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Medication Safety Initiative Model
Rod Hicks, MSN, MPA
United States Pharmacopeia
Notes Available
Four Stages of a Medication Safety Initiative Model
„
„
„
„
Stage one
− Environment/culture
Stage two
− Data collection
Stage three
− Data analysis
Stage four
− Assessing impact of actions taken
3
USP Medication Safety Program Model for Hospitals
„
USP medication safety program model for hospitals and
health care systems
ENVIRONMENT/
CULTURE:
FACILITIES
AND HEALTH
CARE PROVIDERS
Assess Effectiveness
(information, dissemination strategies, and interventions)
Mechanisms
of Error
Identification
COLLECTION
• Spontaneous
reporting
• Direct
observation
• Retrospective
chart review
• Triggers
• Who reports?
• How to report?
• What data?
• Potential
reporting
incentives/
deterrents
Effective Methods to Disseminate
data
information
usefulness
Data
Elements
Communication
ANALYSIS
Types of analyses
• Coding
• Counting
• Sorting
• Trending
• Signals
• Data mining
• Process mapping
• Root cause analysis
• Failure mode effects
and criticality
analysis
Identify risks
Informing staff and patients
Improve safety
Reduce injury
Change delivery systems
IMPACT
• Formats of
information
• Recipients of
information
• Targeted
messages and
alerts
Document Impact
Study of: Cost of medication errors
Cost to implement interventions
Cost of outcomes
4
USP Medication Safety Program: Stage 1
„
USP medication safety program model for hospitals and
health care systems
ENVIRONMENT/
CULTURE:
FACILITIES
AND HEALTH
CARE PROVIDERS
Assess Effectiveness
(information, dissemination strategies, and interventions)
Mechanisms
of Error
Identification
COLLECTION
• Spontaneous
reporting
• Direct
observation
• Retrospective
chart review
• Triggers
• Who reports?
• How to report?
• What data?
• Potential
reporting
incentives/
deterrents
Stage 1
Effective Methods to Disseminate
data
information
usefulness
Data
Elements
Communication
ANALYSIS
Types of analyses
• Coding
• Counting
• Sorting
• Trending
• Signals
• Data mining
• Process mapping
• Root cause analysis
• Failure mode effects
and criticality
analysis
Identify risks
Informing staff and patients
Improve safety
Reduce injury
Change delivery systems
IMPACT
• Formats of
information
• Recipients of
information
• Targeted
messages and
alerts
Document Impact
Study of: Cost of medication errors
Cost to implement interventions
Cost of outcomes
5
Become a High Reliability Organization (HRO)
„
„
„
„
„
Establish a non-punitive culture
Strive for a high rate of error detection (Detection Sensitivity
Level)
Conduct data analysis
Disseminate findings—seek staff feedback
Take action
Agency for Healthcare Research and Quality. (2001). Making healthcare safer:
A critical analysis of patient safety practices (pp. 451–462). Evidence Report/
Technology Assessment No. 43, AHRQ Publication No. 01-E058.
6
Detection Sensitivity Level (DSL)*
„
„
„
The number of events reported is an indication of the
organization’s detection sensitivity level
Higher reporting = higher DSL
Lower reporting = lower DSL
* Kaplan, H. S., Battles, J. B., et al. (1998). Identification and classification of the
causes of events in transfusion medicine. Transfusion, 38, 1701–1781.
7
Relationship between Accidents and Near Misses
Sentinel Events (G, H, I; n = 138)
Harmful Errors
(E, F; n = 3,419)
Non-harmful Errors
(B, C, D; n = 195,579)
Potential Errors
(A; n = 37,023)
Adapted from: Heinrich, H. (1941). Industrial accident prevention: A scientific approach. McGraw-Hill: New York and London.
8
Estimating Your DSL
„
„
„
Error rates range from 6–20%*
Therefore, a 200-bed hospital with an average occupancy rate
of 50% has roughly 36,500 patient days per year
At a 6% error rate, there would be:
− 2,190 error events per year
− 182 error events per month
− 6 error events per day
* ADE Prevention Study Group. (1995). JAMA, 274, 29–34.
9
Estimating Your DSL (cont.)
„
Using an overall harm rate of 2%* there would be:
− 44 harmful events per year
− 3.6 harmful events per month
* Based on the average rate of harm for reports submitted to USP’s MedMARx
program for the four-year period 1999–2002
10
Resources for Improving Organizational Safety Culture
„
„
Safety Climate Survey
− www.qualityhealthcare.org
− www.mers-tm.net/support/Marx_Primer.pdf
− AHRQ: The Safety Climate Survey
www.psnet.ahrq.gov/resource.aspx?resourceID=1438
Involving patients in safety activities
− Dana-Farber Cancer Institute www.danafarber.org
− National Patient Safety Foundation www.npsf.org
− Institute for Family-Centered Care
www.familycenteredcare.org
11
Guide to Just Decisions about Behavior
Disciplined
Intentionally
causes harm;
or tampers
with error
reporting
process
Reckless or
intentional
disregard
for
patient
safety
GRAY AREA
Blame-free
Near miss Carelessness Employee
Employee
Repeatedly
Failure to
or error
in providing made error made error
violates
participate occurred due
patient
in judgment by incorrectly
hospital
in patient
to minor
care or
when no
interpreting
policies,
safety
deviation
adherence
policy or
ambiguous
processes or
initiative
from process
to policy
process
policy or
standards
or policy
or process
in place
process
Employee
made error
while
following
hospital
policy or
process
Key “Gray Area” Questions
1. Was the act or omission reckless?
2. Was the act or omission repeated or very similar to others?
3. Did the act or omission undermine patient safety initiatives?
Notes Available
12
USP Medication Safety Program Model: Stage 2
„
USP medication safety program model for hospitals and
health care systems
ENVIRONMENT/
CULTURE:
FACILITIES
AND HEALTH
CARE PROVIDERS
Assess Effectiveness
(information, dissemination strategies, and interventions)
Mechanisms
of Error
Identification
COLLECTION
• Spontaneous
reporting
• Direct
observation
• Retrospective
chart review
• Triggers
Data
Elements
• Who reports?
• How to report?
• What data?
• Potential
reporting
incentives/
deterrents
Stage 2
Effective Methods to Disseminate
data
information
usefulness
Communication
ANALYSIS
Types of analyses
• Coding
• Counting
• Sorting
• Trending
• Signals
• Data mining
• Process mapping
• Root cause analysis
• Failure mode effects
and criticality
analysis
Identify risks
Informing staff and patients
Improve safety
Reduce injury
Change delivery systems
IMPACT
• Formats of
information
• Recipients of
information
• Targeted
messages and
alerts
Document Impact
Study of: Cost of medication errors
Cost to implement interventions
Cost of outcomes
13
Stage 2: Improving Data Collection—Helpful Tools
„
„
Error report form template
− Defines key/essential data elements in the reporting
program
− “Gatekeeper” role (e.g., medication safety officer)
National Coordinating Council for Medication Error Reporting
and Prevention (NCC MERP) error category taxonomy and
algorithm
14
USP Medication Safety Program Model: Stage 3
„
USP medication safety program model for hospitals and
health care systems
ENVIRONMENT/
CULTURE:
FACILITIES
AND HEALTH
CARE PROVIDERS
Assess Effectiveness
(information, dissemination strategies, and interventions)
Mechanisms
of Error
Identification
COLLECTION
• Spontaneous
reporting
• Direct
observation
• Retrospective
chart review
• Triggers
• Who reports?
• How to report?
• What data?
• Potential
reporting
incentives/
deterrents
Effective Methods to Disseminate
data
information
usefulness
Data
Elements
Communication
ANALYSIS
Types of analyses
• Coding
• Counting
• Sorting
• Trending
• Signals
• Data mining
• Process mapping
• Root cause analysis
• Failure mode effects
and criticality
analysis
Identify risks
Informing staff and patients
Improve safety
Reduce injury
Change delivery systems
IMPACT
• Formats of
information
• Recipients of
information
• Targeted
messages and
alerts
Stage 3
Document Impact
Study of: Cost of medication errors
Cost to implement interventions
Cost of outcomes
15
Stage 3: Analysis
„
„
„
Why do it?
− JCAHO standard PI.2.10—“Data are systematically
aggregated and analyzed”
What/how to do it?
− Using tables, bar graphs, cross tabs
Setting priorities and thresholds
16
USP Medication Safety Program Model: Stage 4
„
USP medication safety program model for hospitals and
health care systems
ENVIRONMENT/
CULTURE:
FACILITIES
AND HEALTH
CARE PROVIDERS
Assess Effectiveness
(information, dissemination strategies, and interventions)
Mechanisms
of Error
Identification
COLLECTION
• Spontaneous
reporting
• Direct
observation
• Retrospective
chart review
• Triggers
• Who reports?
• How to report?
• What data?
• Potential
reporting
incentives/
deterrents
Effective Methods to Disseminate
data
information
usefulness
Data
Elements
Communication
ANALYSIS
Types of analyses
• Coding
• Counting
• Sorting
• Trending
• Signals
• Data mining
• Process mapping
• Root cause analysis
• Failure mode effects
and criticality
analysis
Identify risks
Informing staff and patients
Improve safety
Reduce injury
Change delivery systems
IMPACT
• Formats of
information
• Recipients of
information
• Targeted
messages and
alerts
Stage 4
Document Impact
Study of: Cost of medication errors
Cost to implement interventions
Cost of outcomes
17
Stage 4: Assessing Impact of Actions Taken
„
„
„
„
„
JCAHO standard PI.3.0 (3.1 and 3.2)
Determining what and how to disseminate
Formats of information
− How do you disseminate? (memo, meeting, bulletin
board, narrative vs. charts/graphs)
Recipients of information
− Unit-specific vs. institution?
− Patient safety committee, P & T, all managers, all staff?
Trending to assess impact of actions taken
18