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IIntegration of predictive and ntegration of predictive and retrospective risk analysis retrospective risk analysis in health carein health care
Tjerk van der Schaaf Tjerk van der Schaaf Leiden University Medical Center Leiden University Medical Center
Eindhoven University of TechnologyEindhoven University of Technology
overview
• retrospective method: PRISMA-medical• predictive method : HFMEA • 3 examples of possible integration
– direct comparison of predicted vs “actual”causes (radiotherapy)
– components combined in a Healthcare Safety Management System (convergent approach)
– evaluating major interventions (impact of IT on medication safety)
retrospective risk analysis : PRISMA- medical
• (voluntary) incident reporting and analysis
• learning from actual / reported process deviations
PRISMA-Medical
• Prevention and Recovery Information System for Monitoring and Analysis
• Three subsequent steps:– Description by means of causal trees– Classification according to the Eindhoven
Classification Model (medical version)– Determination of countermeasures by
means of the Classification/Action Matrix
Causal tree example
Wrong route
Lines at same place
Nurses not informed
Similar linesConnection
possibleInadequate
check
No protocol
Catheters not removed
No coding
O
O
T
T H
Database
• Root causes for failure failure profile
• Root causes for recovery recovery profile
• Context variables black-spot analysis
PRISMA failure profile: hospital medication errors
0
5
10
15
20
25
Pe
rce
nta
ge
(%
)
T-E
X
TD
TC
TM
O-E
X
OK
OP
OM
OC
H-E
X
HK
K
HR
Q
HR
C
HR
V
HR
I
HR
M
HS
S
HS
T
PR
F X
PRISMA category
Classification/Action Matrix
ECM code
Design: Technology/work-
place
Procedures Information and Commu
nication
Training Motiva
tion
Escala
tion
Reflection
T-EX ×
TD ×
TC ×
TM ×
O-EX ×
OK ×
OP ×
OM ×
OC ×
H-EX ×
HK_ × NO
HR_ ×
HS_ × NO
predictive risk analysis HFMEA / SAFER
• series of group meetings to build a set of failure scenario’s for a (small) process of care : what may go wrong; why; what to do about it
• pro-active appeal
Healthcare Failure Mode and Effect Analysis (HFMEA)
• A systematic approach to identify and prevent product and process problems before they occur
• Developed by the "VA National Center for Patient Safety"
(http://www.patientsafety.gov/)
Relevance of predictive risk analysis
• Retrospective (incident) analysis takes place after incidents did occur hindsight bias
• Because of underreporting, biases can arise in incident databases identification of "missing risks"
Definitions
• Failure Mode: Different ways that a process or subprocess can fail to provide the anticipated result (i.e. think of it as what could go wrong)Prescribing the wrong dose
• Failure Mode Cause: Different reasons as to why a process or subprocess would fail to provide the anticipated result (i.e. think of it as why it would go wrong)Miscalculation
HFMEA process
• Step 1: Define the topic
• Step 2: Assemble the team
• Step 3: Graphically describe the process
• Step 4: Conduct a hazard analysis
• Step 5: Identify actions and outcome measures
examples of integration (1)
• direct comparison of predicted (HFMEA) vs reported causes
• user problems with a new radiation therapy technology
• both types of failure causes expressed in the same PRISMA-medical classification (sub-)categories
PRISMA vs HFMEA : main categories
0%
10%
20%
30%
40%
50%
60%
Per
cen
tag
e
Tech Org Humanother
PRISMA main category
PRISMA
HFMEA : predicted causes
PRISMA vs HFMEA : subcategories
Frequency category HFMEAless than yearly yearly monthly weekly
Weight-factor (= translation to 9 months) 0,1 0,89 9 36
0%
17%
4%
2%
0%
3%
17%
8%
4%
0%
4% 5%
1%
13%
16%
1%1%
0%
4%
1%0%
21%
1%
4%
0%
5%
13%
33%
0% 0%
3%
0%
2%
4%
8%
2%1%
0%
3%
0%
0%
5%
10%
15%
20%
25%
30%
35%T-
EX TD TC TMO-
EX OK OP OM OCH-
EX HKK
HRQ
HRC
HRV
HRI
HRM
HSS
HST
PRF X
PRISMA category
Perc
enta
ge
PRISMA
HFMEA
examples of integration (2)
• combining retrospective and predictive components in an overall Healthcare Safety Management System
• convergent approach of two imperfect risk identification methodologies
• mutual checks, comparisons, and inputs
possible
examples of integration (2)continued
• are repeatedly predicted problems (failure modes) ever being reported?
• can frequently reported problems help to select suitable processes for HFMEA and generate realistic failure modes?
• can frequently predicted causes steer the information gathering after an initial report?
• are proposed interventions for predicted vs “reported” causes similar?
• etc…
examples of integration (3)
• developing a process-based evaluation methodology for major (patient safety) interventions
• predicting and monitoring the impact of IT on medication safety
Medication safety: definitions
Adverse drug reactions Medication error Harm
Medication error No harm
Medical error (not drug related)
Drug
Harm
Error
[Van den Bemt et al., 2000]
Medication errors: causes (1)
• Handwritten prescriptions and drug orders• Look-alike drug names• Sound-alike drugs and verbal orders• Use of abbreviations• Similar packaging and labelling• Inadequate training and supervision• Staff shortages• Overwork and fatigue
[Habraken, 2004]
IT: possibilities and problems
[Bates et al., 1995; Bates, 2000]
PrescribingPhysician order entry/ Computerised decision support
TranscribingElectronicorder transcription
DispensingRobots / Bar coding/ Automated dispensingdevices
AdministeringBar coding/ Automateddispensingdevices
MonitoringComputerisedmonitoringof adversedrug events
MedicationadministrationrecordComputerisedmedication administration record
56%
6%
4%
34%
IT: possibilities and problemsIT application PROS CONS
CPOE Legible prescriptions; no handwriting required
Possibility of substitution errors
Data entry only necessary once Failure to warn
Exchange of data is easy
Computerised decision support
Drug information Risk of low vigilance and overtrust
Patient-specific information and advice
Bar coding Ensure five "rights": right drug, right patient, right dose, right route, right time
Degraded coordination and communication
Computerised medical record
Legible prescriptions; no handwriting required
Possibility of substitution errors
Data entry only necessary once
Exchange of data is easy
[Habraken and Van der Schaaf, 2006]
Barriers to the implementation of IT
• Significant costs: technical, process redesign, and implementation and support
• Cultural obstacles: resistance to change
• Privacy and protection of (patient) data
• Lack of data standards
• Lack of (clinical) evaluation
[Habraken, 2004]
Evaluation of effects and impact of IT: PRISMA and HFMEA
• Not only outcomes of care but also the mechanisms underlying those outcomes
• Impact of IT on "error recovery " :– Detection– Diagnosis– Correction
of earlier errors / deviations
Evaluation of effects and impact of IT: PRISMA
• PRISMA can be used to obtain an insight into the behavioural mechanisms underlying medication errors
• Classification/Action Matrix enables us to predict which types of human behaviour will be influenced by IT
Evaluation of effects and impact of IT: PRISMA
ECM code
Design/ Technol
Procedures Information and Communication
Training Motivation Escalation Reflection
T-EX ×
TD ×
TC ×
TM ×
O-EX ×
OK ×
OP ×
OM ×
OC ×
H-EX ×
HK_ × NO
HR_ ×
HS_ × NO
Evaluation of effects and impact of IT: PRISMA
• IT applications would fall in two categories: "technology" and "information and communication"
• In case of improved technology reduction of skill based human errors
• In case of information and communication support reduction of knowledge based errors
• BUT: rule based human errors would not be influenced by IT
Evaluation of effects and impact of IT: PRISMA and HFMEA
• Theoretical predictions could be reinforced by predictive risk analysis, such as HFMEA
• Empirical evaluation of actual impact of IT by means of intensified incident reporting
• Comparison of causal patterns of incidents that occur before, during, and after the IT intervention
Conclusion (1)
• IT often mentioned as prerequisite for reduction of medication errors
• Results regarding effects of IT vary greatly
• Effects of IT on behavioural mechanisms are not/hardly taken into account
• PRISMA and HFMEA offer a framework for in-depth analysis of impact of IT
Conclusion (2)• Two types of predictions can be made of
expected effects of IT on error and error recovery:– Theoretical predictions by means of PRISMA– HFMEA scenario-based predictions
• Intensified incident reporting and analysis would enable a fast comparison between predicted and actual effects
• On-line corrections of implementation process could prevent actual adverse events
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