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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. WP4 Medical Radiation Physics. WP1 Quality Assurance and Clinical Audit. WP5 Radionuclide therapy.
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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
WP4 Medical Radiation Physics WP1 Quality Assurance and Clinical Audit WP5 Radionuclide therapy WP2 Vigilance system WP6 Education and administrative simplification WP3 Justification and optimization 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 20th July 2001 (ARBIS/RGPRI) on application of ionizing radiation in medicine Marleen Vandecapelle - 15/06/2011
What Clinical Audit ? • Euratom 97/43 “Council Directive on health protection against the dangers of ionizing radiation in relation to medical exposure” • RD 20th 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 againstagreed 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 Marleen Vandecapelle – 15/06/2011
Clinical Audit: international initiatives 2009 2010 2008 Sufficient guidelines to determine modalities of clinical audit Marleen Vandecapelle – 15/06/2011
Clinical Audit: national initiative • 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
01/09/2010 01/07/2011 Pilot 18 NM Timing Clinical Audits • 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 B ? Auto-evaluation + Internal CA + External CA All NM All NM All NM Marleen Vandecapelle – 15/06/2011
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 B 01/09/2010 01/07/2011 01/07/2012 01/07/2013 Pilot Auto-evaluation + Internal CA + External CA 18 NM All NM All NM All NM Marleen Vandecapelle – 15/06/2011
B-QUANUM AUDIT DE GESTION DE LA QUALITE EN MEDECINE NUCLEAIRE - AUDIT GLOBAL AUDITS DE GESTION DE LA QUALITE EN MEDECINE NUCLEAIRE - AUDIT GLOBAL AUDITS VAN HET KWALITEITSBEHEER IN DE NUCLEAIRE GENEESKUNDE - UITGEBREIDE AUDIT Marleen Vandecapelle – 15/06/2011
B-QUANUM annexes Annexe 1 Example of annual report 20101 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 scintigraphy2 Annexe 4 Extract SOP Whole Body 18F-FDG2 Annexe 5 Extract ISO Manual2 Annexe 6 Extract Quality Manual2 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
B-QUANUMchecklists • Strategies and policies • Administration and management • Human resources • Radiation protection of personnel and environment • Radiation protection of the patient and his direct environment • Quality assurance system • Quality control of imaging equipment and dose calibrator • Computer systems and data handling • Acceptance tests • General aspects - diagnostics • General aspects - radionuclide therapy Marleen Vandecapelle – 15/06/2011
B-QUANUMchecklists CHECKLIST 6: QUALITY ASSURANCE SYSTEM Corrective actions ? Required by legislation, IAEA technical document or other external standard-setting bodies. Urgent corrective action should be instituted. 0 25 50 75 100 Not compulsory, but are expected to be reached by all departments. Corrective action is recommended. Desirable but not essential. Corrective action may improve the overall functioning of the department. REMARQUE: Checklists are just the starting point for discussion ! Not applicable is also an answer ! Marleen Vandecapelle – 15/06/2011
B-QUANUMchecklists CHECKLIST 1: STRATEGIES AND POLICY (9 questions) 1 Explanation in annexe 1: Example of an annual report Marleen Vandecapelle – 15/06/2011
B-QUANUMchecklists CHECKLIST 3: HUMAN RESOURCES (10 questions) Marleen Vandecapelle – 15/06/2011
B-QUANUMchecklists CHECKLIST 4: RADIATION PROTECTION OF PERSONNEL AND ENVIRONMENT (21 questions) Marleen Vandecapelle – 15/06/2011
B-QUANUMchecklists CHECKLIST 5: RADIATION PROTECTION OF PATIENTS AND DIRECT ENVIRONMENT (12 questions) Marleen Vandecapelle – 15/06/2011
B-QUANUMchecklists CHECKLIST 6: QUALITY ASSURANCE SYSTEM (18 questions) 1 a list of SOP’s is available in annexe 2 2 extracts from SOP’s are availabel in annexe 3 and 4 Marleen Vandecapelle – 15/06/2011
B-QUANUMchecklists CHECKLIST 7: QUALITY CONTROL OF IMAGING EQUIPMENT AND DOSECALIBRATORS (21 questions) CHECKLIST 9: ACCEPTANCE TESTS (6 questions) Marleen Vandecapelle – 15/06/2011
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
B-QUANUM • 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 free Marleen Vandecapelle – 15/06/2011
Why Clinical Audit ? • 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
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 Why Clinical Audit ? Marleen Vandecapelle – 15/06/2011
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
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) B 01/09/2010 01/07/2011 01/07/2012 01/07/2013 Pilot Auto-evaluation + Internal CA + External CA 18 NM All NM All NM All NM Marleen Vandecapelle – 15/06/2011
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 • 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) Marleen Vandecapelle – 15/06/2011
Thank You for listening ! Marleen Vandecapelle Federal Agency for Nuclear Control Ravensteinstreet 36 1000 Brussels firstname.lastname@example.org ++32 (0)2 289 21 78 http://www.fanc.fgov.be/ Marleen Vandecapelle – 15/06/2011