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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 Dijen
Vice president Cap Gemini Ernst & Young
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 1420 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)
Fafr-Fatal Accident Frequency
• Hospitals
± 50
Rate hospital stay similar as traffic
• Traffic (total)
± 50
• ICU stay
± 1000
The penalty of anything less than
• Anesthesia
± 4700
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)
prevention and continuous improvement
(emphasis on causes and organisation)
unacceptable few (high risk situations: what can go
wrong)
integral processes, including processes with
minimal risks
structures (static)
processes (dynamic)
primary process
all processes (integral)
must (negative: answering requirements is ‘burden’): want (positive: personal identification with safety):
employee control
employee involvement
safety department
integration in organisation
‘personal interpretation of professional functioning’
of individuals (input)
real performance in terms of process results
(output)
identification of errors
identification of risks in the system
meeting standards
real benchmark against ‘world class’ organisations
individual failure
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
no action for
90+ %
of outcomes
focus on high risk/
emergency situations
(what can go wrong)
measurability?
controlability?
minimal
risks
level of acceptance
action toward
unacceptable 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 structure
safety  categories  characteristics  indicators  safety aspects questions
Excellent
Good
Good
Amply sufficient
Sufficient
Good
Sufficient
Mediocre
Mediocre
Good
Mediocre
Poor
Poor
Poor
Insufficient
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
each with their recognizable
categories of answers
• With respect to experiences
• With respect to facts
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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 System
Conclusions
3. Pilot hospital 3
Own
Best
hospital
hospital
Performance
The conclusions below relating to characteristics and indicators refer to the category
03
Complaints and claims
The following results by indicator refer to the characteristic
01 Complaints and claim pattern
The results by indicator are:
01 Claim sort
good
good (25)
02 Claim causes
poor
good (12)
03 Claim pattern
good
good (8)
Based upon the above results, the assessment for the characteristic
mediocre
good (25)
Complaints and claim pattern
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Patient Safety Audit System
Tree diagram patient safety
03 Complaints and claims
mediocre
01 Complaints and claim pattern
mediocre
02 Dealing with complaints
03 Complaints awareness
04 Dealing with claims
poor
mediocre
good
3. Pilot hospital 3
01
Claim sort
good
02
Claim causes
poor
03
Claim pattern
good
01
Patient complaints regulation
good
02
Complaints registration, analysis
and report
poor
03
Measures on account of complaints
poor
01
Joining RIP and complaints
good
02
Instruction, training and attitude
with reference to dealing with complaints
poor
01
Procedure dealing with claims
good
02
Claims registration, analysis and report
good
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Patient Safety Audit System
Explanation of performances in graphic form
1. Hospital
The performance relates to: Overall patient safety
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Patient Safety Audit System
Part 3: Explanation by categoristic in graphic form
3. Pilot hospital 3
Expertise/professional compentence
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Patient Safety Audit System
Benchmark part 5: Overall patient safety for all hospitals
The performance relates to: Overall patient safety for all hospitals
The extent to
which the
hospital result
is “excellent”
100
90
80
70
60
50
40
30
20
10
0
7
6
4
1
8
10
2
9
12
11
3
5
Hospital code
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Patient Safey Audit System
Benchmark part 6: Frequency distribution of performance by safety
category
good
sufficient
mediocre
poor
01
Provision of health care
21%
63%
16%
0%
02
Accident prevention
0%
33%
48%
18%
03
Complaints and claims
7%
84%
9%
0%
04
Client orientation
12%
28%
38%
22%
05
Policy and management
16%
45%
34%
5%
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Patient Safety Audit System
Part 4: Reliability analysis
01 02 01 07
Is secretarial support reserved to record, modify
and distribute medical protocols?
DIR
VMS
1. YES
2. NO
6. DO NOT KNOW / NOT APPLICABLE
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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)
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