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Patient Safety: state of Patient Safety: state of art and perspectives in art and perspectives in ItalyItaly
Carlo LivaCarlo LivaDpt Quality & AccreditationDpt Quality & Accreditation
Rome - ItalyRome - Italy
National Agency for Regional Health National Agency for Regional Health
SystemsSystems
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 problemQuick 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 2004 – Situation for Insurance Companies AssociationAssociation
Costs for Insurance Companies413 millions euros
Requests 2,5 billions euros
Lawsuits 12.000
Patients involved320.000
Inabitans: 1.180.000.Actual cost for insurance in Regional Health System is about 15 millions euros (12 in 2003)
ARS
Situation of Complaints for Citizens Situation of Complaints for Citizens OrganisationsOrganisations (source: Cittadinanzattiva)
3,03,1Neurology4,82,5Cardiosurger
y
4,97,1Cardiology5,53,5Dentistry8,25,5Oculistics
12,013,8Gen. Surgery13,210,1Gynaecology13,310,1Oncology18,518,2Orthopaedy20041999
National GroupsNational Groups
National Ministry of Health’s Special Committee
ASSR’s Research project
Regional Ministries of Health’s Committee on Clinical Risk Management (RM)
National activitiesNational 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
risk2006: monitoring sentinel events
ASSR’s Research on Risk ASSR’s Research on Risk Management Management
Promotion of innovation and risk management (2005-2007)
University of TurinUniversity of Rome (Tor Vergata)Gutenberg (Private Co.)
10 Regions:
ToscanaEmilia RomagnaVenetoCampaniaFriuli Venezia GiuliaLombardiaPugliaPiemonteAbruzzoLazio
Main objectives of researchMain 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 activitiesRegional 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
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.)
Regional activitiesRegional activities (2)
Tuscany Clinical Risk Management Tuscany Clinical Risk Management SystemSystem
Each Hospital has: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
R AAAAAARRAAEventi di formazione locali RR RImpostazione politiche regionali formazione RR Progetti Formativi Regionali altri livelliRR *R R Progetti Formativi Regionali su Risk Manager
EDUCATION
AA AR Rischio AmbientaleR AAAA ARR Rischio PatrimonialeR AAAA AAARARischio Struttura e DispositiviR AAAAAAARRARischio OperatoreR AAAAAARRRARischio Clinico
FIELDS OF INTEREST
R A R R R Obiettivi Direttori GeneraliR R A Partnership con Società Scientifice, Enti di Ricerca, UniversitàR ®AR RR Partnership con Mercato AssicurativoAA RA Attivazione Processi di MediazioneRA A ARAR Istituzione Gruppi di Valutazione Sinistri
R AAAAAARRR Istituzione Gruppi di Coordinamento Aziendali (UGR)
R R RRRAIstituzione di un Gruppo di Coordinamento a livello Regionale Istituzione di una Unità Operativa a livello Regionale
A AAR Individuazione figura professionale del Risk Manager e sua collocazione organizzativa
R A A RAR2RAIndividuazione del Risk Manager
ORGANIZATION
R AAAAA AAAAGestione apparecchiature e dispositiviR ARRRARRRRAProgrammi di accreditamentoR AAA AAA A Percorsi Diagnostico Terapeutici
R AAA AAR A Comunicazione - Informazione - Campagne (interna - esterna - operatore/paziente)
AAAARARAAConsenso InformatoAAAAAAAAR Cartella Clinica
TOOLS FOR SUPPORT
AA A ARRA AUDIT CLINICO / ORGANIZZATIVO A AARRA Analisi di processo (FMEA, HAZOP, IDEF, …) A A RRA Analisi reattive (RCA, Diagramma Causa - Effetto, …)
TOOLS FOR ANALYSIS AND PREVENCTION
A AAAAAA Incidenti e infortuni operatoriR AAAA AARA Revisione cartelle clinicheR AAA AR1A Indicatori R AAAAAARRA Eventi sentinellaR AAA ARRA Incident reportingR AAAAAAARR ReclamiRAAAA RRRRMappatura sinistri
TOOLS FOR MEASURE
A L E T Pi L Pu C V F
RegionsActivities in RegionsActivities in Regions
Some of research projects on Some of research projects on Quality IndicatorsQuality Indicators
ASSR’s Researches on indicatorsASSR’s Researches on indicators
Hospital Performance (2003) Ambulatory and Primary Care
(2004) Record Linkage (2005)
Continuity of Care (2006)
Two levels of AnalysisTwo levels of Analysis
First Level First Level IndicatorsIndicators(outcome)(outcome)
Medical RecordMedical Record EvaluationEvaluation
Second LevelSecond LevelIndicatorsIndicators (process)(process)
Quality ofQuality of Medical RecordsMedical Records
HDRHDR
The numbers of the researchThe numbers of the research
708708
Outcome Outcome (discharge (discharge
status)status)
8.7378.737
Quality of Quality of Medical RecordsMedical Records
687687
Diagnosis and Diagnosis and proc. validationproc. validation
8.9238.923
Process Process indicatorsindicators
MedicalMedical RecordsRecords
100.000100.000
(DQE)(DQE)6.682.181 6.682.181 HDRHDR
Quality Quality control on control on ICD9CM ICD9CM codingcoding
RecordsRecords20022002
Implementation problems with Safety Implementation problems with Safety IndicatorsIndicators
• In Italy hospital discharge records do not use E In Italy hospital discharge records do not use E Codes, thus two indicators cannot be usedCodes, thus two indicators cannot be used
• Coding style and awareness of adverse effects Coding style and awareness of adverse effects heavily affect a second group of indicators, heavily affect a second group of indicators, which are useful only if a Risk Management which are useful only if a Risk Management System has been implementedSystem has been implemented
• A third class of indicators (Mortality in low A third class of indicators (Mortality in low mortality DRGs and Failure to rescue) have mortality DRGs and Failure to rescue) have been proved to be very useful at the present been proved to be very useful at the present stage of development of the informative systemstage of development of the informative system
How to use Safety IndicatorsHow to use Safety Indicators
• The size of occurence of “Failure to rescue” or The size of occurence of “Failure to rescue” or “Mortality in low mortality DRGs” makes every “Mortality in low mortality DRGs” makes every case to be treated as a sentinel eventcase to be treated as a sentinel event
• No “statistical” rate is reportedNo “statistical” rate is reported
• Risk adjustment is not used for comparative Risk adjustment is not used for comparative purposes: variability of secondary diagnoses purposes: variability of secondary diagnoses coding and outcome classification bias can coding and outcome classification bias can produce misleading adjusted rates estimatesproduce misleading adjusted rates estimates
• A high proportion of coding errors was A high proportion of coding errors was discovered in “Failure to rescue” and “Mortality discovered in “Failure to rescue” and “Mortality in low mortality DRGs”: these indicators have in low mortality DRGs”: these indicators have high sensitivity and low specificityhigh sensitivity and low specificity
• Most safety indicators are useful if a risk Most safety indicators are useful if a risk management system has been implementedmanagement system has been implemented
• Two safety indicators (“Failure to rescue” and Two safety indicators (“Failure to rescue” and “Mortality in low mortality DRGs”) have shown to “Mortality in low mortality DRGs”) have shown to be “provisionally” useful, that is at the present be “provisionally” useful, that is at the present stage of informative system developmentstage of informative system development
• Risk adjustment can be used in order to estimate Risk adjustment can be used in order to estimate the difference between expected rate and the the difference between expected rate and the occurrence of the event, not to adjust the “rate”occurrence of the event, not to adjust the “rate”
Conclusion about Safety IndicatorsConclusion about Safety Indicators
Thank you for your Thank you for your attentionattention
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