INTRODUCTION OF FACT/JACIE COMPLIANT ISBT 128 BARCODE LABELS FOR STEM CELL & IMMUNOTHERAPY PRODUCTS Amy Millar1, Alan Lankester2, Ewan Hampson3 and Suzanne M Watt4 Stem Cells and Immunotherapies NHSBT Birmingham1, Bristol2, Oxford4, IT Software Development NHSBT Bristol3 BACKGROUND In 2004 Medinfo were contracted to supply Hematos IIG as a national IT package for the NHS Blood and Transplant (NHSBT) patient services, including collection and processing of cellular therapy products. With the introduction of a new database Stem Cell and Immunotherapy (SCI) departments within the NHSBT required a national system to uniquely identify all products. NHSBT already used ISBT128 for blood banking and processing and SCI departments used ISBT 128 donation numbers for donor virology screening so ISBT128 was the obvious choice. As well as using ISBT128 barcode identification, labels had to be compliant with JACIE standards as all of the labs were in the process of accreditation. Conflicts between JACIE and the ISBT128 technical standard were identified, and a resolution was submitted to the UK ISBT128 Advisory Committee and agreed as a national format. This has since been further developed following international discussion facilitated by ICCBBA into the ISBT128 Labelling Standards for Cellular Therapy Products. Significant numbers of products remain in cryostorage for many months or years, therefore we required an interim labelling solution for cryopreserved products to minimise manual product management post Hematos go-live, it is the interim solution that has been introduced so far and is described in this poster. SOFTWARE DEVELOPMENT CYCLE INTERIM SOLUTION: PARTIAL LABELS for CRYOPRODUCTS Example SCIBarcode Label -------------------38mm-------------- Key user develops User Requirement Specifications (URS) NHSBT already had ISBT128 barcode replication software for Zebra demand label printing written by an in-house programmer. It was proposed that this could be modified to include both donation and product identifiers, with controls to prevent duplication of previously printed unique combinations and ensure that product description (HPC-A, HPC-M etc) and donation type (autologous, directed etc) were consistently applied for a given donation number. The unique barcode label would then be applied to a base label containing the intended recipient details which could be extracted from the simple databases or spreadsheets in use in the individual Stem Cell facilities. In-house software developer writes Software Specification document Quality Manager approves documentation Test version of software produced -------------------------48mm---------------------- Lead Trainer becomes familiar with Test system, & highlights any errors MINIMUM REQUIREMENT for FACT-JACIE COMPLIANT PARTIAL LABELS Example Base Labels Spreadsheet Prepare Test Scripts for acceptance testing Unique numeric or alphanumeric identification of individual donations/products Proper name of the product Recipient name Further recipient identifier e.g. hospital number Plus NHSBT requires recipient date of birth Acceptance Testing completed and passed QM sign off of Acceptance Test scripts SCIBARCODE APPLICATION for BARCODE LABEL PRINTING Prepare Standard Operating Procedure SCIBarcode total development time 13 weeks Network application written in Delphi 7 MS SQL Server 2000 back end database Output for Zebra printer in ZPLII User identifies product (and associated code) software assigns donor type code and split codes Restrictions on products available from a single donation e.g. impossible to have HPC-A and HPC-M product from single donation Donation type (autologous, designated, directed) can not be changed between product labels for a single donation number Each printed bar-coded product label requires scanned read validation of the donation number and the product barcodes. If validation fails, explanation for failure is required before reprint is allowed. Standard user and supervisor access levels Timeout feature assumes labels have been printed if validation is not attempted or failed validation reason not given Users able to view an audit report which details prints, failed prints, validations, deletions, additions etc by donation number. TRAINING Lead Trainer identified key trainers at all NHSBT SCI sites Key trainers individually trained using test scripts as basic scenarios, & SOP for correct procedure and troubleshooting All key trainers cascade training to other users at their site ‘Go-Live’ dates set and individual IT departments notified Final label: folded and sealed in Cryobag label pocket Documentation detailing support for Go-Live issued to all key trainers, QA, and Desktop Support Manager Recipient details readable from other side GO-LIVE BASELABEL SPREADSHEET SCI Bristol pilot go live with SCIBarcode in September 2007, followed by the remaining SCI departments during October. Initial problems when the software was used ‘Live’ included: some label damage from alcohol sterilisation, unfamiliarity with software and hardware and MS Office upgrade during roll out to labs changed macro handling in spreadsheet. Problems were dealt with swiftly and smoothly by support measures put in place for release. MS Office 2003 Excel Spreadsheet User scans donation number, VB macro looks for associated patient details in database or spreadsheet linked to user site. Manual entry of recipient details possible if local database is incompatible with lookup macro Print macro creates audit trail of all base label printouts CONCLUSIONS SCI Barcode is an interim package to reduce the numbers of products requiring manual management for issue or discard when NHSBT SCI labs go live with our new national IT system. However it has proven robust in use and has greatly improved label print quality, regulatory compliance and audit trail in the 7 laboratories using it. This low cost solution demonstrates that demand print barcode labelling of stem cell and immunotherapy products is within reach for small facilities without the need to purchase expensive IT packages.