Governance of Screening Programs Unit, Health Management Staff, Local Health Authority of Bologna, Bologna, Italy.
Screening Center, Department of Public Health, Local Health Authority of Bologna, Bologna, Italy.
J Med Screen. 2024 Jun;31(2):70-77. doi: 10.1177/09691413231197300. Epub 2023 Sep 7.
The first level of a colorectal cancer (CRC) screening process was systematically analysed using the Healthcare Failure Mode and Effects Analysis (HFMEA) approach by a multidisciplinary team aiming to improve the programme quality.
The study was conducted at the Local Health Authority of Bologna, Northern Italy.
Seven brainstorming sessions were conducted and all the activities performed were recorded on a FMEA worksheet consisting of individual records reporting the specific phases of the analysed process along with associated activities, possible failure modes, their causes and effects, the obtained risk priority numbers (RPNs) and the control measures to plan.
Twenty-three failure modes, 14 effects and 12 possible causes were identified. Nine failure modes were prioritised according to the RPN obtained; most resulted in possible false-negative faecal immunochemical test (FIT) results (66.7%), followed by sample loss (22.2%) and not reaching the entire target population (11.1%). This leads to 66.7% of corrective/preventive actions being applied to the phase of returning the stool sample by the citizen. For this phase reorganisation, the local pharmacies were involved not only as FIT kit delivery points but also as specimen collection and sending points to the laboratory. These organisational changes allowed the introduction of complete traceability of kits and specimens flow, as well as temperature control. A re-evaluation of the prioritised failure modes 6 months after launching the implemented screening process showed that HFMEA application decreased the risk of potential errors by 75.9%.
HFMEA application in CRC screening programme is a useful tool to reduce potential errors.
一个多学科团队采用医疗保健失效模式与效应分析(HFMEA)方法对结直肠癌(CRC)筛查流程的第一级进行了系统性分析,旨在提高项目质量。
该研究在意大利北部博洛尼亚地方卫生局进行。
进行了七次头脑风暴会议,并将所有执行的活动记录在 FMEA 工作表上,该工作表由个人记录组成,报告了分析过程的各个阶段以及相关活动、可能的失效模式、其原因和影响、获得的风险优先数(RPN)以及计划的控制措施。
确定了 23 种失效模式、14 种效应和 12 种可能的原因。根据获得的 RPN,对 9 种失效模式进行了优先级排序;大多数导致可能的粪便免疫化学测试(FIT)结果为假阴性(66.7%),其次是样本丢失(22.2%)和未达到整个目标人群(11.1%)。这导致 66.7%的纠正/预防措施应用于公民返还粪便样本的阶段。为此阶段的重组,当地药店不仅作为 FIT 试剂盒的交付点,还作为标本采集和发送到实验室的点。这些组织变更允许引入试剂盒和标本流的完整可追溯性,以及温度控制。在实施筛查计划 6 个月后重新评估优先失效模式表明,HFMEA 的应用将潜在错误的风险降低了 75.9%。
HFMEA 在 CRC 筛查计划中的应用是减少潜在错误的有用工具。