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Verification policies in Croatian medical biochemistry laboratories: a survey of the practice
Authors:Lara Milevoj Kop inovi&#x;  Gordana Juri i&#x;  Adriana Bokuli&#x;  Ines Vukasovi&#x;  Ivana &#x;elap  Helena i ak  Marija Kocijan i&#x;  Marija Milo&#x;  Mila Lovri&#x;  Marija Siter Kupre&#x;anin  Snjeana Hrabri&#x; Vlah  Manuela Mileti&#x;
Abstract:IntroductionThe aim of this study was to screen practices used in verification procedures for methods/analysers among medical biochemistry laboratories (MBLs) in Croatia. We hypothesized that these procedures differ widely from laboratory to laboratory and wanted to gather specific data on steps used in the verification workflow.Materials and methodsIn order to obtain data, an online survey was conducted. The survey, divided in two sections, contained 29 questions and statements addressing general characteristics and specific steps of the verification workflow of each individual MBL. The survey was disseminated among managers of all MBLs in Croatia.ResultsA total of 108/196 (55%) laboratories participated in the survey. Forty nine MBLs were excluded from the second part of the survey: 14 have not implemented verification procedures, and 35 MBLs due to the absence of answers. The most relevant results of the second part of the survey showed that: 18/59 (0.31) of the responding MBLs have difficulties when defining acceptance criteria, 27/59 (0.46) used the Clinical and Laboratory Standards Institute protocol for precision estimation; the majority of MBLs used a median of 20 samples for method/analyser comparisons and estimated bias using internal quality control samples; reference intervals provided by external sources are mainly adopted; 60% of MBLs do not include linearity verification in their protocol and do not use the national document for the estimation of measurement uncertainty.ConclusionsHeterogeneous verification protocols are routinely utilized across Croatian MBLs which clearly confirms that a national document might help in the harmonization of verification procedures.
Keywords:accreditation  examination procedures  verification  survey
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