THE IMPACT OF LEGISLATIVE CHANGES ON QUALITY OF ACTIVITIES IN MEDICAL LABORATORIES
Abstract:
The goal of this study is to correlate the legislative changes on quality of medical laboratories
activities demonstrating the increase of the quality of the service provided by them through comparing the
average coefficient of variation of the results reported to the external quality control organized by a
national provider in 2008, 2010, 2013 and the round in November 2014, in the fields of biochemistry,
hemostasis, hematology for the selected analytes and parameters attended by, between 139 and 233
laboratories in Romania in almost all counties (keeping the confidentiality of the individual results of
evaluations of performance in medical laboratories). The methods used are the comparison of articles of
legislative texts on the organization and functioning of medical laboratories in the period 2004 – 2015,
statistical calculations and comparison of average percentage coefficients of variation as a measure of
dispersion values reported by participants for the analytes and parameters included in the study between
2008 – 2014. There was observed a correlation between legislative changes and significant decrease of the
mean average coefficients of variation for the analytes and parameters selected from the fields of
biochemistry, hematology and hemostasis in the period performing the study. The legislative changes in the
period 2004 – 2015 have had a positive impact on the quality of services provided by medical laboratories
demonstrated by the significant decrease in the mean average coefficients of variation for the analytes and
parameters selected from the fields of biochemistry, hematology and hemostasis in the period 2008-2014
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