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ISBT 128: Beyond the Label
Marianne A. Silva, MS, MT(ASCP)SBB, CQA(ASQ)
(AABB Consulting Services Division, Bethesda, MD)
DOI: 10.1309/HDFCMF4CXD8H8PKV
labmedicine.com
April 2007 䊏 Volume 38 Number 4 䊏 LABMEDICINE
213
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lood suppliers in the United States are in the
process of implementing ISBT 128. Many
have initiated communication with hospital
transfusion services in preparation for this
transition. Most facilities use one or more
bar codes on the blood bag label to identify,
inventory, distribute, or administer the blood
component. Changes in labeling will require active communication with many areas of the hospital as information from
the blood bag label must be capable of being read, transmitted, translated, printed, and retained in a manner that
maintains traceability and unique identification of the component. The transition to ISBT 128 will require evaluation
of processes and coordination of multiple departments in
each facility.
B
Beyond Codabar: Why the Transition
to ISBT 128
Every label communicates important information to the
consumer. While it is common to expect certain types of information on every food or drug label, the same expectation
holds true for the label of blood components.
The Food and Drug Administration (FDA) specifies in the
Code of Federal Regulations1 the information to be included
on the label of all blood components. The format or placement
of specific information has been consistent for years, based on
the “Guidelines for the Uniform Labeling of Blood and Blood
Components.”2 This document defined the requirement for the
font size, color, and the location of information included on the
label of the blood bag. The bar code symbology, Codabar, also
has been used for many years by industries worldwide.
During the past 20 years, however, as technology has expanded, Codabar has reached the limit of its ability to communicate critical information. It is not able to provide the
depth of detail in the product code to adequately describe the
donation type, component collected, and modifications made
to the component. Additionally, blood centers have found
that with Codabar, donor unit numbers may need to be “repeated” within a 10-year period. This can become problematic because a unit of red blood cells can be frozen for that
duration of time, raising the potential for a duplicate donation identification number in a facility’s blood inventory.
Some facilities also have experienced situations where scanning the bar code of a Codabar label has led to misread or
misinterpreted information.3
The complexity of manipulations that can be made to any
blood component today demands a robust system for labeling
components, and the ability to electronically verify that an appropriate label has been applied to a component provides
tremendous value in support of patient safety. Conversion to
ISBT 128 bar code symbology will support the advances that
have occurred in transfusion medicine and provide a method
to communicate critical information.
Implementation of ISBT 128 is not mandated by the
FDA, but it does fulfill a requirement that specific information
on any blood component be “machine readable” by April 24,
2006. This requirement was part of a final rule, the “Bar Code
Label Requirement for Human Drug Products and Biological
Products,”4 published in the Federal Register (Feb. 26, 2004).
The elements that must be machine readable, according to the
final rule, include the donation identification number, the
ABO/Rh, the product code, and unique facility identifier.
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LABMEDICINE 䊏 Volume 38 Number 4 䊏 April 2007
Beyond the United States
Growth in the fields of transfusion medicine and cellular
therapies demands a universal standard specifying a globallyunique donation identification number, an international
product reference database, and a standard layout for the
product label. ISBT 128 symbology allows a unit to be identified around the world without relying on eye-readable information that may be in a different language to
communicate critical data to the end user. This becomes increasingly important when considering international patient
and donor databases, military operations, and multinational
disaster relief programs.
The assignment of a unique facility identification code
and the maintenance of the product database is coordinated
by ICCBBA, formerly known as the International Council for
Commonality in Blood Bank Automation,5 the organization
maintaining ISBT 128 and the international information
standard. It sets a global standard for the identification, labeling, and information processing of human blood and tissue.
Beyond the Blood Bank
Implementation of ISBT 128 will not only affect individuals within the blood bank, as other areas of the laboratory
may be integrally involved in performing testing on a blood
component. For example, the microbiology department may
be involved in the evaluation of a transfusion reaction requiring documentation of the donation identification number and
component. The hematology department may be involved in
the evaluation of a platelet count or white count on a specific
blood component, or it may perform testing for hemoglobin
S. The chemistry department may be involved in viral marker
testing. Anyone involved in recording a donation identification number, whether by electronic or manual means, will
need to become familiar with the changes in the blood bag
label that will occur with the transition to ISBT 128 as well.
Facilities using electronic scanners or interfaces with laboratory equipment will need to evaluate their ability to read and
appropriately transmit the information to work lists as well as
to a final report. Facilities relying on manual documentation
will need to evaluate current documents and forms and ensure
that adequate space is available to record the new 13-character
donation identification number.
Staff will benefit from understanding the structure of the
donation identification number (Figure 1). The first 5 characters consist of 1 letter followed by 4 numbers. This is the
unique identification number assigned to all facilities worldwide registered with ICCBBA. Facilities within the United
States will begin with the letter “W” followed by 4 digits. The
following 2 digits represent the year of collection. Unit identification labels that include “07” may be used between December 1, 2006, and January 31, 2008. The inclusion of the
year in the donation identification number is to ensure a
unique number every 100 years and is not intended to establish a collection or expiration date. Following the year is
the 6-digit sequential number representing the donation. The
perpendicular numbers are flag characters incorporated into
the bar code. These will be read by equipment during scanning. The final character is a manual check character that assists in verifying that the 13-digit donation identification
number has been entered correctly when entered manually
(using a keyboard) into a computer system. It is not a part
of the actual donation identification number.
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Feature
Figure 1_ISBT 128 13-character donation identification number.
Beyond the Laboratory
Even beyond the laboratory, there are many departments
involved in the administration of blood components within a
hospital that will need to become aware of the changes inherent
in the transition to ISBT 128. The development of a crossfunctional team with representatives from nursing, anesthesiology, information systems, billing, and medical records may be
indicated. They will need to evaluate and revise forms and
computer or electronic records to ensure that the 13-character
donation identification number can be read, transmitted,
printed, and retained appropriately.
All health care professionals will need to become familiar
with the change in appearance of both allogeneic and autologous
blood components (Figures 1 and 2). Currently, the label of the
blood bag may have a series of colored tags, stickers, and other
labels. Implementation of ISBT 128 will obviate the need for
many of those additions to the blood bag label as the information will be incorporated into the bar code.
Beyond the Basic Implementation Plan
The best way to assess the operational impact of ISBT 128
implementation is to develop a plan that identifies the scope of
services provided by a facility. This will determine whether the
facility needs to register with ICCBBA. Registration with
ICCBBA is different from registration with the FDA, and the
criteria defining who must register is not the same (Table 1).
The FDA registration (completion of Form FDA 2830 on an
annual basis) is required of facilities involved in blood collection
and modification of blood components to include irradiation,
leukoreduction, washing, freezing, or deglycerolization. Facilities
that only pool or aliquot blood components do not need to register with the FDA, but they must register with ICCBBA. Registration with ICCBBA is required for all facilities involved in
blood collection and component modification as well as those
facilities involved in pooling or the preparation of aliquots,
because the label applied to the final component will need to
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Figure 2_ISBT 128 autologous label.
include ISBT data structures. It is also required for any facility
applying a label that uses ISBT 128 data structures. Pooling
components, whether platelets or cryoprecipitate, will require
the application of a new unit number to the pool. The preparation of an aliquot will require that the product name be changed
to reflect that the unit has been divided. This is a change for
most who have been involved in transfusion medicine because,
with Codabar, an aliquot was represented by adding a suffix to
the donation identification number (eg, J12345 is divided into
three aliquots represented by J12345A, J12345B, and J12345C).
With ISBT 128, when a unit is divided into aliquots, the donation identification number remains the same (J12345), but the
product code is changed to reflect that the product is now a divided unit (A0, B0, C0) (Figure 3). Subsequent aliquots—
“syringe aliquots”—prepared from the divided unit A0 will be
labeled Aa, Ab, etc.
Table 1_Registration With ICCBBA Versus Registration
With the FDA
Services Provided
Register
With ICCBBA
Register
With FDA
Distribution of blood components only
Compatibility testing, distribution
Perform any of the following:
• Pool platelets
• Pool cryoprecipitate
• Aliquot components
Perform any of the following
component modifications:
• Irradiate
• Leukoreduce
• Wash
• Freeze
• Deglycerolize
Collect autologous or allogeneic blood
No
No
Yes
No
No
No
Yes
Yes
Yes
Yes
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Conclusion
Figure 3_Example of a unit that is divided into three, with two syringe
aliquots prepared from aliquot A0 and one syringe aliquot prepared
from C0. Once the original unit “00” is divided into three portions, the
original “00” no longer exists, but is identified as the divided units A0,
B0, and C0.
Facilities that divide red cell components into aliquots must
also request a variance from the FDA. This applies to registered
and non-registered facilities. A variance must be requested because the Code of Federal Regulations requires that for wholeblood and red-cell-containing components, the name of the
component must have the anticoagulant preceding the component name.6 This is not required for other divided components.
If whole-blood or red-cell-containing aliquots are prepared, a
letter of request for variance7 from the Code of Federal Regulations6 must be submitted to the FDA, since implementation of
ISBT 128 will not include the name of the anticoagulant preceding the name of the product.
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During collection, processing, and administration of components, the health care community takes great care to review
the detailed information on the blood bag labels. The appearance of the label has to change in order to ensure that each
donation includes a globally-unique donation identification
number and to ensure there is an adequate description of the
contents of the blood bag. With implementation of ISBT 128,
the information that must be verified prior to transfusion will be
located in a different area of the bag. The coordination of efforts
of people beyond the blood bank and processes that extend beyond the laboratory will help drive the success of ISBT 128 implementation efforts. LM
Acknowledgment: Thanks to Pat Distler, MS, MT(ASCP)
SBB, Technical Director of ICCBBA, who provided the examples of the blood bag labels as well as a technical review of this
article prior to submission.
Note: ISBT 128 is copyright-protected by United States law
and is not in the public domain. Information on how to register
is available at www.iccbba.org.
1. 21 CFR 606.121
2. “Guidelines for the Uniform Labeling of Blood and Blood Components”
prepared by Food and Drug Administration. Center for Biologics Evaluation
and Research, 1985.
3. Silva MA, Shadler A, Figueroa PI, Unit identification error in spite of the use
of bar code technology. Transfusion. 2005;45:86A
4. “Bar Code Label Requirement for Human Drug Products and Biological
Products” Final Rule. February 26, 2004.
5. www.iccbba.org.
6. 21 CFR 606.121 (e)(1)(ii) and 21 CFR 606.121 (e)(2)(i).
7. 21 CFR 640.120.
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