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July 26, 2002

Bar Code Label Requirements for Human Drug Products

**Statement of**

**American Association of Blood Banks and America's Blood Centers**

### Presented by

**Kay R. Gregory, MS, MT(ASCP)SBB)**

**Director, Regulatory Affairs, AABB**

The American Association of Blood Banks (AABB) is the professional
society for over 8,000 individuals involved in blood banking and
transfusion medicine and represents approximately 2,000 institutional
members, including blood collection centers, hospital-based blood banks,
and transfusion services as they collect, process, distribute, and
transfuse blood and blood components and hematopoietic stem cells. Our
members are responsible for virtually all of the blood collected and
more than 80 percent of the blood transfused in this country. For over
50 years, the AABB\'s highest priority has been to maintain and enhance
the safety and availability of the nation\'s blood supply.

America's Blood Centers is an international network of community-based
blood centers that collects nearly half of the U.S. blood supply and
about 25% of the Canadian blood supply. The largest provider of blood
components and services, America's Blood Centers\' members are located
in 45 states, serving more than 125 million people at 450 blood donation
sites. For 40 years, America's Blood Centers\' members have been
committed to serving the needs of their local communities by saving
lives through volunteer blood donation.\"

The American Association of Blood Banks (AABB) and America's Blood
Centers (ABC) agree that medication errors are a serious concern and are
pleased to see that the Food and Drug Administration (FDA) is addressing
the issue. Since blood and blood components are classified as both a
drug and a biologic, the AABB and ABC are very interested in plans to
consider the development of a regulation on bar code labeling for human
drug products, including biologics.

The primary problem that must be addressed in transfusion medicine is
reduction of human error. The AABB and ABC believe that the introduction
of new technologies, such as bar coding or other systems or symbologies,
aimed at reducing the risk of human error can save patient lives.

The AABB and ABC suggest that the FDA adopt a broad systems approach to
the issue of minimizing the need for human interface. Mandating the use
of bar codes without also considering how the bar code can be read and
how it will be utilized within the various hospital systems will not
reduce human error. And, while bar codes may offer one approach to
reducing transfusion errors, the FDA must not codify policy that would
limit the use of other equally effective technologies, such as radio
frequency tags. **The important issue is not to mandate the particular
symbology to be used. Rather, FDA and providers should focus on
requiring electronic data interchange and the definition and use of
standard data structures.** **In addition, any system developed for
patient and product identification for drugs and pharmacies must also be
compatible with blood and transfusion services.**

## Bar Coding of Blood Products

In answer to the questions posed in the June 18, 2002, *Federal
Register* notice, the AABB notes that blood and blood components are
already barcoded. Codabar has been in use since the 1980s. A newer bar
code, ISBT 128, has been successfully introduced in other countries and
is currently under consideration in the US. The FDA endorsed ISBT 128 in
a guidance document published June 6, 2000, *Guidance for Industry:
Recognition and Use of a Standard for the Uniform Labeling of Blood and
Blood Components*. It is expected that the 22^nd^ edition of the AABB
*Standards for Blood Banks and Transfusion Services*, will require ISBT
Code 128, if a facility is to remain accredited by the AABB.

Since many of the considerations discussed in its design are also under
consideration at this public meeting, the following description of ISBT
128 labeling and the attached sample label provide useful information.

ISBT 128 is an international standard for the data associated with blood
transfusion and stem cell and tissue transplantation. It provides for a
globally unique donation numbering system, internationally standardized
product definitions and standard data structures for bar coding and
electronic data interchange (EDI).

ISBT 128 utilizes Code 128 symbology, but is also capable of using other
formats (e.g., other bar codes, two-dimensional bar codes or radio
frequency tags) for transferring information electronically. Code 128
symbology was chosen for the following reasons:

1.  It is highly accurate. By use of multiple check digits, including
    ones to verify the accuracy of keyboard entries, accurate data entry
    is assured.

2.  Concatenation is allowed. Concatenation is a method by which two bar
    codes can be read as if they were a single bar code. This provides a
    means for checking one bar code against the other to see that both
    are in place. It further ensures that data that are interdependent
    (such as the unit identification number and ABO/Rh type or the
    product code and expiration date/time) can be scanned together to
    prevent errors caused by staff scanning label elements separately.
    Such errors could occur, for example, if a staff member scanned a
    unit identification number on one blood component, was interrupted,
    and then scanned the ABO/Rh label of the next blood component to be
    label-verified. Errors can obviously occur if staff associates the
    unit identification number of one blood component with the ABO/Rh of
    another.

3.  High-density printing is allowed. When a great deal of information
    must be encoded, and limited space is available for the label, Code
    128 allows double density printing. This allows large amounts of
    data to be printed on small labels.

4.  Code 128 is a common symbology. Most printers are capable of
    printing it and most scanners are capable of reading it.

ISBT 128 coding provides blood, hematopoietic progenitor cell and tissue
transplantation centers with many advantages. These include:

# Internationally agreed upon placement of labeling information

> The placement of information on a container of blood, hematopoietic
> progenitor cell or tissue products is standardized. (See attached
> example of blood label.) This ensures that regardless of where a
> product is collected and where it is used, the end-user (physician or
> nurse) knows exactly where to find the necessary information.

# Internationally unique numbering system for blood, hematopoietic progenitor cell and tissue donations

> As each blood, hematopoietic progenitor cell or tissue donation is
> made, it is given a unique number that identifies the facility at
> which the donation occurred, the year and day that it was donated, and
> a serial number. By incorporating the facility, date of collection and
> a serial number into the product identification number, the number is
> unique and can repeat itself only every 100 years, which is well
> beyond the storage period for blood, stem cell or tissue donations.
> This unique identification number allows the transfer of blood,
> hematopoietic progenitor cells and tissue products throughout the US
> and the world without having to assign local numbers because of
> possible duplication. By avoiding the assignment of local
> identification numbers (renumbering the product), traceability of the
> product from donor to patient is assured.

1.  **Internationally standardized product codes**

Over 4000 codes have been developed to uniquely and clearly define
blood, hematopoietic progenitor cell and tissue products. The code is
easily expandable as new products are defined. By standardizing these
codes through international consensus, sharing of precious resources is
allowed while avoiding obstacles caused by writing on labels in
different languages. In addition, where needed or desirable, these data
structures encode product potency (e.g., range of platelets present in
the product). This is analogous to defining the dose for drug products.

2.  **Encoding of date and time of collection, production and
    expiration**

> The dates and times critical to the product (collection, production
> and expiration) can be encoded.

3.  **Encoding of special testing results**

The results of specialized testing (e.g., CMV, red cell or HLA
phenotype) of the product can be encoded onto the label. Following
transfer of laboratory results from an analyzer into a computer system
(or data entry, if tests are performed manually), bar-coded labels (or
other electronically scannable labels) can be generated without the need
of human transcription and its inherent risk of errors. Currently, under
the older Codabar system used in the US, such information is handwritten
onto labels. Not only is there risk of transcription errors, but also
the legibility of handwriting is a problem.

4.  **Encoding of the manufacturer, catalog number and lot numbers of
    blood, hematopoietic progenitor cell or tissue containers**

Because it is essential to be able to trace the containers in which
blood, hematopoietic progenitor cell or tissue products are prepared,
this information is also encoded into an electronically scannable format
on the label. This information can then be scanned accurately into the
computer system of the collection facility. Given the length of many lot
numbers, scanning of these numbers is the only way to ensure accuracy of
records.

5.  **Mechanism for maintenance and growth of standard**

Finally, a major benefit of ISBT 128 is that there is a mechanism for
continued maintenance and growth. This is accomplished through the
International Council for Commonality in Blood Banking Automation
(ICCBBA), a not-for-profit entity incorporated in Virginia in 1995.
Funded by user fees, the ICCBBA holds regular international meetings to
develop consensus on issues related to the creation and maintenance of
codes necessary for information transfer related to blood, hematopoietic
progenitor cell and tissue products.

The AABB and ABC believe that the advantages described above warrant
movement to a system where all blood components in the United States are
packaged with ISBT 128 or comparable labeling. Such a system will reduce
the risk of human error and improve patient safety for individuals
receiving transfusions.

**[Additional Technologies Needed to Prevent Mistransfusion of Wrong
Unit of Blood]{.underline}**

Currently, the bar-coded information on a blood product is used by the
blood collection facility to identify the exact product, to track
manufacturing steps and to ship the product to hospitals for use. Within
the hospital transfusion service, the bar-coded information is used to
identify the manufacturer and the product and to determine which product
is assigned to a particular patient. However, more needs to be done to
ensure that the right patient receives the right product.

Transfusion of incompatible blood, or mistransfusion of blood, is the
most common cause of serious morbidity and mortality related to
transfusion. Serious errors are made at the time of sample collection,
within the laboratory, at the moment of blood issue from the laboratory,
and at the bedside. ABO-incompatible transfusions due to the
misidentification of recipients at the time of transfusion are the
*reported* cause of fatality for as many as two dozen patients each year
in the US. It is believed that such mistransfusions are underreported.
(Linden JV, Wagner K, Voytovich AE, Sheehan J Transfusion errors in New
York State: an analysis of 10 years\' experience. *Transfusion* 2000;
40:1207-13. Sazama K. Reports of 355 transfusion-associated deaths: 1976
through 1985. *Transfusion* 1990; 30:583-90)

The AABB and ABC strongly encourage research, development and widespread
application of new technologies aimed at ensuring the right patient gets
the right unit of blood. Some such technologies, including certain
methods of computerized bar coding and patient wrist bands, are already
being introduced in individual hospitals. Unfortunately, there has been
only limited application of existing technology to reduce
mistransfusion, overtransfusion and undertransfusion. This inadequate
use of existing technologies in the US is most likely the result of the
existing reimbursement system, under which blood is not separately coded
and reimbursed. This system operates as a disincentive to the
development and application of new technologies in blood transfusion.
This problem must be addressed if patients are to have access to and
obtain the benefits of new technology.

The entire transfusion medicine community ---government and private---
must move forward to encourage the use of such promising technologies
designed to avoid patient harm. Whatever system is devised for patient
and product identification systems for drugs and pharmacies must also be
applicable to blood and transfusion services.

In summary, the AABB and ABC urge FDA to:

1.  Require the blood banking community to adopt the United States
    Industry

> Consensus Standard for the Uniform Labeling of Blood and Blood
> Components.
>
> This standard would currently mandate bar codes using ISBT 128
> symbology, but
>
> is readily adaptable to change.

2.  Encourage the development and use of patient and product
    identification systems for blood products that are compatible with
    drug and pharmacy systems.

The AABB and ABC welcome the opportunity to work with the FDA and other
interested parties in advancing our common goal of enhancing patient
safety through the use of beneficial technologies.

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