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July 2018: FACT Update

By Kate Jacobson posted 07-09-2018 04:45 PM

  

This article is part of the July 2018 issue of ASBMT eNews. View the full issue in PDF format here

Study Compares Standards and Accreditation

A comparison of cord blood banking standards and voluntary accreditations has been completed by the Cord Blood Association (CBA) Quality Standards Committee.

The committee’s report is the result of an extensive review and analysis of banking standards, as well as questions posed to AABB and the Foundation for the Accreditation of Cellular Therapy (FACT).

The report compares:

  • ways in which the standards are identical, similar and different
  • each agency’s standards development process
  • methods by which compliance is determined and inspections conducted

The CBA Board of Directors requested this study to assist banks that are seeking either or both accreditations.

Read full study here

FACT Prepares for New Portal Launch

In 2015, the FACT Technology Committee committed to replacing the FACTWeb Portal. This April, after three years, the first users logged into the new FACT Accreditation Portal. Ten different organizations were selected to serve as beta testers and complete their applications in the new portal.

Feedback on the new portal has been positive:

  • “So much faster than the old portal. It is nice that the tabs do not stay open as you move along the application. […] I generally am not a fan of being a beta site, but in this case, I am glad we are as this portal is such an improvement.”

    – Karen Klinker, Dana-Farber Cancer Institute/Brigham and Women's Hospital Adult Hematopoietic Stem Cell Transplant Program

  • “Easy to move between application components. Easy to see where you are within the application. Color coding is very helpful.”

    – Peggy Appel, Northwest Marrow Transplant Program at Oregon Health & Science University, Legacy Good Samaritan Hospital and Medical Center and Doernbecher Children's Hospital

  • This is a major improvement over the first portal. The ease of use and the speed are complete upgrades! I appreciate everything that has been put into this new portal and realize that we will continue to strive to improve it. Very pleased to have been a beta tester!”

    – Kim Kasow, UNC Bone Marrow Transplant and Cellular Therapy Program

With a successful beta test underway, the new FACT Accreditation Portal is scheduled for launch this August.

Upcoming Training Sessions

Online training opportunities are now available on the FACT Event Calenda/r. Advance registration is required. The first training session of each type will be recorded and made available online for on-demand viewing.

Draft 2nd Edition FACT Common Standards Available for Public Comment

FACT published the draft 2nd edition FACT Common Standards for Cellular Therapies for public comment during a 60-day period.

Comments will be accepted from June 1, 2018 through July 31, 2018.

These Standards represent the basic fundamentals of cellular therapy that can be applied to any cell source or therapeutic application, and are intended to be used throughout product development and clinical trials.

The final Standards will be published on March 15, 2019 and will become effective on June 13, 2019.

Description and instructions for the FACT Common Standards

Draft 2nd Edition FACT Common Standards

To submit comments regarding the draft 2nd edition FACT Common Standards, follow the steps below. Comments will be accepted through July 31, 2018.

  1. Access the Comment Form here.
  2. Type in your contact information and comments on the form. Fill in all fields to ensure the Standards Committee fully understands your position.
  3. Submit the form when you are finished. Once the form is submitted, it cannot be changed. However, additional comments may be submitted by completing the form again. There is no limit to the number of forms that can be submitted.
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