Cellular Therapy Accreditation Committee News and Notes
Article written by Suzanne Birnley, FACT Accreditation Coordinator
The Cellular Therapy Accreditation Committee reviews Accreditation Reports for programs inspected under the FACT-JACIE International Standards for Hematopoietic Cellular Therapy, the FACT Common Standards for Cellular Therapies, and the FACT Standards for Immune Effector Cells. After review, the committee makes recommendations to the FACT Board of Directors regarding an applicant’s accreditation status.
The first quarter of 2018 has been an exciting and busy one for the committee. Despite no meeting in February due to the BMT Tandem meetings, the committee was still able to review 13 programs for renewal accreditation in January and March 2018. Additionally, the committee reviewed the first program to apply for standalone accreditation under the FACT Standards for Immune Effector Cells.
The following are some notes regarding the function of the Cellular Therapy Accreditation Committee:
- At each meeting, as deficiencies indicate potential needs for revisions or additions to future sets of FACT Standards, the issues are compiled into a list for future review by the Standards Committee. This feedback from the Cellular Therapy Accreditation Committee promotes improvement and greater clarity with each publication of Standards.
- As programs complete the renewal accreditation process, in addition to the inspector’s assessment, they will be reviewed by the FACT-CIBMTR Data Audit Committee and possibly the Clinical Outcomes Improvement Committee. Recommendations related to data management and clinical outcome deficiencies are considered by the Cellular Therapy Accreditation Committee when determining the accreditation outcome for an applicant.
- One of the most commonly cited requirements is validation. A satisfactory validation will include the following at a minimum:
- An approved validation plan, including conditions to be validated
- Acceptance criteria
- Data collection
- Evaluation of data
- Summary of results
- References, if applicable
- Review and approval of the validation plan, validation report, and conclusion by the Quality Manager or designee and the Clinical Program Director/Facility Director or designee
The seventh edition of the FACT-JACIE Standards for Hematopoietic Cell Therapy was published at the beginning of March 2018. Programs must be compliant with this set of Standards by May 30, 2018. It is important for programs to remember that as they add new accredited services, such as immune effector cellular therapy or more than minimal processing, these must be implemented in compliance with the FACT Standards and reported to FACT. Additionally, if your program uses or plans to use contracted services in your organization, you are responsible for notifying FACT and monitoring the accreditation status of those service providers.