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Maria Stella Graziani

Deputy Director
Martina Zaninotto

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

EIC Assistant
Francesco Busardò

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada

Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282


ISSN print: 0393 – 0564
ISSN digital: 0392- 7091

Articoli con TAG: raccomandazioni

Esame fisico, chimico e morfologico delle urine: raccomandazioni per la fase postanalitica del Gruppo Interdisciplinare Laboratorio e Clinica Apparato Urinario (GIAU)
Physical, chemical and morphological urine examination: recommendations for the postanalytical phase from the Interdisciplinary Urinalysis Group (GIAU)
<p>This document of the Interdisciplinary Urinalysis Group (GIAU) is aimed to provide recommendations on how to improve and standardize the postanalytical approach to physical, chemical and morphological urine examination (ECMU). The main tool to emphasize the value of the ECMU is the development of a laboratory report suitable for the clinical needs. As a consequence, these recommendations are mainly related to the structure and content of the report. They include: the layout, the parameters to be included, the measurement units, the reference values, the inclusion of interpretative comments. Really, an important section of the report is dedicated to the interpretative comments: these are a real add-on value and are tailored on the type of laboratory performing the analysis (general or with a specific section dedicated to the urine examination). The different levels of the laboratory competence determine the category of possible comments. The basic one concerns comments that evaluate the non-conformity of the sample (i.e. presence of urethral, seminal, vaginal, faecal contamination; too concentrated/too diluted samples). The second level of comments is dedicated mainly to the reporting of the discrepancies between the biochemical analysis and the microscopy examination (i.e. presence of haemoglobin and no erythrocyte detection; presence of leucocyte esterase and no leucocyte detection). The third level requires a specific competence of the pathologist together with a strict collaboration with the clinic; these comments are elaborated on the basis of a specific clinical request. The detection of the &ldquo;decoy cells&rdquo; in immunosuppressed solid organ transplant recipients, that are typical of a poliomavirus infection, is a good example of the third level of interpretative comments. A final section of the document is dedicated to the opportunity to implement and adopt specific programs of external evaluation of the urinary sediment.<br />After the issuing of the recommendations dedicated to pre-analytical and analytical phases, this GIAU document gives suggestions for the standardisation and harmonisation of post-analytical phase in the attempt to emphasize the diagnostic importance of ECMU.</p>
Biochimica Clinica ; 44(1) 086-099
Documenti SIBioC - SIBioC Documents
Raccomandazioni per la rilevazione e la gestione dei campioni non idonei nei laboratori clinici
Recommendations for the detection and management of unsuitable samples in clinical laboratories
<p>A large body of evidence supports that quality improvement efforts tailored to the analytical phase only, are less likely to generate further clinical and economical progresses. Actually, most diagnostic errors made within the laboratory diagnostics emerge in the extra-analytical domains of testing, especially within the preanalytical phase. It is now clear that the underlying causes are most frequently due to system errors or to the implementation of poorly standardized procedures for collection, handling, transportation, preparation and storage of biospecimens. Some of these problems could generate a number of issues related to the quality of clinical samples, ending up with the reception by the laboratory of unsuitable samples. The identification and the management of unsuitable samples represent thus unavoidable practices in clinical laboratories to guarantee the quality of test results throughout the total testing process. Due to the ongoing evolution of the in vitro diagnostic market and the availability of new evidence, this paper provides a revision of the national recommendations issued by the Italian Society of Clinical Biochemistry and Clinical Molecular Biology in 2007 for detection and practical management of unsuitable specimens in clinical laboratories.</p>
Biochimica Clinica ; 44(2) 180-193
Documenti SIBioC - SIBioC Documents
Adesione alle raccomandazioni dei gruppi di studio SIBioC-SIPMeL (Società Italiana di Patologia Clinica e Medicina di Laboratorio) e SID (Società Italiana di Diabetologia) sulla fase preanalitica per la determinazione della glicemia: ancora margini di miglioramento. Risultati di una indagine conoscitiva nazionale
Adherence to the recommendations of the SIBioC-SIPMeL (Società Italiana di Patologia Clinica e Medicina di Laboratorio) and SID (Società Italiana di Diabetologia) study groups on the preanalytical phase for blood glucose measurement: still room for improvement. A National Survey on the state of art.
<p>Introduction: glucose measurement is pivotal in the management of subjects with diabetes mellitus. Laboratories should provide the most useful information to the clinician in order to ensure the best patient outcome.<br />Methods: in October 2019 a survey has been conducted by SIBioC and SIPMeL Study Groups on &ldquo;Diabetes Mellitus&rdquo; and by the Italian Diabetes Society to verify if their recommendations on preanalytical phase have had an impact on Italian laboratory procedures. Fifteen questions were submitted to all SIBioC and SIPMeL members and 190 complete responses were collected, corresponding to around 5% of all Italian laboratories.<br />Results: 74% of the laboratories (n=46) are aware of the recommendations of the &ldquo;Diabetes Mellitus&rdquo; Study Groups, but only 24% apply them. 61% of the first group centrifuges the collection tubes immediately, providing a rapid plasma separation; 9% place the tubes immediately in an ice-water slurry and separate the plasma within 30 minutes. Only 14 of the responders use citrate buffer/sodium EDTA/sodium fluoride (NaF) tube in lyophilic formulation.<br />The survey allowed to determine also which kind of tube is commonly used: for outpatients, 52 (30%) laboratories use serum or heparinized tubes with separator gel, 46 (24%) of the remaining of laboratories use NaF plasma and heparinized plasma tubes. For hospitalized patients, 99 (52%) laboratories utilizes tubes with separator gel or coagulation activator, while 19 (10%) and 15 (8%) respectively use NaF plasma and heparinized plasma. To perform the Oral Glucose Tolerance Test (OGTT), 84 (43%) laboratories uses tubes without glycolysis inhibitors or separator gel, and only 12 laboratories uses tubes with acidified ternary mixture.<br />Conclusion: considering these non-completely satisfactory findings, the educational activity of SIBioC working groups on &ldquo;Diabetes Mellitus&rdquo; and &ldquo;Variability of Extra-analytical phase&rdquo; should be continued, since they appear to be essential for the improvement of the laboratory procedures.</p>
Biochimica Clinica ; 45(3) 248-257
Contributi Scientifici - Scientific Papers
Questionario conoscitivo sull'Esame Chimico Morfologico delle Urine in Italia a cura del Gruppo Interdisciplinare Laboratorio e Clinica dell’Apparato Urinario
Results of the survey on chemical and morphological examination of urine in Italy issued by the Italian Interdisciplinary Urinalysis Group
<p>Introduction: the Italian Interdisciplinary Urinalysis Group (GIAU) is a study group aimed to harmonize the standard chemical and morphological urine examination in Italy. The aim of this paper is to present the results of a survey recently released. The survey has been prepared to evaluate the state of the art of the routine standard urine examination in Italy after the issuing by GIAU of the recommendations related to the pre-analytical, analytical and post-analytical phases of the Urine Chemical Morphological Examination (ECMU).<br />Methods: the questionnaire (47 questions) was made available through the web-based Survey Monkey platform to the members of the two Italian Laboratory Medicine scientific societies (SIBioC and SIPMel).<br />Results: 553 replies were collected. Regarding the pre-analytical phase, the most critical issue is the use of a monitored (time and temperature) sample transportation to the clinical laboratory only by a small percentage of the laboratories (30%). More than 80% of the laboratories recommends the collection of the mid-stream urine. Regarding the analytical phase, the majority of the participants utilizes dedicated automated analyzers for urine sediment. Only 15.5% of the participants includes the albumin to creatinine ratio in the standard urine examination.<br />Discussion: the results of the survey give a picture of the state of art of the standard urine examination in Italy. From the comparison with the GIAU previous surveys, it can be concluded that the urinalysis practice in Italy is nowadays more compliant to the indications of the available recommendations and that a general improvement of this laboratory test is observed. Some unsatisfactory answers have been collected for a number of issues, so the role of the GIAU is and will remain fundamental to guide all the laboratory professionals who operate in this laboratory medicine field, towards further advancements.</p>
Biochimica Clinica ; 45(3) 256-266
Contributi Scientifici - Scientific Papers
Principi per l’implementazione e la gestione del point-of-care-testing (POCT): indicazioni essenziali
Implementation and management of the point-of-care testing (POCT): essential indications
<p>In recent years, the field of medicine has considerably changed; an important, widespread trend is the reorganization of medical laboratories. These facilities made an effort to improve their efficiency through a process of consolidation and decentralization. In this context, Point-of-Care Testing (POCT) devices offer numerous advantages, but also pose a clinical risk, particularly in Italy, which is limited by its varied, often inadequate, regional regulations. Some examples are reported, representing scenarios of frequent or bothersome POCT use. This document outlines the SIBioC Working Group recommendations for the safe use of POCT instruments. It defines how these have been updated to the state of technologies and medical requirements. Particular attention has been paid to clinical governance, connectivity, the role of the laboratory director and staff, quality control, education, risk management and the role of the in vitro diagnostic companies. Most of the Italian medical practice is based on hospital experience, but the recent pandemic outbreak of SARS-CoV-2 forces us to re-think about the use of POCT in settings that are outside of the hospital such as local clinics, nursing homes and primary care facilities. These facilities will be the next important field of application for those indispensable tools. Networks of instruments, professionals and competence should be carefully tailored to meet local needs and specific clinical settings.</p>
Biochimica Clinica ; 45(3) 312-326
Documenti SIBioC - SIBioC Documents