External quality assessment scheme in Tuscany, Italy

Area of Science:

• Clinical Chemistry
• Laboratory Quality Assurance
• Medical Diagnostics

Background:

• Regional Law n. 44 of 6/6/1988 mandates internal quality control and external quality assessment (EQA) for all public and private laboratories in Tuscany, Italy.
• The "Regione Toscana" manages EQA schemes via the "Centro regionale di riferimento per la sicurezza di qualità".

Purpose of the Study:

• To describe the evolution and structure of the EQA programs for clinical chemistry and blood coagulation in Tuscany.
• To outline the mandatory participation and analytical requirements for laboratories within these EQA schemes.

Main Methods:

• The clinical chemistry EQA program began in 1990 with lyophilized serum samples for key analytes, expanding to eighteen analytes by 1992.
• The blood coagulation EQA program was initiated in 1992, requiring participants to perform 16 analyses on 8 pairs of samples from different pools.
• Samples are dispatched separately and in random order to ensure varied analytical sequences for participating laboratories.

Main Results:

• The EQA program successfully expanded its scope from initial clinical chemistry analytes to include blood coagulation parameters.
• Laboratories are required to consistently perform a defined set of analyses within each EQA cycle.
• The randomized sample delivery ensures laboratories process samples in diverse sequences, testing their analytical robustness.

Conclusions:

• The established EQA programs in Tuscany provide a framework for continuous quality improvement in clinical chemistry and blood coagulation testing.
• Mandatory participation and standardized procedures in EQA schemes contribute to reliable laboratory diagnostics and patient safety.
• The systematic management and evolution of these EQA programs underscore a commitment to high-quality laboratory services in the region.