Just the FACTs, Volume 3

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

Hello to a changed world from the last time I wrote to you. As much as I’d like to talk about something else, everything we are doing is affected by COVID-19. You will see a lot of this newsletter deals with cancellations and delays. One silver lining from a programmatic standpoint is the six-month accreditation extension to all programs but that will fly by, I’m sure.

Practice changes are coming fast and the FACT FAQs are being updated frequently by Dr. Warkentin, please note the links for the FDA and always pay attention to the ASTCT for evolving clinical practice guidance. FACT is not determining these practice changes and there are not changes in standards as the practice evolves. The principles that the standards reflect remain the same.

Convalescent plasma is an exciting potential therapy for our patients, and I’m aware that our cell therapy teams have been integrally involved, from collecting plasma to making collection kit components in biosafety cabinets, so kudos to all who are stepping up/stepping outside their roles to help our patients.

Keep physical distancing and remember, just flattening the curve is like your parachute slowing you down, it doesn’t mean it’s time to take off your parachute at 5,000 feet, there’s still a ways to go . . . I’m sure I’m preaching to the choir, but keep your patients, your kids, your grandparents all safe while keeping yourself as safe as possible. To use one more simile, the canoe gets to its destination only if everyone paddles in the same direction. Let’s get our shared canoe through these rough waters paddling together.

Sincerely,

 

 

Dennis Gastineau, MD
FACT President


FACT COVID-19 Resources

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

 

 

 

 

 

COVID-19 Update: FACT Accreditation
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.

On-site Inspections Postponed
FACT has postponed all scheduled on-site inspections until there is more information available about the timeline of this pandemic.

  • Rescheduling of these and additional inspections will resume when an appropriate timeline can be determined.
  • No accreditation will lapse due to delays and postponements related to COVID-19.

Accreditation Extension
Effective immediately, the accreditation expiration date for all FACT-accredited organizations will be extended by six months, regardless of the current expiration date. This includes all:

  • Clinical hematopoietic cell transplant programs
  • Immune effector cell programs
  • Apheresis centers
  • Laboratory facilities
  • Cord blood banks

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 on the FACT website. 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 review this information, and provide other assistance as needed.

Frequently Asked Questions
FACT continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is available on the FACT website. Topics include:

  • Rescheduled inspections
  • Renewal process
  • Allogeneic transplant numbers
  • Relocating transplant patients
  • Deviations
  • Care adjustments related to COVID-19

If you have further questions or concerns, please contact Dr. Phyllis Warkentin (402-559-6781), or the FACT office (402-559-1950)

Other Resources Available:
ASTCT Resources
WMDA Resources
Centers for Disease Controls
World Health Organizations


United States Food and Drug Administration Issues Guidance on COVID-19 Convalescent Plasma

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

The Food and Drug Administration (FDA) announced on April 8, 2020 the issuance of final guidance regarding the administration and study of convalescent plasma collected from individuals who have recovered from COVID-19. The use of COVID-19 convalescent plasma is regulated by the FDA as an investigational product, and health care providers wishing to use this therapy as an option must therefore participate in investigational pathways. The guidance provides information on this and a variety of topics as listed below:

  • pathways for use of investigational COVID-19 convalescent plasma,
  • patient eligibility,
  • collection of COVID-19 convalescent plasma, including donor eligibility and donor qualifications,
  • labeling, and
  • recordkeeping

Review the guidance


New Product Description Codes for Convalescent Plasma COVID-19

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

In response to recent requests from blood transfusion services, ICCBBA has fast-tracked the release of new product description codes for COVID-19 Convalescent Plasma. The new codes can be found in the latest release of ISBT 128 Standard Product Description Code Database available at the ICCBBA website,. Inquiries and new PDC requests can be sent to iccbba@iccbba.org.


Integration of Immune Effector Cellular Therapy into a FACT-Accredited Transplant Program presented by Dr. Carlos Bachier

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020


Canceled: FACT Cellular Therapy Collection Inspection and Accreditation Workshop

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

The American Society for Apheresis (ASFA) Board of Directors has decided not to proceed with the ASFA 2020 Annual Meeting, originally scheduled for May 6 – 9, 2020 in Austin, Texas due to the coronavirus (COVID-19) outbreak.

For the same considerations, the associated FACT Cellular Therapy Collection Inspection and Accreditation Workshop scheduled for May 6, 2020 has also been cancelled.

The ASFA Board of Directors is currently assessing the feasibility of rescheduling the Annual Meeting for later this year. If ASFA reschedules the annual meeting, the FACT workshop will also be rescheduled. Your payment will be applied to the new FACT Collection Inspection and Accreditation Workshop date. If the meeting is not rescheduled for 2020, your payment can be applied to the FACT workshop at the 2021 ASFA Meeting. If you prefer to receive a refund, please contact the FACT Business Manager, Jay Ann Witt at jawitt@unmc.edu.

The health and well-being of our cellular therapy community, volunteers, staff, and patients is our utmost concern. We look forward to seeing you at our next workshop. If you have questions, please do not hesitate to contact the FACT Office.


Canceled: FACT Cord Blood Inspection and Accreditation Workshop at ISCT Annual Meeting

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

The International Society of Cell and Gene Therapy (ISCT) has decided not to proceed with the ISCT 2020 in-person Annual Meeting, originally scheduled May 27 – 30, 2020 in Paris, France due to the coronavirus (COVID-19) pandemic. The ISCT 2020 Annual Meeting is rescheduled to take place virtually on May 28 and 29, 2020.  The virtual meeting will be accessible remotely and on-demand, including live and recorded sessions that are certified for CME and CMLE accreditation in addition to networking events, poster halls, and 1-on-1 partnering opportunities. The highly curated ISCT 2020 virtual meeting program will leverage state-of-the-art virtual meeting technology to provide the full ISCT Annual Meeting experience that you expect from ISCT.  For more details visit: http://www.isct2020.com/.

Because there will not be an in-person ISCT meeting, the associated FACT Cord Blood Inspection and Accreditation Workshop scheduled for May 26, and the ISCT-FACT Quality Boot Camp scheduled for May 27, 2020 have been cancelled.

If the FACT workshop is not rescheduled as a virtual session, your payment can be applied to the FACT workshop at the 2021 ISCT Meeting. If you prefer to receive a refund, please contact the FACT Business Manager, Jay Ann Witt at jawitt@unmc.edu.


FACT Cord Blood Inspection and Accreditation Workshop at the 2020 Cord Blood Connect International Congress on Hold

Posted in :: 2020 Volume 3 :: Friday, April 24th, 2020

Given the rapidly evolving COVID-19 pandemic, a temporary moratorium has been placed on pre-registrations for the Cord Blood Connect international congress, scheduled for Sept. 10-12 in Miami Beach. The acceptance of abstracts also has been suspended while CBA leaders continue to assess the viability of this year’s congress.

For the same considerations, registrations for the FACT Cord Blood Inspection and Accreditation Workshop scheduled for September 9, 2020 are also on a temporary hold.

Options being evaluated include re-scheduling, as well as alternatives for the in-person conference. Updates will be provided by FACT as information is made available.