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Step #1
Register with ICCBBA if your transfusion service is computerized or you intend
to use ISBT 128 for products collected in-house. If you have not
already registered with ICCBBA, contact them and request registration
information.
Becoming a Registered Licensee with ICCBBA, Inc
Step #2
Assign responsibility to develop an implementation plan and coordinate its
progress. You may want to start by contacting your blood supplier and
determining what their plans are relative to ISBT 128 implementation.
Included should be developing a plan for handling ISBT 128 labeled
products (directed or autologous units) before your facility is actually
ready.
Sample Implementation Plan
Step #3
Determine training objectives for the transfusion service staff and blood
administration personnel. Assign responsibility for developing and
implementing a training plan.
Step #4
Identify those SOP’s (Standard Operating Procedures) that will require
revision. Assign responsibility for revising SOP’s in a timely manner.
Step #5
Determine whether modified blood components will be labeled with pre-printed
(purchased) or on-demand printed labels. On demand labels may require
the use of separate software and a dedicated label printer.
Step #6
Determine how change control will be monitored.
Step #7
Determine how look-backs will be handled.
Step #8
Ensure that all critical process control points are addressed as defined by
your quality plan.
Additional Steps for those Transfusion Services with Computerized Product
Inventories
Step #9
Determine the need for software changes to accommodate ISBT 128.
This may include: software upgrades from vendor, assessing the need to change
or expanding the facility product code database and assessing the impact of
ISBT 128 on other departments.
Step #10
Determine the need for hardware changes to accommodate ISBT 128.
This may include: evaluating printers for capability to print ISBT 128
barcodes, assessing the need to reconfigure barcode readers, evaluating the
ability to autodiscriminate between ISBT 128 and other barcode
languages, and assessing the ability of the barcode reader to use
concatenation as well as deciding if this feature will be utilized by your
facility.
Step #11
Select component product codes that will be used for on-site collections or
modifications to blood products.
Step #12
Establish a plan for handling units labeled with ISBT 128 if
software/hardware changes cannot be made before the blood suppliers begin
shipping the new labels.
Step #13
Assign responsibility for development and implementation of a validation plan
for all software and hardware changes.
Step #14
Determine capability for handling both ABC Codabar and ISBT 128 during
the transition period and for the duration of the frozen inventory.
Step #15
Verify that traceability is maintained if blood products are relabeled with an
internal number.
Step #16
Assess potential impact of ISBT 128 bar code labels on the clinical
laboratory or medical records department.
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