Guidance for faecal occult blood testing: quantitative immunochemical method (FIT-HB) in colorectal cancer screening programmes: GISCoR First Level Working Group

Background: Colorectal cancer screening in Italy is included in the LEA (Livelli Essenziali Assistenziali – Essential Care Levels) and the European Guidelines, indicating quantitative FIT-Hb testing as the most appropriate strategy for organised screening programmes. To ensure and standardise operating standards in the Member States, the European regulations require the implementation of healthcare and diagnostic process certification and accreditation. Required standards are based on ISO 17021 - ISO 9001 certification models and, for laboratories, on the ISO 15189:2012 accreditation model. Methodology: The various phases of the analytical process (pre-testing, testing, post-testing) are evaluated in detail, with the provision of operational guidelines for adjusting the analytical and management procedures, using the following sources of information: feedback from the members of the screening laboratory of the scientific society (GISCoR); performance data obtained from a thorough review of the literature and the annual Osservatorio Nazionale Screening survey; recommendations relating to the laboratory practice reported by the World Endoscopy Organization FIT for Screening working group; guidelines selected from the National Clearinghouse database and websites of the Canadian, Australian and European screening programmes. The information compiled by the GISCoR Level 1 Working Group have been reviewed and revised by inspectors from the Italian certification body (ACCREDIA) against the ISO 15189:2012 standard for medical laboratory accreditation, to assess their consistency and completeness with the aim of verifying the final operational processes. Conclusions: The implementation and maintenance of the operational standards required by complex systems, such as screening programmes involving constant interaction between facilities and distinct operational models, cannot be taken for granted. The manual aims to provide laboratories with the guidelines they require to manage the process properly.

RUBECA Tiziana;  RAPI Stefano;  DEANDREA Silvia;  MALASPINA Morena;  PASSAMONTI Basilio Ubaldo;  GRASSI Elena;  CIOCCARELLI Anna Maria;  MARCHETTI Enrico;  BONI Michela;  CELLAI Filippo; 

2017-11-20

INFERENZE SCARL

JRC107024

1120-9763,   

https://publications.jrc.ec.europa.eu/repository/handle/JRC107024,   

10.19191/EP17.5-6S1.P001.101,