Angelo Ghirardini

Efficiency of organ procurement and transplantation programs.

Abstract The number of donations per million population (pmp) per year and the number of transplants pmp/year enables one to compare donation or transplant programs made in different years in the same area or made the same year in different areas. These pmp indexes may be integrated with an evaluation system by which each organ is evaluated separately in terms of the efficiency of its procurement and transplant systems using the procurement index (percentage in terms of number of organs utilized/number of organs procurable from donors utilized in a single area during 1 year) and the transplant index (percentage in terms of number of transplants performed/number of organs harvested in a single area during 1 year). We have called them Caldes I (procurement) and Caldes II (transplant) indexes. The harvest index evaluates the efficiency of utilization of organs retrieved from suitable donors. It usually ranges between 80‐90% for the kidney, 70‐95 % for the liver, 40‐50 % for the heart, and 5‐15 % for the lungs. The transplant index evaluates for each organ the transplant team capacity to use available organs which can be harvested locally or in different areas. It usually ranges between 60‐120%. Index determination did not require information different from the standard data available. Both the harvest and transplant indexes could be used to compare the efficiency of donation and transplant programs and policies in the same area during different years or at the same time in different areas. They can be critical in evaluating: (a) marginal donor utilization, (b) marginal organ utilization, and (c) dishomogeneity of organ retrieval and organ transplantation in different regions belonging to the same area. They also enable to evaluate if organs considered not available in a single area are offered to other areas or are not retrieved at all from available donors.

The EUROCET Network: Support for Coding, Vigilance and Surveillance.

Background: In the last years, there have been increasing concerns about the safety and traceability of human tissues and cells in Europe. In order to regulate this part of medical practice, the European Commission issued 3 directives between 2004 and 2006 and endorsed EUROCET to support member states in fulfilling some of their obligations. Methods: EUROCET created a connection with the European Union (EU) Competent Authorities (CAs) and set up a website where lists of the CAs, the authorized Tissue Establishments (TEs) and the activity data are published and updated. Moreover, EUROCET is involved within the Vigilance and Surveillance of Substances of Human Origin (SOHO V&S) project, aiming to support the EU member states in the establishment of vigilance and surveillance systems for tissues and cells. EUROCET is also working with EU stakeholders to develop a common coding system concerning donation and products. Results: There are 33 countries in EUROCET and 57 CAs. 3,974 TEs are recorded: 1,108 for tissues, 1,480 for haematopoietic progenitor cells and 1,386 for assisted reproduction. On the website, it is possible to find the 2010 activity data report. Conclusion: Based on its cooperation with the CAs, EUROCET represents them in the European network. Nowadays, the EU member states can rely on a web portal and database in order to put the tissue and cell directives into practice.

International forum on tissue coding: response from Italy

Describe your regional area: Area and organization: Italy, National Transplant Centre (CNT). The Italian transplant organization for organs and tissues involves: 1 national centre (CNT, the national Competent Authority for tissues and cells), 3 interregional transplant co-ordination centres, 19 regional transplant co-ordination centres (21 regions), more than 100 organ transplant centres, 13 eye banks, 5 vascular tissue banks, 7 musculoskeletal tissue banks, 5 skin banks and 7 amniotic membrane banks. The total population in Italy is about 60 million. In 2007, the Italian Ministry of Health, in collaboration with CNT, decided to implement a tissue donor identification system, to comply with art. 8 comma 2 of Directive 2004/23/EC, which requires that a unique donation code (UDC) is assigned to each tissue/cell donation. This was achieved through the extension of the Transplant Information System (SIT) that had been implemented in 2000 for organ donation and transplantation. SIT is a branch of the National Health Information System and is managed by CNT. The 3 inter-regional centers and the 19 regional centers are directly connected to the SIT and the information and data can be exchanged via internet between SIT and the regional information systems. Each potential donor is referred in real time to SIT, which assigns the donation code, and subsequently receives all data on organs and tissues procured and on organs transplanted. The organ coding and traceability system was extended to tissue donations in 2008. Since then, a national unique code is assigned to all organ and tissue donations from cadaveric (both heart-beating and nonheart-beating) and living donors through the SIT. Tissue Establishments (TEs) use the regional information system to manage donation and procurement activities and SIT provides the official allocation and registration of the UDC. Each TE accesses the SIT using a smart card assigned to it and accepts the allocated UDC, printing the official document. The TE must attach the UDC to every tissue, at the moment of the procurement or at the point of entry in the bank; this code must appear on the tissue container through to the final tissue disposition, whether transplant or discard.