Q&A with Pat Distler, MS, MT(ASCP)SBB
Technical Director, ICCBBA
MedicalLab Management: What is the basic background signaling the need for comprehensive, standardized labeling of human blood and tissue products?
Pat Distler: The first standardized coding system for blood products was called ABC Codabar, which was created in the late 1970s and implemented by blood banks beginning in 1980. Shortly after it was introduced, it became evident that while it was a major step forward in identification and communication, it had its shortcomings. One of the most significant was that it did not provide a globally, or even nationally, unique identifier for each blood donation. Further, there was no on-going support to help the system evolve. Thus, once implemented, the system began to develop differently in different countries. Another, more technical problem was the unacceptable number of bar code misreads associated with its use.
MLM: How has the creation and use of ISBT 128 helped to address these issues?
Distler: Based on the problems encountered with the use of ABC Codabar, and the recognition that this was a global problem, the International Society of Blood Transfusion (ISBT) was asked to address the issue. The ISBT Working Party on Automation and Data Processing, later renamed Working Party on Information Technology, developed the first specification for ISBT 128 in 1994; by 1997, a blood center in Estonia became the first to implement it.
To address the issue of on-going support, the ICCBBA (International Council for Commonality in Blood Bank Automation) was established in 1995 to maintain and further develop the standard. To date, the ISBT 128 standard has been expanded to include a number of medical products of human origin—cellular therapy (CT) products, tissue grafts (including ocular and reproductive tissues), organs, and human milk. Plasma derivatives for which ABO/Rh(D) appears on the label (eg, solvent detergent treated plasma) may also be labeled with ISBT 128 in some countries, although not currently in the US. To date, facilities in 73 countries are licensed to use ISBT 128 to label a variety of medical products of human origin. Furthermore, the World Health Organization (WHO) Global Forum on Blood Safety has recently identified the promotion of the use of ISBT 128 as a priority for action in improving quality management and haemovigilance.2 This significant step is the latest in a range of international initiatives that recognize the importance of a comprehensive strategy for the traceability and vigilance of all products derived from human donors based on the global use of ISBT 128.
MLM: What are some of the risks in not using bar coded labeling in the laboratory?
Distler: The biggest risk is the increased potential for clerical errors that result in the transfusion or transplantation of a product to the wrong patient. In order to ensure global uniqueness of the identifiers used on medical products of human origin, a long identifying number must be used. This makes clerical errors in recording the number (and the loss of traceability that results from such errors) more likely. Bar coding of blood samples collected for testing from donors of medical products of human origin is also critical to ensure the integrity of matching results to the correct donation.
However, including bar codes on labels alone is not sufficient. The information within a bar code must also be standardized to provide interoperability between differing computer systems. Hospital software often simply cannot interpret these bar codes properly. In a busy clinical laboratory, it is not reasonable to rely on a system that requires keyboard entry or manual recording of traceability information for blood, tissue grafts, and CT products. If a product is recalled, there may be a race against time to quarantine that product before it can be transfused or transplanted. Computerized records wherein the data have been accurately captured from bar code scans is the best way to ensure rapid identification of products involved in a recall and to identify the patients who may have already received such products. Ultimately, manual recording of such information is quite inefficient and is a waste of increasingly limited human resources.
MLM: How does ISBT 128 enable trackability and traceability of blood, tissues, and CT products?
Distler: ISBT 128 provides a globally unique identifier called a donation identification number (DIN) for each donation of blood or CT products. The globally unique nature of the identifier is especially important for CT products. According to the World Marrow Donor Association, almost 46% of non-related CT products were shipped across national borders in 2011 and this percentage continues to grow every year.3
For tissue grafts, the unique identifier may be assigned at the level of a recovery event (a single donor) or it may be assigned by processors of the tissue if more than one tissue bank is involved. To support rapid recalls related to a donor issue, the long-term goal will be to assign the unique identifier at the recovery event level. Furthermore, ISBT 128 also provides standardized product codes, which allow hospitals to receive products that are coded in the same way from different suppliers. The combination of the DIN and the product code creates a globally unique identification for each product. This unique identification is essential for trackability and traceability of these products.
MLM: How has implementation of ISBT 128 directly resolved issues in the clinical laboratory setting?
Distler: One of the most common comments we hear after a laboratory has implemented ISBT 128 is that it was a lot of work to set up, but once in operation, it facilitates workflow for the staff. This is likely because product codes are more detailed; unlike ABC Codabar, there are standardized codes for thawed plasma (FFP, plasma frozen less than 24 hours after phlebotomy, room temperature hold plasma, and 5-day plasma). Anticoagulants also are encoded, so making sure the right anticoagulant appears on the label is no longer a manual process.
One of the major problems ISBT 128 helps to solve is the need to renumber blood units within the lab. Under ABC Codabar, hospitals often received duplicate identification numbers on blood from different suppliers (and sometimes, over time, from the same supplier). This meant renumbering units of blood and having to remove the number if the units were subsequently returned to the supplier. Not only did this process create opportunities for error in mapping the supplier identifier to the hospital identifier, it also was labor intensive.
Another major difference from ABC Codabar is that expiration times can be encoded in the bar code, as can the differentiation between open and closed system products. That means that computers can calculate and ensure accurate printing of expiration times on products.
Some efficiencies are still to come, such as the resulting effects of ISBT 128 allowing for encoding of red cell antigens other than ABO and Rh(D). Blood centers are now looking into how this can be added to their systems, and when blood centers and hospitals are able to utilize such bar coded information, it will allow electronic verification of the suitability of units for immunized patients.
MLM: What areas of the clinical laboratory rely most on ISBT 128 labeling?
Distler: Transfusion service is the area most affected by ISBT 128 labeling. Not only do they receive all blood products, they may also manage CT products and tissue grafts. By the nature of their work, transfusion services have tremendous expertise in product trackability and traceability, and it is therefore not surprising that many hospitals ask them to manage medical products of human origin other than blood.
MLM: What automation or computer technology is necessary to read and interpret ISBT 128 labeling?
Distler: Transfusion services software from all US vendors can manage ISBT 128 labeled blood products. A transfusion service may also label products they modify, such as aliquots, pooled products, irradiated products, etc. Furthermore, 21 CFR 606.121 (c) (13) (iii) requires that certain information (unique identifier, facility ID, ABO/RhD, and product code) be machine readable.4 This means facilities must either purchase preprinted labels or print their own bar coded labels if modifications are made to blood products (other than thawing cryoprecipitate or some plasma products). Labeling software may be purchased that interfaces with the laboratory information system (LIS) if the LIS does not have its own labeling module, and label printers also would be required.
One thing all laboratory directors and managers should keep in mind is that today, all blood products and many CT products use linear bar codes. However, 2D bar codes may become more commonplace in the future because of their increased efficiency (users need only scan one bar code instead of four or five) and because some CT products come in very small containers; ocular products almost certainly will use 2D bar codes. 2D bar codes require a special type of scanner called an imaging scanner and all imaging scanners can read both linear and 2D bar codes. Therefore, if older bar code scanners in the transfusion service need to be replaced, purchasing an imaging scanner is a wise investment for the future.
MLM: What information is contained on a standard ISBT 128 label?
Distler: The information on an ISBT 128 blood label meets FDA requirements stated in 21 CFR 606.121 (c) (13) (iii). This consists of a text and bar coded DIN (referred to as a lot number relating to the donor in the regulations), facility ID (contained within the DIN), ABO/Rh(D), and a text version of the product code. The product’s expiration date also is frequently in a bar code, but this is not required. Additional information that may be bar coded includes the collection date of the unit and any special testing (eg, CMV, Hemoglobin S, red cell antigens).
For CT products, the information integrated on the bar code is a bit different. The DIN and product code will be bar coded on a full label, and the ABO/Rh(D) will often be present on the affixed label, but it may not be included if it was not known at the time of cryopreservation. The expiration date will often be present and bar coded, but on a product collected for the National Marrow Donor Registry, the collection date may be bar coded and a statement such as Infuse within 48 hours of collection or as soon as feasible may appear instead of an expiration date. Labels on smaller containers (eg, some cord blood products have a 2x2 inch label) may only be partial labels; full information may appear on an attached label or accompanying information.
Because ISBT 128 has an on-going support mechanism, it is continually evolving. For example, a collection and/or expiration date and time must include time zone if CT products will cross a time zone. A new ISBT 128 data structure has been developed specifically for CT products to support this requirement.
MLM: Are there registration and ongoing licensing fees for using ISBT 128?
Distler: Current registration and licensing costs can be found on the ICCBBA website (http://www.iccbba.org/registration-licensing/what-are-the-fees). See Table 1 for license fees as of June 2013.
MLM: How does a standardized label coding system directly impact patient care and error reduction?
Distler: Errors in manually recorded information are very common and the use of bar codes in the laboratory, and at the bedside, have been found to significantly reduce clerical errors. Where products of human origin are involved, a clerical error can have a severely detrimental impact on patient safety; transfusing blood of the wrong ABO group can be fatal. For CT products, even delays while clerical errors are investigated can render a product less potent. These are just a few of the ways in which, standardized, comprehensive labeling can directly impact patient safety.
MLM: Can you give some examples of how flag characters can be used to increase efficiency?
Distler: Flag characters are associated with the DIN and are used to identify where the instance of the DIN appeared (ie, on a test tube, on the red cell bag, on the platelet bag, on a donor record, etc). For blood, flag characters are used primarily by the blood processor.
For cellular therapy, there is a unique use of flag characters that does impact clinical laboratories. Because some containers are too small to accommodate a full size label, a partial label is affixed to the product and the full information appears on an attached label. In order to electronically link the information on the full label to that on the partial label, flag characters may be used.
MLM: How should local codes be used?
Distler: Local product description codes should be used when (A) there is neither an internationally standardized code nor a nationally standardized code and (B) the product does not meet the requirements for a standardized code. For example, local codes should be used when a product is only produced in one, or a very small number of facilities. A local code is sometimes used when a facility wants to include CMV or HLA test results within the product code rather than as a special testing data structure code.
If there are any questions about whether a standardized or a local product description code should be used, the ICCBBA office should be consulted.
MLM: What are the benefits of ISBT 128 standardization outside the clinical lab (ie, for manufacturers, regulatory bodies, etc)
Distler: One of the major benefits outside the clinical lab is that ISBT 128 paves the way for bedside matching of the products to their intended patient. This has greatly enhanced safety by ensuring the right patient gets the right product. Software developers appreciate having a standard since it prevents, or greatly reduces, the need for customized software. For accrediting organizations and regulators, auditing is made much easier by standardizing labels across the country.
MLM: In the future, will the ISBT128 application extend to other products or services in the clinical lab?
Distler: ISBT 128 is designed for the terminology, coding, and labeling of medical products of human origin. Enhancing the safety of these products is the focus of the ICCBBA staff and advisory groups.
MLM: Are there consultants available to help medical facilities adopt and make the best use of ISBT 128?
Distler: Yes, there are a number of consulting organizations that can help with the implementation of ISBT 128. For more information, laboratory managers can contact the ICCBBA office via email at firstname.lastname@example.org.
- Blood Products Advisory Committee. Center for Biologics and Evaluation. June 20, 1997:19.
- Proceedings of the World Health Organization Global Forum for Blood Safety. Florianopolis, SC – Brazil. May 6-10, 2013.
- Chapman J. Global regulatory harmonization. Proceedings of the 2012 International Donor Registry Conference. The World Marrow Donor Association website. http://www.worldmarrow.org/Accessed June 26, 2013.
- Code of Federal Regulations. Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels. FDA website. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073362.htm#FDAREVIEWANDCONCLUSIONSAccessed June 19, 2013.
Patricia Distler, MS, MT(ASCP)SBB, has been the technical director for ICCBBA, the organization that manages the ISBT 128 information standard since 2005. In this position she manages documents, databases, and user support for ISBT 128. Pat works with blood banks, tissue banks, cellular therapy facilities, and milk banks around the world in support of their efforts to implement ISBT 128. Prior to working for ICCBBA, she was the vice president of operations at the Blood Bank of San Bernardino and Riverside Counties from 1984 to 2004. Managing the laboratory and the labeling process made her keenly aware of the errors that could be avoided by further automating processes such as labeling of blood. Pat received her BS in Medical Technology from the University of Sioux Falls and her MS in Immunohematology and specialist in blood banking certification from the University of Cincinnati.
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