We succeeded, making a decisive step that led to the new structure that still plays a key role: the Operational National Transplant Center (CNT Operativo, CNTO).
As always, innovation was initially unwelcome, but the entire network understood its importance and gave strong, significant support.
Since November 4, 2013, the CNTO has been operational 24/7.
Staff consisted of nurses experienced in transplantation, selected through a national call of interest and coordinated by a Nursing Manager structured in the CNT for ten years. Physicians, also coordinated by a Medical Director, were particularly responsible for clinical-diagnostic control of potential transmission of infections, neoplasms, and other donor pathologies, supported by second opinion networks dedicated to infectious and neoplastic transmission risks, helped by other experts in hematology, immunology, and coagulation.
Meanwhile, much happened on the donation front.
In 2010, the kidney transplant center in Pavia started a program for donation after cardiac death (DCD). A key issue remained the law mandating 20 minutes of flat-line electrocardiogram recording, during which anoxia could damage all organs. The 1993 law’s objective was to ensure irreversible and complete brain damage to confirm death, not organ use for transplants. Two key factors radically changed this longstanding view:
- the use of ECMO to maintain residual oxygenation after death determination and availability of perfusion devices that oxygenate and circulate blood in organs post-mortem;
- verification that donor organ damage was much less than expected.
Thanks to a courageous group of surgeons who first dared with kidney retrievals, then liver, and in subsequent years, heart transplants, the CNT firmly supported these “Galilean” positions, as opposed to the “Ptolemaic” view that was obvious due to organ deterioration. The CNT Director, after years of national and international debates – often facing the refrain “with the 20 minutes it’s impossible” and “change the law” (the 1993 death determination law) – demonstrated that, as always in donation and transplantation, organization and equipment availability, not the law, were and remain keys to the system 10.
Meanwhile, based on results and best international and regional practices, the Committee developed over two years the “national donation program”, approved as a State-Regions agreement in 2018. Great care was taken to create an organizational and methodological model based on shared principles, progressively adopted and customized by all regions. The goal was to provide a common language and use quality improvement pathways throughout all donation phases, conduct data analysis, implement national and regional auditing, and provide training.
Specifically, it established that organ donation is an institutional activity of healthcare facilities and an essential objective of Regional Health Systems (SSR), that donation is a routine function of intensive care units following death determination by neurological or circulatory criteria. Organ donation must be organized and evaluated by SSRs based on shared clinical governance standards and increasing objectives with homogeneous quality indicators included in the Essential Levels of Care (LEA).
More could be said.
For example, the CNT coordinated 13 European projects and participated as a partner in 20 others; from 2011 to 2024, through the NOTIFY initiative, it played an important role as a WHO collaborating center; it concluded major international agreements and had a respected voice in the European Commission.
It should also be noted that the CNT contributed to hundreds of training courses nationally and internationally; the rule on declarations in identity cards was parliamentary and not determined by the CNT, which since then has managed a complicated issue; regarding tissues, cells, and especially hematopoietic stem cells, the CNT networked with key national and international scientific organizations, creating internationally admired networks such as the close link with the IBMDR in Genoa.
The CNT itself was divided into operational units that all significantly contributed to the work (Communication, Administration, Training, IT Systems Management, International Relations, Organ Transplant, Tissues and Cells, Donations, Hematopoietic Stem Cells, CNT Operations). Notably, the Communication Office collected and managed – all in agreement with corresponding Ministry offices – news, crisis events, and information campaigns, keeping the CNT instantly informed of all news media reports in the transplant sector.
I will finish with two points.
We unified, for kidneys and contributed to unifying for liver, thanks to collaboration with transplant centers, criteria and methods used in all regions for organ allocation to patients on waiting lists.
If I were to choose an adjective to define the CNT, I would say: “concrete, reliable, and innovative.” Thanks to all who have worked on it.
Acknowledgments
Paola Di Ciaccio, Daniela Storani, Vito Sparacino, Francesco Procaccio, Lucia Rizzato, Letizia Lombardini
Conflict of interest statement
The authors declare no conflict of interest.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Ethical consideration
Not applicable.
History
Received: May 2, 2026
Accepted: May 2, 2026
Figures and tables
| Technical and structural characteristics of the transplant center |
| Management methods of waiting lists; |
| Monitoring of transplantation from deceased donors |
| Monitoring of transplantation from living donors (liver and kidney) |
| Verification and analysis of transplant activity outcomes |
| Evaluation of management aspects related to organs reported, accepted, transplanted, refused |
| Comparison between audit data and those provided by respective coordination centers |
| Verification of immunological procedures and methods adopted by the center |
| Analysis of a sample of randomly selected patient clinical charts followed in the transplant follow-up, assessing management consistency |
