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

Area of Science:

• Gastroenterology
• Clinical Laboratory Science
• Public Health

Background:

• Colorectal cancer screening is a key component of Italy's National Health Service (SSN) and aligns with European Guidelines.
• Quantitative fecal immunochemical test (FIT-Hb) is recognized as the optimal strategy for organized colorectal cancer screening programs.
• European regulations mandate certification and accreditation for diagnostic processes, including ISO 9001 for systems and ISO 15189 for laboratories.

Framework:

• The study evaluated pre-test, test, and post-test analytical phases to develop operational guidelines.
• Guidance was informed by feedback from GISCoR screening laboratories, literature reviews, and the National Screening Observatory (ONS) Survey.
• Recommendations from the World Endoscopy Organization's
• FIT for Screening
• Working Group and international screening program websites were incorporated.

Implementation:

• The developed guidance aims to assist laboratories in managing screening processes effectively.
• It addresses the complexities of maintaining operational standards in integrated healthcare systems.
• Auditors from ACCREDIA, the Italian certification body, reviewed and revised the guidance against ISO 15189:2012 standards.

Implications:

• Successful implementation of these guidelines can enhance the quality and consistency of colorectal cancer screening programs.
• Compliance with ISO 15189 accreditation ensures robust laboratory practices and reliable test results.
• This initiative supports the standardization of diagnostic and care-related processes across European Member States.