COVID-19 And BMT - EBMT

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COVID-19 and BMT

In the context of the coronavirus disease (COVID-19), the EBMT has set up this section to provide you with an array of useful information and resources.

EBMT Recommendations

Due to fast spreading of SARS-CoV-2 a panel of experts of EBMT recommends the following guidelines for transplant units, recipients, and donors of hematopoietic cells. These guidelines will be updated when new information is obtained about COVID-19 epidemiology and clinical outcome.

EBMT COVID RECOMMENDATIONS UPDATE - January 2024

Working Parties' recommendations

working party	download
Infectious Diseases Working Party Recommendations regarding pre-therapy positivity for SARS-CoV-2	/node/5342/
Severe Aplastic Anemia Working Party	Download Bone Marrow Failure and PNH
Autoimmune Diseases Working Party; Infectious Diseases Working Party; Paediatric Diseases Working Party; JACIE Committee; Nurses Group; Patient Advocacy Committee	Download ADWP recommendations
Acute Leukaemia Working Party	/node/3095/

EBMT COVID-19 Task Force

The EBMT COVID-19 Task Force was created to support patients and the EBMT Community throughout the COVID-19 pandemic.

Their goal is to tackle the different aspects of the pandemic: infectious issues, other non-infectious complications, donor and organisational issues, organisation of outpatient clinics and wards including medical and nursing activities, quality (JACIE) and educational activities.

The structure of the Task Force consists of transversal participation across the different EBMT Groups and Committees. Two coordinators and the IDWP chair will be leading the group, along with representatives from the:

• Executive Committee representative
• IDWP and TCWP Working Parties Chairs since the complications of SARS-CoV-2 implicate these two WPs directly
• All additional WP Chairs from the ALWP, CTIWP, LWP, CMWP, ADWP, IEWP, SAAWP and PDWP
• JACIE Committee
• Nurses Group
• Executive Office representative for education activities
• Donor Outcomes Committee

COVID-19 Task Force Studies

Impact of Covid-19 on stem cell transplant recipients and CAR-T cell recipients Study type Non-interventional Prospective Studies Diseases Complications: infectious Group Infectious Diseases Working Party (IDWP) COVID-19 Type of treatment Allogeneic Autologous CAR T Principal investigator Per Ljungman, Rafael de la Camara, Nicolaus Kröger, Jan Styczynski, Stephan Mielke, Malgorzata Mikulska Impact of Covid-19 in HSCT activity Study type Retrospective Studies Diseases Complications: infectious Group Infectious Diseases Working Party (IDWP) COVID-19 Type of treatment Allogeneic Autologous Principal investigator Rafael de la Camara, Per Ljungman, Zofia Szmit, Krzystztof Kalwak Impact of SARS-CoV-2 vaccination in non-transplanted AA/PNH patients Study type Retrospective Studies Diseases Bone marrow failure Group Severe Aplastic Anaemia Working Party (SAAWP) COVID-19 Type of treatment Principal investigator Morag Griffin Survey on attitude to deferral of transplantation or chemotherapy due to SARS-CoV-2 infection Study type Retrospective Studies Diseases Complications: infectious Group Infectious Diseases Working Party (IDWP) COVID-19 Type of treatment Allogeneic Autologous Principal investigator Jan Styczynski

Publications

2024 Improved outcome of COVID-19 over time in patients treated with CAR T-cell therapy: Update of the European COVID-19 multicenter study on behalf of the European Society for Blood and Marrow Transplantation (EBMT) Infectious Diseases Working Party (IDWP) and the European Hematology Association (EHA) Lymphoma Group Group Infectious Diseases Working Party (IDWP) 1st listed author Anne Mea Spanjaart Journal Leukemia. 2023 Update of recommendations for the management of COVID-19 in patients with haematological malignancies, haematopoietic cell transplantation and CAR T therapy, from the 2022 European Conference on Infections in Leukaemia (ECIL 9) Group Infectious Diseases Working Party (IDWP) Other society 1st listed author Simone Cesaro Journal Leukemia. 2023 Fresh or frozen grafts for allogeneic stem cell transplantation: conceptual considerations and a survey on the practice during the COVID-19 pandemic from the EBMT Infectious Diseases Working Party (IDWP) and Cellular Therapy & Immunobiology Working Party (CTIWP) Group Cellular Therapy & Immunobiology Working Party (CTIWP) Infectious Diseases Working Party (IDWP) 1st listed author N Worel Journal Bone Marrow Transplant. 2023 SARS-CoV-2 vaccination in 361 non-transplanted patients with aplastic anemia and/or paroxysmal nocturnal hemoglobinuria Group Severe Aplastic Anaemia Working Party (SAAWP) Infectious Diseases Working Party (IDWP) 1st listed author Morag Griffin Journal Haematologica. 2023 Outcome of SARS-CoV2 infection in hematopoietic stem cell transplant recipients for autoimmune diseases Group Autoimmune Diseases Working Party (ADWP) Infectious Diseases Working Party (IDWP) 1st listed author Raffaella Greco Journal J Autoimmun. 2023 Improved outcomes over time and higher mortality in CMV seropositive allogeneic stem cell transplantation patients with COVID-19; An infectious disease working party study from the European Society for Blood and Marrow Transplantation registry Group Infectious Diseases Working Party (IDWP) 1st listed author Per Ljungman Journal Front Immunol. 2022 Recommendations for the management of COVID-19 in patients with haematological malignancies or haematopoietic cell transplantation, from the 2021 European Conference on Infections in Leukaemia (ECIL 9) Group Infectious Diseases Working Party (IDWP) Other society COVID-19 1st listed author Simone Cesaro Journal Leukemia. 2020 The challenge of COVID-19 and hematopoietic cell transplantation; EBMT recommendations for management of hematopoietic cell transplant recipients, their donors, and patients undergoing CAR T-cell therapy Group Acute Leukemia Working Party (ALWP) COVID-19 Severe Aplastic Anaemia Working Party (SAAWP) Autoimmune Diseases Working Party (ADWP) Chronic Malignancies Working Party (CMWP) Cellular Therapy & Immunobiology Working Party (CTIWP) Inborn Errors Working Party (IEWP) Infectious Diseases Working Party (IDWP) Transplant Complications Working Party (TCWP) Lymphoma Working Party (LWP) Paediatric Diseases Working Party (PDWP) Patient Advocacy Committee Nursing Research Committee 1st listed author Per Ljungman Journal Bone Marrow Transplant. 2021 COVID-19 and stem cell transplantation; results from an EBMT and GETH multicenter prospective survey Group Infectious Diseases Working Party (IDWP) 1st listed author Per Ljungman Journal Leukemia. 2021 Hematopoietic stem cell transplantation for autoimmune diseases in the time of COVID-19: EBMT guidelines and recommendations Group Autoimmune Diseases Working Party (ADWP) Infectious Diseases Working Party (IDWP) Paediatric Diseases Working Party (PDWP) JACIE Committee Patient Advocacy Committee Nursing Research Committee 1st listed author Raffaella Greco Journal Bone Marrow Transplant. 2020 Management of patients with acute leukemia during the COVID-19 outbreak: practical guidelines from the acute leukemia working party of the European Society for Blood and Marrow Transplantation Group Acute Leukemia Working Party (ALWP) 1st listed author Eolia Brissot Journal Bone Marrow Transplant. 2021 Poor outcome of patients with COVID-19 after CAR T-cell therapy for B-cell malignancies: results of a multicenter study on behalf of the European Society for Blood and Marrow Transplantation (EBMT) Infectious Diseases Working Party and the European Hematology Association (EHA) Lymphoma Group Group Infectious Diseases Working Party (IDWP) Other society 1st listed author Anne Mea Spanjaart Journal Leukemia. 2021 Defining the impact of SARS-COV-2 on delivery of CAR T-cell therapy in Europe: a retrospective survey from the CTIWP of the EBMT Group Cellular Therapy & Immunobiology Working Party (CTIWP) Infectious Diseases Working Party (IDWP) 1st listed author Sara Ghorashian Journal Bone Marrow Transplant. COVID-19 Webinars

JACIE

Remote Assessments EBMT-JACIE Self-Check for post-COVID19 adaptation and preparedness

FAQ COVID-19 and implications for accreditation processes

Our inspection was scheduled and then cancelled when COVID-19 interrupted normal services. When will our inspection be rescheduled?

We will not be scheduling on-site inspections until it is safe to return to on-site visits. JACIE continues to monitor the situation and we have recently started to reach out to inspectors and our network of national representatives to assess conditions in those countries where centres are preparing for accreditation. We are working on the basis of being able to resume at least some activity in the autumn and to give ourselves and our users a ‘horizon’ on which to fix. Needless to say, the safety of our volunteer inspectors is our priority and their willingness to travel and availability will be key to being able to form teams and agree dates with the centres. For that reason, we kindly ask centres for flexibility and patience in this complex task of reactivation and to support the inspectors with all necessary safety measures. In the case of those cancelled inspections, JACIE will make every effort to assign the same inspection team as inspectors will have already made preparations for the on-site visit.

We are in the pre-inspection phase of the accreditation process. What should we do?

Centres should continue to submit documents and maintain correspondence with their assigned Accreditation Coordinator. Accreditation Coordinators are available by email or teleconference (on request) to assist you. JACIE understands that the situation will affect centres’ preparations and can offer flexibility with regard to timelines so please notify your Coordinator when you anticipate delays. Note that where processes take longer than expected, centres may be asked to update information provided earlier and to provide any updated versions of documentation in order for inspectors to have the most recent information and related files.

What happens if our accreditation expires?

Centres whose accreditation expired after 31 March 2020 automatically received a 12-month extension of this accreditation cycle and were notified in early April by email. Accreditations that had already expired before 1 April 2020 were not extended. Those centres that have submitted an application for accreditation are listed as "In Process" in a separate list from the Accredited centres. This is referred to as "coverage", a term limited to acknowledging that a given centre is in the accreditation process without having yet achieved accreditation. A letter to this effect can be requested by the centre by writing to jacie@ebmt.org.

The JACIE website is the official source of the lists of Accredited Centres and Centres in Process. See www.ebmt.org/jacie-accredited-centres for details. In some cases, a centre may appear in both lists because their most recent accreditation is still in force AND they have submitted an application to renew their accreditation e.g. accreditation expiring in December 2020 and application for reaccreditation submitted in December 2019. It is up to the centre if they wish to proceed with their new application. In any case, JACIE encourages early applications for reaccreditation (at least 12 months before expiry and earlier if possible) to avoid or minimise gaps between accreditations.

Centres with expired accreditation awards are not listed. A letter confirmed previous accreditation awards can be provided upon request.

Due to the pandemic, we have had to make temporary changes to our set-up and processes. What do we need to report to JACIE?

JACIE is aware that centres may have to move patients or change services temporarily due to the current extraordinary circumstances. These changes do not require immediate reporting nor JACIE approval. Nonetheless, such changes occurring in centres currently accredited should be reported to JACIE as soon as possible using the Changes affecting Accreditation Report document found at https://www.ebmt.org/ebmt/documents/changes-affecting-accreditation-report. These reports will be provided to inspectors at the next inspection.

Centres should apply quality management principles to these changes including a risk assessment with appropriate mitigation of any identified risks to the extent possible. By definition, these changes represent deviations from normal procedures and practice and so should follow internal processes for planning and approving or for reporting and documenting when unplanned. Standards B/C/D4.12 and B/CM/C/D5.7 apply.

Regarding changes to patient care, centres are directed to the EBMT COVID-19 resources page where guidance and recommendations by EBMT and other organisations are collated. See www.ebmt.org/covid-19-and-bmt

I am already accredited. When should I receive my certificate ?

Due to the COVID-19 pandemic, activities in the JACIE office have been affected. It is not currently possible to print the certificates on our official stamped paper. This is expected to be resolved in the coming weeks when staff can return to the office. A PDF accreditation letter will be provided by email in the meantime. Please contact your Accreditation Coordinator with all requests.

My centre has been already inspected and we are waiting for the inspection report. How can we demonstrate we applied for re-accreditation?

The COVID-19 has impacted the activity of our inspectors and the Office, which may lead to delays in the inspection reports. Centres can ask for a letter from JACIE stating that the centre is in process of being JACIE accredited.

For any queries please contact: jacie@ebmt.org

My centre has to go through the Interim Audit (IA) this year. Are interim audits being postponed?

If your centre is due to send the IA documents in 2020, the process will remain as scheduled. As the audit is only document-based, centres can still present documentation focused on quality management aspects. The JACIE office will send them to the inspectors for review.

Be kindly reminded that your interim audit is due in the same month you obtained the accreditation. If your centre requires some extra time to gather the documents please contact jacie@ebmt.org, We can extend the deadline for a month if required.

The required documents can be found here:

Novel coronavirus additional information

The following resources are being updated regularly with timely information:

International & European authorities

• World Health Organisation (WHO)
• Centers for Disease Control and Prevention (CDC)
• European Centre for Disease Prevention and Control (ECDC)
• The European Commission has clarified that Substances of Human Origin (SoHO) are considered to be essential goods/services for which free circulation within the EU is crucial
• European Network for Health Technology Assessment (EUnetHTA)
• The ECDC has published a guidance document on COVID-19 and SoHO

Epidemiology website

• Johns Hopkins University and Medicine

Scientific societies

• American Society for Transplantation and Cellular Therapy (ASTCT)
• Amercian Society of Hematology (ASH) American Society of Clinical Oncology (ASCO)
• National Comprehensive Cancer Network (NCCN)
• European Hematology Association (EHA)
• British Society of Blood and Marrow Transplantation and Cellular Therapy (BSBMTCT): recommendations for COVID Adult BMT
• Grupo Español de Transplante Hematopoyético y Terapia Celular (GETH)
• Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC)
• Anthony Nolan: Coronavirus and your stem cell transplant
• World Marrow Donor Association (WMDA)
• National Institute for Health and Care Excellence (NICE): Rapid NICE Guideline for COVID-19 in HSCT

Scientific Journals

• The Lancet COVID-19 resource centre
• The New England Journal of Medicine: A collection of articles and other resources on the Coronavirus (Covid-19) outbreak, including clinical reports, management guidelines, and commentary.
• BMJ
• JAMA

Additional information for patients