External Quality Assessment: an effective tool for Clinical Governance in laboratory medicine.

The implementation of Clinical Governance will require a redefinition of duties and accountability as a prerequisite to develop and achieve an overall improvement in clinical care through a culture of assessment and monitoring of quality. External Quality Assessment Schemes (EQAS) are the main tool enabling laboratories to measure the quality of their results; they must carefully assess and monitor all elements contributing to the formulation of laboratory information (results, reference ranges/decisional levels, interpretative comments and diagnostic algorithms). There are different ways to design and manage a Scheme and EQAS coordinators are mainly responsible for its effectiveness. The present paper reports, as an example, some experiences of the Centre of Biomedical Research (CRB), which manages EQAS according to high quality specifications and laboratories' needs, that can reflect the Clinical Governance philosophy. Our findings show that EQAS are able to control all the above aspects and, if organisers are committed to fulfilling the responsibility and accountability principles, they will be of great value in quality assessment and in developing an External Quality Assurance Program (EQAP). This is an inter-laboratory comparison designed and conducted to assure the following: evaluation of participants' performance (by evaluating not only analytical performance, but also test interpretation, and advice for clinicians on laboratory requests and diagnosis); evaluation of method performance; and continuous education, training and help. The main aim of the activities of an EQAP in Laboratory Medicine is to sustain improvements in the quality of services provided by participating laboratories for the benefit of patients.