Presentation on theme: "INTRODUCTION OF FACT/JACIE COMPLIANT ISBT 128 BARCODE LABELS FOR"— Presentation transcript:
1 INTRODUCTION OF FACT/JACIE COMPLIANT ISBT 128 BARCODE LABELS FOR STEM CELL & IMMUNOTHERAPY PRODUCTSAmy Millar1, Alan Lankester2, Ewan Hampson3 and Suzanne M Watt4Stem Cells and Immunotherapies NHSBT Birmingham1, Bristol2, Oxford4, IT Software Development NHSBT Bristol3BACKGROUNDIn 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 CYCLEKey user develops User Requirement Specifications (URS)In-house software developer writes Software Specification documentQuality Manager approves documentationTest version of software producedLead Trainer becomes familiar with Test system, & highlights any errorsPrepare Test Scripts for acceptance testingAcceptance Testing completed and passedQM sign off of Acceptance Test scriptsPrepare Standard Operating ProcedureSCIBarcode total development time 13 weeksINTERIM SOLUTION: PARTIAL LABELS for CRYOPRODUCTSNHSBT 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.Example SCIBarcode Label mm mm MINIMUM REQUIREMENT for FACT-JACIE COMPLIANT PARTIAL LABELSUnique numeric or alphanumeric identification of individual donations/productsProper name of the productRecipient nameFurther recipient identifier e.g. hospital numberPlus NHSBT requires recipient date of birthExample Base Labels SpreadsheetSCIBARCODE APPLICATION for BARCODE LABEL PRINTINGNetwork application written in Delphi 7MS SQL Server 2000 back end databaseOutput for Zebra printer in ZPLIIUser identifies product (and associated code) software assigns donor type code and split codesRestrictions on products available from a single donation e.g. impossible to have HPC-A and HPC-M product from single donationDonation type (autologous, designated, directed) can not be changed between product labels for a single donation numberEach 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 levelsTimeout feature assumes labels have been printed if validation is not attempted or failed validation reason not givenUsers able to view an audit report which details prints, failed prints, validations, deletions, additions etc by donation number.TRAININGLead Trainer identified key trainers at all NHSBT SCI sitesKey trainers individually trained using test scripts as basic scenarios, & SOP for correctprocedure and troubleshootingAll key trainers cascade training to other users at their site‘Go-Live’ dates set and individual IT departments notifiedDocumentation detailing support for Go-Live issued to all key trainers, QA, and Desktop Support ManagerFinal label: folded and sealed in Cryobag label pocketRecipient details readable from other sideGO-LIVESCI 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.BASELABEL SPREADSHEETMS Office 2003 Excel SpreadsheetUser 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 macroPrint macro creates audit trail of all base label printoutsCONCLUSIONSSCI 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.