Just the FACTs, 2020 Volume 2
It was great to see many of you at the TCT meetings in Orlando (I didn’t pack a warm enough jacket!) where the solid emergence of cell therapies was in constant evidence. The Quality Boot Camp was another smashing success, as were the applicant and inspector training courses at the FACT Inspection & Accreditation Workshop, and the cellular therapy leadership courses. I had an opportunity to make a presentation on FACT Immune Effector Cell Accreditation to the administrative track, which evoked many questions, some showing the importance of educating our administrative colleagues in the importance of coordinated, comprehensive, quality-driven care to optimize outcomes for our patients and the role community-driven accreditation plays. We had a chance to express our thanks to Mark Litzow for his many years of service on the FACT Board of Directors and as the first FACT Technology Committee chair. You are already missed, Mark! Travel restrictions and meeting cancellations are coming at a rapid pace and paper goods are flying off the shelves as COVID19 cases increase. Our patients would be among the greatest affected—if you are ill take care of yourself and stay home for their sake.
Hand wave from greater than 6 feet—see you soon.
Dennis Gastineau, MD
FACT President
COVID-19 Update: FACT Accreditation
UPDATE: 17 March 2020
Program Directors, Medical Directors, and Quality Managers:
The health and safety of our cellular therapy community continues to be our utmost concern as we all work to mitigate the effect of the COVID-19 pandemic. Due to travel restrictions and CDC recommendations for social distancing, FACT has postponed all scheduled on-site inspections through June 30, 2020. Rescheduling of these and additional inspections will resume when an appropriate timeline can be determined. We will continue to follow recommendations from the CDC, health officials, and governmental agencies.
There have been many questions related to delays and postponements of on-site inspections due to travel restrictions and recommendations for social distancing.
Effective immediately, the accreditation expiration date for all FACT-accredited organizations will be extended by six months. This includes all clinical hematopoietic cell transplant programs, immune effector cell programs, apheresis centers, laboratory facilities, and cord blood banks, regardless of the current expiration date. This is our current best estimate of an appropriate timeline, however, if circumstances warrant, additional extensions will be implemented. New accreditation certificates will be prepared and distributed to eliminate confusion. The official list of accredited organizations is available at factwebsite.org.
To the extent possible, programs should continue to submit documents and complete Compliance Applications during this period when on-site inspections are not being scheduled. FACT staff are available by phone or email to receive and review this information, and to provide other assistance as needed.
FACT also continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is available at factwebsite.org.
If you have further questions or concerns, please contact me (402-559-6781; pwarkent@unmc.edu) or the FACT office (402-559-1950; fact@unmc.edu).
Published March 13, 2020
The health and well-being of our cellular therapy community, volunteers, staff, and patients is our utmost concern as new cases of Coronavirus are reported across the US and around the world. We are continuing to monitor recent developments surrounding the coronavirus (COVID-19) pandemic and are focused on recommendations from the CDC, health officials, and government agencies.
Numerous institutions have implemented travel policies banning both domestic and international travel for their employees, including our FACT inspectorate. Organizations should anticipate postponements and delays in scheduling. We understand the inconvenience; however, these restrictions represent the best effort to safeguard the health of all involved. We thank you for your understanding and cooperation as we work together to meet the challenges posed by COVID-19. Please be assured that organizations’ accreditation will not lapse due to these circumstances. Additional time will be allotted in the accreditation process.
Our parent society, the American Society for Transplantation and Cellular Therapy (ASTCT) and its Infectious Disease Special Interest Group have developed interim guidelines for COVID-19 management of HCT and cellular therapy patients. These guidelines will be modified as new information becomes available, including more data on epidemiology, clinical outcomes, and efficacy of drug therapies including clinical trials of novel therapeutics.
COVID-19 Interim Patient Care Guidelines
In addition, FACT global partner The World Marrow Donor Association (WMDA), has provided international blood and tissue donor guidelines and resources for cord blood banking including:
- Cord Blood Support Service
- Information specified per country (on restrictions on import/export)
- Donor suitability criteria
- European Centre for Disease Prevention and Control
For additional resources, please consult the World Health Organization and the Centers For Disease Control.
If you have questions, or concerns, please contact the FACT office at 402-559-1950 or fact@unmc.edu.
FDA Releases Suggestions for Evaluating Donors for Coronavirus
The United States Food and Drug Administration (FDA) published Important Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the 2019 Novel Coronavirus Outbreak on February 14, 2020. This announcement notes that the FDA has been working closely with the Center for Disease Control (CDC) and other federal and international agencies to monitor the outbreak of coronavirus (COVID-19).
The FDA stated that respiratory viruses are not generally known to be transmitted by HCT/Ps, potential for coronavirus transmission via these products is unknown. Although routine screening measures for infections are already in use, some programs may wish to use additional donor screening in response to this outbreak. Based on limited information available, the FDA says programs may wish to consider the donor history in the 28 days prior to cell collection for potential donors who have:
- traveled to areas with COVID-19 outbreaks, as defined by CDC
- lived with individuals diagnosed with or suspected of having COVID-19 infection; or
- been diagnosed with or suspected of having COVID-19 infection.
The following are additional details provided by FDA:
FACT Events at the 2020 TCT Meetings Were a Success!
FACT hosted several popular events at the 2020 TCT | Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR in Orlando, Florida. On February 18, the FACT Cellular Therapy Inspection and Accreditation Workshop brought together 155 attendees. The workshop included two tracks: Applicant training and inspector training. The applicant track described the accreditation process from application to accreditation. Applicants were given a short overview on how to navigate the accreditation application in the Accreditation Portal, and evaluated documentation to ensure compliance. In addition, applicants learned how to organize the on-site inspection process, structure a program tour, evaluate deficiencies, and maintain accreditation readiness.
The inspector training track was required for all inspector trainees. This track was designed to guide the trainee through the inspection experience: from accepting an inspection assignment, through submitting the inspection report, and participating in the Accreditation Committee review. Each trainee received an inspection checklist accompanied by applicable inspection documents. Trainees were instructed on the duties of the inspector prior to the inspection and how to navigate an application using the Accreditation Portal. Also, trainees developed a plan for review of documents submitted in advance of the on-site inspection, evaluated documents to determine compliance, used an inspection checklist, and prepared for all duties post-inspection.
Also on February 18, FACT hosted two Cellular Therapy Leadership Courses for over 30 people who have, or aspire to, a leadership position in cell therapy. Attendees of the Cellular Leadership 101 course learned a variety of leadership strategies including:
• The leader as coach
• Differences between managing and leading
• Basic styles of leadership and how to recognize your own style
• When each style of leadership may be appropriate
• Chairing and participating in effective meetings
• Delegation skills
• How to build consensus
• Ways to motivate, ignite, inspire, transform and engage teams
Participants who participated in the Advanced Cellular Therapy Leadership Course dug deeper into leadership skills and organizational health, and examined the following topics:
- Characteristics of a healthy organization
- Adapting an organization to a changing environment
- Leading from where you are
- Multiplying and diminishing team effectiveness
- Servant leadership
- How to be change agent
- Effective governance boards
- Legal liability and fiduciary responsibilities in decision-making
- Strategic planning with a focus on outcomes
On February 19, FACT teamed up with ASTCT to host the 5th annual Quality Boot Camp, setting record breaking attendance with over 160 participants. The day featured many interactive sessions, including how to assess the effectiveness of your Quality Management Program, practicing interview techniques when performing an audit, and identifying the difference between a verification, qualification, audit, and validation. Attendees were engaged throughout the day, asking questions and participating in productive discussions. One attendee commented, “the speakers made the presentations relative to actual practice – not just definitions on slides. Overall, the boot camp made my trip to Orlando worthwhile and offered more learning opportunities…”
On February 20, FACT hosted a Mingle and Mimosas Networking Event for Inspectors to show our appreciation and toast our essential volunteers for their continued dedication and time devoted to FACT.
Special invitations were extended to all international delegates attending the TCT Meetings for a wine and cheese reception on February 20. Members of the FACT Global Affairs Committee presented information about the international accreditation program featuring a stepwise certification approach in Latin America, the new joint FACT-SBTMO Accreditation Program in Brazil, and efforts to provide guidance to transplant centers in India. This program was developed to assist transplant centers in emerging economies who may require additional assistance and education in developing quality systems and adhering to global accreditation requirements.
In addition to these events, FACT welcomed visitors to its exhibit booth and invited meeting participants to the booth to meet the leaders of Accreditation Services and have accreditation and standards questions answered.
All events were successful and FACT looks forward to the 2021 Transplantation and Cellular Therapy Meetings in Hawaii!
SBTMO meeting at TCT
FACT Board members met during the TCT Meetings with its newest accreditation partner, Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) to continue planning to assist Brazilian transplant centers to achieve FACT-SBTMO Accreditation.
Andrea Kondo, who is a member of SBTMO and is part of the Accreditation Committee, was responsible for presenting to the Latin American Bone Marrow Transplant Group (LABMT) during the TCT Meetings the steps already taken in the FACT-SBTMO Accreditation Program. Dr. Kondo announded there are already 24 hematopoietic stem cell transplant centers that want to participate in the program and achieve certification. This is because “the accreditation attests to the institution that it offers safety, excellence and quality in each of the processes practiced by it, not only in the part of the clinical program, but also in the collection of progenitor cell products, in the processing and infusion of cells -trunk, ”explains Andrea.
“These centers that have already joined and the others that have been contacting us, show us that there is really a movement to strengthen and improve our HSCT practice, which is a gain not only for services, but especially for patients” declared the president of SBTMO, Nelson Hamerschlak.
It is worth mentioning that Brazil was the pioneer in Latin America, since 2012, to gain FACT recognition, through the accreditation of Hospital Israelita Albert Einstein (HIAE), which has been re-accredited in 2015 and 2018.
Educational efforts to support the Brazilian centers in preparing for accreditation are underway. Andrea Kondo is currently working on the development of educational tools and webinars to assist transplant centers. Planning is underway for a FACT Inspection & Accreditation workshop scheduled to take place during the SBTMO Annual Congress slated for October 2020 in Sao Paolo.
Mark Litzow Receives Service Award
FACT’s Board of Directors honored Dr. Mark Litzow for his contributions to our organization. Dr. Litzow most recently served on the FACT Board from 2011 – 2019. As a FACT Inspector, Dr. Litzow has performed 30 clinical inspections over the last 20 years!
Mark was appointed as the inaugural chair for FACT’s Technology Committee and served since 2009 – 2019. Dr. Litzow’s charge as Chair of the Technology Committee was to enhance, refine, streamline and improve the efficiency of the accreditation process and educational programs through the continued development of FACT’s online presence. Mark has survived the development of two accreditation portals!
Through Dr. Litzow’s leadership, the Technology Committee:
- Launched the first FACTWeb Portal automating the accreditation process.
- Launched the new FACT Accreditation Portal to replace FACTWeb and better position FACT for long term success.
- Evaluated features to enhance the user’s accreditation portal experience including an improved document library experience and the addition of an inspector trainee feature within the portal allowing trainees to get firsthand experience within the portal.
- Developed online training materials for accreditation portal users.
- Improved the online accreditation application including the Eligibility and Compliance application.
- Continued to provide training for users of the accreditation portal.
Mark your contributions have been invaluable and you have certainly left us as a stronger organization. You will be greatly missed!
Comments Requested on Standard Labeling Proposed for Apheresis Collection Products: Due April 24, 2020
FACT is pleased to announce that ICCBBA, administrator of the ISBT 128 coding and labeling standard, has released a draft document and label for public review and comment. The document, “Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing,” and the described label applies to collected cells, commonly referred to as “starting material,” intended for further manufacturing in support of clinical cellular therapy trials and commercial cell products. This draft is a result of a multi-stakeholder effort to standardize labeling requirements of apheresis collection facilities, including the Standards Coordinating Body, the Deloitte NextGen Industry Working Group, FACT, and many others.
Variations in sponsors’ labeling requirements have been a notable challenge for apheresis facilities in recent years and introduce risks of errors and misinterpretation of patient data. The use of an ISBT 128-compliant label will reduce manual transcription errors and promote chain of identity, including for autologous cells. Furthermore, the use of ISBT 128 for these collections will allow the use of processes, labels, equipment, and software compatible with those already in use for other types of cellular therapy products collected by apheresis facilities for clinical application.
The next step of this important standardization effort is to solicit input from the entire community. Please review this document and provide comments by April 24, 2020 to Dawn Henke of the Standards Coordinating Body (dhenke@regenmedscb.org). Equally important, please distribute this announcement to your industry, hospital, vendor, and professional colleagues to make them aware of this opportunity and encourage them to review the document and submit feedback.
Standard Labeling for Apheresis Collection Products for Sponsor Cellular Therapy Manufacturing
Submit Comments (due April 24, 2020)
FDA Finalizes Gene Therapy Guidances
In 2018, the United States FDA released six draft guidance documents regarding gene therapy, and the final versions of these documents were released in January 2020. More details can be found in the Just the FACTs newsletter article, FDA Releases Six Draft Guidance Documents for Gene Therapy (2018).
The final documents can be accessed online:
- Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry
- Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry
- Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry
- Human Gene Therapy for Retinal Disorders; Guidance for Industry
- Human Gene Therapy for Rare Diseases; Guidance for Industry
- Human Gene Therapy for Hemophilia; Guidance for Industry
2020 FACT-ASTCT Quality Manager Engagement and Resiliency Survey
Resilience is the ability to recover from or adjust easily to change. Highly resilient individuals thrive in an environment of change. The Quality Manager’s capacity to be resilient during change, a constant in their work life, is a critical skillset.
Since 2017, the FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group have collaborated to identify opportunities to increase the QM’s resiliency. During that year, the quality groups developed an anonymous survey to collect data on Quality Manager personal resilience and their perceived benefits of improved resilience. The survey included a validated “Brief Resilience Scale”2 (BRS) which quantitatively measures resilience (1 = low to 5 = high).
To assess possible work stressors, Quality Managers were queried about their responsibilities, program size/complexity, and the nature of interactions with others, e.g. direct supervisors. Respondents were also asked to rank selected resources for increasing resiliency.
Since that initial survey, results have been analyzed and presented as abstracts during TCT | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR. Additionally, survey findings have been used to identify resources to help, among others, build resilience through improved workplace communications, workload management. This resources list was uploaded to the FACT website at: http://www.factwebsite.org/WorkArea/DownloadAsset.aspx?id=1898.
It’s come time to reassess…Quality managers, we need you!
The committees are reaching out more broadly to cellular therapy program and cord blood bank Quality Managers around the world requesting that you complete a follow-up survey. This year’s anonymous survey takes approximately 20 minutes to complete. The survey can be accessed at the web address or by scanning the QRS code included below.
https://www.surveymonkey.com/r/FACT-ASTCT2020QMResiliency
The FACT Quality Management Committee and the ASTCT Administrative Directors SIG Quality Working Group plan to analyze information provided by respondents later this year and publish early in 2021.
Education Events
Labeling and Chain of Custody for IEC Products presented by Dr. Sarah Nikiforow
Wednesday, April 22, 2020
11:00 am ET, 15:00 GMT
Dr. Sarah Nikiforow from Dana-Farber Cancer Institute / Cell Manipulation Core Facility, will present Labeling and Chain of Identity and Custody for IEC Products. Dr. Nikiforow will review the IEC Standards related to labeling and chain of identity and custody and explain FACT expectations for clinical trial research product labeling and chain of custody from bench to bedside. In addition, she will describe how ISBT 128 coding and labeling can be used with commercial cellular therapy products.
Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier
June 17, 2020
11:00 am ET, 15:00 GMT
Dr. Carlos Bachier, Program Director and Processing Facility Director at Sarah Cannon Blood and Marrow Transplant Program in Nashville, will present Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program. Dr. Bachier will begin by discussing the requirements for transplantation and immune effector cellular therapy. He will highlight opportunities and challenges when incorporating immune effector cellular therapy into an existing Quality Management Plan, and provide steps that can be taken to incorporate immune effector cellular therapy into a transplant program.
FACT Cord Blood Inspection & Accreditation Workshop
September 9, 2020
8:00 am – 5:00 pm
This training workshop is designed to explain the requirements for FACT accreditation of cord blood banks. FACT representatives will clarify the intent of the NetCord-FACT Standards, provide inspectors tips for conducting inspections, and assist programs in organizing and preparing for the accreditation process.
The workshop includes an applicant and inspector training track. The applicant track will begin with an overview of the FACT accreditation process and continue with hands-on activities to guide the applicant through the accreditation process.
The inspector training track is required for all inspector trainees. This track is designed to walk the trainee through the entire inspection experience; from the moment the inspector accepts an inspection assignment through submitting the inspection report. Each trainee will receive their own checklist accompanied by applicable inspection documents. In order to attend this track, you must be pre-approved as an inspector trainee. Inspector trainees have required assignments to complete before attending the workshop.
Apply to train as a FACT inspector. If approved, you can attend the workshop FREE of charge!
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the applicant and inspector training track!
