Assessing the quality of medical laboratories for licensing
Medical laboratories conduct tests on clinical specimens in order to obtain information about the health of a patient for the diagnosis, treatment and prevention of diseases. These laboratories must be reliable, to protect the health and safety of the patients depending on these testing services.
To guarantee this reliability, legal provisions apply to the laboratories for medical biology (Royal Decree of 03/12/1999 and Royal Decree No. 143 of 30/12/1982) and the laboratories for anatomical pathology (Royal Decree of 05/12/2011).
Our service verifies the compliance of medical laboratories and carries out inspections to evaluate, monitor and improve the quality of the functioning of medical laboratories. To do this, we work together with the Commission for Medical Biology and the Commission for Anatomical Pathology as well as the Belgian Accreditation Body (BELAC).
We are responsible for managing the licenses of medical laboratories for clinical biology and anatomical pathology.
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In order for a medical laboratory to be able to apply for reimbursement for the performed laboratory analyzes, in accordance with the provisions of the National Institute for Sickness and Disability Insurance (INAMI/RIZIV), it must be licensed by the Minister of Health.
To obtain this license, the laboratory must comply with all the legal provisions as described:
- Royal Decree No. 143 of 30/12/1982 and Royal Decree of 03/12/1999 on the accreditation of laboratories for clinical biology, or
- RD of 05/12/2011 on the licensing of laboratories for anatomical pathology.
Within the framework of these legal provisions, we are responsible for:
- granting licenses for a period of 5 years
- the administrative management of licenses and communicating changes to the National Institute for Sickness and Disability Insurance (INAMI/RIZIV)
- carrying out audits, either documentary or on site, in order to:
- evaluate the implementation of the quality system
- follow-up on anomalous external quality assessment (EQA) results that could impact analyses of patient’s specimen.
We also provide the secretariat for the Commission for Medical Biology and the Commission for Anatomical Pathology. These commissions address the EQA results and problems associated with licensing. Both commissions also periodically review the rules of nomenclature and legal texts.
As competent authority we also participate in audits carried out by BELAC, within the framework of the accreditation of medical laboratories.