การประยุกต์ใช้ระบบ lean สำหรับการตรวจวิเคราะห์ HbA1c ในโรงพยาบาลชลบุรี

Hemoglobin A1c (HbA1c) assay is used to determine blood sugar levels over the past three months, enabling physicians to monitor and evaluate the treatment of diabetic patients. The Medical Technology Department, Chonburi Hospital, receives approximately 20,000 samples per year for HbA1c testing, guaranteed turnaround time (TAT) of 1 hour after receiving specimens. However, some cases are unable to report results in a timely manner. This study aimed to develop a process for HbA1c assay by applying a Lean system to reduce waiting times with a target value of 95%. This prospective study started on January 1, 2020, to December 31, 2020 comprising the causes and related factors affecting reporting of HbA1c with delayed TAT; processes and steps after Lean implementation in the testing process; collecting data on the number of samples submitted and samples with delayed TAT; problems by type of flag errors, as well as the time to receive specimens affecting tests with prolonging TAT, and compared the data obtained between before and after the Lean implementation. The results revealed that before application from 1 January to 31 July 2020 and after applying the Lean system from 1 August to 31 December 2020, 16,012 samples and 13,721 samples were found at TAT for more than 60 minutes, 179 cases (1.11%) and 140 cases (1.02%). The most common periods were 04.01-06.00, 06.01-08.00, and 08.01-10.00 and there was a statistically significant difference when compared with the other periods (p<0.05). When the process of HbA1c assay classified by flag errors, the median time of pre-analytic, analytic, and post-analytic processes after applying the Lean system, was significantly reduced, especially flag error type >test (p<0.05) compared with before lean implementation. The number of samples with delayed TAT before and after the Lean application classified by the analytical processes, there was no difference in Sample S. and test were significantly decreased (p<0.05), especially in the pre-and post-analytic. In conclusion, the percentage of HbA1c samples with delayed TAT was not different before and after the Lean implementation. However, after applying the Lean system, the time and sample number of flag error type >test reduced in both pre-and post-analytic processes. This study is a strategy for further development of another laboratory testing.

糖化血红蛋白A1c（HbA1c）检测用于评估受试者近三个月的血糖水平，助力临床医师监测并评估糖尿病患者的治疗效果。春武里医院医学技术部年均接收约20000份HbA1c检测标本，承诺接收标本后1小时内出具检测报告（周转时间 turnaround time, TAT）。但仍有部分病例无法及时出具检测结果。本研究旨在通过应用精益管理（Lean）体系优化HbA1c检测流程以缩短等待时长，设定达标目标为95%。本前瞻性研究周期为2020年1月1日至2020年12月31日，研究内容涵盖：导致HbA1c报告延迟、周转时间（TAT）超时的成因及相关影响因素、精益管理实施后检测流程的优化环节、送检标本量与延迟TAT标本量的收集、标记错误（flag errors）类型对应的问题，以及影响检测时长延长、导致TAT延迟的标本接收时长，并对比精益管理实施前后的相关数据。
研究结果显示，在实施前（2020年1月1日至7月31日）与实施后（2020年8月1日至12月31日）两个阶段，TAT超过60分钟的标本量分别为16012份、13721份，对应延迟病例数分别为179例（占比1.11%）与140例（占比1.02%）。检测延迟高发时段为04:01-06:00、06:01-08:00与08:01-10:00，与其余时段相比差异具有统计学意义（p<0.05）。按标记错误类型对HbA1c检测流程分类后可见，实施精益管理后，分析前、分析中与分析后流程的中位时长均显著缩短，其中以“标记错误类型＞检测项”类错误的改善最为显著（p<0.05），较精益实施前差异突出。按分析流程对精益实施前后的延迟TAT标本量进行分类后可见，样本S相关指标无显著差异，但检测项相关指标显著降低（p<0.05），尤以分析前与分析后流程的改善最为明显。
综上，精益管理实施前后，HbA1c检测中延迟TAT标本的占比无显著差异。但实施精益管理后，标记错误类型＞检测项相关的时长与标本量在分析前及分析后流程中均有所降低。本研究可为其他实验室检测项目的优化提供参考策略。