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Waiting game nearly over for ISBT 128

October 2003
Karen Southwick

A long-awaited 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.

Everyone agrees 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 Developed more than two decades ago, Codabar “is really outdated,” says Kay Gregory, director of regulatory affairs for the American Association of Blood Banks.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 blood.

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.

“For hospitals 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.

Waiting 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.

The proposed 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.”

“ISBT 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.

“We want 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 transfusions.

“The Red 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 actual rule.

The ABC’s 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.”

While Stanton 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.

Stanton says 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,” he says.
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.

The proposed 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.

Organizations 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.”

Keeper 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.

Although there 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.”

Another criticism 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.

Steane predicts 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.”

Suzanne Butch, 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.)

ATAG members 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.

“What 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.”

“The more 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.

Early adopters
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.)

St. Luke’s 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.

“We knew 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.

The conversion 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.

The Community 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.

“We are 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 says.

The Community 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.

“We’re 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 control.”

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.”

Holliman says 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 willing.”

BloodSource 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.”

Vendors ready
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.

“We have 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.”

Wyndgate, based 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 programs.

“Wyndgate 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.

Other vendors, 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.

“Our systems 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 change.”

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.

“The FDA 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.