FACT Virtual Inspections in Response to COVID-19

Posted in :: 2020 Volume 8 :: Thursday, October 29th, 2020

FACT plans to begin virtual inspections this fall. There are many details to be finalized, however, the FACT Board of Directors has approved the plans outlined below. Thank you in advance for your flexibility and patience as we undertake this new process to protect the safety of our volunteer inspectors, personnel at accredited programs, and patients.

Eligibility for Virtual Inspections

Situations eligible for a virtual inspection include:

  • Renewal accreditation inspections of clinical, apheresis, or cell processing programs applying independently or together as a hematopoietic cell transplantation program, including immune effector cells.
  • Add-on service involving an existing accredited program (such as immune effector cells [IECs] or more than minimal manipulation processing).
  • Reinspection of all or a portion of a program following Accreditation Committee review of an in-person inspection, provided at least one member of the original inspection team participates in the virtual inspection, and there were no citations related to the physical integrity of the location itself.

Situations not currently eligible for a virtual inspection, and for which an on-site inspection is required, include:

  • Initial accreditation
  • Addition of an entirely new service in a new space, such as a pediatric program at a Children’s Hospital being added to an existing accredited adult program in another facility or a new current Good Manufacturing Practices (cGMP)-compliant processing facility added to an accredited transplant program.

In general, inspections will be either virtual or on-site, not a mixture. There may be exceptions. For example, an add-on to an existing program that is in the renewal process could have a virtual inspection for the renewal portion and an on-site visit of only the add-on portion (e.g., a cGMP facility for IECs added onto an accredited transplant program).

FACT is also working toward resuming some prioritized on-site inspections where these can be done in compliance with state, local, and CDC guidance and within facility and inspector restrictions.  This applies primarily to new applicants.

Prioritization of Virtual Inspections

Priority for virtual inspections will be given to cellular therapy programs whose on-site inspections were canceled, then to those who were in the process of scheduling when the on-site inspections were suspended in March 2020. Cord Blood Banks will begin virtual inspections slightly later.

All programs have been given an additional 6-month extension of their accreditation expiration dates as we resume inspections in this new way. This represents a total of a one year extension to the accreditation expiration.

Preparing for Virtual Inspections

Programs will receive direct individual communications regarding additional documentation that will be required either as an extra annual report or additional pre-inspection updates, depending on where they are in the accreditation cycle.

Please watch for communication from your FACT Accreditation Coordinator. You may contact your FACT Accreditation Coordinator for additional information and share this information with other appropriate individuals in your program, including apheresis and cell processing services. Your Accreditation Coordinator’s contact information can be found at http://www.factwebsite.org/About_FACT/FACT_Staff.aspx.

If you do not know who your coordinator is, contact Suzanne Birnley, Manager of Accreditation Services at suzanne.birnley@unmc.edu.

The Virtual Inspection Process

The platform for the interactive virtual inspections will be a FACT HIPAA-compliant ZOOM Healthcare account. There will be video tours expected, however, inspections will not be recorded. Video tours and additional documentation will be submitted through the FACT Accreditation Portal.

Cellular Therapy Program inspections will most likely occur over two days to allow both inspectors and program staff additional time to review and prepare additional documentation.

The Virtual Inspection Task Force is finalizing:

  • The list of additional documents that will be submitted in advance.
  • A list of documents that the program must be prepared to show to the inspector via ZOOM shared screen, which may include electronic documents such as SOPs, a portion of the EMR, or other scanned documents. Paper records may be shared via scanning or document or portable camera.
  • A list of items that will be demonstrated via a video tour of each site.
  • A proposed inspection agenda, including additional persons to be interviewed during the inspection, such as staff nurse, pharmacist, ICU / ER physician or staff.

Confidentiality of the Virtual Inspection

FACT has a Business Associate Agreement in place with each accredited and applicant program to cover confidentiality issues, including protected health information that may be viewed as part of the accreditation process, but is not recorded or retained by FACT or its volunteers.  FACT’s legal counsel has determined that the current Business Associate Agreement is sufficient to safeguard the virtual inspection process. FACT will work with any institution individually if there are concerns. All FACT staff and volunteers annually sign Confidentiality and Conflict of Interest Agreements.

In addition, the virtual inspection process will incorporate practices to enhance confidentiality, such as requirement for a private room for the inspector to conduct the inspection and lack of recording of the inspection.

Frequently Asked Questions

In addition to questions directly related to accreditation, FACT continues to receive questions related to patients, donors, and other COVID-19 related issues. A Frequently Asked Questions document is periodically updated and 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 [phyllis.warkentin@factglobal.org or 402-559-6781],  the FACT office (402-559-1950), or your FACT Accreditation Coordinator.

Other Resources Available:

ASTCT Resources
WMDA Resources
Centers for Disease Controls
World Health Organizations
NMDP/BeTheMatch


FACT Professional Relations Committee Provides a Forum for Sharing Experiences in Challenging Year

Posted in :: 2020 Volume 6 :: Monday, August 24th, 2020

The cellular therapy community is well known for its spirit of collaboration. One testament to the teamwork enjoyed by the field is the FACT Professional Relations Committee. One of the purposes of this committee is to enhance communications with relevant organizations in the field. This year, 13 organizations are members, and each has nominated a representative to meet at least quarterly to discuss any issues that have captured its attention, new initiatives that might be of interest to other organizations, and requests for input or participation.

Catherine Bollard, MD, inaugural committee chair and Director for the Center for Cancer and Immunology at the Children’s National Medical Center, recently transitioned committee leadership after many years of service to Bruce Levine, PhD, Professor in Cancer Gene Therapy at the University of Pennsylvania. Dr. Levine has called special meetings throughout the COVID-19 pandemic to allow organizations to share ideas, provide updates to processes, and ask questions of each other. The benefits of these discussions were the ability to seek advice and learn from each other, communicate changes impacting cellular therapy programs to a wider audience through multiple channels, and establish some consistency among processes. Topics included, among others, training on caring for transplant patients with COVID-19, cryopreservation of unrelated allogeneic products, virtual meetings, and remote inspections.

FACT thanks the following organizations for their participation on the committee and leadership during this challenging year:

  • AABB
  • American Association for Tissue Banking (AATB)
  • American Society for Apheresis (ASFA)
  • American Society for Gene & Cell Therapy (ASGCT)
  • American Society for Histocompatibility & Immunogenetics (ASHI)
  • American Society for Transplantation and Cellular Therapy (ASTCT)
  • College of American Pathologists (CAP)
  • Cord Blood Association (CBA)
  • International Society Cell & Gene Therapy (ISCT)
  • National Marrow Donor Program (NMDP)
  • Standards Coordinating Body (SCB)
  • World Marrow Donor Association (WMDA)

FACT Inspections Amid the Pandemic

Posted in :: 2020 Volume 5 :: Wednesday, July 29th, 2020

FACT is eagerly anticipating resumption of accreditation activities. In March 2020, FACT suspended on-site inspections and extended all accreditation deadlines and expiration dates by six months due to the COVID-19 Pandemic.  During this time, FACT staff have continued to review submitted applications and responses, prepared and presented educational webinars, and facilitated the vital committee work in standards development, accreditation, quality, clinical outcomes, data audits, education, immune effector cell initiatives, and international accreditation support.

Although the pandemic is not over, some travel has resumed, and some institutions are opening elective procedures and in-person visits. A FACT Task Force will determine the best approach to resumption of on-site inspections. Options include virtual inspections, in-person inspections associated with limited travel, or a combination of methodologies. Factors to be assessed include inspector availability, inspector ability to travel, openness of institutions to non-essential individuals, and characteristics of the applicant program such as prior accreditation and the time remaining until accreditation expiration. Inspector availability and on-site options are being assessed through a survey distributed to inspectors and Program Directors. FACT will publish periodic updates related to inspections through the Newsletter and email communications.


FACT-CBA Webinar: The Effect of the COVID-19 Pandemic on Cord Blood Banking

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT

Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:

Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing

Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.

Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom

Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.

Arvin Faundo, MD
Cordlife Group Limited, Singapore

Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.

Donna Regan MT(ASCP), SBB
NMDP

Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.

Lydia Foeken, LN
WMDA, Executive Director

Register now:
The Effect of the COVID-19 Pandemic on Cord Blood Banking


COVID-19 Update: FACT Accreditation

Posted in :: 2020 Volume 4 :: Thursday, June 18th, 2020

 

 

 

 

 

 

FACT continues to receive questions related to patients, donors, and other COVID-19 related issues, therefore we will provide weekly updates to the Frequently Asked Questions  document available on the FACT website.

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.

The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT

Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:

Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing

Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.

Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom

Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.

Arvin Faundo, MD
Cordlife Group Limited, Singapore

Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.

Donna Regan MT(ASCP), SBB
NMDP

Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.

Lydia Foeken, LN
WMDA, Executive Director

Register now:
The Effect of the COVID-19 Pandemic on Cord Blood Banking

Guidance for Autologous Transplant Patients
Is there any specific guidance for autologous transplant patients, specifically about screening
for COVID-19, documentation of screening, sedation, and other issues?

  • For documentation of screening of autologous transplant patients prior to transplant, prior to collection of the hematopoietic cellular therapy product, or prior to a clinic or apheresis visit, FACT recommends this documentation follow routine medical record documentation practices.
  • There may be specific institutional screening policies that should also be followed. Programs that want to implement enhanced screening for COVID-19 prior to collection of autologous HCT/Ps should follow FDA recommendation to include questions whether in the previous 28 days, the patient/donor has:
    • Cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
    • Been diagnosed with or suspected of having COVID19 infection.
  • For specific guidance about sedation, medications, consideration for delay of transplant, or other clinical issues, refer to the recently updated ASTCT Interim Guidelines for COVID-19 Management in Hematopoietic Cell Transplant and Cellular Therapy Patients at: https://higherlogicdownload.s3.amazonaws.com/ASBMT/a1e2ac9a-36d2-4e23-945c-45118b667268/UploadedImages/COVID-19_Interim_Patient_Guidelines_4_20_20.pdf

Written Agreements
HPC products destined for our clinical program are being cryopreserved at the collection center or occasionally by a third party facility due to COVID-19 travel restrictions and other concerns. Is our program expected to have written agreements in place to be in compliance with standards B4.6.1 and D12.1.1?

  • Presumably these products are unrelated donor products facilitated by a donor registry. Most likely, any single program will receive only one such product from a specific collection site or cryopreservation facility. This makes it impractical to have an individual written agreement in place with each collection or cryopreservation facility. FACT would consider these services of cryopreservation and shipment to be an extension of the program’s written agreement with the Donor Registry.

When our laboratory cryopreserves an unrelated donor product for another transplant center, what records should we include with the shipment?

  • FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration, Seventh Edition, require [D13.5.2] the Processing Facility to provide “a copy of all records relating to the collection, processing, and storage procedures performed related to the safety, purity, or potency of the cellular therapy product”. This would include at a minimum, the volume, total nucleated cell count, cell viability, CD34+ and CD3+ cell counts if performed, microbial culture results, testing, processing, and cryopreservation methods, identification and quantification of additives and cryoprotectants, and the freezing curve. The Processing Facility records should also identify any other facility participating in the collection or processing, and the extent of its responsibility [D13.5.3].

In addition, the Donor Registry will provide registry-specific product analysis forms and potentially, additional data forms related to collection, processing, or storage that should be included with the product shipment. Data required will include identifiers for the donor and recipient, collection date, and product characteristics, including anticoagulants, additives, and the results of all testing performed.

If the Collection Center or Laboratory providing products to an accredited Clinical Program is not FACT or JACIE accredited, the Clinical Program may have to specifically request processing information, including the data listed above.

Laboratories undertaking cryopreservation for another transplant program should obtain recipient information necessary to perform the optimal pre-cryopreservation processing. Particularly in the case of bone marrow products, documentation of the donor and recipient ABO group is critical to ensure red cell reduction strategies are used prior to cryopreservation in the case of incompatibility.

Frequently Asked Questions
Other topics addressed in the FAQ document include:

  • Donor Screening for Allogeneic Transplants
  • Written Agreements
  • Unrelated Donor Products
  • Annual Report
  • Accreditation Extension
  • Updated Accreditation Certificate
  • Allogeneic Donor Screening and Testing Requirements
  • COVID-19 Trials and HCT Accreditation

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
BMT Resources
Centers for Disease Control
World Health Organization


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.


COVID-19 Update: FACT Accreditation

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

 

 

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:

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

Posted in :: 2020 Volume 2 :: Monday, March 16th, 2020

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: