1. Clinical Audits meaning and strategy results of the pilot study with participation of centers Marleen Vandecapelle Protection of Health Federal Agency Nuclear Control 15/06/2011

2. Round Table and Working Parties 27/11/2009: Round Table Radioprotection in Nuclear Medicine: physicians, medical radiation physicists, radiation experts, radiopharmacist, auxiliaries, competent authorities,… Input for revision/clarification of Chapter VI of RD 20 th July 2001 (ARBIS/RGPRI) on application of ionizing radiation in medicine WP6 Education and administrative simplification WP4 Medical Radiation Physics WP3 Justification and optimization WP1 Quality Assurance and Clinical Audit WP2 Vigilance system WP5 Radionuclide therapy Marleen Vandecapelle - 15/06/2011

3. www.fanc.fgov.be/nl/page/werkgroepen-stralingsbescherming-in- de-nucleaire-geneeskunde/1291.aspx

4. Euratom 97/43 “Council Directive on health protection against the dangers of ionizing radiation in relation to medical exposure” RD 20 th July 2001 “General Reglementation on the Protection of Population, Workers and Environment against the Dangers of Ionizing Radiation” (ARBIS/RGPRI) “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.” Clinical audits shall be carried out in radiological installations determined by the Agency and following the modalities determined or approved by the Agency.” 2010: not implemented in Belgium and 2/3 of Europe ! Clear need for further guidance to improve its implementation and to harmonize the approaches among the Member States What Clinical Audit ? Marleen Vandecapelle – 15/06/2011

5. 20092010 Marleen Vandecapelle – 15/06/2011 Clinical Audit: international initiatives 2008 Sufficient guidelines to determine modalities of clinical audit

6. WP1 QA and Clinical Audit –Basis QUANUM –Timing agreed –Collaboration ≠ competent authorities QUANUM –Essentially consists of checklists Y/N questions on 13 ≠ topics –Audit by peer review of multi-disciplinary teams –General because globally applicable Marleen Vandecapelle – 15/06/2011 Clinical Audit: national initiative

7. Pilot study: –performed by 18 NM departments –Belgian version B-QUANUM –suggestions for extra support –01/09/2011 – 01/07/2011 Auto-evaluation Internal CA Final destination: external CA in all NM departments with QUANUM ? Timing Clinical Audits + External CA All NM B Marleen Vandecapelle – 15/06/2011 01/09/2010 Pilot 18 NM 01/07/2011 + Internal CAAuto-evaluation All NM

8. Timing Clinical Audits Auto-evaluation : 01/07/2011 - … –to auto-evaluate and take corrective actions based on B-QUANUM –continuous process –by colleagues within the department Internal clinical audit : 01/07/2012 - … –1x/year –by colleagues within the hospital External clinical audit : 01/07/2013 - … –1x/5years –by colleagues within Belgium + External CA+ Internal CAAuto-evaluation 01/07/201301/07/2012 All NM 01/07/201101/09/2010 Pilot 18 NM Marleen Vandecapelle – 15/06/2011 B

9. AUDITS VAN HET KWALITEITSBEHEER IN DE NUCLEAIRE GENEESKUNDE - UITGEBREIDE AUDIT AUDIT DE GESTION DE LA QUALITE EN MEDECINE NUCLEAIRE - AUDIT GLOBAL AUDITS DE GESTION DE LA QUALITE EN MEDECINE NUCLEAIRE - AUDIT GLOBAL Marleen Vandecapelle – 15/06/2011 B-QUANUM

10. B-QUANUM annexes Annexe 1 Example of annual report 2010 1 –Practical information on content and format of annual report Annexe 2 List of Standard Operating Procedures (SOP’s) –Clinical procedures –Medical radiation physics –Radiopharmacy –Support Annexe 3 Extract SOP Bone scintigraphy 2 Annexe 4 Extract SOP Whole Body 18 F-FDG 2 Annexe 5 Extract ISO Manual 2 Annexe 6 Extract Quality Manual 2 Annexes 7-17 Checklists Annexe 18 Regulatory basis checklists from ARBIS/RGPRI 1 Courtesy to dr. J. Rutten, AZ Turnhout 2 Courtesy to dr K. Van Laere, UZ Leuven If not performed = not applicable Marleen Vandecapelle – 15/06/2011

11. B-QUANUM checklists 1.Strategies and policies 2.Administration and management 3.Human resources 4.Radiation protection of personnel and environment 5.Radiation protection of the patient and his direct environment 6.Quality assurance system 7.Quality control of imaging equipment and dose calibrator 8.Computer systems and data handling 9.Acceptance tests 10.General aspects - diagnostics 11.General aspects - radionuclide therapy Marleen Vandecapelle – 15/06/2011

12. NoComponentClass ARBIS/ RGPRI %Comments Date achieved 6.1Are Standard Operating Procedures available for all tasks performed by the department? A51.4§3 6.10Does the department perform self- evaluation or internal audit once a year? B 6.11a.Is the satisfaction of the patients evaluated? b.Is the satisfaction of the referring physicians evaluated? C B-QUANUM checklists Required by legislation, IAEA technical document or other external standard- setting bodies. Urgent corrective action should be instituted. Desirable but not essential. Corrective action may improve the overall functioning of the department. Not compulsory, but are expected to be reached by all departments. Corrective action is recommended. Marleen Vandecapelle – 15/06/2011 REMARQUE: Checklists are just the starting point for discussion ! Not applicable is also an answer ! 0 25 50 75 100 Corrective actions ? CHECKLIST 6: QUALITY ASSURANCE SYSTEM

13. NoComponentClass 1.3a. Does the department make a policy plan ? a.1. Are quality objectives formulated ? a.2. Is there a system to evaluate the policy plan and quality objectives ? b. Does the department make an annual report ? 1 B 1.7Are there written agreements with a.other clinical departments b.technical department of the hospital with indication of each tasks and responsibilities ? A Marleen Vandecapelle – 15/06/2011 B-QUANUM checklists CHECKLIST 1: STRATEGIES AND POLICY (9 questions) 1 Explanation in annexe 1: Example of an annual report

14. NoComponentClass 3.2Have all categories of professionally exposed persons active in the department followed basic education radioprotection ? A 3.7Do all categories of professionally exposed persons active in the department follow continuing education radioprotection ? A 3.9Is there a system within the hospital to identify the need for education of its personel ? B 3.10Does all personnel have access to scientific literature through e-learning, recent books and magazines ? B Marleen Vandecapelle – 15/06/2011 B-QUANUM checklists CHECKLIST 3: HUMAN RESOURCES (10 questions)

15. Marleen Vandecapelle – 15/06/2011 B-QUANUM checklists CHECKLIST 4: RADIATION PROTECTION OF PERSONNEL AND ENVIRONMENT (21 questions) NoComponentClass 4.1a.Does the department have a authorisation granted by the FANC ? b.Is it up to date ? A 4.12Are there calibrated, funtioning contamination monitors for all radioisotopes stated in the authorisation granted by the FANC ? A 4.14Do all profesionnaly exposed persons wear a chest dosimeter delivered and read by a dosimetric service recognised by the FANC ? A 4.19Is there a separate toilette for personnel ?B

16. Marleen Vandecapelle – 15/06/2011 B-QUANUM checklists CHECKLIST 5: RADIATION PROTECTION OF PATIENTS AND DIRECT ENVIRONMENT (12 questions) NoComponentClass 5.1Are all applications approved and justified by a nuclear physician authorised by the FANC for a. diagnostic procedures ? b. therapeutic procedures ? A 5.3Are all administerd activities conform (inter)national DRL’s for a. diagnostic procedures ? b. therapeutic procedures ? A 5.6 5.7 Are oral/written instructions given to the patient (or his legal guardian) ? A 5.10 5.11 5.12 Is before administration of the radiopharmaceutical a. His/her name and date of birth asked ? b. asked whether she is pregnant or is lactating ? c. checked whether he/she had similar imaging procedure ? A

17. Marleen Vandecapelle – 15/06/2011 B-QUANUM checklists CHECKLIST 6: QUALITY ASSURANCE SYSTEM (18 questions) NoComponentClass 6.2Do al SOP’s for clinical procedures performed by the department contain the following (if applicable): 1,2 a. Clinical question/Purpose of the examination ?b. Principle ? c. Indications and contra-indications ?d. How to make an appointment ? e. Preparation of the patient ?f. Planning ? g. Reception of the patient ?h. Preparation of the radiopharmacon ? i. Administration of the radiopharmacon ?j. Execution of the examination ? k. Reconstruction and processing ?l. After examination ? m. Assessment/making protocol ?n. references ? o. Version ?p. Person validating SOP ? q. Person approving SOP ? B 1 a list of SOP’s is available in annexe 2 2 extracts from SOP’s are availabel in annexe 3 and 4

18. Marleen Vandecapelle – 15/06/2011 B-QUANUM checklists CHECKLIST 7: QUALITY CONTROL OF IMAGING EQUIPMENT AND DOSECALIBRATORS (21 questions) NoComponentClass Based on Quality Assurance Protocols for gamma camera and dosecalibrator (soon to be published in a degree of the FANC) and Feed back from medical radiation physicists nuclear medicine on QUANUM A NoComponentClass Based on feed back from medical radiation physicists nuclear medicine on QUANUM A CHECKLIST 9: ACCEPTANCE TESTS (6 questions)

19. B-QUANUM Self-evaluation: 1 coordinator/department Audit: Peer review by multi-disciplinary teams of ≥ 3 experts Internal audit:External audit: – physician nuclear medicine– physician nuclear medicine – (medical radiation physicist)– (medical radiation physicist) – (technologist medical imaging)– (technologist medical imaging) – (radio/hospital pharmacist)– (radio/hospital pharmacist) – (referring physician) – (hospital management) Auditors should be independant, have enough knowledge and experience ! Marleen Vandecapelle – 15/06/2011

20. First time round: probably not a lot of 100% Not important !!! If start of corrective actions Look for input from: –Hospital management –Human Resources Management department hospital –Quality coordinator/department hospital –Medical radiation physicist (internal or external) –Health physics department (internal or external) –IAEA, FANC, –Scientific societies (Belnuc, EANM, SNM, NVNG, BSNM, …) –… Document management tool: –MITRAS –Knowledge tree (www.knowledgetree.com) avaible for freewww.knowledgetree.com B-QUANUM Marleen Vandecapelle – 15/06/2011

22. To assess current status of a NM department and to identify areas for future improvement Opportunity to improve yourselves based on experience from peer reviewers Stop and think about “Are we doing the right things ?” “Are we doing them right ?” at every level (nuclear physician, medical radiation physicist, technologist,…) Marleen Vandecapelle – 15/06/2011 Why Clinical Audit ?

23. Optimization of –Radiation protection personnel –(Radiation) protection patient –Patient care Optimization of use of –resources –infrastructure –personnel Lower risk (near)incidents Protection against potential damage claims from patients/personnel Proof of quality: –towards NM community –towards referring physicians –towards patients –towards hospital management –to attract potential (commercial) partners Marleen Vandecapelle – 15/06/2011

24. Who should organize ? Federal Authority for Public Health ? –Contract “Coordination of quality and patient-safety in Belgian Hospitals” –2004-2012 College for Medical Imaging of Federal Authority for Public Health ?// RT Belnuc ? // NVNG, BSNM, DGN Marleen Vandecapelle – 15/06/2011

25. Timing Clinical Audits 01/07/2011: start of auto-evaluation for all NM departments Active mailing to all NM departments + corresponding hospital management FANC website: –B-QUANUM (Fr + D) –Annexes (Fr +D) –Already available: QUANUM (E + Fr + D + G) EC159 (E) Extracts from quality manual and from SOP’s (Fr + D) + External CA+ Internal CAAuto-evaluation 01/07/201301/07/2012 All NM 01/07/201101/09/2010 Pilot 18 NM Marleen Vandecapelle – 15/06/2011 B

26. Acknowlegments 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 Tienen Stedelijk Ziekenhuis 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 Marleen Vandecapelle – 15/06/2011 18 pilot study participants Dr P. De Bondt (OLV Aalst) Dr B. Krug (UCL Mont-Godinne) Dr J. Rutten (AZ Turnhout) Dr K. Van Laere (UZ Leuven) G. Lapeirre (AZ Groeninge) Pascal Froment (AVC) Philippe Van Boxem (EBNM/CANMD + QUANUM auditor for IAEA) Tom Clarijs and Petra Willems (FANC)

27. Thank You for listening ! Marleen Vandecapelle Federal Agency for Nuclear Control Ravensteinstreet 36 1000 Brussels marleen.vandecapelle@fanc.fgov.be ++32 (0)2 289 21 78 http://www.fanc.fgov.be/ Marleen Vandecapelle – 15/06/2011