Patient Safety: state of art
and perspectives in Italy
Carlo Liva
Dpt Quality & Accreditation
Rome - Italy
National Agency for Regional Health Systems
The ASSR - National Agency for Regional Health Care
Systems, founded in 1995 by a National Decree, provides
support to National and Regional Health Services by:
• Analysing quality, effectiveness and efficiency of services offered to
the public
• Promoting innovation in health care
• Performing research projects aimed at analysing/comparing the
different regional health care systems.
Regions can give their advice for nominating Assr’s Chair,
Management Board and Director, but the ultimate word is
by the National Ministry of Health
Quick worsening of the problem
Medical errors always existed, but in the last 5
years, the situation took a turn for the worse:
- Patient-physician relationship has changed
- Health expectations (quantity and quality)
increased
- Scientific literature reports about high number of
deaths due to medical errors
- Rapid increase of insurance costs
2004 – Situation for Insurance Companies
Association
320.000
Patients involved
12.000
Lawsuits
2,5 billions euros
Requests
413 millions euros
Costs for Insurance
Companies
A
R
S
Inabitans: 1.180.000.
Actual cost for insurance in
Regional Health System is about
15 millions euros (12 in 2003)
Situation of Complaints for Citizens Organisations
(source: Cittadinanzattiva)
Orthopaedy
Oncology
Gynaecology
Gen. Surgery
Oculistics
Dentistry
Cardiology
Cardiosurgery
Neurology
1999
18,2
10,1
10,1
13,8
5,5
3,5
7,1
2,5
3,1
2004
18,5
13,3
13,2
12,0
8,2
5,5
4,9
4,8
3,0
National Groups
 National Ministry of Health’s Special
Committee
 ASSR’s Research project
 Regional Ministries of Health’s
Committee on Clinical Risk Management
(RM)
National activities
2003: National Ministry of Health
Committee on Clinical Risk
2004: first paper
- classification of errors
- methods for risk analysis
- clinical risk management
- technical papers on sectorial risk
2006: monitoring sentinel events
ASSR’s Research on Risk Management
Promotion of innovation and risk management
(2005-2007)
10 Regions:
Toscana
Emilia Romagna
Veneto
Campania
Friuli Venezia Giulia
Lombardia
Puglia
Piemonte
Abruzzo
Lazio
University of Turin
University of Rome (Tor
Vergata)
Gutenberg (Private Co.)
Main objectives of research
• Consensus on classification and
management of adverse events
• Models for identification and analysis of
adverse events
• Analysis of existing organizational
models
• To test and spread good practicies
Regional activities (1)
Most Regions are taking measures to deal with patients safety
problems in health organizations.
Their main objectives are to:
1. Reduce or stabilize lawsuits and costs for insurance
2. Improve quality of services related to safety
Programs are managed at different levels:
 At a macro level:
In 4 Regions by Regional Agencies for Health Services (Emilia, Veneto,
Friuli, Piemonte)
In 2 by Special Units of Regional Ministry of Health (Toscana, Campania).
 At a meso level:
In others by Local Health Trust or Hospital level
A National Committee’s survey has shown that in 86% of
hospitals there are activities on risk management, usually
within Quality Units/Office
Regional activities (2)
LOMBARDIA:
•
In 2004 a Regional Act on risk management was issued; Regional database for adverse
events.
•
Regional Guide lines on risk management
•
In every hospital: person in charge for risk management, risk management team in each
departments, committee for adverse events assessment, maps of risks
EMILIA-ROMAGNA:
•
Clinical Risk is managed within the regional quality system and it is widespread and well
organized
•
A regional system for Incident Reporting (IR) was implemented in “high risk” departments
•
Use of FMEA & FMECA
•
Educational Campaigns
VENETO:
•
RM in regional accreditation program, with guidelines
•
IR system
•
Use of HDR for safety indicators and to track adverse events
FRIULI-VENEZIA GIULIA
•
Regional Risk Management Programs
•
IR
•
use of HDR for safety indicators
•
Specific campaigns (use of complaints, use of drugs, trasfusion etc.)
Tuscany Clinical Risk Management System
Each Hospital has:
A Clinical Risk Manager
A CRManagement Working Group
A Patient Safety Committee
Facilitators in each departments for
developing M&M review and Clinical
Audit
Collaboration with forensic medical
doctors and administrators for
assessing litigations
Activities in Regions
TOOLS FOR MEASURE
TOOLS FOR ANALYSIS AND
PREVENCTION
TOOLS FOR SUPPORT
ORGANIZATION
Mappatura sinistri
Reclami
Incident reporting
Eventi sentinella
Indicatori
Revisione cartelle cliniche
Incidenti e infortuni operatori
Analisi reattive (RCA, Diagramma Causa - Effetto, …)
Analisi di processo (FMEA, HAZOP, IDEF, …)
AUDIT CLINICO / ORGANIZZATIVO
Cartella Clinica
Consenso Informato
Regions
A L E T Pi L Pu C V
R
A
Comunicazione - Informazione - Campagne (interna - esterna operatore/paziente)
Percorsi Diagnostico Terapeutici
Programmi di accreditamento
Gestione apparecchiature e dispositivi
Individuazione del Risk Manager
Individuazione figura professionale del Risk Manager e sua
collocazione organizzativa
Istituzione di una Unità Operativa a livello Regionale
Istituzione di un Gruppo di Coordinamento a livello Regionale
A
A
A
A
Partnership con Società Scientifice, Enti di Ricerca, Università
FIELDS OF INTEREST
EDUCATION
R
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R
A
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R
R
A
R
A
Istituzione Gruppi di Coordinamento Aziendali (UGR)
Istituzione Gruppi di Valutazione Sinistri
Attivazione Processi di Mediazione
Partnership con Mercato Assicurativo
Obiettivi Direttori Generali
Rischio Clinico
Rischio Operatore
Rischio Struttura e Dispositivi
Rischio Patrimoniale
Rischio Ambientale
Progetti Formativi Regionali su Risk Manager
Progetti Formativi Regionali altri livelli
Impostazione politiche regionali formazione
Eventi di formazione locali
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ASSR’s Researches on indicators
Some of research projects on
Hospital Performance
Quality
Indicators (2003)
Ambulatory and Primary Care (2004)
Record Linkage (2005)
Continuity of Care (2006)
Two levels of Analysis
First Level
Indicators
(outcome)
HDR
Medical Record
Evaluation
Second Level
Indicators
(process)
Quality of
Medical Records
The numbers of the research
2002
HDR
Medical Records
Records
6.682.181
Quality control
on ICD9CM
coding
100.000
(DQE)
687
8.923
Diagnosis and proc.
Process indicators
validation
8.737
Quality of Medical
Records
708
Outcome
(discharge status)
Implementation problems with Safety Indicators
• In Italy hospital discharge records do not use E Codes,
thus two indicators cannot be used
• Coding style and awareness of adverse effects heavily
affect a second group of indicators, which are useful
only if a Risk Management System has been
implemented
• A third class of indicators (Mortality in low mortality
DRGs and Failure to rescue) have been proved to be
very useful at the present stage of development of the
informative system
How to use Safety Indicators
• The size of occurence of “Failure to rescue” or “Mortality
in low mortality DRGs” makes every case to be treated
as a sentinel event
• No “statistical” rate is reported
• Risk adjustment is not used for comparative purposes:
variability of secondary diagnoses coding and outcome
classification bias can produce misleading adjusted rates
estimates
• A high proportion of coding errors was discovered in
“Failure to rescue” and “Mortality in low mortality
DRGs”: these indicators have high sensitivity and low
specificity
Conclusion about Safety Indicators
• Most safety indicators are useful if a risk management
system has been implemented
• Two safety indicators (“Failure to rescue” and “Mortality
in low mortality DRGs”) have shown to be
“provisionally” useful, that is at the present stage of
informative system development
• Risk adjustment can be used in order to estimate the
difference between expected rate and the occurrence of
the event, not to adjust the “rate”
Thank you for your
attention