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.