# **Bar Code Label Requirements for Human Drug Products**

Submitted by Computype, Inc., St. Paul, MN \[Supplier of bar code
systems & software\]

##### Introduction

The case for bar code use in healthcare is compelling, and its broad
implementation long overdue. As Laura Landro recently wrote in *The Wall
Street Journal:* "For years, doctors and hospitals have lagged behind
other industries in joining the information technology club\--and it
didn't look like they'd ever sign up. Because of the unusual payment
structure of the healthcare industry, providers have never had many
incentives to actually improve the quality of their product or install
clinical information systems that would let them manage patient care
better. In addition, health care tends to be local, and not subject to
the competitive forces that have forced quality improvement
elsewhere\--such as the auto industry after Japanese carmakers arrived.
Don Berwick, founder of the non-profit Institute for Healthcare
Improvement, once famously said, 'So far, healthcare has no Toyota.'"

Whether or not Toyota has finally arrived in healthcare is now
irrelevant---other market forces have combined to fuel an interest in
information technology along with the benefits automated data collection
via bar codes can provide. These market forces include:

-   Proof it works

-   Concerns about terrorism

-   New federal rules

-   Safety issues

-   A powerful watchdog

*Proof it works*. Significant studies have proven the pay-off in
automation. "There is a clear linkage now between technology and better
patient outcomes" according to the president of Health Information and
Management Systems Society.

*Concerns about terrorism*. A national information network to detect
bio-terrorism attacks and disease outbreaks is at the top of the
government's agenda for the first time since the idea first took root a
decade ago. The Office for Public Health Preparedness is seeking more
than \$1 billion for programs like the CDCs Health Alert Network and a
National Electronic Disease Surveillance System.

*New Federal rules*. Starting next year the Health Insurance Portability
and Accountability Act (HIPAA) takes effect which mandates a
standardized method for insurance companies and doctors to exchange
financial and administrative information electronically.

*Safety issues*. The oft-sited Institute of Medicine study (1999) served
as a wake-up call to health care---between 40,000 and 98,000 deaths per
year in the US attributable to medical errors, costing up to \$177
billion per year. By the FDA's own estimates, 28% - 95% of those errors
could have been prevented, and 30% - 50% were caused by devices they
regulate.

*A powerful watchdog*. The Leapfrog Group is a coalition of more than
100 public companies and private organizations that provide health-care
benefits to more than 31 million enrollees. They're using their
purchasing clout to prod hospitals to improve safety and patient care.
Leapfrog members spend about \$53 billion annually on their employees'
health care; they run a web-site that rates how well hospitals meet its
standards\--and to get a good grade, hospitals will have to make big IT
investments.

For these reasons, healthcare is finally arriving at the automated data
collection party. Let us hope it is not too late to catch up.

## Bar Codes in Blood Banks

The modern blood bank could scarcely function without bar codes. From
blood collection to manufacturing to distribution, the role played by
automated data collection via bar code scanning is critical.

The international blood bank community was one of the first groups to
standardize on the use of bar code technology. In 1974, the Committee
for Commonality in Blood Banking Automation (CCBBA) was formed through a
joint effort of the American Association of Blood Banks, the American
Red Cross, and the Council of Community Blood Centers, now known as
Americas Blood Centers. Through their efforts towards commonality, they
pioneered the use of bar codes in blood identification. In the mid
1980s, some of those same organizations issued *Guidelines for the
Uniform Labeling of Blood and Blood Components*, the bar code standard
still in use today.

###### Why Bar Codes?

The use of bar codes in blood banks has proliferated because it is both
fast and accurate (see table below). While it is not the only method of
data collection available, it is superior to most because there is no
trade-off between speed and accuracy. Equally important is its ease of
use. Unlike Optical Character Recognition technology (OCR), in which it
is critical to carefully align the reading head with a row of small
printed characters, bar codes are vertically redundant. That is, the
message at the top of the bars is the same as at the bottom, so a
precise straight-line scan is not necessary for successful decoding.
This might seem an obvious characteristic of bar codes, but its
advantage became clear during a length study done by the Department of
Defense in the early 1980s comparing the time and costs associated with
data collection via key-entry, OCR, and bar codes. Add to that the
dramatic performance increases and cost decreases of microprocessors,
and the rationale for bar code technology becomes compelling---fast,
accurate, easy-to-use, and inexpensive.

#### 

#### Comparison of Manual Data Entry vs. Bar Code Data Entry

+-----------------------------+------------------+---------------------+
| (12-character alphanumeric  | **MANUAL ENTRY** | **BAR CODE          |
| message)                    |                  | SCANNING**          |
+-----------------------------+------------------+---------------------+
| #####                       | 4 to 6 seconds   | 1 to 2 seconds      |
|                             |                  |                     |
| ##### TIME REQUIRED         |                  |                     |
+-----------------------------+------------------+---------------------+
| #####                       | 1 error/300      | 1 error/10 million  |
|                             | characters       | characters          |
| ##### ACCURACY              |                  |                     |
+-----------------------------+------------------+---------------------+

How well has Codabar served the blood bank community? In the early
1990s, a major blood bank on the East Coast did an extensive study of
their use of bar code scanning technology over a two-year period. The
overall substitution error rate (the likelihood that incorrect
information is entered into the system via bar code scanning) was
0.00007%. The new symbology being implemented by the international blood
bank community contains a check character, which Codabar does not, which
would further reduce the likelihood of an error.

###### How Do Bar Codes Work?

While most people see bar codes every day, fewer understand the
technology. Bar code scanning is based on a simple principle---Light is
reflected in different amounts by different colored surfaces. To decode
the information in a bar code, a small spot of light is passed over the
bars and spaces via a scanning device. This bar code scanner can be a
hand-held wand, a fixed beam device, or a moving beam device. The bar
code will reflect the spot of light back into the scanner in varying
amounts. That is, the dark bars of the bar code will absorb light, while
the white spaces will reflect light. These differences in reflectivity
are translated into electrical signals by a light detector inside the
scanner. The signals are converted into binary ones and zeros; these are
used in various combinations to stand for specific numbers and letters.

> Scanning A Single Bar Code Character

And The Corresponding Analog Signal

![](media/image1.jpeg){width="2.842361111111111in"
height="2.527083333333333in"}

Scanning an Entire Symbol

![](media/image2.png){width="3.1770833333333335in"
height="1.0833333333333333in"}

What the Scanner "Sees"

![](media/image3.jpeg){width="5.404861111111111in"
height="1.6041666666666667in"}

**The New Bar Code Standard in Blood Banks**

Recent standardization efforts within the international blood bank
community have led toward adoption of a new symbology standard---Code
128. Code 128 was recommended for use within the international blood
bank community to address several concerns regarding Codabar, the
standard in place since the mid-1970s:

-   Susceptibility to substitution errors, and the lack of space to
    incorporate a check character to reduce the likelihood of such an
    error;

-   Consolidation of testing facilities increasing the possibility of
    duplicate numbers being received within a single facility because of
    limitations of the seven-digit field;

-   Product code structure had not been updated to reflect the
    proliferation of new blood products.

The selection of Code 128 was made unanimously because a number of
important features made it the best choice:

-   [Fully alphanumeric]{.underline}---Code 128 has the capability of
    encoding ten digits, (0-9), all upper- and lower-case alphabetic
    characters (A-Z, a-z), and more than thirty ASCII control
    characters, such as Carriage Return, Line Feed, Start Transmission,
    End Transmission, etc.

-   [Widely supported]{.underline}---Created in 1981, Code 128 was
    quickly accepted by the Automatic Identification Manufacturers, Inc.
    (AIM) as a Uniform Symbology Specification. All major scanner (bar
    code reader) companies support Code 128 in their decoders; it is in
    the public domain and is probably one of the three most popular
    symbologies based in the world today.

-   [Continuous/High density code]{.underline}---Continuous codes make
    use of every bar and space in the symbol. No space is wasted
    separating adjacent characters. In addition, Code 128 has a special
    numeric-only subset of particular usefulness when encoding a long
    string of numeric data. Subset C of Code 128 contains all numeric
    pairs from "00" to "99". Each character in this subset translates to
    two numbers, so twice as much data is encoded in the space that
    would otherwise be occupied by a single non-numeric character. In
    the figure below, note that both Code 128 symbols encode eight data
    characters; the one on the left is shorter because it is all numeric
    and utilizes Code 128 Subset C, one of the most space-efficient
    linear symbologies ever developed.

> Density Differences

![](media/image4.jpeg){width="0.8972222222222223in"
height="0.7493055555555556in"}

> Subset C (above); Subset B (below)

![](media/image5.jpeg){width="0.94375in" height="0.5430555555555555in"}

-   [Flexibility]{.underline}---Code 128 provides unique flexibility by
    enabling the user to switch from one subset to another even within
    the same symbol. For example, in the *ISBT 128* Donation
    Identification Number, the first two characters of the bar code are
    in Subset B because they are not available in any other subset.
    Then, a special character is inserted that switches to Subset C for
    the remainder of the message that is entirely numeric.

-   [Data security]{.underline}---This was a critical concern for blood
    banking. Each character within each Code 128 symbol has three
    separate self-checking features, as indicated below. (A bar code
    symbology is termed "self-checking" if a single printing defect will
    not cause a character to be transposed into another valid character
    in the same symbology.) In addition to three self-checks per
    character, every Code 128 message requires a modulus 103 check
    character, designed to ensure that the entire message has been
    scanned correctly. This weighted check digit routine is capable of
    detecting both errors of transcription and errors of transposition.

> ![](media/image6.png){width="5.647222222222222in" height="4.2in"}

##### 

##### 

-   [Ease of printing]{.underline}---Although it has served the blood
    banking community

> well for over a quarter of a century, Traditional Codabar is not an e

-   [Ease of printing]{.underline}---Although it has served the blood
    banking community

> well for over a quarter of a century, Traditional Codabar is not an
> easy symbology to print because of its 18 different element widths and
> therefore the need for high resolution printing processes. Code 128,
> with only four element widths, is easy to print using all common bar
> code printing technologies.

Automated instruments within the blood bank typically use moving-beam
laser scanners built in to the mechanism of the instrument. Orientation
of the symbol with respect to the scanner is determined by the rack or
carousel employed. These scanners typically require a minimum number of
successive identical decodes before declaring a valid scan and
transmitting the data.

In the mid-1980s, bar code scanners became available that were "wedge"
devices; that is, they were wedged between keyboards and PCs and
emulated keyboard data entry. That allowed blood bankers to use their
current software applications that continued to function exactly as
before, but with the added benefit of fast and error-free data entry.
Wedge readers are common in blood banks, and allow either key-entry or
bar code data entry simultaneously.

**What's Next In Healthcare Auto ID?**

Linear bar codes are not the only method of automated data collection.
While they are clearly superior, for example, to Optical Character
Recognition and manual data entry, linear bar codes have inherent
limitations that other, newer technologies do not have. Technology is
changing at an ever-increasing rate, but the summary that follows will
highlight most of the major identification technologies that may replace
or enhance the scanning of a simple bar code in healthcare.

[Stacked bar codes]{.underline} are a series of linear bar codes stacked
directly on top of one another that form one continuous message. An
example of a stacked code is shown below.

> *Advantages*: Higher capacity than linear codes, read by conventional
> laser scanners, error detection/correction in most symbologies,
> printed similar to linear
>
> *Disadvantage*: Read-only
>
> Code 16K Symbol
>
> ![](media/image7.png){width="3.6in" height="1.36875in"}

[Matrix codes]{.underline} are made up of a block of cells that are
filled or unfilled to represent binary data, generally arranged on a
square grid. Examples of matrix codes are shown below.

> *Advantages*: Large data capacity, well-founded optical technology,
> error detection/correction, printed similar to linear
>
> *Disadvantages*: Must be ready by image processors (2-D array of CCD
> sensors); read-only
>
> Data Matrix Symbol
>
> ![](media/image8.png){width="1.9in" height="1.4in"}

PDF-417 Symbol

PDF Symbol

![](media/image9.png){width="2.6in" height="2.1618055555555555in"}

What are the relative information encodation capabilities of the
multi-row and 2-D symbologies? The graphic below indicates that for
short message lengths, all three of the original multi-row symbologies
have similar sizes, but the "micro" version of PDF417 is considerably
smaller. Each symbol encodes the same 20-character message and uses the
same "X" dimension.

![](media/image10.png)

Here is a comparison of three symbologies encoding the same eleven data
characters using the same "X" dimension. It is clear that the 2-D matrix
symbology (Code One in this example) occupies much less label space and
is therefore more efficient.

![](media/image11.png)

![](media/image12.png)Using a 20-character message with a 10 mil "X"
dimension (0.010"), the outlines below indicate the relative size of
space required to by each symbology. The cross-hatched areas represent
the minimum required quiet zones.

What about scanning these new symbologies? The chart below summarizes
the scanning equipment required to successfully read each type.

**Symbology Type**

**[Scanner Type Linear 2-D Stacked 2-D Matrix]{.underline}**

Wands X

CCD Scanner X X

Handheld laser X X

Handheld rastering laser X X

Fixed-Mount laser X X

(single scan line)

Fixed-Mount laser X X

(multiple scan lines)

Image-Based scanner X X X

[Contact memory]{.underline} devices are data carriers typically
packaged similar to button-type batteries; as a result, this technology
is sometimes referred to as button memory.

> *Advantages:* Read-write, high capacity, relatively low-cost tags,
> programming, and readers
>
> *Disadvantages:* Direct contact required, limited use (about 40
> million worldwide)

[Magnetic stripe]{.underline} technology is far from new. It is used on
credit and ATM cards, as well as many hotel room "keys" and in other
access control applications.

*Advantages:* Widely-used, low-cost media, fairly durable, read-write

*Disadvantages*: Contact-read only, susceptible to fraud, limited data
capacity

[Smart cards]{.underline} are true portable data files. They are
essentially a "chip in a card," where data is transferred electronically
through a set of contacts.

> *Advantages:* Read-write and processing capabilities, high data
> capacity, more secure than magnetic stripe through selective access
> and encryption
>
> *Disadvantage:* Requires contact or close proximity

[Radio Frequency Identification]{.underline} Of all the "exotic"
technologies for automatic identification in healthcare, RFID is perhaps
the most powerful and most likely to be implemented in the near future.
RFID systems use radio transmissions to communicate with an object
having an attached transponder, or tag. Data is returned by radio to a
reader linked to a host. "Smart labels" have an RFID integrated circuit
embedded in them which can be stored, read, or updated via radio
signals.

> *Advantages:* Do not require a battery (passive RFID), unlimited
> operating life, excellent environmental endurance, working distance
> from contact to 3+ feet, line-of-sight not required, reader can
> differentiate among many tags simultaneously, read/append or
> read/rewrite on the fly, on-demand printers available for smart label
> printing and encoding
>
> *Disadvantage:* Cost per tag remains high, around \$0.40 to \$1.00
> each, although this is expected to decrease as usage increases.

While many of these newer technologies offer great promise for use
within the blood bank, the standard against which they all must be
measured is the bar code---the easiest and most cost-effective method
for automatic identification available today. That which is efficient
and effective is also safe---the health care community can and will be
well served by bar codes.

**Recommendations**

1.  The FDA should require the use of machine-readable symbols on all
    human drug and biologic products. Eye-readable interpretation of
    significant information should always accompany the machine-readable
    symbol(s).

2.  Rather than require a specific bar code symbology (language), the
    FDA should mandate that an agreed-upon data structure be encoded for
    machine reading.

3.  Guidelines should be provided to each stakeholder industry group by
    the FDA which outline the minimum information content of their
    symbol(s), and the timeline for implementation.

4.  An Auto ID Coordinating Council should be appointed to help resolve
    implementation issues. The AIDCC would be made up of volunteers from
    the disciplines involved in the new requirements, bar code
    suppliers, and the FDA. It would be charged with ensuring that
    minimum information requirements were being met, that the best
    technology available was being used, and that costs to individual
    institutions and firms would be minimized.

**List of Works Consulted**

Allais, David C., *Bar Code Symbology: Some Observations on Theory and
Practice*; Intermec Technologies Corporation, Lynnwood, WA; 1982

Anonymous, *Bar Coding and Blood Banking: Changes for the 21^st^
Century*; Zebra Technologies Corporation, Vernon Hills, IL; 1995

AABB, ARC, CCBC, ABC, and FDA; [Guidelines for the Uniform Labeling of
Blood and]{.underline} [Blood Components]{.underline}, Draft, 1989

Harmon, Craig K., and Adams, Russ; [Reading Between The Lines: An
Introduction to Bar Code Technology;]{.underline} Helmers Publishing
Company, Peterborough, NH; 1989.

ICCBBA, [*ISBT 128*: Bar Code Symbology and Application Specification
for Labeling of Whole Blood and Blood Components (Version
1.2.0)]{.underline}; September, 1998.

Landro, Laura, "Health Care Goes Digital," *The Wall Street Journal,*
June 10, 2002.

Palmer, Roger C., [The Bar Code Book: Reading, Printing, Specification,
and Application of Bar Code and Other Machine Readable
Symbols]{.underline} 3^rd^ Edition; Helmers Publishing Company,
Peterborough, NH; 1995.

Wray, Bruce R., *An Introduction to Bar Coding*; International Council
for Commonality in Blood Banking Automation, York, PA; 1996.

Wray, Bruce R., Technical Bulletin---*Why Code 128? The Rationale Behind
ISBT 128*; International Council for Commonality in Blood Banking
Automation, York, PA; 1997

For additional information regarding:

***ISBT 128***

ICCBBA, Inc.

204 St. Charles Way

Unit 179E

York, PA 17402

*To order ICCBBA documents*: 717/845-4790

www.iccbba.com

American Association of Blood Banks (AABB)

8101 Glenbrook Road

Bethesda, MD 20814

*To order AABB documents*: www.aabb.org

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research (CBER)

1401 Rockville Pike

Rockville, MD 20852-1800

*To order FDA documents*: 800/835-4709

**Bar Code Print Quality Guideline (X3.182-1990)**

American National Standards Institute

11 West 42^nd^ Street

New York, NY 10036

*To order ANSI documents*: 212/642-4900

**Uniform Symbology Specifications**

AIM-USA

(Automatic Identification Manufacturers)

634 Alpha Drive

Pittsburgh, PA 15238

*To order AIM documents*: 412/963-8588

www.aimglobal.org

**Health Industry Standards (non blood banks)**

HIBCC

(Health Industry Business Communications Council)

5110 North 40^th^ Street

Phoenix, AZ 85018

*To order HIBCC documents*: 602/381-1091