Sentinel Event System The Italian Experience

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Sentinel Event System The Italian Experience
1 OECD Healthcare Quality Indicators Seminar on
improving Patient Safety Data Systems June 29-30,
2006

• Giuseppe Murolo, MD
• Ministry of Health, Department of Quality
• General Directorate for Health Planning and
  Policy
• g.murolo_at_sanita.it

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Outline

1. Background
2. Sentinel Event System
3. The Sicilian case
4. Strategies

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National Health Services
Camera
Parliament
Commissioni parlamentari
Senato
Government
Conferenza Stato - Regioni
Ministero della Salute
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
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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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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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National Commission (2003)
Manual on clinical risk
2002 Survey on patients safety within the NHS
Hospitals
Clinical Risk Management Unit ? 17
www.ministerosalute.it
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Working group, 2004

• 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).

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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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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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• 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 gt 2,500 grams
• Violence on patients
• Any other adverse event in which death or serious
  harm to a patient has occurred.

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• 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

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Preliminary Results (September 2005 - April
2006) 
Sentinel event N
1. Wrong Patient 0 -
2. Wrong site surgery 0 -
3. Inpatient Suicide 7 11
4. Foreign body retention 5 8
5. Transfusion error 3 5
6. Medication error 0 -
7. Maternal death or serious morbidity 4 6
8. Violence 1 2
9. Perinatal death (weightgt2.500 gr) 6 10
10. Other catastrophic event 37 59
Total number of sentinel event 63 100
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Preliminary Results (September 2005 - April
2006) 
Source of Sentinel Event N
Media 39 62
Self-reported 24 38
Total 63 100
Other catastrophic event N
Surgery complications 10 27
Emergency management 7 19
Fetal Complications of delivery 4 11
Anesthesia Complications 3 8
Patient falls (death or serious injury) 3 8
Embolism 2 5
Other 8 22
Total 37 100
Patient Outcome N
Death 49 78
Loss of function 5 8
Other 9 14
Total 63 100
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Analysis of contributing and causing factor
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Characteristics of Successful Reporting Systems
Confidential Yes
Expert analysis Yes
Timely Yes
Systems-oriented Yes
Responsive Yes
Independent Partially
Non-punitive Partially
Leape, L.L. Reporting adverse event. NEJM, 2002,
347 (20) 1633-8
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Work in Progress
Recommendations Working group Open Consultation Regions/Hospitals/Professionals
Medication error v v v
Wrong patient, site, procedure v v
Retained instruments v v
Suicide v v
Maternal death v v
Disclosure of adverse event v v
Violence v
Transfusion reaction v
Neonatal death( gt2500 gr) v
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Short term effectThe Sicilian case
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Administrative data
Percentage of postoperative Pulmonary Embolism or
Deep Vein Thrombosis (surgical discharges)
2001 2002 2003
Sicilia 0,12 0,10 0,10
Italia 0,14 0,14 0,13
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Sentinel event comparison between Sicily and Italy
Sentinel events
Total hospital discharges
Regione N
Sicilia 29 46
Italia 63 100
Regione N
Sicilia 1.286.751 10
Italia 12.942.935 100
Regional Authorities document (2005) recommends
to report sentinel events to Ministry of Health
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Mainstream Actions

• Patient Safety Board
• Program developement Chair (Clinical leader)
• Stakeholder involvement

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Agreement Ministry of Health - Sicilian
RegionRegional 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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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
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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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How to remove the main barrier to patient safety ?
Long term Law to ensure protection of reporting
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Partnership for Patient Safety
Ministry of Health Regions Hospitals Scientific
Societies Professionals Patients
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Reporting system and Feedback
Ministry of Health
Regions Hospitals Health professionals
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Thank you for your attention

• Your experience and suggestions are welcome