Maria Stella Graziani

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Giampaolo Merlini
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Paola Pezzati
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Matteo Vidali

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BC: Articoli scritti da F. Balboni

Il Grading of Recommendations Assessment Development and Evaluation(GRADE) quale metodologia sistematica e trasparente per valutare l’esame di laboratorio nella formulazione di raccomandazioni e linee guida
The Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology assystematic and transparent framework to evaluate diagnostic test value in supporting guide lines andrecommendations issuing.
<p>A multidimensional pathway based on GRADE Evidence to Decision (EtD) frameworkis presented. The aim of the document is to define a valid process to assess the adoption of a diagnostic test and theconsequences of the decision. The framework includes three sections reflecting the main steps of GRADE EtD:formulating the relevant question, making an assessment of the evidence, and drawing conclusions. As a matter ofexample, the EtD framework is used to present the evidence concerning the molecular diagnosis of sepsis inneonates including seven dimensions: (1) formulating the question; (2) assessment of diagnostic test accuracy; (3)certainty of the evidence; (4) effects of test on the main patient outcome; (5) balance between the desirable andundesirable effects; (6) resource use; (7) equity, acceptability and feasibility. The example is used to better elucidatethe concepts and to show how reviewers may complete each dimension with the relevant information avaiable.Several factors could influence the final decisions: the relevance of the problem, the values of diagnostic accuracy,the effects of the test on main patient outcome; other issues may play a role. The framework consists of acomprehensive decision aid model to ensure that all important criteria are considered to explain a judgment. Thisapproach could help health professionals to use the best available research evidence in a structured and transparentway to inform decisions in the context of laboratory medicine.</p>
Biochimica Clinica ; 43(1) 076-089
Documenti - Documents
Medicina di laboratorio e Medicina d’urgenza: un connubio indissolubile
Laboratory Medicine and Emergency Medicine: an essential partnership
<p>Laboratory Medicine and Emergency Medicine: an essential partnership. A better understanding of the pathophysiological bases of many pathologies, along with the considerable technological advances occurred over last few years, have allowed to broaden number and complexity of in vitro diagnostic tests. The emergency department is the clinical setting with the highest risk of forensic disputes, and this explains the inclination that many emergency physicians have towards defensive medicine. Disproportionate request of laboratory tests, with poor awareness on the impact of inappropriateness, is one of the leading negative aftermath of this attitude. The predictable consequences are economic, but also encompass the risk of generating direct damage to the patients, especially in the presence of false positive test results. Since diagnostic appropriateness represents an essential element for patient safety and for sustainability of the National Healthcare System, the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and the Academy of Emergency Medicine and Care (AcEMC) have organized a joint meeting entitled &quot;Laboratory Medicine and Emergency Medicine: an essential partnership&quot;, of which this document is a summary. The issues that have been discussed represent major diagnostic dilemmas faced by emergency physicians, and for which the contribution of laboratory medicine may be decisive. These include acute systemic infections, acute abdominal pain, acute chest pain, head injury and acute bleeding. Since timely transmission of test results is an additional critical element for the clinical decision making in emergency settings, the document will also include considerations on sample transportation from the emergency room to the laboratory.</p>
Biochimica Clinica ; 42(4) 335-342
Documenti - Documents
Sicurezza del paziente e rischio clinico nel processo ematologico di laboratorio
Patient safety and clinical risk in the clinical laboratory haematological process
<p>&nbsp;Patient safety, defined as the prevention of harm to patients, is the ultimate goal for medical laboratories. Risk management principles should therefore be considered an integral part of laboratory processes, especially of those activities directly impacting on patient care. This work aims to identify the most critical phases of haematological process and the risk reduction actions that improve patient safety. Risk analysis of the laboratory haematological process was carried out through Failure Mode, Effects and Analysis Criticality methodology. A form including the phases of the process, error modes and their possible effects, errors occurrence, detectability and severity scores and risk index (RI), has been prepared and sent to eight Italian laboratories. A multidisciplinary team performed the analysis in each laboratory, then two team leaders of the project comprehensively analysed the collected data. The process was divided in 8 phases (medical prescription, request acceptance, sample collection, transportation, reception and processing, results reporting and validation), 25 activities (17 pre-analytical, 4 intra-analytical, 4 post-analytical) and 43 failure modes. RI, calculated for each activity, ranged from 11 to 33. The most critical topics (RI &gt;25) were: patient identification, peripheral blood smear review, interpretative comments and report validation. Staff training plays a central role in the entire laboratory haematological process and in the phases identified as critical. An effective management related to the attainment and maintenance of skills represents the best action in order to reduce risks of adverse events for patients. The promotion of procedures aimed to harmonize the interpretative comments and peripheral blood smear review is also pivotal</p><p>&nbsp;</p>
Biochimica Clinica ; 42(4) 300-312
Contributi Scientifici - Scientific Paper
La gestione del rischio clinico in medicina di laboratorio: risultati del questionario congiunto SIBioC-Medicina di Laboratorio e Società Italiana di Ergonomia (SIE) inviato ai laboratori della Regione Toscana
Misidentification in laboratory medicine: results of the Tuscany survey of the Clinical Risk Management Study Group SIBioC and the Italian Society of Ergonomy (SIE)
<p>In the year 2016 the Study Group on Clinical Risk Management of the SIBioC-Laboratory Medicine Society issued a joint survey with the Italian Society of Ergonomics (SIE); the survey was sent to all the clinical laboratories of the Tuscany Region in Italy. This survey had the aim to understand the level of awareness of the clinical laboratory about the clinical risk management, particularly in the patient misidentification field. The results show a very variable consciousness of the problem among different laboratories, with a very multi-faced approach to this important topic. More than the 93% of the participants state that the errors on misidentification are always registered and in the 80% the consequent actions are tracked.</p>
Biochimica Clinica ; 42(2) 141-145
Contributi Scientifici - Scientific papers
Raccomandazioni per l’identificazione e la gestione dei risultati critici nei laboratori clinici
Recommendations for the detection and management of critical results in clinical laboratories
<p>Critical results, (also known as panic or alarm results) identify a laboratory test result associated with a serious risk for the patient&rsquo;s health, requiring immediate communication to the physician to establish appropriate therapeutic interventions. The adoption of an efficient procedure for the communication of critical values/results is crucial for clinical, ethical, organizational reasons, because it is a requirement for laboratory accreditiation and because of potential legal consequences related to the lack of notification of harmful laboratory results. In 2008, the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) published its first consensus-based recommendation for the detection and management of critical values in clinical laboratories, with the aim to improve the implementation of standardized and universally accepted procedures, promoting an essential policy toward rational and efficient solutions to this issue. These new recommendations represent a complete review of the first document. Using the same consensus conference method between experts of scientific societies, the main aspects of clinical risk, patient safety and legal liability of health care workers were re-considered. The SIBioC and the Italian Society of Laboratory Medicine (SIPMeL), Intersociety Study Group on Standardization of extra-analytical variability of laboratory results, together with the Italian Society of Ergonomics and Human Factors (SIE) collaboration, issued the present join document.</p>
Biochimica Clinica ; 42(2) 167-179
Documenti SIBioC - SIBioC Documents
Documento di consenso SIBioC-Medicina di Laboratorio e Academy of Emergency Medicine and Care (AcEMC) sull’utilizzo in Pronto Soccorso dei biomarcatori per la diagnosi di sepsi batterica
Biomarkers for diagnosing sepsis in the emergency department: a consensus document by SIBioCMedicina di Laboratorio and the Academy of Emergency Medicine and Care
<p>This article is drafted as a consensus document involving eight members of the Italian Society of Clinical Biochemistry and Laboratory Medicine (SIBioC) and eight members of the Academy of Emergency Medicine and Care (AcEMC), to whom a questionnaire was submitted for obtaining opinions on some recommendations about the use of biomarkers for diagnosing sepsis and managing antibiotic therapy in the emergency department. These recommendations were drafted following the National Guidelines Program (PNLG). According to the cumulative consent, three &quot;A&quot; recommendations (strongly recommended indication) emerged, which include biomarker availability (always available on prescription), clinical use (always interpreted in according to clinical data) and timing of the request based on half-life of the analyte. Recommendations of type &quot;B&quot; (indications carefully considered) included a general agreement about the clinical usefulness of sepsis biomarkers, the combination of procalcitonin (PCT) and Creactive protein (CRP), the possibility to be free on prescription to the laboratory, the use of cut-offs favoring a high negative predictive value, the use of more analytically sensitive assays and the possibility of using PCT for monitoring antibiotic therapy, with timing of ordering defined according to the metabolism of the analyte. As regards the specific biomarkers, a similar &ldquo;B&rdquo; consensus has been reached for measuring both PCT and CRP, and for measuring lactic acid. The measurement of other biomarkers is discouraged except for presepsin, for which there is still substantial uncertainty in favor or against.</p>
Biochimica Clinica ; 42(1) 62-73
Documenti SIBioC - SIBioC Documents
Gestire il rischio clinico in medicina di laboratorio: un’inaspettata piastrinopenia
Clinical risk management in laboratory medicine: an unexpected thrombocytopenia
<p>It is acknowledged that the risk management strategy is cardinal to maintain safety in health care organisations. Clinical risk assessment and management is a continuous and dynamic process aimed to evaluate risks and to develop appropriate plans to reduce them. Internationally, there is an increasing recognition of the need to collect and analyse data on patient safety incidents to facilitate cultural growth and to develop appropriate solutions. The practice of reporting is commonly used, and several countries have established national reporting systems to facilitate large scale monitoring and analysis of data. This activity provides information on the extent, types and causes of errors, adverse events and near misses, supporting healthcare workers in the activity of reporting errors. This case shows how a non-optimal communication between laboratory and clinicians has caused an adverse advent and which corrective actions have been undertaken.</p>
Biochimica Clinica ; 41(1) e1-e3
Casi Clinici - Case Report
I commenti interpretativi nel referto ematologico di laboratorio
Interpretative comments in the laboratory hematology report
<p>Interpretative comments in the laboratory reports&nbsp;can improve the quality of diagnostic information. The complete blood count with differential (CBC-diff) is one of the&nbsp;hematology laboratory tests with demonstrated clinical usefulness. CBC-diff may include a peripheral blood smear if&nbsp;numerical or morphological review criteria are fulfilled. As such, hematologists need specific skill for interpreting and&nbsp;conveying the diagnostic information to clinicians by using adequate communication approaches. A survey carried&nbsp;out by the SIBioC Diagnostic Hematology Study Group (GdS-DE) showed a heterogeneous situation about the use&nbsp;of the hematological interpretative comments. In each laboratory, different descriptions were used even for the same&nbsp;cell abnormalities. Moreover, some laboratories omit to report relevant morphological abnormalities, such as&nbsp;activated or atypical lymphocytes as well as immature granulocytes, which are often necessary for the diagnosis.&nbsp;Therefore, the GdS-DE has decided to select appropriate comments and to propose a standardized reporting system.&nbsp;First, 423 comments from 13 laboratories were analyzed. These comments were revised with the purpose of: a)&nbsp;reducing the number, b) standardizing the language, c) providing an information in a format that could be easily&nbsp;understood by patients and clinicians, and d) increasing the quality of clinical information. The GdS-DE decided to&nbsp;provide written information for both physicians and patients or for physician&rsquo;s use only. The former is represented by&nbsp;59 comments using a simple and not frightening language, whereas the latter is a letter for the physician in which&nbsp;more specific information is provided.</p>
Biochimica Clinica ; 40(3) 255-269
Documenti SIBioC - SIBioC Documents
Valutazione multicentrica dei conteggi cellulari ottenuti con 8 analizzatori ematologici automatici
Multicenter evaluation of blood cell counts on 8 automated hematology analyzers
<p>The cellular analysis&nbsp;performed on hematology analyzers is based on the interaction of cells with electrical or optical signals. The&nbsp;heterogeneity of adopted methods and technologies by different analyzers can translate in a lack of homogeneity in&nbsp;analytical performance. This study compares 8 hematological analyzers vs. optical microscopy (OM) and, where&nbsp;possible, also compares the analyzers among each other. Correlations were assessed by Pearson&#39;s coefficient of&nbsp;correlation, Passing and Bablock regression and Bland-Altman bias plot analysis. The comparison among analyzers&nbsp;regarding leukocyte differential counts showed a good level of agreement, except for the basophil cell count. For this&nbsp;&ldquo;critical population&rdquo;, the bias ranged from -5,8% (Cell-Dyn Sapphire vs. XN-9000) to 30,6% (Advia 2120i vs. XE-2100). The comparison between automated differential leukocyte counts and OM showed also a good level of&nbsp;agreement, with a bias ranging from -0,9% to 8.9%. The bias for basophil cell count was however very high (79.5%).</p>
Biochimica Clinica ; 40(3) 195-203
Contributi scientifici - Scientific Papers
Armonizzazione del referto ematologico con l’impego di unità di misura conformi al Sistema Internazionale
Harmonization of the hematology test report by using units according to the International System (SI)
<p>The&nbsp;need for harmonizing hematology reporting units remains an important challenge for the clinical laboratory community.&nbsp;In 2014, the SIBioC Diagnostic Hematology Study Group (GdS-DE) carried out a survey to assess the state-of-the-art&nbsp;of the Italian hematology laboratories. The survey showed that the majority of laboratories report results using units of&nbsp;measurement that do not conform to SI. In some European countries, initiatives to harmonize hematology reporting&nbsp;units were taken some years ago. In particular, in the UK for the reporting of laboratory hematology results the SI units&nbsp;have been used since April 2013 (this includes hemoglobin and mean corpuscular hemoglobin concentrations in g/L).&nbsp;The aim of this GdS-DE proposal is to advocate a national initiative for promoting the adoption of SI units for&nbsp;hematology reporting. This will optimise the comparability of results among different laboratories and prevent the&nbsp;misinterpretation of data, which may worsen the patient&#39;s outcome.</p>
Biochimica Clinica ; 39(6) 627-630
Opinioni - Opinions
Copeptina e patologie cardiocerebrovascolari
Copeptine in cardiocerebrovascular disease
P. Pezzati  |  F. Balboni  | 
<p>Copeptin (CP) is a 39 amino acid glycopeptide including the Cterminal&nbsp;domain of the arginine vasopressine precursor. CP is known to be a stable and sensitive surrogate marker&nbsp;for arginine-vasopressine release and it has been investigated as possible diagnostic and prognostic marker in&nbsp;cardiovascular and cerebrovascular diseases. In particular, the role of CP in the early diagnosis of acute myocardial&nbsp;infarction has been widely investigated and various systematic reviews are currently available. CP associated with&nbsp;cardiac troponin T has been reported to carry a good diagnostic accuracy. These data need, however, to be revised&nbsp;according to the introduction of highly sensitive assays for measuring troponins. Although some evidence on the&nbsp;prognostic value of CP in various cardiovascular frameworks is available, natriuretic peptides maintain a leading role.&nbsp;The research on CP is currently investigating its prognostic value in stroke and transient ischemic attack. However,&nbsp;due to the small sample size of studies and the lack of sound evidence, there are no minimal indications for&nbsp;requesting CP in this framework.</p>
Biochimica Clinica ; 39(3) 168-177
Rassegne - Reviews
Stato dell’arte della diagnostica ematologica nei servizi di Medicina di Laboratorio in Italia
State of the art of diagnostic hematology in clinical laboratories in Italy
<p>One of the challenges for laboratories&nbsp;performing diagnostic hematology is the harmonization of diagnostic process. This is a consequence of the rapid&nbsp;technological advancement that has characterized the recent development of automated blood cell counters, with&nbsp;new automation models and new types of parameters provided. In this context, the SIBioC Study Group of Diagnostic&nbsp;Hematology has conducted a survey among Italian laboratories. The aim was to focus on the different ways of&nbsp;organizing the service. The questionnaire consisted of 36 questions, made available on the SIBioC website for&nbsp;members and non members of the society. Responses were received via e-mail, regular mail or fax from 78&nbsp;laboratories. The survey showed differences among laboratories with regard to the organizational models adopted,&nbsp;degree of automation and completeness of final laboratory reports. However, a relative homogeneity in the validation<br />rules, review rate, turnaround time and amount and type of available resources was observed. An unexpected finding&nbsp;was the low relevance that the majority of laboratories gave to the occurrence of atypical lymphocytes, thus not&nbsp;reporting the presence of these cells in interpretative comments.</p>
Biochimica Clinica ; 39(1) 025-040
Contributi scientifici - Scientific Papers
Il fenomeno del “light chain escape”
Light chain escape phenomenon
A. Terreni  |  F. Balboni  | 
Biochimica Clinica ; 38(2) 156-157
Lettere all'Editore - Letters to the Editor
Procalcitonina e sepsi: alcuni aspetti relativi all’appropriatezza della richiesta
Procalcitonin and sepsis: hints on clinical appropriateness
<p>Sepsis in know to be a challenge for clinicians, given the poor outcome and high costs. Both diagnosis and management are a matter of concern, as appropriate and early therapy can result in higher survival rate. Various biological parameters have been proposed to establish diagnosis<br />and evaluate risk. Procalcitonin (PCT), the precursor of calcitonin, has gained attention as serological marker of sepsis and several authors have claimed for PCT a role in rapid diagnosis as well as risk stratification and prognosis evaluation. Data from systematic reviews support the use of PCT as an alternative to C-reactive protein in adult intensive care unit patients, although its use as sole diagnostic marker does not appear to be appropriate in critical patients. In the emergency department setting PCT can be used to rule out sepsis in adult febrile patients. Data on risk stratification and prognosis are less clear cut and specific clinical questions need further investigation.</p>
Biochimica Clinica ; 37(1) 15-22
Rassegne - Reviews
Glossario dei principali termini in uso nell'ambito di ricerche bibliografiche
Glossary of terms used for literature search.
<p><strong>Glossary of terms used for literature search.</strong> The challenge for modern Laboratory Medicine is to find and apply the best available evidence. Electronic access to databases and scientific journals makes information easily retrievable and solves the issue of finding current best evidence. On the other hand, searches may yield a huge amount of data and result in information overload difficult to manage. To be useful, searches should be&#160; made using specific techniques that can be taught and learned. The aim of this glossary is to introduce readers in the world of the literature&#8217;s searches by defining the common use terms. It follows to the glossary, published in 2010 (Biochim Clin 2010;34:212-7), related to the terms used to describe and evaluate clinical trials and papers reporting on the diagnostic performance of laboratory tests.</p>
Biochimica Clinica ; 35(6) 474-480