Oba Junna, Toriya Masako, Uwamino Yoshifumi, Matsuo Koichi
Department of Extended Intelligence for Medicine, the Ishii-Ishibashi Laboratory, Keio University School of Medicine, Tokyo, Japan.
Global Research Institute, Keio University, Tokyo, Japan.
Risk Manag Healthc Policy. 2024 Mar 21;17:649-662. doi: 10.2147/RMHP.S441618. eCollection 2024.
During the COVID-19 pandemic, there was an increasing need to expand diagnostic testing in hospitals. At Keio University Hospital (KUH), clinical staff were concerned that the demand for PCR testing might exceed the capacity of the Clinical Laboratory. In response, basic researchers at Keio University School of Medicine (KUSM) set out to build a new, collaborative, PCR testing system. To be authorized to perform such diagnostic PCR testing, KUSM registered its core laboratory as an external clinical laboratory (ECL).
In the pandemic, there was a pressure to build the PCR system quickly. Speed required discussions that developed a shared understanding of the unprecedented, new KUH/KUSM PCR system. To design, construct, and archive the new PCR testing system, we used a systems engineering (SE) approach. This included diagram visualization of functional flows and application of the Unified Architecture Framework (UAF), both of which are often used in system building. We considered daily demand for PCR testing at KUH and KUSM, and daily COVID-19 infections in Japan.
We operated the collaborative PCR testing system from August 2020 to June 2022. Given public health insurance reimbursement policies, KUH focused on individuals with suspicious symptoms, while the ECL at KUSM screened samples from asymptomatic individuals. KUSM performed about half as many tests as KUH. Interviewing KUH staff revealed that diagrams helped promote a better understanding of the KUH/KUSM PCR testing system.
When designing temporary systems that may be repurposed in the future, we suggest using an SE approach with diagrams and UAF perspectives. This approach will enable stakeholders to understand what is being proposed to be built, and facilitate achieving an informed consensus on the proposed system. We suggest that SE approaches should be widely used in projects that involve building and operating complex, collaborative systems, and documenting the process.
在新冠疫情期间，医院对扩大诊断检测的需求日益增加。在庆应义塾大学医院（KUH），临床工作人员担心聚合酶链反应（PCR）检测的需求可能超过临床实验室的能力。对此，庆应义塾大学医学院（KUSM）的基础研究人员着手建立一个新的协作式PCR检测系统。为获得进行此类诊断性PCR检测的授权，KUSM将其核心实验室注册为外部临床实验室（ECL）。
在疫情期间，有迅速建立PCR系统的压力。速度要求进行讨论，以形成对前所未有的新KUH/KUSM PCR系统的共同理解。为了设计、构建和存档新的PCR检测系统，我们采用了系统工程（SE）方法。这包括功能流程的图表可视化和统一架构框架（UAF）的应用，这两者在系统构建中经常使用。我们考虑了KUH和KUSM对PCR检测的每日需求以及日本每日的新冠病毒感染情况。
我们从2020年8月至2022年6月运行了协作式PCR检测系统。根据公共医疗保险报销政策，KUH专注于有可疑症状的个体，而KUSM的ECL对无症状个体的样本进行筛查。KUSM进行的检测数量约为KUH的一半。对KUH工作人员的访谈表明，图表有助于更好地理解KUH/KUSM PCR检测系统。
在设计未来可能重新利用的临时系统时，我们建议采用带有图表和UAF视角的SE方法。这种方法将使利益相关者能够理解提议构建的内容，并有助于就提议的系统达成明智的共识。我们建议SE方法应广泛应用于涉及构建和运营复杂协作系统以及记录过程的项目中。
