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BC: Articoli scritti da A. Padoan

Garantire la comparabilità dei risultati nel rispetto dei requisiti di qualità e delle esigenze organizzative: l’esempio di una procedura operativa
How to guarantee the comparability of test results in compliance with the quality requirements andorganizational needs: the example of an operative procedure
<p>Medical laboratories are responsible for the qualityof test results, also when the same patient sample is evaluated using different analytical systems within the same lab.Indeed, as stated by ISO 15189:2012, laboratories should define means to compare procedures for evaluating thecomparability of patients&rsquo; samples results within the same healthcare system. In this study we report the approachused to define a procedure for assessing results comparability, developed in our laboratory before the ISO15189:2012 accreditation in 2016. Firstly, the approach was focused on the identification of all the different situationsthat may potentially require alignment of test results within the laboratory. Therefore, after evaluating guidelines anddocuments available in the literature, we defined a workflow applicable both to quantitative and qualitative methods.For quantitative methods, bias was estimated by means of statistical analyses such as Bland Altman and PassingBablok. For qualitative methods, results comparability was assessed by concordance. Criteria for defining theacceptability of systematic errors were also included in the procedure.</p>
Biochimica Clinica ; 43(2) 135-142
Contributi Scientifici - Scientific Papers
 
Protocollo operativo per la verifica della comparabilità dei risultati di laboratorio ottenuti su più procedure analitiche
Protocol to verify the comparability of quantitative laboratory results obtained with different measurementprocedures.
<p>With the growth and merging of clinical laboratories, very frequently analytical tests are performed onmultiple instruments within one or multiple locations. In these situations, there is the need of verifying thecomparability of patient results obtained with different analysers and/or different measurement procedures. Theimportance of this verification is further emphasised when considering that it is included into the ISO 15189specifications. This protocol provides step-by-step guidance on how to assess results comparability in differentscenarios. Up to four experimental designs are presented to meet laboratories&rsquo; needs, with details and examples onfrequency of testing, definition of acceptability criteria, samples selection, sample size calculation, statistical analysisand reporting.</p>
Biochimica Clinica ; 43(2) 228-243
Documenti SIBioC - SIBioC Documents
 
Gli indicatori di qualità nel processo di armonizzazione in Medicina di Laboratorio
Harmonization of quality indicators in Laboratory Medicine
<p>According to the International Standard for medical&nbsp;laboratories accreditation ISO 15189:2012, the laboratory should establish and periodically review quality indicators&nbsp;(QIs) to monitor and evaluate performance throughout critical aspects of pre-, intra and post-analytical processes.&nbsp;The use of QIs is needed to provide information and accountability to users and to establish a program of continuous&nbsp;improvement to ensure the quality of care and patient safety. In this context, we designed a QIs system as a part of&nbsp;a coherent and integrated quality improvement strategy. The management of QIs is based on an internal assessment&nbsp;system (IAS), which allows us to evaluate our performance over time and on the participation in an interlaboratory&nbsp;comparison managed as an EQA program, in order to compare our performance with other laboratories. The IAS&nbsp;includes a list of QIs, a form describing the specifications of each QI and a standard operating procedure. We&nbsp;participated in the project developed by the Working Group &ldquo;Laboratory errors and patient safety&rdquo; of IFCC on QIs.&nbsp;The project aims to identify a model of QIs that can be used worldwide through an EQA program. This paper aims to&nbsp;stimulate harmonization initiatives concerning QIs on the basis of the method and results of described experience.</p>
Biochimica Clinica ; 39(6) 601-608
Contributi scientifici - Scientific Papers
 
Identificazione di potenziali biomarcatori sierici di adenocarcinoma pancreatico
Identification of potential serum biomarkers of pancreatic cancer
A. Padoan  |  P. Fogar  |  E. Greco  |  E. Fadi  |  D. Bozzato  |  S. Moz  |  F. Navaglia  |  C.F. Zambon  |  R. Seraglia  |  M. Pelloso  |  A. Rossi  |  M. Plebani  | 
Biochimica Clinica ; 35(4) 280
CONTRIBUTI SCIENTIFICI - CONTRIBUTI SCIENTIFICI
 
Interferenza da biotina negli immunodosaggi: raccomandazioni del Gruppo di Studio SIBioC sulla Variabilità Extra-Analitica (SIBioC-VEA)
Biotin interference in immunoassays: recommendations of the SIBioC Working Group on Extra-AnalyticalVariability (WG-VEA).
Biochimica Clinica ; 17(1)
Documenti SIBioC - SIBioC DOCUMENTS