engleski

Quality improvement; experience of Clinical Institute of Chemistry

EN ISO 15189:2008 accepted as national standard in Croatia in 2006 (HR EN ISO 15189) has been used for assessment of medicala laboratories by Croatian Accrediation Agency. Clinical Institute of Chemistry, Sestre milosrdnice University Hospital, Zagreb was one of the first two laboratories accredited in Croatia. The aim of this presentation is to describe modular MS access datebase program in frame of LIS, servihg the quality management system document control. The programs developed and chacked for efficacy are: a) ordering, enabling continuous record of reagent, control, calibrator and conumable requiremments and containing all items required in standard ; b) equipment cards, having all data included identity, manufacturer, maintance/calibration, etc ; c) personnal records, providingcontinuous update of licences, training and education of each laboratory worker ; d) nonconformities, records on nonconformities of request form and quality of primary sample ; e) measurement uncertainty, offering its easy calculation and record ; f) measurement procedures, enabling continuous specification updating ; g) document control tool, enabling issuing, re-issuing and distribution of all major and important documents and continuous updating lists of approved documents. This LIS upgradet with described programs enables simpler and more transparent daily laboratory work leading to easier fulfillment of quality management requirements.

ISO 15189 standard ; quality control ; medical-biochemical laboratory

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