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. International Workshop on Practical Implementation of Clinical Audit for Medical Exposure to Ionizing Radiation, Tampere, Finland, 7-10 September 2008 EUROPEAN COMMISSION (Simeonov) 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.

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

11. CANMD goals and achievements L.Maffioli

12. Acronyms C.A.N.M.D. Committee for Accreditation of Nuclear Medicine Departments U.E.M.S./ E.B.N.M. Nuclear Medicine Board European Union of European Medical Specialists 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. 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. Download ISO Software

15. Guide ISO Software: the “read me”

16. CANMD ISO Software: “Main Documents”

17. CANMD ISO Software: General Procedures

18. 18

19. How to download the software www.eanm.org (or http://uems.eanm.org ) www.eanm.orghttp://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 medicinenuclear 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. 1.STRATEGY AND OBJECTIVES Components: NoComponentClass Verifiable – Manual, Reference Documentation, SOP, QC Data, Patient file etc. Y/NComments/Planned ActionDate achieve d. 5.2.1Is the nuclear medicine service guided by specific objectives developed at the national level? A IAEA Nuclear Medicine Resources Manual 5.2.2Is the nuclear medicine service guided by specific objectives developed by the management of the service and is consistent with the overall stated aims of the nation or hospital? A IAEA Nuclear Medicine Resources Manual 5.2.3Does hospital management seek the participation of the nuclear medicine staff in decisions which will affect the Department ’ s role and function? B IAEA Nuclear Medicine Resources Manual 5.2.4Is the range of specific nuclear medicine diagnostic imaging and therapeutic services appropriate to the size and scope of the hospital ’ s clinical service? B IAEA Nuclear Medicine Resources Manual 5.2.5Do the objectives of the nuclear medicine service include the provision of services on urgent requests? B

26. Type of investigati on Type of study Clinical proble m Patient preparation Radio- pharmaceutical and activity Acquisition parameters Processing parameters ImagesFinal report Recommend ations PlanarThyroid IAEA Nuclear Medicine Resources Manual. e.g. I/II/III Planar Whole body Bone IAEA Nuclear Medicine Resources Manual DynamicRenography IAEA Nuclear Medicine Resources Manual SPECTe.g. bone IAEA Nuclear Medicine Resources Manual Cardiac SPECT MPS IAEA Nuclear Medicine Resources Manual IMAGING DIAGNOSTIC PROCEDURES Final summary table

27. 03.10.2015 Slide 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. Slide 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