Marco Pradella

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

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...

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...

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...

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/...

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...

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).

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...

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...

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...

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...

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...

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...

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...

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...

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...

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. -

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...

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,...

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...

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 /...

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...

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...

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...

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...

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...

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...

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...

● 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

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...

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...

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...

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...

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...

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...

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...

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...

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 (...

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...

Burlina A (1993) La visione olistica della qualità. Med Lab 3:77–78 - sequenza temporale + dimensone spaziale + fasi operative = modello tridimensionale della qualità (Editoriale)

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...

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

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...

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'

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

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...

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)

Controllo qualità analitico ● Equivoco del CQI ● ...prestazioni ● Regole Analytical quality control ● Misunderstanding of the CQI ● ... performance ● Rules

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...

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...

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.

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...

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

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...

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...

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...

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...

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...

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...

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...

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-...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...