As our world faces an unprecedented medical crisis, we are all busy either dealing with or preparing to deal with caring for patients with COVID-19 – AND all of the other patients who still need our attention. In transplant programs across the globe, people are taking measures to prevent infections in their patients and in the people who care for them, to treat those with infection in the best possible way and to continue to provide transplants to those who need them.
We want to share with you what the CIBMTR is doing in the face of this pandemic and to answer a few questions you may have.
CIBMTR Operations
The CIBMTR is open for business. All CIBMTR staff on both campuses (Milwaukee and Minneapolis) are working from home. Our remote work procedures and experience allow us to fully function while working from home.
Data Collection
We are continuing to collect data and reimburse centers during this time. FormsNet3 is fully operational, including CIBMTR Center Support to answer any of your center's questions.
We altered our data collection forms to facilitate data collection on the impact of the COVID-19 pandemic on our transplant and cellular therapy recipients. A COVID-19 diagnosis can now be reported on the F2100 and F4100. Effective 4/24/20, we will update the Recipient Death Data Form (2900) and the Post-Transplant Essential Data Form (2450) to include a new option for COVID-19 (SARS-CoV-2) as the primary and contributing causes for death. For more information, see the Collecting Data on the Impact of the COVID-19 Pandemic on our Transplant and Cell Therapy Recipients communication sent 3/26/20 (PDF).
We released a new form, Respiratory Virus Post-Infusion Data Form (2149), to collect more detailed data regarding the diagnosis, treatment, and outcomes of COVID-19 infections. Centers will be reimbursed for completing this form. Currently the form is available as a fillable PDF, which should be securely submitted via CIBMTR Center Support. The form will be released in FormsNet3 in early May. For more information, including CIBMTR Center Support submission instructions, see the COVID-19 Updates: Respiratory Virus Post-Infusion Form (2149) communication sent 4/1/20 (PDF).
If you're unable to submit data as you normally would …
We understand that data, including enrollment (CRID generation) may be sent at a reduced rate, or not at all, during this pandemic. We also understand that each center will have different capabilities and may have variable access to FormsNet3 and their institutional data. Therefore, we are suspending continuous process improvement (CPI) requirements for the trimester ending June 30, 2020, for all product types: allogeneic related, allogeneic unrelated, autologous, and cellular therapy infusions. For more information, see the COVID-19 and CPI Standards communication sent 3/16/20 (PDF).
We are also suspending the requirement that centers must complete forms within a year of their due date in order to be reimbursed for all forms reaching the one-year time point on or after 3/1/20. When we reinstate CPI requirements, we will also the address the timeline for reinstating the one-year reimbursement requirement. In the meantime, any form you submit that reaches the one-year time point on or after 3/1/20 will be reimbursed for the full amount. For more information, see the COVID-19 Updates: Reimbursement for Forms Submitted One Year After Due Date –Temporary Change communication sent 4/1/20 (PDF).
If your center is still submitting data, please prioritize data for the transplant center specific analysis (queries, data review, and follow-up), consecutive transplant audit (CTA), and recipients on studies, especially BMT CTN. We strongly recommend you continue to consent patients to the research database, particularly if this can be done by the clinical staff already consenting the patient to their transplant. Even if CRID generation and data submission are delayed, it is important to obtain consent so data can be provided later and be used for research. For more information, please see the memos regarding the impact of COVID-19 to US and international centers, dated 3/20/20 and 3/24/20, respectively.
If you have a data audit scheduled …
Due to travel restrictions, on-site CIBMTR data audits are currently on hold. We will contact any center currently scheduled for an on-site audit March through September to determine if remote access to your electronic medical record can be granted in order to conduct the audit remotely. If remote access is not an option, we will reschedule your center's on-site data audit next fiscal year. For more information, please see the memos regarding the impact of COVID-19 to US and international centers, dated 3/20/20 and 3/24/20, respectively.
Studies
CIBMTR studies will continue. We are currently trying to keep to the previously established timelines for ongoing studies and to accept additional studies that were discussed at the recent Working Committee meetings in Orlando. If you are a Working Committee study principal investigator who does not have as much time to devote to these studies as you originally anticipated, we understand. Please communicate with your statistician to let them know if you will be delayed from working on their studies for a long time. If you are participating in a study that requires a lot of queries to centers or supplemental data collection, please be aware that many centers now have limited capacity to respond to these, and those studies may be delayed.
We are also focusing on analyses deemed important to aid the community in dealing with the COVID-19 crisis. For example, we are analyzing recipients of cryopreserved grafts with subsequent post transplant cyclophosphamide to determine the relative efficacy of fresh and frozen cells with that GVHD prophylactic regimen. We expect results of the analysis to be available during the week of March 29. We also plan to use the data in our cellular therapy registry to determine whether patients who received tocilizumab to treat cytokine release syndrome have an increased risk of infection.
For more information, please see the memo to CIBMTR Working Committees, dated 3/27/20.
Communications
Additional Resources
ASTCT's Interim Guidelines for COVID-19 Management of HCT and CT Patients
Members of the American Society for Transplantation and Cellular Therapy's (ASTCT) Infectious Disease Special Interest Group (SIG) have developed interim guidelines for COVID-19 management of HCT and cellular therapy patients. These guidelines are modified as new information becomes available, including additional data on epidemiology and clinical outcomes, and efficacy of drug therapies including clinical trial outcomes of novel therapeutics. Click here to view updated guidelines from the ASTCT.
Additional resources and information can be found in the ASTCT's COVID-19 Resource Community.
BMT CTN and COVID-19
BMT
CTN COVID-19 documents are posted on the BMT CTN SharePoint website (password
required): http://www.bmtctnsp.net/COVID19%20Documents/Forms/AllItems.aspx
COVID-19 FAQs from Be The Match
In an effort to help patients and donors, Be The Match has assembled frequently asked questions and answers related to COVID-19 and health and safety. Click here to view common FAQs for patients and donors.
