Download Sentinel Events

Ministero della Salute
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
[email protected]
1
Ministero della Salute
Outline
1. Background
2. Sentinel Event System
3. The Sicilian case
4. Strategies
2
Ministero della Salute
National Health Services
Camera
Parliament
Commissioni parlamentari
Senato
Government
Central Agencies
Ministero della Salute
Conferenza Stato - Regioni
Consiglio Superiore di
Sanità
Istituto Superiore di
Sanità
Agenzia Nazionale per i
Servizi Sanitari
Istituto Nazionale per
la Prevenzione e
Sicurezza sul lavoro
Conferenza dei
Presidenti
Regions
Province
Autonome
Regioni
ordinarie
Aziende Unità
Sanitarie Locali,
Aziende Ospedaliere
Ospedali
Universitari,
IRCCS
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
Ministero della Salute
Patient safety and Risk Management
Activities
1. National Commission (2003)
2. Working group, 2004
3. Working Group on Patient safety, 2006
National Commission (2003)
Ministero della Salute
Mi n i s t e r o d e lla
Sa lu t e
Manual on clinical risk
DIPARTIMENTO DELLA QUALITA’
DIREZIONE GENERALE DELLA PROGRAMMAZIONE SANITARIA, DEI LIVELLI ESSENZIALI
DI ASSISTENZA E DEI PRINCIPI ETICI DI SISTEMA
Risk management in Sanit à
Il problema degli errori
à
Commissione Tecnica sul Rischio Clinico
(DM 5 marzo 2003)
Roma, marzo 2004
www.ministerosalute.it
2002 Survey on patients
safety within the NHS
Hospitals
Clinical Risk Management Unit
 17%
Working group, 2004
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).
Ministero della Salute
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%
8
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
Ministero della Salute
1.
2.
3.
4.
5.
6.
7.
8.
9.
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 reoperation 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
10
has occurred.
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
Ministero della Salute
Preliminary Results (September 2005 - April 2006)
Sentinel event
1. Wrong Patient
2. Wrong site surgery
3. Inpatient Suicide
4. Foreign body retention
5. Transfusion error
6. Medication error
7. Maternal death or serious morbidity
8. Violence
9. Perinatal death (weight>2.500 gr)
10. Other catastrophic event
Total number of sentinel event
N°
%
0
0
7
11
5
8
3
5
0
4
6
1
2
6 10
37 59
63 100
Ministero della Salute
Preliminary Results (September 2005 - April 2006)
Source of
N° %
Sentinel Event
Other catastrophic event
Surgery complications
Media
Self-reported
Total
Emergency management
Fetal Complications of delivery
Anesthesia Complications
39 62
24 38
63 100
N°
10
%
27
7
4
3
19
11
8
Patient falls (death or serious injury) 3
8
Patient Outcome N° % Embolism
2
5
Death
49 78 Other
8 22
Loss of function
5 8 Total
37 100
Other
9 14
Total
63 10
0
Analysis of contributing and causing factor
Ministero della Salute
policies/procedures or
guidelines
patient issue
patient safety mechanism
communication
patient assessment
equipment
staff training/competency
lack/misinterpretation of
information
0%
5%
10%
15%
20%
25%
30%
Ministero della Salute
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
Work in Progress
Ministero della Salute
Recommendations
Working Open
group
Consultation
Medication error
√
√
Wrong patient, site, procedure
√
√
Retained instruments
√
√
Suicide
√
√
Maternal death
√
√
Disclosure of adverse event
√
√
Violence
√
Transfusion reaction
√
Neonatal death( >2500 gr)
√
Regions/Hospita
ls/Professionals
√
Ministero della Salute
Short term effect
The Sicilian case
Ministero della Salute
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
Ministero della Salute
Sentinel event comparison between Sicily
and Italy
Sentinel events
Regione N° %
Sicilia
29
46
Italia
63 100
Total hospital discharges
Regione
N°
%
Sicilia
Italia
1.286.751 10
12.942.935 100
Regional Authorities document (2005) recommends to
report sentinel events to Ministry of Health
Ministero della Salute
Mainstream Actions
• Patient Safety Board
• Program developement Chair
(Clinical leader)
• Stakeholder involvement
Agreement Ministry of Health - Sicilian Region
Ministero della Salute 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)
Ministero della Salute
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 selfassessment
Program on quality improvement
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
Ministero della Salute
How to remove the main barrier to patient
safety ?
Right to citizen
defense
Jurisdictional
framework
Quality
improvement
Patient safety
Long term: Law to ensure protection of reporting
Ministero della Salute
Partnership for Patient Safety
Ministry of Health
Regions
Hospitals
Scientific Societies
Professionals
Patients
Ministero della Salute
Reporting system and Feedback
Ministry of Health
Regions
Hospitals
Health professionals
Ministero della Salute
Thank you for your attention
Your experience and suggestions are
welcome