The quality and safety requirements on cell and tissue transplants were set recently by the European Parliament and Council Directive 2004/23/EC and precised in the European Commission Directives 2006/17/EC and 2006/86/EC. The principles of voluntary and unpaid donation were already included in the National Transplantation Act; a proposal of a special new Act setting the safety and quality norms is now undergoing the standard parliamentary process. As an immediate action the system of tissue bank licensure was established by the Ministry of Health, and the total of 19 institutions were licensed in 2004. Changes of the system of the work of a tissue bank are demonstrated on work experience of the Tissue Bank of the University Hospital Hradec Králové, designed and rebuilt as a combination of cryogenic and clean-room technology. The system of secondary contamination prevention is based on processing in the environment of the grade A with the background of grade B, regularly validated by an authorised company. The validation results showed maintaining of the grade A in the critical processing area both at rest and at operation conditions. The non-compliance rate of aseptically prepared cell and tissue grafts with the quality criteria set by the tissue bank management in specifications of individual products varied between 0.73% in peripheral blood progenitor cells concentrates and 6.4% in minimally manipulated solid tissue grafts (bone, cartilage ligaments, fascia lata) used for reconstructive operations in orthopaedics, traumatology and neurosurgery.
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