Abstract
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. 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 (%). The accuracy of data transfer from laboratory analyzers to LIS was 99.5% and of that from LIS to HIS 100%. We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose.
Highlights
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
We presented our established validation protocol for laboratory information system and demonstrated that a system meets its intended purpose
Our acceptance criteria were a complete match between numeric data obtained from laboratory analyzers and results transferred into LIS, and between data entered into LIS and into HIS
Summary
Accreditation according to an internationally recognized standard such as ISO 15189 „Medical laboratories – Particular requirements for quality and competence“ is a recognition of a laboratory’s competence and compliance with the requirements of the standard [3]. It is acknowledged as the single most effective route to comprehensive quality assurance [4]. The Institute of Clinical Chemistry and Laboratory Medicine of the Merkur University Hospital, Zagreb, Croatia, has successfully installed the Laboratory Information System (LIS) [7,8], and the Department of Laboratory Medicine, a part of the Institute, is integrated into the Hospital Information System (HIS).
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