The preanalytical phase is crucial for assuring the quality of in vitro diagnostics. The leading aspects which contribute to enhance the vulnerability of this part of the total testing process include the lack of standardization of different practices for collecting, managing, transporting and processing biological specimens, the insufficient compliance with available guidelines and the still considerable number of preventable human errors. As in heavy industry, road traffic and aeronautics, technological advancement holds great promise for decreasing the risk of medical and diagnostic errors, thus including those occurring in the extra-analytical phases of the total testing process. The aim of this article is to discuss some potentially useful technological advances, which are not yet routine practice, but may be especially suited for improving the quality of the preanalytical phase in the future. These are mainly represented by introduction of needlewielding robotic phlebotomy devices, active blood tubes, drones for biological samples transportation, innovative approaches for detecting spurious hemolysis and preanalytical errors recording software products.
The role and responsibilities of laboratory managers have considerably evolved during the past decades. This revolution has been mostly driven by biological, technical, economic and social factors, such as deepened understanding of the pathophysiology of human diseases, technical innovations, renewed focus on patient safety, cost-containment strategies and patient empowerment. One of the leading consequences is an ongoing process of reorganization, consolidation and automation of laboratory services, whose propitious realization strongly relies on establishing an efficient project management plan. In a practical perspective, the leading drivers of project management in laboratory medicine encompass various activities supporting a clear definition of the local environment, an accurate planning of technical resources, the acknowledgement of staff availability and qualification, along with the establishment of a positive and constructive interplay with hospital administrators. Therefore, the aim of this article is to provide a personal overview on the main drivers and outcomes of project management in laboratory medicine, which will expectedly contribute to construct a new consciousness and an innovative and multifaceted job description of laboratory professionals worldwide.
Giuseppe Lippi, Laura Chiozza, Camilla Mattiuzzi and Mario Plebani
Background: Patient and sample misidentification may cause significant harm or discomfort to the patients, especially when incorrect data is used for performing specific healthcare activities. It is hence obvious that efficient and quality care can only start from accurate patient identification. There are many opportunities for misidentification in healthcare and laboratory medicine, including homonymy, incorrect patient registration, reliance on wrong patient data, mistakes in order entry, collection of biological specimens from wrong patients, inappropriate sample labeling and inaccurate entry or erroneous transmission of test results through the laboratory information system. Many ongoing efforts are made to prevent this important healthcare problem, entailing streamlined strategies for identifying patients throughout the healthcare industry by means of traditional and innovative identifiers, as well as using technologic tools that may enhance both the quality and efficiency of blood tubes labeling. The aim of this article is to provide an overview about the liability of identification errors in healthcare, thus providing a pragmatic approach for diverging the so-called patient identification crisis.
Giuseppe Lippi, Ruggero Buonocore, Michele Mitaritonno and Gianfranco Cervellin
Background: We performed a retrospective case-control study to assess the values of cardiac troponin I (cTnI) in a large number of patients admitted to the emergency department (ED) with different types of trauma.
Methods: The study population consisted of all patients aged 18 years or older admitted to the local ED with all types of traumas over a 1-year period. Results of cTnI were compared with those of 125 consecutive blood donors and 25 non-cardiac chest pain ED patients.
Results: The final study population consisted of 380 trauma patients, 10 with isolated abdominal trauma, 99 with isolated trauma of the limbs, 49 with isolated chest trauma, 145 with isolated head trauma and 77 with polytrauma. The concentration of cTnI did not differ among the three study populations, but the frequency of measurable values was substantially higher in patients with trauma (63%) than in blood donors and non-cardiac chest pain ED patients (both 20%). The frequency of cTnI values above the 99th percentile of the reference range was significantly higher in trauma patients (20%) than in blood donors (0%) and noncardiac chest pain ED patients (8%). Increased cTnI values were more frequent after head trauma (21%), chest trauma (27%) and polytrauma (29%) compared to patients with abdominal (0%) or limbs trauma (8%).
Conclusions: These results suggest that the measurement of cardiac troponin may be advisable to identify potential cardiac involvement in trauma patients, especially in those with polytrauma and head or chest trauma.
Gian Luca Salvagno, Davide Demonte, Matteo Gelati, Giovanni Poli, Emmanuel J. Favaloro and Giuseppe Lippi
This study aimed to verify whether blood drawn into six different commercial coagulation tubes generated comparable results of thrombin generation.
Blood was sequentially collected from 20 healthy subjects into different brand and draw volume 3.2% sodium citrate tubes (4.3 mL Sarstedt, 3.0 mL Greiner, 2.7 mL Becton Dickinson, 2.0 mL Kima, 1.8 mL Sarstedt and 1.0 mL Greiner). Thrombin generation was measured in plasma with the fully-automated ST Genesia analyzer using the weakest trigger (STG-BleedScreen).
Different values of lag time (LT), time to reach thrombin peak (TP), thrombin peak height (PH) and endogenous thrombin potential (ETP) were commonly found in different tubes. Thrombin generation was the lowest in 4.3 mL Sarstedt tubes and the highest in 1.0 mL Greiner tubes. Other tubes displayed intermediate values. In multiple comparisons, LT was significantly different in 6/15 cases (40%), whilst PH, TP and ETP were significantly different in 14/15 (93%), 13/15 (87%) and 13/15 (87%) cases. The mean percent bias of LT, PH, TP and ETP ranged between -6% and +1%, -27% and +116%, -22% and +8%, and between -18% and +65%. The intra-assay imprecision of LT, PH, TP and ETP was exceeded in 0/15 (0%), 13/15 (87%), 6/15 (40%) and 13/15 (87%) comparisons. The correlation of LT, PH, TP and ETP values in different tubes ranged between 0.718–0.971, 0.570–0.966, 0.725–0.977 and 0.101–0.904.
Blood collection for thrombin generation assays requires local standardization using identical tubes for brand and draw volume, and reference ranges calculated according to type of tubes.
Gian Franco Veraldi, Luca Mezzetto, Lorenzo Scorsone, Marco Macrì, Fabio Simoncini and Giuseppe Lippi
The identification of patients at higher risk of developing percutaneous transluminal angioplasty (PTA)-related complications is pivotal for achieving better clinical outcomes. We carried out a single-center, observational, retrospective study to explore whether in-hospital changes of red blood cell distribution width (RDW) may help predicting early development of PTA-related complications.
The study population consisted of all consecutive patients who underwent PTA for severe peripheral artery occlusive disease (PAOD) during a 2-year period. RDW was measured at hospital admission and discharge, and the delta was calculated. Patient follow-up was routinely performed 1-month after hospital discharge, and was based on thoughtful medical assessment and arterial ultrasonography. The control population consisted of 352 ostensibly healthy subjects.
The final PTA group consisted of 224 patients. Hemoglobin was lower, whilst mean corpuscular volume (MCV) and RDW were higher in PAOD cases than in controls. Overall, 11 PAOD patients (4.9%) developed clinically significant PTA-related complications 1-month after hospital discharge. Patients who developed 1-month PTA-related complications had lower hemoglobin concentration, but higher RDW and delta RDW than those who did not. Patients with delta RDW >1 had 60% higher risk of developing 1-month PTA-related complications and 88% higher risk of developing early reocclusion. Overall, RDW exhibited an area under the curve (AUC) of 0.68 and 0.74 for predicting 1-month PTA-related complications and early reocclusion, respectively.
The results of this study suggest that RDW may play a role for guiding the clinical decision making of PTA patients immediately after hospital discharge.
Gianni Turcato, Gianfranco Cervellin, Gian Luca Salvagno, Eleonora Zaccaria, Giuseppe Bartucci, Marco David, Antonio Bonora, Massimo Zannoni, Giorgio Ricci and Giuseppe Lippi
Background: Universally accepted and validated instruments for predicting the outcome of patients presenting to the emergency department (ED) with severe dyspnoea do not exist so far, nor are they regularly used by the emergency physicians. This study hence aimed to establish whether red blood cell distribution width (RDW) may be a predictive parameter of 1-year mortality in a population of patients admitted to the ED with severe dyspnoea attributable to different underlying disorders.
Methods: We retrospectively evaluated all the patients undergoing arterial blood gas analysis for severe dyspnoea (irrespective of the cause) during admission to ED of University Hospital of Verona from September 1, 2014 to November 31, 2014.
Results: The final study population consisted of 287 patients for whom complete clinical and laboratory information was available. Overall, 36 patients (12.5%) died after a 1-year follow-up. The RDW value was found to be considerably increased in patients who deceased during the follow-up compared to those who survived (17.2% versus 14.8%; p<0.001). In both univariate and multivariate analyses, the RDW value was found to be a significant predictor of 1-year mortality. In particular, patients with RDW ≥ 15.0% displayed a 72% increased risk of 1-year mortality after multiple adjustments.
Conclusions: The measurement of RDW, a very simple and inexpensive laboratory parameter, may represent an important factor for predicting medium-term mortality in patients presenting to the ED with severe dyspnoea.
Patrizia Bonelli, Ruggero Buonocore, Rosalia Aloe and Giuseppe Lippi
Background: The measurement of vitamin D is now commonplace for preventing osteoporosis and restoring an appropriate concentration that would be effective to counteract the occurrence of other human disorders. The aim of this study was to establish whether blood sampling seasonality may influence total vitamin D concentration in a general population of Italian unselected outpatients.
Methods: We performed a retrospective search in the laboratory information system of the University Hospital of Parma (Italy, temperate climate), to identify the values of total serum vitamin D (25-hydroxyvitamin D) measured in outpatients aged 18 years and older, who were referred for routine health check-up during the entire year 2014.
Results: The study population consisted in 11,150 outpatients (median age 62 years; 8592 women and 2558 men). The concentration of vitamin D was consistently lower in samples collected in Winter than in the other three seasons. The frequency of subjects with vitamin D deficiency was approximately double in samples drawn in Winter and Spring than in Summer and Autumn. In the multivariate analysis, the concentration of total vitamin D was found to be independently associated with sex and season of blood testing, but not with the age of the patients.
Conclusions: According to these findings, blood sampling seasonality should be regarded as an important preanalytical factor in vitamin D assessment. It is also reasonable to suggest that the amount of total vitamin D synthesized during the summer should be high enough to maintain the levels > 50 nmol/L throughout the remaining part of the year.
Arialdo Vernocchi, Ermanno Longhi, Giuseppe Lippi and Silvia Gelsumini
Background: Identification, quantification and typing of MProteins (MP) play an important role in the diagnosis, classification and monitoring of monoclonal gammopathies both of malignant origin (eg. Multiple Myeloma) and of unknown origin. Previous evidence attests that MGUS (Monoclonal Gammopathy of Undetermined Significance) detected by agarose gel electrophoresis has a prevalence of 3.2% in the general population. Therefore, our study aimed to verify this data by means of capillary zone electrophoresis (CZE).
Methods: CZE was performed to evaluate the prevalence of M-Protein (MP) in 44.474 consecutive outpatients of all ages with a prescription for serum protein electrophoresis over a 2-year period (2008 and 2009). All MPs that were identified were then typed by immunofixation electro pho - resis on agarose gel (IFE).
Results: In subjects aged over 50 (23.408, i.e., 52.6% of the whole cohort) MP ≤30 g/L (MGUS) was identified in 6.0% of cases, with a frequency nearly double than that previously reported. The population was then divided into ten-year age groups: the 71-80 age group had the highest percentage of MP (29%), followed by 61-70 (27%), 51-60 (18%), 81-90 (12%), 41-50 (8%), 31-40 (3%), >90 (2%) and <30 (1%). The frequency of MP types (IFE) was the same in each age group, with IgG Kappa being the most represented class.
Conclusions: According to the high MGUS prevalence observed in this study, these results may be useful especially for general practitioners, because the identification even of small MP (analytical sensitivity: 0.5 g/L) may help optimize clinical management.