1. Clinical Audits in Nuclear Medicine Pilot study Marleen Vandecapelle Dr. M. Haelterman Dr. J. Rutten 25/08/2010 10.00-12.30h

2. Nuclear Medicine 27/11/2009 : Round Table (Radioprotection) Nuclear Medicine www.fanc.fgov.be/nl/page/werkgroepen-stralingsbescherming-in-de- nucleaire-geneeskunde/1291.aspxwww.fanc.fgov.be/nl/page/werkgroepen-stralingsbescherming-in-de- nucleaire-geneeskunde/1291.aspx Input for revision of Chapter VI of Royal Degree 20/07/2001 WG6 Education and administrative simplification WG4 Medical Radiation Physics WG3 Justification and optimization WG1 Quality Assurance and Clinical Audit WG2 Vigilance system WG5 Radionuclide therapy

3. Clinical audit NM in Europe and Belgium Euratom 97/43 “Council Directive on health protection against the dangers of ionizing radiation in relation to medical exposure” –Clinical audit: a systematic examination or review of medical radiological procedures which seeks to improve the quality and the outcome of patient care through structured review whereby radiological practices, procedures and results are examined against agreed standards for good medical radiological procedures, with modification of practices where indicated and the application of new standards if necessary. –Article 6.4. Clinical audits shall be carried out in accordance with national procedures. Royal Degree 20 th July 2001 “General Reglementation on the Protection of Population, Workers and Environment against the Dangers of Ionizing Radiation” –Same definition –Article 51.4. Clinical audits shall be carried out in radiological installations determined by the Agency and following the modalities determined or approved by the Agency. BELGIUM 2010: ARTICLE 51.4 NOT IMPLEMENTED !!!

4. Not implemented in: 1. Austria 2. BELGIUM 3. Cyprus 4. Danmark 5. Estonia 6. Greece 7. Hungary 8. Italy 9. Lithuania 10.Luxembourg 11. Malta 12. Netherlands 13. Portugal 14. Republic of Ireland 15. Slovakia 16. Spain 17. Sweden 18. United Kingdom Implemented in: 1. Bulgaria 2. Czech Republic 3. Finland 4. France 5. Germany 6. Latvia 7. Poland 8. Romania 9. Slovenia CA NM in Europe Source: Maffioli, EANM course 2010 There was a clear need for further guidance on clinical audit in order to improve its implementation and to harmonize the approaches among the Member States

5. Clinical Audit NM in Europe 2009 2010

6. WG1 QA and Clinical Audit –Stakeholders approvement –Basis QUANUM (IAEA, 2008) QUANUM : –Checklists on 11 ≠ topics : Dr. J. Rutten –Regulatory basis –Translation Dutch + French + German Collaboration ≠ competent authorities Clinical Audit NM in Belgium

7. Timing Clinical Audits NM in Belgium Auto-evaluation –Pilot study : 01/09/2010 – 01/03/2011 (Feed back meeting half way : ± 01/12/2010) –All NM departments : ± 01/03/2011 – 01/03/2012 Internal clinical audit –± 01/03/2012 – 01/03/2013 –Become part of project on hospital quality contracts (Health Care Authority, Dr. M. Haelterman) External clinical audit 01/03/2013 External CA Internal CAAuto-evaluation All NM 01/09/201001/03/2012 01/12/2010 01/03/2011 PilotAll NM

8. Pilot study participants Aalst OLV Ziekenhuis Arlon St-Joseph Hornu CH Hornu-Frameries Kortrijk AZ Groeninge Mons CHR Oostende AV Serruys Roeselare Stedelijk Ziekenhuis St-Truiden St-Trudo Tournai A.I.T. Site Union Turnhout AZ St-Elisabeth Bruxelles Jules Bordet Bruxelles CHU St-Pierre Charleroi CHU de Charleroi Jette UZ Brussel La Louvière CHU Tivoli Leuven UZ Gasthuisberg Yvoir UCL Mont-Godinne Total 17 Flanders 7 Wallone 7 Brussels 3 University 7 Non university 10

9. Aim of pilot study TO EVALUATE THE QUANUM CHECKLISTS The (individual) answers to questions are not important ! Wether or not questions are clear is important ! Webpage relevant announcments, documents, FAQs,… http://www.fanc.fgov.be/nl/page/clinical-audit-in-nuclear-medicine-pilot-study/1316.aspx http://www.fanc.fgov.be/nl/page/clinical-audit-in-nuclear-medicine-pilot-study/1316.aspx (Feed-back meeting half way ± 01/12/2010) Suggestions ? How can we help ? How much time ? All questions clear ? All questions applicable ? What can we do to make QUANUM easier ?

10. THANK YOU ! Marleen Vandecapelle Federal Agency for Nuclear Control Ravensteinstreet 36 1000 Brussels marleen.vandecapelle@fanc.fgov.be ++32 (0)2 289 21 78 ++32 (0)2 289 21 12 Absent on Wednesdays http://www.fanc.fgov.be/nl/page/clinical- audit-in-nuclear-medicine-pilot- study/1316.aspx