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[Laboratory Medicine: specialists of tomorrow] Laboratory Medicine rides the wave of technological progress, the metamorphosis of information systems and data management. The Young Specialist is not a mere observer, but rather takes a leading role in this change, taking advantage of the opportunities offered by “omics” technologies, capturing new ideas and innovative stimuli that lead to a new concept of work and research oriented to health and prevention. Thanks to the support of international web platforms, training and exchange programs supported by the International Scientific Societies and Federations that favor professional and scientific growth, Young Scientists work in a global context. In this scenario, the SIBioC Young Scientists Study Group, with the auspices of SIBioC, EFLM and IFCC, organized a meeting on "Laboratory Medicine: Specialists of tomorrow" with the aim of discussing and highlighting some of the most important challenges, such as technological progress, training and internationalization of young people. Finally, the future of laboratory medicine looks at a multidisciplinary approach that leads to integrated diagnosis, identification of the frail patient, the use of the Point of Care Testing as an indispensable tool in crisis areas, making the dialogue between physician and laboratory specialist a fundamental step for the diagnosis and treatment with the final aim of a better outcome for the patient.

The importance of the process of purchasing or changing blood collection devices is often overlooked. This is likely attributable to many factors such as the limited knowledge that policymakers, healthcare administrators and also laboratory managers have on the significance of preanalytical quality, but also to the lack of validated criteria for analyzing the quality of blood collection devices. Since a gap remains to be filled between companies' and laboratory's validation, the EFLM Working Group on Preanalytical Phase (WG-PRE) has published a comprehensive document, which contains essential prerequisites and technical issues (e.g., physical imperfections, defects of functioning, safety deficiencies) to support local clinical laboratories for the development of tenders for blood tubes and for the validation of new materials ahead of local routine use. This consensus document is a national adaptation of these guidelines.

Context.—A strong independent association has been recently observed between elevated red blood cell distribution width (RDW) and increased incidence of cardiovascular events. Objective.—To assess whether RDW is associated with plasma markers of inflammation since the mechanism(s) underlying this association remain unknown. Design.—We retrospectively analyzed results of RDW, hemoglobin, mean corpuscular volume, ferritin, high-sensitivity C-reactive protein (hsCRP), and erythrocyte sedimentation rate (ESR) in a large cohort of unselected adult outpatients who were consecutively referred by general practitioners for routine medical check-up. Results.—Cumulative results of RDW and other factors were retrieved from the database of our laboratory information system for 3845 adult outpatients during a 3-year period. When participants were grouped according to RDW quartiles, there were strong, graded increases of ESR and hsCRP (P < .001), both parameters being up to 3-fold higher in the fourth versus the first quartile. Accordingly, the percentages of those with hsCRP greater than 3 mg/L (from 28% to 63%; P < .001) and ESR greater than 40 mm/h (from 8% to 40%; P < .001) increased steadily across RDW quartiles. In multivariable regression analysis, ESR and hsCRP predicted RDW independently of age, sex, mean corpuscular volume, hemoglobin, and ferritin. Conclusions.—To our knowledge, our study demonstrates for the first time a strong, graded association of RDW with hsCRP and ESR independent of numerous confounding factors. If confirmed in future follow-up studies, this association might provide a rationale to introduce the easy, inexpensive RDW in algorithms for cardiovascular risk prediction.

Context.—Lipoprotein(a) (Lp(a)) is receiving major emphasis as an independent risk factor for cardiovascular disease. Results of studies on Lp(a) in patients with impaired renal function are contradictory, and no information is available on the association between Lp(a) and estimated glomerular filtration rate and cystatin C.Objective.—To evaluate the potential relationships among the biochemical markers creatinine, estimated glomerular filtration rate, and cystatin C and their association with Lp(a) in patients with impaired renal function.Design.—We performed a retrospective analysis using the database of our laboratory to retrieve results of Lp(a), creatinine, and cystatin C tests performed on consecutive outpatients referred by general practitioners for routine blood testing during the last year.Results.—Cumulative results for all of the above-mentioned variables were retrieved for 150 adults older than 35 years. After stratifying Lp(a) values according to thresholds of creatinine, estimated glomerular filtration rate, and cystatin C, no significant differences in Lp(a) concentration were observed in subjects with abnormal values of these biochemical markers. The prevalence of Lp(a) values greater than or equal to 300 mg/L was not significantly different in subjects with biochemical markers suggestive of impaired renal function, as compared with those without such markers. In multivariable linear regression analysis, none of the parameters tested was significantly associated with Lp(a).Conclusions.—We suggest that unless renal function is completely compromised, measurement of biochemical markers of renal function might be relatively unimportant to improve clinical usefulness of Lp(a) testing.

Context.—Preanalytical factors influencing the reliability of laboratory testing are commonplace. It is traditionally accepted that hemolytic samples are unsuitable for coagulation assays because of the release of hemoglobin, intracellular components, and thromboplastic substances from damaged blood cells. Objective.—To evaluate the influence of blood cell lysis on routine coagulation testing. Design.—Twelve aliquots prepared by serial dilutions of homologous lysated samples collected from 10 different subjects, and displaying a final percentage of lysis ranging from 0% to 9.1%, were tested for prothrombin time, activated partial thromboplastin time, fibrinogen, and dimerized plasmin fragment D. Lysis was achieved by subjecting citrated whole blood to a freeze-thaw cycle. Outcome Measures.—Interference from blood cell lysis on routine coagulation testing. Results.—Statistically significant increases in prothrombin time and dimerized plasmin fragment D were observed in samples containing final lysate concentrations of 0.5% and 2.7% respectively, whereas significant decreases were observed in activated partial thromboplastin time and fibrinogen in samples containing a final lysate concentration of 0.9%. The current analytical quality specifications for desirable bias are ±2.0% for prothrombin time, ±2.3% for activated partial thromboplastin time, and ±4.8% for fibrinogen. Percent variations from the baseline values exceeding the current analytical quality specifications for desirable bias were achieved for lysate concentrations of 0.9% (prothrombin time and activated partial thromboplastin time) and 1.8% (fibrinogen), corresponding to average free plasma hemoglobin concentrations of 1.7 and 3.4 g/L, respectively. Conclusion.—Our results confirm that, although slightly hemolyzed specimens might still be analyzable, a moderate blood cell lysis, as low as 0.9%, influences the reliability of routine coagulation testing. Because the interference in coagulation assays has a wide interindividual bias, we do not recommend lysis correction and we suggest that the most appropriate corrective measure should be free hemoglobin quantification and sample recollection.

Vitamin D deficiency is a public healthcare issue and its correction is increasingly regarded as a cornerstone of preventive medicine.We designed a retrospective observational study to clearly define the burden of total vitamin D (25-hydroxyvitamin D) deficiency in a supposedly healthy population of outpatients residing in two regions (Emilia Romagna and Veneto) of Northern Italy.25-hydroxyvitamin D results were available for a total number of 5,096 outpatients in the two centers. The median value of 25-hydroxyvitamin D was 60 nmol/L, and was higher in women than in men (62 nmol/L versus 56 nmol/L; plt;0.001). The rate of 25-hydroxyvitamin D deficiency was 36%, and was marginally but significantly higher in men than in women (40% versus 35%; p=0.003). A significant variation in the rate of 25-hydroxyvitamin D deficiency was found throughout different age ranges, exhibiting a significant increase in the elderly.The results of this large observational study show that the burden of 25-hydroxyvitamin D deficiency in two regions of a Mediterranean country without a policy of food fortification is as high as 36%, and this evidence represents a background for healthcare preventive measures aimed at reducing the prevalence of this condition in the general population. (www.actabiomedica.it).

Introduction: The activities involving phlebotomy, a critical task for obtaining diagnostic blood samples, are poorly studied as regards the major sources of errors and the procedures related to laboratory quality control. The aim of this study was to verify the compliance with CLSI documents of clinical laboratories from South America and to assess whether teaching phlebotomists to follow the exact procedure for blood collection by venipuncture from CLSI/NCCLS H03-A6 - Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture might improve the quality of the process. Materials and methods: A survey was sent by mail to 3674 laboratories from South America to verify the use of CLSI documents. Thirty skilled phlebotomists were trained with the CLSI H03-A6 document to perform venipuncture procedures for a period of 20 consecutive working days. The overall performances of the phlebotomists were further compared before and after the training program. Results: 2622 from 2781 laboratories that did answer our survey used CLSI documents to standardize their procedures and process. The phlebotomists’ training for 20 days before our evaluation completely eliminated non-conformity procedures for: i) incorrect friction of the forearm, during the cleaning of the venipuncture site to ease vein location; ii) incorrect sequence of vacuum tubes collection; and iii) inadequate mixing of the blood in primary vacuum tubes containing anticoagulants or clot activators. Unfortunately the CLSI H03-A6 document does not caution against both unsuitable tourniquet application time (i.e., for more than one minute) and inappropriate request to clench the fist repeatedly. These inadequate procedures were observed for all phlebotomists. Conclusion: We showed that strict observance of the CLSI H03-A6 document can remarkably improve quality, although the various steps for collecting diagnostic blood specimens are not a gold standard, since they may still permit errors. Tourniquet application time and forearm clench should be verified by all quality laboratory managers in the services. Moreover, the procedure for collecting blood specimens should be revised to eliminate this source of laboratory variability and safeguard the quality.