BACKGROUND-AIM
; In order to support the Belgian Medical Centers of Human Genetics (BMCHGs) in the
; development of a Quality Management System and the participation to External
; Quality Assessment programs (EQAs), the Belgian National Institute for Health and
; Disability Insurance in collaboration with the Belgian Institute for health, Sciensano
; has developed a funding for the participation of the BMCHGs to EQAs focused on
; genetic tests performed in the context of hereditary rare diseases and hereditary
; rare cancers. Indeed,
; participation to external quality assessments (EQAs) is required for the ISO15189
; accreditation of the Belgian Medical Centers of Human Genetics (BMCHGs). However,
; no directives on the minimal frequency of participation to genetic EQAs exist and
; European recommendations in this field are heterogeneous and it potentially impacts
; healthcare quality.
; METHODS
; In order to address this lack, genetic EQA schemes offered by accredited providers
; and focused on analyses used for rare diseases’ diagnosis were analyzed by a working
; group in order to propose minimal frequencies of participation to EQA schemes with
; reference to international recommendations and national laboratory practice.
; Recommendations for dealing with poor performances and change management were
; also formulated.
; RESULTS
; Our guidelines recommend to assess annually all methods if possible through EQAs
; covering the technique, genotyping and clinical interpretation. A triennial
; assessment of performance of individual diagnostic tests is also recommended. In
; case of poor performances impacting the diagnosis of the patient, centers should
; participate to an EQA the following year and implement actions to avoid future
; errors.
; CONCLUSION
; These first Belgian guidelines help the BMCHGs to improve their quality management
; system. Moreover, they help the Belgian healthcare authorities to estimate the
; budget required to cover the participation of the BMCHGs to EQAs. Therefore, we
; are convinced that these guidelines could be used as a starting point for discussion
; at a broader level.