验证符合 ISO 15189 标准的医学实验室的实验室和医院信息系统。
Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO 15189.
机构信息
Merkur University Hospital, Institute of Clinical Chemistry and Laboratory Medicine, Zagreb, Croatia.
出版信息
Biochem Med (Zagreb). 2012;22(1):86-91. doi: 10.11613/bm.2012.009.
INTRODUCTION
The aim of the study was to present a protocol for laboratory information system (LIS) and hospital information system (HIS) validation at the Institute of Clinical Chemistry and Laboratory Medicine of the Merkur University Hospital, Zagreb, Croatia.
MATERIALS AND METHODS
Validity of data traceability was checked by entering all test requests for virtual patient into HIS/LIS and printing corresponding barcoded labels that provided laboratory analyzers with the information on requested tests. The original printouts of the test results from laboratory analyzer(s) were compared with the data obtained from LIS and entered into the provided template. Transfer of data from LIS to HIS was examined by requesting all tests in HIS and creating real data in a finding generated in LIS. Data obtained from LIS and HIS were entered into a corresponding template. The main outcome measure was the accuracy of transfer obtained from laboratory analyzers and results transferred from LIS and HIS expressed as percentage (%).
RESULTS
The accuracy of data transfer from laboratory analyzers to LIS was 99.5% and of that from LIS to HIS 100%.
CONCLUSION
We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose.
简介
本研究旨在介绍克罗地亚萨格勒布默克丘尔大学医院临床化学和检验医学研究所的实验室信息系统（LIS）和医院信息系统（HIS）验证方案。
材料与方法
通过将所有虚拟患者的检验申请输入 HIS/LIS 并打印相应的条码标签，从而检查数据可追溯性的有效性，这些标签为实验室分析仪提供了请求检验的信息。将实验室分析仪的原始检验结果打印件与从 LIS 获得的数据进行比较，并将其输入到提供的模板中。通过在 HIS 中请求所有检验并在 LIS 中生成的发现中创建真实数据来检查从 LIS 到 HIS 的数据传输。将从 LIS 和 HIS 获得的数据输入到相应的模板中。主要观察指标是从实验室分析仪获得的数据传输的准确性以及从 LIS 和 HIS 传输的结果，以百分比（%）表示。
结果
从实验室分析仪到 LIS 的数据传输准确性为 99.5%，从 LIS 到 HIS 的数据传输准确性为 100%。
结论
我们提出了已建立的实验室信息系统验证方案，并证明该系统符合其预期目的。
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