Kayseri Public Health Laboratory, Kayseri, Turkey.
Clin Chem Lab Med. 2019 Sep 25;57(10):1530-1538. doi: 10.1515/cclm-2019-0019.
Background Quality indicators (QIs) and risk management are important tools for a quality management system designed to reduce errors in a laboratory. This study aimed to show the effectiveness of QI-based risk management for the continual improvement of pre-analytical processes in the Kayseri Public Health Laboratory (KPHL) which serves family physicians and collects samples from peripheral sampling units. Methods QIs of pre-analytical process were used for risk assessment with the failure modes and effects analysis (FMEA) method. Percentages and risk priority numbers (RPNs) of QIs were quantified. QI percentages were compared to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) performance specifications and RPNs were compared to risk level scale, and corrective actions planned if needed. The effectiveness of risk treatment actions was re-evaluated with the new percentages and with RPNs of predefined QIs. Results RPNs related to four QIs required corrective action according to the risk evaluation scale. After risk treatment, the continual improvement was achieved for performance and risk level of "transcription errors", for risk levels of "misidentified samples" and "not properly stored samples" and for the performance of "hemolyzed samples". "Not properly stored samples" had the highest risk score because of sample storage and centrifugation problems of peripheral sampling units which are not under the responsibility of the KPHL. Conclusions Public health laboratories may have different risk priorities for pre-analytical process. Risk management based on predefined QIs can decrease the risk levels and increase QI performance as evidence-based examples for continual improvement of the pre-analytical process.
背景
质量指标（QIs）和风险管理是质量管理系统的重要工具，旨在减少实验室中的错误。本研究旨在展示基于 QI 的风险管理在凯瑟里公共卫生实验室（KPHL）中分析前过程持续改进的有效性，该实验室为家庭医生服务，并从周边采样单位收集样本。
方法
使用失效模式和影响分析（FMEA）方法对分析前过程的 QIs 进行风险评估。量化 QIs 的百分比和风险优先数（RPN）。将 QI 百分比与国际临床化学和实验室医学联合会（IFCC）性能规格进行比较，并将 RPN 与风险级别进行比较，如果需要，则计划采取纠正措施。使用新的百分比和预定 QIs 的 RPN 重新评估风险处理措施的有效性。
结果
根据风险评估量表，与四个 QIs 相关的 RPN 需要采取纠正措施。风险处理后，实现了“转录错误”的性能和风险水平、“样本识别错误”和“未妥善储存样本”的风险水平以及“溶血样本”的性能的持续改进。“未妥善储存样本”的风险评分最高，因为周边采样单位的样本储存和离心问题不在 KPHL 的责任范围内。
结论
公共卫生实验室可能对分析前过程有不同的风险优先级。基于预定 QIs 的风险管理可以降低风险水平，提高 QI 性能，为分析前过程的持续改进提供循证依据。
