https://www.labmed.theclinics.com/article/S0272-2712(07)00089-3/pdf

Medical Laboratory Informatics

A laboratory information system (LIS) manages information about patients, examinations, results, and quality control. In this context, software quality is important in order to prevent risks for the patient. Studies show that many LISs have a low quality degree, and although the ISO/IEC 25010 standard defines software quality in general, so far there is no specific customization for a quality evaluation model tailored for such systems. This paper presents a case study applying a customized evaluation model -- the AdEQUATE model -- in order to evaluate the software quality of a LIS widely used in the State of Santa Catarina, Brazil -- the LACEN system -- from the perspective of its end users. Analyzing the characteristics of the LACEN system, we customized the AdEQUATE model -- a model for quality evaluation of telemedicine systems based on the ISO/IEC 25010 standard through the use of a questionnaire. The questionnaire has been answered by 69 users (including physicians and biochemists), and its answers were analyzed using descriptive statistics. In general, the quality of the LACEN system has been considered as good, specifically for characteristics like effectiveness, efficiency, satisfaction, freedom from risk, functional suitability, and security. On the other hand, few characteristics have been considered of low quality, including performance efficiency and compatibility. Also, the collected data shows that it is feasible to use AdEQUATE's systematically derived questionnaire for detailed observations of quality degrees of the ISO/IEC 25010 standard characteristics and subcharacteristics.

Software Quality Evaluation of the Laboratory Information System Used in the Santa Catarina State Integrated Telemedicine and Telehealth System

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.

/pdf/validation-of-a-laboratory-and-hospital-information-system-3qwnqhac0p.pdf

Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO 15189

Laboratory Information Systems Management and Operations.

Laboratory Information Systems Management and Operations

The use of computer systems and computerized devices in the laboratory is becoming nearly universal, and increasingly processes once performed by people are being transferred to machines, the inner workings of which may be only dimly understood. The task of the people managing the work of the laboratory is to comprehend the processes by which the computerized laboratory information system (LIS) in use, usually acquired as a package from a vendor, may be shown to be doing the job it is expected to do. The functions of the system must be validated. Useful discussions of regulation1 and inspection and accreditation2 of laboratory information systems are available. However, despite its importance there is remarkably little published outside the blood bank literature about the validation of laboratory information systems that is accessible to general users of the systems, that is, addresses specifically laboratory issues in terms and concepts familiar to the laboratorian. Our intention here is to discuss LIS validation as it applies in the laboratory in general, to define the issues related to validation, and to suggest an approach to dealing with them.

Validation of the laboratory information system.

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Validation of the laboratory information system.