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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 F. Tosato

Indagine conoscitiva sulla qualità del referto dell’esame emocromocitometrico
A survey on the quality of the hematological reporting among the Italian laboratories
<p>Introduction: the Working Groups &ldquo;Hematology&rdquo; and &ldquo;Extra-Analytical Variability&rdquo; of the Italian Society of Clinical Biochemistry (SIBioC) promoted a survey investigating the quality of the complete blood count reporting among Italian Laboratories.<br />Methods: the survey included 36 questions and was sent to all the SIBioC members. 251 laboratories participated in the survey.<br />Results: there is a full concordance in reporting the traditional parameters (leukocytes, erythrocytes and platelet count, hemoglobin, hematocrit and the calculated indices, plus the leukocytes differential count), while other relatively new parameters, like the mean platelet volume (MPV) and the platelet distribution width (PDW) are reported by 70% of the laboratories. A low percentage of laboratories (20-30%) do not report the presence of abnormal cell populations, if detected (blasts, immature granulocytes, plasma cells, prolymphocytes and erythroblasts). 70% of laboratories do not report the erythrocyte and leukocyte related parameters available on the new analyzers. Specific reference intervals for gender and age are adopted by 68% of the laboratories, but only 50% have instrument-specific intervals. 83% of the laboratories include interpretative comments in the report, but only in less than half of them these are harmonized according to the recent available recommendations. 83% of the laboratories have a shared document to manage critical values, that are communicated to the requesting physician by 90% of the laboratories.<br />Discussion: activities promoted by the SIBioC Hematology working group to harmonize the hematological report have been effective on traditional parameters reporting with a substantial improvement compared to the 2014 survey. Two issues remain however unresolved: the inclusion of interpretative comments and of the recent available parameters in the report.</p>
Biochimica Clinica ; 44(2) 129-142
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
 
Un caso di anemia multifattoriale
A case of anemia from intricate causes
<p>A 52 year old female, born in Ecuador, was admitted to the medical ward because of dizziness, blurred vision, sweating and vomiting started 3 days earlier. Complete blood count showed a severe anemia, while mean corpuscolar volume, mean corpuscolar hemoglobin, white blood cell, differential and platelet count were normal. Biochemical tests revealed a very high LDH and a low haptoglobin value. The blood smear revealed marked anisocytosis, hypocromia, oval erythrocytes, teardrop cells and fragments, with the presence of hypersegmented neuthrophils. These morphological features, together with the information obtained by the hematology analyzers, gave rise to the suspicion of vitamin B12 deficiency. Further investigation confirmed a low level of vitamin B12. Variant hemoglobin was detected by high performance liquid chromatography and capillary electrophoresis; an elevated soluble transferrin receptor value was observed. A diagnosis of sickle cell disorder associated to alpha thalassemia with iron and B12 deficiency was formulated.</p>
Biochimica Clinica ; 42(2) e18-e21
Casi clinici - Case report
 
Armonizzazione della diagnostica ematologica: lo stato della valutazione dei reticolociti
Harmonization in hematology: the status of reticulocyte count
E. Piva  |  S. Secchiero  |  F. Spolaore  |  F. Tosato  |  M. Plebani  | 
<p>Harmonization is a crucial step in laboratory&nbsp;medicine to provide reliable information. The reticulocyte count and even more maturity parameters and indices seem&nbsp;to be still highly variable, despite their proven clinical usefulness. Three hematology analyzers (Siemens Advia 2120,&nbsp;Sysmex XN-1000, Mindray BC-6800) were used to assess reticulocyte count (percentage and absolute count),&nbsp;parameters and indices of blood samples from 82 adult patients. Results from 92 participant laboratories to the last&nbsp;3 cycles (2012-2015) of EQA program of the Center of Biomedical Research were also evaluated. Statistical&nbsp;comparisons demonstrated an excellent correlation among the 3 instruments for reticulocyte count, both in&nbsp;percentage and absolute values. A systematic, not proportional difference in immature reticulocyte fraction results&nbsp;was observed between Advia 2120 and the other two analyzers, which conversely showed an excellent correlation&nbsp;between them. For the measurement of reticulocyte hemoglobin content, we found a systematic proportional&nbsp;difference between Advia 2120 and XN-1000, an excellent concordance between Advia 2120 and BC 6800 and a&nbsp;systematic not proportional difference between XN-1000 and BC 6800. Comparison between reticulocyte mean&nbsp;volume results obtained with Advia 2120 and BC 6800 showed a good correlation, even if systematic differences&nbsp;between the two methods were observed. For the reticulocyte counts the interlaboratory variability showed a CV&nbsp;Z10%, except for Advia 2120. EQA demonstrated the need of harmonization of reference intervals, which should go&nbsp;together with the harmonization of analytical methods for a correct clinical interpretation.</p>
Biochimica Clinica ; 40(3) 208-216
Contributi scientifici - Scientific Papers
 
Emoglobinuria parossistica notturna
Paroxysmal nocturnal hemoglobinuria
<p>Paroxysmal nocturnal hemoglobinuria (PNH) is a rare acquired&nbsp;hematological disease of the hematopoietic stem cell. PNH arises as a consequence of non-malignant clonal&nbsp;expansion of hematopoietic stem cells and progeny mature blood cells of both myeloid and monocyte lineage, which&nbsp;are deficient in some surface proteins, including the two complement regulators CD55 and CD59. As a result, PNH&nbsp;erythrocytes are incapable to modulate on their surface physiologic complement activation, leading to complement-mediated&nbsp;intravascular hemolysis, which is the central clinical feature of PNH. Diagnosis and monitoring of PNH&nbsp;clones currently rely on the analysis of CD59 expression on red blood cells and FLAER (fluorescent aerolysin) and&nbsp;some glycophosphatidylinositol-anchored proteins on granulocyte and monocyte lineages by flow cytometry. Despite&nbsp;the availability of safe and effective targeted therapy that controls intravascular hemolysis, the management of PNH&nbsp;remains difficult because of disease heterogeneity and close association with bone marrow failure syndromes.</p>
Biochimica Clinica ; 37(4) 268-274
Rassegne - Reviews
 
Un caso di emoglobinuria parossistica notturna associata a mielodisplasia
A case of paroxysmal nocturnal hemoglobinuria in a patient with myelodysplasia
<p>Paroxysmal nocturnal&nbsp;hemoglobinuria (PNH) is a rare acquired hematological disease of the hematopoietic stem cell. PNH arises as a&nbsp;consequence of non-malignant clonal expansion of hematopoietic stem cells and progeny mature blood cells of both&nbsp;myeloid and monocyte lineage, which are deficient in some surface proteins, including the two complement regulators&nbsp;CD55 and CD59. As a result, PNH erythrocytes are incapable to modulate on their surface physiologic complement&nbsp;activation, leading to complement-mediated intravascular hemolysis, which is the central clinical feature of PNH. We&nbsp;present a case of a 16 years old Ukrainian boy who presented with a diagnosis of myelodysplastic syndrome and&nbsp;who was found to be affected by PNH.</p>
Biochimica Clinica ; 37(4) 326-328
Casi clinici - Case Report
 
Errori di identificazione del paziente: un progetto SIBioC orientato alla gestione di un problema persistente
Wrong blood in tube: a SIBioC project for a persistent problem
A. Aita  |  A. Padoan  |  R. Guerranti  |  M. Fiorini  |  C. Bellini  |  F. Tosato  |  M. Pelloso  |  E. Piva  |  R. Pajola  |  M. Lorubbio  |  B. Cremonesi  |  A. Bassi  |  R. Rolla  |  G. Introcaso  |  M. Plebani  |  S. Buoro  |  F. Balboni  | 
<p>Introduction: recently, multi-analytes delta-check (MDC) has been proposed as a more effective tool in identification errors (IE) prevention. In this context, &ldquo;Haematology&rdquo; and &ldquo;Clinical Risk&rdquo; SIBioC working groups launched a project aiming to develop a cell blood count (CBC) MDC. This work is aimed to describe the project and some preliminary results.<br />Methods: the project consists of four phases: collection of CBC results from 15 Italian laboratories to create an original dataset (OD); pilot study on a smaller dataset (SD) i.e., creation of an artificial mix-up dataset-MD containing IE by casual resampling of the SD and identification of the best statistical model to create a MDC; identification of the most accurate MDC on OD; testing the MDC in involved labs and verification of its effectiveness.<br />Results: the SD included 2,367 pair of consecutive results for the same patient (patients&rsquo; age: 0-100 years; the majority of repetitions were within days). The SD casual resampling generated a MD with 2,000 pair of patient-mixed consecutive results. When one of the most frequent used delta-check alert (&Delta;MCV=7fL) was applied to detect IE in MD, the method accuracy was low (AUC=0.542). On the contrary, testing of a multivariate model, obtained by a stepwise logistic analysis, allowed to obtain a more accurate MDC in IE detection (AUC=0.931, sensitivity=91.6%, specificity=94%).<br />Conclusions: MDC may offer a practical strategy to identify IE prior to test reporting, improving patient safety. However a good planning of project workflow, selection of methodology, tools and staff competence are key elements to reach the objectives.</p>
Biochimica Clinica ; 17(1)
Contributi Scientifici - Scientific Papers