International journal for quality in health care : journal of the International Society for Quality in Health Care最新文献

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Evolution and national benchmarking of patient safety culture in a newly established hospital: a two-year repeated cross-sectional study. 新成立医院患者安全文化的演变和国家基准:一项为期两年的重复横断面研究。
IF 2.2
ShouYung Huang, Jim C Huang
{"title":"Evolution and national benchmarking of patient safety culture in a newly established hospital: a two-year repeated cross-sectional study.","authors":"ShouYung Huang, Jim C Huang","doi":"10.1093/intqhc/mzag171","DOIUrl":"https://doi.org/10.1093/intqhc/mzag171","url":null,"abstract":"<p><strong>Background: </strong>Patient safety culture is a fundamental component of healthcare quality, yet empirical evidence on how it evolves during the early life cycle of newly established hospitals remains limited. This study aimed to examine changes in patient safety culture over the first two years of operation of a newly established hospital and to benchmark its performance against national reference data.</p><p><strong>Methods: </strong>A repeated cross-sectional study was conducted in a newly established regional hospital in Taiwan. Hospital-wide surveys using the Safety Attitudes Questionnaire (SAQ-Taiwan) were administered during the first year (2024, n = 361) and second year (2025, n = 781) of operation. Differences in eight safety culture dimensions were analysed using independent-samples t-tests and Cohen's d effect sizes. Multivariable linear regression analyses were additionally conducted to estimate the adjusted year effect after controlling for sex, professional role, hospital tenure, work unit, and supervisory role. Results from the second year were benchmarked against national norms published by the Joint Commission of Taiwan.</p><p><strong>Results: </strong>Mixed trends were observed across the two years. Significant improvements occurred in working conditions (d = 0.18) and work-life balance (d = 0.17). Conversely, job satisfaction (d = -0.14), perception of management (d = -0.13), and stress recognition (d = -0.20) declined significantly. After adjusting for workforce composition differences, improvements in working conditions and work-life balance remained statistically significant, while the decline in perception of management was attenuated, suggesting partial confounding by changes in staff composition. Despite these declines, Year 2 performance remained broadly within the national interquartile range across most dimensions.</p><p><strong>Conclusion: </strong>Safety culture in a new hospital evolves dynamically. While infrastructure maturation may improve working conditions, rapid expansion was associated with an unadjusted decline in job satisfaction and stress recognition, though only the latter remained significant after adjustment. Early investment in systems may mitigate the \"liability of newness,\" but sustained cultural reinforcement is essential for long-term resilience.</p>","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149229828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Feeling safe is not the same as being safe: a question of construct validity. 感觉安全并不等同于安全:这是一个构念效度的问题。
IF 2.2
Andi Ratu Boelqiah Assaad, Wahyu Nisawati Mafrukha, Silmi Fadhila Ihsani, Raisa Zuhra Salsabila Awaluddin, Raup Padillah
{"title":"Feeling safe is not the same as being safe: a question of construct validity.","authors":"Andi Ratu Boelqiah Assaad, Wahyu Nisawati Mafrukha, Silmi Fadhila Ihsani, Raisa Zuhra Salsabila Awaluddin, Raup Padillah","doi":"10.1093/intqhc/mzag172","DOIUrl":"https://doi.org/10.1093/intqhc/mzag172","url":null,"abstract":"","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149225661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rethinking Surgical Governance Through Structured Prospective Challenge. 通过结构化前瞻性挑战重新思考手术治理。
IF 2.2
Mohamed Alkashty
{"title":"Rethinking Surgical Governance Through Structured Prospective Challenge.","authors":"Mohamed Alkashty","doi":"10.1093/intqhc/mzag168","DOIUrl":"https://doi.org/10.1093/intqhc/mzag168","url":null,"abstract":"","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149225665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmaceutical company payments to medical school deans and university hospital directors in Japan: a nationwide cross-sectional study. 制药公司向日本医学院院长和大学医院院长支付的费用:一项全国性的横断面研究。
IF 2.2
Keita Shimizu, Akemi Hara, Piotr Ozieranski, Ivan D Florez, Yangqin Xun, Janne Estill, Yaolong Chen, Yudai Kaneda, Tetsuya Tanimoto, Akihiko Ozaki
{"title":"Pharmaceutical company payments to medical school deans and university hospital directors in Japan: a nationwide cross-sectional study.","authors":"Keita Shimizu, Akemi Hara, Piotr Ozieranski, Ivan D Florez, Yangqin Xun, Janne Estill, Yaolong Chen, Yudai Kaneda, Tetsuya Tanimoto, Akihiko Ozaki","doi":"10.1093/intqhc/mzag170","DOIUrl":"https://doi.org/10.1093/intqhc/mzag170","url":null,"abstract":"<p><strong>Background: </strong>Financial relationships between pharmaceutical companies and the leaders of academic medical institutions may generate institutional conflicts of interest, yet payments to medical school deans and university hospital directors have not been examined nationally. We assessed the magnitude, concentration, and specialty pattern of pharmaceutical company payments to the leaders of all Japanese academic medical centres.</p><p><strong>Methods: </strong>In this nationwide cross-sectional study, we identified the deans and main-hospital directors of all 82 universities with a medical school in Japan for fiscal year 2023 (82 deans and 84 directors). Using payment disclosures from companies affiliated with the Japan Pharmaceutical Manufacturers Association, we aggregated personal payments (lecture, manuscript, and consulting fees) to each leader and described their amount, concentration, and distribution by specialty and payment category.</p><p><strong>Results: </strong>Overall, 67 of 82 deans (81.7%) and 77 of 84 hospital directors (91.7%) received payments. Total payments were US$901,128 for deans (median US$4,894) and US$1,843,565 for directors (median US$14,031). Payments were highly concentrated: the top decile of recipients accounted for 43.9% (deans) and 36.4% (directors) of the total, and lecture fees comprised 85.2% and 88.5% of payments, respectively. The highest-paid specialties were orthopaedic surgery, urology, and pharmacology among deans, and respiratory medicine, urology, and haematology among directors.</p><p><strong>Conclusion: </strong>Pharmaceutical payments to the leaders of Japanese academic medical centres were common, substantial, and concentrated among a small number of individuals and specialties, supporting the case for prohibiting personal promotional payments to institutional leaders while they hold office, with public disclosure as a minimum floor rather than an endpoint.</p>","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149225649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Challenges and opportunities with adapting international health care quality indicators to local contexts: A descriptive case study. 使国际卫生保健质量指标适应当地情况的挑战和机遇:一个描述性案例研究。
IF 2.2
Isabelle Vedel, Deniz Cetin-Sahin, Geneviève Arsenault-Lapierre, Clara Bolster-Foucault, Marwa Ilali, Amélie Quesnel-Vallée
{"title":"Challenges and opportunities with adapting international health care quality indicators to local contexts: A descriptive case study.","authors":"Isabelle Vedel, Deniz Cetin-Sahin, Geneviève Arsenault-Lapierre, Clara Bolster-Foucault, Marwa Ilali, Amélie Quesnel-Vallée","doi":"10.1093/intqhc/mzag165","DOIUrl":"https://doi.org/10.1093/intqhc/mzag165","url":null,"abstract":"<p><strong>Background: </strong>International quality of care indicators provide a common framework for interoperability among different health care systems. We aimed to demonstrate the challenges and opportunities with adapting such quality indicators through the case of adapting the International Consortium for Health Outcomes Measurement (ICHOM) set of patient-centered outcome measures for older persons to the context of Canada.</p><p><strong>Methods: </strong>In this descriptive case study, we purposefully recruited diverse stakeholders. Adapting a nominal group technique, we conducted group discussions to identify additional aspects deemed important for the context and needed to be added to the ICHOM. Transcripts were thematically analyzed to describe challenges and opportunities with adapting the ICHOM.</p><p><strong>Results: </strong>Four older persons, seven clinicians, five health managers, and four decision-makers participated. Four emerging themes indicated that the ICHOM set for older persons was: 1) focusing on the negative aspects of care, suggesting an opportunity to have a positive perspective and strength-based approach; 2) omitting equity in care delivery, which should be across all domains; 3) disease-centered while a holistic approach was preferable; and 4) primarily descriptive although it is key to generating action plans. Ageing in place-helping older persons remain in the communities through integrated care-was viewed as the optimal outcome.</p><p><strong>Conclusion: </strong>International quality of care indicators are excellent starting points, but care must be taken to adapt them for use in local contexts. Social norms, relationships between users and health care providers, trust in health and social care systems, and contextual values are important factors to situate the quality indicators in an action-oriented context.</p>","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149198726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Understanding Workplace Violence in Healthcare: Insights from an Eight-Year Case Study in a Swiss Hospital Network. 了解医疗保健中的工作场所暴力:来自瑞士医院网络八年案例研究的见解。
IF 2.2
Angela Greco
{"title":"Understanding Workplace Violence in Healthcare: Insights from an Eight-Year Case Study in a Swiss Hospital Network.","authors":"Angela Greco","doi":"10.1093/intqhc/mzag166","DOIUrl":"https://doi.org/10.1093/intqhc/mzag166","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Workplace violence against healthcare workers is a growing concern worldwide, with consequences for staff well-being, care quality, and patient safety. However, longitudinal evidence from hospital networks remains limited, and few studies have used statistical process control-informed visual methods to monitor trends over time. This study examined whether reported aggression trends showed distinct temporal patterns across a Swiss public hospital network and whether such patterns could generate hypotheses regarding potentially associated organizational and contextual factors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a retrospective observational study of reported aggressions toward healthcare staff across the Ente Ospedaliero Cantonale (EOC), the public hospital network of southern Switzerland, over an eight-year period (2017-2024). Data were extracted from the network's internal quality and occupational safety reporting platform. Two standardized indicators were calculated annually for each hospital: aggressions per 1,000 inpatient days and aggressions per 1,000 discharges. Individual control charts with boundaries at ± 1, ±2, and ±3 standard deviations were used to examine temporal patterns, complemented by exploratory simple linear regression to estimate overall linear trends across the full network, the network excluding Locarno Hospital (ODL), and ODL alone.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Across the network, reported aggressions showed an overall upward pattern, with the highest levels recorded in 2024. When standardized by inpatient activity and discharges, both indicators showed increasing trajectories at network level. In contrast, at ODL aggression rates increased from 2018 to 2021, followed by consecutive annual decreases through 2024. Aggressions per 1,000 inpatient days decreased from 1.32 in 2021 to 0.78 in 2024. This temporal pattern differed from the continuing upward pattern observed across the rest of the network. Exploratory linear regression over the full 2017-2024 period did not show statistically significant overall linear trends at ODL. Most reported incidents in 2022-2024 were perpetrated by patients, nursing staff were the most affected professional group, and geriatric units accounted for the largest proportion of reports.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study extends previous single-hospital evidence by adopting a network-level perspective, a longer observation period, and statistical process control-informed visual methods. The findings suggest that aggression trends may not be uniform across comparable hospital settings. Although causal inference is not possible, the distinct temporal pattern observed at ODL generates hypotheses regarding organizational and contextual factors potentially associated with differences in workplace violence trajectories and warrants further investigation. Continuous monitoring using standardized indicators may support organizational learning, be","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149187807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
When Teamwork Is Not Enough: How Organizational Learning and Continuous Improvement Strengthen the Teamwork-Handoff Relationship in Hospitals. 当团队合作不够时:组织学习和持续改进如何加强医院的团队-交接关系。
IF 2.2
Seung-Hwan Kim
{"title":"When Teamwork Is Not Enough: How Organizational Learning and Continuous Improvement Strengthen the Teamwork-Handoff Relationship in Hospitals.","authors":"Seung-Hwan Kim","doi":"10.1093/intqhc/mzag167","DOIUrl":"https://doi.org/10.1093/intqhc/mzag167","url":null,"abstract":"<p><strong>Background: </strong>Hospital handoffs, including shift changes and transfers across units, are vulnerable points in care delivery where communication failures may lead to information loss and preventable adverse events. Although teamwork is a well‑established driver of handoffs, prior research suggests that its effectiveness varies across organizational contexts. Organizational Learning and Continuous Improvement (OL-CI)-defined by routine review of work processes, testing of changes, and prevention of recurring problems-may strengthen the degree to which teamwork translates into more reliable handoff processes. This study examines whether OL-CI moderates the relationship between teamwork and handoffs in a hospital.</p><p><strong>Methods: </strong>A cross‑sectional dataset of 394 hospital‑unit observations was analyzed using validated composites from the Hospital Survey on Patient Safety Culture Version 2.0 (HSOPS 2.0). Handoffs and Information Exchange served as the dependent variable, Teamwork as the independent variable, and OL-CI as the moderator. All focal variables were mean‑centered and entered into a moderation model using the PROCESS macro (Model 1). Conditional effects were evaluated at low, median, and high levels of OL-CI.</p><p><strong>Results: </strong>The model accounted for 50.7% of the variance in handoff quality. Teamwork demonstrated a significant positive association with handoffs (b = 0.416, p < .001), and OL-CI independently predicted better handoffs (b = 0.458, p < .001). The Teamwork × OL-CI interaction was significant (b = 0.223, p = .004), indicating that OL-CI strengthened the effect of teamwork on the quality of handoffs. Simple‑slope analyses showed a progressively stronger relationship between teamwork and handoffs at low (b = 0.372), median (b = 0.423), and high (b = 0.458) OL-CI levels, demonstrating that teamwork yields greater gains in units with stronger OL-CI practices.</p><p><strong>Conclusion: </strong>The findings indicate that teamwork contributes to higher-quality handoffs, with greater benefits in organizations that support continuous learning and improvement. To promote reliable handoffs, hospitals should combine teamwork development and structured handoff tools with established practices for process review, recurring feedback, and the prevention of repeated communication failures. Longitudinal research is recommended to clarify these relationships and determine which organizational practices are most effective in sustaining high-quality handoffs over time.</p>","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149187841","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Waiting for elective orthopaedic surgery: A qualitative scoping review of the patient experience. 等待择期骨科手术:患者经验的定性范围审查。
IF 2.2
Elizabeth Walkley, Katheryn Hall, Dannielle Hopkinson, Mina Nichols-Boyd, Elise Williams, Nicole Pope
{"title":"Waiting for elective orthopaedic surgery: A qualitative scoping review of the patient experience.","authors":"Elizabeth Walkley, Katheryn Hall, Dannielle Hopkinson, Mina Nichols-Boyd, Elise Williams, Nicole Pope","doi":"10.1093/intqhc/mzag164","DOIUrl":"https://doi.org/10.1093/intqhc/mzag164","url":null,"abstract":"<p><strong>Background: </strong>Public health waiting lists for elective or planned orthopaedic surgery are increasing to the point where demand far exceeds our ability to treat. This is largely due to ageing populations, rising obesity and the continued impact of delays caused by the COVID-19 pandemic. While waiting, patients suffer debilitating physical pain, functional limitation, social isolation and associated mental health impacts while some are unable to work. This qualitative scoping review explored and mapped the experiences of patients of waiting for elective or planned orthopaedic surgery.</p><p><strong>Methods: </strong>This review was conducted according to the Joanna Briggs Institute Scoping Review methodology and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews. A comprehensive database search was conducted to identify English language articles from 2009 until June 2025. Data extraction was informed by the Standards for Reporting Qualitative Research. Results were thematically analysed and presented using the Quality Health Outcomes Model.</p><p><strong>Results: </strong>The initial search identified 4713 articles, of which, 21 manuscripts met inclusion criteria. The 21 articles comprised 17 primary qualitative research studies and four review articles published within the designated time period (2009 to 2025). Two key themes were identified: 1. Patients waiting for elective orthopaedic surgery need psychosocial support and 2. System-level, multi-factorial communication issues with the waiting list leave patients feeling lost between primary and specialist care. These themes suggest that the challenges faced due to lengthy elective surgery waiting lists are not simply a capacity issue, but also a challenge of coordinated, patient- centred care.</p><p><strong>Conclusion: </strong>Waiting for surgery is consistently described by patients as a source of anxiety and distress. With waiting list times for elective surgery increasing, the experience can be improved in part with adequate communication from healthcare providers. A re-focus on what matters most to the patient and their family is required in order to deliver adequate patient-centred care while patients wait for surgery.</p>","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149168107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Healthcare Workflow Interventions to Reduce Delays in Urological Care: A Systematic Review. 医疗工作流程干预减少泌尿科护理延误:系统回顾。
IF 2.2
Rafaela Rosalba de Mendonça, Marcello Perez Marques de Azevedo, Maria Claudia Bicudo, João Paulo Zambon
{"title":"Healthcare Workflow Interventions to Reduce Delays in Urological Care: A Systematic Review.","authors":"Rafaela Rosalba de Mendonça, Marcello Perez Marques de Azevedo, Maria Claudia Bicudo, João Paulo Zambon","doi":"10.1093/intqhc/mzag163","DOIUrl":"https://doi.org/10.1093/intqhc/mzag163","url":null,"abstract":"<p><strong>Background: </strong>Delays in urological care can increase symptom burden, defer diagnosis and treatment, and reduce the efficiency of outpatient and surgical pathways. This review evaluated organisational interventions intended to improve patient flow and timely access to urological care.</p><p><strong>Methods: </strong>PubMed/MEDLINE, Cochrane CENTRAL, Web of Science, and Lens.org were searched for English-language studies published from 1 January 2020 to 25 July 2026. Two reviewers independently screened records and appraised methodological and reporting quality. Because interventions, designs, and outcomes were heterogeneous, findings were synthesized narratively. Reference-list (citation) searching identified additional eligible primary studies. The four-source search was rerun on 25 July 2026 and all retrieved records were re-screened against the prespecified eligibility criteria.</p><p><strong>Results: </strong>Twenty studies met the intervention eligibility criteria and were included in the synthesis; two further studies reporting patient experience without an implemented intervention are summarised separately as contextual evidence. Interventions were grouped into six domains: workforce redesign, fast-track pathways and service redesign, digital health and monitoring, surgical scheduling optimisation, waiting-list management, and system-level prioritisation. The largest reported improvements followed pathway redesign and active list management, including a decrease in urgent-referral waiting time from 59.0 to 21.6 days and a 76% reduction in patients waiting at least 12 months. Methodological and reporting quality scores ranged from 24 to 35 of 39 (mean 29.0); individual ratings and methodological concerns are provided in the supplementary material. Patient experience and long-term sustainability were infrequently measured. Several included studies were pandemic-specific, limiting direct generalisation to routine delivery.</p><p><strong>Conclusion: </strong>Workflow interventions can reduce delays in urological care, particularly when they combine explicit triage rules, protected capacity, workforce redesign, and active queue management. However, heterogeneous designs, limited patient-reported outcomes, and short follow-up reduce certainty about comparative effectiveness and sustainability.PROSPERO registration: CRD420261377822.</p>","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149169923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preparing HSCT and CAR‑T Therapy Programmes for JACIE Inspection: A Structured Methodological Approach to Implementing a Quality Management System. 为JACIE检查准备HSCT和CAR - T治疗方案:实施质量管理体系的结构化方法。
IF 2.2
Dimitrios Bourantas, Carlos Panizo
{"title":"Preparing HSCT and CAR‑T Therapy Programmes for JACIE Inspection: A Structured Methodological Approach to Implementing a Quality Management System.","authors":"Dimitrios Bourantas, Carlos Panizo","doi":"10.1093/intqhc/mzag162","DOIUrl":"https://doi.org/10.1093/intqhc/mzag162","url":null,"abstract":"<p><strong>Background: </strong>Certification by the Joint Assurance Committee of the International Society for Cell & Gene Therapy and the European Society for Blood and Marrow Transplantation (JACIE) is a key mechanism for strengthening quality, safety, and organisational performance in haematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor T (CAR‑T) therapy Programmes. However, practical guidance on implementing a JACIE‑aligned quality management system (QMS) and preparing Programmes for inspection remains limited. We present a structured methodology, developed and implemented within our Programme, to support HSCT and CAR‑T therapy Programmes in achieving inspection readiness while establishing a sustainable QMS that promotes continuous quality improvement.</p><p><strong>Methods: </strong>We developed and implemented a stepwise approach based on the Plan-Do-Check-Act cycle. It encompasses Programme mapping and regulatory alignment, implementation of core QMS components across the Collection, Processing, and Clinical areas, and QMS maintenance and inspection readiness, culminating in JACIE inspection with subsequent corrective actions. Key elements include process mapping, standard operating procedures, personnel competency, quality indicators, incident and deviation management, audits, validations and qualifications, product traceability, data submission, change control and risk assessment, feedback mechanisms, document management, and structured QMS review.</p><p><strong>Results: </strong>The framework was successfully implemented within our HSCT and CAR‑T therapy Programme, establishing a unified JACIE-aligned QMS across the Collection, Processing, and Clinical areas. It strengthened governance, multidisciplinary coordination, and standardisation of quality management activities, providing an approach applicable to both initial JACIE accreditation and subsequent reaccreditation.</p><p><strong>Conclusion: </strong>This structured methodology provides a practical and scalable framework for implementing and maintaining a JACIE-aligned QMS in HSCT and CAR-T therapy Programmes, supporting inspection readiness, multidisciplinary coordination, and the safety of patients, donors, and hematopoietic cellular therapy products. JACIE certification and its associated QMS should be viewed not as the endpoint of quality management but as part of an ongoing process of organisational learning and continuous quality improvement.</p>","PeriodicalId":520651,"journal":{"name":"International journal for quality in health care : journal of the International Society for Quality in Health Care","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149122632","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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