Transcript piacevoli_3

Preventing and managing
errors and adverse events
in ICU
From information to
action
Prof Quirino PIACEVOLI
Purposes of reporting
An effective reporting system is
the corner stone of safe practice
and, within a hospital or other
health-care organization, a
measure of progress towards
achieving a safety culture.
Why should individuals or health-care organization
report adverse events and errors?
If the event is reported and the
findings from the investigation are
entered in to a database, the event can
be aggregated with similar incidents to
elucidate common underlying causes.
A variety of solutions could emerge,
ranging from medical and nursing
practice standards.
Core concepts
fundamental role of patient safety reporting
systems is to announce patient safety by learning
from failures of the health care system
 reporting must be safe. Individuals who report
incidences must not be punished or suffer other illeffects from reporting
 reporting is only of value if it leads to a
constructive response.

meaningful analysis, learning and dissemination
of lessons learned requires expertise and other
human and financial resources.

Key messages
the primary purpose of patient safety
reporting system is to learn from experience

a reporting system must produce a visible,
useful response to justify the resources
expended and to stimulate reporting

the most important function of reporting
system is to use the results of data analysis and
investigation to formulate and disseminate
recommendations for system change.

What is reported
adverse events: is an injury realted to medical
management, in contrast to a complication of desease
 errors: has been defined as “the failure of a
planned action to completed as intended or the use of
a wrong plan to achieve an aim
 near miss or close call: is a serious error or
mishap that has the potential to cause an adverse
event, but fails to do so by chance or because it was
intercepted
 hazards and unsafe condition: is another way to
achieve prevention without the need to learn from an
injury

Safety Assessment Code Matrix
PROBABILITY
SEVERITY
catastrophic
major
moderate
minor
Frequent
16
12
8
4
Occasional
12
9
6
3
Uncommon
8
6
4
2
Remote
4
3
2
1
Czech Republic

Type of reporting system: Mandatory and

What is reported: reportable events

How they report: simple statistics of
voluntary reporting only for 2 years in 50
hospitals
include nosocomial infections, adverse drug
reactions, trasfusion reactions and medical
equipment failures
adverse events
Denmark

Type of reporting system: Mandatory (Act

What is reported: events resulting from

How they report: to the National database
on Patient Safety in the Danish Health Care
System from January 1th 2004)
treatment by or stay in a hospital
with the identified reports
England and Wales

Type of reporting system: the National

What is reported: any unintended or

How they report: to the National database
Reporting and Learning System (NRLS) has
been developed by the National Patients Safety
Agency (NPSA) to promote an open reporting
culture
unexpected incident that could have or did lead
to harm for one or more patients
The Netherlands

Type of reporting system: non-punitive,

What is reported: serious adverse events
How they report: by mail, fax or phone
voluntary reporting system for adverse events.
A mandatory system also exist for reporting
serious adverse events

Ireland

Type of reporting system: liability under a

What is reported: events arising as

How they report: to local risk management
Clinical Indemnity Scheme (CIS)
consequence of provision of or failure to
provide clinical care that results in injury,
disease, disability, death, near misses
personnel
Slovenia

Type of reporting system: voluntary
What is reported: sentinel events include:

How they report: to the Ministry of Health

unexpected death, major permanent loss of
function, suicide, hemolytic transfusion
reaction, surgery on a wrong patient or body
part
Sweden

Type of reporting system: mandatory
What is reported: sentinel events include:

How they report: paper format via mail or

unexpected death, major permanent loss of
function, suicide, hemolytic transfusion
reaction, surgery on a wrong patient or body
part
fax to the National Board of Health and Welfare
A DATABASE MANAGEMENT
SYSTEM FOR ADVERSE EVENTS:
AN ITALIAN EXPERIENCE
Results of the run in period
(December 1999 to December 2006)
Prof. Quirino Piacevoli
Risk Management
 A national on going project of total quality
improvement is underway in several Italian
Hospitals since 1999
 Risk Management involving both patients and
health care professionals is an important aspect
of a total quality concept in order to:
 increase the standard of care
 improve efficiency in organization
 obtain better resource allocation
 reduce legal exposure
Prof. Q. Piacevoli
Objective of clinical risk management
• To identify major risk factors in Italian
Hospitals
• To measure their frequency
• To identify causes and facilitating
conditions
• To propose realistic solutions capable of
reducing risks
Prof. Q. Piacevoli
Methodology
 Multicentre research
underway in eleven major
Italian hospitals since 1999
 Specific potential risks were indentified in a prestudy phase and classified into 6 main
categories
 An “event declaration report” was created and
staff were trained to compile the incident report
 At the end of each year all reports were certified
by auditors
Prof. Q. Piacevoli
Total events classified by main
categories
Prof. Q. Piacevoli
Total events classified by main categories
Over 61.518 reports were completed in the Italian Hospitals,
and a total of 70.213 events were recorded. 68.281 were
classified as follows
Patient
Equipment
5.462
8.876
8%
13%
Nursing
19.802
29%
Inefficiency
21.851
32%
Therapy & Treatment
Drugs
Total
4.779
7%
7.511 11%
68.281 100%
Total events by main category
35%
32%
29%
30%
25%
20%
13%
15%
10%
11%
8%
7%
5%
0%
Patient
Equipment Nursing Inefficiency Therapy
Drugs
The most frequent category is “inefficiency”; this area offers
better margin for improvement with only some minor changes
in organizational procedure
Prof. Q. Piacevoli
Total events of errors/incidents for each macro category
Trend from beginning of data collection
45%
40%
35%
30%
25%
Dic- Feb
20%
Dic-Mar
15%
Dic-Apr
10%
5%
0%
Patient
Equipment
Nursing
Inefficiency
Therapy
Drugs
The three time periods are similar and confirm the
adverse events recorded earlier
Prof. Q. Piacevoli
Total events per department
60%
OPERATING ROOM
39.535
57,9 %
ONCOLOGY AND INTERNAL MEDICINE
12.495
18,3 %
INTENSIVE CARE
7.101
10,4 %
EMERGENCY
9.150
13,4 %
TOTAL
68.281
100 %
57,9%
50%
40%
30%
18,3%
20%
10,4%
13,4%
10%
0%
OPERATING ROOM
ONCOLOGY AND INTERNAL
MEDICINE
INTENSIVE CARE
Prof. Q. Piacevoli
EMERGENCY
Total events for each department
Prof. Q. Piacevoli
Total events for
each unit
Prof. Q. Piacevoli
General Surgery
Cardio Surgery
Vascular Surgery
Haemodynamic
Breast Surgery
Ob/Gyn Surgery
TOTAL EVENTS (%) FOR EACH UNIT
EMERGENCY ROOM
I.C.U.
OPERATING ROOM
TOTAL
Neuro Surgery
Reconstructive Surgery
Orthopaedics/Trauma Surgery
Oculistic
Radiology
Paediatric
Urology
ORL
Oncology
Internal Medicine
Emergency
Anaesthesia
General surgery, followed by
Orthopaedics and Oncology, have
the highest number of risk events
Liability in Northern Europe
Total events in I.C.U. “by main category”
25%
24%
20%
18%
15%
21%
16%
14%
10%
5%
7%
0%
Patient Equipment Nursing Inefficiency Airways
Drugs
7.101 events in I.C.U.: The most frequent category is still
“inefficiency”; multiple causes are identified as 24% system-based
and 76% human factor based
Prof. Q. Piacevoli
Adverse Events:
Total data compared with I.C.U. data
35%
32%
29%
30%
25%
20%
13%
15%
10%
11%
8%
7%
5%
0%
Patient
Equipment
Nursing
Inefficiency
Therapy
Drugs
25%
24%
20%
18%
15%
21%
16%
14%
10%
7%
5%
0%
Patient
Equipment
Nursing
Inefficiency
Prof. Q. Piacevoli
Airways
Drugs
Total events breakdown in microcategories in I.C.U.
Prof. Q. Piacevoli
Total events breakdown in micro-categories in I.C.U.: Patient
Patient
%
5
Incorrect Patient identification
15
Incorrect medical record chart
Tot.
49
30
Incorrect Patient
identification
30
25
28
149
20
Mistake in medical report
21
recording/reading
Adverse drug events
Refusal of surgical procedure
Lack of adequate information to the
patient / relatives
209
Mistake in medical report
recording/reading
21
15
30
298
1
11
10
28
278
5
Adverse drug events
15
Refusal of surgical
procedure
Lack of adequate
information to the patient /
relatives
5
TOT
100
994
Incorrect medical record
chart
0
1
With the exception of “adverse drug events” which is difficult to
identify even with accurate analysis, all other events can be
managed with simple methodology in quality control
Prof. Q. Piacevoli
Total events breakdown in micro-categories in I.C.U.: Equipment
Equipment
%
Failure
37
Tot.
184
40
35
37
30
Unexpected
breakage
21
105
Accidental dropping
16
80
Misuse
23
115
N/A
3
15
25
20
Failure
Unexpected breakage
Accidental dropping
Misuse
N/A
23
21
15
10
16
5
TOT
100
498
0
3
Although corrective factors have a more limited range of action
compared to other categories, there is the opportunity to
significantly reduce risk.
Prof. Q. Piacevoli
Total events breakdown in micro-categories in I.C.U.: Equipment
Equipment
low
medium
high
very high
NS
Tot
%
Failure
48
61
30
13
32
184
37
Unexpected breakage
35
17
25
16
10
105
21
Accidental dropping
27
11
27
15
0
80
16
Misuse
89
11
0
0
15
115
23
N/A
0
0
0
0
15
15
3
Total
199
101
82
44
72
498
100
The number of events decreases when the
complexity of the equipment increases, almost as
if the level of staff attention is proportional to
complexity
Prof. Q. Piacevoli
Total events breakdown in micro-categories in I.C.U.: Equipment
Failure
90
80
Unuspected
breking
Accidental
drop
Misuse
70
60
50
40
30
N/A
20
10
0
low
medium
high
very high
N/A
%
Complexity
Prof. Q. Piacevoli
Total events breakdown in micro-categories in I.C.U.: Nursing
Nursing
Line, tube and drain
incidents
Inappropriate turn off of
alarms
Extubation / selfextubation
%
Tot.
50
45
31
12
6
396
153
77
Inadequate dressings
3
38
Accidental patient falls
1
13
Other
47
601
TOT
100
1.278
47
40
Line, tube and drain
incidents
Inappropriate turn off of
alarms
Extubation / selfextubation
Inadequate dressings
35
30
25
31
20
Accidental patient falls
15
10
Other
12
5
0
6
3
1
An in depth analysis is necessary in order to further define the
“other” category in order to decide follow up. Detailed analysis
showed the need for training in manual procedures.
Prof. Q. Piacevoli
Total events breakdown in micro-categories in I.C.U.: Inefficiency
Inefficiency
%
Tot.
Increased hospital lenght of stay
Adequate ICU staffing
Unnecessary procedure repetition
ICU beds unavailable
Difficult Team Communication
Haste
Tension levels
Examination procedures not performed for lack
of diagnostic instruments
Procedure not performed due to staff shortage
Other
25
16
15
13
10
6
4
426
272
256
221
172
85
85
2
34
1
8
100
17
136
1704
TOT
Prof. Q. Piacevoli
Total events breakdown in micro-categories in I.C.U.: Inefficiency
30
28
26
24
22
20
18
16
14
12
10
8
6
4
2
0
Increased hospital lenght of stay
Adequate ICU staffing
Unnecessary procedure repetition
25
ICU beds unavailable
Difficult Team Communication
16
Haste
15
13
Tension levels
10
8
6
4
2
1
Examination procedures not
performed for lack of diagnostic
instruments
Procedure not performed due to staff
shortage
Other
Through behaviour change and reorganization (especially in procedure
schedule) many inefficiencies can be avoided especially where due to poor
communication and organization between OR team members.
Prof. Q. Piacevoli
Total events breakdown in micro-categories in I.C.U.: Airway
Airway
%
Obstruction or
leakage of artificial
airway
41
VAP
22
Tot.
45
40
466
250
Obstruction or
leakage of artificial
airway
VAP
41
35
30
25
Inappropriate turn-off
of alarms
14
159
20
Inappropriate turnoff of alarms
22
15
Loss of artificial way
7
80
Other
16
181
TOT
100 1.136
10
5
16
14
Loss of artificial
way
Other
7
0
In the “other” category other specific problems related to the
procedure have also been included together with events already
included in other categories.Prof. Q. Piacevoli
Breakdown per micro category per total events in I.C.U.: Drugs
Drugs
%
Tot.
Mistaken Drug
Mistaken syringe
Illegible labelling
Drug unavailable
Drug past date of use
Mistaken dosage
Unauthorised use and dosage
Mistaken administration times
Mistaken route of administration
Mistaken dilution
Other
TOT
11
6
1
16
2
23
7
15
3
5
11
89
164
89
15
239
29
343
104
224
45
74
164
1.490
Prof. Q. Piacevoli
Breakdown per micro category per total events in I.C.U.:
30
Drugs
Mistaken Drug
Mistaken syringe
25
Illegible labellling
Drug unavailable
20
23
Mistaken dosage
15
10
5
0
Drug past date of use
15
16
Unauthorised use and dosage
Mistaken administration times
11
11
7
6
1
5
3
2
Mistaken route of administration
Mistaken dilution
Other
With minor intervention ie. set rules for writing, colour coded labels
and easily accessible guidelines in all departments , it is possible to
reduce most of the mistakes belonging to this category.
Prof. Q. Piacevoli
Risk Events and
patient injury
Prof. Q. Piacevoli
7.101 adverse events in I.C.U. were recorded
for a total of 68.281 events and 61.518
Risk events and patient injury
reports, including also multiple injuries;
39,4% of the risk events caused patient
injury.
Staff involved in risk reporting
Prof. Q. Piacevoli
Staff involved in risk reporting
Internist
Surgeon
Anaesthesist
Nurse
Technician
Resident
Total events
7.511
9.559
18.436
21.167
1.366
6.828
% on total
11
14
27
31
2
10
House-
ns
2.048
665
701
9.416
3
1
1
100
keeping
(*) Over 61.518 reports completed and a total of 68.281 events recorded.
Nurses,
Anaesthetists and
Surgeons seem to
be most involved in
risk events
Prof. Q. Piacevoli
Total staff
Other
involved (*)
Total events for each
macrocategory for error/
incident and time of shift
change for nursing and
medical staff
Prof. Q. Piacevoli
Total events for each macrocategory for
error/ incident and time of shift change for
nursing and medical staff
80.000
70.000
60.000
57.418
50.000
Events
Total
40.000
30.000
20.000
10.000
Shift change
4.655
1.501
1.564
0
Nurses
Doctors
7-14
8-14
14-21
14-20
21-7
20-8
N.S.
If you want one year of prosperity, plant
corn
If you want ten years of prosperity, plant
trees
If you want 100 years of prosperity,
cultivate
men
Ancient Chinese proverb
Prof. Q. PIACEVOLI