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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
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Tel. 0245498282


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

BC: Articoli scritti da M. Quercioli

Elementi utili per implementare un sistema per il controllo dell'accuratezza dei risultati nella diagnostica di SARS-COV-2 (RNA virale, antigeni e anticorpi)
Useful elements for implementing a system to control the accuracy of results in the diagnosis of SARS-CoV-2 (viral RNA, antigens and antibodies)
<p>As SARS-CoV-2 swiftly spread globally becoming a pandemic, the urgent need to provide a laboratory diagnosis of the infection - to allow both the clinical management of individual patients and to monitor the outbreak in the community by health authorities - arose. This resulted in a rapid development of diagnostic tests - promptly available on the market - including methods for the direct detection of the virus in biological samples (molecular and antigenic tests) and for indirect detection by documenting a contact with SARS-CoV-2 (serological antibodies tests). To fast-track the availability of these tests, an &quot;emergency&quot; authorization was issued for their use in medical laboratories, which then resulted in the urge to verify their reliability and to monitor carefully their performances, in order to avoid the risk to provide inaccurate results. This document illustrates the main potential sources of error, which can be pre-pre-analytical (i.e. test utilization in an incorrect diagnostic window), pre-analytical (i.e. incorrect collection, manipulation, sample transport and storage), analytical (i.e. pipetting errors during manual sample dispensing, incorrect RNA extraction, cDNA synthesis and amplification) and post-analytical (i.e. incorrect test report and interpretation). Furthermore, the key elements for creating a system to keep continuously under control these potential sources of error are presented, both implementing an adequate control of the</p>
Biochimica Clinica ; 45(4) 400-407
Opinioni - Opinions
I laboratori sono in grado di rispondere ai requisiti previsti dalla norma EN ISO 15189 per la Valutazione Esterna di Qualità? Studio esplorativo sui laboratori toscani per i più comuni misurandi di chimica clinica
A scooping study assessing the compliance of clinical laboratories in Tuscany to ISO /IEC 15189 2012 requirements for clinical chemistry EQAS results
<p>Caro Editore, desideriamo proporre ai lettori di Biochimica Clinica alcuni spunti di riflessione sui requisiti previsti dalla norma EN ISO 15189:2012&nbsp; &ldquo;Medical laboratories-Requirements for quality and competence&rdquo; (1), relativi alla partecipazione a programmi di VEQ come declinati da Accredia, l&#39;ente unico nazionale di accreditamento designato dal governo italiano, con il Regolamento Tecnico (RT) 26 Prescrizioni per l&#39;accreditamento con campo di accreditamento flessibile (2). La norma EN ISO 15189 specifica che, per la concessione o il mantenimento dell&rsquo;accreditamento, i laboratori debbano presentare evidenza di aver conseguito risultati positivi durante la partecipazione agli esercizi VEQ. Il RT 26 richiede che il laboratorio, nel periodo precedente l&rsquo;inoltro della richiesta di accreditamento, abbia ottenuto quattro risultati positivi consecutivi per ogni misurando di cui venga richiesto l&rsquo;accreditamento in campo flessibile. Il documento RT 26 lascia tuttavia, di fatto, spazi per l&rsquo;interpretazione sia al provider che al laboratorio.</p>
Biochimica Clinica ; 42(4) 347-349
Lettere all'editore - Letters to the editor
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
Stabilità delle principali droghe d’abuso in campioni di urine non trattate rispetto a campioni di urine stabilizzate
Drug of abuse stability in native urine specimens vs. stabilized urine samples
<p>Effective urine drug of abuse testing&nbsp;requires an understanding of the stability of drugs and their metabolites excreted in the urine matrix. As timing of&nbsp;specimen collection is crucial in urine screening of drugs, potential degradation that may occur between, e.g., the initial&nbsp;test and the re-test of samples, should be considered. Stability characteristics depend on the drug, specimen&rsquo;s pH,&nbsp;storage temperature, light exposure, bacteria contamination and material of the urine container. The purpose of this&nbsp;study was to determine the stability in urine specimens of four classes of drugs and their metabolites (cannabinoids,&nbsp;opiates, cocaine and methadone) for a maximum of 20 weeks. In the study design, a freshly authentic pooled urine&nbsp;specimen was aliquoted into vials (plastic and glass) and these were stored at freezing (-20 &deg;C), at fridge (4 &deg;C) and at&nbsp;room temperatures and reanalyzed every one/two weeks up to 20 weeks. In parallel, we extended the study analysing&nbsp;one urine pool stabilized using various techniques of thawing and filtration for preventing the decomposition of drugs of&nbsp;abuse. In the native specimens, analytes were relatively stable when stored for extended periods of time at -20 &deg;C.&nbsp;Concentrations of cannabinoids, cocaine metabolites and morphine in not-pretreated samples decreased over time at 4&nbsp;&deg;C and at room temperature. Methadone did not show relevant loss of drug concentrations during fridge storage.&nbsp;Manufactured urine pool was stable, showing little changes between day 1 and after 10 weeks at 4 &deg;C. Morphine,&nbsp;cannabinoids and methadone showed no loss in drug concentrations after two weeks at room temperature, while&nbsp;benzoylecgonine concentrations significantly decreased after one week.</p>
Biochimica Clinica ; 38(2) 103-109
Contributi scientifici - Scientific papers