Patient Safety Audit System(Patient Risk Audit System)

PSAS risk management instrument for measuring and assessing patient safety

Luzern, April 9, 2001

Dr. Monique van DijenVice president Cap Gemini Ernst & Young

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Contents

• Why a patient safety audit system?

• PSAS: how? The concept

• PSAS: structure & contents what in fact is it?

• PSAS: reporting of results what does the conclusion look like?

• PSAS: history and current situation in an international perspective

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Why a patient safety audit system?

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Safety terms

• Unsafe situations Any situation that affects safety adversely

• Incident Near accidents: some damage/injury may be involved

• Accident (Multi causal) event with damage/injury

Be aware: reported accidents & incidents are just tip of iceberg (safety professionals):

1 fatal accident

100 accidents

10.000 incidents/near accidents

100.000 unsafe actions/situations

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Introduce PSAS: alarming figures

• Patients are confronted with consequences of numerous unsafe situations– University of Groningen, Netherlands: 2000/3000 deaths annually (average 14-

20 per hospital > Zelders) = 0,20% of admitted patients die because of avoidable mistakes

– Harvard: 0,5% admitted patients die because of iatrogenic damage (iatrogenic = caused bij medical interventions); 50% is avoidable = 0,25% of admitted patients die because of avoidable mistakes

– Trunet, France: 9% of admissions ICU is because of iatrogenic damage

– Husi&Stalder, Swiss: 12% of admitted patients suffer from iatrogenic damage

– Cepod Study, Great Britain: 7% of post-operative deaths caused by iatrogenic factors

– Tempelaar:• 10% of death of patients, who died at home or in hospital, is evitable• Indicative, annually: 1 per 15 admitted patients gets bacterial infection • 1/3 to 1/2 of surgical patients get avoidable complications; 25% serious

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Introduce PSAS: more alarming figures

• Numerous unsafe situations (cont’d)– Institute of Medicine (American Institute of Science), Report ‘To err is human’:

Medical errors kill more Americans than traffic accidents or aids: some 98.000 deaths a year, attributed to medical mistakes

– Number of fatal accidents per 100 million hours spent on activity concerned (Zelders; similar results)• Hospitals ± 50• Traffic (total) ± 50• ICU stay ± 1000• Anesthesia ± 4700

Fafr-Fatal Accident Frequency

Rate hospital stay similar as traffic

The penalty of anything less than

perfection is death

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Introduce PSAS: anything less than perfection is unacceptable

• 99% safety means:

– Every minute 427 air plane crashes

– Every minute 27 train accidents

– 4 million deaths annually in ship calamities

– Daily telephone failure for 14 minutes

– Monthly 520.000 km sewerage disorder

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Introduce PSAS: rapidly rising costs of unsafety

• Number of claims is rapidly increasing (costs quadrupled over past 5 years)

– Currently only ± 15% is being claimed

– Increase in ‘injury compensation counsellors’ for malpractice suing on no cure no pay basis

– Decrease in tolerance, increase in emancipation

– Shift in emphasis from effort commitment to outcome obligations (reversed onus probandi)

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Introduce PSAS: substantial savings

• Patient savings: less suffering, reduction of waiting lists/times, reduction of hospital stay

• Cost/benefit analyses: cost savings by using PSAS average 4 (up to 10) times the cost of PSAS-introduction

• International Loss Control Institute & Centre for Risk Management and Insurance Research, Georgia State University (report ‘The Effect of International Safety Rating System on Organizational Performance’): decrease in losses by 50%

• Personnel savings: less frustration, higher work satisfaction, better moral and better motivation

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PSAS: how?

• Relation to other patient safety audit systems

• Benchmarking

• Premises and focus of the PSAS

• Added value knowledge technology

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PSAS; how? Relation to other patient safety audit systems

•

Current safety systems emphasize: PSAS emphasizes:

safety inspection (emphasis on symptoms, technical aspects, problem solving)

unacceptable few (high risk situations: what can go wrong)

structures (static)

primary process

must (negative: answering requirements is ‘burden’): employee control

safety department

‘personal interpretation of professional functioning’ of individuals (input)

identification of errors

meeting standards

individual failure

prevention and continuous improvement (emphasis on causes and organisation)

integral processes, including processes with minimal risks

processes (dynamic)

all processes (integral)

want (positive: personal identification with safety): employee involvement

integration in organisation

real performance in terms of process results (output)

identification of risks in the system

real benchmark against ‘world class’ organisations

system failure

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PSAS built on current major safety audit systems

• TNO: SMART Safety Guidelines

• NZI: ‘Working on safe patient care’

• LCC Loss Control Centre: ISRS International Safety Rating System

• CGEY: Quick Scan Health Care Systems/Quality Early Warning System

• Merett: ‘Health Risk Management’

• RISK-International Safety Centre: Guidelines on Patient Safety and Working Conditions

• St. Paul International Insurance Cy: Organisational Behaviour Programme

• EQS-European Committee for Quality Systems Assessment & Certification

• Blaak Risk Managers: Hospital Audit

• HOPE: proceedings Working Party on Quality Care in Hospitals, and others

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Benchmarking on patient safety offers:

• External position of the hospital

– Comparison with other countries

– Comparison with other hospitals

– Comparison with other branches

– Comparison of present and future risk management practices (trends)

• Insight in management practices that lead to performance improvement (increasing patient safety, reducing risks)

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Traditional (Risk) Management Systems often address the unacceptable few

focus on high risk/emergency situations(what can go wrong)

measurability?controlability?

no action for90+ %of outcomes

level of acceptance

minimalrisks

action towardunacceptable few(high or low)

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Premises of the PSAS

1. Safety: the control of loss that can arise from undesirable events

2. To realise safety objectives regular information on safety is necessary

3. Only an overall approach guarantees complete steering information

Overall approach

a) provision of health care

b) accident prevention

c) complaints and claims

d) client orientation

e) policy and management

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Premises (2)

4. The patient safety audit system contains an internal and very limited external audit

5. Patient safety is a multi dimensional concept. The audit is taken from ca. 30 parties, for example:

– Nurses

– Hospital management

– Doctors, paramedical employees

– Patients

– Family doctors

– Et cetera

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Premises (3)

6. Application of the patient safety audit system is part of a cycle focused on

a) Enhancement of the risk awareness in the hospital

b) Continuous improvement of patient safety

c) Picturing risks on losses more exact

7. Information gotten from the PSAS primary focused on giving steering information on patient safety (present HIS only financial focus): risk management, safety policy and safety plan

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PSAS; how? Focus on organizational conditions

85% of defects in safety caused by system failure

• Multiple causes for accidents and iatrogenic damage (from 7 up to 70)

• Fast innovations in technique: procedures, technologies, equipment, instruments and ICT (people can’t cope)

• Limitations human brain versus knowledge system:

– inadequate assumptions lead to logical errors

– Insufficient capacity and data for adequate decisions

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PSAS: how? Knowledge system required

Several assessors with essentially the same knowledge do not all come to the same conclusion about the same hospital because:

1. Number of relevant factors > number that the expert (assessor) can weigh in mutual cohesion

2. A human being is not able to allocate directly the correct weightings to each safety aspect

3. Influence by irrelevant aspects as mood, fatigue, prejudice, et cetera

4. No direct access to the know-how and experience of other experts

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PSAS: how? Knowledge system required

Prevention of arbitrariness in the conclusions/decisions because:

• Criteria/characteristics on the basis of which is concluded/decided are unlimited, explicit and always taken completely

• Correct valuing of each patient safety aspect

• Consistence of conclusions/decisions: increase internal consistency - validity (repeatable)

• Knowledge & experience of assessor(s): integrated, explicit, open to discussion and controllable

• Reporting with safety scores, conclusions and explanation of conclusions are fully automatically generated

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PSAS: structure & content

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PSAS: Tree structuresafety categories characteristics indicators safety aspects questions

Excellent

Good

Amply sufficient

Sufficient

Mediocre

Insufficient

Poor

Good

Sufficient

Mediocre

Poor

Good

Mediocre

Poor

Good

Poor

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Example content patient safety audit system

1. Health care provision

• Expertise/professional competence

• Medical records

• Nursing records/standard nursing plans

• Nursing working methods

• Intradisciplinary collaboration

• Interdisciplinary collaboration

• Collaboration between units

• Filing/reporting (professional)

• Hospital hygiene

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Example content patient safety audit system

• Drugs

• Medical-scientific research

• Clinical/chemical laboratory

• Policy of the medical staff

• Quality management of the primary processes

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Example content patient safety audit system

2. Accident prevention

• Safety management

• Safety in operations

• Reporting Incidents Patients (RIP/MINA)

• Risks of falling and accidents involving falls

3. Complaints and claims

• Dealing with complaints

• Pattern complaints and claims

• Complaints awareness

• Dealing with claims

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Example content patient safety audit system

4. Client orientation• Patient valuation/satisfaction research

• Influenceness

• Patient information

• Carefulness

5. Policy and management• Organization

• Communication

• Overall policy

• Social policy

• Working conditions and absenteeism policy

• Internal steering and control

• Quality management

• Environmental system

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PSAS, how? Tree structure

PSAS distinguishes 3 typologies of questions

• With respect to system

• With respect to experiences

• With respect to facts

each with their recognizable categories of answers

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Question level

Category: Accident prevention

Characteristic: Safety management

Indicator: Policy and organisation patient safety

Question: 02 01 01 02 Respondents: MT CMS

Does the hospital have a written policy on patient safety?

There is no such policy in writing

There is such policy in writing, but insufficient staff awareness of it

There is such a policy in writing, staff are aware of it, but it has not been implemented

There is such a policy in writing, staff are aware of it, it has been implemented, but it is not regularly evaluated and amended

There is such a policy in writing, staff are aware of it, it has been implemented and is regularly evaluated and amended

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PSAS: reporting of results

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The safety performance on the level of overall patient safety is: Sufficient

The performance on category level underlies this assessment. The safety performances for the categories are:

• Provision of health care: good

• Accident prevention: sufficient

• Complaints and claims: mediocre

• Client orientation: sufficient

• Policy and management: sufficient

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Patient safety Audit SystemConclusions 3. Pilot hospital 3

The conclusions below relating to characteristics and indicators refer to the category

Complaints and claims

The following results by indicator refer to the characteristic

Complaints and claim pattern

The results by indicator are:

Claim sort good good (25)

Claim causes poor good (12)

Claim pattern good good (8)

Based upon the above results, the assessment for the characteristic

Complaints and claim pattern

03

01

01

02

03

mediocre

Own

hospital

Best

hospitalPerformance

good (25)

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Patient Safety Audit SystemTree diagram patient safety 3. Pilot hospital 3

Complaints and claims

Complaints and claim pattern Claim sort

Claim causes

Claim pattern

Dealing with complaints Patient complaints regulation

Complaints registration, analysisand report

Measures on account of complaints

Complaints awareness Joining RIP and complaints

Instruction, training and attitudewith reference to dealing with complaints

Dealing with claims Procedure dealing with claims

Claims registration, analysis and report

01

01

01

01

01

03

03

03

03

02

02

02

02

02

04 good

mediocre

good

poor

good

good

poor

poor

good

poor

good

good

mediocre

mediocre

poor

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Patient Safety Audit SystemExplanation of performances in graphic form 1. Hospital

The performance relates to: Overall patient safety

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Patient Safety Audit SystemPart 3: Explanation by categoristic in graphic form 3. Pilot hospital 3

Expertise/professional compentence

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Patient Safety Audit SystemBenchmark part 5: Overall patient safety for all hospitals

7 6 4 1 8 10 2 9 12 11 3 50

102030405060708090

100

7 6 4 1 8 10 2 9 12 11 3 5

The performance relates to: Overall patient safety for all hospitals

The extent towhich thehospital resultis “excellent”

Hospital code

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Patient Safey Audit SystemBenchmark part 6: Frequency distribution of performance by safety category

Provision of health care 21% 63% 16% 0%

Accident prevention 0% 33% 48% 18%

Client orientation 12% 28% 38% 22%

Policy and management 16% 45% 34% 5%

Complaints and claims 7% 84% 9% 0%

0101

0202

0404

0505

0303

good sufficient mediocre poor

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Patient Safety Audit SystemPart 4: Reliability analysis

0101 0202 07070101Is secretarial support reserved to record, modifyand distribute medical protocols?

Is secretarial support reserved to record, modifyand distribute medical protocols?

1. YES

2. NO

6. DO NOT KNOW / NOT APPLICABLE

VMSVMSDIRDIR

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Benchmark results of 18 hospitals (1)

• Development and control medical records (47%)

• Development and control standard nursing plans (53%)

• Appliance standard nursing plans (76%)

• Co-operation between clinical departments among each other (59%)

• Rules about medical (poly) status activities (59%)

• Internal organisation medical staff (53%)

• Quality committee/medical audit committee professionals (76%)

• Control quality of operating external professionals (82%)

• Policies and organisation patient safety (88%)

• Education and communication patient safety (94%)

• Confidence of employees in the patient safety policy (88%)

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Benchmark results of 18 hospitals (2)

• Risk management (59%)

• Prevention of unwanted behaviour employees (53%)

• Reporting of falling incidents (75%)

• Preventive operating for falling risks (94%)

• Material means to prevent falling (82%)

• Registration, analysis and reporting of claims (94%)

• Trustworthy (71%)

• Communication structure/internal communicationn plan (76%)

• Decision making at the hospital level (76%)

• Strategic policies (59%)

• Training policy in respect of refresher and further training (53%)

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Benchmark results of 18 hospitals (3)

• Assessments (100%)

• Working conditions policy (53%)

• Process and product management/efficiency (100%)

• Management information (65%)

• Preparation of quality control policy (100%)

• Implementation of quality control policy (71%)

• Quality control system (94%)

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PSAS: history and current situation in an international perspective

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PSAS: history & current situation

• Centramed: parties involved:

– Insurance Cy Nationale Nederlanden (Centrameter)

– 2001: 25 hospitals in the Netherlands > 18 started in 1998 (contacts with AMC en LUMC to develop a module for university hospitals)

– NIAZ - Dutch Accreditation Institute for Hospitals investigates the possibility of using PSAS in their accredition procedures

• Scientific involvement

– University of Twente, Prof. Robert Stegwee

– University of Leuven, P. Henderikx

– Others, to be suggested

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PSAS: history & current situation (cont.’d)

• Advocates– OvM, Order of Medical Specialists (Dr. Valentijn)

– KNMG, Royal Dutch Association of Medicine

– Ministry of VWS - Health, Welfare & Sport (Dr. Borst)

– Inspection for Health Care in the Netherlands (Dr. Herre Kingma)

– NVZ - Dutch Association of Hospitals (Lemstra)

– NVZD - Dutch Association of Hospital Directors (Pim ‘t Hooft)/EAHD

– CP Comité Permanent des Médecins de la Communauté Européenne - Standing Committee of European Doctors (Prof. Dr. Aarimaa/Dr Grethe Aasved)

– Standing Committee of Hospitals of the European Union (HOPE/HEALLO; Prof. Dr. Kris Schutyser)

– Zorgverzekeraars Nederland - Association of Health Insurance Companies (Hans Wiegel)

– End-users of PSAS (explicit a.o. Medical Staff Molendael Hospital, Baarn, Dr. Willem Zwart)

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PSAS: history & current situation (cont.’d)

Other contacts– European Health Managers Forum (encouraging high standards of health care

provision; Mr. Souto)

– EHPF European Health Policy Forum (Prof. Dr. Mia Defever)

– European Association of Nurses

– EAHD European Association of Hospital Directors

– STG-Foundation for Future Health Scenario’s (Prof. Van Londen)

– RVZ-Council for Health and Social Services (chairman Prof. Van Londen)

– LOIB-Dutch Forum for International Health Policies (chairman A.T.J. Krol MSc)

– European Parliament, a.o. J. Bowis (former Minister of Health UK)

– Council of Europe

– European Health Management Association (director Dr. Ph. Bermand)

– Health Clients’ Association / National Organization of Patients Councils

– Suggestions?

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How might the Working Party contribute to further improvement of patient safety on European scale?

• Strongly support an application for EU subsidy to introduce PSAS on a European scale (see also sheet 12)

– Write letter of recommendation; eventually joint application HOPE/CGE&Y for EU subsidy (adopt PSAS?)

– Mobilise network • to involve right persons to further support PSAS• to find the right way to apply for EU subsidy (WHO?)

– Assist in convincing government officials in necessity of PSAS

– Assist in mobilising pilot hospitals in European countries (financial participation required > at least 50/50); HOPE / CGE&Y flag?

• Generate ideas for creation European Center Patient Safety

– Benchmark as basis for policy & decision making (per hospital, per country, on a European scale)

– Agree on minimum safety requirements

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• Involve universities and Quality Institutes in health care for scientific anchorage

• Prepare for building knowledge system in cooperation with E-solutions / ISM

• ‘Walk the corridors’ in Brussels

• Write the application for the EU subsidy, with 12 hospitals in 4 countries and with writers of recommendation letters

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PSAS

• Unique system for measuring and improving patient safety

• System can be easily customized for hospitals in Switzerland or anywhere in European hospitals

• Benchmarking of hospitals on a National and/or European level

• Creates the possibility to have a (inter)national standard for risk management and patient safety (f.i. EU)