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Maria Stella Graziani

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Martina Zaninotto

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Ferruccio Ceriotti
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Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
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Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

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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
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Ana-Maria Simundic Croatia
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Giuseppe Agosta

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

BC: Articoli scritti da E. Piva

La check list in medicina di laboratorio quale strumento di assicurazione della qualità e sicurezza del paziente: l'esempio del prelievo venoso
Check-list in laboratory medicine: an important tool to improve patient safety. The blood collection
A. Aita  |  R. Marin  |  C. Pozzato  |  E. Piva  |  L. Sciacovelli  |  M. Plebani  | 
<p>This work aims to describe the results concerning the implementation of a check-list (CL) on blood collection procedures as a tool to prevent errors in laboratory medicine. Literature and operating procedures carried out in three outpatients phlebotomy sites (SMa, SMb, PN) were analysed to identify check-points (CPs). CL draft was evaluated by a multidisciplinary team and tested for one month (September 2014) by 25 physicians and 15 nurses. The filled in CLs were analysed together with the involved staff and a final version was released. CL effectiveness was evaluated immediately after experimentation and one year later. 5661 CL were filled in, out of 9469 venipunctures (59.8%). The percentages of CPs filled in within SMa, SMb and PN were respectively: 100% patient identification and label-sample-identification matching; 80.2, 73.1 and 51.9% vein selection; 96.7, 95.8 and 97.9% needle selection; 82.5, 85.8 and 89.9% tourniquet application time; 98.9, 97.9 and 98.7% tubes filling; 98.4, 97.4 and 98.7% tubes mixing; 27.6, 23.5 and 15% temperature transport; 16.4, 20.8 and 1.3% time transport. The percentages of unsuitable samples in SM and PN were respectively: 0.040 and 0.013% (September 2014); 0.041 and 0.012% (October 2014); 0.024 and 0.16% (September-October 2015). The insufficient number of available CLs, difficulties over communication concerning purpose and methodology, and patients crowding affected the results in SM; anyway the CL was very helpful for trainees. An effective CL should: include only critical CPs, be shared with the staff, take into account organizational peculiarities. CL is a powerful tool to ensure patient safety only when it becomes an integral part of quality management system.</p>
Biochimica Clinica ; 42(2) 131-140
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
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
Verifica locale dei sistemi di prelievo nei laboratori clinici: adattamento delle linee guida EFLM
Blood collection systems in clinical laboratories: local adaptation of the EFLM guidelines
<p>The importance of the process of purchasing or changing blood collection devices is often overlooked. This is likely attributable to many factors such as the limited knowledge that policymakers, healthcare administrators and also laboratory managers have on the significance of preanalytical quality, but also to the lack of validated criteria for analyzing the quality of blood collection devices. Since a gap remains to be filled between companies&rsquo; and laboratory&rsquo;s validation, the EFLM Working Group on Preanalytical Phase (WG-PRE) has published a comprehensive document, which contains essential prerequisites and technical issues (e.g., physical imperfections, defects of functioning, safety deficiencies) to support local clinical laboratories for the development of tenders for blood tubes and for the validation of new materials ahead of local routine use. This consensus document is a national adaptation of these guidelines.</p>
Biochimica Clinica ; 40(4) 347-352
Documenti SIBioC - SIBioC Documents
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
A multicentre observational study evaluating the effectiveness of a phlebotomy check-list in reducing preanalytical errors
<p>Several preanalytical errors are attributable to inappropriate or poorly standardized activities during the venous blood&nbsp;collection. We designed a multicenter observational study to establish whether the implementation of a phlebotomy&nbsp;check-list in 7 phlebotomy centers and 4 emergency departments is effective in reducing the rate of preanalytical&nbsp;errors related to the blood drawing. The investigation was divided in two 3-month periods during which 5 common&nbsp;preanalytical errors were systematically recorded. After the introduction of the phlebotomy check-list, the rate of&nbsp;preanalytical errors was significantly decreased in phlebotomy centers (0.04% vs. 0.05%, P=0.001), but remained&nbsp;unchanged in emergency departments (0.83% vs. 0.82%, P=0.84). A significant decrease was achieved for sample&nbsp;identification errors and clotted specimens in phlebotomy centers and emergency departments, whereas a significant<br />reduction in hemolysis was noticed only in phlebotomy centers. The rate of inappropriate filling and wrong containers&nbsp;remained unchanged. The results obtained in this study show that the introduction of a phlebotomy check-list may&nbsp;help in reducing preanalytical errors related to misidentification and undue clotting.</p>
Biochimica Clinica ; 39(6) 559-562
Contributi scientifici - Scientific Papers
Armonizzazione della notifica dei valori critici come contributo al miglioramento della sicurezza e della cura del paziente
Harmonization of the notification of critical values as contribution to the improvement of patient safety and care
<p>A project for harmonizing the notification of critical values was performed in our department, which covers 3&nbsp;different hospitals. We achieved the harmonization of definitions by distinguishing critical values, critical tests and&nbsp;abnormal results, according to the Joint Commission proposal. For critical tests, the requesting physicians should&nbsp;verify the availability of results as soon as possible, while the laboratory professionals must ensure appropriate and&nbsp;timely results. As an example, all requests from the Emergency Room are relevant and considered as critical tests,&nbsp;avoiding overload of alarms or calls, which distract the busy medical team. Identification of critical values was based&nbsp;on consensus, guidelines and clinicians&rsquo; opinion. The practice was harmonized by automated notification systems&nbsp;and by establishing who should report critical values on an established time frame to the responsible licensed&nbsp;caregiver, so that the patient can be promptly treated. Timeliness was linked with clinical effectiveness with the aim<br />to provide the best outcome at the lowest cost. Finally, harmonization was directed to develop quality indicators&nbsp;regarding the policies of critical value communication, the monitoring of the timeliness in reporting and the need to&nbsp;evaluate how the effectiveness of improved communication assures better clinical outcomes. The realization of&nbsp;harmonized critical value notification may support the clinical decision making, leading to an improvement in patient&nbsp;safety and care.</p>
Biochimica Clinica ; 39(6) 595-600
Contributi scientifici - Scientific Papers
Proposta di una “checklist” per il prelievo di sangue venoso
Proposal of a checklist for venous blood collection
<p>The collection of venous blood is central in clinical laboratory&nbsp;activity. Although there is widespread perception that this practice is simple and free of complications and side effects,&nbsp;it is undeniable that the vast majority of laboratory errors arises from ignorance, incompetence or negligence during&nbsp;venipuncture. It has hence become advisable to prepare a document in simplified form of checklist, consisting of a&nbsp;concise but comprehensive list of activities to be completed or verified in order to prevent errors during venous blood&nbsp;collection. In the intention of authors, this synthetic checklist is a modular tool, adaptable to different local contexts,&nbsp;it can be easily and gradually implemented, it is supported by scientific evidence and consensus of experts and&nbsp;created with the support of different healthcare professionals and it is adherent to the best practices and requires&nbsp;minimal resources for implementation. It is reasonable to assume that this checklist may be able to withstand system&nbsp;and individual changes, strengthening the standards for safety of both operators and patients, limiting potential failure&nbsp;patterns. We hope that the checklist may be implemented in all healthcare facilities where routine venous blood&nbsp;collection is performed, after adaptation to suit characteristics of local organization.</p>
Biochimica Clinica ; 37(4) 312-317
Documenti SIBioC - SIBioC Documents
Raccomandazioni di consenso SIBioC-SIMeL per la rilevazione e gestione dei campioni emolisati e utilizzo dell'indice di emolisi
SIBioC-SIMeL consensus recommendations for the identification and management of hemolysed specimens and the implementation of hemolysis index
<p><strong>SIBioC-SIMeL consensus recommendations for the identification and management of hemolysed specimens</strong><br /><strong>and the implementation of hemolysis index.</strong> The presence of hemolysis in a biological blood sample is mainly<br />caused by hemolytic anemia or hemolysis in vitro. The latter is caused by inappropriate collection and processing of biological samples, which may affect the reliability of test results. Hemolysis is assessed by free hemoglobin quantification, whose limit is 0.02 g/L in plasma and 0.05 g/L in serum, and visually observed when the concentration of free hemoglobin exceeds 0.30 g/L. Since hemolysis is the most frequent cause of unsuitable biological samples in clinical laboratories, with a prevalence approaching 3% of all received samples, these recommendations have been drafted specifically to assist laboratory professionals in detection and management of hemolysed specimens. In summary, the recommended approach is based on: (i) systematic detection and quantification of hemolysis, by visual inspection and subsequent quantification of the hemolysis index on all samples with visually detectable hemolysis; (ii) immediate notification to the referring department of the presence of hemolysis in the sample, as locally determined; (iii) suppression of all results affected by the presence and/or degree of hemolysis; and (iv) timely request of a second sample, on which the previously deleted tests can be performed.</p>
Biochimica Clinica ; 35(6) 481-490
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