Rizk Mostafa M, Zaki Adel, Hossam Nermine, Aboul-Ela Yasmin
aClinical Pathology Department, Faculty of Medicine bBiostatistics Department, Medical Research Institute, Alexandria University, Egypt.
J Egypt Public Health Assoc. 2014 Dec;89(3):105-13. doi: 10.1097/01.EPX.0000453262.85383.70.
The performance of clinical laboratories plays a fundamental role in the quality and effectiveness of healthcare.
To evaluate the laboratory performance in Alexandria University Hospital Clinical Laboratories using key quality indicators and to compare the performance before and after an improvement plan based on ISO 15189 standards.
The study was carried out on inpatient samples for a period of 7 months that was divided into three phases: phase I included data collection for evaluation of the existing process before improvement (March-May 2012); an intermediate phase, which included corrective, preventive action, quality initiative and steps for improvement (June 2012); and phase II, which included data collection for evaluation of the process after improvement (July 2012-September 2012).
In terms of the preanalytical indicators, incomplete request forms in phase I showed that the total number of received requests were 31 944, with a percentage of defected request of 33.66%; whereas in phase II, there was a significant reduction in all defected request items (P<0.001) with a percentage of defected requests of 9.64%. As for the analytical indicators, the proficiency testing accuracy score in phase I showed poor performance of 10 analytes in which total error (TE) exceeded total error allowable (TEa), with a corresponding sigma value of less than 3, which indicates test problems and an unreliable method. The remaining analytes showed an acceptable performance in which TE did not exceed the TEa, with a sigma value of more than 6. Following an intervention of 3 months, the performance showed marked improvement. Error tracking in phase I showed a TE of (5.11%), whereas in phase II it was reduced to 2.48% (P<0.001).For the postanalytical indicators, our results in phase I showed that the percentage of nonreported critical results was 26.07%. In phase II, there was a significant improvement (P<0.001). The percentage of nonreported results was 11.37%, the reasons were either inability to contact the authorized doctor (8.24%), wrong patient identification (1.0%), lack of reporting by lab doctor (1.11%), and finally, lack of reporting by the lab technician (1.03%).
Standardization and monitoring of each step in the total testing process is very important and is associated with the most efficient and well-organized laboratories.
临床实验室的表现对医疗保健的质量和有效性起着根本性作用。
使用关键质量指标评估亚历山大大学医院临床实验室的实验室表现，并比较基于ISO 15189标准的改进计划前后的表现。
该研究针对住院患者样本进行了7个月，分为三个阶段：第一阶段包括在改进前（2012年3月至5月）收集数据以评估现有流程；中间阶段，包括纠正、预防措施、质量倡议和改进步骤（2012年6月）；第二阶段，包括在改进后（2012年7月至9月）收集数据以评估流程。
在分析前指标方面，第一阶段不完整的申请表显示收到的申请总数为31944份，缺陷申请的百分比为33.66%；而在第二阶段，所有缺陷申请项目均有显著减少（P<0.001），缺陷申请的百分比为9.64%。至于分析指标，第一阶段的能力验证准确性得分显示10种分析物表现不佳，其中总误差（TE）超过允许总误差（TEa），相应的西格玛值小于3，这表明测试存在问题且方法不可靠。其余分析物表现可接受，其中TE未超过TEa，西格玛值大于6。经过3个月的干预后，表现有显著改善。第一阶段的误差追踪显示TE为（5.11%），而在第二阶段降至2.48%（P<0.001）。对于分析后指标，我们在第一阶段的结果显示未报告关键结果的百分比为26.07%。在第二阶段有显著改善（P<0.001）。未报告结果的百分比为11.37%，原因包括无法联系授权医生（8.24%）、患者身份识别错误（1.0%）、实验室医生未报告（1.11%），以及最后实验室技术人员未报告（1.03%）。
全面检测过程中每个步骤的标准化和监测非常重要，且与最高效、组织最完善的实验室相关。
