The Foundation for the Accreditation of Cellular Therapy (FACT) and the Joint Accreditation Committee of ISCT-EBMT (JACIE) have published the draft 7th edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration for inspection and public comment for a 90-day period.

Comments will be accepted from May 1, 2017 through July 30, 2017. Please submit your comments on the draft 7th edition via this form. Once the form is submitted, it cannot be changed. However, you may submit additional comments by completing the form again. This form allows for up to 20 comments, but there is no limit to the number of forms that can be submitted.

Please review the following documents, which are available on the FACT website:

1. FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Draft 7th Edition.

This is a redline document intended to highlight the changes made to the Standards. Reorganizational changes are not tracked unless the reorganization was significant. We caution you that not all changes affect the intent of the requirements; rather, some changes are meant to improve the clarity or verbiage of a standard.

2. FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual, Draft 7th Edition.

The Accreditation Manual is published to provide you with an explanation of the Standards. Comments generally are not expected regarding this guidance information unless reviewers feel it contradicts a standard.

This form first asks for feedback specifically requested by the Standards Committee, and then any comments related to the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration may be entered.

* Name

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* Question 1
The 6th edition FACT-JACIE Standards required that facilities be actively implementing ISBT 128 at a minimum. The 7th edition draft Standards requires that ISBT 128 or Eurocode be fully implemented. Appendix II, “Cellular Therapy Product Labeling,” has been updated to concisely convey requirements specific to both ISBT 128 and Eurocode. (CM/C/D7.1, Appendix II) Do you have any comments regarding these requirements?

* Question 2
A new standard in the 7th edition draft Standards recommends Clinical Programs set benchmarks for non-relapsed mortality at 100 days after cellular therapy product administration and describe the rationale and process for review in the Quality Management Plan. These benchmarks should allow the program to assess non-relapsed mortality at 100 days, and identify specific corrective actions to take when a benchmark is not met. See accompanying Accreditation Manual for additional guidance. (B4.7.6) Do you have any comments regarding this new standard?

* Question 3
The 7th edition draft Standards includes increased requirements for inclusion of risk assessment as part of document control, change control, occurrence investigations, qualifications, and validations throughout the transplant program (clinical, collection, and processing). In previous editions, the inclusion of risk assessment was limited to validation studies in the collection and processing sections. (B/C/D4.15) Do you have any comments regarding these edits?

* Question 4
The Clinical Program must refer planned discharges and post-transplant care to facilities and health care professionals adequate for post-transplant care. A new substandard requires that recipients who have not achieved hematological stability shall only be discharged to Clinical Programs that meet FACT-JACIE Standards. Note this Standard is not intended to require discharge only to fully accredited programs. See accompanying Accreditation Manual for additional guidance. (B7.8.1) Do you have any comments on the inclusion of this requirement?

* Question 5
Electronic record requirements (similar to those applicable to processing facilities) were added to the clinical section to address systems used to support cellular therapy-specific activities. It is not the intent of these Standards to include hospital-based electronic medical records, but only those electronic systems that are under the control of the Clinical Program. (B10.4) Do you have any comments regarding these requirements?

* Question 6
The requirement that autologous and/or CMV-appropriate and irradiated blood components be available during the collection procedure for all donors is currently in the 6th edition Standards. The 7th edition draft Standards includes a substandard that requires allogeneic blood components administered to a donor during the collection procedure be irradiated prior to transfusion to protect the recipient of the product from third-party donor lymphocytes. (CM8.4.1, C8.5.1) Do you have any comments on the inclusion of this requirement?

* Question 7
Use of supplies and reagents of the appropriate grade is currently required. The Accreditation Manual includes the explanation that if the appropriate grade of reagent is not used, lot-to-lot functional validation is required. The 7th edition draft Standards includes a proposed standard that explicitly states this requirement. Informative guidance is based on review and comparison of labeling and accompanying documentation of various DMSO products in common use. (D6.2.4.1) Does this added information provide clarity? Do you have any other comments regarding this requirement?

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