Articoli in pubblicazione

Urgenttests requesting is variable across different institutions in the same country and at international level. The percentageof urgent testing has been found to be about 33% in Italy, but only some of these tests are really related to clinicalneeds. Various reports are available to document the growth of extra-laboratory testing, otherwise referred to as nearpatient, bedside or Point-of-Care testing (POCT). The key objective of extra-laboratory testing, particularly POCT, isto generate a result quickly so that appropriate treatment can be implemented rapidly, but few data are available todemonstrate an effective improvement in operational and clinical outcomes. This paper sets out the requirements fordelivering an effective extra-laboratory testing by reviewing the data of the literature as well as the performancespecifications for assuring quality and patient safety.

Laboratory services are undergoing substantial consolidation and changes through mechanisms ranging from mergers, acquisitions and outsourcing, primarily based on the expectation towards increasing volumes, improving efficiency, and reducing cost per test. However, in laboratory medicine the relationship between volume and costs is not linear, as numerous variables may influence the comprehensive costs. In particular, the relationship between volumes and costs does not span the entire pattern of clinical laboratories: high costs are associated with low volumes up to a threshold of about one million test per year. Over this threshold, there is no linear association between volumes and costs, as the laboratory organization rather than test volumes affects the final costs more significantly. Available evidence collected in the last decades, namely data on laboratory errors and associated diagnostic errors and risk for patient harm emphasizes the need for a paradigmatic shift: from a focus on volumes and efficiency to a patient-centered vision restoring the nature of laboratory services as an integral part of the diagnostic and therapy process. In particular, the vulnerability of extraanalytical phases and the lack of reliable quality specifications in pre- and post-analytical steps do not allow an improvement in the ultimate laboratory information. Process and outcome quality indicators have been proposed as effective tools to measure and improve laboratory services by stimulating a competition based on intra- and extraanalytical performance specifications, intermediate outcomes and customer satisfaction. Rather than competing with economic value, clinical laboratories should adopt a strategy based on a set of harmonized quality indicators and performance specifications, active laboratory stewardship, and improved patient safety.

There is a continual debate on what type of sample a clinical laboratory should use. While serum is still considered the gold standard and remains the required sample matrix for some assays, laboratories must consider turn-around time, which is an important metric for laboratory performance and, more importantly, plays a critical role in patient care. In addition, a body of evidence emphasize the choice of plasma samples in order to prevent modifications of some measurands due to the coagulation process and related interferences. Advantages and disadvantages of serum and plasma are discussed on the basis of current literature and evidence. In addition, data are provided on the current utilization of the matrix (serum or plasma) in Italy and in other Countries. Finally, a rational for a possible shift from serum to plasma is provided.

The issue of the appropriateness in laboratory medicine has been discussed from several years in association to theparallel onset of two aspects: 1) the significant increase in tests demand and utilization, thanks to the developmentof laboratory automation and information laboratory systems (LIS), that allow to provide timely and reliable results toclinicians; 2) the opportunity, thanks to new pathophysiological knowledge and new technologies to introduce newand more sophisticated tests in clinical practice, providing a relevant support to the clinician in the management ofpatients, according to the improved vision of personalized medicine. As a consequence, the potentialinappropriateness in test utilization and the need to manage demand and to reduce the redundant testing havereceived increasing concern. Several papers, in the recent literature, demonstrated that the inappropriateness inlaboratory test utilization may represent a potential source of errors, and interesting strategies have been proposedand progressively adopted in order to limit this problematic outcome. An essential issue is to assure appropriatenessnot only in test request, but in all steps of the testing cycle. In particular, some of the more relevant issues has beenlinked to: rationalization of laboratory test ordering prescription, thanks to development of a computerized clinicaldecision support systems; implementation of the reflexing tests rule; definition of the minimum retesting intervalaccording to the clinical and pathophysiological criteria; timely revision of the available panel tests in order to deletethose considered obsolete from clinical and analytical point-of-view and, finally, improving the education in demandmanagement. The “clinical laboratory stewardship” seems to be the new and shared strategy, that guarantees notonly the appropriate utilization and interpretation of laboratory tests improving efficacy and providing efficiency but,more importantly, the future of the discipline and the role of laboratory professionals in the context of new and morecomplicated clinical and economical scenarios.

Italian Federation of Laboratory Medicine Societies (FISMeLab) recommendations for biological samples transportation. In recent years the transport of biological samples has become a strategic issue and a frequent practice, due to the tendency of public laboratories to move towards consistent consolidations and of private laboratories to join other, bigger or more equipped ones (hub and spoke model), to process a substantial part of the analytical repertoire. Moreover, the sampling centers have become more numerous and more widespread to improve the service to the citizens. The time and the way of remote transport of biological samples is a source of potential corruption of the matrix that can generates preanalytical errors of various kinds and severity. The lack of unequivocal national indications in Italy has prompted the Italian Federation of Laboratory Medicine Societies (FISMeLab) to set up a working group that includes representatives from the scientific societies members of the Federation, with the aim of assembling a practical recommendation on transport requirements of biological samples. In order to enable the users to consult the document quickly and effectively, the recommendation lists the single measurands from different areas of laboratory medicine and reports for each of them the ideal transportation modalities. These are based on the time elapsed from the blood collection: less or more than three hours; it is however recommended that the time from the blood collection to the transport be as short as possible.