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Maria Stella Graziani

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Martina Zaninotto

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Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

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Sergio Bernardini Italy
Marcello Ciaccio Italy
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Kjell Grankvist Sweden
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Eric Kilpatrick UK
Magdalena Krintus Poland
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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

Biochimica Clinica: VOL.43 N.2

Scarica intero fascicolo
Il consolidamento dei Servizi di Medicina di Laboratorio
Biochimica Clinica 2019; 43(2) 123-124
DOI: 10.19186/BC_2018.048
Pubblicato online il: 23.05.2019
Editoriale - Editorial
La tele-ematologia nel consolidamento dei laboratori clinici
Tele-haematology in the consolidation of clinical laboratories
D. Giavarina  |  M. Carta  | 

Haematological laboratory diagnostics couldbenefit widely from telematics, but some critical issues need to be addressed for a successful organization. Imagetransmission is probably the most critical item. In fact, specific competences are required for the selection of thesamples to be reviewed, preparing of the slides, choosing fields and cells to be examined, and so on. Thetransmission of the entire blood film could be a good solution, but it is not yet available for laboratory haematology,while expert automated systems are nowadays ready for high performance processes without the need of specificskills.
Digitization of laboratory haematology can harmonize the activities utilizing the same rules of selection of thepreparations to be reviewed, and for the control, verification and validation of the analysed samples and finally forreporting. It offers support for consultancy and training. When these needs involve different sites far from each other,the transmission of data and images effectively requires automation technologies for preparing and reading thepreparations, information technologies for an integrated management of all the necessary data helpful for thediagnosis and a suitable network to make communications travel in suitable quantities and speeds.
The new frontiers of artificial intelligence will probably have a greater role both in the management of process, in theverification of automatic validations, and finally in the recognition of pathological morphological patterns. All this toolscannot replace the specialized expertise in the final supervision of haematological diagnoses, but will allow simpler,faster and safer management of haematological analyses and revisions, meeting the changing needs of modernlaboratory medicine.

TAG: Intelligenza artificisle   ematologia   automazione  
Biochimica Clinica 2019; 43(2) 125-134
DOI: DOI: 10.19186/BC_2019.032
Pubblicato online il: 16.04.2019
Rassegne - Reviews
Garantire la comparabilità dei risultati nel rispetto dei requisiti di qualità e delle esigenze organizzative: l’esempio di una procedura operativa
How to guarantee the comparability of test results in compliance with the quality requirements andorganizational needs: the example of an operative procedure

Medical laboratories are responsible for the qualityof test results, also when the same patient sample is evaluated using different analytical systems within the same lab.Indeed, as stated by ISO 15189:2012, laboratories should define means to compare procedures for evaluating thecomparability of patients’ samples results within the same healthcare system. In this study we report the approachused to define a procedure for assessing results comparability, developed in our laboratory before the ISO15189:2012 accreditation in 2016. Firstly, the approach was focused on the identification of all the different situationsthat may potentially require alignment of test results within the laboratory. Therefore, after evaluating guidelines anddocuments available in the literature, we defined a workflow applicable both to quantitative and qualitative methods.For quantitative methods, bias was estimated by means of statistical analyses such as Bland Altman and PassingBablok. For qualitative methods, results comparability was assessed by concordance. Criteria for defining theacceptability of systematic errors were also included in the procedure.

TAG: accreditamento   flusso di lavoro   sistema analitico  
Biochimica Clinica 2019; 43(2) 135-142
DOI: 10.19186/BC_2019.016
Pubblicato online il: 12.04.2019
Contributi Scientifici - Scientific Papers
Analisi di laboratorio in un Punto di Primo Intervento: l’esperienza di sei anni di Point-of-Care Testing
Diagnostic test in a First Aid Point Service: a six years Point-of-Care Testing experience
G. Micca  |  G. Patrucco  | 

For many yearslaboratory medicine services have been focused on reorganization interventions aimed at improving efficiency, inorder to respond to new care needs and to reduce costs. In some situations, when the centralized laboratory is notable to guarantee the service with an adequate timeliness, a Point-Of-Care Testing system designed for the clinicalmanagement of critically ill patients could be the solution. These systems can guarantee the immediate availability ofdiagnostic tests for diagnosis, monitoring and therapy, both for critical ill patients and for the continuity of health-care.
In this paper a six years’ experience of a Point-of-Care Testing implementation and management is described in aFirst Aid point service, in a particular territorial health-network created to guarantee continuity between the referencelaboratory and the local hospitals.

TAG: Laboratorio clinico   sistemi analitici   parametri analitici  
Biochimica Clinica 2019; 43(2) 143-149
DOI: DOI: 10.19186/BC_2019.022
Pubblicato online il: 16.04.2019
Contributi Scientifici - Scientific Papers
La fase pre-analitica dei campioni provenienti dal Pronto Soccorso: impatto della introduzione di un impianto di posta pneumatica nel miglioramento del tempo di risposta
Improving pre-analytical laboratory turnaround time for the emergency department: outcomes of a pneumatic tube system introduction

Background: the pre-analytical phase of the stat tests requested by the Emergency Department (ED) has been rarelystudied in relation to the containment of the laboratory turnaround time (TAT).
Methods: through a pre-analytical workflow analysis in a large ED with "Lean" methodology, some improvementshave been activated, including the installation of a pneumatic tube system (PTS).
Results: significant improvement of TATs (23 minutes at 90th percentile) and also of length of stay (LOS) of EDpatients (53 minutes at 90th percentile) has been documented. The plasma concentrations of a number of analytesmeasured in samples transported manually and by PTS were very similar (lactic dehydrogenase excluded),demonstrating that PTS does not alter the integrity of the samples.
Conclusions: compared to manual transportation, the use of this PTS significantly reduced transport time and alsoimproved some pre-analytical flow phases within the ED. The system is suitable for the measurement of most of theanalytes commonly requested for ED patients.

TAG: Turnaround time   Posta pneumatica   fase pre-analitica  
Biochimica Clinica 2019; 43(2) 150-155
DOI: DOI: 10.19186/BC_2019.036
Pubblicato online il: 16.04.2019
Contributi Scientifici - Scientific Papers
Laboratorio clinico: non sempre più grande è migliore
Clinical laboratories: not always bigger is better.
M. Plebani  | 

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.

TAG: laboratory medicine   values   performances  
Biochimica Clinica 2019; 43(2) 156-161
DOI: 10.19186/BC_2018.066
Pubblicato online il: 15.11.2018
Opinioni - Opinions
Gli esami urgenti nel consolidamento dei laboratori: analisi decentrate, “Point-of-Care and Near-Patient testing”
Urgent testing and laboratory consolidation: Extra-laboratory, Point-of-care and Near-Patient testing.
M. Plebani  | 

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.

TAG: Organizzazione laboratorio clinico   armonizzazione   esami di laboratorio  
Biochimica Clinica 2019; 43(2) 162-167
DOI: 10.19186/BC_2019.011
Pubblicato online il: 14.03.2019
Opinioni - Opinion
La valutazione delle prestazioni analitiche dei laboratori mediante programmi di valutazione esterna di qualità: una analisi multifattoriale
The evaluation of laboratories’ analytical performance through external quality assessment programs: amultifaceted analysis

The Italian accreditation body, Accredia, requires that clinical laboratories obtained positiveanalytical performances in the last four External Quality Assessment (EQA) surveys in order to undertake theaccreditation with flexible scope (document RT-26).
In addition to the choice of acceptability limits (AL), other factors contribute to define the analytical performance:nature and commutability of control materials, definition of target value (TV), homogeneous group classification, dataelaboration, procedures for outliers exclusion.
In this study, the creatinine performances of 106 participants, obtained in the last four surveys of the year 2017 ofthe Centre of Biomedical Research (CRB) EQA program, have been evaluated using two different AL and TV: the ALproposed by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and by the RegionalReference Centre of the Azienda Ospedaliera Universitaria “Careggi” of Firenze (Italy) (CRRVEQ); the TV assignedwith the reference method (RV) and as consensus value, i.e. median of the results obtained with the same method(AV).
The percentage of laboratories satisfying the RT-26 requisite was different on the basis of the AL and TV considered:with the EFLM-AL, 68.8 % laboratories complied the requisite if AV was used and 60.4% if RV was applied; with theCRRVEQ-AL, 50.0% and 48.1%, respectively.
These data demonstrate that harmonized criteria and procedures for evaluation of EQA results are needed to obtainhomogeneous classification of laboratories’ performance.
In order to support the laboratory professionals in accreditation processes and, above all, to guarantee theirperformance reliability, time has come that the Scientific Societies of Laboratory Medicine promote the merging of thedifferent Italian EQA schemes in a consolidated network of EQA providers.

TAG: Accreditamento   sistemi di qualità   prestazioni analitiche  
Biochimica Clinica 2019; 43(2) 168-172
DOI: DOI: 10.19186/BC_2019.035
Pubblicato online il: 16.04.2019
Opinioni - Opinion
Il contributo dell’automazione alla qualità del consolidamento nei servizi di medicina di laboratorio
Automation is a sound enabler for clinical laboratory consolidation
G. Minola  | 

Consolidation is a modern phenomenonthat is heavily affecting all economic segments and healthcare as well, where the mergers and acquisitions carriedout by the big pharma vendors are followed by care providers that are consolidating into big groups. As part ofhospitals and institutions, clinical laboratories are impacted by this trend and must deliver more results with fewerresources. On this scenario, automation is a tremendous booster for clinical laboratories, since it can speed up thewhole process, offering shorter turnaround times, improving staff motivation, increasing workflow control, reducingfootprint. This opinion paper offers a summary of the many advantages provided by the automation of processes inthe different steps of the specimen workflow inside the laboratory.

TAG: Automazione   flusso di lavoro   laboratorio clinico  
Biochimica Clinica 2019; 43(2) 173-177
DOI: 10.19186/BC_2019.045
Pubblicato online il: 23.05.2019
Opinioni - Opinions
Siero o plasma? Un quesito non nuovo che attende risposte nuove
Serum or plasma? An old question awaiting for new answers.

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.

TAG: Matrice biologica   matrice sierica   matrice plasmatica  
Biochimica Clinica 2019; 43(2) 178-186
DOI: 10.19186/BC_2018.069
Pubblicato online il: 26.11.2018
Documenti - Documents
Raccomandazioni FISMeLab per il trasporto del materiale biologico
C. Ottomano  | 

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.

TAG: Biological sample transportation   Biological sample stability   Time and temperature  
Biochimica Clinica 2019; 43(2) 187-199
DOI: 10.19186/BC_2018.070
Documenti SIBioC - Italian Federation of Laboratory Medicine Societies (FISMeLab) recommendations for biological samples transportation
Raccomandazione congiunta EFLM-COLABIOCLI per il prelievo di sangue venoso
Joint EFLM-COLABIOCLI Recommendation for venous blood sampling

This document provides a joint recommendation for venous blood sampling of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) and Latin American Working Group for Preanalytical Phase (WG-PRE-LATAM) of the Latin America Confederation of Clinical Biochemistry (COLABIOCLI). It offers guidance on the requirements for ensuring that blood collection is a safe and patient-centered procedure and provides practical guidance on how to successfully overcome potential barriers and obstacles to its widespread implementation. The target audience for this recommendation are healthcare staff members directly involved in blood collection. This recommendation applies to the use of a closed blood collection system and does not provide guidance for the blood collection with an open needle and syringe and catheter collections. Moreover, this document neither addresses patient consent, test ordering, sample handling and transport nor collection from children and unconscious patients. The recommended procedure is based on the best available evidence. Each step was graded using a system that scores the quality of the evidence and the strength of the recommendation. The process of grading was done at several face-to-face meetings involving the same mixture of stakeholders stated previously. The main parts of this recommendation are: 1) Pre-sampling procedures, 2) Sampling procedure, 3) Postsampling procedures and 4) Implementation. A first draft of the recommendation was circulated to EFLM members for public consultation. WG-PRE-LATAM was also invited to comment the document. A revised version has been sent for voting on to all EFLM and COLABIOCLI members and has been officially endorsed by 33/40 EFLM and 21/21 COLABIOCLI members. We encourage professionals throughout Europe and Latin America to adopt and implement this recommendation to improve the quality of blood collection practices and increase patient and workers safety.

TAG: Identificazione del paziente   fase pre-analitica   preparazione del paziente  
Biochimica Clinica 2019; 43(2) 200-227
DOI: 10.19186/BC_2019.012
Pubblicato online il: 15.03.2019
Protocollo operativo per la verifica della comparabilità dei risultati di laboratorio ottenuti su più procedure analitiche
Protocol to verify the comparability of quantitative laboratory results obtained with different measurementprocedures.

With the growth and merging of clinical laboratories, very frequently analytical tests are performed onmultiple instruments within one or multiple locations. In these situations, there is the need of verifying thecomparability of patient results obtained with different analysers and/or different measurement procedures. Theimportance of this verification is further emphasised when considering that it is included into the ISO 15189specifications. This protocol provides step-by-step guidance on how to assess results comparability in differentscenarios. Up to four experimental designs are presented to meet laboratories’ needs, with details and examples onfrequency of testing, definition of acceptability criteria, samples selection, sample size calculation, statistical analysisand reporting.

TAG: Laboratorio Clinico   criteri di accetabilità   esami di laboratorio  
Biochimica Clinica 2019; 43(2) 228-243
DOI: 10.19186/BC_2019.047
Pubblicato online il: 23.05.2019
Documenti SIBioC - SIBioC Documents
Approccio alla chimica clinica
S. Brenna  | 

Il volume APPROCCIO ALLA CHIMICA CLINICA di Lorenzo Prencipe si presenta nella forma di un trattato,con l’intento quindi di toccare tutti gli argomenti inerentila disciplina della Chimica Clinica anche se in formato necessariamente compatto.

Biochimica Clinica 2019; 43(2) 244
Pubblicato online il: 21.03.2019
Recensioni - Book Review
Lab Tests Online: un successo che parte da lontano
M. Berardi  | 
Biochimica Clinica 2019; 43(2) 245-247
DOI: 10.19186/BC_2019.013
Pubblicato online il: 12.04.2019
Notizie SIBioC - SIBioC News
In memoria del Professor Howard A. Morris
Biochimica Clinica 2019; 43(2) 248
Pubblicato online il: 29.04.2019
Notizie SIBioC - SIBioC News
2019 AACC Outstanding Contributions Through Service to the Profession of Clinical Chemistry Award
Biochimica Clinica 2019; 43(2) 249
Pubblicato online il: 29.04.2019
Notizie SIBioC - SIBioC News
Astenia e urine intensamente colorate: una associazione da indagare attentamente
Asthenia and extremely colored urine: an association to be investigated carefully

Autoimmune hemolyticanemia (AIHA) is a relatively rare disease where red blood cells are selectively destroyed by auto-antibodies. Ingeneral, direct antiglobulin test (DAT) is the test used for confirmation even if there are other markers to guide thedifferential diagnosis and to evaluate the degree of hemolysis. We present a case of severe warm-type AIHA occurredin a thirty-six year old man with initial symptoms of asthenia and dark urine. The case shows how specialists inlaboratory medicine can play a fundamental role in the diagnostic process through an appropriate use of the tests,speeding up the management of the patient, improving thus the prognosis.

TAG: Emolisi   anemia emolitica autoimmune   test di Coombs   auto-anticorpi  
Biochimica Clinica 2019; 43(2) e009-e011
DOI: DOI: 10.19186/BC_2019.023
Pubblicato online il: 16.04.2019
Casi Clinici - Case Report
Un effettivo vantaggio dello screening neonatale allargato
A real benefit of an extended neonatal screening

Methylenetetrahydrofolate Reductase (MTHFR) deficiency, is avery rare congenital defect of folate metabolism, inherited in an autosomal recessive pattern included in newbornscreening (NBS) programs in Italy. It is caused by mutations in the MTHFRgene and is characterized by elevatedplasma homocysteine and borderline-low or normal methionine levels, causing severe neurological signs, recurrentapnoea, microcephaly and convulsions, generally during the neonatal period. An early treatment may prevent theclinical manifestations with a positive impact on patient’s health.
We report a new case of MTHFRdeficiency, identified during NBS that showed hypomethioninemia 4.6 μmol/L (r.i.6-20). The second level-test revealed hyperhomocysteinemia (106.7 μM, r.i. 5-15). The whole sequencing of theMTHFRgene showed two missense mutation: c.176G>C (p.Trp59Ser), reported as disease causing and the novelc.1769T>G (p.Leu590Arg), classified as likely pathogenetic. The baby was immediately treated with vitamin B12,folate and betaine; after 12 months of follow-up he has no signs or symptoms of the disease.
In conclusion, this case report highlights the importance of NBS for inborn errors of metabolism and genetic analysis,that can prevent the establishment of a serious disorder of folate metabolism.

TAG: Iperomocisteinemia   acido folico   mutazione  
Biochimica Clinica 2019; 43(2) e12-e16
DOI: DOI: 10.19186/BC_2019.028
Pubblicato online il: 16.04.2019
Casi Clinici - Case Report
Utilità dell’esame citologico del liquido cerebrospinale
Clinical utility of cerebrospinal fluid cytological examination

Cerebrospinal fluid (CSF) of a 64 year old malepatient was sent from the hematology unit to laboratory for cell count and morphology and chemical-physicalexamination. CSF was clear, colourless and with increased total protein concentration. Cell count was first performedin Burker camera with a result of 40/μL; some of the cells showed an abnormal morphology. Our laboratory workflowincludes the CSF examination utilizing an automatic cell counter: it showed a few white blood cells (3/μL), but a highnumber of total cells (64/μL). The morphological evaluation, with cytocentrifugation and May-Grunwald Giemsa stain,identified the elements as mature plasma cells; the result was then confirmed by immunophenotyping.
These findings suggest a neurological localization of a multiple myeloma (MM). Actually, the patient had beendiagnosed as IgA lambda MM, with bone involvement that caused progressive loss of walk. Positron EmissionTomography revealed hyperdense areas, but it wasn’t able to distinguish between lymphoproliferative disease andthrombotic phlogosis. In spite of the therapy, patient neurological conditions worsened till irreversible coma. He dieda few days later.

TAG: Mieloma Multiplo   immunofenotipizzazione   plasmacellule  
Biochimica Clinica 2019; 43(2) e17-e19
DOI: DOI: 10.19186/BC_2019.029
Pubblicato online il: 16.04.2019
Casi Clinici - Case Report
Paziente pediatrico con oliguria e adenopatia cervicale: il ruolo degli analizzatori a cattura di immagine per l’esame standard delle urine
Urinalysis in a pediatric patient with oliguria and cervical lymphadenopathy: role of automated imageanalysis systems.

Automated urinalysis instruments image-based for cell analysis can identify non-squamousepithelial cells (NSE). Among these elements, expert pathologists can distinguish the so called Decoy Cells (DC),Polyomavirus BK (BKV)-infected elements primarily seen in immunocompromised patients. Epstein-Barr virus (EBV)infection can induce a transient immunosuppression in immunocompetent patients, and this could lead to areactivation of a latent BKV infection in urothelial cells: this is a rare event in pediatric patients. This study reports thecase of a 4 year-old child with lateral lymphadenopathy, fever and oliguria. Automated urinary sediment analysisevidenced the presence of many NSEs identifed as DC, generating a subsequent virological investigation with a finaldiagnosis of concomitant BKV and EBV infection. The combination of an automated technology, an efficientmiddleware and the expertise of the laboratory professionals , allowed the proper identification of these peculiarreactive elements, which could easily be mistaken for malignant atypical cells.

TAG: Linfoadenopatia   virus Epstein-Barr   poliomavirus BK  
Biochimica Clinica 2019; 43(2) e20-e23
DOI: DOI: 10.19186/BC_2019.030
Pubblicato online il: 16.04.2019
Casi Clinici - Case Report