Fundamentals of Patient Safety and Risk Management

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Fundamentals of Patient Safety and Risk Management
Dr Tommaso Bellandi PhD, Eur.Erg. Quality and
Safety Manager bellandit_at_aou-careggi.toscana.it
http//www.salute.toscana.it/sst/grc/rischio-cli
nico.shtm
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The scale of the problem
Eight studies including a total of 74 485 patient
records were selected. The median overall
incidence of in-hospital adverse events was 9.2,
with a median percentage of preventability of
43.5. More than half (56.3) of patients
experienced no or minor disability, whereas 7.4
of events were lethal. Operation- (39.6) and
medication-related (15.1) events constituted the
majority.
E N de Vries et al, Qual. Saf. Health Care, Jun
2008 17 216 - 223
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Incidence of adverse events
Aranaz, 2011
COUNTRY AUTHOR, YEAR PERSPECTIVE PATIENTS AE Avoidable
EE.UU. (C) Schimel 1964 Quality 1014 23,6 -
EE.UU. (NY) Brenann 1984 Medical- legal 30195 3,7 27,6
EE.UU. Andrews 1989 Quality 1047 45,8 -
EE.UU. (U y C) Thomas 1992 Medical- Legal 14564 2,9 27,4 / 32,6
Australia Wilson 1992 Quality 14179 16,6 51,2
New Zealand Davis 1998 Quality 6579 11,3 37
United Kingdom Vincent 1999 Quality 1014 10,8 48
United Kingdom Healey 2000-01 Quality 4743 31,5 48,6
Denmark Shioler 2002 Quality 1097 9 40,4
Canada Baker 2002 Quality 3720 7,5 41,6
Canada Foster 2002 Quality 502 12,7 38
Canada Ross 2004 Quality 3745 7,5 36,9
France Michel 2005 Quality 8754 5,1 35
Spain Aranaz 2005 Quality 5624 9,3 46
Colombia Gaitán 2006 Quality 6688 4,6 61
Holland Zegers 2009 Quality 8400 5,7 40
Swedish Soop 2009 Quality 1967 8,7 70
Brazil Mendes 2009 Quality 1103 7,6 66,7
Tunisia Letaief 2010 Quality 620 10 60
Latin America (Prevalence) Aranaz 2011 Quality 11379 10,5 60
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2005 European Survey - Eurobarometer(http//ec.eu
ropa.eu/health/ph_information/documents/eb_64_en.p
df)?
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2010 European Survey - Eurobarometer(http//ec.eu
ropa.eu/public_opinion/archives/ebs/ebs_327_en.pdf
)?
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WHO World Alliance for Patient Safety
http//www.who.int/patientsafety/en/
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EU Patient Safety framework
Support the establishment or strengthen
blame-free reporting and learning systems on
adverse events EU Council recommendation
9thJune 2009
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Canadian FrameworkEnhancing patient safety
across the health professions
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The WHO Curriculum Guide topics
1. What is patient safety? 2. Why applying human
factors is important for patient safety 3.
Understanding systems and the effect of
complexity on patient care 4. Being an effective
team player 5. Learning from errors to prevent
harm 6. Understanding and managing clinical
risk 7. Using quality-improvement methods to
improve care 8. Engaging with patients and
carers 9. Infection prevention and control 10.
Patient safety and invasive procedures 11.
Improving medication safety
http//www.who.int/patientsafety/education/curricu
lum/en/index.html
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What is patient safety?
Patient safety the reduction of risk of
unnecessary harm associated with health care to
an acceptable minimum.
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The Patient Safety cycle
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Why applying human factors is important for
patient safety
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Applied ergonomics in healthcare
Physical Ergonomics Health-care facilities,
furnitures and devices design Noise and lighting
assessment and improvement Patient falls
prevention Hospital layout and wayfinding Cognit
ive Ergonomics Reporting and learning
systems Human errors analysis Interfaces
usability assessment and user centred
designs Organizational Ergonomics Team training
and teamwork assessment Analysis and redesign of
patient clinical pathways Assessment of safety
culture Design and implementation of systems for
patient safety management
Bellandi, 2010
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Being an effective team player

• Communication Teamwork
• Leadership
• Decision making
• Stress management
• Situation awareness

S. Yule, R. Flin, S. Paterson-Brown, N. Maran
Non-technical skills for surgeons in the
operating room A review of the literature.
Surgery, 2009, 139 (2) 140-149
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Being an effective team player

• Effective teams possess the following features
• A common purpose
• Measurable goals
• Effective leadership and conflict resolution
• Good communication
• Good cohesion and mutual respect
• Situation monitoring
• Self-monitoring
• Flexibility

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Learning from errors to prevent harm
1990
2008
The new vision on Human Error Planned sequences
of mental or physical activities that fail to
achieve their intended outcomes, when these
failures cannot be attributed to the intervention
of some chance agency.
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Learning from errors to prevent harm
System defences
Training
Organization
Technology environment
Patient factors

Adapted from Reason, 1990
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Learning from errors to prevent harm
Proactive approach
Reactive approach
Vincent, 2010
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Understanding systems and the effect of
complexity on patient care
Vincent, 2005?
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Understanding systems and the effect of
complexity on patient care
Carayon, 2006?
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Understanding and managing clinical risk
(Bellandi et al, 2005, 2008)?
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Understanding and managing clinical risk
Claims and complaints
Mandatoryreporting systems
Patient safety indicators
Voluntary reporting systems
Record review
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Understanding and managing clinical risk

• Different methods reveal different type of
  adverse events
• No single method is sufficient to estimate the
  nature and scale of adverse events
• An integration of the different methods is
  recommended for an efective risk management
  system

Olsen, Vincent et al. Qual. Saf. Health Care
20071640-44
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Understanding and managing clinical risk
Investigation methods recommended for the
application in healthcare according to the
criteria of validity, relaibaility and
sustainability Root Cause Analysis
(RCA) Significant Event Audit (SEA) Organizational
Accident Casuation Model (OACM) Australian
Incident Monitoring System (AIMS) Critical
Incident Technique (CIT) Confidential Inquiry
Method (CIM)
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Understanding and managing clinical risk
Benn et al, 2011
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Understanding and managing clinical risk
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Using quality-improvement methods to improve care
Use 'plan-do-study-act' cycles to conduct
small-scale tests of change Plan a change Do
it in a small test Study its effects Act on
what learned Team uses and links small PDSA
cycles for broader implementation
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Using quality-improvement methods to improve care
Max risk 7 flows of blood samples (7 flows of
lab orders2) 98 error modes
Blood group
Risk assessment of donor, organs and tissues
Lab 1
Materials Informations
Clinical pathology
RTC/IRTC/Tissue Bank
Lab 2
Immunogenetics
Lab 3
Serology
Informations
Lab 4
Biomolecular
Retrivial, packaging and mailing of blood samples
Lab 5
Microbiology
ICU LC
Lab 6
Bellandi, 2011
Bio-bank
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Using quality-improvement methods to improve care
Min risk 1 flow of blood samples (1 flow of
lab order2) 2 error modes
HUB Laboratory
Blood group
Risk assessment of donor, organs and tissues
Clinical pathology
Materials Informations
RTC/IRTC/Tissue Bank
Immunogenetics
Serology
Biomolecular
Informations
Microbiology
Retrivial, packaging and mailing of blood samples
Bio-bank
ICU LC
Bellandi, 2011
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Engaging with patients and carers
http//www.who.int/patientsafety/patients_for_pati
ent/en/
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Engaging with patients and carers
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Infection prevention and control
http//whqlibdoc.who.int/publications/2009/9789241
597906_eng.pdf
http//whqlibdoc.who.int/publications/2012/9789241
503181_eng.pdf
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Patient safety and invasive procedures
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Improving medication safety
http//www.ismp.org/
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Other on-line resources
AHRQ Patient Safety Network psnet.ahrq.gov/ AHRQ
WebMM Morbidity Mortality Rounds on the
Web www.webmm.ahrq.gov/ NPSA - National
Patient Safety Agency www.npsa.nhs.uk/ Canadian
Patient Safety Institute www.patientsafetyinstitut
e.ca/ Haute Autorité de Santé - Sécurité du patien
t www.has-sante.fr/portail/.../securite-du-patient
Seguridad del Paciente Ministerio de Sanidad y
Política Social www.seguridaddelpaciente.es/ Danis
h Society for Patient Safety patientsikkerhed.dk/i
ndex.php?id473 Governo clinico, qualità
e sicurezza delle cure - Ministero della
Salute www.salute.gov.it/qualita/qualita.jsp