Summary of the EANM quality course 27 – 28 March 2010

1. Summary of the EANM quality course 27 – 28 March 2010 P. De Bondt J. Rutten

2. Summary • EANM-UEMS: accreditation of nm departments (ISO mandatory) • IAEA: QUANUM: checklist + int and ext audits • EURATOM directive 97/43: clinical audits

3. The main rules: EURATOM Directive 97/43 Ph. Van Boxem, ING UEMS/EBNM CANMD – Vice Chairman 2010

4. Where can you find 97/43/Euratom?? • Title: « Council Directive on health protection against the dangers of ionizing radiation in relation to medical exposure » • On the web: europa.eu.int/comm/environment/ radprot/legislation/9743.pdf europa.eu.int/comm/environment/radprot/ legislation/9743_fr.pdf

5. Content of the 97/43/Euratom • Justification: • Medical exposure shall show a sufficient net benefit (advantages) If no justification, it should be prohibited. • Optimization A.L.A.R.A. consistent with obtaining the required diagnostic information. • Diagnostic reference levels should be established • Responsibilities • Prescriber and the practitioner • Procedures • Written protocols shall be established for standard practice • Referral criteria are available for prescribers including radiation doses • Medical physics expert are available for NM (optimization , QA, QC, …) • Clinical audits must be carried out • Inspection: • Competent authorities shall establish a system of inspection.

6. What does it mean for the NM department? • All examinations must be justified • ALARA compatible with the set goal • Written protocols to realize examinations • Involved people must be qualified • QA, QC, clinical audit • Continued education

7. What does it mean for the NM department? • Equipment must be conform (old and new) • Special care for pediatric exams • Special care for CT examinations • Patient information is important.

8. The basis:Council Directive 97/43 EURATOM « Council Directive on health protection against the dangers of ionizing radiation in relation to medical exposure »

9. Clinical audit in MED Directive Article 6.4. Clinical audits shall be carried out in accordance with national procedures. Aim of the EC Guidelines • To provide guidance on clinical audit in order to improve implementation of Article 6.4 of Council Directive 97/43/ EURATOM. EUROPEANCOMMISSION International Workshop on Practical Implementation of Clinical Audit for Medical Exposure to Ionizing Radiation, Tampere, Finland, 7-10 September 2008 (Simeonov)

10. Clinical audit is... a systematic examination or review of medical RADIOLOGICAL procedures

11. CANMD goals and achievements L.Maffioli

12. Acronyms Committee for Accreditation of Nuclear Medicine Departments E. B. N. M. U. E. M. S. / European European Union of Board Medical Nuclear Specialists Medicine C. A. N. M. D. is a permanent committee of

13. Aims of the Committee To implement the introduction of an accreditation system in Europe. To give assistance and help to all nuclear medicine departments in Europe which apply for an accreditation. To have a Quality Manual with respect to the ISO 9001:2008 standard as a basis to create a specific Quality Management for an individual nuclear medicine facility.

14. Download ISO Software This software package is not intended to do everything for you, or take over your job. It will guide you in the (sometimes unusual) quality vocabulary, explain what a quality system is, show you some examples and templates for documents, and overall help you to implement step by step YOUR quality system.

15. ISO Software: the “read me” Guide

16. CANMD ISO Software: “Main Documents”

17. CANMD ISO Software: General Procedures

19. How to download the software • www.eanm.org (or http://uems.eanm.org ) • UEMS/EBNM • Committees • Accr. Nuclear Medicine Dept. • Download ISO software • Fill the form and begin the download

20. The IAEA perspective: introduction to QUANUM Maurizio Dondi Nuclear Medicine Section Division of Human Health International Atomic Energy Agency

21. Nuclear Medicine Section • Mission: • By strengthening quality of practice, to enhance capabilities of Member States to address health needs by the use of nuclear medicine Many hospital facilities in poor state. Lack of understanding of procedural guidelines. Staff maybe poorly trained and lack appropriate understanding and qualifications. Very little or no end-user QC. Poor radiation hygiene and waste management. Customer satisfaction rarely taken into account

22. The need for Quality management (QM) in Nuclear Medicine • Customer oriented organizations committed to quality care • Improvements in effectiveness and efficiency • Continuous educational process The Quality Management Audits of Nuclear Medicine Practices project QUANUM is a means by which nuclear medicine facilities can demonstrate the level of patient care they provide by following a process of self- and external evaluation (audits)

23. QUANUM http://www-pub.iaea.org/MTCD/publications/PDF/Pub1371_web.pdf

24. Pre-mission Requests • Internal self appraisal (checklist provided) • Complete NUMDAB – database http://nucmedicine.iaea.org/ • infrastructure & equipment • qualified staff & training • programmes • QA programme

25. STRATEGY AND OBJECTIVES Components:

26. IMAGING DIAGNOSTIC PROCEDURES Final summary table

27. QC of equipment http://www-pub.iaea.org/MTCD/publications/PDF/Pub1394_web.pdf http://www-pub.iaea.org/MTCD/publications/PDF/Pub1393_web.pdf

28. IAEA-Operational Guide on Hospital Radiopharmacies http://www-pub.iaea.org/MTCD/publications/PDF/Pub1342/Pub1342_web.pdf http://www-pub.iaea.org/MTCD/publications/PDF/Pub1344_web.pdf http://www-pub.iaea.org/MTCD/publications/PDF/TCS-39_web.pdf

29. QC - dose calibrators constancy test linearity accuracy For each of different isotopes used Closer look behind the lead shield! Accurate and traceability of actual records of patient dose