The quality indicator paradox

The old management adage “You can’t manage what you don’t measure” is applicable to the field of clinical laboratories. Quality in laboratory medicine can be improved upon without being measured, for example, by introducing new technologies or more effective tests. Yet measurement itself is of fundamental importance in achieving improvement [1]. In laboratory medicine, the measurement of analytical quality through internal quality control and external quality assessment programmes has led to a significant improvement in accuracy in terms of both precision and trueness [2]. However, in the last few decades, a large body of evidence has demonstrated the high vulnerability of the preand post-analytical phases [3]. This finding depends on numerous factors, including the complexity of the processes entailed, limited automation and standardization, and the involvement of different health care operators at the interface between laboratories and clinical practices [4]. In this context, a pressing issue is the lack of valuable quality indicators for evaluating, monitoring and improving the extra-analytical phases [5]. Quality indicators (QIs) have been explicitly defined as measurable items pertaining to processes and/or outcomes allowing the measurement of quality of care and services [6]. According to the definition of quality of care made by the Institute of Medicine, a QI is a tool enabling the user to quantify the quality of a selected aspect of care by comparing it with an appropriate criterion [7]. In order to promote measurement and improvement programmes, quality indicator data should be collected over time to identify, correct, and continuously monitor performance and patient safety by identifying and implementing effective corrective and preventive interventions in the total testing process (TTP). According to the latest version of the International Standard for clinical laboratory accreditation (ISO 15189:2012), “quality indicators can measure how well an organization meets the needs and requirements of users and the quality of all operational processes”. In addition, the document specifies that: “the laboratory shall establish QIs to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post-examination processes” [8]. Implementing QIs is therefore a pre-requisite for being accredited, as the reported requirements highlight the importance of these tools for measuring and improving not only analytical but also extra-analytical processes. The question, indeed, is not whether QIs should be implemented, but which QIs should be used, and how they should be measured. Any clinical laboratory should select and use its own list of QIs for “in-house quality improvement programs”, but by doing so they miss the opportunity to use QIs for two other main goals. The first, most interesting goal is to provide an objective benchmark between different laboratories, thus allowing the comparison of performances in the extra-analytical phase. The data thus obtained should be part of effective external quality assessment (EQA/PT) programmes that aim to evaluate all steps of the TTP. The second goal is to provide interested stakeholders, including physicians, patients and administrators, with a source of objective information on the total quality of laboratory services. The harmonization of QIs represents a fundamental step in achieving these goals, as only a list of harmonized QIs and a standardized reporting system will allow the inter-laboratory comparison of data and performances [9, 10]. Based on these premises, the Working Group “Laboratory Errors and Patient Safety” (WG LEPS) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has developed a preliminary model of QIs (MQI) and a specific website (www.ifcc-mqi.com) in order to enable interested laboratories to undertake data collection [11, 12]. As a further step in this initiative, a Consensus Conference bringing together all experts and interested parties was organized in order to design a road map for the harmonization of QIs. An account of the consensus achieved in the Conference on the characteristics of harmonized QIs, and on the standardized system of data collection and reporting has been given [13]. The list of harmonized QIs and information on a dedicated website designed to explain the rationale of the MQI project and enable clinical laboratories to collect data and to compare individual performances with all participating laboratories (benchmark) have been made available thanks to participation in national and international scientific meetings, issuing of documents through the International