Abstract
Barth has provided a comprehensive overview on clinical quality indicators of the total testing process, i.e. throughout the preanalytical, analytical and postanalytical phases of laboratory practice. 1 We agree on the essential concept that a paradigm shift might occur in the delivery of laboratory medicine towards a clinical service measured by outcomes, as well as on the importance of the ‘pre–pre’ and ‘post–post’ analytical phases in assuring patient safety. 2,3 In addition, it should be welcome that a high proportion of UK laboratories provide an advisory and interpretative service to their users. This seems to represent a further step in improving quality in the whole ‘brain-to-brain loop’ and in avoiding errors that may jeopardize patient safety. 4 Although the concern raised in the article about the ‘paucity of literature on quality indicators’ was indeed founded some years ago, a huge number of nationwide experiences are ongoing and consistent data on this topic have already been gathered. Along with the worldwide project of the International Federation of Clinical Chemistry Working Group on laboratory errors and patient safety, 5 other valuable experiences are ongoing in several countries, such as those supported by the Association for Clinical Biochemistry, 1 the Sociedad Española de Bioquímica Clínica y Patología Molecular, 6 the external quality assessment scheme developed in Croatia for monitoring the extra-analytical areas of testing, 7 as well as the over 12-year series of pilot pre- and postanalytical programmes that have been developed and trialled in volunteer pathology laboratories throughout Australia and New Zealand. 8 In the USA, the Centers for Disease Control and Prevention convened a conference in 2007 aimed to improve laboratory services. Five major recommendations emerged including focusing on preanalytic and postanalytic processes as areas of potential quality improvement. 9
Therefore, the leading issue can no longer be identified as a ‘paucity’ of data, but rather the independent and somehow disharmonic outburst of national or supranational initiatives, which are currently based on heterogeneous and not always comparable sets of quality indicators and related terminology.
There is now a compelling need to reorganize and possibly unify these ongoing projects, as well as establish an international consensus for producing joint recommendations focused on the adoption of universal quality indicators and common terminology. This is supported by a recent review which concluded that current laboratory medicine quality indicators did not fulfil minimum standard evaluation criteria for quality or performance measures, thereby highlighting the need for consistently specified, reliable, useful, and evidence-based, laboratory-related quality and performance measures. 10 Inherent to this process, the term ‘reliable’ designates that quality indicators should be mostly ‘patient-centered’, should be implemented in different types of clinical laboratories worldwide and should provide the ideal basis for establishing a reliable policy of incident reporting in laboratory medicine. 11 We firmly believe that harmonization of practices for monitoring quality throughout the total testing process would result in mature quality assurance programmes capable of identifying and driving real improvements in laboratory medicine and health care.
DECLARATIONS