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International Cellular Therapy Coding and Labeling Advisory Group

Meeting Summaries

May 2007 - Conference Call

The group discussed recent activity in the development of an EC Coding System for Tissues and Cells.  The Chairman of the group, Paul Ashford, has been corresponding with various journals to publish the CT Standards and the Implementation Guideline created by CTCLAG. 

New product coding may commence under the newly finalized CT terminology.

There will be a 90 minute session on ISBT 128 at the NMDP International Breakout Meeting on November 2nd, 2007 in Minneapolis. 

An ISBT 128 educational teleconference, sponsored by AABB and ISCT, is scheduled for August 2007.

April 2007 - Conference Call

The group discussed the need for an additional speaker for the ISCT meeting in June.

Members were asked to review (1) the combined standard (labeling and terminology) document that had been updated to include revisions based on comments received and (2) the formal responses to comments received.  The upcoming meeting of the EU to organize a group to determine a common coding system for Europe was discussed.  The group also discussed how to help registries resolve operational issues in the use of ISBT 128.  It was agreed that the October 31-November 4 meeting of the WMDA and NMDP would be an ideal time to meet with this group.  In the meantime, some of these issues should be identified and discussed by CTCLAG. 

March 2007 - Bethesda, Maryland, USA

Minutes from the conference calls on December 5 and January 3 were approved.  Members discussed the comments received in response to the labeling, terminology and implementation documents that were published for comment during January and February 2007 during the formal comment period.  Comments were generally favorable.  The committee’s responses will be published on the ICCBBA website.  The final documents, incorporating revisions based on the comments received, will be submitted to several journals for publication.

Plans were finalized for the two ISBT 128 workshops which will be held at the ISCT meeting in Sydney, Australia in June.  

AABB and ISCT will jointly sponsor a teleconference on ISBT 128 for Cellular Therapy organizations in August 2007.

January 2007 - Conference Call

Three documents were approved for posting on Websites of sponsoring organizations for comment:

• Terminology
• Labeling
• Implementation plan

Comments to these documents will be forwarded to group chairman and ICCBBA.

There will be two workshops on ISBT 128 at the ISCT meeting in Sydney, Australia, in June.

October 2006 - Bethesda, Maryland, USA

Participants updated the group on the status of ISBT 128 in their respective organizations.

The use of two-dimensional (2D) barcodes for small containers was discussed.  Because of the small size of some storage containers, such space-saving bar codes may be needed.

The Terminology group finalized its recommendations for product classes, modifiers and attributes.

The Labeling group finalized its recommendations for a 4” x 4” (102 mm x 102 mm) label and one smaller label.  2D bar codes may be needed to encode information on cryo vials.  A design was suggested for this.  It was suggested that manufacturers might be able to place a base label in the pocket of small storage containers. 

The Implementation group presented its ISBT 128 Implementation plan for cellular therapy facilities.  This was discussed and several changes were recommended.

It was decided that the three groups would each prepare a document of its recommendations for public comment during January and February of 2007.  The comments would be taken into consideration and final documents released in June 2007.

The CTCLAG will present a workshop at the ISCT meeting in Sydney, Australia, in June 2007.

The FDA proposed rule, “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated under a Biologics License Application, and Animal Drugs”, was discussed.  Concern was expressed about requiring the National Drug Code (NDC) on the label of cellular therapy products since this would lead away from International Standardization.  Alternatives were discussed.

May 2006 – Berlin

The previous day’s workshop at the ISCT meeting was discussed.  It was well attended and stirred a great deal of interest in ISBT 128.

The terminology group presented their work on updating the product coding classes, modifiers and attributes.  After discussion, the group reached agreement on what had been presented.

The labeling group presented their work.  A number of suggestions were offered and a proposed design for the 4” x 4” label was accepted.  The label for the vial will await a decision on a two-dimensional bar code decision. 

The implementation group presented issues to be considered by the group.  These included the capability of facilities to prepare on-demand labels and whether or not this was necessary.  Standardizing the positions of bar codes on accompanying paperwork was also determined to be desirable since there is inadequate space on the affixed label for all the necessary information.  Use of bar codes on paperwork would overcome language barriers when transporting products internationally.

A document will be published with the final decisions of the group following these steps:

1. Send a draft for review to boards of organizations represented by this group.   

2. Send to regulatory agencies for comment

3. Place a notice in professional journals that draft document is on the ICCBBA website for open comments. 

April 10, 2006 Terminology Group

It was agreed to limit one attribute group to Cryoprotectant. Cryoprotectant variables were determined. It was agreed that the number of containers in the final product should be encoded in the 7th and 8th characters of the product code rather than in the attributes.

April 3, 2006 Terminology Group

Cryogenic storage temperatures were discussed and <=-150C was recommended. The currently defined Intended Use variables were accepted. Cryoprotectant variables were discussed.

March 31, 2006 - Labeling Group

Mock label designs were discussed and approved for presentation at the ISCT meeting in Berlin. Two-dimensional bar codes and the need for special scanners were discussed. While this would add to the cost of implementation, it may represent the only way to bar code information on small containers. Attention will need to be given to labels used by the BioArchive systems in many cord blood banks. More information on these labels and what information will be required on them will be gathered.

March 27, 2006 - Terminology Group

The term “selected” was discussed since “selected” may be at the donor or cellular level. It was decided to use the terms “matched” for donor level and “enriched” for cellular level. The group agreed on definitions for various classes modifiers. Core conditions, except for temperature, were also established. The appropriate storage temperature for cryogenic storage was discussed.

March 14, 2006 - Implementation Group

Logistical issues concerning the implementation of ISBT 128 were discussed. These included the feasibility of implementation in small centers and the changes that would be required to existing systems. FDA requirements for bar coding were also discussed.

February 2006 – Labeling Group

The Labeling Group met by conference call and reviewed its tasks. The aim is to develop a design for ISBT 128 labels that would work for the different products and container sizes found in Cellular Therapy. The various applicable Cellular Therapy Standards will be reviewed and mock labels generated, first for both allogeneic and autologous apheresis products. Once completed, ideas will be shared with the full advisory group. Recommendations will be shared with various international facilities and presented at the ISCT meeting in Berlin in May 2006.

January 2006—Terminology Group

The Terminology Group met by conference call and reviewed its tasks. The group is to review existing ISBT 128 terminology; recommend definitions for cellular therapy products for use with the ISBT 128 product description database; and to recommend rules for future code assignment. The group reviewed existing classes and modifiers defined by the ISBT 128 product coding document and determined which existing terms should continue to be used. The group will continue with the process of reviewing terminology and share their recommendations with the full advisory group. Recommendations will be shared with various international facilities and presented at the ISCT meeting in Berlin in May 2006.

December 2005 - Atlanta

Reports were received from the Task Groups.

The Terminology Task Group is scheduled to meet in January 2006 by conference call.  The group will review the existing ISBT 128 Product Database for CT Products, identifying any products which are no longer in use.  Where possible new code requests will be deferred until the new terminology has been defined.

The Label Design Task Group have collated information on the labeling requirements from the various regulatory and accreditation bodies and are working on providing a template meeting these requirements.

The group is keen to establish links with the European Commission and the Council of Europe.

It was agreed to run a workshop on the work of the Advisory Group during the ISCT Congress in Berlin.  The Advisory Group and Task Groups will meet immediately after the ISCT Congress.

September 2005 - Athens

This was the first meeting of the full Advisory Group.  The Terms of Reference were presented and approved.  Elections were held for the positions of Chairman and Secretary, and Mr Paul Ashford and Dr Adrian Gee were elected.

The scope of work was discussed, and a decision made to focus initially on two areas for standardization: terminology and label design.  Working groups were appointed under the leadership of Professor Phyllis Warkentin and Dr Adrian Gee respectively.

Posted: 21 May 2007