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"JACIE" accreditation status of the transplant team by November 2012 and outcome of patients transplanted between 1999 and 2006. (A) Kaplan-Meier estimates of overall survival of 17,655 patients with an allogeneic HSCT, transplanted in the years 2004-2006 in a center accredited (green line; n=8,983) or not (blue line; n=8,672) by 2012. The respective hazard ratios are presented in Table 2A. (B) Overall survival (OS) and non-relapse mortality (NRM) at 72 months by EBMT risk score for 17,243 patients transplanted with an allogeneic HSCT in a large center accredited by November 2012 (blue line) or not (red line). (C) Overall survival and non-relapse mortality at 72 months by EBMT risk score for 28,052 patients transplanted with an autologous HSCT in a large center accredited by November 2012 (blue line) or not (red line).
Source publication
Competent authorities, healthcare payers and hospitals devote increasing resources for quality management systems but scientific analyses searching for an impact on clinical outcome remain scarce. Earlier data indicated a stepwise improvement in outcome after allogeneic hematopoietic stem cell transplantation with each phase of the accreditation pr...
Contexts in source publication
Context 1
... a consequence, non-relapse mortality (HR 0.86; 0.73 to 1.03) and relapse incidence (HR 0.82; 0.70 to 0.97) were lower for the 22,008 patients who underwent allogeneic HSCT in "JACIE pos " centers, resulting in significantly high- er adjusted overall survival (HR 0.86; 0.73 to 0.98) and relapse-free survival (HR 0.85; 0.75 to 0.95) (Table 2A). A cohort of patients who received an allogeneic HSCT between 2004 and 2006 illustrates the impact of accredita- tion on outcome ( Figure 2A). Effects were detected in patients with a low or intermediate (not high) EBMT risk score, as illustrated by a subgroup of patients transplanted in a large center ( Figure 2B). ...
Context 2
... cohort of patients who received an allogeneic HSCT between 2004 and 2006 illustrates the impact of accredita- tion on outcome ( Figure 2A). Effects were detected in patients with a low or intermediate (not high) EBMT risk score, as illustrated by a subgroup of patients transplanted in a large center ( Figure 2B). ...
Context 3
... | 2014; 99(5) 0 12 24 36 48 60 72 0,I II,III IV,V VI,VIII 0,I II,III IV,V accreditation status at the time of transplantation, the data failed to show a significant effect of "JACIE" accreditation by 2012 on either reduction of mortality over time or on any of the four outcomes after autologous transplantation (n= 66,281; HR 1.03; 1.00 to 1.06; overall survival) ( Figure 2C; Table 2B). ...
Citations
... [42][43][44] Although this approach may provide short-term flexibility, it can fragment data flows and complicate consistency. Moreover, centers with QMSs for blood banks or stem cell transplantation, 45,46 may attempt to extend their systems to cell therapy manufacturing. However, these systems are often rigid, lacking flexibility for modifications or tailoring, and fail to provide specialized functionalities required by CGT manufacturing. ...
... Operating on standardized procedures, the JACIE accreditation system has attracted nearly 400 different centers seeking accreditation. The positive impact of accreditation on hematopoietic transplant outcomes, the predominant focus of JACIE-accredited centers, has been substantiated, underscoring the correlation between new center accreditation and enhancements in patient survival and reduction of procedural mortality 14,15 . ...
... To ensure quality of care in HSCT, accreditation standards and quality management systems are used, which require periodic analysis of outcome, auditing, and entry of data in a central registry [2]. This leads to improved quality of care, which may improve survival after HSCT in accredited centres [3][4][5]. However, investing in accreditation comes with significant recurring costs [6], which is especially relevant for low-and middle-income countries [7]. ...
Hematopoietic stem cell transplantation is a high-risk procedure. Auditing and yearly outcome reviews help keep optimal quality of care and come with increased survival, but also has significant recurring costs. When data has been entered in a standardized registry, outcome analyses can be automated, which reduces work and increases standardization of performed analyses. To achieve this, we created the Yearly Outcome Review Tool (YORT), an offline, graphical tool that gets data from a single center EBMT registry export, allows the user to define filters and groups, and performs standardized analyses for overall survival, event-free survival, engraftment, relapse rate and non-relapse mortality, complications including acute and chronic Graft vs Host Disease (GvHD), and data completeness. YORT allows users to export data as analyzed to allow you to check data and perform manual analyses. We show the use of this tool on a two-year single-center pediatric cohort, demonstrating how the results for both overall and event-free survival and engraftment can be visualized. The current work demonstrates that using registry data, standardized tools can be made to analyze this data, which allows users to perform outcome reviews for local and accreditation purposes graphically with minimal effort, and help perform detailed standardized analyses. The tool is extensible to be able to accommodate future changes in outcome review and center-specific extensions.
... In transplants from PB, a lower rate of deaths was found in the first three post-transplant phases but not in the late phase, which may be caused by the indirect effect of GVHD in allogeneic HCT from PB hematopoietic cells. Similarly, there was an increased risk of death from infections in the HY + setting [7,17]. Both in the COD-1 and COD-2 study, transplant center size, and experience were associated with reduction of infectious deaths in the very early, and early phase. ...
We previously analyzed trends in incidence and factors associated with lethal complications in ALL/AML/CML patients (causes of deaths; COD-1 study). The objective of this study was the analysis of incidence and specific causes of death after HCT, with focus on infectious deaths in two time periods, 1980–2001 (cohort-1) and 2002–2015 (cohort-2). All patients with HCT for lymphoma, plasma cell disorders, chronic leukemia (except CML), myelodysplastic/myeloproliferative disorders, registered in the EBMT-ProMISe-database were included (n = 232,618) (COD-2 study). Results were compared to those in the ALL/AML/CML COD-1 study. Mortality from bacterial, viral, fungal, and parasitic infections decreased in very early, early and intermediate phases. In the late phase, mortality from bacterial infections increased, while mortality from fungal, viral, or unknown infectious etiology did not change. This pattern was similar for allo- and auto-HCT in COD-1 and COD-2 studies, with a distinct and constant lower incidence of all types of infections at all phases, after auto-HCT. In conclusion, infections were the main cause of death before day +100, followed by relapse. Mortality from infectious deaths significantly decreased, except late phase. Post-transplant mortality has significantly decreased in all phases, from all causes after auto-HCT; it has decreased in all phases after allo-HCT except late phase.
... Keeping HSC products sterile is crucial for successful and safe transplantation. Controlling microbial contamination in HSC products is one of the most important issues in terms of QC [7,8]. Although culture-positive HSC products do not necessarily cause serious infection in recipients, microbial contamination of HSC products often leads to arrest of or delay in the treatment plan [9][10][11]. ...
Background:
Sterility and safety assurance of hematopoietic stem cell (HSC) products is critical in transplantation. Microbial contamination can lead to product disposal and increases the risk of unsuccessful clinical outcomes. Therefore, it is important to implement and maintain good practice guidelines and regulations for the HSC collection and processing unit in each hospital. We aimed to share our experiences and suggest strategies to improve the quality assurance of HSC processing.
Methods:
We retrospectively analyzed microbial culture results of 11,743 HSC products processed over a 25-year period (January 1996 to May 2021). Because of reorganization of the HSC management system in 2008, the 25-year period was divided into periods 1 (January 1996 to December 2007) and 2 (January 2008 to May 2021). We reviewed all culture results of the HSC products and stored aliquot samples and collected culture results for peripheral blood and catheter samples.
Results:
Of the 11,743 products in total, 35 (0.3%) were contaminated by microorganisms, including 19 (0.5%) of 3,861 products during period 1 and 16 (0.2%) of 7,882 products during period 2. Penicillium was the most commonly identified microorganism (15.8%) during period 1 and coagulase-negative Staphylococcus was the most commonly identified (31.3%) during period 2. HSC product contamination occurred most often during HSC collection and processing.
Conclusions:
The contamination rate decreased significantly during period 2, when the HSC management system was reorganized. Our results imply that handling HSC products by trained personnel and adopting established protocols, including quality assurance programs, aid in decreasing the contamination risk.
... • Ensure that procedures are being performed in line with agreed standards, with full participation by all staff members. In a HSCT programme, this ensures that the clinical, collection and laboratory facilities are all working together to achieve excellent communication, effective common work practices, shared policies where appropriate, increases guarantees for improved patient outcomes and the use of international donor criteria for related donors (Gratwohl et al. 2014;Anthias et al. 2015Anthias et al. , 2016. Nurses have successfully taken on the role of improving communications for donor mobilisation, collections and liaising with the staff of the processing facility. ...
... Data shown by Gratwohl and colleagues (Gratwohl et al. 2014) demonstrate that the use of a clinical quality management system is associated with improved survival of patients undergoing allogeneic HSCT. ...
Laboratory medicine, along with the airline industry, has a long history of utilising quality management systems. It took until 1999 for the Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and the European Group for Blood and Marrow Transplantation (EBMT), known as JACIE, to be established as an accreditation system in the field of haematopoietic stem cell transplantation (HSCT). The aim was to create a standardised system of accreditation to be officially recognised across Europe, and it was based on the accreditation standards established by the US-based Foundation for the Accreditation of Cellular Therapy (FACT).
Since the concept of JACIE was originally launched, many European centres have applied for initial accreditation with other centres gaining reaccreditation for the second, third or fourth time. Transplant units, outside of Europe, have accepted the importance of the JACIE Standards, with units in South Africa, Singapore and Saudi Arabia also gaining accreditation.
There is evidence that both donor and patient care have improved within the accredited centres (Passweg et al., Bone Marrow Transplant 47:906–923; 2012: Demiriz IS, Tekgunduz E, Altuntas F (2012) What is the most appropriate source for hematopoietic stem cell transplantation?).
Peripheral Stem Cell/Bone Marrow/Cord Blood Bone Marrow Res. (2012):Article ID 834040 (online)). However, there is a lack of published evidence demonstrating that this improvement directly results from better nursing care. Therefore, the authors conducted a survey of nursing members of the European Blood and Marrow Transplantation Nurses Group (EBMT (NG)) to identify how nurses working in the area of HSCT felt that JACIE impacted in the care they delivered and the general implications of JACIE for nurses.
... The JACIE accreditation program was established by EBMT more than 20 years ago with the aim of quality improvement and ultimately better survival outcomes in HSCT patients through a system of external inspection and assessment of compliance against minimum quality standards. The positive impact of the JACIE accreditation program has been supported by a retrospective registry analysis of outcomes in allogeneic transplantation in Europe [23] with similar results also reported in North America [24]. The current and recent versions of the FACT-JACIE Standards require that Clinical Programs should achieve 1-year survival and nonrelapse mortality at 100 days outcomes within or above the expected range when compared with national and international outcome data and the Center should also benchmark for nonrelapse mortality at 100 days. ...
From 2016 EBMT and JACIE developed an international risk-adapted benchmarking program of haematopoietic stem cell transplant (HSCT) outcome to provide individual EBMT Centers with a means of quality-assuring the HSCT process and meeting FACT-JACIE accreditation requirements relating to 1-year survival outcomes. Informed by previous experience from Europe, North America and Australasia, the Clinical Outcomes Group (COG) established criteria for patient and Center selection, and a set of key clinical variables within a dedicated statistical model adapted to the capabilities of the EBMT Registry. The first phase of the project was launched in 2019 to test the acceptability of the benchmarking model through assessment of Centers’ performance for 1-year data completeness and survival outcomes of autologous and allogeneic HSCT covering 2013–2016. A second phase was delivered in July 2021 covering 2015–2019 and including survival outcomes. Reports of individual Center performance were shared directly with local principal investigators and their responses were assimilated. The experience thus far has supported the feasibility, acceptability and reliability of the system as well as identifying its limitations. We provide a summary of experience and learning so far in this ‘work in progress’, as well as highlighting future challenges of delivering a modern, robust, data-complete, risk-adapted benchmarking program across new EBMT Registry systems.
... Based on these standards, JACIE offers accreditation to transplant programs to encourage health institutions and facilities to establish and maintain quality management systems for all of their activities and to engage in continuous improvement. 4,[15][16][17] The primary aim of the JACIE is to promote high-quality patient care and laboratory performance in terms of specimen collection and processing in transplant centers through an internationally recognized system of accreditation. [15][16][17] Our adult stem cell transplant center is licensed by the Ministry of Health and is one of the few centers in the world to have JACIE reaccreditation. ...
... 4,[15][16][17] The primary aim of the JACIE is to promote high-quality patient care and laboratory performance in terms of specimen collection and processing in transplant centers through an internationally recognized system of accreditation. [15][16][17] Our adult stem cell transplant center is licensed by the Ministry of Health and is one of the few centers in the world to have JACIE reaccreditation. ...
Objectives:
The adoption of international quality and accreditation standards is important for the success of transplant centers. Guidelines from the Joint Accreditation Committee ISCT-Europe and EBMT (JACIE) have enabled quality management of the operations of clinical units of cellular therapy centers, including cell collection and processing, thus minimizing errors and adverse events. COVID-19 has had significant implications for immunocompromised patients, particularly hematopoietic stem cell transplant recipients, as well as their donors and caregivers. Here, we retrospectively examined measures, taken in our transplant center in Turkey during the pandemic period between March 2020 and October 2021, to investigate how JACIE accreditation has affected patient, donor, product, and employee safety.
Materials and methods:
We analyzed data on transplant activity, as well as donor, patient, product, and employee safety, during the pandemic in 3 separate 6- month periods. The measures were analyzed starting from March 2020, when the first COVID-19 case was seen in Turkey.
Results:
Since the beginning of the pandemic, 140 patients have undergone stem cell transplant in our center. Stem cell transplant was delayed in 22 patients because of the pandemic. Transplant was also postponed due to COVID-19 positivity in 6 patients, and 2 patients died due to COVID-19 infection during the transplant process. Unrelated donor activity continued to be performed safely throughout this period. COVID- 19 infection developed in 12 of the 52 personnel working in the bone marrow transplant unit, one of whom needed intensive care due to severe pneumonia. In terms of quality management activities, the impact of the pandemic was greatest during the first month.
Conclusions:
Results from our retrospective study examining the impact of JACIE accreditation in a stem cell transplant center during the COVID-19 pandemic showed that, when national and international guidelines are followed, JACIE accreditation can facilitate adaptation to changing conditions in transplant centers.
... The experience in hematopoietic stem cell transplantation (HSCT) with the quality management scheme promoted by the Foundation for the Accreditation of Cellular Therapy (FACT)-Joint Accreditation Committee of the ISCT-Europe & EBMT (JACIE) offers a clear example of the confirmed correlation between the occurrence of new center accreditation with FACT-JACIE standards and significant improvements in patient survival and reduction of procedural mortality, therefore demonstrating the clinical benefits of adoption of quality standards. 5 Consistently, centers in advanced phases of FACT-JACIE accreditation are linked to significantly higher survival rates, independent of other risk factors. 6 Similarly, adherence to good pharmaceutical practices (GxP) is a tool to ensure that products are fit for their intended use, establishing acceptable safety and efficacy profiles, and providing a framework to streamline the revision and approval processes. ...
The development of cell-, gene- and tissue engineering (CGT)-based therapies must adhere to strict pharmaceutical quality management standards, as for any other biological or small-molecule drug. However, early developments often failed to fully comply with good laboratory practices (GLP) in non-clinical safety studies. Despite an upward trend of positive opinions in marketing authorization applications, evidence of adherence to the principles of GLP is not openly reported; therefore, their relative impact on the overall quality of the product development program is unknown. Herein we investigated the actual degree of GLP implementation and the underlying factors impeding full compliance in non-clinical developments of CGT-based marketed medicines in the EU and USA, including (i) the co-existence of diverse quality management systems of more strategic value for small organizations, particularly current Good Manufacturing Practices n(GMP); (ii) lack of regulatory pressure to pursue GLP certification; and (iii) the involvement of public institutions lacking a pharmaceutical mindset and resources. As a final reflection, we propose conformity to good research practice criteria not as a doctrinaire impediment to scientific work, but as a facilitator of efficient clinical translation of more effective and safer innovative therapies.
... JACIE has been increasingly recognised by governmental bodies and competent authorities in several EU member states and extends beyond Europe with accredited centres worldwide. Importantly, JACIE accreditation appears to have an impact on survival outcomes and donor safety [232,[338][339][340][341][342][343][344]. During the pandemic, JACIE supported self-assessment by centres to help maintain minimum quality standards in the midst of the challenges faced by health services. ...
For over two decades, the EBMT has updated recommendations on indications for haematopoietic cell transplantation (HCT) practice based on clinical and scientific developments in the field. This is the eighth special EBMT report on the indications for HCT for haematological diseases, solid tumours and immune disorders. Our aim is to provide general guidance on HCT indications according to prevailing clinical practice in EBMT countries and centres. In order to inform patient decisions, these recommendations must be considered in conjunction with the risk of the disease, risk of HCT procedure and non-transplant strategies, including evolving cellular therapies. HCT techniques are constantly evolving and we make no specific recommendations, but encourage harmonisation of practice, where possible, to ensure experience across indications can be meaningfully aggregated via registry outputs. We also recommend working according to JACIE accreditation standards to maintain quality in clinical and laboratory components of practice, including benchmarking of survival outcomes. Since the last edition, the COVID-19 pandemic has affected clinical decision making and activity across indications. Although the full impact of the pandemic is yet to be determined, we recommend that decision making across indications is delivered with ongoing reference to EBMT and national COVID-19 guidance, in accordance with current local conditions.
