The 47^th Annual Meeting of the European Society for Blood and Marrow Transplantation: Quality Management Group – Oral Session (O175-O178)

14–17 March, 2021 ● Virtual Meeting

Copyright: Modified and published with permission from https://www.ebmt.org/annual-meeting

Sponsorship Statement: Publication of this supplement is sponsored by the European Society for Blood and Marrow Transplantation. All content was reviewed and approved by the EBMT Committee, which held full responsibility for the abstract selections.

Quality Management Oral Session

O175. The RTN transplant policy and activity during Covid-19 pandemic

Antonio Bruno¹, Ilaria Mangione¹, Raffaella Cerretti¹, Gottardo De Angelis¹, Benedetta Mariotti¹, Andrea Mengarelli², Francesco Marchesi², Laura Cudillo³, Michele Cedrone³, Giuseppe Avvisati⁴, Maria Cristina Tirindelli⁴, Paolo De Fabritiis⁵, Teresa Dentamaro⁵, Mariagiovanna Cefalo⁵, Agostino Tafuri⁶, Antonella Ferrari⁶, Gaspare Adorno¹, Marco Andreani⁷, Maria Troiano⁷, Marianna Velocci¹, Silvia Miccichè¹, Alessandra Picardi¹, William Arcese¹

¹ University Tor Vergata, Rome, Italy, ² Regina Elena National Cancer Institute, Rome, Italy, ³ San Giovanni Addolorata Hospital, Rome, Italy, ⁴ University Campus Bio-Medico, Rome, Italy, ⁵ Sant’ Eugenio Hospital, Rome, Italy, ⁶ Sant’Andrea Hospital, Sapienza 2nd University, Rome, Italy, ⁷ Bambino Gesù Hospital, Rome, Italy

Background: A number of problems related to Covid-19 pandemic have affected the standard management of transplant. In particular, travel restrictions among Countries with a consequent reduced availability of unrelated donors searched through the International Registries and the risk of SarsCov2 donor infection have to lead to modify the current policy adopted by transplant Centers. In Italy, starting from February the SarsCov2 viral infection became progressively pandemic. In order to evaluate the impact of viral pandemic on the transplant activity of the Rome Transplant Network (RTN), a JACIE accredited metropolitan transplant program, we compared number and type of autologous and allogeneic hematopoietic stem cell transplant (HSCT) during the first 6 months of the last 3 years.

Methods: For patients with hematological malignancy eligible to an allogeneic HSCT, the RTN policy is the identification of a suitable donor in order to perform transplant in adequate timing, which was established as ≤3 months from the start of search for patients with advanced or high-risk disease progression. The algorithm of donor choice is based on a hierarchy according to the following selection criteria: (1) HLA identical sibling; (2) Matched Unrelated Donor (MUD): ≥8/10 HLA antigen matching tested at high resolution for both class I and class II HLA loci; (3) Cord Blood (CB): single unit selected on the base of cell dose and number (≤2) of HLA mismatched antigens; (4) Haploidentical Related Donor (HRD), as GCS-F primed, unmanipulated bone marrow. HSC from peripheral blood or bone marrow was harvested from Covid-19 negative donor and cryopreserved prior to the start of conditioning regimen. For patients undergoing an AlloHSCT myeloablative or reduced-intensity regimen, infection prophylaxis, transfusion therapy, and supportive care were identical for all patients.

Results: Between 1st January 2018 and 30th June 2020, a total of 434 adult patients underwent a HSCT, which was Autologous in 325 and Allogeneic in 154. Considering the only first 6 months of each year (’18, ’19, ’20), a total of 188 and 91 patients received an Autologous or an Allogeneic transplant, respectively. The number of AutoHSCT or AlloHSCT was not substantially different during the three 6-month periods: AutoHSCT n = 69 for ’18 vs n = 58 for ’19 vs n = 61 for ’20; AlloHSCT n = 31 for ’18 vs n = 29 for ’19 vs n = 31 for ’20. No significant differences were observed for patient characteristics, diagnosis, or disease risk between the 3 cohorts of patients. During the first 6 months of 2020, the number of haploidentical transplants increased about 3-fold with a corresponding 2-fold less of transplants from unrelated donors.

Table 1

January.June	2018	2019	2020
HLA id.Sib.	5	8	5
MUD + CB	20	14	9
Haploidentical	6	7	17
Total	31	29	31

Conclusions: The current RTN policy applied during the viral pandemic status has been shown to allow all patients to receive an AlloHSCT avoiding any delay.

Disclosure: Nothing to declare.

O176. Compliance and cost efficacy for cellular therapies, can these two go hand in hand?

Janik Adriaansen ¹, William Schaut¹, Jean Stanton¹, Robert Bowden¹

¹ Janssen Biotech, Inc, Raritan, United States

Background: Over the last decade, cancer immunology has progressed from an academically interesting field to one of the most promising forms of new treatments in which not cancer, but the immune system is treated. In particular, the genetic modification for purposeful redirection of autologous T-cells is providing hope to many treatment-resistant patients. This expensive, yet personalized form of medicine is radically different from more traditional oncologic drugs.

Methods: With these evolving medical advancements and more cellular therapies becoming available, the European regulations have progressed, resulting in the Guidelines for Good Manufacturing Practice specific to Advanced Therapy Medicinal Products, adopted in 2017. These are specifically suited for the manufacture of gene and cell therapy final products. The correct interpretation is crucial since theoretical approaches to implementing GMP can easily lead to disproportionate and unwarranted restrictions which may not address the specific risks that regulators were intending to control.

Results: This is especially the case for cell collection and biopreservation preceding the manufacturing process. Both the fresh and cryopreserved apheresis material are generally accepted as minimally manipulated starting materials by authorities. As such, the processing of this cellular material is regulated by the dedicated EU Tissue and Cells Directives. This allows for a more tailored approach to the operational quality regime by identifying, evaluating, and managing process-specific risks while factoring in the complexity of the process.

Conclusions: We describe how this can compliantly be designed and implemented leading to substantial cost reductions while maintaining robustly high quality and safety standards.

Disclosure: Nothing to declare.

O177. How to maintain a continuous training program for nurses in times of pandemic

Sheila Saco ¹, Ariadna Domenech¹, Nuria Borràs¹, Lourdes Corominas¹, Montserrat Valverde¹, Anna Serrahima¹

¹ Hospital Clinic of Barcelona, Barcelona, Spain

Background: JACIE (Joint Accreditation Committee ISCT-Europe & EBMT) standards define continuous training as a requirement for nurses working in accredited transplant units. Obtaining continuous education can be difficult, so our center decided to implement their own accredited training course. Since 2008 a specific training course, accredited by regular authorities, free of charges in the workplace and held by staff nurses, has been organized. Through all these years, the structure has been modified according to the needs and opinions of the attending nurses. Currently, it consisted of 10 sessions that take place through the year; each session was held at two or three different times (depending on the availability of the speaker), and so nurses from all shifts could attend. At the beginning of the pandemic caused by SARS-COVID 2, in March 2020, we had to suspend the program and reconsider how we could maintain the educational sessions.

Methods: From June to November we reinitiated the course. Now, several options were offered to participate: (a) in person, since in our country meetings were restricted to ten people, with previous registration required, (b) synchronously through the Zoom platform, and (c) deferred, as all sessions were recorded so nurses were able to access through the internal training platform of our center. To justify attendance and get the accreditation, when the session was viewed in a delayed manner through the platform, three questions about the viewed session were required to be answered. The course has been accredited by our national system of accreditation.

Results: 91 nurses participated in the course. 63.8% of the attendance was virtual. At the end of the course, a satisfaction survey was carried out among the participants. The average score of the questions was 9,25. The lowest score was 8,57 and, the highest, 9,53. There was also a final question in an open format to make comments and suggestions for future editions.

Conclusions: Offering quality and up-to-date training to nurses in hematological transplantation wards is one of the JACIE’s standards that sometimes is difficult to achieve due to the difficulty of combining nursing schedules and shifts, and the lack of economic resources. The appearance of the pandemic has been an added challenge in order to be able to maintain continuous training as it was established in our center. It was not easy initially to organize it, but it helped us that our center already had a training platform, the availability of online streaming platforms and our background in offering training courses. The high participation and satisfaction of the attendance nurses encourage us to explore and continue new training formats for highly specialized nurses.

Disclosure: Nothing to declare.

O178. The disaster plan adjustment to the Covid-19 pandemic at aorn cardarelli transplant program in Naples, Italy

Lucia Ammirati ¹, Mariangela Pedata¹, Maria Celentano¹, Cira Riccardi¹, Serena Marotta¹, Dalila Salvatore¹, Marta Raimondo¹, Ilaria Migliaccio¹, Vincenzo Petrillo¹, Antonio Meles¹, Alessandra Picardi¹

¹ AORN Antonio Cardarelli, Naples, Italy

Background: JACIE standards establish criteria for comprehensive quality management that covers the major domains of activity in hematopoietic stem cell transplantation (HSCT), including disaster plans. The spread of Covid-19 pandemic represents an unprecedented health condition with a significant impact on HSCT programs and it requires the disaster plans adjustment in the clinical practice. Herein, we report the adjustment of the disaster plan at AORN Cardarelli Transplant Program during the Covid-19 pandemic.

Methods: From June 2019, Transplant Program of AORN Cardarelli has started the allogeneic activity and is actively working in order to achieve the JACIE accreditation. In this context, from January 2019 to date, 144 transplant procedures have been carried out (110 autologous/34 allogeneic). In order to face COVID19 pandemic, since March 2019, no visitors were allowed in our clinical unit and Covid-19 swabs were performed 48 h before admission of patients for transplant whereas anamnestic questionnaire and capillary serologic test were performed in outpatients. Subsequently, National and EBMT guidelines for donors and patients were followed.

Results: Outcomes: Since first report of Covid-19 in Italy, overall, 14 cases of Covid-19 infection have been observed at Cardarelli Transplant Program in Naples. Among the outpatients, 4 (3 AL and 1 NHL) were in post-allogeneic, 1 (MM) in post-autologous transplantation follow-up and 8 (4 patients and 4 stem cell donors) were performing pre-transplant screening. Moreover, 1 patient affected by AML experienced Covid-19 pneumonia at day +32 during hospitalization for allogeneic transplantation. Lastly, coronavirus spread among healthcare workers too: 2 physicians, 5 nurses, 2 cleaning, and 1 health worker, resulting in a shortage of trained staff. Overall, nobody on transplant team needs hospitalization, 2 patients (1 NHL/1MM) died for Covid-19 pneumonia at 6 months from allogeneic and autologous HSCT, respectively, while 1 patient, who developed Covid-19 pneumonia during allogeneic transplant procedure, is well and was discharged on day +62.

Discussion: The occurrence of Covid-19 pneumonia in the hospitalized patient with inability of transfer to the Covid unit, led to the disaster plan adjustment including:

• (1) switching the positive in negative pressure of the HEPA filtered room in which Covid-19 patient was hospitalized;

• (2) implementation of clean and dirty path for accessing to the patient’s room;

• (3) training of all personnel on the Covid-19 dressing procedure;

• (4) block of admissions;

• (5) communication of the emergency to the National and Regional competent authority for transferring the patients on the waiting list to other Transplant Programs;

• (6) mandatory FFP2 mask use for hospitalized patients, during the contact with health care workers;

• (7) weekly staff screening for Covid-19, through molecular swab;

• (8) hospitalized patients screening for Covid-19 through molecular swab, twice a week.

Conclusions: The prompt adjustment of the disaster plan allowed no further spread of Covid19 infection among hospitalized patients and staff. Our experience confirm that the JACIE accreditation system represents a useful tool for the transplant programs allowing the management even of unprecedented clinical condition as Covid19 pandemic, limiting severe adverse events.

Disclosure: Nothing to declare.