February 17, 1999

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Re: FDA Docket No. 98D-0965: United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 -
AABB Written Comments

To Whom It May Concern:

The American Association of Blood Banks (AABB) appreciates the opportunity to submit written comments to the Food and Drug Administration (FDA) regarding the draft document entitled, "United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128," dated December 1997 and released for comment on November 27, 1998 (hereinafter referred to as ISBT 128). The International Council for Commonality in Blood Banking Automation (ICCBBA) submitted the draft document to FDA with a recommendation that it serve as the basis for current FDA guidance on the labeling of blood and blood components. ISBT 128 would replace the coding system "ABC Codabar," currently in use. The AABB strongly supports implementation of ISBT 128. AABB feels very strongly that implementation of this system will increase safety and reduce regulatory errors. To this end, AABB has established an ISBT 128 implementation timeline for its members to be completed by January 2002. It is essential that FDA also support this same timetable.

The AABB is the professional association for approximately 2200 institutions engaged in the collection and transfusion of blood and blood products, including all American Red Cross blood services regions, independent community blood centers, hospital-based blood banks and transfusion services, and more than 8500 individuals engaged in all aspects of blood collection, processing and transfusion. Our members are responsible for virtually all of the blood collected and more than eighty percent of the blood transfused in this country. The AABB’s highest priority is to maintain and enhance the safety of the nation’s blood supply.

AABB Position

This document delineates the US specifications for the use of ISBT 128 and provides the necessary information to standardize blood product labeling. Critical information such as ABO and Rh blood groups, expiration date and description can be clearly understood. This information as well as the critical identifying information such as donation identification number and product code can be accurately captured by a computer system providing enhanced traceability. The AABB has established January 2002 as the expected date of implementation of standard product labeling using ISBT 128. The FDA should facilitate industry efforts to improve safety and traceability by adopting the United States Industry Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 as a replacement to the August 1985 Guidelines for the Uniform Labeling of Blood and Blood Components.

ISBT 128 Name Changes and Enhanced Product Description

• The FDA specifically requested comments on the proposed "rule-based" system for naming blood components. While it is true that adopting ISBT 128 will require changing some of the currently accepted names, the change will not be onerous for manufacturers and users. Product names will still be recognizable and in fact will be more descriptive of the product content than some of the current terminology. In addition the rule based system makes it possible to logically determine appropriate terminology for new products. This should eliminate the confusion of having manufacturers using different locally derived names for the same identical product.

ISBT 128 Implementation and Compliance

• FDA also requested comment on timeframes and procedures for the transition and full implementation of ISBT 128. AABB is making every effort to help members implement ISBT 128. AABB has an established interagency task force which has developed an implementation plan. This plan is available free to all AABB members and to non members at a nominal charge. AABB has adopted a position which will require all members to be in compliance with ISBT 128 by January 2002. FDA should also take the necessary steps to permit the use of the ISBT 128 by this time, including any revisions of the language in the Code of Federal Regulations to permit use of the proper names used in the new system.

ISBT 128 Technical Specifications and NATAG

• AABB is aware that there are some technical details that need to be addressed regarding the specifications for ISBT 128 as outlined in the consensus standard. AABB understands that these issues will be delineated in comments from the North American Technical Advisory Group (NATAG) of the ICCBBA. Therefore, AABB will not address these issues in these written comments, but does anticipate that NATAG will work with FDA to provide resolutions to such concerns.

ISBT 128 Continuous Improvement

• A great deal of important information is presented on a blood product label. The United State Industry Consensus Standard for the Uniform labeling of Blood and Blood Components Using ISBT 128 must remain a living document subject to continuous improvement. FDA should establish a mechanism to permit industry to make additions and corrections as needed without undue delay in obtaining FDA concurrence where such concurrence is deemed necessary.

Discussion

Since the 1970s, the blood community has agreed and supported the concept of uniform blood labeling. In the past 20 years, operations have changed dramatically; data structures (bar codes) and labeling have not changed. We currently have a system in which labeling is not uniform, as best exemplified by the multiple formats for donor identification numbers and conflicting product codes. At a time when blood moves around the country more than ever, it is important that we return to a consistent, uniform way to label blood. There are many important reasons for adopting a new product labeling standard. The following is a summary of AABB’s perception of some of the major advantages of implementing ISBT 128.

ISBT 128 Allows Better Traceability

• ISBT 128 allows for greater accuracy in manual recording of unit identification numbers. It includes a check digit at the end of the unit identification number. With appropriate software, this check digit can ensure that the unit number was manually entered into the computer correctly. The check digit is based upon a calculation of the unit number. If any character in the unit number was entered incorrectly, the check digit will not ?match? and an error message will be given. This in turn would lead to greater traceability in lookback situations. And while manual entry is discouraged, there are times when it is needed.

• ISBT 128 unit identification numbers are unique worldwide. Unique numbers eliminate the need to reassign local numbers when more than one blood supplier is utilized. Because current unit identification numbers are only unique to a given blood center, hospitals with more than one supplier (or who obtain blood from a supplier who is an importer) either must reassign local numbers or risk duplication of numbers. Since the original number may not be obliterated, and the original number is in the ?standard? location on the label, hospital staff may record the ?incorrect? (original) number into patient records. The local number, through which the unit may be traced, is in a location other than where it ?belongs? and may be ignored.

• ISBT incorporates the year of collection into the unit identification number. This is important because many hospital transfusion service computer systems will not allow duplicate unit identification numbers. With over ten years of using Codabar numbers, the frequency of "reused" numbers is increasing. Assigning a local number by definition leads to further opportunity to lose track of the final disposition of a unit.

• Unique numbers allow for centralized testing. ISBT 128 allows for more characters in a unit identification number, which in turn allows the drawing center location to be encoded as a part of the unit number. Codabar unit identification numbers, on the other hand, are short and duplicated frequently across the country. This lack of uniqueness leads to duplicate numbers when a laboratory does testing for other facilities. In order to accommodate this centralized testing, at least one laboratory is using Code 128 on sample tubes and Codabar on blood labels. The unit identification number (e.g., 31 GJ 12334) is the same from an eye readable standpoint on both tubes and blood labels. However, because Codabar cannot accommodate such long numbers, labels show an eye readable number that is different from the bar coded number (e.g., eye readable is 31 GJ 12334 but bar code reads GJ 12334). Thus, when you scan the identification number on the unit of blood, it has two fewer digits than its corresponding eye readable number. For hospitals and importing centers receiving such units, manual data entry of the unit identification number must be performed in order to capture the entire identification number. This is inherently inaccurate (especially because there is no check digit) and reduces traceability of the unit. But, in a very large operation, the chance of duplication of unit numbers using Codabar is too high to do anything but what this laboratory is doing. As more blood centers combine their laboratory operations, this will become a major problem.

ISBT 128 is Inherently More Accurate than Codabar

• Codabar is based upon very old technology. It is quite possible to get a reproducible misread of a bar code using Codabar. This may lead to test results being posted to the wrong unit number.

ISBT 128 Allows for Better Definition of Product Codes

• Codabar cannot distinguish between an open and a closed system in component preparation. This creates problems when two similar components (e.g., aliquoted red blood cells created in an open system versus a closed system) have two different outdates. Computers are programmed to determine a single outdate for a given component. Blood facilities tend to choose the outdate of the more common component. Thus, in the above example, if producing aliquoted red blood cells in a closed system is more frequently performed, the computer system will be set to calculate the outdate as that on the original component. If an open system is used, the outdate must be edited. This editing is subject to error. Under ISBT 128, open and closed systems are taken into consideration and are assigned different product codes, which in turn allows different outdates for similar components to be calculated by a computer.

• Codabar does not encode anticoagulant on platelet or plasma components, and yet the eye readable portion of the label contains this information (e.g., both CPD and CPDA-1 platelets are encoded 12000). The component is considered misbranded if the label does not correctly identify the anticoagulant. Thus, we are in a situation of manually trying to ensure that the correct label is on the unit. Only a computer can truly ensure such label accuracy in a busy component preparation lab.

• As more blood banks switch to 500 mL collection bags, we will be faced with the same situation. Codabar does not distinguish between a 500 mL and a 450 mL collection. However, eye readable portions of the label must contain this information. The computer cannot ensure that the correct label has been applied to the component so we are dependent on manual, less accurate, systems.

• While neither of the last two issues directly impact the safety of the component, indirectly they do. Component laboratory managers must spend unnecessary time setting up systems to ensure the correct label gets on the component instead of focusing on more important safety issues.

ISBT 128 Allows Encoding of CMV and Antigen Screening Information

• CMV and antigen phenotyping may be both bar coded and eye readable on ISBT 128 labels. For the collection facility, this allows on demand printing of this information onto the label and computer verification of the label against laboratory testing results. At the transfusion service, this allows computer verification of the selection of blood with appropriate attributes for patients with special requirements.

ISBT 128 Allows for Better Auditing

• ISBT 128 allows for differentiating manual versus scanned entry of data. Since scanned data are more accurate, this allows auditing to verify that staff are truly scanning information. It also allows for this determination in the investigation of errors when a manually entered number is much more likely to be in error than a scanned one.

ISBT 128 Accommodates Accurate Labeling of Autologous Units

• Codabar labels were designed before autologous units were a significant issue. The autologous label replaces the standard ABO/Rh label, which prevents encoding of ABO/Rh information onto the label of the unit. Information such as patient name and blood type are generally handwritten on the label. ISBT 128 allows for encoding the ABO/Rh type of a unit on a very distinctive autologous label. ABO/Rh are thus verified by a computer when the unit is labeled and when it is received by the transfusion service. ISBT 128 even allows the computer to determine if a biohazard label needs to be printed on autologous units. Given the complex rules for applying biohazard labels, this is a distinct advantage.

ISBT 128 Allows for Inclusion of Expiration Time As Well As Date, Allowing for Computer Verification of Labeling

• The expiration date and time are extremely important in blood transfusion. This information appears on the blood labels and it is critical to capture that information quickly and accurately.

ISBT 128 Allows for Concatenation of Labels

• Blood unit identification labels and ABO/Rh labels may be scanned with a single sweep. This absolutely ties the unit identification number to its ABO/Rh for error reduction.

• Likewise, product code and outdate may be scanned with a single sweep. Since the outdate is a function of product code, this ensures both labels have been changed when required (e.g., irradiation of red blood cells shortening the outdate).

Conclusion

It is for these reasons that AABB supports the implementation of ISBT 128 and has established an implementation timeline for its members to achieve implementation by January 2002.

Once again, AABB appreciates the opportunity to comment on ISBT 128.

Sincerely,

Susan L. Wilkinson, EdD, MS, MT(ASCP)SBB
President

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator