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Evaluating a hospital’s carbon footprint – A method using energy, materials and financial data 评估医院的碳足迹——一种使用能源、材料和财务数据的方法
Pub Date : 2022-11-27 DOI: 10.5430/jha.v11n2p33
B. X. Lum, Hubert M. Tay, Rachel X. Phang, Steven B. Tan, E. H. Liu
Background: Healthcare systems have to prepare for climate change’s health impact, while reducing healthcare’s contribution to global warming. Most evaluations of healthcare’s greenhouse gas emissions involve national level methodologies.Objective: As sustainability metrics become a key factor in hospital management, the paper describes a method for quantifying emissions at a large tertiary care hospital in Singapore.Methods: Hospital operational and financial data was used to determine the greenhouse gas effect of the hospital. Emission factors from government and academic sources were used for on-site and purchased energy emissions. Spend based emission factors from the environmentally-extended multiregional input-output (EE-MRIO) Eora database were used for other indirect emissions. This provided the total carbon footprint across the various scopes.Results:The hospital had an annual carbon footprint of 245,962 tonnes of carbon dioxide equivalents (CO2e). Scope 1 emissions accounted for 4,223 tonnes of CO2e, scope 2 for 38,380 tonnes of CO2e and scope 3 for 165,190 tonnes of CO2e. Operating carbon totalled 207,793 tonnes of CO2e, and 38,169 tonnes of scope 3 CO2e was attributed to capital expenditure projects. Medical equipment, pharmaceutical supplies and electricity were the largest contributors to the hospital’s carbon footprint.Conclusions: Identifying key areas contributing to emissions can enable targeted approaches in reducing a hospital’s carbon footprint, better preparing the hospital as the carbon economy evolves to include the healthcare sector.
背景:卫生保健系统必须为气候变化对健康的影响做好准备,同时减少卫生保健对全球变暖的影响。对卫生保健温室气体排放的大多数评估涉及国家一级的方法。目标:随着可持续发展指标成为医院管理的关键因素,本文描述了一种量化新加坡一家大型三级医院排放的方法。方法:采用医院运营和财务数据对医院温室气体效应进行分析。来自政府和学术来源的排放因子用于现场和购买的能源排放。从环境扩展的多区域投入产出(EE-MRIO) Eora数据库中获得的基于支出的排放因子用于其他间接排放。这提供了不同范围内的总碳足迹。结果:该医院每年的碳足迹为245,962吨二氧化碳当量(CO2e)。范围1的排放量为4,223公吨二氧化碳当量,范围2的排放量为38,380公吨二氧化碳当量,范围3的排放量为165,190公吨二氧化碳当量。运营碳排放总量为207,793吨二氧化碳当量,第三类二氧化碳当量的38,169吨归因于资本支出项目。医疗设备、医药用品和电力是该医院碳足迹的最大贡献者。结论:确定导致排放的关键领域可以使有针对性的方法减少医院的碳足迹,使医院在碳经济发展到包括医疗保健部门时更好地做好准备。
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引用次数: 0
Queuing management study at the Multidisciplinary Anesthesia and Intensive Care Clinic of CNHU-HKM in April 2022 2022年4月我校多学科麻醉重症监护门诊排队管理研究
Pub Date : 2022-11-22 DOI: 10.5430/jha.v11n2p25
C. P. Makoutodé, T. Nougbode, C. Sossa-Jérôme, G. Sopoh
Objective: Constant availability of inpatient beds in an intensive care unit (ICU) is part of the resilience of health systems, especially in an emergency context, namely in public health. This study aims to appraise the management of inpatient waiting lines in the ICU of Hubert Koutoukou Maga National Hospital and University Center (CNHU-HKM) in Benin, in March-April 2022.Methods: This was an analytic cross-sectional study of inpatients or their relatives and staff, selected by convenience and reasoned choice, respectively, carried out from March 21 to April 15, 2022. Logistic regression was used to identify associated factors with queues management.Results: Altogether 55 patients were surveyed. On a daily basis, 13 ± 1 patients were hospitalized in 18 functional beds for 3 ± 1 admissions and 3 ± 1 discharges. The average bed occupancy rate was 89.8% ± 3.8%; the average waiting time before patient care was 3.6 ± 1.2 minutes and the traffic intensity were 0.03. Per hour, the odds of having a patient were 33.29%, with a 97% chance of a bed being occupied. The probability that an admitted patient would spend a whole week there was 37%. Only patient arrival flow was significantly associated with insufficient queuing management. There was also a lack of inpatient beds and technical boards. The construction of two wards and the installation of seven additional beds could improve queues management.Conclusions: The management of AF in our study site depends mainly on the daily flow of arriving patients, but also on the number of available hospital beds, the working organization and the existing technical and structural measures. Addressing these parameters will significantly improve the situation.
目标:重症监护病房(ICU)住院床位的持续供应是卫生系统复原力的一部分,特别是在紧急情况下,即在公共卫生方面。本研究旨在评估2022年3 - 4月贝宁休伯特库图库马加国立医院和大学中心(CNHU-HKM) ICU住院候诊队列的管理情况。方法:采用横断面分析方法,于2022年3月21日至4月15日对住院患者或其家属和工作人员分别进行方便选择和合理选择。采用逻辑回归方法确定与队列管理相关的因素。结果:共调查55例患者。每日18张功能床住院13±1例,入院3±1例,出院3±1例。平均床位入住率为89.8%±3.8%;就诊前平均等待时间为3.6±1.2分钟,交通强度为0.03。每小时有病人的几率是33.29%,而床位被占用的几率是97%。住院病人在那里待上整整一周的概率是37%。只有患者到达流量与排队管理不足显著相关。医院也缺少住院床位和技术委员会。新建两个病房和增加七张床位可以改善排队管理。结论:本研究区房颤的管理主要取决于每日到达的患者流量,还取决于可用病床数量、工作组织和现有的技术和结构措施。处理这些参数将大大改善这种情况。
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引用次数: 0
Implications of Current Procedural Terminology code accuracy on surgical workflow and financial reimbursement 现行程序术语代码准确性对手术工作流程和财务报销的影响
Pub Date : 2022-10-25 DOI: 10.5430/jha.v11n2p18
Malcolm Su, L. Leonard, David Marchant, Jeniann A. Yi, E. Cumbler, R. Meguid, J. Kutner, K. Colborn, Brent Rikhoff, S. Tevis
Objective: Inaccuracies in Current Procedural Terminology (CPT) coding entries for surgical procedures have a profound impact on hospital systems and surgeon compensation for services. We sought to characterize the variations of surgical CPT entry at a multi-site academic medical center and estimate the financial burden implicated by improper code entry.Methods: A mixed methods study was conducted to evaluate variations in CPT entry across an academic center. Semi-structured interviews with 8 surgical schedulers were conducted and analyzed to understand the current scheduling process. Coding data for surgical procedures performed within a 31-day period during September and October 2020 within the large healthcare system were assessed for appropriate CPT code entry. Reimbursement for the 2020 fiscal year was then analyzed to determine the impact of pre-operative CPT code accuracy on reimbursements and denials.Results: Interviews revealed a lack of standardization in the surgical scheduling process across the hospital system. Lack of standardized onboarding and variations in workflow contributed to difficult cross coverage for schedulers and errors in CPT entry. On quantitative analysis, the accuracy of pre-operative CPT code entry was poor with only 59.3% of pre-operative CPT code entries being correct. In the 2020 fiscal year, $5.4 million was lost due to problems related to CPT code entry.Conclusions: Variations and lack of standardization in CPT code entry can greatly contribute to financial losses and disrupt surgical scheduling. Standardization of workflow and CPT entry schemes can help minimize scheduling complications and enhance the quality of care provided to patients.
目的:当前外科手术术语(CPT)编码条目的不准确性对医院系统和外科医生的服务报酬产生了深远的影响。我们试图在一个多地点的学术医疗中心描述外科CPT输入的变化,并估计不适当的代码输入所涉及的经济负担。方法:采用一种混合方法进行研究,以评估跨学术中心CPT进入的变化。对8名手术调度人员进行了半结构化访谈,并对其进行了分析,以了解当前的调度流程。评估了2020年9月至10月31天内大型医疗保健系统内进行的外科手术的编码数据,以确定适当的CPT编码输入。然后分析2020财年的报销情况,以确定术前CPT代码准确性对报销和拒绝的影响。结果:访谈显示在整个医院系统的手术调度过程缺乏标准化。缺乏标准化的入职和工作流程中的变化导致了调度程序的难以交叉覆盖和CPT输入中的错误。定量分析,术前CPT码录入准确率较差,术前CPT码录入正确率仅为59.3%。在2020财年,由于与CPT代码输入相关的问题,损失了540万美元。结论:CPT编码输入的变化和缺乏标准化会极大地造成经济损失并扰乱手术计划。工作流程和CPT入职方案的标准化可以帮助最大限度地减少调度并发症并提高向患者提供的护理质量。
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引用次数: 0
Restorative just culture significantly improves stakeholder inclusion, second victim experiences and quality of recommendations in incident responses 恢复性公正文化显著提高了利益相关者的包容性、第二受害者的经历和事件响应中建议的质量
Pub Date : 2022-10-19 DOI: 10.5430/jha.v11n2p8
K. Turner, Jerneja Sveticic, D. Grice, M. Welch, Catherine King, Jennifer L. Panther, Claire Strivens, Brad Whitfield, Geoffrey Norman, A. Almeida-Crasto, Tamirin Darch, Nicolas J. C. Stapelberg, S. Dekker
Objective: Matching safety and quality improvements to the complexity of healthcare, Gold Coast Mental Health and Specialist Services implemented a new response to clinical incidents: the Gold Coast Clinical Incident Response Framework (GC-CIRF). It utilises a Restorative Just Culture (RJC) framework and Safety II principles. This paper evaluates its impact.Methods: Staff surveys measured perceptions of just culture and second victim experiences. Quality of recommendations were compared before and after implementation. For the 19 incidents that occurred after the implementation of GC-CIRF, audits of the review processes were undertaken, measuring several components.Results: Results show significant improvement in staff perceptions of just culture and second victim experiences. Review of incident review data showed several shifts in line with Safety II and RJC. The process audit demonstrated inclusion of a broad range of stakeholders, and significant improvements in the quality and strength of recommendations.Conclusions: Embedding RJC and Safety II concepts into the incident review process is associated with improved measures of culture and review outputs. The integration of Safety II concepts and support of cultural shifts will require further work and committed leadership at all levels.
目的:与医疗保健的复杂性相匹配的安全和质量改进,黄金海岸心理健康和专家服务部实施了一项新的临床事件响应措施:黄金海岸临床事件响应框架(GC-CIRF)。它采用恢复性公正文化(RJC)框架和安全II原则。本文评价了其影响。方法:员工调查测量了对公正文化和第二次受害者经历的看法。比较建议实施前后的质量。对于GC-CIRF实施后发生的19起事件,对审查过程进行了审计,测量了几个组成部分。结果:结果显示员工对公正文化和第二次受害者经历的看法有显著改善。对事故回顾数据的回顾显示了符合Safety II和RJC的几次转变。过程审计显示了广泛的利益相关者的参与,并在建议的质量和力度方面有了重大改进。结论:在事件评审过程中嵌入责任责任和安全II的概念与文化和评审产出的改进措施有关。安全II概念的整合和文化转变的支持将需要进一步的工作和各级坚定的领导。
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引用次数: 2
From pandemic to endemic: A comparison of first, second, and third waves of COVID-19 for applicability in communicable disease management 从大流行到地方性流行:第一波、第二波和第三波COVID-19在传染病管理中的适用性比较
Pub Date : 2022-08-09 DOI: 10.5430/jha.v11n2p1
K. Kennedy, Gregory N Orewa, A. G. Hall, Sue S. Feldman, F. Zengul, T. Peters, Kristine R. Hearld
Background: The COVID-19 pandemic created pressure on healthcare systems worldwide. Hospitals have developed strategies to efficiently address the demand for inpatient beds.Objective: This paper examines changes in length of stay at a southern academic medical center and documents the intervention efforts aimed at providing high quality care and reduced lengths of stay.Methods: Data include 3,279 patients receiving inpatient treatment for COVID-19 between March 29, 2020, and October 31, 2021. The study data mirrors the three major waves of COVID-19 pandemic in Alabama as reported in Johns Hopkins’ coronavirus resource center. To account for the chronological change in care processes, we interviewed Hospitalists and categorized the interventions by month, June 2020-February 2021. We examined changes in average length of stay and differences in sociodemographic characteristics among the three waves using ANOVA and chi-square tests. Socio demographic factors analyzed include age, gender, race/ethnicity, marital status, and insurance.Results: The average length of stay, ICU admissions, and 30-day readmissions each decreased in the second and third waves compared to the first wave. Statistically significant differences were found for ICU admission, age, and insurance for hospitalized patients among waves.Conclusions: This study contributes to the COVID-19 literature by providing the chronological evolution of ALOS and interventions during the pandemic by highlighting the case of a southern academic medical center.
背景:2019冠状病毒病大流行给全球卫生保健系统带来了压力。医院制定了有效解决住院床位需求的战略。目的:本文考察了在南方学术医疗中心停留时间的变化,并记录了旨在提供高质量护理和缩短停留时间的干预措施。方法:数据包括2020年3月29日至2021年10月31日期间接受COVID-19住院治疗的3279例患者。该研究数据反映了约翰霍普金斯大学冠状病毒资源中心报告的阿拉巴马州COVID-19大流行的三波主要浪潮。为了解释护理过程的时间顺序变化,我们采访了医院医生,并按月(2020年6月至2021年2月)对干预措施进行了分类。我们使用方差分析和卡方检验检验了三次浪潮中平均停留时间的变化和社会人口学特征的差异。分析的社会人口因素包括年龄、性别、种族/民族、婚姻状况和保险。结果:与第一波相比,第二波和第三波患者的平均住院时间、ICU入院次数和30天再入院次数均有所下降。各波间住院患者的ICU入院、年龄、保险情况差异有统计学意义。结论:本研究通过突出南方学术医疗中心的案例,提供了疫情期间ALOS和干预措施的时间演变,为COVID-19文献做出了贡献。
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引用次数: 0
Impact of a Teletriage program on left without being seen rates and cost 电视分诊计划对左侧不可见的影响的费率和成本
Pub Date : 2022-07-03 DOI: 10.5430/jha.v11n1p35
Andrea Blome, S. Anderson, Mandy Middlebrook-Lovett, Jon Michael Cuba, Jeffrey Kuo, NICHOLAS P. Gorham, Lauren Defrates, N. McCoin
Objective: Emergency Departments (EDs) experience throughput constraints for various reasons, such as space, resources, staffing, and bed placement. These throughput constraints are known to increase the volume of patients who leave without being evaluated. TeleTriage is a method implemented shortly after the arrival of the patient to the ED, as a means to expedite evaluation of patients. The project aimed to implement a TeleTriage program and analyze any impact on Left Without Being Seen (LWBS) rates and cost.Methods: A TeleTriage program was developed within a large, nonprofit, academic health care delivery system. The program was piloted at several campuses and subsequently implemented at multiple sites within the health system. Data on LWBS rates were collected for patients evaluated by the TeleTriage process and those who were not. An analysis of staffing utilization and cost-savings was also performed.Results: The TeleTriage program resulted in an average LWBS rate of 0.12% post-implementation, versus 0.79% for patients who were not in the TeleTriage group. In addition, the staffing consolidation resulted in cost-savings.Conclusions: The use of a TeleTriage program results in decreased LWBS rates, as well as cost-savings.
目的:急诊科(ed)由于各种原因(如空间、资源、人员配置和床位安排)经历吞吐量限制。已知这些吞吐量限制会增加未经评估就离开的患者数量。远程分诊是在病人到达急诊科后不久实施的一种方法,作为一种加快对病人评估的手段。该项目旨在实施TeleTriage计划,并分析其对“无人看护”(LWBS)费率和成本的影响。方法:在一个大型的、非营利性的、学术性的卫生保健服务系统中开发了一个远程分诊计划。该计划在几个校园进行了试点,随后在卫生系统内的多个地点实施。收集了通过TeleTriage过程评估的患者和未接受TeleTriage过程评估的患者的LWBS率数据。还对工作人员的利用和节省费用进行了分析。结果:TeleTriage项目实施后的平均LWBS率为0.12%,而非TeleTriage组的患者为0.79%。此外,合并工作人员也节省了费用。结论:TeleTriage程序的使用降低了LWBS率,并节省了成本。
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引用次数: 0
Critical care resources, disaster preparedness, and sepsis management: Survey results from the Asia Pacific region 重症监护资源、备灾和败血症管理:来自亚太地区的调查结果
Pub Date : 2022-07-03 DOI: 10.5430/jha.v11n1p23
Ashwani Kumar, B. Abbenbroek, N. Hammond, B. Vijayaraghavan, Lowell Ling, L. Thwaites, S. Myatra, S. Finfer
There is paucity of data on critical care resources, disaster preparedness, and sepsis management in countries within the Asia Pacific region. An online survey was conducted from 15 April to 17 July 2020. Snowball sampling through the Asia Pacific Sepsis Alliance and network contacts was used to recruit respondents. Countries were grouped according to the World Bank Country Income 2019 classification into lower-middle income (LMIC), upper-middle income (UMIC), and high-income (HIC). Survey questions addressed to hospital characteristics, critical care resources, disaster preparedness, and sepsis management. In total, 59 hospitals from 15 countries responded (33 LMICs, 8 UMICs, 18 HICs) with most responses from the Philippines (10; 16.9%). Median [Inter-quartile range (IQR)] hospital and Intensive Care Unit (ICU) bed capacity was 798 (500–1,001) and 37 (19–59), respectively. Median (IQR) doctor-to-patient and nurse-to-patient day ratios were 1:5 (1:3–1:8) and 1:2 (1:1–1:2), respectively. Availability of 24/7 physiotherapy services, 24/7 Medical resonance Imaging (MRI), point-of-care lactate, and “reserve” antibiotics was limited. Most ICUs had a disaster management plan (88%) and access to Personal Protective Equipment (96%). The most commonly adopted sepsis guideline was the Surviving Sepsis Campaign guidelines (77%). LMIC/UMIC ICUs had lower nurse-to patient ratio and surge capacity along with limited access to 24/7 physiotherapy and MRI services, and interventions like Extra Corporeal Membrane Oxygenation, and Continuous Renal Replacement Therapy. Self-reported adoption and adherence to sepsis guidelines was higher in LMICs/UMICs than HICs. In the Asia Pacific region, critical care resources, disaster preparedness and management of sepsis vary considerably between countries across different income categories. In particular, low surge and isolation capacity in LMICs highlights the need for better health service planning and preparation.
亚太地区各国缺乏关于重症监护资源、备灾和败血症管理的数据。2020年4月15日至7月17日进行了一项在线调查。通过亚太败血症联盟和网络联系人进行雪球抽样来招募受访者。根据世界银行2019年国家收入分类,将各国分为中低收入(LMIC)、中高收入(UMIC)和高收入(HIC)。调查问题涉及医院特点、重症监护资源、灾难准备和败血症管理。总共有来自15个国家的59家医院做出了答复(33个中低收入国家,8个中低收入国家,18个高收入国家),其中大多数答复来自菲律宾(10家;16.9%)。医院和重症监护病房(ICU)床位容量的中位数[四分位数间距(IQR)]分别为798(500 - 1001)和37(19-59)。中位数(IQR)医生对病人和护士对病人的日比例分别为1:5(1:3-1:8)和1:2(1:1-1:2)。24/7物理治疗服务、24/7医学磁共振成像(MRI)、护理点乳酸盐和“储备”抗生素的可用性有限。大多数icu有灾害管理计划(88%),并可获得个人防护装备(96%)。最常采用的脓毒症指南是生存脓毒症运动指南(77%)。LMIC/UMIC icu的护士与患者比例和激增能力较低,并且获得24/7物理治疗和MRI服务的机会有限,以及诸如体外膜氧合和持续肾脏替代治疗等干预措施。在中低收入/中低收入国家中,自我报告采用和遵守败血症指南的比例高于高收入国家。在亚太地区,不同收入类别的国家在重症监护资源、备灾和败血症管理方面存在很大差异。特别是,中低收入国家的激增和隔离能力较低,突出表明需要更好地规划和准备保健服务。
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引用次数: 0
Implementation of an adverse childhood experiences screening protocol for adults at an outpatient medical psychology practice 在门诊医学心理学实践成人不良童年经历筛查方案的实施
Pub Date : 2022-04-10 DOI: 10.5430/jha.v11n1p8
Jennifer Allain, E. Creel, C. Perry
Objective: Despite an abundance of evidence supporting screening adults for adverse childhood experiences (ACEs), the gap between this knowledge and screening persists. Evidence suggests that screening is warranted, feasible, and desired by patients. This feasibility study aimed to educate and train staff and providers on ACE screening and implement an ACE screening policy and protocol at an outpatient medical psychology practice. The two expected outcomes of this project, provider knowledge after ACE training and provider compliance with the ACE screening protocol, were measured to determine if a clinical practice change occurred.Methods: A quasi-experimental design with a pre-test/post-test was used to determine increases in provider knowledge following an ACEs training intervention. Additionally, post-intervention only data collection was used to determine compliance with ACE screening protocol, to determine practice change and feasibility of continued protocol use.Results: The project results indicated that the implementation of the ACE screening protocol was feasible. Thirty-three adult clients new to the practice completed the ACE screening. Of the 33 clients screened during the 12-week study, 26 clients had an ACE score of three or higher, and 14 (42%) received therapy referrals based on their ACE score after education and discussion by the intake therapist. Weekly chart checks revealed that 100% of clients screened received, at a minimum, the educational packet regarding the impact of ACEs on physical and mental health. The protocol encouraged providers to promote evidence-based interventions to mitigate the potential untoward outcomes associated with ACEs.Conclusions: These findings reflected a change in knowledge based on education and indicated that educational intervention was effective.
目的:尽管有大量证据支持筛查成人的不良童年经历(ace),但这种知识与筛查之间的差距仍然存在。有证据表明,筛查是必要的、可行的,也是患者所希望的。本可行性研究旨在教育和培训工作人员和提供者进行ACE筛查,并在门诊医学心理学实践中实施ACE筛查政策和协议。该项目的两个预期结果,即提供者在ACE培训后的知识和提供者对ACE筛查方案的依从性,被测量以确定临床实践是否发生了变化。方法:采用准实验设计,采用前测/后测来确定ace培训干预后提供者知识的增加。此外,干预后仅收集数据来确定ACE筛查方案的依从性,以确定实践变化和继续使用方案的可行性。结果:项目结果表明ACE筛查方案的实施是可行的。33名初次接触ACE的成年客户完成了ACE筛查。在为期12周的研究中筛选的33名客户中,26名客户的ACE得分为3分或更高,14名(42%)在接受治疗师的教育和讨论后,根据他们的ACE得分接受了治疗推荐。每周的图表检查显示,100%接受筛选的客户至少收到了关于ace对身心健康影响的教育包。该方案鼓励提供者推广基于证据的干预措施,以减轻与ace相关的潜在不良后果。结论:这些发现反映了基于教育的知识变化,表明教育干预是有效的。
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引用次数: 0
Volume-based credentialing: Practical steps to promote high quality, safe care 基于数量的认证:促进高质量、安全护理的实际步骤
Pub Date : 2022-03-16 DOI: 10.5430/jha.v11n1p1
K. Shute, P. Zarone, Erin McCluan
All hospitals engage in credentialing to evaluate the qualifications of practitioners who request clinical privileges. Credentialing always includes verifying an applicant’s education, training, licensure and board certification, and evaluating information provided by references who have worked with the applicant. Far fewer hospitals consider whether a practitioner’s volume of cases is sufficient to demonstrate proficiency in a specialty area. This is surprising, given the well-established relationship in the medical literature between volume and proficiency. The authors identified several reasons for hospitals’ reluctance to use volume-based credentialing. These include the fear of lawsuits by physicians and the practical difficulties of satisfying volume requirements in smaller hospitals with fewer patients. The authors conclude that legal challenges to volume-based credentialing are unlikely to be successful and that techniques exist to enable small hospitals to use volume-based credentialing to promote high quality and safe care.
所有医院都实行资格认证,以评估申请临床特权的执业医师的资格。资格认证通常包括验证申请人的教育、培训、执照和董事会认证,以及评估与申请人一起工作的推荐人提供的信息。很少有医院考虑医生的病例量是否足以证明他在某一专业领域的熟练程度。这是令人惊讶的,因为在医学文献中,数量和熟练程度之间建立了良好的关系。作者指出了医院不愿使用基于数量的认证的几个原因。其中包括害怕医生起诉,以及在病人较少的小医院满足数量要求的实际困难。这组作者的结论是,对基于数量的认证提出的法律挑战不太可能成功,而且现有的技术使小医院能够使用基于数量的认证来促进高质量和安全的护理。
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引用次数: 0
In vitro diagnostic tests: Ensuring test accuracy and patient safety when used as companion diagnostics 体外诊断测试:确保作为辅助诊断使用时测试的准确性和患者的安全性
Pub Date : 2022-03-01 DOI: 10.5430/jha.v10n6p34
U. Ifediora, Wendy Schroeder
Risks associated with drugs and treatments are a key concern in clinical investigations of therapeutics. There is a keen attention to side effects and adverse events included in critical safety documentation presented in regulatory submissions for new drugs. Likewise, Companion Diagnostic (CDx) technology is subject to rigorous regulated research and testing because of the risk associated with a false test result that could affect clinical decisions and treatment. The rigor of testing imposed by the regulatory path to clearance or approval is intended to ensure an assay is reliable when performance criteria are defined by a fixed set of these variables so that there is the least risk of false test results. The clinical validation of these assays is especially important when the test result is used to manage therapeutic decisions for patients. The same patients that expect a clinician to use reliable diagnostics to recommend treatment may also be recruited to participate in CDx clinical investigations. This educational review of CDx product development, regulations, and clinical investigations involving human subjects is important to: (1) Clinicians who rely on the test results to manage patient care; (2) Patients who trust these test results are informing the clinician, and (3) Hospital administrators who oversee human subjects safety and data intergrity for clinical investigations in the personalized medicine space.
与药物和治疗相关的风险是治疗学临床研究中的一个关键问题。对于新药监管机构提交的关键安全文件中包含的副作用和不良事件,人们非常关注。同样,伴随诊断(CDx)技术也受到严格监管的研究和测试,因为错误的测试结果可能会影响临床决策和治疗。审批或批准的监管途径所规定的严格检测旨在确保当性能标准由一组固定的这些变量定义时,检测方法是可靠的,以便将错误检测结果的风险降到最低。当检测结果用于管理患者的治疗决策时,这些检测的临床验证尤为重要。期望临床医生使用可靠的诊断来推荐治疗的患者也可能被招募参加CDx临床调查。这篇关于CDx产品开发、法规和涉及人类受试者的临床研究的教育综述对于:(1)依赖测试结果来管理患者护理的临床医生很重要;(2)信任这些测试结果的患者正在告知临床医生;(3)在个性化医疗领域监督人类受试者安全和临床调查数据完整性的医院管理人员。
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Journal of Hospital Administration
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