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Editor-in-chief
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


Publisher
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
email: biochimica.clinica@sibioc.it

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



BC: Articoli scritti da C. Scapellato

Emoglobina glicata (HbA1c): confronto tra gli analizzatori Premier Hb9210 e ADAMStm A1c HA-8180V
Glycated hemoglobin (HbA1c): Comparison between Premier Hb9210 and ADAMStm A1c HA-8180V analyzers
<p>Introduction: in this study we evaluated the analytical performance of the Trinity Biotech HbPremier Hb9210 (Bray, Ireland/Kansas city, US), a boronate affinity chromatography-based high performance liquid chromatography (HPLC) system for the measurement of glycated hemoglobin. The ADAMSTM A1c HA-8180V (ARKRAY, Inc., Kyoto, Japan) analyzer was used for the comparison.<br />Methods: three pool of blood (L1, L2, L3) and two control materials (B1, B2) were used to evaluate analytical precision of the HbPremier Hb9210, analyzing five replicates of each sample per day for five days. For the comparison, blood specimens were analyzed according to the Clinical and Laboratory Standard Institute (CLSI) guidelines. Both the available reference systems (IFCC, NGSP) were used.<br />Results: the total CVs of for low, medium and high values of the three pools (L1, L2, L3) were 0.68%, 1.72%, 1.31% respectively; and were 1.57%, 1.38% for low, and medium values (B1, B2) of the two controls when the values were expressed in mmol/mol (SI units) and 0.39%, 1.18%, 1.08% (L1, L2, L3), 0.95%, 1.07% (B1, B2) when the values were reported in % (NGSP units). Passing-Bablok regression used for the comparison of methods showed a small proportional error (slope 1.05, 95%CI: 1.02-1.07) using the IFCC reference system (mmol/mol); the error was not present with the NGSP (%). The bias found was -1.87 mmol/mol (95%CI: -4.33- 0.58) and -0.17% (95%CI: -0.39-0.05).<br />Discussion: the analytical performances of HbPremier Hb9210 have been successfully verified. The instrument performs well and provides results in good agreement with those obtained with the ADAMS analyzer.</p>
Biochimica Clinica ; 46(1) 062-067
Contributi Scientifici - Scientific Papers
 
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
 
Ruolo del laboratorio nella valutazione di un donatore di organi con sospetta emofilia A
Role of the laboratory in the evaluation of an organ donor with reported haemophilia A
<p>The case concerns a 82-year-old patient, organ donor, affected by diabetes mellitus, hypertension and reported type A haemophilia, showing a traumatic severe cerebral haemorrhage. The Medical Committee started the donor evaluation process: the liver was compatible for a recipient in life-threatening conditions. Although the first level coagulation tests were within the normal range, the Regional Center for Organ and Tissue Allocation of the Tuscany Region - Italy requested further investigations in order to clarify the reported diagnosis of haemophilia and to exclude the presence of a specific FVIII inhibitor. FVII activity was evaluated to assess the protein synthesis of the liver, and FVIII for suspected haemophilia; both of them were normal. Considering the importance of the diagnosis, the parallelisms of both FVII and FVIII were performed; the tests were negative for the presence of inhibitors. Second-level tests therefore rejected the diagnosis of haemophilia and excluded the presence of a specific inhibitor of FVIII. The absence of coagulative alterations allowed the liver explant, which was successfully transplanted on a 59-year-old male recipient.</p>
Biochimica Clinica ; 42(3) e37-e39
Casi clinici - Case report
 
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