Standards
A1.000 Introduction and Purpose
a) The main goal of the Bulgarian Association of Tissue Banks (BgATB) is to ensure the implementation of medical standards that are reflective and compatible with all relevant legal, regulatory and peer review requirements established in the European Union by all its member tissue banks. The BgATB sees its role in providing assistance to the Bulgarian professional tissue banking community as well as, to the Bulgarian Competent Authority (the Executive Transplant Agency and the Ministry of Health) in order to make the Euro-integration processes in the field of tissue donation and transplantation as effective and smooth as possible.
b) These Standards have been developed to assure consistently acceptable levels of quality, proficiency, and ethics in dealing with tissue donation and transplantation and define the minimum standards of practice in the recovery, preservation, storage and distribution of tissue for transplantation and research, as determined by the Bulgarian and European surgical and tissue banking community.
A1.100 Scope
These standards are intended to apply to any and all aspects of tissue banking to include:
- Identification and screening of potential donors of tissues and/or cells.
- Management of consent requirements and evaluation of clinical, medical and social history data.
- Laboratory testing, incl. serological, histological and/or pathological evaluation of potential tissue/cell donors.
- Surgical recovery, intra-operative and quarantine evaluation/management of tissues and/or cells.
- Preservation and processing of tissues and/or cells.
- Storage and distribution of tissues/cells and/or allograft products.
- Adverse effect and adverse reaction management.
These standards shall be reviewed at least annually and revised as necessary to incorporate current research findings, improved clinical practice and technological developments.
