BACKGROUND

1
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.
INTERIM SOLUTION PARTIAL LABELS for
CRYOPRODUCTS 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.
Example SCIBarcode Label
?-------------------38mm--------------?
?-------------------------48mm-------------------
---?

• MINIMUM REQUIREMENT for FACT-JACIE COMPLIANT
  PARTIAL LABELS
• 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

Example Base Labels Spreadsheet

• SCIBARCODE APPLICATION for BARCODE LABEL PRINTING
• 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.

Final label folded and sealed in Cryobag label
pocket Recipient details
readable from other side
GO-LIVE 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.

• BASELABEL SPREADSHEET
• 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.