Guidance for faecal occult blood testing: quantitative immunochemical method (FIT-HB) in colorectal cancer screening programmes.

Autor:	Rubeca T; S.C. Laboratorio regionale prevenzione oncologica, ISPO, Firenze., Rapi S; responsabile del progetto SIBioC-GISCoR sull'armonizzazione della fase preanalitica dei test fecali; curatore processi pre-esame (fase pre-analitica) e fase analitica; AOU Careggi, Firenze., Deandrea S; curatore indicatori prestazionali (KPIs); Joint Research Centre, Ispra (Va)., Malaspina M; USL Umbria 1 Laboratorio unico di Screening, Perugia., Passamonti BU; USL Umbria 1 Laboratorio unico di Screening, Perugia., Grassi E; ASL Brescia, Laboratorio sanità pubblica, Brescia., Cioccarelli AM; ASL Sondrio, Laboratorio sanità pubblica, Sondrio., Marchetti E; USL Umbria 2, Terni., Boni M; Arcispedale S. Anna, Cona (Ferrara)., Cellai F; Laboratorio regionale prevenzione oncologica, ISPO, Firenze., Pradella M; Coordinatore della Commissione nazionale qualità e accreditamento della Società italiana di patologia clinica e medicina di laboratorio (SIPMeL)., Gattafoni F; Ispettore dipartimenti certificazione, ispezione e laboratori ACCREDIA (ente unico nazionale di accreditamento).; Project manager del gruppo di lavoro EA (European Accreditation) per l'European Commission Initiative on Breast Cancer (ECIBC) coordinata dall'European Commission Directorate General Joint Research Centre, Ispra (Varese)., Rotolo S; Ispettore dipartimenti certificazione e laboratori ACCREDIA (ente unico nazionale di accreditamento).
Jazyk:	English; Italian
Zdroj:	Epidemiologia e prevenzione [Epidemiol Prev] 2017 Sep-Dec; Vol. 41 (5-6 (Suppl 1)), pp. 1-31.
DOI:	10.19191/EP17.5-6S1.P001.101
Abstrakt:	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 consistent operating standards in Member States, European regulations require the implementation of certification and accreditation requirements for diagnostic and care-related processes. The requirement, based on ISO 17021 accreditation standards, includes ISO 9001 certification for systems and ISO 15189:2012 accreditation for laboratories. Methodology: various phases of the analytical process (pre-test, test, post-test) were evaluated in detail and provided operational guidelines for adjusting analytical and managerial procedures using: (a) feedback from members of GISCoR screening labs; (b) performance data obtained via a systematic review of the literature and the Osservatorio Nazionale Screening (ONS) Survey; (c) recommendations for laboratory practice issued by the World Endoscopy Organization "FIT for Screening" Working Group; (d) selected guidelines from the National Guidelines Clearinghouse database; and (e) Canadian, Australian and European screening programme websites. With respect to ISO 15189:2012 standards for accreditation of medical laboratories, GISCoR's guidance has been re-evaluated and revised by auditors from the Italian certification body (ACCREDIA) to assess its compliance and completeness with the aim of finalising operating procedures. Conclusions: the implementation and maintenance of operational standards required by complex systems (e.g. screening programmes) involving constant interaction between facilities and the supporting organisational structure are not easy to achieve. The guide aims to provide laboratories with the necessary guidance for proper process management.
Databáze:	MEDLINE
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