Verification policies in Croatian medical biochemistry laboratories: a survey of the practice. 2022

Lara Milevoj Kopčinović, and Gordana Juričić, and Adriana Bokulić, and Ines Vukasović, and Ivana Ćelap, and Helena Čičak, and Marija Kocijančić, and Marija Miloš, and Mila Lovrić, and Marija Siter Kuprešanin, and Snježana Hrabrić Vlah, and Manuela Miletić
Working group for method verification and validation of the Croatian Society of Medical Biochemistry and Laboratory Medicine and Croatian Chamber of Medical Biochemists, Zagreb, Croatia.

The 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. In 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. A 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. Heterogeneous verification protocols are routinely utilized across Croatian MBLs which clearly confirms that a national document might help in the harmonization of verification procedures.

UI MeSH Term Description Entries
D007753 Laboratories Facilities equipped to carry out investigative procedures. Laboratory
D011795 Surveys and Questionnaires Collections of data obtained from voluntary subjects. The information usually takes the form of answers to questions, or suggestions. Community Survey,Nonrespondent,Questionnaire,Questionnaires,Respondent,Survey,Survey Method,Survey Methods,Surveys,Baseline Survey,Community Surveys,Methodology, Survey,Nonrespondents,Questionnaire Design,Randomized Response Technique,Repeated Rounds of Survey,Respondents,Survey Methodology,Baseline Surveys,Design, Questionnaire,Designs, Questionnaire,Methods, Survey,Questionnaire Designs,Questionnaires and Surveys,Randomized Response Techniques,Response Technique, Randomized,Response Techniques, Randomized,Survey, Baseline,Survey, Community,Surveys, Baseline,Surveys, Community,Techniques, Randomized Response
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001671 Biochemistry The study of the composition, chemical structures, and chemical reactions of living things.
D017523 Croatia Created 7 April 1992 as a result of the division of Yugoslavia.
D057766 Policy A course or method of action selected to guide and determine present and future decisions. Policies

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