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Ministero della Salute 1 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 1 OECD Healthcare Quality Indicators Seminar on improving Patient Safety Data Systems June 29-30, 2006

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Ministero della Salute 2 Outline 1.Background 2.Sentinel Event System 3.The Sicilian case 4.Strategies

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

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Ministero della Salute 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

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Ministero della Salute Patient safety and Risk Management Activities 1.National Commission (2003) 2.Working group, 2004 3.Working Group on Patient safety, 2006

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

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Ministero della Salute 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

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Ministero della Salute 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%

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

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Ministero della Salute 10 Sentinel Event List 1.Procedures involving the wrong patient 2.Procedures involving the wrong body part 3.Suicide of patients in inpatient units 4.Retained instruments or other material after surgery requiring re- operation or further surgical procedure 5.Haemolytic blood transfusion reaction resulting from ABO compatibility 6.Medication error leading to the death of a patient 7.Maternal death or serious morbidity associated with labour or delivery 8.Mortality in newborn with => 2,500 grams 9.Violence on patients 10.Any other adverse event in which death or serious harm to a patient has occurred.

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Ministero della Salute Contributing Factors and Root Causes 1.patient assessment 2.staff training or competency 3.equipment 4.lack or misinterpretation of information 5.communication 6.appropriateness or lack policies/procedures or guidelines 7.safety mechanism 8.specific patient issues Risk Reduction Action Plan Recommendation addressing contributing factor(s) Personnel accountable for implementing recommendation Outcome measure

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Ministero della Salute Preliminary Results (September 2005 - April 2006) Sentinel eventN% 1. Wrong Patient0- 2. Wrong site surgery0- 3. Inpatient Suicide711 4. Foreign body retention58 5. Transfusion error35 6. Medication error0- 7. Maternal death or serious morbidity46 8. Violence12 9. Perinatal death (weight>2.500 gr)610 10. Other catastrophic event3759 Total number of sentinel event63100

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Ministero della Salute Source of Sentinel Event N% Media3962 Self-reported2438 Total63100 Patient OutcomeN% Death4978 Loss of function58 Other914 Total6310 0 Other catastrophic eventN% Surgery complications1027 Emergency management719 Fetal Complications of delivery411 Anesthesia Complications38 Patient falls (death or serious injury)38 Embolism25 Other822 Total37100 Preliminary Results (September 2005 - April 2006)

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Ministero della Salute Analysis of contributing and causing factor

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Ministero della Salute Characteristics of Successful Reporting Systems *Leape, L.L. Reporting adverse event. NEJM, 2002, 347 (20): 1633-8 ConfidentialYes Expert analysisYes TimelyYes Systems-orientedYes ResponsiveYes IndependentPartially Non-punitivePartially

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Ministero della Salute Recommendations Working group Open Consultation Regions/Hospita ls/Professionals Medication error Wrong patient, site, procedure Retained instruments Suicide Maternal death Disclosure of adverse event Violence Transfusion reaction Neonatal death( >2500 gr) Work in Progress

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Ministero della Salute Short term effect The Sicilian case

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Ministero della Salute Percentage of postoperative Pulmonary Embolism or Deep Vein Thrombosis (surgical discharges) 200120022003 Sicilia0,120,10 Italia0,14 0,13 Administrative data

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Ministero della Salute Sentinel event comparison between Sicily and Italy RegioneN% Sicilia2946 Italia63100 RegioneN% Sicilia 1.286.751 10 Italia 12.942.935 100 Total hospital discharges Sentinel events Regional Authorities document (2005) recommends to report sentinel events to Ministry of Health

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Ministero della Salute Patient Safety Board Program developement Chair (Clinical leader) Stakeholder involvement Mainstream Actions

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

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Ministero della Salute 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 Risk management project Program on quality improvement

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Ministero della Salute 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

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

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Ministero della Salute Partnership for Patient Safety Ministry of Health Regions Hospitals Scientific Societies Professionals Patients

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Ministero della Salute Reporting system and Feedback Ministry of Health Regions Hospitals Health professionals

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Ministero della Salute Thank you for your attention Your experience and suggestions are welcome