The document summarizes a presentation given by Sara Albolino and Riccardo Tartaglia on applying patient safety solutions in clinical practice. The presentation covered: 1) Barriers to improving patient safety in healthcare, including differences from other high-risk industries and emotional involvement of clinicians. 2) Studies showing the incidence of adverse events is around 9% globally but improving slowly despite efforts. 3) Interventions need to consider the healthcare context and developing a safety culture is important to improving reliability. 4) A systems approach is necessary to address patient safety, not just individual practices or technologies. Standardization and measuring outcomes is important going forward.

1. ALIAS Conference 14-15 June 2012, Florence
(Italy)
A SESAR Innovation Challenge:
Responsibilities, Liabilities and Automation in
Aviation
Apply patient safety solutions to
clinical practice. Why is it so
hard?
Sara Albolino, PHD, CRM
Riccardo Tartaglia, MD, Eur-Erg
www.regione.toscana.it/rischioclinico
rischio.clinico@regione.toscana.it

2. Differences in safety and reliability
Bagnara, Parlangeli, Tartaglia. Applied ergonomics, 2010

3. Risk perception
vs
Unsafe climate
5.6% naval aviators vs 17.5% healthcare
operators (20.9% in emergency department and
operating room) Gaba et al., 2003

4. Emotional involvement
The technology barrier is thin
Direct relationship between the doctor and the patient
“double human being systems”

5. The barriers to ultrasafe
Amalberti, R. et. al. Ann Intern Med 2005;142:756-764

6. When compared with traditional HROs, hospitals are
undoubtedly high-risk organizations, but have
specificities and experience systemic socio-organizational
barriers that make them difficult to transform into HROs
Bagnara, Parlangeli, Tartaglia. Applied ergonomics, 2010

7. Outline
• Incidence of adverse events
• Difficulty in improving patient safety
• Patient safety interventions and system reliability
• What to do: the importance of the system approach and
implications for the future

8. Outline
• Incidence of adverse events
• Difficulty in improving patient safety
• Patient safety interventions and system reliability
• What to do: the importance of the system approach and
implications for the future

9. The starting point

10. Incidence of adverse events (1964-2010)

11. First conclusions (2008)
Eight studies including a total of 74 485 patient
records were selected. The median overall incidence of inhospital
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.

12. Adverse events in developing countries
Of the 15 548 records reviewed, 8.2% showed at least one
adverse event, with a range of 2.5% to 18.4% per country.

13. Adverse events in Italy (2011)
Italy Tartaglia quality 7573 5,17 56,7
Tuscany teaching Tartaglia quality 4227 6,7 42,9
hospitals
Community Tartaglia quality 7066 1,9 56,8
hospitals
600.000 patients experience an adverse events every year

14. Outline
• Incidence of adverse events
• Difficulty in improving patient safety
• Patient safety interventions and system reliability
• What to do: the importance of the system approach and
implications for the future

15. Improving slowly
Advancing the science of patient safety.
Shekelle PG, Pronovost PJ, Wachter RM et Al.
Ann Intern Med. 2011 May 17;154(10):693-6.
• Despite a decade's worth of effort, patient safety has
improved slowly
• Complexity of the interventions and diversity of the
contexts matter

16. The impact of the context
What context features might be important determinants of the effectiveness
of patient safetynpractice interventions?
Peter J Pronovost, John Øvretveit, BMJ Qual Saf 2011

17. A framework for classifying patient
safety practices
A framework for classifying patient safety practices: results from an expert
consensus process
Peter J Pronovost, John Øvretveit, BMJ Qual Saf 2011

18. Improving slowly
Advancing the science of patient safety.
Shekelle PG, Pronovost PJ, Wachter RM et Al.
Ann Intern Med. 2011 May 17;154(10):693-6.
Evaluation of the impact of this characteristics is
important:
• To help organization judge wheter an intervention
shown to be effective elsewhere is likely to work in
their settings
• To propose cointerventions that can support
implementation of a given practice
• To evaluate if the costs of an intervention may
outweigh its benefits

19. The impact of the patient safety culture
Randomized sample of 942 healthcare workers in
18 Italian Hospitals
More of 70% professionals declared to have
experienced an adverse events but half of them did not
report them because:
•It is not a priority
•Fear of mistrust among colleagues
•There is not a reporting culture in my organization

20. We can’t wait so long
B. Pedersen, HEPS Oviedo, 2011

21. Outline
• Incidence of adverse events
• Difficulty in improving patient safety
• Patient safety interventions and system reliability
• What to do: the importance of the system approach and
implications for the future

22. • Clinical information available in hospital
outpatient clinics
• Prescribing for hospital inpatient
• Equipment availability in the operating
theatre
• Equipment available for inserting
peripheral intravenous lines

23. Reliability of the healthcare
system
How reliable are clinical systems in the UK NHS? A study of seven NHS organisations
Burnett S, Franklin BD, Moorthy K, Vincent et al. BMJ Qual Saf
(2012). doi:10.1136/bmjqs-2011-000442

24. Reliability of the healthcare
systems
Based on the approach of the US Institute for Healthcare Improvement
(IHI):
- reliability of <80 e 90%, indicates a lack of any articulated common
process,
- whereas reliability of around 95% suggests the presence of a clearly
articulated process
For healthcare organisations to begin to improve the reliability:
- need for articulating or documenting the process as it is expected to
function
- define the required outputs.
- this is a prerequisite for understanding where processes fail

25. Outline
• Incidence of adverse events
• Difficulty in improving patient safety
• Patient safety interventions and system reliability
• What to do: the importance of the system approach
and implications for the future

26. Understanding systems and the effect of
complexity on patient care
Vincent, 2005

27. Patient safety practices as a system
Right antibiotic
Nutritional Prevention of Falls Check list
at the right
CVC infection Prevention
moment risk
Correct patient Oncologic Communication
Clinical audit Pain
identification therapy of adverse
management
management event
Reporting Prevention of
Clean Incident
never events decubituus
reporting
hands ulcers
Management of Modified eraly
Unified Mortality and
the oral warning systen
morbidity
Therapeutic anticoagulant
review
therapy
form
Prevention of
Preventio of Survellaince of the
Deep venous Post-partum
dystocyia antibiotic
thrombosis
emorragy resistance

28. Good practices in critical care
• Deploy Rapid Response
• Deliver Reliable, Evidence-Based Care for Acute
Myocardial
• Prevent Adverse Drug Events (ADEs)
• Prevent Central Line
• Prevent Surgical Site Infections
• Prevent Ventilator-Associated Pneumonia
Berwick 122.000 Pronovost 33.000

29. Good practices in OR, surgical unit
• look-alike, sound-alike medication names;
• patient identification;
• communication during patient hand-overs;
• performance of correct procedure at correct body site;
• control of concentrated electrolyte solutions;
• assuring medication accuracy at transitions in care;
• avoiding catheter and tubing misconnections;
• single use of injection devices;
• improved hand hygiene to prevent associated infection;
'Nine patient safety solutions’, 2007

30. Surgical checklist:
results
NEJM 360;5 nejm.org january 29, 2009
The rate of death was 1.5% before the checklist was introduced and declined to
0.8% afterward (P = 0.003). Inpatient complications occurred in 11.0% of patients at
baseline and in 7.0% after introduction of the checklist (P<0.001).

31. Certified good practices

32. Efficacy of the accreditation
process on patient safety
Efficacia dell'accreditamento studio
randomizzato che dimostra che ci sono
evidenze sulla parte organizzativa
Health service accreditation as a predictor of clinical and organisational performance: a blinded, random,
stratified study Jeffrey et al.
Qual Saf Health Care 2010;19: 14e21. doi:10.1136/qshc.2009.033928

33. The accreditation system of the
Tuscany Region
Standardization of processes with definition of main phases and quality and safety
standards:
• Surgical pathway
• Oncological/ screening pathway
• Medical pathway
• ER/ critical care pathway
• Trauma pathway
• Pediatric and obstetric pathway
• Rehabilitation pathway
• Mental Health and physical and psychological dependence pathway
Accreditation through
autocertification and random
controls

34. Good Practices 2011
2011 indicator indicator indicator
voluntary accreditation total
AOUC 0,60 3,56 4,16
AOUP 1,56 8,57 10,13 Number of applied
AOUS 0,00 9,18 9,18 patient safety
AUOM 2,23 6,97 9,87
Fond. Monasterio
practices for ecach
0,00 12,90 12,90
AUSL1 2,19 3,33 5,51 clinical unit of the
ASL2 1,05 10,13 11,18 hospital
ASL3 2,52 5,81 7,84
ASL4 1,96 3,25 5,21
ASL5 5,37 4,93 10,30
ASL6 0,00 3,48 3,48
ASL7 3,26 0,65 3,91
ASL8 2,76 7,12 9,88
AUSL9 12,03 2,81 14,84
ASL10 0,96 1,65 2,61
ASL11 0,86 8,22 9,31
ASL12 4,65 2,21 6,85

35. Balancing Patient safety culture

36. Patient safety culture in Tuscany

37. The Disclosure
Best practices
Adverse events
http://web.rete.toscana.it/vetrinaasl/servlet
Claims rate /gateway
There is a positive correlation between public disclosure and
accreditation scores
H Ito, H Sugawara Qual Saf Health Care 2005;
14:87–92. doi: 10.1136/qshc.2004.010629

38. Implications for the future
• Evaluation of the adherence of the units
involved to clinical/ organizational practices
and national recommendations already
diffused
• Standardization of processes with definition
of common safety standards throughout the
units involved
• Measure process indicators and outcome
indicators

39. Thanks for your attention!
Sara Albolino, PHD, CRM
Riccardo Tartaglia, MD, Eur-Erg
www.regione.toscana.it/rischioclinico
rischio.clinico@regione.toscana.it