Plenary
Harmonizing the post-analytical phase and Integrated Diagnostics
The post-analytical phase of laboratory testing is increasingly recognized as a fundamental step in achieving quality and more effective use of laboratory information. Data reporting, downstream interpretation of laboratory results and subsequent appropriate action through close relationships between laboratories and clinicians are crucial in the laboratory testing process. However, harmonization of the post-analytical phase is complicated, mainly because it requires communication between parties speaking different languages, including laboratory staff, physicians, information technology, specialists and patients. It has been said that “good post-analytical quality makes good laboratory information” as analytical quality remains paramount but numerical results are not enough. In fact, numerical data must be accompanied by other parameters, usually defined as “comparators” (mainly, but not only, terminology, units of measurements, reference values, decision limits and interpretative comments) aimed to make the data “actionable” (1). Using population data as a “reference” for individuals has created several drawbacks related to diagnosis, monitoring and treatment of single individuals, since a test result that is considered normal for an individual might still fall outside the limits of the population-based reference interval (popRIs), and vice versa. To overcome this issue, the paradigm should be changed from the population to the individual, to adopt personalized reference intervals (prRI), personalized decision limits (pDLs) and personalized reference change values (pRCVs) (2). This change not only results in the introduction of objective and no longer subjective criteria in the interpretation of laboratory results, but also makes the role of the clinical laboratory in ensuring quality in laboratory examination more evident. Recently, increasing interest has been expressed in integrated diagnostics, defined as convergence of imaging, pathology, and laboratory tests with advanced information technology (IT). Clinical laboratory-pathology-radiology integration workflows must ensure effective communication, the flow of communications, and link structured diagnostic results from laboratorians and pathologists with those of radiologists (3). In particular, a common laboratory, radiology and pathology diagnostic reporting system that integrates text, sentinel images and molecular diagnostic data to an integrated, coherent interpretation enhances management decisions and improves quality of care.
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