26.5 Donation and pool identification number labels
The donation identification number plays a critical role in the safety of the tissue supply. It provides a unique identification number which cross-references tissue donations and products and samples taken at the time of donation. Where tissue products are not further processed, they are issued with the same donation identification number label.
Donation identification number labels must be generated in sets under strictly controlled conditions which ensure that all the labels in a set bear the same number, and that each set is unique. It is the responsibility of the manufacturer of the label sets to undertake appropriate quality control measures to ensure these conditions are met.
Pool identification number labels are generated on demand when donations are processed together, whether from one or more donors.
As tissues are usually transferred from their original containers to secondary and tertiary containers during processing, it is a requirement that donation and pool identification numbers can be printed on demand.
An example set of identification numbers is shown in Figure 26.5. Barcode density information is provided in the ISBT 128 Technical Specification. The structure of the donation identification number is described further below.
Figure 26.5 Donation identification number label set
For identification number labels to be applied to tissue products, the dimensions of the label are as indicated in Figure 26.6. As with all barcodes, there should be a minimum 'quiet zone' of 2.5 mm between the edge of the label and the start of the barcode. This label is affixed to the top left-hand section of the base label.
The donation identification number complies with the structure defined in the ISBT 128 Technical Specification. The Country/Collection Facility Identification Codes defined for tissue banking use in the UK are shown in Table 25.1 (the issue of new codes is controlled by ICCBBA as part of the registration process. Any site within the UK requiring a new code must apply to SACIT in the first instance).
The collection year characters (6 and 7) should correspond to the last two digits of the year in which collection took place. In practice, this cannot be readily achieved using pre-printed labels without considerable wastage. Within the UK it is therefore permissible to allow a maximum variation of one month either way, i.e., it is permissible to use the previous year's collection year characters up to 31 January in the current year, and to use donation numbers with the following year's collection year characters from 1 December in the current year.
All UK donation identification numbers must use the flag characters 'ff' as data transmission check characters in the range 60-96 (Type 3 flag as defined in the Technical Specification). The algorithm for calculating check characters is included in Appendix VII. However, designers of software systems will need to take into account that units imported from countries outside the UK may well use these flag characters for other purposes as permitted in the Technical Specification (Type 1 and 2 flags).
Figure 26.6 Donation number label dimensions
The eye-readable format of the donation identification number in the UK comprises the data characters excluding the flag characters, followed by the manual entry check character. The layout differs from that in the ISBT 128 Technical Specification in that all characters of the number must be of equal size and weight. Printing of the six-digit unit serial number in larger or bold characters is not permitted. Software manufacturers should ensure that only the eye-readable format is presented in screen displays.
The number should be displayed with the characters grouped in a 4, 3, 3, 3, 1 arrangement. It is recommended that the check character be enclosed in a box where this is possible. The check character set uses the characters I and 1, 0 and O and the font selected should be one which allows easy differentiation between these characters.
G151 798 123 456 4
Where the donation identification number has to be recorded manually, form designs that assist accurate recording, such as the use of boxes to encourage correct character grouping, are recommended. An example is given in Figure 26.7.
Figure 26.7 Form boxes designed to enable accurate recording
The full eye-readable donation identification number, including check character, must be recorded and entered in all cases. The use of pre-programmed shortcut keys ('hot' keys) or pre-printing of part of a number is not acceptable.