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Aim: The purpose of this study was to determine a specific indicator model to evaluate the Quality Management System (QMS) in Tissue Banks (TB) for deceased and/or live donors., Methods: Quantitative Indicators for Quality Management are considered for deceased donors as the origin of therapeutic tissues. A glossary of definitions was established (also applicable for tissues from live donors): Deceased Therapeutic Real Donors (DTRD), donors that were processed and at least 1 tissue was harvested for a therapeutic purpose; Deceased Effective Donors (DED), DTRD in which 1 or more tissues were validated, stored, and/or grafted; Processed Tissues (PT), number of tissues harvested from a DTRD, which were processed and counted as final product units; Validated Tissues (VT), number of tissues as final product units, which fulfilled quality criteria to be grafted; Grafted Tissues (GT), number of transplanted tissues for therapeutic purposes; and Grafted Patients (GP), number of patients who were grafted with validated tissues. MANAGEMENT QUANTITATIVE INDICATORS: Deceased donors were considered from 2002 to 2007. The total number of tissues was 15,363: Productivity Index (PI), PI = DED/DTRD; Processing Quality Rate (PQR), PQR = VT/PT%; Productivity Efficiency per Donor (PED), PED = VT/DED; Grafted Tissues Coefficient (GTC), GTC = GT/VT; and Grafted Patients Index per Donor (GID), GID = GP/DED., Results: Results were as follows: PI = 0.80; PQR = 76%; PED = 30.99; GTC = 0.93; and GID = 4. In our study, 80% of DTRD produced VT (PI = 0.80), which represented 76% of PT (average, 31 final products per donor). Also, 93% of the VT were grafted with 5 patients grafted per donor., Conclusions: Defined variables resulted in useful tools to evaluate QMS in a TB.

Human tissues for implants are a biomedical product that is being used more frequently by many medical disciplines. There are infections in the patients related to the implanted tissues. The early detection of infections transmitted by blood and the microbiological study of tissues before their clinical use are strategies in tissue banks to prevent these situations. This work sought to contribute to establish the bases for the operation of a laboratory applied to the microbiological quality control of tissues. Based on classical microbiological principles, we defined the operation of microbiological control and tissues sterilization since 2003. We determine lists of acceptable microorganisms for every tissue, criteria for the interpretation of results, and a diagnostic algorithm of microbiological quality. We observed that the circumstances of donor death can be a determinant of the quality. The environment and the operator should be investigated as probable sources of contamination in outbreaks. The criteria of work based on a solid methodology must help to avoid the transmission of infections between donor and recipient. This is a critical point in the quality management of a tissue bank.

BNOT was created and regulated in 1977 and started its operation in 1978 according to the Decree No. 86/1977. By the Decree 248/005 is transformed in the National Institute of Donation and Transplantation of Cells, Tissues and Organs (Instituto Nacional de Donación y Trasplante de Células, Tejidos y Organos--INDT). The organisation has been operating within the State University Medical School and the Public Health Secretary and it is the governmental organisation responsible for the regulation, policy and management of donation and transplantation in Uruguay. By the Decree 160/2006 is responsible for human cells and tissues regulation too. The participation of the INDT in the IAEA program facilitated the introduction of the radiation sterilisation technique for the first time in the country. The radiation sterilisation of tissues processed by INDT (ex BNOT), was initially carried out in the 60 Cobalt Industrial Plant in the National Atomic Energy Commission of Argentina and now is carried out in INDT, using a Gamma Cell 220 Excel, which was provided by the IAEA through the national project URU/7/005. The results of the implementation of tissues, quality control and quality management system, are showed.