Waiting game nearly over for ISBT 128
new bar-coding standard for blood products may finally
be on its way to widespread adoption, now that the Food and Drug
Administration appears to be ready to throw its regulatory weight
behind the standard.
ISBT 128, as
the new standard is known, was approved in 1994 by the blood banking
community and initially set for adoption in the United States by
mid-1998, but a number of barriers intervened. First, the FDA, though
it said ISBT 128 could be used, did not mandate it. Second, the
American Red Cross, which operates nearly half the blood centers
in the United States, told its centers the standard was voluntary.
And third, other technology requirements—such as coping with
the Y2K problem and initiating a new blood-screening scan—took
precedence for blood banks and hospitals.
Now, with the
FDA poised to adopt a final rule by year’s end that could
incorporate ISBT 128, and with the three major blood banking organizations
aligned in support, the new technology is starting to be rolled
out. At least one major health system and one large blood bank have
gone live with ISBT 128, and several more institutions are expected
to adopt it by year’s end. The process is slow because a regional
blood bank and the hospitals it serves must move in concert for
ISBT 128 to have much value.
that ISBT 128 is superior to the existing bar-code technology employed
by most blood banks and hospitals, known as ABC Codabar. Developed
more than two decades ago, Codabar “is really outdated,”
says Kay Gregory, director of regulatory affairs for the American
Association of Blood Banks. “There are a lot of substitution
errors,” because numbers are not unique, “and it doesn’t
accommodate newer information,” such as autologous or irradiated
Five to 10 percent
of collected blood is sent around the country, says Jim MacPherson,
CEO of America’s Blood Centers. Unlike Codabar, ISBT 128 uses
a unique facility identification number in lieu of the FDA registration
number for the primary site of origin, eliminating the possibility
of duplicate codes. In addition, ISBT 128 makes it easier to assign
numbers for as-yet-undeveloped products and to use new methods of
coding like radio frequency tags.
the compelling reason for using ISBT is the ability to track blood
from its entry point to the patient’s bedside,” MacPherson
says. Today, he adds, “many hospitals don’t even use
automation; they just write the number [of the blood product] down,”
leaving considerable room for error.
for the FDA
In March, the FDA published a proposed new rule designed to reduce
and prevent medication errors associated with drug products. As
part of that, the agency would require bar coding of blood and blood
components intended for transfusion. Blood establishments would
have to use “machine-readable information” approved
by the director of FDA’s Center for Biologics Evaluation and
Research, or CBER.
rule, which had a comment period that ended June 12, did not specify
ISBT 128. When it adopts the final rule, the FDA could choose to
specify ISBT 128 or merely endorse “machine-readable information.”
128 is already acceptable as a ‘machine-readable’ symbol
because the center director approved it for use in June 2000. The
preamble to the proposed rule referred to that fact,” says
Philip Chao, senior policy analyst in the FDA Office of Policy and
Planning. In a public meeting last year, blood banking groups asked
the agency to endorse automatic identification but not to encode
ISBT 128 as regulation.
The FDA received
about 190 comments on the proposed rule, which for blood and blood
component labels specified only “encoded information that
is machine-readable,” not ISBT 128 itself. Although an agency
source did not have an exact breakdown of how many of the comments
dealt with blood issues, the source says that “most”
of the comments they received were “in favor of requiring
ISBT 128.” The FDA is evaluating the comments and expects
to issue a final rule in December.
the FDA to support ISBT 128, but we don’t want it written
into a regulation because we’ll never be able to change it,”
says AABB’s Gregory. The “right way to go” is
for the director of CBER to designate ISBT 128 as the acceptable
code. In the past, she says, while the FDA recognized ISBT 128,
“they did not signal its use in a strong enough manner. I
think a final rule endorsing it would be strong enough.”
In its written
comments, the AABB suggests that the final rule mandate the use
of “machine-readable information” approved by the director
of CBER, who should endorse ISBT 128 as the “recommended symbology.”
This hairsplitting will allow the blood banking community needed
flexibility in adapting ISBT 128 for future use, Gregory says.
The ABC and
the American Red Cross have taken similar positions. “The
ABC strongly recommends that the FDA mandate a uniform standard
for labeling blood components and that ISBT 128 should be that standard,”
says the organization’s written statement. “For all
the public’s focus on transfusion-related infections, [blood]
mixups at hospitals are the single greatest cause of death today
related to blood transfusions,” it says, adding that at least
15 “preventable” deaths a year result from incompatible
Cross strongly endorses the mandatory use of ISBT 128 as a unifying
bar code standard for blood and blood products,” according
to that organization’s statement. “No other step could
help bring about improvements in patient safety as immediately,
and as effectively, as the use of standardized bar coding technology.”
Like the AABB, the Red Cross suggests that ISBT 128 be mandated
through endorsement by the director of CBER and not as part of the
MacPherson says without an FDA endorsement, hospital blood banks
would not be able to get the funding to do an upgrade to ISBT 128.
The price tag can be in the range of $100,000 to $200,000 for a
hospital, he says, because bar-code scanners, printers, and lab
software for blood tracking all have to be updated or replaced.
And if hospitals don’t move, it makes no sense for blood banks
to do it on their own, he adds.
If the entire hospital has to switch to bar coding to track all
medications, as the FDA’s proposed rule indicates, “that
will make it easier for their blood banks to piggyback,” he
says. But that won’t happen without the FDA requiring it and
setting a deadline.
In the past,
says Mike Stanton, the Red Cross’ senior director for ISBT
128 implementation, “the lack of anybody putting their foot
down and saying you have to do this” stymied adoption. “Everyone
was relying on each other to get it started,” he says, “and
there were organizational priorities that bumped it.”
declined to comment on the Red Cross’ organizational priorities
in the late 1990s, when he was not there, he says, “I can
tell you now that we’re committed and moving forward with
ISBT 128.” The Red Cross is now registering all its sites
with an ISBT facility identifier and sending those numbers to the
International Council for Commonality in Blood Banking Automation,
or ICCBBA, which oversees the ISBT 128 code. He says the Red Cross
has already implemented ISBT 128 for progenitor cells.
the Red Cross will move in concert with the AABB to have ISBT 128
implemented in all its centers by 2006, but he declined to set a
more specific date. “Until we get the estimates on the change
in our software systems, we won’t know the exact timelines,”
The Red Cross is putting finishing touches on a survey it plans
to send to customers to find out their status on ISBT 128. The survey
will look at how many are computer-automated and how many are ISBT-capable.
“We’re very interested in providing support to our customers
to facilitate this move,” Stanton says.
rule gave hospitals and blood banks three years from the adoption
of a final rule to implement machine-readable code. Digi-Trax Corp.,
of Buffalo Grove, Ill., a supplier of on-demand printing solutions
for bar coding, would like to see the FDA set an earlier deadline
for ISBT 128. “If the FDA gives three years, you’ll
see slow acceleration [in adoption] for two years, and then in the
final year everybody will go,” says Richard Kriozere, president
of the company.
could move more quickly if given the incentive, he says. Digi-Trax
has sold about 40 licenses to use ISBT 128 products, both to blood
centers and hospitals. “That means people are primed to do
it,” he says, but are waiting for other centers and hospitals
in their area to move. “When the FDA sets a deadline, that
will force people to comply. It’s silly to wait three years
when it could be done in one year, since most all computer systems
now accept ISBT 128.”
of the code
The International Council for Commonality in Blood Banking Automation,
which oversees ISBT 128 and is based in York, Pa., charges annual
fees to blood centers for licensing it—1.1125 cents per unit
of blood collected, says executive director Ed Steane. Hospitals
that collect blood pay $100 for up to 10,000 units annually. The
yearly ICCBBA budget is about $400,000, the bulk of it coming from
fees paid by the 200 U.S. blood centers, Steane says.
has been criticism of the ICCBBA fees, the blood banking groups
defend them. “Some may view ICCBBA licensing fees as a barrier,
but it’s very important to have a way of maintaining the standard,”
Gregory says. “I don’t think the fees are exorbitant
for what ICCBBA does,” such as defining how the label should
look and keeping the code up to date.
“Somebody has to be the keeper of the code,” MacPherson
adds. “That issue was settled when ICCBBA was created a decade
ago and blood organizations coughed up a grant to support it until
it could support itself with annual fees.”
of ICCBBA has been that it’s slow to respond to requests for
information or software fixes, but Steane rejects that. “We’ve
just put out version 2 [of ISBT 128], which is a complete rewrite,
easier to understand and follow,” he says. It also incorporates
coding for stem cells. European centers have asked ICCBBA to start
looking at coding implantable devices, so “we have our work
cut out for us.”
He says the
ICCBBA can’t be blamed for the delays in implementing ISBT
128. Rather, it was the FDA’s failure to act strongly and
the Red Cross’ inaction in the past. “In the final rule,
the FDA will say ‘Thou shalt,’ and that will give everyone
the incentive to use it,” Steane says. “Our fees are
minuscule,” he adds, noting that some of the complaints arise
because customers fail to separate the ICCBBA portion from fees
on bar-code products for drugs.
that “the day the Red Cross converts is the day that everyone
else will move too.” Already, he believes, the movement toward
ISBT 128 has begun. “Once the water starts to run it takes
a big dam to stop it, and this time there isn’t one.”
CLDir(NCA), chair of America’s Technical Advisory Group, which
answers technical questions and makes recommendations on changes
to the ISBT 128 code, agrees with Steane that delays in adopting
the technology were related to the industry, not to ICCBBA. (America’s
Technical Advisory Group, or ATAG, is a part of ICCBBA.) (See Butch’s
comments on ISBT 128 on page 38 in this issue.)
include vendors, hospitals, and blood banks, all of whom “have
a vested interest in making sure we understand the standard in the
same way,” says Butch, who is chief technologist of the blood
bank and transfusion service at University of Michigan Health System.
we needed was somebody to go first, and there were a lot of politics
associated with going first,” she says. When hospitals would
balk, blood banks would shy away too. “Going first didn’t
seem to offer any advantage.”
“Blood centers had other problems to solve,” she adds,
such as the increased risk of bioterrorism after Sept. 11, 2001.
Now, with patient and donor identification again at the forefront
of issues for the blood banking industry, use of ISBT 128 “is
becoming more important.”
you tell people they have to do something, the more they dig their
heels in,” she says of the long delays in adopting ISBT 128.
“That’s why everybody wants the federal government to
be the bad guy and mandate it.”
It will be easier
for independent blood banks with a limited blood distribution system
to convert because they have fewer customers, Butch notes. A nationwide
blood bank system, like the Red Cross, has a greater challenge because
it must convince more customers to change.
In any event, experts agree that for the next few years, blood banks
and their hospitals will have to work with a mixture of Codabar
and ISBT 128. However, scanners, software, and printers that can
handle ISBT 128 can also read the older Codabar.
Late last year, St. Luke’s Episcopal Health System, Houston,
became the first nonmilitary hospital to go live with ISBT 128.
(The military, with its huge overseas commitment, has moved more
swiftly to ISBT 128 than civilian institutions.)
was in an advantageous situation for switching, says Kathy Brient,
MT(ASCP)SBB, LIS manager for the health system. That’s because
it is a largely closed system that draws 60 percent of the blood
it transfuses, she says. Thus, St. Luke’s could move on its
own, though it is urging its major outside supplier, Gulf Coast
Blood Center, to convert to ISBT 128 as soon as possible. And St.
Luke’s does ship excess plasma and platelets to neighboring
hospitals, which now relabel them with Codabar.
it was coming,” says Brient of ISBT 128, “and we were
in the process of selecting a replacement system,” so St.
Luke’s last year upgraded its software, using SafeTrace and
SafeTrace Tx from Wyndgate Technologies, which tracks the new bar-code
technology. The health system also bought bar-code readers from
Symbol and printers from Digi-Trax, and spent “less than $20,000,”
she estimates. Full-face label stock and ribbons and preprinted
unit number label sets were also purchased from Digi-Trax.
Why switch so
early? “We switched to be able to have a label where there’s
only one number for each product,” Brient says. “It’s
higher-quality care because the error read rate is lower. Codabar
codes are not complete and not uniformly followed by all blood centers.
There was a lot of redundancy.”
She says that
health systems like St. Luke’s, which draw their own blood,
see eliminating the possibility of error as the reason to switch
to ISBT 128. Being able to scan every field during each step of
processing, testing, labeling, shipping, and issuing eliminates
error, she adds. “The transfusion service can reprint full-face
labels after modifying products to pooled, leukoreduced, or irradiated,
which is a big improvement over the preprinted Codabar product labels
and handwritten expiration dates. With unique bar codes on each
product, St. Luke’s plans to piggyback software applications
which administer blood by scanning bar codes.” In general,
hospitals that don’t draw blood “may lack the expertise
to understand ISBT and why they need to do this,” she says.
went smoothly and they’ve had no problems in using ISBT 128.
Brient says that because their donor testing is done by Gulf Coast
Blood Center, which was not yet ready to switch to ISBT, Wyndgate
developed a transition program that could upload donor testing results
on a Codabar accession number, which is linked at donor registration.
The preprinted unit number label sets obtained from Digi-Trax avoid
double labeling, which is required by many testing centers and is
prone to error, she adds. The hospital, because it still brings
in outside blood and ships to a few outsiders, has a dual system
where it can also read Codabar. Brient expects that situation will
last for a while. “What our experience shows is that blood
centers could move forward without their hospitals, because they
can relabel,” she says.
Blood Center of Greater Kansas City (Mo.) went live with ISBT 128
in July, the first one to do so. The switch was handled by a team
of representatives from data processing and affected departments
and led by Kim Peck, director of donor laboratories. She says the
AABB, which sent out numerous directives asking people to switch,
“was trying to convince everyone to do this.” Consequently,
the Community Blood Center began working on the conversion as early
as 1997, but was diverted for a few years by other projects.
fortunate in that we have an in-house software system,” Peck
says, so the re-programming needed to read ISBT 128 could be done
internally. In the late ’90s, “we did a few tweaks like
making fields bigger to accommodate numbers with more characters.
We resumed working on the project about two years ago.” The
blood center converted because it recognized that ISBT 128 was superior
technology, “not as prone to misreads as Codabar,” she
Blood Center collects about 140,000 units a year and works with
about 75 hospitals, most of which converted with it, Peck reports.
“Some of our hospitals in outlying areas are not computerized,
so they just write the number down,” she says. But “our
major hospitals have converted. They can scan the new bar code and
their system accepts it.”
The blood center
undertook a painstaking conversion in which it developed flow charts
for all its blood-handling processes. “Each department had
a flow chart to determine how this would impact them,” says
Peck, from collection through distribution. Then the center did
a trial run through the entire system before going live in July,
several months after the original March deadline. The hospitals
and the blood center can still read Codabar because “we may
import products from other suppliers, and we have an inventory of
Codabar-labeled frozen products,” she says.
Peck says she
can’t estimate a price tag for switching because most of it
was in labor costs. But the conversion “went smoothly and
everybody was very cooperative,” she says. “And now
we don’t have to piecemeal labels together. We get one label
with all the information we need.”
Brient and Peck
say they’ve gotten inquiries from around the country about
their conversions, so they expect more hospitals and blood centers
will do it. One of those is BloodSource in Sacramento, Calif., which
collected 220,000 units last year. It has set a target date of Dec.
15 to go live with ISBT 128.
doing it to take advantage of the features that ISBT offers,”
says Sallie Holliman, MT (ASCP) SBB, operations administrator for
BloodSource. “We believe these features enhance the safety
of the blood supply as well as providing operational benefits.”
The safety benefits
she cites include the unique donor number and standard product codes.
The latter support more efficient billing for blood centers and
hospitals, Holliman notes. If someone is providing antigen-screened
or leukocyte-reduced blood cells that were irradiated, ISBT 128
can accommodate that, making it possible to bill for the special
services using information from the ISBT 128 product code. In addition,
there are fewer misreads, resulting in greater safety and lower
operating costs, she says. ICCBBA maintains and upgrades the ISBT
128 databases, while with Codabar “there is no standardized
In moving to
ISBT 128, BloodSource is coordinating with the 40 hospitals it serves.
“Our activities began in 1996, with workshops for the hospitals
and their LIS people,” she says. “We hit a wall because
of Y2K. Now we’ve resurrected the process.”
it’s important for blood centers to make it a collaborative
effort. Although not all of BloodSource’s hospitals are computerized
and capable of upgrading to ISBT-128-compatible software, “we’re
getting the indication that most of our hospitals are ready and
will maintain a dual system that can accept both ISBT 128 and Codabar.
“Not only do we have occasional imports from other systems,
but also dual inventory,” such as frozen products with longer
shelf lives that are still labeled with Codabar. BloodSource uses
Wyndgate’s SafeTrace, which automatically discriminates between
Codabar and ISBT 128, Holliman says.
The cost of
conversion hasn’t been great, Holliman says. “We were
going to spend money to upgrade our printers and scanners anyway.
We see this as another enhancement.” Besides, it will cut
operational costs in the long run. “If people are not motivated
by the operational improvements,” she says, “then it
may come down to the fact that they’re only motivated when
the FDA mandates it. That’s just because everybody’s
got a full plate.”
Specialty vendors like Digi-Trax and Wynd- gate already have products
ready for ISBT 128. Digi-Trax provides “total solutions for
on-demand printing,” including software under the HemaTrax
label, needed hardware, printers, and scanners, as well as the materials
for labeling, Kriozere says. “The military has used our system,”
as have blood banks and hospitals.
sold a lot of licenses through Wyndgate,” he says. “Many
have purchased but not done the implementation. When somebody jumps
off the fence and does it, that helps to foster change.”
in El Dorado Hills, Calif., has developed donor management software
called SafeTrace, for donor centers and hospital-based donor facilities,
and transfusion management software called SafeTrace Tx, for large,
multifacility, and centralized transfusion services and small hospital
transfusion services. The company has 57 clients, representing more
than 100 hospitals, who have purchased SafeTrace Tx, according to
Patti Larson, senior director of marketing development. SafeTrace
has been sold to 32 clients representing 123 donor collection facilities,
including large donor centers and hospitals that have donor collection
has put a lot of development time into its software products to
ensure that they provide the ISBT 128 functionality required in
the industry, and we’re anxious to see our customers implement
ISBT 128,” Larson says. “To the best of my knowledge,
people are still waiting for the FDA rule.” She expects ISBT
128 implementation to be a hot topic at Wyndgate’s next user
group meeting in spring 2004.
too, are preparing for the move. Kansas City, Mo.-based Cerner makes
software for transfusion and donor centers as part of its Classic
and Millennium lines. Both are now ISBT-compliant, according to
Kathy Davis, solution manager for blood banking.
know how to interpret ISBT and Codabar,” notes Art Houck,
MD, physician executive for laboratory enterprise at Cerner. “We
need to provide what the market demands.” As former blood
bankers, he and Davis believe that “Codabar has run out of
steam,” Houck says. “ISBT represents a more unified
and more extensive way of labeling blood products. We welcome the
Davis adds that
she’s pleased to see institutions like St. Luke’s and
the Kansas City blood center converting because it means others
have someone to emulate.
absolutely is the spur,” Houck says. “It’s a big
change, and the blood banking software community wasn’t ready
[with products] in the late 1990s.” Today, he says, “we
are ready.” It’s just a matter of getting blood centers
and hospitals to move.
Karen Southwick is a writer in San Francisco.