FACILITY C
MEDICAL CENTER
Department X
Document Control System
ISBT 128 IMPLEMENTATION PLAN
Cellular Therapy Center
Facility C Medical Center
ISBT 128 OVERVIEW AND HISTORY AT FACILITY C MEDICAL
CENTER
The International Society of Blood Transfusion (ISBT) developed, through international
consensus, a new standard for labeling blood components. ISBT 128 process uses barcode
symbology Code 128 with specific flags/data identifiers that are used internationally for
process control when manufacturing blood products. ISBT 128 also revises and expands all
blood component product codes and defines additional required information for the
component label.
The Transfusion Medicine Service at Facility C Medical Center began implementation of
ISBT 128 in the early 2000 so that ISBT 128 labeled components received from an outside
supplier could be received, processed and issued. As the computer system in use at that
time (Software A) did not support the printing of labels for modified ISBT 128-labeled
units a full implementation of ISBT 128 was not possible at that time. The implementation
of Software B (in July, 2008) allowed for the use of a standalone printer server and the
printing of the required ISBT 128 labels when new products were created via product
modification. At that time the full ISBT 128 implementation was built, tested and
validated. The Blood Donor Program was also converted to ISBT 128 labeling but as they
were still using Software A, the required ISBT 128 product labels were printed via a
standalone print system. When the Blood Donor Program was converted to ISBT 128
labeling all progenitor cell collections were assigned ISBT 128 donation identification
numbers. The Transfusion Medicine Research Lab, established in 2010, also is utilizing a
full ISBT 128 implementation. As Software B did not support the use of the S code series
of product codes (assigned to Cellular Therapy components) a process similar to the one
first used in the Blood Bank was designed, tested and validated. This allowed the CTC to
accept ISBT 128 labeled units, process and dispense without the printing of the new labels
when a component was modified; appropriate labels were attached to the units following
processing and at dispense.
With the implementation of a new Software B upgrade the use of S codes is supported and
our existing components can be aliased to these S codes. However, the standalone printer
system in use for the rest of Transfusion Medicine Service will not support the use of S
codes so another print system will be utilized as a stand-alone system until an interface
with Software B is available.
ISBT 128 Implementation Plan for CTC
April 1, 2015
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FACILITY C
MEDICAL CENTER
Department X
Document Control System
ADVANTAGES

Most importantly, ISBT 128 allows blood to be shipped all over the world and accepted
into any blood bank or transfusion service without altering the donation number or
component code. Global standardization is becoming increasingly important.

The Donation Number allows for complete traceability as it identifies the collection site
by using a defined format.

ISBT 128 is a more secure symbology than ABC Codabar. It prevents most miss-scans
and improves scanning accuracy.

ISBT 128 allows for future expansion of product codes and barcode information;
Codabar is almost at its limit.

More information, such as the type of donation, is encoded on the label.

ISBT 128 labels allow us to concatenate (read concurrently) several fields when
scanning, thereby reducing the number of scans needed for several processes.

ISBT 128 eliminates duplicate Donation Number problems.

ISBT 128 reduces product label cost significantly.
IMPLEMENTATION SCOPE





ISBT 128 labeling is already in place in Blood Bank and the Blood Donor Program. A
full implementation for the Cellular Therapy Center is planned with the implementation
of Software B upgrade, which is scheduled for implementation late in 2011.
As the Cellular Therapy Center currently uses ISBT 128 donation numbers all support
staff, both in the Cellular Therapy Center and on the patient care units, are familiar with
the ISBT 128 unit numbers and product codes. Billing will not be affected as the
donation number is not sent with billing files.
Three printers for use with the CT print software will be required in the Cellular
Therapy Center ( full face product labels, cryo vial labels, and a face perforated label
for folding and placing in a pouch attached to the unit). Appropriate label stock will
also be required.
Barcode scanners have been purchased and validated for use with ISBT 128 labeling
standards.
The Cellular Therapy Center will evaluate all policies, procedures, and forms to ensure
compliance with the ISBT 128 labeling format.
ISBT 128 Implementation Plan for CTC
April 1, 2015
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FACILITY C
Department X
Document Control System
MEDICAL CENTER
ICCBBA REGISTRATION


Facility C Medical Center has maintained ICCBBA registration since approximately
2000.
Facility codes are assigned for locations through ICCBBA. At this time all locations at
Facility C Medical Center utilize the same facility registration number.
OVERSITE OF IMPLEMENTATION PROCESS


The implementation process is guided by a select team of representatives from multiple
areas and functions of Facility C Medical Center.
The team is referred to as the ISBT 128 Implementation Team.
o The team members and the area(s) they represent are listed below.
Cellular Therapy Center
NAME
Dr. John Doe
Jane Doe
Joyce Doe
Jane Doe
Jill Doe, Jan Doe
June Doe
Jeff Doe
JOB TITLE
Medical Director
LIS Specialist,
Transfusion
Medicine Service
Quality Specialist,
Transfusion
Medicine Service
LIS Specialist,
Transfusion
Medicine Service
Cellular Therapy
Specialists
Cellular Therapy
Supervisor
Clinical Pathology
Manager
AREA
Executive Sponsor
Project Manager
Quality Assurance
Computer System
Production Management
Production Management
Laboratory Management
Implementation documentation for the Cellular Therapy Center at Facility C Medical
Center is maintained in a designated ISBT 128 Implementation notebook which will be
available in the Cellular Therapy Center at the conclusion of the implementation
process .
 Documentation of activities in the notebook includes:
o validation of equipment such as printers and labels
o minutes from implementation meetings
o internal communications and/or directives
ISBT 128 Implementation Plan for CTC
April 1, 2015
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FACILITY C
MEDICAL CENTER

Department X
Document Control System
Documentation of ISBT 128 implementation activities are maintained by Jane Doe,
Project Manager
 Computer, procedures, and other validation documents are maintained using current
Facility C Medical Center, Transfusion Medicine Service, policies and procedures.
IMPLEMENTATION OVERVIEW AND TIMELINE


The following is a high level outline of the project steps and associated timeline.
Details are defined and tracked via a Task List document maintained by the ISBT 128
Implementation Team.
Dates Action
Comment
Select core team.
Educate core team.
Develop project plan.
Communication timeline to internal customers.
Make basic decisions concerning label design,
label printing.
Communicate with computer vendors and obtain
a working environment.
Develop initial overview training.
Assess impact, compatibility with ISBT 128 and
upgrades needed for all other systems. Included
are:
 Finance
 Collections
 Laboratory
 Manufacturing
Determine equipment needs: additional label
printers and/or scanners.
Create a computer system ISBT 128
environment available.
Populate parameters in computer ISBT 128
environment.
Begin assessment of procedure impact.
Order and implement equipment upgrades.
ISBT 128 Implementation Plan for CTC
April 1, 2015
Team decisions
Develop
presentations
Each area must
assess their
system.
Includes label
printers,
scanners, new
donation number
sets.
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FACILITY C
Department X
Document Control System
MEDICAL CENTER
Dates Action
Comment
Validate computer systems.
Teams of
personnel for test
script writing and
execution.
Validate other automation systems as needed.
Revise internal procedures.
Develop training for staff.
Develop post implementation evaluation plan.
Develop transition plan.
Deliver procedures and training internally.
Implement.
ANTICIPATED RESOURCES NEEDED
The table below lists anticipated resources and either time commitment or FTEs as
appropriate.
Cellular Therapy Center
Resource
Specifics
Time
Commitment
(estimated)
Project Manager
Project Manager
80 hours
Quality Assurance
Computer System
Training Department
Process change coordination
Process change coordination
20 hours
40 hours
Develop training both internal and
external, plus procedures changes
Production Management Process change coordination
Laboratory Management As needed
40 hours
80 hours
4 hours
ANTICIPATED CAPITAL EQUIPMENT NEED
In this section, list anticipated capital equipment needs, for example:
The table below lists the Capital Equipment needed including individual and total costs.
ISBT 128 Implementation Plan for CTC
April 1, 2015
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FACILITY C
Department X
Document Control System
MEDICAL CENTER
Capital Equipment
Scanners
Quantity Needed
Cost per item
Total Cost
On-demand label printers
3
$500.00`
$1500.00
Label stock
Full face – 1 case
Cryo vials – 1
case
Intended recipient
– 1 case
$194.00
$67.56
$194.00
$67.56
$178.00
$178.00
$6000.00
Includes cost for
interface)
$6000.00
Software
Print labeling
software
Overall Totals
$7939.56
NOTE: All of the above items, with the exception of the interface, have
already been purchased. The interface will require funding when it
becomes available.
ISBT 128 Implementation Plan for CTC
April 1, 2015
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FACILITY C
MEDICAL CENTER
Department X
Document Control System
Examples of labels:
Full face:
Cryo label:
ISBT 128 Implementation Plan for CTC
April 1, 2015
Page 7 of 8
FACILITY C
MEDICAL CENTER
Department X
Document Control System
Intended recipient label:
APPROVED: __________________________________________ DATE: __________
Signature of Executive Sponsor
ISBT 128 Implementation Plan for CTC
April 1, 2015
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