COVID-19 Update: FACT Accreditation
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
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
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
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:
Centers for Disease Control
World Health Organization