Sentinel Event System The Italian Experience

1. 1° OECD Healthcare Quality Indicators Seminar on improving Patient Safety Data Systems June 29-30, 2006 Sentinel Event System The Italian Experience Giuseppe Murolo, MD Ministry of Health, Department of Quality General Directorate for Health Planning and Policy g.murolo@sanita.it

2. Outline Background Sentinel Event System The Sicilian case Strategies

3. National Health Services Camera Parliament Commissioni parlamentari Senato Government Ministero della Salute Conferenza Stato - Regioni Consiglio Superiore di Sanità Istituto Superiore di Sanità Central Agencies Istituto Nazionale per la Prevenzione e Sicurezza sul lavoro Agenzia Nazionale per i Servizi Sanitari Conferenza dei Presidenti Regioni ordinarie Ospedali Universitari, IRCCS Regions Aziende Unità Sanitarie Locali, Aziende Ospedaliere Province Autonome

4. National Health Service Essential levels of health care 2001 • National Health Plan 2006 – 2008 • Promotion of Clinical Governance and quality in the NHS: • Clinical Risk Management and Patient Safety • Reporting systems • Cooperation among institutional level • national • regional • local • First step  sentinel event system

5. National Commission (2003) Working group, 2004 Working Group on Patient safety, 2006 Patient safety and Risk Management Activities

6. National Commission (2003) Manual on clinical risk 2002 Survey on patients safety within the NHS Hospitals Clinical Risk Management Unit  17% www.ministerosalute.it

7. Methods and tools for reporting Sentinel Events Advers events Near Misses Education and training General framework on national training Basic course for all Health professional Recommendation: to provide health professionals and administrators with information on high risk medications that have the potential to cause serious or catastrophic harm to patients. The aim is to raise awareness of the potential harm and provide a strategy for local level response (KCl). Working group, 2004

8. Working Group on Patient safety, 2006 • SG.1. Sentinel Event System and Recommendations • SG.2. Methodologies to Analyze adverse events and education packages and tools for Health professionals • SG.3. Patients involvement • SG.4. Methods to investigate Insurance costs and medico legal aspects 2005 Survey Insurance costs in the NHS Hospitals Clinical Risk Management Unit  28%

9. Sentinel events are rare and preventable events that lead to catastrophic patient outcomes*. Sentinel Event Reporting System • Australian Council for Patient Safety and Quality and the • JCAHO • OECD

10. Sentinel Event List Procedures involving the wrong patient Procedures involving the wrong body part Suicide of patients in inpatient units Retained instruments or other material after surgery requiring re-operation or further surgical procedure Haemolytic blood transfusion reaction resulting from ABO compatibility Medication error leading to the death of a patient Maternal death or serious morbidity associated with labour or delivery Mortality in newborn with => 2,500 grams Violence on patients Any other adverse event in which death or serious harm to a patient has occurred.

11. Contributing Factors and Root Causes patient assessment staff training or competency equipment lack or misinterpretation of information communication appropriateness or lack policies/procedures or guidelines safety mechanism specific patient issues Risk Reduction Action Plan • Recommendation addressing contributing factor(s) • Personnel accountable for implementing recommendation • Outcome measure

12. Preliminary Results (September 2005 - April 2006) 

13. Preliminary Results (September 2005 - April 2006) 

14. Analysis of contributing and causing factor

15. Characteristics of Successful Reporting Systems *Leape, L.L. Reporting adverse event. NEJM, 2002, 347 (20): 1633-8

16. Work in Progress

17. Short term effectThe Sicilian case

18. Administrative data Percentage of postoperative Pulmonary Embolism or Deep Vein Thrombosis (surgical discharges)

19. Sentinel event comparison between Sicily and Italy Sentinel events Total hospital discharges Regional Authorities document (2005) recommends to report sentinel events to Ministry of Health

20. Patient Safety Board Program developement Chair (Clinical leader) Stakeholder involvement Mainstream Actions

21. Task force against Adverse event Context Analysis Professional Training Implementation of clinical guidelines, pathways and recommendations Agreement Ministry of Health - Sicilian RegionRegional Coordination Center on Patient safety • Improvement of Emergency management • Investment on facilities (buildings, operating theaters and medical equipments) • Inspection Taskforce (40 professionals)

22. Risk management project Development of a methodology for clinical risk management Pilot project on 6 hospitals Training program on audit and tutorship Implementation of a Software for hospital self-assessment Program on quality improvement

23. Strategies • Education and training on clinical risk management and patient safety at regional and hospital level • Analysis on contributing factors in all settings • Implementation of recommendations and preventive actions

24. Right to citizen defense Quality improvement Jurisdictional framework Patient safety How to remove the main barrier to patient safety ? Long term: Law to ensure protection of reporting

25. Partnership for Patient Safety Ministry of Health Regions Hospitals Scientific Societies Professionals Patients

26. Reporting system and Feedback Ministry of Health Regions Hospitals Health professionals

27. Your experience and suggestions are welcome Thank you for your attention