Spring 2008
A Letter from President C. Fred LeMaistre, MD
It is fitting that the inaugural President's Letter is featured in this edition of the FACT newsletter because it includes announcements that fit with the current goals of the FACT Board of Directors. A general theme that underlines many topics of discussion is how to serve the heart and soul of FACT. To press the analogy a little, the applicant facilities are the heart, assuring our health. The volunteer inspectors are very much our soul, continuously making contributions to improve the process as well as giving of their time to help their colleagues improve their programs.
FACT appreciates the hard work undertaken by inspectors to review compliance with the expanded requirements in the third editions of the FACT-JACIE Cellular Therapy Product (CTP) Standards and NetCord-FACT Cord Blood Banking (CBB) Standards. We are happy to return the favor by revising the CTP Inspection Checklist to reduce redundancies and make the inspection day more efficient. Feedback from inspectors regarding how to best incorporate rigorous standards for Quality Management and Policies and Procedures into the FACT-JACIE Standards have also been incorporated into the development of the fourth edition of the Standards. We believe these changes will help improve the process for the applicant facilities as well. We recognize that FACT accreditation must signify that a facility has demonstrated a commitment to quality, not just an ability to generate paper. Furthermore, the first Accreditation Manual for the NetCord-FACT CBB Standards has been published, which provides tips and explanations for complying with and inspecting against the Standards.
As outlined within the newsletter, FACT has several resources for inspectors and applicants. Many opportunities for education are available, including workshops, guidance manuals, online tools, and the tips within this newsletter. The FACT accreditation process is a collegial one in which we want every inspector and applicant program and facility to succeed. After all, we all have a common goal in such success as the ultimate beneficiaries are the patients we all serve.
Enjoy the newsletter,
In This Issue
Cord Blood Accreditation Manual
Inspection and Accreditation Workshops
Changes to FACT Checklists
QA Coordinator Receives Certification
4th Edition of CTP Standards
World Leaders at ISCT Annual Meeting
Accreditation Summary
3rd Edition Cord Blood Accreditation Manual Available
The Accreditation Manual for the 3rd edition of the NetCord-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release is now available for download and/or purchase.
The purpose of the Accreditation Manual is to provide guidance to applicants for accreditation and to on-site inspectors. The manual is intended to explain the intent and rationale for specific standards and to provide explanations, examples, and alternative approaches that will be helpful in the accreditation process.
The Accreditation Manuals for both Cord Blood Banking Standards and Cellular Therapy Product Standards can be found on the FACT website.
Inspection and Accreditation Workshops
FACT unveiled its new training workshop format at the CTP Inspection & Accreditation Workshop in San Diego, CA, on February 12, 2008 and at the CBB Inspection & Accreditation Workshop in Florence, Italy, on March 30, 2008. Based upon feedback from past participants, the new format included more participant interaction and real-world examples. The new format was a success, with participants indicating on average either agreement or strong agreement that each session was presented in an interesting, effective, and organized manner.In addition to asking questions during the workshop, participants were encouraged to ask any remaining questions via the workshop evaluation form or via email. Click here for questions the FACT office has received, with the answers provided.
The following FACT Inspection and Accreditation Workshops are now open for registration:
- May 17, 2008 - ISCT Annual Meeting in Miami, FL (Cellular Therapy Products)
- June 8, 2008 - Cord Blood Symposium in Los Angeles, CA (Cord Blood Banking)
Changes to FACT Checklists Expected to Assist Inspectors and Applicants
Throughout the first quarter of calendar year 2008, FACT's continuous improvement activities have focused on making the inspection process more efficient for both inspectors and applicants. Two immediate changes are near implementation based upon feedback from inspectors and applicants.
The Inspection Checklist for the third edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration has been reordered on a topical basis to reduce redundancies throughout the checklist and streamline the process of preparing for and conducting an on-site inspection of Quality Management, Policies and Procedures, and Bone Marrow Collection Facility standards.
Furthermore, the Document Checklist for the FACT-JACIE Standards has been updated to include more specific requirements for documentation of continuing medical education and to require preparation of electronic record system validation and documentation for onsite review. These clarifications and additions are intended to allow applicants more time and guidance for preparing the necessary documentation and reduce the amount of time spent during the inspection day retrieving and accessing the documentation.
To implement these changes, inspectors and applicants will begin receiving the revised checklist prior to on-site inspections. Visit the FACT website for updates in the future. FACT appreciates inspectors' and applicants' time and efforts devoted to inspections, and aims to make the best use of these resources. To provide more feedback and/or recommendations, please email FACT at fact@unmc.edu.
FACT's Quality Assurance Coordinator Receives ASQ-Certified Manager of Quality/Organizational Excellence
The Certification Board of the American Society for Quality is pleased to announce that Jill C. Hempel has completed the requirements to be named an ASQ-Certified Manager of Quality/Organizational Excellence. As such, Ms. Hempel has reached a signifcant level of professional recognition, indicating a proficiency in and a comprehension of quality management principles and practices. For more information regarding Jill's achievement and the ASQ in general, read the full press release on FACT's website.
Fourth Edition of FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration Currently Under Development
FACT and JACIE are currently developing the fourth edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration. The draft Standards will be posted in July 2008 for a 90-day public comment period, and the final Standards will be published in November 2008. FACT encourages all stakeholders to comment on the Standards. An addition to the standards development process for this edition is the concurrent development of the accompanying Accreditation Manual, which provides guidance on the intent of the Standards and examples of how to be in compliance with the requirements. Stay tuned for more information regarding the public comment process.
World Leaders in Cellular Therapy at the 14th ISCT Annual Meeting - May 17-20, 2008
One of FACT's parent organizations, the International Society for Cellular Therapy (ISCT), is hosting its 14th Annual Meeting on May 17-20, 2008, at the Miami Convention Center & Hyatt Regency Miami in Miami, Florida. The program contains cellular therapy sessions and exciting cutting edge science. The organizers are planning the meeting around diseases with active research and clinical trials in Regenerative Medicine and Stem Cell Biology, and have included world experts in diabetes, cardiology, neurology, cancer, and immunotherapy. Details regarding the Annual Meeting, including a Preliminary Program Update, can be found on the ISCT's website.
For a complete listing of programs and facilities obtaining accreditation or renewal accreditation, see the quarterly accreditation report.
Give Us the FACTs Poll
In Your Opinion . . .
FACT's Inspection & Accreditation Workshops include PowerPoint slides, activities, discussions, and interactive quizzes. How would you prefer to receive this information?
Inspectors: Thorough preparation for an on-site inspection is vital. Prior to the on-site inspection, inspectors should note which portions of the checklist will be completed using a medical chart/record, facility and process observation, and/or personnel interviews.
Applicants: Programs seeking accreditation for both pediatric and adult allogeneic and autologous transplants need to submit five consecutive Transplant Essential Data (TED) forms for each population (to total 10 consecutive allogeneic transplant recipients and 10 consecutive autologous transplant recipients) for data management review. The allogeneic and autologous transplant recipients do not need to be from the exact same time frame.
Online Tools
Applicant Tools: These tools are available to assist programs in preparing, organizing and scheduling their on-site visit.
Inspector Tools: These tools are provided for use by FACT Inspectors to aid in preparing, organizing and conducting an on-site inspection.
U.S. FDA Cellular Therapy Regulatory Updates