Le linee guida europee sugli audit clinici radiologici.

1. Le linee guida europee sugli audit clinici radiologici. Vincenza Viti Dipartimento Tecnologie e Salute Istituto Superiore di Sanità, Roma Simposio AIRO Lombardia 13 giugno 2009

2. Legislazione • Directive 97/43/Euratom (June 30 1997) MED Articolo 6.4 – clinical audit • DECRETO LEGISLATIVO 26 maggio 2000, n.187 – Attuazione della direttiva 97/43/Euratom in materia di protezione sanitaria delle persone contro i pericoli delle radiazioni ionizzanti connesse ad esposizioni mediche. G.U. n.157 del 7 luglio 2000 Articolo 6.4 – verifiche cliniche

3. Come effettuare gli audit clinici? • Primo convegno – Tampere (Finlandia) 24-27 maggio 2003 • EUROPEAN COMMISSION GUIDELINE ON CLINICAL AUDIT FOR MEDICAL RADIOLOGICAL PRACTICES (DIAGNOSTIC RADIOLOGY, NUCLEAR MEDICINE, AND RADIOTHERAPY) The purpose of this EC guideline is to provide guidance on clinical auditing in order to improve implementation of Article 6.4 of Council Directive 97/43/ EURATOM • Secondo Convegno Tampere (Finlandia) 8-10 settembre 2008 • Approvata dalla EC – in corso di approvazione da parte dell’art. 31

4. Schema della linea guida (1) • Executive summary • 1. Introduction • 2. Purpose and scope • 3. Definitions • 4. Basic principles and prerequisites • 5. Interrelation of clinical audit with other audit systems • 6. Interrelation with regulatory control • 7. Practical implementation • 8. Generic criteria of good practice • 9. Specific audit criteria

5. Schema della linea guida • APPENDIX 1: Summary of regulatory frameworks in the EU Member States • APPENDIX 2: Summary of problems in the implementation of clinical audits • APPENDIX 3: Summary of major benefits in the implementation of clinical audits • APPENDIX 4: Examples of quality indicators • APPENDIX 5: Example on classification of audit findi • APPENDIX 6: Comparison of external audit systems • APPENDIX 7: Example of level 2 detailed criteria of good practices and audit programme • APPENDIX 8: Available literature for setting the standards of good practice

6. Punti principali sottolineati nelle linee guida • Differenze e somiglianze con altri tipi di verifiche • Audit clinici radiologici come parte di attività di miglioramento continuo di qualità • Necessità di effettuare audit esterni ed interni • Necessità di implementare gli audit secondo procedure nazionali

7. Definizione Clinical audit is a systematic examination or review of medical RADIOLOGICAL procedures. It 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. Modifications of the practices are implemented where indicated and new standards applied if necessary

8. Cosa non è un audit clinico E’ importante spiegare le differenze con altre attività che possono essere confuse con gli audit. Un audit clinico • non è ricerca • non è un audit di qualità per verificare la conformità a standard (di qualità) • non è procedura di accreditamento • non è un’ispezione

9. Differenze tra audit e ispezioni (1)

10. Obiettivi dell’audit Gli obiettivi generali dell’audit sono relativi al • PMiglioramento della qualità della cura del paziente • Promozione di un efficiente uso delle risorse • Aumento di numero e organizzazione dei servizi forniti • Contribuire alla formazione professionale Gli obiettivi dettagliati dell’audit vanno definiti in relazione agli standard di buona pratica clinica • Per gli audit esterni gli obiettivi vanno concoordati tra le organizzaione di auditing e il Centro dove viene effettuato l’audit • Per audit interni gli obiettivi sono stabiliti da chi ha la responsabilità organizzativa del Centro

11. Chi Deve Fare Cosa: Ruolo degli Organismi Ispettivi Gli organismi ispettivi non devono effettuare gli audit clinici nè devono da soli stabilirne i criteri, ma devono consigliare e in particolare essere di ausilio nelle prime fasi dello sviluppo degli audit

12. Chi Deve Fare Cosa: Ruolo delle Società Professionali Il ruolo delle soocietà professionali sarà di grande ausilio nello sviluppo di criteri di buona pratica clinica e nel fornire consigli pratici, stimoli e sostegno per l’organizzazione più appropriata e per la ricerca di soluzioni pratiche per effettuare gli audit.

13. Dimensioni della Qualità • Clinical audit can be partial but should eventually become comprehensive and cover the whole clinical pathway in RADIOLOGICAL practices, outlining a course of care provided to a patient. It should address the three main elements: structure, process, and outcome. These should be covered both in internal and external audits. • It is accepted that the outcome can only partly be assessed through external audits. As a minimum approach for auditing the outcome, there should be a clear indication as to how outcomes are measured within the RADIOLOGICAL unit.

14. Dimensioni della Qualità: Le priorità

15. Audit esterni e Audit interni • Internal clinical audits and self-assessments are carried out within the health care unit as part of its overall quality assurance procedures. The principle of independence is implemented whenever possible by nominating auditors from sub-units or departments of the institution different from the sub-unit to be audited. However, for small units this might not be possible and internal audits can take more a form of a self-assessment rather than actual audit. • External clinical audits are carried out by an external auditing body or auditors, independent from the health care unit to be audited. An external audit could help to assure good practice, as it might be difficult or inadequate to reveal problems only by internal efforts.

16. Gli standard (1) • Standards of good practice can be based on results of research, consensus statements, recommendations by learned societies, legal requirements or local agreement (if there is no other more universal reference). Evidence-based standards of good practice should be disseminated in a timely fashion to the entire health care community. Clinical audit should promote the development and use of international standards of practice.

17. Gli standard (2) • Both generic and specific criteria should be applied for the standards of good practice, as highlighted in sections 8 and 9 of this Guideline. The recommendation in this document (Sections 8 and 9) should be considered as the minimum criteria, while more specific criteria should be developed for specific examinations and treatments, for the advanced level of clinical audits. The list of publications given in Appendix 6 of this document can serve as a source of information for developing and adopting the criteria of good practices.

18. Gli standard (3) • As a minimal approach, when there are no written criteria available, the criteria of good practice could be based on the professional knowledge and experience of the auditor. Professional judgement is truly the minimal approach because it dose not ensure the uniformity and impartiality of judgements. In the long term systematic implementation of clinical audits the aim should be to adopt or to develop suitable written criteria for good practices at least for the major parts of the audit. • Quality indicators should be developed when possible as a practical measure of performance. These are useful in particular in internal audits. • The standards of good practices should be reconsidered from time to time with the development of evidence based medicine.

19. Frequenza degli audit • The internalclinical audits should be a continuous activity with the aim of having significant parts of the overall audit programme covered once a year. The recommended frequency for external audits may depend on the local infrastructure and the intensity of other quality review activities, but a minimum frequency of five years seems to be a reasonable aim. Besides these minimum frequencies, extra audits are recommended whenever there are major changes of the installation or operation.

20. Benefici attesi • Improvement of medical RADIOLOGICAL services, the quality of care and the radiation protection of patients (in a broad view). • Improved quality assurance • Achievement of required quality and acceptable tolerances in accordance with standards • Improved patient satisfaction • Benefit to patients • A tool for quality improvement • Improved capacity and efficacy

21. Benefici attesi • Improvement of medical RADIOLOGICAL services, the quality of care and the radiation protection of patients (in a broad view). • Improved quality assurance • Achievement of required quality and acceptable tolerances in accordance with standards • Improved patient satisfaction • Benefit to patients • A tool for quality improvement • Improved capacity and efficacy

22. Benefici attesi • Improved standardization of procedures and practices. • More frequent application of evidence based guidelines and protocols • Development of internal and national standards • Adherence to national standards

23. Benefici attesi • Financial benefits.Less expenditures on radiation related service • Special applications on a European basis Decrease of dose • Lowering patient and staff exposure to ionising radiation • Optimization of the patient exposures • Revealing the weak points of the practices and malpractices • Recognition for quality • Demonstration of need for resources

24. Benefici attesi • Financial benefits.Less expenditures on radiation related service • Special applications on a European basis • Decrease of dose • Lowering patient and staff exposure to ionising radiation • Optimization of the patient exposures • Revealing the weak points of the practices and malpractices • Recognition for quality • Demonstration of need for resources • Avoidance of incidents and accidents • Reduction of errors

25. The audit: How to start • Internal audits and special projects to undertake external clinical audit can be a good start of clinical auditing • However, the long term aim should be towards special organizations, in order to ensure the continuity and credibility of the audit system

26. The audit: How to start • The administration of health care and the head of the unit should consider first of all if • national and/or regional legislation on clinical audits exist • a steering commitee for the coordination of clinical audits has been established

27. Preparation of the audit –Institution to be audited Request of the audit Preparation of the audit visit •Prepare data and relevant documentation according to questionnaire sent by the auditing organization. •Identify individuals responsible for interaction •Inform the entire unit of the institution and nature of the audit.

28. Preparation of the audit –Auditing organization • Prepare a clear outline of the objectives of the audit • Select an appropriate audit team • Inform the institution about the methodology • Review previous audits (if any) • Prepare a checklists of the topics that must be audited

29. The audit • Entrance briefing: auditors and staff member • Complete tour of the facility • Staff interviews • Review and evaluation of procedures and all relevant documentation, data and results • Practical measurements and other tests of the performance of local systems and procedures, where appropriate and relevant • Observation of practical implementation of working procedures. • Exit briefing

30. The audit: Final part • The auditors - Conclusions from the audit • The auditors - The audit report • The unit should pay due attention to considering and fulfilling the recommendations