The Department of Paediatric Laboratory Medicine in Children’s Health Ireland at Crumlin comply with Irish National Accreditation Board (INAB) regulations and the International Standard ISO15189: Medical Laboratories – Requirements for Quality and Competence. In addition, the Blood Transfusion Department complies with AML-BB titled “Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC”. The Blood Transfusion Department is accredited to ISO15189. The current scope of accreditation is available on the INAB website under registration number 375MT.
The Biochemistry, Haematology, Histology & Microbiology laboratories, have voluntarily withdrawn from ISO15189 accreditation, effective 16th February 2025. Laboratory Management, with the approval of Clinical Directorate-B, Children’s Health Ireland, have chosen not to have the laboratory tests performed in Biochemistry, Haematology, Histology and Microbiology formally inspected and accredited by the Irish National Accreditation Board (INAB) this year. This reflects the requirement of laboratory staff to redirect their focus toward the commissioning of the new laboratory in the new children's hospital. All of laboratory tests and other laboratory activities performed in Biochemistry, Haematology, Histology and Microbiology, CHI at Crumlin, will continue to be performed in exactly the same way and to the same quality and patient safety standards despite the change in accreditation status. The Blood Transfusion Department is not impacted by this decision and will be inspected by INAB as usual in April 2025.