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Continuous Quality Improvement: Learning from Events
9/6/2016
Copyright ECRI Institute, 2016 1
©2016 ECRI INSTITUTE
Continuous Quality Improvement:
Learning from Events
September 8, 2016
©2016 ECRI INSTITUTE2
Action Planning Team
QI coordinator (facilitator)—Mary Beth Mitchell
Electronic health record (EHR) manager—Lee Patrick
Practice educator—Pat Stahura
Continuous Quality Improvement: Learning from Events
9/6/2016
Copyright ECRI Institute, 2016 2
©2016 ECRI INSTITUTE3
Learning Objectives
Develop action plans that are linked to identified root
causes
Develop action plans that are effective and impactful
Develop measures of effectiveness for action plans
©2016 ECRI INSTITUTE4
Root cause analysis seeks to identify systemic or
individual problems that contribute to an event
These causes go deep enough to reveal the system
issues underneath
Once root causes are identified, they point to
vulnerabilities and fixes at a systems level
The fixes at the systems level can prevent
recurrences
Systems Thinking
Continuous Quality Improvement: Learning from Events
9/6/2016
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Action Plans
A “thorough” system analysis is fruitless without
effective improvement strategies
Action plans should mitigate the risk and prevent a
reoccurrence of similar events
©2016 ECRI INSTITUTE6
Adverse Event
Root Cause
Root Cause Root CauseRoot
Cause
Action ActionAction ActionAction
Causal FactorCausal Factor Causal Factor Causal Factor
Action
Root Cause
Root Cause
Root Cause
Action Action
Action
Adapted from Vanden Heuvel et al. Root cause analysis
handbook. 3rd ed. Houston (TX): ABS Consulting; 2008.
Actions Should Be Tied Directly to Causal
Factors and Underlying (Root) Cause
Continuous Quality Improvement: Learning from Events
9/6/2016
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Adverse Event
Root Cause
Root Cause Root CauseRoot
Cause
Action ActionAction ActionAction
Causal FactorCausal Factor Causal Factor Causal Factor
Action
Root Cause
Root Cause
Root Cause
Action Action
Action
Recognition of abnormal sinus CT
scan report delayed
Radiology report sent to ordering
physician’s inbox but she was on
vacation
Dr. trained that in her absence test
results would default to assigned
covering provider’s inbox to follow up
Sinus CT scan report did not
automatically default to
assigned covering provider
Following the last EHR upgrade,
the automatic default
malfunctioned
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Developing an Action Plan:
A Basic Three-Step Process
Develop at least one action for each root cause
Track action plans: who, what, when, where, how
Follow-up to make sure action plans have been implemented completely, correctly, and in a timely manner
Continuous Quality Improvement: Learning from Events
9/6/2016
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Case Scenario Dr. Smith sees a female patient with complaints of nasal
congestion and watery eyes. Dr. Smith prescribes Flonase
nasal spray and orders a sinus CT scan
When ordering the prescription in the EHR, she types
“FLO” in the medication order screen and the EHR
automatches Flomax, a medication for an enlarged
prostate that is not approved by the Food and Drug
Administration for women
Without noticing the error, Dr. Smith selects the incorrect
medication
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Case Scenario (cont.)
The patient fills the prescription and takes it as directed
Flomax also has a side effect of hypotension. Several
days after beginning the medication, the patient presents
to the emergency department (ED) with dizziness and the
error is discovered
Continuous Quality Improvement: Learning from Events
9/6/2016
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Case Scenario (cont.)
The patient returns to the health center as directed by
the emergency room
Dr. Smith examines the patient
Results of sinus CT scan are not available
Dr. Smith leaves for vacation
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Case Scenario (cont.)
Radiology calls the health center with abnormal CT
results
Receptionist writes the telephone report down and places
in Dr. Smith’s inbox
Results of abnormal sinus CT scan are also emailed to Dr.
Smith’s portal. Assigned covering provider for Dr. Smith is
unaware CT results are pending for the patient
Delayed follow-up to the CT scan report for a sinus mass;
rule-out squamous cell carcinoma
Continuous Quality Improvement: Learning from Events
9/6/2016
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Root Causes
1. Protocols or systems were not developed to require
verification of prescriptions to intended medications
before sending prescription to the pharmacy
2. Abnormal CT scan report did not automatically drop into
the assigned covering provider’s inbox during Dr. Smith’s
absence (automatic default malfunctioned)
©2016 ECRI INSTITUTE14
Developing Action Plans: Using Evidence
When looking to redesign your process to correct causes
and mitigate hazards, look to best practices and
established science from sources such as:
■ Professional, regulatory, and accreditation bodies
■ Recognized subject matter experts
■ Peer-reviewed/refereed literature
■ National/regional practice standards
14
Continuous Quality Improvement: Learning from Events
9/6/2016
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Root Cause #1
Protocols or systems were not developed to require
verification of prescriptions to intended medications before
sending prescription to the pharmacy
■ American Health Information Management Association.
Best practices in electronic health records:
http://library.ahima.org/PdfView?oid=67876
■ American Academy of Family Physicians. Workflow &
redesign for EHR: http://www.aafp.org/practice-
management/health-it/product/workflow-redesign.html
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Root Cause #1 (cont)
■ Office of the National Coordinator for Health
Information Technology, HHS. How to implement
EHRs: https://www.healthit.gov/providers-
professionals/ehr-implementation-steps/step-1-
assess-your-practice-readiness
■ American Medical Association. Error-proofing your
office: rules and protocols to help reduce risk:
http://www.amednews.com/article/20040112/profe
ssion/301129964/4/
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9/6/2016
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Root Cause #2
Following the last EHR upgrade, automatic default did not
function as anticipated and was not reported
■ SAFER Guides to Improve EHR System
https://www.healthit.gov/safer/
■ Massachusetts Coalition for the Prevention of Medical
Errors (MA Coalition). Build reliability into the system
[online]. [cited 2011 May 24]. Available from Internet:
http://www.macoalition.org/Initiatives/CCTRDiscussio
n3.shtml
■ White B. Four principles for better test-tracking. Family
Practice Management 2002 Jul/Aug:41-4.
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Creating Impactful Action Plans
Continuous Quality Improvement: Learning from Events
9/6/2016
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Hierarchy of Action Plan Strategies
High/strong
• Best strategy for removing dependence on the human to “get it right” (these strategies are physical and permanent, rather than procedural and temporary)
Medium/ intermediate
• Reduces reliance on the human to get it right, but does not fully control for human error
Low/weak
• Supports/clarifies the process, but relies solely on the human. These actions do not necessarily prevent the event/cause from occurring
Sources: VA National Center for Patient Safety, U.S. Department of
Veterans Affairs. Root cause analysis tools. 2015 Feb 26.
http://www.patientsafety.va.gov/docs/joe/rca_tools_2_15.pdf;
National Patient Safety Foundation. RCA2: Improving root cause
analyses and actions to prevent harm. Version 2. 2016 Jan.
http://www.npsf.org/?page=RCA2
©2016 ECRI INSTITUTE20
Low/ weak
•Document
•Education/information
•Rules and policies
•“Be more careful”
•Warnings and labels
•Double checks
Strength of Strategy: Low-Impact
Measures
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9/6/2016
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Medium/ intermediate
•Use checklists/cognitive aids
•Standardize to reduce process variability
•Minimize choices
• Increase detectability
•Optimize redundancy
•Train with simulation
•Standardize communication tools
Strength of Strategy: Medium-Impact
Measures
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High/strong
•Simplify the process
•Automate
• Incorporate forcing functions/engineering controls
• Incorporate fail-safe mechanisms
•Tangible involvement by leadership
•Architectural/physical plant changes
Strength of Strategy: High-Impact
Measures
Continuous Quality Improvement: Learning from Events
9/6/2016
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Example: Incorrect Medication
Prescribed in EHR
Problem #1: The prescribing physician did not double-
check the prescription she ordered for accuracy
Root cause: Protocols and systems were not developed to
require verification of prescriptions to intended
medications before sending prescription to the pharmacy
©2016 ECRI INSTITUTE24
Action Plan Example
Problem #1: The prescribing physician did not double-
check the prescription she ordered for accuracy
Actions:
■ High impact—Hardwired pop-up requires the physician
to verify that the prescription has been matched
against the intended medications before sending the
prescription to the pharmacy
■ Medium impact—Updated protocol requires the
provider to verify and document that the prescribed
medications are correct
■ Low impact—Office-wide education on updated
protocols
Continuous Quality Improvement: Learning from Events
9/6/2016
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Example: Abnormal Sinus CT Report Delayed
Problem # 2 Abnormal CT scan report did not
automatically drop into the assigned covering provider’s
inbox during Dr. Smith’s absence
Root cause: Following the last EHR upgrade, automatic
default did not function as anticipated and was not
reported
©2016 ECRI INSTITUTE26
Action Plan Example
Problem #2: Abnormal CT scan report did not automatically
drop into the assigned covering provider’s inbox during Dr.
Smith’s absence
Actions:
■ High—Schedule IT to make the necessary changes in the
EHR to ensure that the problem with automatic default is
fixed; investigate EHR tracking system to address issue
■ Medium impact—Change the process for front desk and
clinical staff on how to handle results and who to contact
when provider is not in the building
■ Low impact—Educate providers and staff to “hand off” to
covering providers
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9/6/2016
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Creating Sustainable Action Plans
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Model of Sustainability for Action Plans
High
Moderate
Medium
Low
Low Medium Moderate High
28
• Document
• Educate or train
• Implement policies
• Simplify the process
• Standardize to reduce process variability
• Minimize choices
• Increase detectability
• Optimize redundancy
• Automate
• Incorporate forcing functions
• Incorporate fail-safe mechanisms
Adapted from Hettinger et al. An evidence-based toolkit for
the development of effective and sustainable root cause
analysis safety system solutions. J Healthc Risk Manag
2013;33(2):11-20.
EFFECTIVENESS
Sustainability
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9/6/2016
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Model of Sustainability for Action Plans
High
Moderate
Medium
Low
Low Medium Moderate High
29
Educate the staff on a new protocol
Implement a new protocol with compliance
requirements
Adapted from Hettinger et al. An evidence-based
toolkit for the development of effective and
sustainable root cause analysis safety system
solutions. J Healthc Risk Manag 2013;33(2):11-20.
EFFECTIVENESS
Sustainability
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Test Drive First: Use PDCA Model
(Plan, Do, Check, Act)
Remember, with a new
process comes new
inherent risks
Look to see how your
changes affect other
processes, not just the one
you redesigned!
Plan
DoCheck
Act
Don’t jump the gun!
Continuous Quality Improvement: Learning from Events
9/6/2016
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PDCA
Plan—The action plan items
Do—Implement the action items
Check—Check to see if intended outcomes are occurring
Act—Make changes in the action plan or continue full
implementation without changes
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Developing Measures of Effectiveness
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9/6/2016
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Measures of Effectiveness
Measurement sometimes looks like “just more work”
Assists with ensuring the new process is occurring as
planned
Measures for the intended outcome
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Measures of Effectiveness (cont)
Process measure: The extent to which a new process
is in place
■ It is how you know that the action is actually taking
place
Outcomes measure: Net change in health status of
designated population
■ Measures the effectiveness of the
recommendation—achieving the overall aim
(outcome)
Continuous Quality Improvement: Learning from Events
9/6/2016
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Measures of Effectiveness Will Contain:
•What is being measured for improvement?
Numerators
•Out of what population/total group is the numerator being sampled?
Denominators
•What is the realistic expected level of compliance (percent)/result of the numerator?
Threshold/target/goal
•How long will it be measured?Timeframe
©2016 ECRI INSTITUTE36
Measure of Effectiveness for Prescription
Verification
Process measure: # times prescription verification box is
checked by the provider/# prescriptions ordered (current)
Outcome measure: # providers and staff attending
education on updated protocol/# health center staff and
providers (retrospective)
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Measure of Effectiveness for Test
Report Tracking
Process measure: # reported malfunctions/# EHR
upgrades (current)
Outcome measure: # reports not automatically dropped
to covering physician/# reports received by health center
(retrospective)
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Designing the Data Collection
Did you define the data so that you get the
intended outcome? Is it based on best
practice?
Who is collecting the data? Does your
collection strategy work?
Where will you report the data?
Who will give input to see if the actions need
to be revised based on the measures of
effectiveness?
What is your target or goal?
Continuous Quality Improvement: Learning from Events
9/6/2016
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Assigning an Individual to Implement the
Action Plan
The individual must have the authority to effect change
Assigning committees or multiple individuals dilutes
accountability for the action
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Sample Action Tracking Sheet
40
Root causes Preventive
actions
Action
strength
Responsible
party/
due date
Measure of
effectiveness
(process,
outcome)
High
Moderate
Low
High
Moderate
Low
High
Moderate
Low
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9/6/2016
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Sample Action Tracking SheetRoot causes Preventive actions Action strength Responsible
party/
due date
Measure of
effectiveness
(process,
outcome)
Protocols and systems
were not developed to
require verification of
prescriptions to
intended medications
before sending
prescription to the
pharmacy
Hardwired pop-up
requires physician to
verify that the
prescription has been
matched against the
intended medications
before sending the
prescription to the
pharmacy
■ High
□ Moderate
□ Low
Lee Patrick—
information
technology
manager
12/31/2016
Report of the # or %
of matches verified /
# prescriptions sent
to the pharmacy
Update protocol to require
provider verify the
prescribed medications
are correct by clicking on
the check box in the EHR
□ High
■ Moderate
□ Low
Pat Stahura—
practice educator
11/15/2016
# times prescription
verification box is
checked in EHR/ #
e-prescriptions
Office-wide education on
updated protocol
□ High
□ Moderate
■ Low
Pat Stahura—
practice educator
11/15/2016
# providers and staff
attending education
on updated protocol/
# health center
providers and staff
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Sample Action Tracking SheetRoot causes Preventive actions Action strength Responsible
party/
due date
Measure of
effectiveness
(process, outcome)
Following the last EHR
upgrade, automatic
default malfunctioned
and was not reported
Schedule IT to make the
necessary changes in the
EHR to ensure that the
break is fixed
■High
□Moderate
□Low
Lee Patrick—
information
technology manager
12/31/2016
# malfunctions reported
by IT/ # EHR upgrades
Change the process for
front desk and staff to
date and time telephone
report received. Provider to
date and time telephone
report received
□High
■Moderate
□Low
Pat Stahura—
practice educator
12/1/2016
# date and time
telephone reports
received by front desk
and staff/# telephone
reports AND
# date and time
telephone reports
received by providers/
#telephone reports
Educate providers and
staff to “hand off” to
covering providers
□ High
□ Moderate
■ Low
Pat Stahura—
practice educator
12/1/2016
# providers and staff
attending in-service/
# health center staff
and providers
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9/6/2016
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Evaluation of Actions
What will be the frequency of measurement/data collection?
What methods will be used?
■ Chart audits/record reviews?
■ Direct observations?
■ Surveys?
■ Incident reports?
How long will this be monitored?
Determine numerators and denominators
Determine the threshold of expected compliance
Where will the data be reported?
Source: Bagian et al. Improving RCA performance: the Cornerstone Award and
the power of positive reinforcement. BMJ Qual Saf 2011 Nov;20(11):974-82.
http://qualitysafety.bmj.com/content/20/11/974.full.pdf+html
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Action item Compliance
rate
(month)
Target Goal Recommendations Responsibility/
due date
Hardwired pop-up requires physician to
verify that the prescription has been
matched against the intended medications
before sending the prescription to the
pharmacy
100%
Update protocol to require provider to verify
the prescribed medications are correct and
document the verification
100%
Office-wide education on updated protocol 100%
Schedule IT to make the necessary changes
in the EHR to ensure that the malfunction is
fixed
100%
Change the process for front desk and staff
to date and time telephone report received.
Provider to date and time telephone report
received
100%
Educate providers and staff to “hand off” to
covering providers 100%
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Action Checklist
Do the actions meet the following criteria?
■ Has leadership support and approval
■ Addresses the root cause and contributing factors
■ Staff have provided feedback on whether action items
make sense to them
■ Are specific, concrete, and measurable
■ Anyone can understand and implement
■ Will be tested prior to implementation when feasible
■ Are based on conclusions from data collected during
the investigation
■ Implemented in all applicable areas of the
organization Adapted from VA National Center for Patient Safety, U.S. Department of Veterans Affairs. Root
cause analysis tools. 2015 Feb 26. http://www.patientsafety.va.gov/docs/joe/rca_tools_2_15.pdf;
and National Patient Safety Foundation. RCA2: Improving root cause analyses and actions to
prevent harm. Version 2. 2016 Jan. http://www.npsf.org/?page=RCA2
©2016 ECRI INSTITUTE46
Reference
American Health Information Management Association
(AHIMA). Integrity of the healthcare record: best practices
for EHR documentation (2013 update):
http://library.ahima.org/doc?oid=300257#.V5jrL-RTHIU
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9/6/2016
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2016 FTCA Risk Management Virtual
Conference Wrap-Up
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Event Scenario: Conclusion
After receiving counseling through the employee
assistance program, targeted education on health center
policies and conduct, and assistance from Dr. Mary
Downs with time management, Dr. Smith’s behavior
improves:
■ Follow-up performance reviews indicate improvement
in all low-scoring areas and improved compliance with
policies
■ No complaints are submitted by patients or colleagues
from February 2015 through September 2016
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9/6/2016
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Event Scenario: Conclusion
Anytown Health Center implemented action plans:
■ Updated protocol requires the provider to verify the
prescribed medications are correct and document the
verification (medium impact) and conducted staff
training on the updated protocol (low impact)
■ Changed process to on how to handle results (medium
impact) and educate on how to “hand off” (low)
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Event Scenario: Conclusion
While implementing the low- and medium-impact actions,
Anytown Health Center worked with its EHR vendor to
make changes to the system (high impact)
During the next round of EHR updates, new safeguards
were implemented (i.e., pop-up requiring the physician to
verify prescription before sending to the pharmacy) (high
impact)
Scheduled IT to make changes in the EHR to ensure that
the problem with automatic default is fixed (high impact)
There were no further incidents of delayed recognition of
abnormal CT scans or incorrect medication orders
Continuous Quality Improvement: Learning from Events
9/6/2016
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