College of American Pathologists
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ISBT 128 revved up and ready to roll

Blood bank information systems

October 2003
Suzanne Butch, CLDir(NCA)

The long-awaited conversion to ISBT 128 blood labeling has begun in earnest in the United States. Community Blood Center of Greater Kansas City (Mo.) and its hospital customers recently converted without major difficulties. And St. Luke’s Episcopal Health System, Houston, has converted its own collections. Several major blood centers are planning to convert by the end of the year.

Some transfusion services, however, have voiced concern about paying the annual registration fee of $100 to the International Council for Commonality in Blood Banking Automation, the organization that maintains ISBT 128, because the services ICCBBA provides are not visible to them. The continued development and expansion of any labeling system, however, requires support, and because ICCBBA is an international nongovernmental organization, it must be funded by user fees. If the entire financial burden for ISBT 128 were placed on blood centers, the overall cost of blood components would increase. (Information about ISBT 128 licensing can be obtained from the ICCBBAWeb site,

Although the FDA recognizes ISBT 128, it requires that users ask for an exception to use the system, providing a significant disincentive to switch. When, however, the proposed rule “Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma” (, published July 30, becomes final, it will no longer be necessary to ask for special permission to use ISBT 128. The FDA’s current guidance for implementing ISBT 128 is “Guidance for Industry: Recognition and Use of a Standard for the Uniform Labeling of Blood and Blood Components” OHRMS/DOCKETS/98fr/980965gd2.pdf), which dates back to June 2000.

The American Association of Blood Banks and ICCBBA have made implementation materials available and are continuing to present educational sessions about ISBT 128. ICCBBA staff and its Americas Technical Advisory Group are interested in learning about any issues that arise during implementation.

The AABB, along with the American Red Cross and other organizations, is proposing a new billing system based on the ISBT 128 system of identifying blood components. Billing for blood components is complex, and transfusion service software has not always facilitated billing.

The health care reimbursement system is based on providing insurance carriers with a code to describe the blood component provided to a patient. This code is then used on insurance forms to determine reimbursement for services provided. The recent proposed reduction in reimbursement for outpatient transfusions was based on cost data submitted by hospitals. This indicates that transfusion services are not billing correctly since the cost of a red blood cell is less than the charges assessed by the average blood supplier.

Also a problem for transfusion services is that few facilities bill for CPT code 36430, Transfusion, blood or components. This fee can only be billed once per day for a patient who has been transfused, and most transfusion services must bill for this manually. Consequently, many forgo such billing. Transfusion service software that facilitates billing for the ABO and Rh reconfirmation testing of red blood cells would also be of value. Many transfusion services confirm the Rh of Rh-negative units and would need a mechanism to automatically bill the recipient for the ABO on all red blood cell units and the Rh of the Rh-negative units.

How billing is coded obviously is critical to obtaining appropriate reimbursement. For example, a unit of red blood cells that has been irradiated receives a higher reimbursement if it is billed as an irradiated red blood cell than if the billing was for a red blood cell processing fee and an irradiation service charge.

Under the ISBT 128 billing system proposed by the AABB and others, products would be billed by component class (red blood cells, apheresis platelets), and additional fees would be assessed for modifiers (frozen, washed, thawed) and attributes (irradiated, leukocyte reduced). Once the new billing system was identified, it would be up to the software vendors to ensure that their transfusion service software could use ISBT 128-based billing.

In the meantime, blood bank software vendors need to consider how best to meet their clients’ billing needs using their current software. Billing issues are an excellent topic for any software user group meeting.

Appearing on pages 40 through 50 are 18 blood bank information systems from 10 vendors. Several of the vendors in this year’s lineup claim to offer full support of ISBT 128 unit labeling, among other features.

New to this year’s survey is PathNet Blood Bank Donor, from Cerner, which received FDAclearance at CAPTODAY press time.

In another development at press time, Wyndgate Technologies announced that it will provide McKesson Information Solutions with its SafeTrace Tx transfusion management system, which will be privately labeled as Horizon Blood Bank and marketed as an integrated module of McKesson’s Horizon Lab laboratory information system. (For more information about the marketing agreement, see “Newsbytes,” page 82.)

The profiles presented on the following pages were generated from vendors’ answers to a questionnaire. Please verify the accuracy of vendors’ claims before making a purchase.

Suzanne Butch is chief technologist of the blood bank and transfusion service, University of Michigan Health System, Ann Arbor. She is responsible for validating and implementing blood bank software. For more on ISBT 128, see “Waiting game nearly over for ISBT 128,” page 1.