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AVOID BAND-AID SOLUTIONSStrengthening Adverse Event Investigations
Presenters:Mary Ludlum
Melissa ParkertonLynn Trexler
OUR MISSION
Reduce the risk of serious adverse events occurring in Oregon’s
healthcare system and encourage a culture of patient safety
Who We Are
• Separate from regulatory agencies• 17-member board appointed by Governor and
confirmed by Legislature (representing diverse healthcare interests, including consumers)
• Funded by fees assessed on Oregon healthcare organizations, state general funds, and grants supporting mission-appropriate work
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Early Discussion and Resolution
Patient Safety Reporting Program
Quality Improvement and Disseminating Best Practices
Improve patient safety by reducing the risk of serious adverse events occurring in Oregon’s healthcare system and
by encouraging a culture of patient safety (§442.820)
Oregon Patient Safety Commission
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What motivates your patient safety work?
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Today’s Objectives
• Review basics of patient safety and adverse events• Demonstrate how to collect and organize the facts • Identify system-level contributing factors using
cause-effect diagram• Identify root causes using the 5 Whys• Develop strong, system-level action plans• Use PDSA and Model for Improvement for
implementation strategies
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BASICS OF PATIENT SAFETY AND ADVERSE EVENTS
Melissa Parkerton
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How many preventable deaths are happening just in hospitals each year?
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Preventable Deaths
1999 44,000 – 98,000Kohn, L. T., Corrigan, J., & Donaldson, M. S. (2000). To err is human: Building a safer health system. Washington, D.C: National Academy Press.
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2003 210,000 – 400,000James, J.T. (2013). A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. Journal of Patient Safety, 9(3): 122-128.
2016 250,000Makary, M.A. (2016). Medical error—the third leading cause of death in theUS. BMJ, 353(i2139).
“…safety issues are far more complex—and pervasive—than initially appreciated.”National Patient Safety Foundation. (2015). Free from Harm: Accelerating Patient Safety Improvement Fifteen Years After To Err is Human.
Adverse Events
An event resulting in unintended harm or creating the potential for harm that is related to any aspect of a patient's care (by an act of commission or omission) rather than to the underlying disease or condition of the patient. Adverse events may or may not be preventable.
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Systems Approach
Individual Blame and Shame
Systems ApproachFocus on human factors engineering(e.g., design of protocols, processes)
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James Reason’sSwiss Cheese Model
13
Sources: Skybrary; Institute for Healthcare Improvement
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Some holes due to active failures and others are due to latent conditions
Successive layers of defenses, barriers, and safeguards
Unsafe Acts
An action doesn’t go as intended (an inadvertent, unconscious lapse when performing an automatic process)
An action goes as intended but is the wrong one (a result from incorrect choices due to lack of knowledge, experience or training)
Little problems that crop up in our daily routine become so familiar that we start assuming they’re completely normal
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Slip
Mistake
Normalized Deviance
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Culture of Safety
Culture of safety: the attitudes, perceptions, and values that employees share in relation to safetyCharacteristics of a strong culture of safety: • Psychological safety. Concerns openly received and respected• Active leadership. Leaders create environment where all staff
are comfortable expressing their concerns• Transparency. Patient safety problems aren’t swept under the
rug; organizations learn from problems to improve the system• Fairness. People know they will not be punished or blamed for
system-based errors
Source: Institute for Healthcare Improvement
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AHRQ Surveys on Patient Safety Culture
• Ambulatory surgery center survey• Community pharmacy survey• Hospital survey • Nursing home survey
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What is a Root Cause Analysis (RCA)?
• A structured team process to identify the underlying cause(s) that increase the likelihood of errors within a process
• Also called systems analysis (Agency for Healthcare Research and Quality) or Comprehensive Systematic Analysis (The Joint Commission)
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Why a RCA?
To determine…
• What happened• Why it happened• What changes need to be made
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CONDUCTING REVIEWS:TIMELINE, CAUSE-EFFECT DIAGRAM, CONTRIBUTING FACTORS
Lynn Trexler
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What Should I Review?
• Any unanticipated, usually preventable event that results in patient harm
• Any serious adverse events that result in patient death or serious injury
• Specific event type lists for each reporting entity are available on OPSC’s website (e.g., surgical events, device events, retained objects, falls, and medication errors)
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Prioritizing Reviews
• Aggregated review of similar, high frequency close call events• E.g., falls or medication events can be reviewed
quarterly to identify themes and potential system fixes
• Safety Assessment Code (SAC) Matrix• Allows you to assign a numeric scores based on the
probability and severity of an event• Evaluates what actually happened as well as worst
case scenarios based on potential harm
http://www.npsf.org/?page=RCA2
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SAC Numeric Scores
Probability• Frequent. likely to occur
immediately or within a short period of time (may happen several times in the next year)
• Occasional. Probably will occur (may happen several times in 1 to 2 years)
• Uncommon. Possible to occur (may happen sometime in 2 to 5 years)
• Remote. Unlikely to occur (may happen sometime in the next 5 to 30 years)
Severity• Catastrophic. Actual or potential
death or major permanent loss or function
• Major. Actual or potential permanent lessening of bodily function
• Moderate. Actual or potential increase length of stay or level of care
• Minor. No injury, nor increased length of stay or level of care
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SAC Matrix
• A score of 3 (highest risk) warrants review, whereas scores of 1 (lowest risk) or 2 (intermediate risk) are not mandated
• Catastrophic events are always a “3” and therefore reviewed
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Care Delay Event
Severity = catastrophicProbability = frequentScore = 3
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Surgery/Procedural Event
Severity = moderateProbability = frequentScore = 2
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Step 1: Gather the Data
• Interview those involved including patient/resident or family members and staff • Use open ended questions (e.g., “Please tell me, from your
perspective, what happened before you fell or before you received the wrong medicine?)
• Listen to their story
• Pictures or drawings of the scene or inspections of the environment
• Relevant policies or procedures• Devices, supplies or equipment involved
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System versus Individual Causes
KnowledgeUnderstandingBehavior
ProcedurePracticeProcesses
Individual
System
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Step 2: Select the Review Team
• Select review team members with personal knowledge of the processes and systems involved in the event as well as those who will need to be engaged in the action plan
• Focus away from individuals (who did it) to the system (how/why/where)
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Review Team
• Patient representative• Direct care staff• Nurse(s)• Management• Providers• Rehab staff/social services/nutrition• Pharmacist
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Review Team Considerations
• Able to discuss and review what happened in an objective and unbiased manner
• Keep the number of management or supervisory individuals to a minimum so staff feel comfortable speaking up
• Clarify that the discussion is confidential and information shared is not punishable
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Step 3: Describe What Happened
Collect and organize the facts surrounding the event to understand what happened
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Mike’s Story
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Mapping Out Your Timeline
Recovering from
anesthesia
Ready for discharge
Trying to get dressed Mike falls
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Mike’s Perspective
I was done with my
surgery and I was ready to
go home
I was sitting in a chair and
the nurse said to get
dressed
I needed to pull up my
pants
I fell when I stood up
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Nurse’s Perspective
I reviewed the discharge
packet with Mike and his wife; his wife
went to get the car and Mike needed to get
dressed
Mike wanted privacy getting
dressed, so I told him not to
stand up because he might fall
I heard Mike holler when I
was getting my other patient ready to go
Mike falls
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Administrator’s Perspective
Mike was a frequent and
familiar patient so assumed he
and his wife knew the drill and that this nurse could assume care for
an additional patient
Other nurse assigned to this
unit had to leave early due to sick child; this nurse
took over care of other patient
ready for discharge
This nurse left Mike unattended Mike falls
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What Should Have Happened?
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Patient assessed to be ready for
discharge
RN assists patient to get
dressed
Family member goes
to get car
RN takes patient to car
Patient assessed to be
ready for discharge
RN instructs patient to get dressed and
leaves unattended
Family member goes
to get carPatient falls
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Step 4: Identify Contributing Factors
• Communication• Device or Supply• Human and Environmental• Organizational• Policy or Procedure• Patient/Resident Management
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Mike’s Perspective
I was done with my
surgery and I was ready to
go home
I was sitting in a chair and
the nurse said to get
dressed
I needed to pull up my
pants
I fell when I stood up
Miscommunication
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Nurse’s Perspective
I reviewed the discharge
packet with Mike and his wife; his wife
went to get the car and Mike needed to get
dressed
Mike wanted privacy getting
dressed, so I told him not to
stand up because he might fall
I heard Mike holler when I
was getting my other patient ready to go
Mike falls
Clarity of policy and procedure and patient
assessment
Personnel stress (caring for 2
patients)
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Administrator’s Perspective
Mike was a frequent and
familiar patient so assumed he
and his wife knew the drill and that this nurse could assume care for
an additional patient
Other nurse assigned to this
unit had to leave early due to sick child; this nurse
took over care of other patient
ready for discharge
This nurse left Mike unattended Mike falls
Assignment/work allocation Staffing levels
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Picture of the Area
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Cause-Effect Diagram
Patient fell while
getting dressed
Human or Environmental
Patient ManagementPolicy/ProcedureOrganizational
Communication Device/Supply
Patient
Assignment/work allocation
Staffing levels
Work area design
Personnel stress
Patient assessmentClarity of P & P
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Charlie’s Story
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Charlie’s Story: Timeline
Exercise: 20 minutes• Read Charlie’s Story• Plot out the timeline • Identify the contributing factors
Recovering from
anesthesia
Ready for discharge
Trying to get dressed Mike falls
Miscommunication
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CONDUCTING REVIEWS:5 WHYS, ROOT CAUSE, CAUSE/EFFECT STATEMENTS
Mary Ludlum
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5 Whys
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Why did event happen?Because of situation/circumstance A
Why A?Because of factor B
Why…B?Because of factor C
Why C?Because of factor D
Why D?…………until root cause is reached
5 Whys (cont’d)
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Why did you get a flat tire?Because I ran over nails on the garage floor.
Why did you run over nails on the garage floor?Because the box of nails on the shelf was wet; the box fell apart and the nails from the box fell onto the floor.
Why was the box of nails wet?Because there was a leak in the roof and it rained last night.
The Jefferson Memorial and the 5 Whys
Problem: The stone exterior of the memorial was deteriorating due to the use of high pressure washers to clean the walls.
Solution:Put up nets to deter birds from getting too close to memorial.
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https://www.youtube.com/watch?v=V9N6l0gwtik
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The Jefferson Memorial and the 5 Whys
Problem: The stone exterior of the memorial was deteriorating due to the use of high pressure washers to clean the walls.
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Solution: Decrease the time spotlights shine on the building at night.
https://www.youtube.com/watch?v=V9N6l0gwtik
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Importance of Drilling DownAt first glance, solutions seem obvious
Obvious solutions may have major drawbacks and may not address the root cause of the problem
• Washing less frequently may deter paying visitors• Replacing the damaged stone is expensive and doesn’t
address the issue of stone deterioration
Stone is deteriorating from frequent washing
Wash Memorial less frequently
Replace damaged stone
Cause Statement Tips
• Describe the system rather than an individual• Use full sentences or phrases• State in “Because...then…” format
if possible• Do not use generalized categories (e.g.,
“communication”) as a cause• Avoid words like “failed” or “inadequate”
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Cause Statement Examples
Cause Statement:Attending nurse had inadequate training.
Revised Cause Statement:Because Hospital A does not see many cases ofprocedure X, staff were not familiar with how to safely perform the procedure.
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Cause Statement Examples
Cause Statement:Epic and the lab computer system do not interface well.
Revised Cause Statement:Because our EMR and lab computer systems are not fully integrated, the lab results did not get entered into the patient’s medical record.
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Cause Statement Examples
Cause Statement:Staff did not communicate with one another about resident’s fall risk.
Revised Cause Statement:Because there was not a place within the resident’s record to document fall risk, staff were unaware that the patient needed additional assistance.
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Examples of Root Causes?
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Charlie’s Story: Root Cause
Exercise: 15 minutes• Use the 5 Whys identify the root cause(s) of
this event• Write a cause statement for one root cause
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Problem Statement Mike fell while getting dressed
Why Mike stood up while unassisted
Why Mike asked nurse for privacy and wife went to get the car
Why Mike uncomfortable with dressing in front of nurse
Cause Statement Because Mike was uncomfortable getting dressed in front of the nurse, he was unassisted while he got dressed
DEVELOPING STRONG AND EFFECTIVE ACTION PLANS
Lynn Trexler
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Action Plan Strengths
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Strong Action Plan?
• Choose actions which address each root cause
• Ask: “Will this action eliminate or greatly reduce the likelihood of an event?”
• Consider actions that do not depend on staff memory to do the right thing
• Provide tools to help staff to remember or promote clear communication
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Eliminate/Reduce Distractions
Designate a no-interruption zone/signal during critical times.
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Simplify Processes
Simplify processes by identifying factors causing medication errors.
• Are there redundancies?• Do they add value?
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Leadership Support in Patient Safety
SPEAK UP!Develop a Red Rule to “Speak Up!” when a time out is not performed or not performed adequately.
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Standardize Practice
Safe Surgery Checklist
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Standardize Equipment
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Standardize Room Set Up
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Forcing Function
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Education-Related Action Plans
Review six rights of medication at staff meeting.
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Education-Related Action Plan
All new staff will have specific training and return competency regarding EMR entry and use.
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Communication-Related Action Plans
Remind patient with dementia to use call light.
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Communication-Related Action Plans
A two-way read back/hear back confirmation will be documented with every verbal order.
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Communication-Related Action Plans
• TeamSTEPPS tools• CUS• Briefing• Check Back
Limited English Proficiency modulehttp://www.ahrq.gov/professionals/education/curriculum-
tools/teamstepps/lep/videos/opportunity/index.html
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Stop the Line: CUS
http://www.ahrq.gov/professionals/education/curriculum-tools/teamstepps/lep/videos/cuswords/index.html
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Briefs
• Planning• Form the team• Designate team roles and responsibilities• Establish climate (psychological safety) and
goals• Engage team in short- and long-term planning
http://www.ahrq.gov/professionals/education/curriculum-tools/teamstepps/lep/videos/briefing/index.html
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Check-Back Is…
http://www.ahrq.gov/professionals/education/curriculum-tools/teamstepps/lep/videos/checkback/index.html
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Communication-Related Action Plans
Success video for Mr. Hernandez
http://www.ahrq.gov/professionals/education/curriculum-tools/teamstepps/lep/videos/success/index.html
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Examples of System Level Action Plans?
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Making Action Plans Stronger
WeakerPatient candidate selection policy and procedure (P&P) requires conversation between anesthesiologist and surgeon. Review P&P with all providers including locums.
StrongerRequire sign-off that indicates both the anesthesiologist and surgeon who will be performing surgery have agreed on patient selection before outpatient surgery is scheduled. (Forcing function)
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Making Action Plans Stronger
WeakerRemind nurse to follow six medication rights.
StrongerHave resident “teach back” what medications they are prescribed and what they have received from nurse before taking medications (for residents that are able to understand and communicate this safely). (Redundancy, Teach Back)
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Making Action Plans Stronger
WeakerRemind staff to double check medication orders and medication administration record (MAR).
StrongerWhen entering new orders, have independent verification by two different staff of original order and what was entered in the EMR and MAR. (Independent verification)
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Making Action Plans Stronger
WeakerKeep talking to a minimum; keep volume in pharmacy down so it is easier to communicate. Wait for pharmacist to be ready to listen.
StrongerHave pharmacist give a distinct signal or communication when they are ready to listen without interruption (e.g.,“Ready!”). (Eliminate/reduce distraction)
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Making Action Plans Stronger
WeakerDirect care staff to ensure intended alarms are activated prior to leaving the room.
StrongerInclude check of intended alarms on hourly rounding tool. (Checklist)
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Where Do You Get Ideas for Action Plans?
• Patients/residents/families• Front line staff• Clinical guidelines and best practice• Other facilities• Toolkits
http://oregonpatientsafety.org/news-events/past-events/strengthening-ae-investigations/1663/
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In Summary…
Address the identified root cause/contributing factors
Focus on systems, not on individuals Be specific and concrete Include stronger actions, which are more likely to
eliminate or greatly reduce the likelihood of an event (see Action Plan Strengths in your packet)
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Action Plan Exercise
Take 5 minutes to complete the Action Plan Exercise in your packet.
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Charlie’s Story: Action Plan
Exercise: 15 minutesWith your group, brainstorm and write on the easel two action plans that you would do related to your root cause and contributing factors.
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IMPLEMENTATION STRATEGIESMelissa Parkerton
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Change ideas
Testing ideas before implementing changes
Measurement
Aims
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What Are We Trying to Accomplish?
By when? For whom?How much do we want
to improve?
Aim Statement
Aim statement: Reduce hospital-associated CDI on med-surgunit by 10% in 2016 as compared to 2015.
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How Will We Know That a Change is an Improvement?
Outcome Measures. What is the result?
Process Measures. Are the parts/steps in the system performing as planned?
Balancing Measures. Are changes that improve one part of the system causing new problems in other parts of the system?
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How Will We Know That a Change is an Improvement?
MeasuresOutcome
% of patients with HA CDI
ProcessHand hygiene compliance rates% of patient encounters with full contact precautions
BalancingGown/glove costs per monthPatient satisfaction
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Every Improvement is a Change,But Not Every Change is an Improvement
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What Changes Can We Make?
Where can you find change ideas?
• Literature• Clinical guidelines• Toolkits• From each other• From other healthcare
facilities
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What Changes Can We Make?
Establish “secret shoppers”Transparent data sharingCreate an environmental
services occupied room checklist
Implement new isolation STOP signs
Bleach for terminal cleaning
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Conducting Small Tests
What is our aim (goal)?Reduce hospital-associated CDIon med-surg unit by 10% in 2016 as compared to 2015.
What will we measure?% of patients with HA CDIHand hygiene compliance ratesPatient satisfaction rates
What will we change?Establish “secret shoppers”Implement new isolation STOP signs
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PDSA Cycle
• Objective, questions and predictions (why)
• Plan to carry out the cycle (who, what, where, when)
• Carry out the plan• Document problems and
unexpected observations• Begin analysis of the data
• Complete the analysis of the data
• Compare data to predictions• Summarize what was learned
• What changes will you make?• Will you adopt, adapt or
abandon your plan?
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Repeated Use of the Cycle
Hunches, theories,
ideas
Changes that result in
improvement
A PS D
A PS D
Very small scale test
Follow-up tests
Wide-scale tests of change
Implementation of change
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Why Test?
• Increase the belief that the change will result in improvement
• Predict how much improvement can be expected from the change
• Learn how to adapt the change to conditions in the local environment
• Evaluate costs and side-effects of the change• Minimize resistance upon implementation
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Guidance for Testing a Change
• Test on a small scale and collect data over time• Build knowledge sequentially with multiple PDSA
cycles for each change idea• Include a wide range of conditions in the
sequence of tests• Avoid the “cookie cutter” approach• People who touch the patients are the “feasibility
filters” for changed processes
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Understanding the PDSA Process
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The Threaded Rod Exercise
Threaded Rod Rules
• The rod is your organization• The wingnuts are your patients/residents• Every patient/resident must safely traverse the rod
• They all start off the rod• They all must be safely caught at the end
• Every member of your team must touch the process – no observers
• When prompted, you will begin• When you’re done, raise your hand • Goal: Move your patients through your system as quickly
and safely as possible
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The Threaded Rod Exercise
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Know your baseline
How Did it Go?
Take a couple minutes to brainstorm as a group
• What went well?• What do you want to improve?• What will you do differently next time?
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Creating Meaningful Aim Statements
• Know your baseline or establish a baseline• Set stretch goals that are realistic and time
bound• Set smaller goals with shorter timelines
that build towards long term goals• Clearly describe your aim so it is easy to
follow
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PDSA Worksheet
By the end of Q2, we will reduce our wingnut travel time by 20% with 0 dropped wingnuts.
Fill out your PDSA Exercise sheet….
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PDSA Worksheet
By the end of Q2, we will reduce our wingnut travel time by 20% with 0 dropped wingnuts.
# of seconds for all three wingnuts to traverse the rod decreases 20% End of Q2# of dropped wingnuts 0 errors End of Q2
Fill out your PDSA Exercise sheet….
One person will stabilize the rodOne person responsible for catching all wingnuts
MelissaLynn
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Threaded Rod ExerciseFirst Test of Change
• Take a minute to plan as a group
• Identify your team roles
• When instructed, ensure that all wingnuts traverse the entire rod as quickly and safely as possible
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The Threaded Rod Exercise
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First Test of Change
How Did it Go?
Take a couple minutes to brainstorm as a group
• What went well?• What do you want to improve?• What will you do differently next time?
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PDSA Worksheet
By the end of Q2, we will reduce our wingnut travel time by 20% with 0 dropped wingnuts.
# of seconds for all three wingnuts to traverse the rod decreases 20% End of Q2# of dropped wingnuts 0 errors End of Q2
Fill out your PDSA Exercise sheet….
One person will stabilize the rodOne person responsible for catching all wingnuts
MelissaLynn
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Reduced time by 10%, dropped one wingnut, and almost dropped another.
Adapt
What Changes Can We Make?
Consider your own experienceIs there guidance in the literature? Known best practices?What are your peers doing that seems to be working?
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PDSA Worksheet
One person will stabilize the rodOne person responsible for catching all wingnuts
MelissaLynn
AdaptTime reduced by 10%, dropped one and nearly dropped another
One person holds rodEach team member responsible for one wingnut
MelissaLynn, Mary, Carrie
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Threaded Rod ExerciseSecond Test of Change
• Take a minute to plan as a group
• Identify your team roles
• When instructed, ensure that all wingnuts traverse the entire rod as quickly and safely as possible
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The Threaded Rod Exercise
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Second Test of Change
How Did it Go?
Take a couple minutes to brainstorm as a group
• What went well?• What do you want to improve?• What will you do differently next time?
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PDSA Worksheet
One person will stabilize the rodOne person responsible for catching all wingnuts
MelissaLynn
AdaptTime reduced by 10%, dropped one and nearly dropped another
One person holds rodEach team member responsible for one wingnut
MelissaLynn, Mary, Carrie
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Time reduced by 20%, none dropped, very high stress
Adapt
The Threaded Rod Exercise
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Third Test of Change
The Value of “Failed” Tests
“I did not fail one thousand times; I found one thousand ways how not to make a light bulb.”
Thomas Edison
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Testing and Implementation
• Testing: trying and adapting existing knowledge on small scale; learning what works in your system
• Implementation: making this change a part of the day-to-day operation of the system
Would the change persist even if its champion left the organization?
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Lack of Structured Approach to Improvement
It’s the equivalent ofwanting to play the guitar, not taking lessons, failing to practice regularly, and then getting rid of the guitar because you can’t play it.
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Putting It Back Together
Aim Statement +Measures +New Ideas +Testing Changes =
IMPROVEMENT!
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Questions?
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What’s Next: Using PSRP and EDR
• Submit adverse events to Patient Safety Reporting Program (PSRP)• System collects causes and associated action plans • Non-identifiable data is shared in aggregate to improve patient
safety• ASCs, hospitals, nursing facilities, and pharmacies can participate
• Request a conversation through Early Discussion and Resolution (EDR)• Engage in a transparent conversation to reach resolution• Events resulting in serious physical injury or death • Can be started by a patient or provider
• Both systems are protected, confidential, and voluntary
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Resources
Available on our website:• Patient Safety Resources• Patient Safety Glossary• Tips for Ensuring a Strong
Report
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More Information
Materials from today’s event are available at:http://oregonpatientsafety.org/news-events/past-events
Contact OPSC: [email protected]
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Stay Connected
• Subscribe to our newsletter• Follow us on Facebook, Twitter, LinkedIn,
Google+• Attend other OPSC events
oregonpatientsafety.org
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"The names of the patients whose lives we save can never be known. Our contribution
will be what did not happen to them. And, though they are unknown, we will know that
mothers and fathers are at graduations and weddings they would have missed, and that
grandchildren will know grandparents they might never have known, and holidays will be
taken, and work completed, and books read, and symphonies heard, and gardens tended
that, without our work, would have been only beds of weeds." - Donald M. Berwick
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