Marco Pradella

Marco Pradella
Società Italiana di Patologia Clinica e Medicina di Laboratorio (SIPMeL) · Commissione Nazionale Qualità e Accreditamento

Doctor of Medicine

About

141
Publications
18,626
Reads
How we measure 'reads'
A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. Learn more
835
Citations
Introduction
Skills and Expertise

Publications

Publications (141)
Poster
Full-text available
The Eurachem/CITAC Guide Assessment of Qualitative Analysis is an innovative document, very useful for laboratories. We compared EURACHEM statements with ISO 3534-2, International vocabulary of metrology (VIM), ISO Guide 99, ISO 17025, ISO 15189, ISO 20914, ISO 16393 and ISO 27877 statements. We see at least two critical issues in the EURACHEM docu...
Article
ISO 17025 chiede l'incertezza dei risultati ma non distingue tra quantitativi e qualitativi. La Guida EURACHEM/CITAC ha quindi una importanza straordinaria per risollevare il tema ad un livello paragonabile agli altri che compongono la complessa costruzione del sistema di gestione della qualità. È un vero peccato che la Guida EURACHEM/CITAC abbia s...
Article
Eurachem/CITAC published a very useful and important Guide on Uncertainty of Qualitative Results. However, the Guide does not include the evaluation of precision, and does not address the alternative of uncertainty of qualitative results obtained from quantitative measurements described by ISO documents. Keywords: Uncertainty; Qualitative; Precisio...
Article
Scientific evidence shows for artificial intelligence and machine learning a future and sometimes even a present as a valuable resource for medicine in general. The laboratory is being transformed by it, willingly or unwillingly, as it continues to change in the digital revolution. The SIPMeL document of recommendations on informatics (DOI 10.1007/...
Poster
Obiettivo La revisione di ISO 15189 mantiene il requisito della stima dell'incertezza, riferendo a ISO/TS 20914 le modalità di applicazione. [1] [2] Con il documento Q16, SIPMeL raccoglie le principali indicazioni ISO, della letteratura e di CLSI sul tema, che riguardano sia i risultati quantitativi che quelli qualitativi, nominali e ordinali. Qui...
Presentation
Part one: ISO accreditation in the national and international regulatory context. Part two: the ISO package of standards for medical laboratories. Criticalities of Eurachem/CITAC Guide: Assessment of performance and uncertainty in qualitative chemical analysis. LDE(T)Laboratory Developed Examination (Test) (ISO/AWI 5649).
Presentation
Il documento SIPMeL sull'informatica descrive il nuovo paradigma dei risultati. L'uso di sistemi di supporto alle decisioni cliniche (CDSS) comporta ancora maggiore attenzione al valore clinico ed alla affidabilità del singolo dato, non più agli aspetti formali ed alle aggregazioni di risultati dal punto di vista del laboratorio, diverso da quello...
Article
Measurement uncertainty is required for the accreditation of medical laboratories. Documents of the International Organization for Standardization (ISO), as well as various documents of the Clinical & Laboratory Standards Institute (CLSI), provide guidance for the estimation of uncertainty, both for quantitative and qualitative results. The Recomme...
Poster
La revisione di ISO 15189 mantiene il requisitola della stima dell'incertezza, riferendo a ISO/TS 20914 le modalità di applicazione. Con il documento Q16 (DOI: 10.13140/RG.2.2.31013.63207/2), SIPMeL raccoglie le principali indicazioni ISO, della letteratura e di CLSI sul tema. Qui si presentano esempi tipici di applicazione delle Raccomandazioni Q1...
Poster
The points of the 2019 Croatian Recommendations for post-examination processes (CR) that merit revision are selected, in comparison with SIPMeL Recommendations on informatics in the medical laboratory (SR) and the review made by Cappelletti (PC) that compared IFCC. This topic has become very relevant for the 2022 revision of ISO 15189. The fast ev...
Preprint
The estimation of measurement uncertainty is required for accreditation of medical laboratories, according to the International Organization for Standardization (ISO). ISO provides adequate indications to obtain uncertainty and above all precision and repeatability with simplicity in laboratories of any type and size, both for numerical quantitativ...
Research Proposal
Full-text available
The ISO 15189 standard for medical laboratories is in the middle of its revision process. The working group, structured in drafting groups for individual parts of the standard, receives some guidance from the ISO CASCO top: use as a template and follow a process like the one used for the revision of ISO/IEC17025:2017, drafting by small groups, revi...
Article
The estimation of measurement uncertainty is required for accreditation of medical laboratories, according to the International Organization for Standardization (ISO). ISO provides adequate indications to obtain uncertainty and above all precision and repeatability with simplicity in laboratories of any type and size, both for numerical quantitativ...
Article
Are we going to see some sort of conflict between Europe and America over internal quality control management? The Westgard concerns are well founded and can be shared. The so-called "recommendations" of the Milanese metrologists are the result of their personal position, not supported by official documents of bodies or associations. Most medical l...
Article
Full-text available
The Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) Quality and Accreditations Commission produced its recommendations on this matter [3] acknowledging ISO 15198:2004 [4] document, confirmed for the first time in 2008 and revised with a positive result in December 2018. Key points are shared responsibility between the laborat...
Presentation
Parte prima: accreditamento ISO nel contesto normativo nazionale ed internazionale. Parte seconda: il pacchetto ISO delle norme per i laboratori medici. - Part one: ISO accreditation in the national and international regulatory context. Part two: the ISO package of standards for medical laboratories. -
Article
La traduzione ufficiale in italiano dei documenti ISO compete a UNI nell’ambito dell’attività di normazione. Il documento SIPMeL L5Q15 non traduce integralmente alcune norme, ma propone soluzioni solo per le parole definite nei capitoli “Termini e definizioni” dei principali documenti ISO dedicati al rapporto tra laboratorio e fabbricante di dispos...
Article
ISO 15189 accreditation of medical laboratories requires the comparability of results between different laboratories, preferably by means of metrological traceability to the international system (SI). The twin standards ISO 17511 and ISO 21151 draw a robust framework to provide laboratory methods with calibration, harmonization and standardization,...
Article
The new European regulations, and in particular that on in vitro diagnostics, have made the principles already developed by ISO and CEN mandatory obligations. In particular, in post-market surveillance laboratories and manufacturers are now obliged to share important information throughout the life cycle of devices. Both serious accidents with the...
Poster
On 5 April 2017 the European Parliament approved the two new EU regulations relating to medical devices. The regulations entered into force on May 26, 2017. In spring 2022, the IVDR one for in vitro diagnostics will be applied. ISO contributes to the quality of in vitro diagnostics with ISO 13485, ISO 14971, ISO 15198 and ISO 20916 documents. ISO /...
Article
LA TARATURA NELLA NUOVA ISO 15189 PER I LABORATORI MEDICI La nuova ISO 15189 per l'accreditamento dei laboratori medici, prevista per il 2022, contiene requisiti per la confrontabilità tra diversi laboratori e la riferibilità metrologica dei risultati al sistema internazionale delle misure (SI), con materiali di riferimento conformi a ISO 17034, ta...
Article
Full-text available
La norma ISO 15189, actualmente en fase de desarrollo, supone tener que reevaluar el rendimiento de los métodos, esto es, realizar un control de calidad (QC), tal como se define en la sección 3.3.7 de la norma ISO 9000. La Comisión de Calidad y Acreditaciones de la Sociedad Italiana de Patología Clínica y Medicina de Laboratorio (SIP-MeL) emitió su...
Poster
The L5Q15 document proposed by the SIPMeL Quality and Accreditation Commission intends to offer diagnostic manufacturers and laboratories a tool for the correct use in Italian of the terms defined in the new ISO 17511 and 18113 standards, as well as in the ISO 15198 document for quality control. The official translation of ISO documents into Italia...
Research Proposal
Full-text available
https://www.sipmel.it/en/lineeguida/sviluppo/118107 L5Q15 Recommendations for the glossary in the new ISO standards for medical laboratories on calibration and "labels" (ISO 17511, ISO 18113, and 15198) In the complex articulation of the ISO 18113 family of documents, some elements are of absolute importance. First, the use of terms corresponding t...
Article
Nell'articolazione complessa dei documenti della famiglia ISO 18113 sono di assoluta rilevanza alcuni elementi. Innanzitutto, l'uso di termini corrispondenti alle definizioni date dalla norma ISO, per evitare evidenti rischi di fraintendimento. Si introduce il sistema unico di identificazione dei dispositivi (UDI). Viene promosso l'aggiornamento ai...
Article
These notes can serve both for labs to set purchasing specifications and for manufacturers who have to meet these specifications. ISO 15189 accreditation of medical laboratories requires comparability of results between different laboratories, preferably by means of metrological traceability to the SI. The twin standards ISO 17511 and ISO 21151 dra...
Article
ISO, the International Organization for Standardization, is preparing document ISO/TS 17822-2 on the quality control of nucleic acid amplification techniques (NAAT). ISO 17822-2 takes into consideration many aspects that affect quality. ISO 17822 prescribes the use of control materials and describes different types of them. ISO 17822-2 states that...
Presentation
Full-text available
● ISO ● AI ML ● CDSS (farmaci) ● IPS ● Neuromorfismo ● Laboratori, gestione rischi ● Nuovo paradigma risultati ● Raccomandazioni ● ISO ● AI ML ● CDSS (drugs) ● IPS ● Neuromorphism ● Laboratories, risk management ● New results paradigm ● Recommendations
Article
The ongoing revision of ISO 15189, the standard for accreditation of medical laboratories that will be launched in 2022, shall use ISO/IEC 17025:2017 as a model. The most significant changes of ISO 17025 are introduced in the management system, now aligned with that of the ISO 9001:2015 standard. The ISO 9001:2015 standard introduced several innova...
Article
The ongoing revision of ISO 15189 for accreditation of medical laboratories, includes the references to ISO 15190, for occupational safety in medical laboratories.. With ISO 35001, the 'ISO package' of standards for medical laboratories is enriched with a new, indispensable element: biohazard management. It is not a guideline, but the imperative to...
Article
The new ISO 15189 for medical laboratories should incorporate the requirements of ISO 22870 for POCTs. The SIPMeL Quality and Accreditation Commission has identified ISO 22870 standard points which should be absorbed by the corresponding ISO 15189 points, other ISO 15189 points which should be modified in light of the specific requests of ISO 22870...
Method
Full-text available
Società Italiana di Patologia Clinica e Medicina di Laboratorio Componente della World Association of Societies of Pathology and Laboratory Medicine www.sipmel.it Commissione Nazionale Qualità ed Accreditamento Coordinatore: Marco Pradella GdS-VEA Variabilità Extra-Analitica del dato di Laboratorio Coordinatore: Margherita Morandini GdS-MS Manageme...
Article
Full-text available
dalla presentazione al Corso Residenziale: Statistica del controllo di qualità interno per l'accreditamento ISO 15189, 11 maggio 2018 - Santorso (VI), Sala Convegni Bolla Rossa Ulss 7, Pedemontana, Ospedale Alto Vicentino e dalla presentazione al seminario Informatica e statistica del controllo di qualita' interno nel laboratorio medico per l'accre...
Article
Full-text available
La revisione in corso di ISO 15189, norma per l’accreditamento dei laboratori medici che vedrà la luce nel 2022, prevede diversi requisiti sulla sicurezza degli operatori e l’inserimento dei riferimenti a ISO 15190, la norma per la sicurezza sul lavoro dei laboratori medici. - The ongoing revision of ISO 15189, a standard for medical laboratory acc...
Method
Full-text available
Commissione Nazionale Qualità ed Accreditamento Coordinatore: Marco Pradella - Gruppo di Studio Informatica GdS-I Coordinatore: Marco Pradella - versione 1,0 documento Q11P1 ISO 15198 e controllo di qualità 20/3/2019 Raccomandazioni per il controllo di qualità interno: compiti del produttore di diagnostici in vitro - Riferimenti normativi • UNI EN...
Research Proposal
Full-text available
SIPMeL Commissione Nazionale Qualità ed Accreditamento Coordinatore: Marco Pradella Gruppo di Studio Informatica GdS-I Coordinatore: Marco Pradella Q11P1 document ISO 15198 recommendations and quality control - Riferimenti normativi • UNI EN ISO 15189:2013 Laboratori medici-Requisiti riguardanti la qualità e la competenza. • ISO 15198:2004 Clinica...
Article
Full-text available
Italian expressions for ISO / IEC 17011: 2017 Terms defined in ISO 17011 can influence regulations, check-lists and quality system documents. In ISO 17011 we find words with a conventional meaning (3.4 conformity assessment body), false friends (3.6 scope of accreditation), words confused by law (3.1 accreditation), others with restricted meaning (...
Article
UNI CEI EN ISO/IEC 17025:2018 is the Italian version of the ISO standard for the competence of testing and calibration laboratories, published by ISO on the same day of ISO/IEC 17011: 2017, which specifies the requirements applicable to accreditation bodies. The words of the two ISO standards are capable of influencing numerous documents, including...
Data
Burlina A (1993) La visione olistica della qualità. Med Lab 3:77–78 - sequenza temporale + dimensone spaziale + fasi operative = modello tridimensionale della qualità (Editoriale)
Book
Full-text available
Le parole delle norme ISO 17025 e ISO 17011 sono in grado di influenzare numerosi documenti, tra cui regolamenti, check-list e documenti dei sistemi qualità. La corretta traduzione ed interpretazione dei termini usati nelle norme è perciò importante per la corretta applicazione nelle attività sia degli enti di accreditamento che dei soggetti accred...
Presentation
Full-text available
AAS5 " Friuli Occidentale" - Via Grado n 7 33170 Pordenone Progetto formativo aziendale Dipartimentale 2018 13 dicembre 2018 - 14 dicembre 2018 – dalle 14:30 alle 17:00 - Aula n. 5 Centro Formazione Maran - SIPMeL GdS-I e ISO/TS 20658 - Trasporto - Identificazione paziente e campione - Richiesta di esami
Book
Full-text available
Espressioni italiane per ISO/IEC 17011:2017-libro digitale completo labmedico.blogspot.com/2018/11/espressioni-italiane-per-isoiec_28.html EBOOK con lo studio completo (gratuito) Terms defined in ISO 17011 can influence regulations, check-lists and quality system documents. In ISO 17011 we find words with a conventional meaning (3.4 conformity ass...
Presentation
Full-text available
Come entrare in un laboratorio ed uscirne sani ed integri. Dalla patient safety ai killer silenziosi Giovedì 25 Ottobre 2018, dalle 09.00 alle 10.15 AGENAS 2011/24/EU ISO 15189 ISO 15190 CLSI GP17 ISO 45001 ISO 35001 SGS SANITA'
Presentation
Full-text available
11 maggio 2018 - SANTORSO (VI), Sala Convegni Bolla Rossa Ulss 7, Pedemontana, Ospedale Alto Vicentino ● Equivoco del CQI ● Misunderstanding of the CQI ● ...prestazioni ● ... performance ● Regole ● Rules
Presentation
Full-text available
12° FORUM RISK MANAGEMENT IN SANITÀ 2017 Firenze 29 novembre 2017 RISK MANAGEMENT E PATIENT SAFETY IN MEDICINA DI LABORATORIO Ore 12:00 – 14:00 ICT come strumento di Patient Safety in Medicina di Laboratorio 13:10 – 13:30 ICT come strumento di Patient Safety in Medicina di Laboratorio decreto legge 18 ottobre 2012, n. 179 “Ulteriori misure urgenti...
Presentation
Full-text available
Centro Congressi, Molo Angioino Stazione Marittima Venerdì 17 Novembre 2017, 15.00 - 16.00 Sala Galatea Sessione Parallela Il sistema qualità nelle strutture di genetica medica Moderatori: Francesca Torricelli (Firenze), Domenico Coviello (Genova)
Presentation
Full-text available
Controllo qualità analitico ● Equivoco del CQI ● ...prestazioni ● Regole Analytical quality control ● Misunderstanding of the CQI ● ... performance ● Rules
Article
Full-text available
Background: in Italy, colorectal cancer screening is included as part of the Italian National Health Service - SSN (Servizio Sanitario Nazionale) Essential Levels of Care - LEA (Livelli Essenziali Assistenziali) and the European Guidelines, which specify quantitative FIT-Hb testing as the best strategy for organised screening programmes. To ensure...
Article
Background: Biological reference values (RVs) explore the relationships between humans and their environment and habits. RVs are fundamental in the environmental field for assessing illnesses possibly associated with environmental pollution, and also in the occupational field, especially in the absence of established biological or environmental li...
Article
hp://rdcu.be/r053 In definitiva, non aver considerato lo standard ISO per i Laboratori medici (ISO 15189) ha compromesso seriamente la qualità della proposta HL7 Italia, che sembra riproporre prassi adottate qua e là nei Laboratori, più che precise disposizioni normative di legge o di norme tecniche.
Article
A situation is emerging in which the new born "Azienda zero" (Law 19/2016) carries out tenders for the acquisition of laboratory IT services for the entire region and at the same time the existing IT systems are harmonized with respect to regional standards. The Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) with its Informa...
Presentation
Full-text available
1° modulo: 23 Maggio 2016 I Sistemi di Gestione e il fenomeno infortunistico Requisiti di sistema per la gestione ● Accreditamento in Europa ● EN 15224 ● 0 - GQ in sanità ● 3 - Glossario ● 4 - Contesto organizzativo ● 5 - Direzione - Leadership ● 7 - Attività di supporto ● 8 - Fase operativa ● 9 - Valutazione prestazioni ● 10 - Miglioramento
Article
Background. Accreditation standards (ISO 15189 and ISO 22870) require both the medical laboratory and the manufacturer of systems and reagents to compare methods that provide results for the same examination. CLSI guideline EP09 and EP31 provide some operational tools and statistics. Methods. The text of the CLSI guidelines EP09 and EP31 has been c...
Article
Full-text available
Il Gruppo di Studio in Autoimmunologia della SIPMeL ha riveduto e aggiornato le linee guida già proposte nel 2005 alla luce delle evidenze scientifiche comparse negli ultimi 10 anni per l’inquadramento diagnostico e il monitoraggio del paziente celiaco. L’identificazione della non celiac gluten sensitivity come entità nosologica a se stante ha reso...
Presentation
Full-text available
1994/95, 1995/96, 1996/97,19 97/98, 1998/99, 1999/00, 2000/01, 2001/02, 2002/03, 2003/04,2005/06, 2006/07, 2007/8, 2008/9, 2009/10, 2010/11: Corso e seminari di Statistica applicata al controllo di qualità presso la Scuola di Specializzazione in Patologia Clinica della Facoltà di Medicina e Chirurgia dell'Università di Padova luoghi comuni - vision...
Article
Infectious hepatitis: a worldlwide emergency. Infections by hepatitis B (HBV) and C (HCV) viruses are the most important agents of acute and chronic hepatitis, being involved in more than a half of all chronic liver diseases. They have a major impact on public healthcare both in terms of caregiving need and resources consumption. The challenge invo...
Article
This article attempts to provide a "helicopter view" on the issues linked to the various sub-sets involved in the problem of legionella. The involved eco-environments are reviewed, as well as the habitat and the technical solutions. The double track linked to the involved structures, in particular hospitals and hotels, is discussed. The economic an...
Article
The SIMeL Infectious Diseases Study Group has completed a national survey on blood culture in Italy. Data collected include the type of hospital, number of beds, number of hospitalizations; the autonomy of Microbiology service; the activity during the holidays; the protocols with clinical departments, the number of blood cultures per year; the perc...
Article
Today the traditional laboratory reques(order)-report cycle is broken by several factors. The flow of the diagnostic activities of the laboratory changes to compensate the discontinuities of the health system. The good professional practice requests both the verification and the validation of test results, based on various examples exposed in the C...
Article
Reports of a possible correlation between anti-Scl-70 antibody concentration and clinical manifestations in systemic sclerosis patients have recently appeared in the scientific literature. The goal of our study was to evaluate, by means of a multicenter study, the analytical reliability of immunoassay systems in the quantitative measurement of Scl-...
Article
The diagnosis of celiac disease is made on the basis of a patient's clinical and genetic history, the finding of specific antibodies and auto-antibodies, and the evidence of histological damage revealed by a duodenal biopsy. These guidelines were written in order to provide education and guidance for the appropriate use of serological and genetic t...
Article
Full-text available
Celiac disease (CD) may be found in association with other autoimmune diseases. We investigated the relation between autoimmune hepatitis (AIH) and CD by assessing the prevalence of IgA and IgG anti-tissue transglutaminase (tTG) antibodies in AIH, and by verifying whether the findings were associated with clinical and histological features of CD. F...
Article
The answer-report of the laboratory has a noble and ancient history, but the evolution of the information technology and the regulations about data treatment implies the review of the current concepts. A pathology of the answer-report exists, made by the refusal of some operators to be involved and from the claim of exclusive right of others, based...
Article
Background: While the aspects of "industrial" nature, like structure of production of examinations, are well present in the people's imagination of the medical laboratory, the medical function as "appropriateness engine" remains unknown to the majority Methods: The most meaningful and recent literature on the topic of the laboratory diagnostic acti...
Article
The use of highly sensitive immunometric methods in clinical laboratories to assay anti-thyroid antibodies has progressively expanded in recent years but it is not known whether the new techniques have improved the analytical variability connected with the preceding methodologies. The Italian Society of Laboratory Medicine Study Group on Autoimmune...
Article
Full-text available
The Italian Society of Laboratory Medicine Study Group on the Diagnosis of Autoimmune Diseases has generated a series of guidelines for the laboratory diagnosis and monitoring of systemic autoimmune rheumatic diseases intendedfor the use of clinical pathologists and laboratory physicians. These guidelines are based on a systematic review of publish...
Article
Full-text available
The ability of immunometric methods to identify anti-topoisomerase I (Scl70) antibodies is controversial. We wished to quantify the performance of the currently available commercial systems for the assay of anti-topoisomerase I antibodies in a large multicenter study. Fifty Italian clinical laboratories analyzed 36 serum samples: 27 from individual...
Article
This study was designed to assess the analytical sensitivity and rate of agreement between commercial methods and reagents, among the most used in Italy for the detection of autoantibodies to extractable nuclear antigens (ENA). Sixty-eight serum samples from patients with clinically diagnosed systemic rheumatic diseases were aliquoted and distribut...
Article
a-Si/insulator multilayers have been deposited on (0 0 1) Si by electron gun Si evaporation and periodic electron cyclotron resonance plasma oxidation or nitridation. Exposure to an O or N plasma resulted in the formation of a thin SiO2 and SiNx layer whose thickness was self-limited and controlled by process parameters. For thin-layer (∼2 nm) Si/S...
Article
This study was performed by the Italian Society of Laboratory Medicine (SIMeL) in order to establish the variability between the different analytical systems currently used in clinical laboratories for the detection of autoantibodies diagnostic of systemic autoimmune disease. Sixteen industrial, and two university laboratories participated in this...
Article
Background and Aim: An increased susceptibility of LDL to oxidation has been related to the genesis of vascular disease. The purpose of this study was to investigate whether this is atherogenic in patients with carotid atherosclerosis and free from other major risk factors. Methods: Seventy-two subjects undenvent echo-color-Doppler examination of t...

Network

Cited By

Projects

Projects (2)
Project
Facilitare il percorso di laboratori medici, POCT e punti prelievo per l'accreditamento ISO 15189 e ISO 22870.