23.1 General considerations
Tissue banks should have dedicated processing and storage facilities designed and operated to prevent contamination, cross-contamination, mislabelling and deterioration of tissues.
All processes and equipment which affect the safety or quality of tissues must be validated. Tissue bank non-disposable instruments and other items which come into direct contact with donor tissue during retrieval and processing must be thoroughly washed and sterilised between uses. Where possible, disposable equipment should be used. Where this is impractical or impossible, non-disposable instruments can be used. These must be batchdedicated to allow tracking through decontamination, sterilization and use. A risk assessment should be performed to determine the period for which instruments are kept before discard. These instruments should be washed and sterilised according to NHS Estates Health Technical Memoranda (HTM) 2010(1), 2030(2) and 2031(3). Prompt removal of residual blood and tissues is an important aspect of decontamination, particularly with regard to CJD.
All purchased materials and solutions which affect the tissue quality and safety must be inspected on receipt to ensure compliance with specification. Local policies must be in place to minimize the risk of tissue contamination by staff e.g. by blood from a cut during retrieval and processing.
UK Blood Transfusion Services tissue banks may use third parties to perform tissue retrieval, processing steps such as irradiation, tissue evaluation such as bacterial tests, quality control tasks such as environmental monitoring or tissue storage, transport and distribution. Wherever such tasks are performed by or on behalf of a third party, this must be subject to a written agreement between the parties involved. This must specify the processes to be performed, the applicable standards and specifications and the responsibilities of both parties in achieving the desired outcome. The processes should be performed, as a minimum, in accordance with the guidance given in the EU Directive and its daughter directives.
In the event of a health care worker sustaining an injury such that his/her blood comes into contact with the tissue, the tissue must be discarded.
Retrieval times and preliminary storage
Tissues should be retrieved as soon after death as possible. If the body has not been refrigerated, procurement of tissues should be completed within 12 hours after death. If the body has been refrigerated within six hours of death, procurement should preferably start within 24 hours and must be completed within 48 hours of death.
Tissues must be placed at a temperature of 0–10°C within four hours of retrieval.
General considerations for tissue retrieval
Every effort must be made to minimize contamination of tissue during procurement.
The procurement facility must be suitable for procurement of tissues, which may include facilities other than an operating room.
A local sterile field must be created using sterile drapes. An appropriate anti-bacterial skin preparation agent must be used before commencing the retrieval.
All instruments used during the retrieval must be sterile and should be stored on a back table which is covered with a sterile drape. Where possible, disposable equipment should be used.
Staff conducting the retrieval must be appropriately gowned in sterile clothing, and wear sterile gloves and protective masks.
Every effort should be made to minimize the number of people present during deceased tissue retrieval and to ensure that a post-mortem is not proceeding during the retrieval.
Where possible the retrieval should precede any post mortem examination of the donor. In cases referred to the Coroner (or the Procurator Fiscal in Scotland), the Coroner's consent must be obtained to enable the retrieval of tissues.
It is integral to the maintenance of the dignity of the donor that the body is cleaned and reconstruction is carefully undertaken. Whenever long bones are removed they must be replaced with appropriate prostheses. All incisions should be neatly sutured.
For similar reasons, skin must not be procured from the neck, arms, face or other areas that may affect funeral viewing.
Every effort should be made to ensure that appropriate advice on the handling of deceased donors after retrieval should be made available for mortuary and funeral home staff.
Labelling of collections
At the time of collection, the container for each category of tissue, for example skin, bone, or heart valves, must be labelled with the nature of the contained tissue and a barcoded tissue or donor identification (ID) label as appropriate.
The accompanying donation record must be labelled with the same tissue or donor identification number(s), key donor identifiers (name, date of birth, etc.), and the date of collection prior to removal from the procurement site. Bacteriology and blood samples, together with accompanying documentation where relevant, must be labelled according to agreed local procedures such that the results can be linked to the correct donor/tissue whilst still preserving anonymity where required. Annex 4 of the first daughter directive describes (in 1.6) the minimum requirements.
A double container system is required for all tissues retrieved. The containers must not be opened until ready for use or further aseptic processing at a facility approved by the tissue bank.