Clinical Audits in Nuclear Medicine Pilot study

Marleen VandecapelleDr. M. Haelterman

Dr. J. Rutten25/08/2010 10.00-12.30h

Nuclear Medicine

• 27/11/2009 : Round Table (Radioprotection) Nuclear Medicine

• www.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

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 20th 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 !!!

Not implemented in:1. Austria2. BELGIUM3. Cyprus4. Danmark5. Estonia6. Greece7. Hungary8. Italy9. Lithuania10.Luxembourg11. Malta12. Netherlands13. Portugal14. Republic of Ireland15. Slovakia16. Spain17. Sweden18. United Kingdom

Implemented in:1. Bulgaria2. Czech

Republic3. Finland4. France5. Germany6. Latvia7. Poland8. Romania9. 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

Clinical Audit NM in Europe

2009 2010

• 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

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 CAInternal CAAuto-evaluation

All NMAll NM

01/09/2010 01/03/2012

01/12/2010

01/03/2011

Pilot All NM

Pilot study participantsAalst OLV ZiekenhuisArlon St-Joseph Hornu CH Hornu-FrameriesKortrijk AZ GroeningeMons CHROostende AV SerruysRoeselare Stedelijk

ZiekenhuisSt-Truiden St-TrudoTournai A.I.T. Site UnionTurnhout AZ St-Elisabeth

Bruxelles Jules BordetBruxelles CHU St-PierreCharleroi CHU de CharleroiJette UZ BrusselLa Louvière CHU TivoliLeuven UZ GasthuisbergYvoir UCL Mont-Godinne

Total 17

Flanders 7Wallone 7Brussels 3

University 7Non university 10

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

• (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 ?

THANK YOU !

Marleen VandecapelleFederal Agency for Nuclear Control

Ravensteinstreet 361000 Brussels

marleen.vandecapelle@fanc.fgov.be++32 (0)2 289 21 78++32 (0)2 289 21 12

Absent on Wednesdayshttp://www.fanc.fgov.be/nl/page/clinical-audit-in-nuclear-medicine-

pilot-study/1316.aspx