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