26.2 The labelling system
The labelling system for retrieved tissues and tissue products comprises the following elements:
base label: the label applied to the retrieved tissue container following tissue retrieval and/or to the final container following tissue processing. It includes guide marks (preferably corner marks to prevent interference with barcode reading) to assist in the positioning of overstick labels. Retrieved tissue may be from living donors (retrieved during surgery) or from cadaveric donors (retrieved after death). It is noted that in the majority of cases, tissue is transferred during processing to a secondary/final container. In these circumstances a new base label is applied to the final container
donation identification number label: a label bearing the ISBT 128 donation number barcode. Produced in sets, these labels ensure the accurate and unique labelling of all tissue donations and samples. Allocated at the point of donation, this number is fundamental to the secure audit trail for tissues. Where a retrieved tissue is processed without pooling or is issued unprocessed, the original donation number barcode is used to identify it to the point of implantation. This label will bear the title of the Blood Transfusion Service supplying the tissue, unless this is included on another label
batch/pool identification number label: a label bearing an ISBT 128 donation number barcode. These labels are demand-printed when different tissues from one donor or tissues from more than one donor are pooled for processing. They ensure the accurate and unique identification of tissues once they have been pooled through to the individual resulting tissue grafts/units each of which bears the same identification number. Ideally, the number sequence used for batch/pool identification numbers should be different from donation number sequences and should be easily identifiable as batches/pools. This label will bear the title of the Blood Transfusion Service supplying the tissue, unless this is included on another label
product label: a label bearing the ISBT 128 tissue product barcode, together with tissue product information, applied at the time of tissue retrieval and final tissue product manufacture. Where individual tissue units have been produced from a pool of tissues (from one or more donors) the product barcode can be used to individually identify up to 999 splits from the pool. This label can include unit-specific information
tissue status label: a label indicating the status of a particular product in barcoded and eye-readable form. This is equivalent to the blood group label in blood banking. The following status labels can be applied:
Fit for clinical use (Rh D not specified)
In quarantine – not yet cleared for clinical use
Rh D POS – fit for clinical use
Rh D NEG – fit for clinical use
Must be sterilized
For in vitro R & D only
See outer container for product status (for cryopreserved products)
Autologous donation - fit for clinical use
Autologous donation - in quarantine
The tissue status label will also bear the nationally defined short form unit identifier and other donation specific information, e.g. date of donation or retrieval site. This label will be applied by the Blood Transfusion Service prior to release into stock, allocation for R & D or discard, except for the 'See outer container' label which will
be applied to the base label before the product is cryopreserved. These labels are positioned to allow concatenation between the unit identifier on the base label and
the short form identifier on the status label
expiry date label: a label indicating the date by which the tissue must be processed
(if in quarantine), issued (if in issuable stock) or used (if dispatched for clinical use). Different expiry date labels may be overstuck on products at different times. For example, some banks shorten the shelf life of products once they are issued from a bank due to concerns relating to appropriate long-term storage and control in hospitals.
The labels indicated above are all affixed onto a base label, except in the case of cryopreserved products where two status labels may be used, one on the product container itself (applied before cryopreservation), 'See outer container for product status' and one on the outer container giving the product status. In this case, a new base label, product label and expiry label should all be attached to the outer container. The arrangement of labels depends on the product and container type. Two options are shown in Figures 26.1 and 26.2; each would require a different base label. These diagrams are for orientation purposes only: see under the appropriate sections for details of each label content and layout.
The four basic quadrant labels may be printed as combination labels; for example, the donation number label and the product description label may be printed as a single vertical strip label and affixed to cover the left-hand half of a square base label. Similarly, expiry date information may be printed on a status label so that the two right-hand quadrants are printed as a single strip.