External quality assessment programs in Lombardy, Italy

Area of Science:

• Clinical Laboratory Science
• Quality Management in Healthcare
• Diagnostic Accuracy

Background:

• National decree mandates regional quality control for clinical laboratories in Italy.
• External Quality Assessment Schemes (EQAS) are inconsistently implemented across Italian regions.
• Lombardy established a comprehensive EQAS in 1986, expanding to multiple disciplines.

Purpose of the Study:

• To detail the organization and implementation of EQAS in Lombardy, Italy.
• To report on the statistical procedures and initial results of these quality control programs.
• To highlight the successful regional approach to laboratory quality assurance.

Main Methods:

• Implementation of compulsory EQAS for public and private laboratories in clinical chemistry, hematology, and coagulation.
• Provision of free participation, including control materials.
• Anonymous management of analytical results to ensure a non-punitive assessment.

Main Results:

• Lombardy operates EQAS covering 20 analytes in clinical chemistry, plus key hematology and coagulation parameters.
• The schemes are supported by regional legislation and a dedicated committee (CROSP).
• Participation is voluntary, free, and results are anonymized, fostering a collaborative quality improvement environment.

Conclusions:

• Lombardy's regional EQAS model demonstrates a successful framework for enhancing clinical laboratory quality control.
• The program's structure, emphasizing anonymity and free participation, encourages widespread adoption and compliance.
• This initiative contributes to improved diagnostic accuracy and patient care through standardized laboratory performance.