Implementation of the ISBT 128 standard-based tissue donation identification system in Poland

Согласно статье. 8.2 из Директивы 2004/23/ЕС Польша одно из государств-членов Европейского союза должна гарантировать выполнение системы идентификации доноров. Чтобы обеспечить доступ к спецификациям и базам данных (поддержка ICCBBA, Inc—некоммерческая международная организация), взимается плата за начальную одноразовую регистрацию и за ежегодные лицензии, которые были централизовано куплены для всех тканевых банков. Это успешное предприятие было возможно, только благодарят финансовой поддержке из национальной программы здравоохранения.


Aim. According to art. 8.2 of Directive 2004/23/EC Poland as a one of European Union Member States shall ensure the implementation of a donor identification system which assigns a unique code to each donation and to each of the products associated with it. Polish Ministry of Health decided to implemented ISBT 128 standard as a national standard for identification and labelling of human blood as well as tissues and cells. The ISTB 128 implementation was one of the objectives of the National Programme for Development of Transplant Medicine POLGRAFT 2006-2009.

Method. The ISBT 128 implementation task group was established and tissue bank managers were invited to join it in. To provide access to the ISBT 128 specification and databases (maintained by ICCBBA, Inc - a non-profit international organisation) fees for initial onetime registration and for annual licenses were centrally purchased for all public tissue banks.

Results.

1. After registration with ICCBBA, Inc all newly registered organisations were assigned the unique Facility Identification Numbers (FIN), one of the crucial component of the globally unique Donation Identification Number (DIN).
2. All ISBT 128 tissue relating technical documentation and tissue product code database were translated from English into Polish.
3. A list and definitions of tissues routinely recovered, processed and distributed by Polish tissue banks were compared with the database of tissue products and definitions provided by ICCBBA, Inc. The ISBT 128 Polish tissue database including both international as well as national codes was developed.
4. Label designs were established.
5. Hardware including personal computers, bar code printers and readers were purchased.
6. One of the two currently existing in Poland ISBT 128 - compliant software system covering all aspects of tissues and cells donation, processing and distribution was developed.
7. Several trainings on ISBT 128 standard and computer system use were performed.
8. Validation studies of the new coding system has been begun.

Conclusion. Implementation of ISBT 128 standard, the most comprehensive and widely used standard for coding and labelling of products of biologic origin was a complex task. This successful venture was possible only thank to financial support from the national public health programme.


^1,2Uhrynowska-Tyszkiewicz I., ^1,2Kaminski A., ^1,2Olender E., ^1,2Gut G.
¹The National Centre for Tissue and Cell Banking, ²Department of Transplantology and Central Tissue Bank, The Medical University in Warsaw, Warsaw, Poland