June 2010

Dear Cellular Therapy Facility,

The Foundation for the Accreditation of Cellular Therapy (FACT), along with the other organizations listed below issued a joint statement in 2005 confirming support for international use of the ISBT 128 Standard for the coding and labeling of Cellular Therapy products. This was followed by a requirement by AABB, FACT and JACIE standards to use the internationally agreed upon ISBT 128 terminology. Subsequently, many organizations have adopted the ISBT 128 terminology for labeling of their products.

Almost five years have passed since we recommended the use of ISBT 128. We would now like to assess the status of ISBT 128 implementation in cellular therapy. We kindly ask you to respond to a survey to determine the global status of ISBT 128 implementation at http://www.surveymonkey.com/s/ISBT_CT. If your organization receives more than one copy of this letter, please respond only once to the survey.

If your organization has not already fully implemented ISBT 128, we encourage you to move to the next step in implementation. That is, we encourage you to begin using ISBT 128 label designs and bar codes.

We believe that this internationally standardized coding and labeling system will improve safety and efficiency. Reasons for implementing this system include:

• Traceability is improved because ISBT 128 provides a globally unique donation identification number.
• Standardized product nomenclature provides unambiguous definitions ensuring receiving institutions understand fully the characteristics of the product being received.
• Critical information is provided in both an eye-readable and electronically readable (bar coded) format reducing transcription errors.
• An internationally shared a product code database allows interpretation of product codes into the local language overcoming language barriers.

We believe your facility will find the long term benefits of using ISBT 128 worth the investment of resources needed to implement the system. Standardized labeling and bar coding can reduce costs by allowing your facility to eliminate or significantly reduce the need for expensive customized labels or label software, improve efficiency by allowing you to rapidly scan critical information into your computer system and reduce the need for follow-up investigations caused by transcription errors.