Innovative software for recording preanalytical errors in accord with the IFCC quality indicators.

The preanalytical phase, encompassing at large all those activities necessary to obtain a suitable biological specimen, is an essential part of the total testing process [1]. Several lines of evidence attest that uncertainties, poorly standardized and even misleading preanalytical procedures produce the vast majority of problems in diagnostic testing, wherein up to 60%–70% of laboratory errors can be brought back to the preanalytical phase [2, 3]. The definition, implementation and monitoring of reliable quality indicators (QIs) is an essential solution for reducing vulnerability in the various phases of testing, including the preanalytical phase. Nearly 10 years ago, the Education and Management Division (EMD) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) established a Working Group on “Laboratory Errors and Patient Safety” (WG-LEPS) [4], aimed at stimulating studies on the topic of errors in laboratory medicine, collecting data and recommending strategies and procedures to improve patient safety. Soon afterwards, a Working Group for the Preanalytical Phase (WG-PRE) was established by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) [5]. The activities of the latter WG are devoted to reducing the vulnerability of the preanalytical phase by producing official recommendations, guidelines and education material for laboratory professionals and healthcare operators. The development of the project of QIs in Laboratory Medicine has been one of the most important and productive initiatives of the WG-LEPS [6], based on the assumption that the use of standardized QIs to assess and monitor the quality system of the laboratory may be valuable in maintaining control of the total testing process by means of a systematic and transparent approach. A first set of QIs was established during a Consensus Conference organized in Padua (Italy), in 2013 [7]. The preliminary list of QIs embraced 45 performance measures in 22 key processes, 12 of which belong to the preanalytical phase. During a second Consensus Conference, organized in the same town 3 years later, the panel of experts decided to introduce a refinement and simplification of the former list of QIs, which may become available later in the 2017. Despite the general consensus that has been reached for using this standardized set of QIs in different laboratories worldwide, a gap remains to be filled. More specifically, the process of recording information about sample quality in different laboratories remains challenging. The many preanalytical errors can be manually registered in paper sheets or forms, directly entered in the laboratory information system (LIS) or elsewhere. Some years ago, a preanalytical errors recording software was developed for easing and standardizing the activity of recording preanalytical errors [8]. This software has been quite successful, as confirmed by the many laboratories requesting *Corresponding author: Prof. Giuseppe Lippi, Section of Clinical Biochemistry, University Hospital of Verona, P.le LA Scuro 10, 37134 Verona, Italy, E-mail: [email protected]. http://orcid.org/0000-0001-9523-9054; Working Group for Laboratory Errors and Patient Safety (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), Italy; and Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), Croatia Laura Sciacovelli: Working Group for Laboratory Errors and Patient Safety (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), Italy; and Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy Ana-Maria Simundic: Working Group for Laboratory Errors and Patient Safety (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), Italy; Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), Croatia; and Department of Medical Laboratory Diagnostics, University Hospital Sveti Duh, Zagreb, Croatia Mario Plebani: Working Group for Laboratory Errors and Patient Safety (WG-LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), Italy; Working Group for Preanalytical Phase (WG-PRE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM), Croatia; and Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy