Development and implementation of evidence-based laboratory safety management tools for a public health laboratory

Keckler, M. Shannon; Anderson, Kayla N.; McAllister, Sigrid K.; Rasheed, J. Kamile; Noble-Wang, Judith

doi:10.1016/j.ssci.2019.04.003

Cited by 13 publications

(8 citation statements)

References 72 publications

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“…As far as we know, this is the first report of an in-house-developed risk registry and management system optimized for clinical laboratories. Recent studies on ‘risk management’ in the laboratory cover a wide variety of topics, including patient safety issues caused by laboratory errors in the testing process [ 8 ], the application of various risk management tools [ 9 , 11 , 13 ], risk-based quality control plans [ 12 ], incident reporting [ 14 ], and environmental/occupational safety [ 10 ]. The concept of risk management is philosophical, and the scope of risk is quite broad.…”

Section: Discussionmentioning

confidence: 99%

“…Many laboratories have yet to apply effective risk management systems for practical management. Recent studies on ‘risk management’ in the laboratory cover a wide variety of topics, including patient safety issues caused by laboratory errors [ 8 , 9 , 10 , 11 , 12 , 13 , 14 ]; however, they do not provide any practical risk management tool optimized for clinical laboratories. Additionally, there is no commercially available risk management package that can be easily used in the clinical laboratory.…”

Section: Introductionmentioning

confidence: 99%

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Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process

2021

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Background and Objectives: Risk management is considered an integral part of laboratory medicine to assure laboratory quality and patient safety. However, the concept of risk management is philosophical, so actually performing risk management in a clinical laboratory can be challenging. Therefore, we would like to develop a sustainable, practical system for continuous total laboratory risk management. Materials and Methods: This study was composed of two phases: the development phase in 2019 and the application phase in 2020. A concept flow diagram for the computerized risk registry and management tool (RRMT) was designed using the failure mode and effects analysis (FMEA) and the failure reporting, analysis, and corrective action system (FRACAS) methods. The failure stage was divided into six according to the testing sequence. We applied laboratory errors to this system over one year in 2020. The risk priority number (RPN) score was calculated by multiplying the severity of the failure mode, frequency (or probability) of occurrence, and detection difficulty. Results: 103 cases were reported to RRMT during one year. Among them, 32 cases (31.1%) were summarized using the FMEA method, and the remaining 71 cases (68.9%) were evaluated using the FRACAS method. There was no failure in the patient registration phase. Chemistry units accounted for the highest proportion of failure with 18 cases (17.5%), while urine test units accounted for the lowest portion of failure with two cases (1.9%). Conclusion: We developed and applied a practical computerized risk-management tool based on FMEA and FRACAS methods for the entire testing process. RRMT was useful to detect, evaluate, and report failures. This system might be a great example of a risk management system optimized for clinical laboratories.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process

2021

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“…• Строгого учета каждого биоматериала от забора до загрузки на борт лабораторного оборудования, и с сокращением сроков выдачи результатов [10]; • Достоверности результатов -с помощью интеграции с лабораторным оборудованием и автоматической интерпретации нормативных значений, исключается человеческий фактор переноса результатов на бумажный носитель; • Отменой бумажных журналов учета, так как все результаты хранятся в виде электронного архива результатов лабораторных исследований, тем самым медицинская лаборатория становится участником программы цифровой Казахстан; • Автоматическая передача информации в НЦЭ, что является немаловажным фактором для контроля эпидемиологического состояние COVID-19. Материалы, представленные в данной статье, являются результатом практического применения решений в сфере автоматизации лабораторной диагностики.…”

Section: основной разделunclassified

Централизованный Сбор И Анализ Результатов Лабораторных Исследований На COVID-19

Кадиркулов¹,

Ismailova²

2020

Scientific Journal of Astana IT University

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В данной статье описывается процесс централизованного сбора результатов лабораторных исследований на COVID-19, и их дальнейшего анализа с применением технологии веб-сервисов, так как распространение COVID-19 отразилась на экономической и социальной жизни во всех странах мира, в том числе и Республику Казахстан, которое привело к ускорению внедрения цифровых технологий в самых разных сферах. Цифровизация способствует переходу в онлайн-среду здравоохранение, трудовой деятельности, образования, и получать больше данных о распространении вируса и обмениваться информацией о результатах лабораторных исследований. Представленное решение является аналитическим модулем, и базируется на платформе ЛИС SmartLAB [1], который производит комплексную автоматизацию лаборатории, в частности ПЦР (полимеразная цепная реакция) [2] лаборатории, соблюдая все рабочие процессы для получения достоверных результатов путем непосредственного взаимодействия с лабораторным оборудованием по международным стандартам HL7 (англ. Health Level 7 — «Седьмой уровень») [3], ASTM (англ. American Society for Testing and Materials – «Американское общество по испытанию материалов») [4] и автоматическому выявлению отклонении от нормативных данных. При реализации решения использовалась собственная платформа ЛИС SmartLAB, в качестве языка разработки API (англ. application programming interface - программный интерфейс приложения) применялся язык PHP 7.3, в качестве СУБД использовался MariaDB 10.3. В настоящий период времени аналитический модуль апробирован в 4-х ПЦР лабораториях для передачи результатов лабораторных исследований на портал РГП на ПХВ «Национальный центр экспертизы» Комитета контроля качества и безопасности товаров и услуг Министерства здравоохранения Республики Казахстан.

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“…Hence, the risk analysis techniques commonly used as aforementioned in industry cannot directly migrate to the laboratories of colleges and universities [ 21 , 22 ]. Moreover, none of these approaches enable a dynamic and holistic analysis, thus failing to describe the variations in laboratory safety, which is a natural characteristic of laboratory safety management [ 23 ]. In addition, these models cannot provide predictions about safety states during the entire life cycle under different risk control measures, which is required for optimizing the risk control strategies [ 24 ].…”

Section: Introductionmentioning

confidence: 99%

A Methodology for Dynamic Assessment of Laboratory Safety by SEM-SD

Zhang

et al. 2021

IJERPH

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Lab safety problems have become an impeding factor that cannot be ignored in normal teaching and scientific research activities at colleges and universities. As the risk factors of lab accidents can be conceptualized as occurring at multiple levels, systematically improving and optimizing lab safety is the crucial route to accident prevention in labs. In this paper, a novel method that integrates a structural equation model (SEM) and system dynamics (SD) is presented to dynamically assess lab safety with the characteristics of insufficient data and uncertainty. On the basis of a questionnaire investigation, the SEM was utilized to determine the influencing factors on lab safety and acquire the path coefficients among these factors, which were embedded into the SD model as the weight of the influencing factors. An illustration was carried out to test and validate the proposed method, and a sensitivity analysis was also conducted to recognize variables contributing the most to the improvement of lab safety. The results demonstrated that the safety input of human and management subsystems is the most effective to improve the lab safety; meanwhile, “safety awareness”, “emergency ability”, “operation skills”, “safety culture” and “safety training” are the top five contributing factors, which can promote lab safety in the shortest time.

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Development and implementation of evidence-based laboratory safety management tools for a public health laboratory

Cited by 13 publications

References 72 publications

Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process

Development and Application of Computerized Risk Registry and Management Tool Based on FMEA and FRACAS for Total Testing Process

Централизованный Сбор И Анализ Результатов Лабораторных Исследований На COVID-19

A Methodology for Dynamic Assessment of Laboratory Safety by SEM-SD

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