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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 POSTER SESSION 33 - QUALITY MANAGEMENT P742 TRIPLE PROPHYLAXIS WITH MESNA,

N ACETYLCYSTEINE INFUSION AND ORAL CIPROFLOXACIN AS A LOW-COST INTERVENTION TO PREVENT BK VIRUS HAEMORRHAGIC CYSTITIS IN HAPLOIDENTICAL HSCT WITH PTCY DEEPA KARMEGAN1, REVATHI RAJ 1, RAMYA

UPPULURI1, VENKATESWARAN VELLAICHAMY SWAMINATHAN1, SATISHKUMAR MEENA1, SOHINI CHAKRABORTY1, KAVITHA GANESAN1, SURESH DURAISAMY1, VIDYA KRISHNA1, ASHWIN NAIR2 1APOLLO CANCER HOSPITALS,

CHENNAI, INDIA, 2PGIMER, CHANDIGARH, INDIA BACKGROUND: Haemorrhagic cystitis (HC) is a significant cause of morbidity in children undergoing post-transplant cyclophosphamide (PTCy) based

haploidentical hematopoietic cell transplantation (HSCT) along with a strong association with BK virus cystitis. Cyclophosphamide-induced cystitis is initiated by acrolein which triggers

oxidative stress and directly damages the bladder membranes and impairs the function of mitochondria and endoplasmic reticulum. Mesna is a metabolite eliminated with urine, containing

numerous thiol groups that have an antagonistic effect on acrolein. N Acetylcysteine (NAC) is another donor of -SH groups, similar to Mesna and has additional antioxidant effect against

oxidative injury and inflammation as it directly binds hydroxyl radicals and increases glutathione production. Fluoroquinolone prophylaxis has been reported to reduce BK viraemia in PTCY

setting. We present here, our data on the use of the low-cost triple prophylaxis with NAC and Mesna as continuous infusion with post-transplant cyclophosphamide (PTCY) and ciprofloxacin

after engraftment as a low-cost intervention to prevent BK virus induced cystitis. METHODS: We prospectively evaluated the incidence of BK viruria and HC in 185 haploidentical HSCT with PTCY

children over a five-year period between June 2017 to June 2022. Our low cost BK prevention protocol included N-acetyl cysteine infusion at 10 mg/kg/hr starting 1 h post cyclophosphamide

infusion till 24 h post cyclophosphamide, Mesna infusion at 1.4 times the dose of cyclophosphamide from the time of starting cyclophosphamide till 24 h post completion with forced alkaline

diuresis protocol and oral ciprofloxacin at 10 mg/kg/day post engraftment till day 60. We prospectively collected data on the incidence of BK virus haemorrhagic cystitis, the impact of the

conditioning regimen and concomitant graft versus host disease (GVHD) and finally the use of cidofovir therapy as per our IEC approval. RESULTS: We included 185 children between 0 to 18

years with 72 (38.9%) males and 113 (61.1%) females. The indication for HSCT was for malignancy in 77 (41.6%) and non-malignant disorders in 108 (58.4%) children. The conditioning regimen

was myeloablative (MAC) in 147 (79.5%) and reduced intensity (RIC) in 38 (20.5%) and included total body radiotherapy either at 2 Gy or 12 Gy in 113 (61.1%) children. We documented acute

GVHD in 28 (15.1%) and BK virus HC in 46 (24.9%) children. The use of MAC regimen (_P_ value 0.019) and TBI based conditioning (_P_ value 0.012) increased the risk of BK HC. The most

significant association of BK HC was in children with acute GVHD (_P_ value < 0.001). A total of 31 children required cidofovir therapy, of which only 5 had isolated BK HC and the others

had refractory cytomegaloviral or adenoviral infection. CONCLUSIONS: A combination of NAC, Mesna and ciprofloxacin is effective in preventing BK virus haemorrhagic cystitis and the reduced

the incidence of BK virus cystitis from 67% in our historical cohort to 24.9%. The cost of triple prophylaxis for a child weighing 15 kg is approximately 60 USD and the cost of one vial of

cidofovir is 600 USD making it an attractive and cost-effective intervention to prevent BK HC and we recommend triple prophylaxis in HSCT with PTCY. DISCLOSURE: Nothing to declare. 33 -

QUALITY MANAGEMENT P743 AN APHERESIS COLLECTION AND PROCESSING FACILITY SYSTEM IN THE SOUTH AFRICAN SETTING LAUREL ANDERSON1, VINCENZO IACONIANNI2, TANYA NADIA GLATT3,1 1THE SOUTH AFRICAN

NATIONAL BLOOD SERVICES, JOHANNESBURG, SOUTH AFRICA, 2ICMED, MILAN, ITALY, UNIVERSITY OF JOHANNESBURG, JOHANNESBURG, SOUTH AFRICA BACKGROUND: The South African National Blood Services

(SANBS) has an apheresis collection facility and a processing facility that services 26 clinical facilities in South Africa and Botswana. The collection facilities are organized to suit the

logistical and economic needs of the clinical facilities. The apheresis collection facility is a mobile facility under the supervision of a single Apheresis Collections Facility Director and

there is a single centralized processing facility. SANBS began its Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) accreditation process 3 years ago and it was decided to apply

for initial accreditation for both the processing facility and one of the collection facilities based in a clinical facility in Johannesburg. The aim of the report is to illustrate the

SANBS haematopoietic stem cell transplantation (HSCT) program, to identify the differences between the JACIE requirements and the SANBS HSCT program and to propose a way to implement JACIE

requirements for the complex realities in the South African situation. METHODS: In order to assess the suitability of the JACIE standards in South Africa, the requirements of the JACIE

Standards (Part C and D version 7) and the SANBS HSCT program Quality System were compared. Cost sustainability was also considered. RESULTS: Two areas were identified in the standards to

which SANBS HSCT program can’t always comply. The same quality standards can however be achieved by suggested adaptions in the SANBS HSCT program: * a. C2.1: Apheresis Collections are

sometimes performed at the patient’s bedside. A designated area, as per the standard, is not always feasible. This could be addressed by performing a risk assessment to ensure all

requirements of C2.1 are still met at each collection. * b. C3.1.3: There is a limited number of doctors with two years of postgraduate training and experience in cellular therapy product

collection and processing in South Africa. The volume of apheresis procedures managed and supervised by the Apheresis Collections and Processing Facilities Directors in SANBS is very high.

The JACIE requirements for overseeing >10 procedures per year is exceeded. The SANBS collection facility performed a total of 209 collections during 2021/2022; while the processing

facility processed and cryopreserved a total of 233 and reinfused 146 HPSC products during 2021/2022. The number of procedures should therefore be taken into account in C3.1.3. * c. Cost

sustainability: the extension of the JACIE accreditation to all SANBS apheresis collection facilities is not sustainable. According to the current model, each apheresis collection facility

will have to pay a specific fee. Of note, it is the same apheresis collection facility team, Apheresis Collection Facility Director and machines that service all clinical facilities. In

order to ensure the extension to all centers, costs should be calculated differently. CONCLUSIONS: JAICE accreditation is a great tool to improve the quality of care for the transplant

patient, however, it must be adjustable to support HSCT programs in different situations. Through these suggestions, the system can be made more flexible and applicable to complex situations

such as found in South Africa while still ensuring a high quality standard is met. DISCLOSURE: Nothing to declare. 33 - QUALITY MANAGEMENT P744 TRANSFERRING AUTOLOGOUS STEM CELL

TRANSPLANTATION PATIENTS ON DAY AFTER INFUSION: A FEASIBLE PROCEDURE AND A RELIEF FOR TRANSPLANTATION CENTERS PAULA LÁZARO-DEL CAMPO1, ADOLFO SÁEZ-MARIN1, MADALENA CORONA-DE LAPUERTA1, IRYNA

LLUTS2, ANA LERMA-VERDEJO2, JUAN CHURRUCA-SARASQUETA3, PILAR BRAVO4, PILAR MARTÍNEZ-SÁNCHEZ1, JOSE MARÍA SÁNCHEZ-PINA1, JUAN JOSÉ LAHUERTA1, JOSÉ ÁNGEL HERNÁNDEZ-RIVAS3, FERNANDO

SOLANO-RAMOS2, JOAQUÍN MARTÍNEZ-LÓPEZ1, ANA JIMÉNEZ-UBIETO1, MARÍA CALBACHO 1 1HOSPITAL 12 DE OCTUBRE, MADRID, SPAIN, 2HOSPITAL NUESTRA SEÑORA DEL PRADO, TALAVERA DE LA REINA, SPAIN,

3HOSPITAL UNIVERSITARIO INFANTA LEONOR, MADRID, SPAIN, 4HOSPITAL UNIVERSITARIO DE FUENLABRADA, FUENLABRADA, SPAIN BACKGROUND: The increasing number of Hematopoietic Stem Cell

Transplantations (HSCT) over the last 20 years and the rapid emergence of chimeric antigen receptor (CAR) T-cell therapies are overwhelming the hospitalization capacity of transplant

centers. The outpatient model in the practice of HSCT has been recognized for its positive results in terms of effectiveness and safety (Fernández-Avilés F et al; JCO 2006). However, many

patients are not eligible for outpatient HSCT management. Here we present the experience of a tertiary Spanish hospital of transferring patients to their referral center on the day after

infusion (day +1) for management post-transplant. METHODS: This prospective study assesses the feasibility of transferring patients receiving an autologous stem cell transplantation (ASCT)

at 1 of 3 selected second level hospitals. It also compares the outcome of patients either transferred on day +1 or treated entirely at our facilities using the Triple Aim framework: health

outcomes, costs, and experience of care. Patients were transferred in a medical ambulance. Inpatient units and management protocols were common to all centers and were consistent with JACIE

standards. In our hospital and in one of the referral centers G-CSF was used since day +5. RESULTS: Between January 2018 to October 2022 a total of 228 ASCT in 220 patients with hematologic

malignancies were performed; 29 of them (12.7%) were transferred to their referral center on day +1. There were no differences in baseline characteristics (Table 1). All non-transferred

patients use G-CSF from day +5 while only 10 (34%) of the transferred patients. There were no complications during transfers. Two (6.9%) patients needed to return to our center. The most

frequent complications were febrile neutropenia, mucositis, and graft syndrome, which were distributed similarly in both groups. The rate of admission to the intensive care unit and

mortality were also not different in the two groups. Neutrophil engraftment was delayed in transferred patients. Platelet engraftment and hospitalization days since day +1 were similar

between groups. This strategy reduces the average length of stay by 15.4 days (table 1) in the transplant center. Patient satisfaction score was excellent, with 93% of them indicating that

they would recommend the procedure to a fellow patient. TABLE 1   Transferred patients Not transferred patients _p_-value Median years (min-max) 57.8 (37.4–71.6) 56.4 (20.8–71.4) 0.51 Sex

(Female/Male) 19/10 104/94 0.19 Diagnosis 0.926  Myeloma and plasma cell disorders 20 122    Lymphoma 9 73   Disease status pre autologous stem cell transplantation 0.465  Complete response

(CR) 16 (55.2%) 122 (62.4)    Other than CR 13 (44.8%) 74 (37.7)   Comorbidity index (HCT-CI) 0.928  0–2 23 154    >=3 6 42   Median engraftment  Neutrophil 14.4 11.8 0.017  Platelet 17.5

16 0.59 Complications  Febrile neutropenia 26 (89.7) 181 (91.9) 0.687  Mucositis 25 (86.2) 162 (82.2) 0.597  UCI admission 0 (0) 12 (6.09) 0.172  Graft syndrome 10 (34.5) 76 (38.8) 0.657  

Death 1 (3.45) 4 (2.02) 0.625  Admission days since infusion 18.7 16.4 0.14 CONCLUSIONS: In our experience, the operation of a “transferring” management model is safe and effective. Its main

advantages include significant decrease in length of hospitalization in transplant centers, alleviating constraints on chronic bed shortage, increasing the number of patients able to be

treated, and facilitating patient convenience. No adverse impact on recipient care was observed. Neutrophil engraftment was delayed in transferred patients probably because only 34% used

G-CSF. The use of G-CSF seems to shorten neutrophil engraftment without increasing the incidence of graft syndrome. Globally we suggest increasing the number of patients included in

“referral programs” around the world. DISCLOSURE: Nothing to declare. 33 - QUALITY MANAGEMENT P745 VALIDATION MASTER PLAN FOR A COMBINED AND INTEGRATED APPROACH OF QUALITY AND RISK

MANAGEMENT BARBARA LOCONTE 1, MAURO BAGLIONI1, GEORG STUESSI1, VINCENZO IACONIANNI2, ROBERTA BORDONE1, ERIKA LERCH1, ALESSANDRA STASIA1, LUCIANO WANNESSON1, DAVIDE SARI1, LAURA ORLANDO1

1ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND, EOC, BELLINZONA, SWITZERLAND, 2ICMED, SESTO SAN GIOVANNI, ITALY BACKGROUND: The terms “validation” and “qualification” describe the activities

required to prove that a procedure, process, instrument, reagent, activity or system is compliant to predetermined criteria. It is a key component of the Quality Management Plan (QMP) of

Cellular Therapy Programs (CTPs), required by international accreditation standards such as The Joint Accreditation Committee ISCT-Europe & EBMT (JACIE) and Good Manufacturing Practice

(GMP), which is applicable for all processes related to cell product (CP) manufacturing. However, it is increasingly difficult for CTPs to have a combined approach with QMP components. For

these reasons, our CTP developed an integrated model, that could be transferable to other contexts. METHODS: In order to define an integrated model, a project was designed, where the

following activities were carried out: 1. IDENTIFICATION OF PROCESSES TO BE VALIDATED. Starting from GMP requirements, processes closely related to CP production were identified, including

autologous donor/recipient mobilization, collection, transport of fresh and cryopreserved CP, storage and manipulation of the CP, release, bedside thawing and administration of CP. 2.

IDENTIFICATION OF ELEMENTS REQUIRING QUALIFICATION. During the process of validation, elements requiring qualification were identified. In our CTP the following elements were qualified:

locals, equipment, materials/reagents, personnel, suppliers, and software. Qualification activities were documented through the acquisition and verification of technical documentation

accompanying the products and through testing within the related process. The qualification process included, if applicable, installation qualification (IQ), operational qualification (OQ),

and performance qualification (PQ). RESULTS: As an initial step, a VALIDATION AND QUALIFICATION PLAN was developed for each process and elements previously identified. After defining the

items and their acceptance criteria, the validation and qualification tests were carried out and reported in specific forms. Subsequently, results, non-conformities, data analysis and

conclusions were reported, elements qualified and processes validated (VALIDATION AND QUALIFICATION REPORTS). Based on the results of these reports, CTP processes were analyzed and potential

risks were identified. The risks were mapped, while the treatment and monitoring of each singular risk was defined in a RISK MANAGEMENT PLAN (RMP). A CHANGE MANAGEMENT PLAN (CMP) was

developed, assuring a risk assessment of the changes to be introduced, as well as an estimation of the impact of changes on validated processes and/or qualified elements, eventually

requiring re-validations and re-qualifications of the processes. Finally, based on the RMP and VMP, each element of the QMP is periodically reviewed by a multidisciplinary team, guaranteeing

continuous monitoring and improvement of the QMP. CONCLUSIONS: This methodology is a tool for the integrated management of each element of the QMP, combining JACIE and GMP requirements,

with a rational approach aimed at process verification and continuous quality improvement. DISCLOSURE: Nothing to declare. 33 - QUALITY MANAGEMENT P746 THE HOSPITAL IS MOVING TO A NEW

BUILDING, CAN JACIE STANDARDS HELP IN THE PROCESS? OLGA LOPEZ-VILLAR 1, MIRIAM LÓPEZ PARRA1, MARÍA LUISA MARTÍN MATEOS1, MARTA FONSECA SANTOS1, BEATRIZ OREJA MARTÍN1, SILVIA HERNÁNDEZ

MUÑOYERRO1, MERCEDES RODRÍGUEZ MARTÍN1, MARTA MANZANO CURTO1, NURIA VICENTE HOLGADO1, ROCÍO SÁNCHEZ CARRERA1, MARÍA DEL MAR CAMBRONERO ESTÉVEZ1, MARÍA ISABEL RAMOS SEVILLANO1, LAURA SÁNCHEZ

DOMÍNGUEZ1, NURIA OLIVA SÁNCHEZ1, MARCOS GONZÁLEZ DÍAZ1 1UNIVERSITY HOSPITAL OF SALAMANCA, SALAMANCA, SPAIN BACKGROUND: Changes that may happen in apheresis and processing units are variable

between sites. When all the units of the hospital move to a new building it is a major change for the entire organization. The situation is stressful and poses challenges to activities and

personnel. Between June 2021 and May 2022 all the units of the University Hospital of Salamanca moved to a new building. Apheresis and processing units are part of the Transfusion Service

(Hematology Department) where the quality management system has been long established. The aim of this work is to describe the situation of moving apheresis and processing to the new

building and assessing whether JACIE standards help. METHODS: The main quality tools that were used in the process where change control, risk assessment, validation and qualification. The

quality management system of the Transfusion Service was certified by ISO9001:2015 and was in the JACIE accreditation process. JACIE standards were the main instrument, since they are

specific for apheresis and processing. RESULTS: The change control was opened three years before the relocation. In the first years the actions were about the acquisition and requirements of

the new equipment. * The risk assessment done showed that all the activities required a revalidation since there were changes either in the facility (apheresis) or in both the facility and

the equipment (processing). Staff was the same, which was strength. * JACIE standards include the qualification of the facilities and equipment. This was crucial in getting those services. *

The delays in getting the new equipment caused reprograming the actions included in the change control and new risk assessments. * The qualification of the processing unit and the hoods was

done in late 2021. Afterwards the prospecting validations in the unit (cleaning, media-fill, process) where planned. * In the risk assessment, the validation of the apheresis procedures

showed a lower risk when compared to processing since there were no changes in equipment nor in personnel. So those validations were done concurrently. * The actions also included up-dating

the procedures and training of personnel. The education in the management of the new storage facility included all the personnel of the transfusion department and also of the maintenance

service of the Hospital. * The communication change was done internally and externally. Two weeks after finishing the activity in the old building, the activity in the new building began in

April 2022. Afterwards some actions were also performed: * Finishing the validations in apheresis and processing. * Performing the validations of the most unusual processes (e.g. transport

of bone marrow). The change control was closed in September 2022. Some occurrences pending and the actions were included in the usual tools of the quality system. CONCLUSIONS: Actions before

and after moving units from one hospital to another are required. The risks are high so validations are required. JACIE standards include those requirements and also the qualification of

units and equipment which helped us in including those parameters. CLINICAL TRIAL REGISTRY: N/A. DISCLOSURE: N/A. 33 - QUALITY MANAGEMENT P747 QUALITY REVIEW IN THE PROCESSING UNIT: WHERE

ARE WE AFTER THE CHANGE CONTROL? VALENTINO GRANERO1, TIZIANA FRANCISCI1, CLAUDIO TIRALONGO1, CLARA PECORARO1, PIERA SONCIN1, VITTORIO SCHIAVO1, MARIKA SALAFIA1, CRISTIANA FRANCONE1,

FRANCESCA CRISTINA CARNICELLA1, MARCO MASSONE1, LUISA GIACCONE 1, MARCO LORENZI1, ALESSANDRO BUSCA1 1A.O.U. CITTÀ DELLA SALUTE E DELLA SCIENZA DI TORINO, TURIN, ITALY BACKGROUND: Stem cell

transplantation is a kind of medicine for cancer: a quality management system (QMS) is required for every transplant program. The QMS ensures that procedures are carried out in line with

agreed standards and involves the full participation of all staff. The more dynamic the system is, the more useful and effective it is for carrying out the activities of each type of unit,

especially in an event where significant changes may affect final quality and safety. This work describes and compares the outcomes and activities related to the Processing Unit (PU) of the

CIC231 Transplant Program (CIC231) following the Change Control (ChC) related to the transfer in the new headquarters of the Blood Bank and Immunohaematology of Turin (Tissue Establishment

n. IT007501). METHODS: ChC: beginning of October 2020 and end of April 2021 (based on a Project Management methodology). References: Current legislation; JACIE, GMP, SOP standards of CIC 231

and related to PU. Comparison period of results: April 1 to November 30: 2022 vs 2021. Key Process Indicators (KPI): defined by the National Transplant Center (CNT) and by the CIC231.

Culture Data Mining: BQC Platform (Fresenius-Khabi). RESULTS: The TE IT007501 is authorized to process all stem cell products and does not carry out cryopreservation. 2021: * Staff: 1

director and 5 technicians. * Audits: 1 regulatory (ISO 9001:2015) and 1 internal. * 20 NC registered with 19 corrective actions. * No adverse events produced. * KPI: sterility 98%: problems

related to bone marrow sampling and not dependent on PUs; CD34+ and CD3+ numbers and viability were achieved for each type of manipulation in accordance with the goal of the transplant

program. 2022: * Personnel: 1 PB director, 1 medical director and 6 technicians. * Audits: 2 regulatory (CNT and ISO9001:2015), 2 by CAR-T companies and 1 internal. * 3 NC registered with 3

corrective actions. * 1 improvement actions. * No adverse events produced. * KPI: 100% sterility; The number of CD34+ and CD3+ and the viability were achieved for each type of manipulation

in accordance with the goal of the Transplantation Program. CONCLUSIONS: Our results confirm that a dynamic QMS can guide the structure and the professionals to guarantee the success of the

activities, even in case of significant changes. Despite the difficulties and complexities, the QMS is the pillar of collaboration, for better and safer products, for better and clearer

communication and for the development of partnerships in order to obtain the best overall results. Therefore, the best quality management is not reserved for an enclosed group but involves

the whole team. DISCLOSURE: Nothing to declare. 33 - QUALITY MANAGEMENT P748 TRANSPLANT OUTCOMES OF FRESH VS CRYOPRESERVED HEMATOPOIETIC STEM CELLS FROM RELATED AND UNRELATED DONOR DURING

THE SARS-COV2 PANDEMIC ANTONIO BRUNO 1, ILARIA MANGIONE1, RAFFAELLA CERRETTI1, GOTTARDO DE ANGELIS1, BENEDETTA MARIOTTI1, GIULIA CIANGOLA1, ADRIANO VENDITTI1, ANDREA MENGARELLI2, FRANCESCO

MARCHESI2, LAURA CUDILLO3, ELEONORA CERESOLI3, GIUSEPPE AVVISATI4, ENRICO SANTINELLI4, PAOLO DE FABRITIIS5, TERESA DENTAMARO5, AGOSTINO TAFURI6, ANTONELLA FERRARI6, LUCA PIERELLI7, PAOLA

IUDICONE7, GASPARE ADORNO1, GIANPAOLO DEL PROPOSTO1, MARCO ANDREANI8, MARIA TROIANO8, MARIANNA VELOCCI1, WILLIAM ARCESE4 1UNIVERSITY TOR VERGATA, ROME, ITALY, 2REGINA ELENA NATIONAL CANCER

INSTITUTE, ROME, ITALY, 3SAN GIOVANNI ADDOLORATA HOSPITAL, ROME, ITALY, 4UNIVERSITY CAMPUS BIO-MEDICO, ROME, ITALY, 5SANT’EUGENIO HOSPITAL, ROME, ITALY, 6SANT’ANDREA HOSPITAL, SAPIENZA 2ND

UNIVERSITY, ROME, ITALY, 7SAN CAMILLO FORLANINI HOSPITAL, ROME, ITALY, 8BAMBINO GESÙ HOSPITAL, ROME, ITALY BACKGROUND: The emergence of coronavirus disease 2019 (COVID-19) and its rapid

evolution has been cause of a serious healthcare crisis affecting ability of transplant centers to infuse fresh donor cells on the scheduled day of transplantation. In March 2020, the EBMT

recommended cryopreservation of unrelated donor grafts before initiating pre-transplant conditioning. Consequently, several transplant centers have adopted similar policy in the setting of

allogeneic hematopoietic stem cell transplantation (allo-HSCT) from related donors. The aim of this study was to evaluate the outcomes of patients undergoing allo-HSCT for hematologic

malignancies with either fresh or cryopreserved grafts during COVID-19 pandemic. METHODS: From January 2020 to December 2021, a total of 96 consecutive patients with hematopoietic

malignancies were transplanted with freshly (_n_ = 56) or cryopreserved (_n_ = 40) allografts at Rome Transplant Network (RTN), a Jacie accredited metropolitan transplant program. No

statistically significant differences were found between the 2 patient groups in terms of age, gender, hematologic malignancy or intensity (myeloablative vs reduced) of the Thiotepa,

Busulphan, Fludarabine (TBF) combination used as conditioning regimen in all patients. Furthermore, infection prophylaxis, transfusion therapy, and supportive care were identical for both

patient groups. RESULTS: The quality control in the post–thawing reference samples of cryopreserved products showed a high median recovery of viable CD34 cells (96%, range: 85–99),

indicating that the cryopreservation procedure did not significantly affect quality of allografts. There was no significant difference in PMN/Plts engraftment between recipients of fresh or

cryopreserved grafts: the median time to neutrophil engraftment to >0.5 × 109/L was 18 days (range, 10–28) and 19 days (range, 11–46) for the fresh and cryopreserved grafts (_p_ = 0.22),

respectively, while the median time to platelet engraftment to 20 × 109/L was 22 days for both groups (_p_ = 0.24). The cumulative incidence of II-IV grade acute GVHD was 30% at 100 days for

both fresh and cryopreserved grafts, respectively. OS at 100 days was 82% and 77.5% (_p_ = NS) for the fresh and cryopreserved grafts, respectively. Our results suggest that cryopreserved

allografts are not inferior to freshly collected preparations and clinical outcomes including engraftment kinetics, OS and GVHD are similar. CONCLUSIONS: The cryopreservation of related and

unrelated donor HSC grafts was a safe option and it offered outcomes comparable with fresh grafts. Nevertheless in allogeneic setting and out of pandemic problems, to better balance economy,

risks and benefits, the HSC cryopreservation procedure should be limited to the cases where a family donor, as potential back-up at time of stem cell collection work-up, is not available.

DISCLOSURE: The authors declare no conflict of interest. 33 - QUALITY MANAGEMENT P749 ROLE OF EMPACT ON PROFESSIONAL AND PERSONAL DEVELOPMENTS OF NURSES IN PAKISTAN AZRA SHAHEEN AINY1,

LAWRENCE FAULKNER2, EUGENIA TRIGOSO 3, ALIA BATOOL4, SADAF KHALID4, ZHOLDASBEKOVA AINUR4, SARAH GILANI4 1EBMT, LEIDEN, NETHERLANDS, 2CURE2CHILDREN, ITALY, ITALY, 3HOSPITAL UNIVERSITARIO LA

FE, VALENCIA, SPAIN, 4DR AKBAR NIAZI TEACHING HOSPITAL, ISLAMABAD, PAKISTAN BACKGROUND: Nurses play a frontline role in all health organizations. Despite being the largest group among health

professionals, nursing still lacks strong models for assuring continuous competency and professional development in developing countries such as Pakistan. EMPACT- Middle Income Countries

Paediatric Advanced care training program, is a pilot educational program by the Outreach Subcommittee, Paediatric Diseases Working Party - European Bone Marrow and Transplant association,

supported by DKMS (German Bone Marrow Donor Center) and Cure2Children. The program was started in June 2021 and is progressing with nurses from India and Pakistan. This study was conducted

at Bone Marrow and Transplant unit, Dr. Akbar Niazi Teaching hospital, Islamabad. The purpose of this study is to highlight the importance of international educational programs in personal

and professional development. METHODS: An online survey was conducted via purposive sampling and Delphi technique including the participant nurses of this program in both Pakistan and India.

The survey consisted of a structured questionnaire for participants enrolled in this training program from Pakistan and India. Content analysis was done using responses collected on google

forms. RESULTS: Total of 8 participants participated in the study. Among them 5 were females and 2 were males. Mean age of the participants were 33.57 years. All participants found EMPACT

helpful. Personal growth that participants noted with this program include better decision making by 100% and improved self learning and mature professional behavior by 87.5%. Professionally

100% of participants noted improved skills for patient care and own presentation skills. 100% of participants believe this training experience will help them get better jobs in future.

Improved communication and enhanced critical thinking was noted by 87.5% of participants. All participants recommended these training programs in Pakistan and all plan to become part of

these programs in future. CONCLUSIONS: This study clearly shows that training programs like EMPACT play a great role in nursing personal and professional developments. More educational

programs like EMPACT should be started at all levels to improve healthcare and their should be policies both locally and globally to endorse such education programs. DISCLOSURE: Nothing to

declare. 33 - QUALITY MANAGEMENT P750 BONE MARROW PROCESSING BY CENTRIFUGATION OR SPECTRA OPTIA KITTY ROOD 1, VANESSA UMMELS1, SENEH MANSOUR1, NATASCHA WEIJERS1, SASKIA SMEETS1, RENÉ

SENDEN1, FATIMA BOUHOUCH1, MONIQUE GROMMÉ1 1MAASTRICHT UMC, MAASTRICHT, NETHERLANDS BACKGROUND: Bone marrow harvests (HPC(M)) may need to be volume-, red blood cell- and/or plasma-reduced

prior to cryopreservation and/or administration of ABO-incompatible allogeneic transplants. In contrast to HPC(A) products, bone marrow grafts have larger volumes and contain more red blood

cells and plasma. In case of major and/or minor ABO-incompatible allogeneic transplants the incompatible red blood cells and/or antibody containing plasma may have an adverse impact on the

recipient because immediate or delayed hemolysis, delayed erythropoiesis and pure red cell aplasia may occur after infusion. For cryopreservation large volumes require more DMSO which may

also lead to adverse events in recipients after infusion. From 2016 to present 31 HPC(M) harvests have been processed and CD34+ cell-content, volume-, red blood cell- and plasma reduction

has been analysed. METHODS: 6 minor ABO-incompatible HPC(M) harvests were processed by centrifugation at 764 g without a break for 15 min at room temperature in a Hettich Rotanta 460 R

centrifuge with a swing-out rotor (5699-R) and blood bag buckets (4890). After centrifugation plasma was removed manually by a plasma extractor and total nucleated cell (TNC) count was

determined in the extracted plasma by Sysmex XN 3000. CD34+ cell-content was determined by flow cytometry (BD FACSCanto or BD FACSLyric with anti-human CD45-FITC/CD34-PE monoclonal

antibodies (BD Biosciences 341071) and 7-AAD (BD Pharmingen 559925). In the extracted plasma CD34+ cell-content was calculated by multiplying the TNC by the %CD34+ of the original HPC(M)

harvest. 3 autologous and 22 ABO-incompatible allogeneic HPC(M) harvests were processed by Specta Optia in a Spectra Optia BMP Accessory set (TerumoBCT, ref.nr. 11300). Volume reduction, RBC

depletion and CD34 recovery of these 31 processed bone marrow harvests were analysed. RESULTS: Results of processing by centrifugation: mean volume reduction 55% (median 55%, range 42–65%);

mean RBC depletion 0% and mean CD34 recovery 97% (median 97%, range 96–99%). Results of processing by Spectia Optia: mean volume reduction 93% (median 93%, range 90–94%); mean RBC depletion

97 (median 98%, range 91–100%) and mean CD34 recovery 110% (median 101%, range 92–158%). CONCLUSIONS: Both HPC(M) processing methods (centrifugation and Spectra Optia) lead to high

recoveries of CD34 cells and plasma reduction. Only Spectra Optia processing will reduce RBC content of HPC(M) grafts. The advantage of the centrifugation method is that it is cheaper, but

it takes just as much time to process the bone marrow transplant by centrifugation as for a Spectra Optia run because the bone marrow harvest needs to be divided into multiple bags and

centrifugation without brake and plasma extraction in the clean room are also time consuming. The advantages of processing by Spectra Optia are that also red blood cells are reduced and that

volume reduction is greater than by centrifugation. In our institute bone marrow grafts that need to be volume-, red blood cell- and/or plasma-reduced are directly harvested in a Spectra

Optia BMP Accessory set to save time and resources. Both methods, depending on the required specifications of the final HPC(M) transplant, can be used as an alternative to processing bone

marrow harvest by a COBE 2991 centrifuge. CLINICAL TRIAL REGISTRY: Not applicable. DISCLOSURE: Nothing to declare. 33 - QUALITY MANAGEMENT P751 THE DYNAMICS OF UNRELATED ALLOGENEIC

TRANSPLANTATIONS IN BELARUS DEPEND ON THE LOGISTICAL CHALLENGES OF RECENT YEARS VOLHA MISHKOVA 1, ALENA HLAZ2, YULIYA MAREIKO1, NATALIA KIRSANOVA1, DMITRY PRUDNIKOV1, ALEXEI ALEXEICHIK1,

MARIYA NAUMOVICH1, LUBOV ZHERKO1, PAVEL YANUSHKEVICH1, NINA MINAKOVSKAYA1, IHAR ISKROU2, ANATOLY USS2 1BELARUSIAN RESEARCH CENTER FOR PEDIATRIC ONCOLOGY, HEMATOLOGY, AND IMMUNOLOGY,

BOROVLYANY, BELARUS, 2MINSK SCIENTIFIC AND PRACTICAL CENTER FOR SURGERY, TRANSPLANTOLOGY, AND HEMATOLOGY, MINSK, BELARUS BACKGROUND: Almost 30 years have passed since the first stem cell

transplantation in Belarus. During this time, invaluable experience in patients’ treatment, support, and rehabilitation has accumulated. Equally important is the interaction with

international donor banks to find the best option for each child and adult patient. The COVID-19 pandemic and subsequent significant socioeconomic events set several tasks for the

coordinators that require immediate and often non-standard solutions. METHODS: This abstract analyzes the experience of the donor search coordinators of the Belarusian Research Center for

Pediatric Oncology, Hematology, and Immunology and the Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology during 2018-2022. RESULTS: Compared to the

flourishing period of 2018–2019, when more than 60 allogeneic unrelated transplantations were performed jointly by the two clinics, the results of 2020 turned out to be a failure. The number

of transplants has halved due to the global COVID-19 pandemic. Through the joint efforts of the donor search coordinators, donor banks, as well as the international courier companies Ontime

and Time:matter, an effective procedure was established for the delivery of stem cells from collection centers in Germany and Poland to Belarus. In 2022, the existing algorithm was revised

to reflect the new socioeconomic constraints. The delivery process has become much more complicated. So, in 2022, options through Azerbaijan and land borders with Poland and Lithuania were

tested in practice for the first time. Despite a notable increase in the cost of delivery and the complication of documentary processes, the figures for 2022 turned out to be significantly

higher than those in 2020 (16 and 23 transplants, respectively). It is expected that by the end of 2022, the number of transplants performed will increase further. Currently, the primary

sources of donor stem cells for Belarus are Germany and Poland. Of the 133 unrelated allogeneic transplantations, 115 were performed using donor material from these countries, which amounted

to 86.45%. Another 15 transplantations (11.3% of the total) were performed from Belarusian donors and only three from donors from other countries (Russia and Great Britain). From time to

time, there is information about finding compatible donors for Belarusian patients in Israel, Turkey, Switzerland, the Czech Republic, and the Netherlands. In the future, we see a real

prospect of cooperation with these countries, even taking into account the strict need to ensure the delivery of the transplant within 72 h from the moment of cell collection. CONCLUSIONS:

Any restrictions, be it a pandemic or geopolitical tensions, lead to a significant complication in organizing a donor search at all stages. At the same time, we are confident that the joint

efforts of all participants in the logistics network will continue to effectively carry out all the processes necessary to save the lives of children and adults in Belarus. CLINICAL TRIAL

REGISTRY: N/A. DISCLOSURE: Nothing to declare. 33 - QUALITY MANAGEMENT P752 A 12-MONTH RETROSPECTIVE DESCRIPTIVE STUDY OF OCCURRENCES FOR THE SOUTH AFRICAN NATIONAL BLOOD SERVICES APHERESIS

COLLECTION AND THE STEM CELL PROCESSING FACILITIES LAUREL ELLEN ANDERSON 1, TANYA NADIA GLATT1,2, RIANA COCKERAN1 1THE SOUTH AFRICAN NATIONAL BLOOD SERVICES, JOHANNESBURG, SOUTH AFRICA,

2DEPARTMENT OF HUMAN ANATOMY AND PHYSIOLOGY, UNIVERSITY OF JOHANNESBURG, JOHANNESBURG, SOUTH AFRICA BACKGROUND: The South African National Blood Services (SANBS) provides Apheresis

Collection (by the Specialised Therapeutic Services—STS) and Processing Services (by the Cellular Therapy Laboratory - CTL) for Haematopoietic Stem Cell Transplant patients in South Africa.

An integral part of these services is to effectively identify, report, document and manage occurrences. The SANBS has a robust system for managing occurrences including performing a root

cause analysis, short term and long term corrective and preventative action and monitoring of effective implementation of the corrective action. We use a risk based approach with the

following risk ratings: Major, Minor, Critical, High/Significant, Medium/Basic, Low/Insignificant, Moderate or Insignificant. Occurrences may arise from poor service, operational

deficiencies, quality of products, vendors, internal and external quality audits, deviations from or gaps identified in operational procedures and processes, reported incidents, errors,

accidents, deviations, adverse events, adverse reactions and complaints. METHODS: A total of 313 stem cell collections and subsequently stem cell processing as well as 177 stem cell

reinfusions took place during the 12 month period. A retrospective review of all occurrences that were logged for the Collection Facility (STS) and the Processing Facility (CTL) for the

period 1 October 2021 to 30 September 2022 was performed. The data was analyzed using simple statistics. RESULTS: The Collection Facility reported a total of 134 occurrences, 14 (10%) of

which were critical/major with the majority being minor 108 (80%) relating to adverse reactions to ACD anticoagulant. The Processing Facility reported a total of 86 Occurrences, of which 28

(33%) were major, 22 (26%) minor and 16 (19%) critical. The most common occurrence in the Processing Facility was record related (33%) and storage related (13%). CONCLUSIONS: The SANBS

Collection and Processing Facilities have a robust program for the management of occurrences in line with JACIE requirements. The most common occurrences did not negatively impact patient

care, but ongoing occurrence monitoring analysis and quality improvement is important to ensure improved patient outcome. The value add of the study to the quality system is to expand the

occurrences into categories that are more descriptive. DISCLOSURE: Nothing to declare. 33 - QUALITY MANAGEMENT P753 AUDIT SYSTEM DURING COVID-19 PANDEMIC – REMOTE AUDITING AS A CHALLENGE FOR

BOTH PARTIES? KATERINA STEINEROVÁ 1, PAVEL JINDRA1, DANIEL LYSAK1 1UNIVERSITY HOSPITAL PILSEN, PLZEN, CZECH REPUBLIC BACKGROUND: Internal and external audits are one of the essential tools

to measure the efficacy of the quality system and its processes. Audit can be defined as a documented, systematic evaluation to determine whether approved policies or standard operating

procedures have been properly implemented and are being followed. Audits represent one of the principal activities of the quality management program.The Covid-19 pandemic turns the world

upside down, but remains important that activities aimed at evaluating and maintaining quality management systems (QMS) continues, including quality audits. Remote audit system was solution

for this period. There are several advantages of remote auditing, to both audited and auditor. They include: saving money relative to travel expenses, more flexibility in audit scheduling,

the time saved from not having to travel to difficult-to-reach sites enables auditors to concentrate solely on the audit, increasing their productivity and the audit content (eg observations

and findings). But there are challenges when it comes to remote audits, mostly for the auditor. METHODS: Our center is JACIE accredited since 2008 for all facilities - Clinical Unit (CU),

Apheresis Unit (AU) and CellProcessing Laboratory (CPL). These parts represent complex stem cell transplantation (SCT) programme with a single Quality Management System (QMS). All these

parts have similar auditing system consisting of internal and external audits. External audits are regularly performed by national institutions (State Institute for Drug Control, ISO) and

system remained unchanged during pandemic situation. Internal audits are performed by JACIE trained auditor, this auditor also leads third parties audits. Remote system have been introduced

especially for third parties audits of cooperating institutions. Our remote auditing delivery modes included detailed checklists and forms together with the off-the-shelf communication

tools, such as Teams and Zoom.It was much easier to deal with remote work when the entire organization has effective and well-practiced quality management, processes, and technology

capabilities. RESULTS: During pandemic situation we have performed 40internal in-person audits and 4 remote audits of third parties. Internal audits showed 8 (18%) minor deficiencies, all

high risk areas were currently well covered. We did not identified risk areas or new areas that do require some audit coverage. Within remote audits no major and only 2 minor deficiencies

have been identified, all corrective actions have been effectively implemented. CONCLUSIONS: Although remote auditing is not appropriate in all facilities, it is worth exploring for those

audit activities that do not require in-person contact. Remote auditing is increasing in use, so developing and refining skills in remote auditing is a smart move for auditors during and

after the coronavirus pandemic. According our experience we can recommend remote audit system especially for previously on-site inspected institution. DISCLOSURE: Nothing to disclosure.

RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE The 49th Annual Meeting of the European Society for Blood and Marrow Transplantation: Quality Management

Group – Poster Session (P742-P753). _Bone Marrow Transplant_ 58 (Suppl 1), 689–695 (2023). https://doi.org/10.1038/s41409-023-02064-7 Download citation * Published: 09 November 2023 * Issue

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