Transcript ANALYTIC APPROACHES TO MANAGING RISK The A-R

ANALYTIC APPROACHES
TO MANAGING RISK:
The I-D-Q Approach
AN INTRODUCTION: Two Analytic
Risk Management Tools:
Root Cause Analysis
• Failure Mode & Effects Analysis
•
Presented by:
Steven D. Staugaitis, Ph.D.
Connecticut DMR - and the
UMASS Medical School, Family Medicine & Community Health
Center for Developmental Disabilities Evaluation and Research
DECEMBER 2003
Creating a Culture of Safety
It has been reported in the medical literature that as many as 180,000 deaths occur in the United
States each year due to errors in medical care, many of which are preventable. In order to take actions
that will improve this situation, it is necessary to have a clear picture as to what is actually happening
so that appropriate steps can be taken that will prevent such occurrences.
Only by viewing the health care continuum as a system can truly meaningful improvements be made.
A systems approach that emphasizes prevention, not punishment is the best method to
accomplish this goal. Other high-risk industries/companies such as airlines and nuclear power have
used this approach to accomplish safety. To make the prevention effort effective, we use methods of
gathering and analyzing data from the field that allow the formation of the most accurate picture
possible.
Because people on the frontline are usually in the best position to identify issues and solutions, Root
Cause Analysis teams at each of the VA Healthcare facilities formulate solutions, test, implement, and
measure outcomes in order to improve patient safety. Findings from the teams are shared nation-wide.
This is really at the core of what we mean by building a culture of safety. This kind of cultural change
does not happen over night. It can only happen as a result of effort on everyone’s part to take a
different approach to the way we look at things. We must constantly question if we can do things in a
better, more efficient, and safer manner. We must never let ‘good enough’ be good enough. We must
be relentless in our pursuit of finding ways to improve our systems. We don’t believe people
come to work to do a bad job or make an error, but given the right set of
circumstances any of us can make a mistake. We must force ourselves to look past the
easy answer that it was someone’s fault - to answer the tougher question as to why the error occurred.
It is seldom a single reason.
Through understanding the real underlying causes we can better position ourselves to prevent future
occurrences. As has been said, “Experience is the best teacher” but is also one of the most expensive
teachers as well. One of the best ways to reduce the expense, is to take advantage of lessons present
in close calls where things almost go awry, but no harm is done. Establishing a culture of safety where
people are able to report both adverse events and close calls without fear of punishment is the key to
creating patient safety.
Reducing errors in Healthcare
It's time to take this more seriously
(Berwick and Leape, BMJ, 1999)
“Ladies and gentlemen, welcome aboard Sterling Airline's Flight
Number 743, bound for Edinburgh. This is your captain speaking.
Our flight time will be two hours, and I am pleased to report both that
you have a 97% chance of reaching your destination without being
significantly injured during the flight and that our chances of making
a serious error during the flight, whether you are injured or not, is
only 6.7%. Please fasten your seatbelts, and enjoy the flight. The
weather in Edinburgh is sunny.”
Would you stay aboard?
Luckily, the safety statistics in airline travel are far, far better than these figures. Between 1990 and 1994 United States airline fatalities were
0.27 per 1000000 aircraft departures, less than one third the rate in mid-century, despite vast increases in the complexity and volume of our
aviation systems. One estimate is that a modern passenger would have to fly continuously for 20 000 years in order to reach a 50% chance of
injury in an airplane accident. In health care it is a totally different story. With the rising complexity and reach of modern
medicine have come startling levels of risk and harm to patients. One recent study in two of the most highly regarded hospitals in the world
discovered serious or potentially serious medication errors in the care of 6.7 out of every 100 patients, and the Harvard
Medical Practice Study, which reviewed over 30 000 hospital records in New York state, found injuries from care itself (“adverse events”) to
occur in 3.7% of hospital admissions, over half of which were preventable and 13.6% of which led to death. If
these figures can be extrapolated to American health care in general then over 120 000 Americans die each year as a result of
preventable errors in their hospital care.
RISK is all around us
In one NE state, if you receive residential services from the
MR/DD agency you have a:
1 in 40 chance of suffering a severe injury
1 in 50 chance of experiencing abuse or neglect
And, you will probably experience 1½ unusual incidents
each year.
Or, if you have mental retardation and are served by the state
agency, and you are:
Mobility dependent - you are 6X as likely
to die as a person who is mobility independent.
On the other hand, if you are:
Female, you are 1.06X as likely to die as a
male served by the state agency.
And, if you are:
Over 85-yrs of age, you have a 50:50 chance
of dying, but less than a 5% chance if you are younger
than 65.
Today’s Presentation
will look at:






Analytic Approaches to Quality
General Principles and Cautions
Managing Risk and Improving Safety
Retrospective Analysis: ROOT CAUSE
ANALYSIS
Prospective Analysis: FAILURE MODE &
EFFECTS ANALYSIS
For More Information: Resources &
References
CONTENTS



Analytic Approaches to Quality
General Principles and Cautions
Managing Risk and Improving Safety
QUESTIONS
WELCOMED
Analysis: ROOT
CAUSE ANALYSIS
 Retrospective


Prospective Analysis: FAILURE MODE &
EFFECTS ANALYSIS
For More Information: Resources & References
FOCUS Today
GENERAL OVERVIEW
WHY IS ANALYTIC RISK
MANAGEMENT USED IN HEALTH
CARE SETTINGS?
Root Cause Analysis, Incident Reporting and Failure Mode and Effects Analysis
have been incorporated into health care due to the growing complexity of
the delivery system and the high rate of adverse events that have resulted in
patient harm and even death.
• 40 potentially harmful drug errors EVERY
•
•
•
IOM: must focus on reducing faulty
SYSTEMS to improve patient safety.
120000
Medical Errors are the
8th Leading Cause of Death
in the United States
100000
No. Deaths
•
DAY in an average hospital.
4% of all hospitalizations have an adverse
event. Of these, 16% lead to death or
serious disabling injuries.
1 in 2.5 chance of experiencing a
complication on a general surgical service
following surgery.
One million people are injured in the
hospital every year.
Each year 44,000 to 120,000 die
as a result of medical error.
Accidental Deaths in U.S.
80000
60000
40000
20000
0
Med Error Motor Veh
Acc
Falls
Comm
Aviation
Source: National Safety Council
•
•
–
•
Learn from previous mistakes
Change organizational processes
don’t just “blame” people
RCA, IR & FMEA are good tools
for doing this
JCAHO
Requires analytic methods to reduce risk
A Position Statement of the Joint Commission on
Accreditation of Healthcare Organizations
The Joint Commission on Accreditation of Healthcare Organizations is committed to improving
patient safety through its accreditation process. Meaningful improvement in patient safety will
eventually be reflected by a significant reduction in the number of medical/health care errors
that result in harm to patients. Achieving this reduction is dependent upon:
• Identification of the errors that occur
• Analysis of each error to determine the underlying
factors – the “root causes”
• Compilation of data about errors (frequency, type, cause)
• Dissemination of information about errors and
causes
• Assessment of effectiveness of risk reduction
efforts.
CMS
requires that states have a comprehensive
QUALITY MANAGEMENT SYSTEM





Planned, systemic, organization-wide approach
to design, performance measurement, analysis
and improvement
Assures compliance with standards
Reduces adverse events
Leads to ongoing improvement
Crosses all waiver programs
States must therefore have policies and practices that include:
• Assessment and protection of participant health and safety on an individual and aggregate basis
• Monitoring compliance with assurances on individual & aggregate basis
• Assessment of quality of services on individual & aggregate basis
J. Tuller, Oregon Technical Assistance Corporation, 2003
USING DATA & ANALYTIC METHODS CAN HELP MEET THESE DEMANDS!
I-D-Q
INFORMATION DRIVEN QUALITY
requires procedures that analyze
INFORMATION ABOUT
WHAT:
HAS
HAPPENED
IS
HAPPENING
WILL
(MOST LIKELY)
HAPPEN
THAT CAN HELP US
LEARN based on the:
PAST
PRESENT
FUTURE
I-D-Q
is an ANALYTIC Process
and can help create a HOLISTIC view by using
RETROSPECTIVE
CONTEMPORARY
PROSPECTIVE
analyses that look at the
analyses that look at the
analyses that look toward the
PAST
PRESENT
FUTURE
Investigation
Mortality Review
Root Cause Analysis
Trends Analysis
Comparative Analysis
Audits
Incident Management
Personal Outcomes
Monitoring/Site Reviews
FMEA
(Failure Mode & Effects Analysis)
TCA
(Task Criticality Analysis)
Predictive Statistics
and can help meet the expectations within the
CMS QUALITY FRAMEWORK
I-D-Q is an
INTERACTIVE PROCESS
Use retrospective and contemporary analyses to
initiate prospective analyses.
INV
Investigations
IR
Incident Data
MR
Mortality Review
IR
Incident Management
LIC
Licensing
RCA
FMEA
Failure Mode & Effects Analysis
TCA
Task Criticality Analysis
PS
Predictive Statistics
Root Cause Analysis
RETROSPECTIVE
CONTEMPORARY
PROSPECTIVE
I-D-Q is an INTERACTIVE PROCESS
Then use results of prospective analyses to enhance
Systems and methods for Retrospective and Contemporary
Analyses
INV
IR
Incident Data
FMEA
IR
Investigations
Failure Mode & Effects Analysis
Incident Management
LIC
MR
Task Criticality Analysis
PS
Licensing
Mortality Review
TCA
RCA
Predictive Statistics
Root Cause Analysis
ANALYTIC METHODS
SYSTEM
Services
Policies
Practices
Standards
The Purpose of I-D-Q:
CONTINUOUS
IMPROVEMENT
INV
Investigations
IR
Incident Data
MR
Mortality Review
IR
Incident Management
LIC
Licensing
RCA
FMEA
Failure Mode & Effects Analysis
TCA
Task Criticality Analysis
PS
Predictive Statistics
Root Cause Analysis
RETROSPECTIVE
CONTEMPORARY
PROSPECTIVE
SYSTEM
IMPROVEMENT
• Changes in Policy
• Protocol Development
• Practice Standards
• Focused Training
• Better Design
QUALITY
FRAMEWORK
Focus
Quality Management Functions
Design
Discovery
Remediation
Participant Access
Participant-Centered
Service Planning and
Delivery
Provider Capacity and
Capabilities
Participant Safeguards
Participant Rights and
Responsibilities
Participant Outcomes
and Satisfaction
System Performance
ANALYTIC
approaches to
performing
QUALITY
FUNCTIONS
can apply to most
FOCUS AREAS
Improvement
Examples of HOW Data and Analytic Methods
can address Framework Functions
TYPE OF
ACTIVITY
DESIGN
DISCOVER
REMEDY
IMPROVE
PAST
Retrospective
PRESENT
Contemporary
FUTURE
Prospective
Build into your QI system the use of data and analytic procedures
that incorporate retrospective, contemporary and prospective approaches
Methods to Analyze Data and Events
using structured and formal processes:
• Root Cause Analysis
• Investigations
• Mortality Review
• Audits
• Comparative Analyses
• Trends Analyses
• Pattern Analyses
Methods to Collect & Analyze Data re:
• Abuse and Neglect Allegations
• Unusual Incidents
• Restraint Utilization
• Medication Errors
• Licensing Citations
• Complaints
• Personal Outcomes
• Deaths
Methods to Analyze Data and Events
using structured and formal processes:
• Predictive Statistics
• Failure Mode & Effects Analysis
• Task Criticality Analysis
Methods to Collect & Use Information
and Data to:
• Take Corrective Actions
• Track Follow-up and Outcomes
• Assess Compliance
• Manage Contracts and Staff
• Assess Effectiveness of Changes
Methods to Use Results of Data
Analyses to:
• Establish Improvement Objectives
• Design/change Policy
• Modify Practices
• Inform Consumers/Families
• Adjust Consumer Plans/Services
FACE VALIDITY ONLY
For Analytic Processes – and most other “DATA”
Specific analytic approaches (e.g., RCA & IR) have NOT yet been
established as an evidence-based practice in health care – or DD.
Data is a tool for inclusion in a more comprehensive system. It is NOT
a “be all, end all” solution to risk management, quality assurance or
quality improvement.
Much of the “data” – information - we use in DD has NOT been tested
for its reliability or validity. And, a lot of it has NOT been properly
analyzed, if analyzed at all. Be CAREFUL!
According to Wald & Shojania (AHRQ, 2001),
AHRQ = Agency for Healthcare Research & Quality
www.ahrq.gov
Flawed analysis can result in:
• blind pursuit of ABSOLUTE SAFETY
• increasingly COMPLEX safeguards – prone to system failures
• DECREASED INTEREST in quality improvement (avoidance)
• EXPENSIVE “solutions” to the wrong problem
However, NO ANALYSIS can result in even GREATER RISK of
harm to people - and - failure of our systems!
BALANCE IS ESSENTIAL
Do not over-emphasize data!
We work in a
REAL world with:
• Limited Staff Resources
• Competing Demands
• Budgets
Must approach use of DATA & ANALYSIS
from a PRACTICAL perspective!
DATA can be powerful – but it is only
one of many different tools we should
use to build a strong Quality
Management System.
PRACTICAL
IDEAL
If we try to build
the IDEAL Analytic
System we will
need to pull
resources from:
Good Consumer Planning, Direct Service & Support, Solid Clinical Services, Attentive Service
Coordination, Timely IDT Review of Progress, Evaluation of Consumer Outcomes, Licensing and
Certification, Risk Assessments, Decent Investigation Systems, Family Surveys, Contract
Monitoring, Family Feedback, etc.
NECESSARY – BUT NOT
SUFFICIENT
Data and analysis are only a small part of an overall quality
management system.
EXAMPLE: Incident Management
A truly comprehensive Incident Management System contains 8
Essential Elements:
1.
2.
3.
4.
Policies and Procedures
Identification
Notification
Triggers Response
5.
6.
7.
8.
Documentation & Follow-up
Analysis
Reporting
Quality Improvement
Data is a NECESSARY BUT NOT SUFFICIENT CONDITION. You
need it. BUT, it must be logically integrated into the overall
MANAGEMENT PROCESS.
ROOT CAUSE
ANALYSIS
A Tool for Retrospective Analysis
Designed to Reduce Risk of Harm
WHAT IS ROOT CAUSE
ANALYSIS?
Root Cause Analysis is a powerful tool for evaluating adverse events in
order to identify why they happened and what can be done to prevent
them from happening again.
• Analytic technique designed to identify a broad range of
factors that have contributed to or directly caused an adverse
event
• Origins in engineering, transportation safety, information
technology
• Expanded to health care in late 1990’s
– JCHAO requirement for hospitals
– Starting to be used in home health care services
• Focus is on:
– Understanding WHY human errors occur
– Developing prevention strategies
• Structured and formal process using a team approach
WHY USE RCA IN MR/DD
SYSTEMS?
“Would you pleeeease elaborate
on ‘then something really bad
happened’?”
MR/DD Director
Common Response to
Adverse Events
Why use it in DD/MR?
For the very same reasons it has become
standard practice in Healthcare!
We serve thousands of people with a variety of different needs. Our
service system is growing more complex every day. There are a lot of
adverse events, most of which we don’t even know about.
We Must Ask 2 BIG Questions:
ARE WE DOING ENOUGH TO REDUCE
RISK
REASONABLE
TO THE PEOPLE WE
SERVE? (And, how do we know?)
HOW MUCH & WHAT KIND OF
RISK ARE
WE WILLING TO TAKE? (For acting – and for not
acting.)
The Day
November 3, 2003
Norwich Nursing Home Cited in Man’s Death
State Inquiry Finds Hamilton Neglected Retarded Patient, 36
Managing
Risk.
Or, failing to!
RCA – ONE TOOL FOR
HELPING MANAGE RISK
Root Cause Analysis is NOT a panacea. It is simply a tool that should
be part of a broader system of incident management that focuses on
the:
Discovery & Prevention of ERROR
Health Care – historically relied on retrospective identification:
• Mortality and Morbidity Committees
• Chart Reviews/Audits
• Computerized Surveillance (e.g., pharmacy ordering)
• Incident Reporting
Very time consuming and expensive options.
Limited scope.
Not usually used in DD/MR systems.
RCA & INCIDENT REPORTING
Historically Closely Linked
1954
Flanagan began Critical Incident Reporting – military aircraft
training accidents
IR = Identification of preventable incidents; events that have or could have led to an
undesirable outcome and that are directly reported by personnel involved in the event
or its discover.
Critical Incident Reporting began to be more widely used in the Military, Civilian
Aviation, the Nuclear Power, Petrochemical Processing, and Steel Production
industries. Engineering introduced RCA as a way of further analyzing critical
incidents.
U.S. HEALTH CARE INDUSTRY:
1975 USFDA mandated IR for blood transfusion reactions
1978 Cooper introduced IR to anesthesiology
1990s CDC included IR in National Nosocomial Infection Surveillance System
New York State introduced IR into NY Statewide Transfusion System
1995
JCAHO mandated hospital-based surveillance system for reporting
sentinel events (voluntary reporting to JCAHO)
1997
JCAHO mandates Root Cause Analysis for sentinel events
RESEARCH
On IR/RCA Effectiveness in Health Care is Lacking
Incident Reporting
Aviation Safety Reporting System (ASRS): 30,000 reports each year
IF same level of reporting in Health Care = Millions of reports annually
JCAHO: Only 1,152 events in 6 years!
And, 76% of these were untimely deaths.
Data represents significant
UNDER Reporting
in Health Care
Existing U.S. research studies suggest:
• only 1.5% of all adverse events are reported
• 6% of ADE are identified through IR systems
• only 5-30% of surgical events are captured through IR (ACS)
NO research studies to date - to establish BENEFIT to patient
outcomes from implementing IR system in health care settings!
Australian research (AIMS):
• 2% of reported incidents resulted in patient death
• 44% had negligible effect on patient outcomes
• 90% had identified SYSTEMS failures
• 79% had human failures
RESEARCH
On IR/RCA Effectiveness in Health Care is Lacking
Root Cause Analysis
Little published literature that evaluates the impact of RCA
on sentinel events or error rates.
Texas Hospital (Rex, et al., 2000):
• applied RCA to all serious adverse drug events (ADE) for 12 mo.
• 45% decrease in rate of reported ADEs (17 mo. Follow-up)
• No fatal ADE on follow-up (however, low baseline)
• Attribute change to “blame-free” RCA – led to:
• leadership focus on safety
• numerous improvements to med ordering/distribution
• targeted changes in staffing levels
Blood Transfusion System (Kaplan, et al., 1998):
• applied RCA to “unique events”
• used classification system from petrochemical industry
• 503 events reported – 1238 causes identified
• Distribution of causes similar to research in petrochemicals:
• 46% - human failure
• 27% - technical failure
• 27% - organizational failure
SPECIAL NOTE: Be
prepared for debate!
Adapted
POLITICALLY RIGHT
Inevitable
intersection
on the
road of IDQ
Structured analytic processes can expose weaknesses in your
systems that may pose moral – clinical - fiscal – programmatic –
political – and especially legal DEBATE!
Introduction to
ROOT CAUSE ANALYSIS
TRADITIONAL APPROACH
to significant adverse events
PROCESS =
INVESTIGATION
PURPOSE =
To Identify
WHAT happened &
WHO was responsible
FOCUS =
is often on
INDIVIDUAL fault
TYPICAL
QUESTIONS:
What happened?
Did anybody do
something wrong?
If so, who messed up?
What disciplinary or
enforcement action is
needed?
RCA APPROACH
to significant adverse events
PROCESS =
ANALYSIS
PURPOSE =
To Identify
WHY it happened &
HOW to prevent
its reoccurrence
FOCUS =
SYSTEMS change
TYPICAL
QUESTIONS:
What exactly happened
and in what sequence?
What factors may have
contributed to human
error?
What “barriers” could
have prevented it?
What changes to our
systems and processes
should we make?
SOME BASIC TENETS
OF RCA
Root Cause Analysis is a formal process of discovery that works to
identify all of the human and system factors that contributed to – or
allowed – an adverse event to happen.
•
•
•
•
•
The goal of RCA is PREVENTION
Belief = errors and failures result from
flaws in the system – not just
people’s actions or inactions.
Try to find out WHY someone made a
mistake, not just who made it.
RCA requires thorough analysis of
• Human factors
• Organizational support systems
• Formal and informal processes
Based on a series of “WHY?”
questions to identify actual and
potential Contributory Factors
that led to the event
ROOT CAUSE ANALYSIS
Process to Discover
WHAT happened
• WHY it happened
• HOW it can be prevented
•
Focus is on UNDERSTANDING,
not BLAMING
Analyses CAUSE & EFFECT
Relationships
Emphasis is on SOLUTIONS
and System IMPROVEMENT
Analog:
Something we are
familiar with in MR/DD
If a consumer acted out and
seriously injured other people.
WOULD YOU ACCEPT:
• Staff blaming the consumer.
• Kicking the person out of the program.
• One person deciding what to do.
• Use of a “trial and error” approach.
• Using a “quick fix” based on assumptions.
• Ignoring whether or not the behavior changes.
WOULDN’T YOU EXPECT
A systematic process to change the conditions
that promote and maintain the problem
behavior?
1. A team of people who know the consumer and have
expertise in modifying behavior will meet to develop an
intervention plan.
2. They will analyze the situation to gain an
understanding of what antecedents and consequences are
maintaining the target behavior(s).
3. Then they will implement strategies to modify those
antecedents and consequences.
4. They will evaluate whether or not their intervention is
working.
5. If it isn’t, they will make revisions – until change takes
place.
GOOD program development for treating challenging
consumer behavior is an analog for GOOD management of
adverse events.
CONSUMER INCIDENT
TEAM APPROACH
IDT
RCA Team
People with knowledge of the
person/incident and content expertise
SYSTEMATIC ANALYSIS
Systematically evaluate environmental and
personal characteristics related to the target
behavior/incident.
INTERVENTION
Develop a plan to modify environmental
antecedents and consequences that promote
and maintain the behavior/incident.
EVALUATION
Establish method to collect data and track
impact or effectiveness of intervention.
REVISION
Plan for changing the intervention if
evaluation indicates it isn’t having the
desired effect.
Functional
Analysis
Root Cause
Analysis
Behavior
Support Plan
Prevention
Strategies
Track Target
Behavior(s)
Track
Incidents
Modify the
Support Plan
Modify
Prevention
Strategies
TEAM APPROACH
When developing any effective intervention you need to involve people who
have specific knowledge of the person/incident under study and specialized
content expertise.
IDT
Consumer, and people who:
• Know the consumer
• Special knowledge of behavior analysis
• Will implement the intervention
RCA
People who:
• Know about the specific incident
• Special knowledge of incident analysis
(RCA)
• Special content knowledge (based on the type
of incident)
• Manage or supervise staff (based on the type
of incident)
RCA is just like FA
FUNCTIONAL ANALYSIS includes an examination of the
behavioral sequence associated with the target behavior.
A–B-C
ANTECEDENTS
BEHAVIOR
CONSEQUENCE
SETTING EVENTS
ANTECEDENT STIMULI
WHY? So we can understand under WHAT CONDITIONS the behavior
occurs and does not occur. This provides information about the
environmental cues and “chain” of events that can trigger or set off the target
behavior, and which can be modified to prevent or reduce the probability the
target behavior will occur in the future.
Both use SYSTEMATIC
ANALYSIS
Like FA, ROOT CAUSE ANALYSIS also includes an
examination of the sequence of events that were associated with the
A–B-C
adverse incident.
SETTING EVENTS
ANTECEDENT STIMULI
WHY? So we can understand WHAT were the CONDITIONS that
contributed to the incident. This provides information about the
environmental factors that increase the probability the incident will occur in
the future – so we can change or modify them.
USE THE SAME
APPROACH
The same logic applies to the development of effective
interventions for consumers as well as for staff. An effective
behavior support plan AND an effective risk management plan
REDUCE THE FUTURE
PROBABILITY of certain behaviors. The foundation of
strive to
both rests on:
TEAM APPROACH
People with knowledge of the person/incident and content expertise
SYSTEMATIC ANALYSIS
Systematically evaluate environmental and personal characteristics
related to the target behavior/incident.
WHEN TO USE ROOT
CAUSE ANALYSIS
Root Cause Analysis can be used to study a wide variety of incidents. It is NOT a
substitute for investigations. And it is a demanding process that should be used
selectively.
USE ROOT CAUSE
ANALYSIS WHEN:
DO NOT USE IT:
The cause of a MAJOR system
Failure is NOT CLEAR.
To review EVERY INCIDENT
or potential system failure.
There are REPEATED
PROBLEMS that are ascribed
to human error.
As a SUBSTITUTE for
Investigation.
A sentinel event results in
DEATH or SERIOUS INJURY.
If the reason is OBVIOUS.
There is TIME to gather
Information, use a Team
Process and “Think” before
Acting.
When there is NOT TIME
to go through a Formal
Process of discovery.
PROCESS OF
ROOT CAUSE ANALYSIS
SOME SPECIAL TERMS
AND CONCEPTS IN RCA
ADVERSE EVENT.
Undesirable incident that causes harm or calls into
question the adequacy of care.
BARRIER.
Represents a process, environmental change, or system that can prevent
or reduce the probability of an adverse event.
CONTRIBUTORY FACTOR.
Additional reasons, beyond the root cause,
that an adverse event has occurred. They increase risk by setting the stage for or
contributing to the probability of an adverse event.
INCIDENTIAL FINDING.
Problems, inefficiencies or failures in a process or
system that did not contribute to the incident under consideration but which require
attention by the organization in order to prevent other types of adverse events.
PROXIMATE CAUSE.
Most obvious reason an adverse event occurred.
Immediately precedes the incident. Usually identified in investigations.
ROOT CAUSE.
Most basic and fundamental or underlying cause of an
adverse event. It is the “root” of the problem and must be addressed if prevention strategies are to
be effective. In most instances the root cause is a systems failure, not human error.
SENTINEL EVENT.
Adverse event that is unexpected and that leads
directly to or places someone at risk of death or serious harm.
HOW DOES IT WORK IN
CONNECTICUT?
CT DMR has established new procedures that activate a formal RCA for
special incidents that may provide valuable information for prevention
and systems improvement.
• DMR Policy and Procedure guide utilization of Root Cause Analysis to
evaluate selected SENTINEL EVENTS.
• The Commissioner, Deputy Commissioner, Director of Quality Assurance or
the Chairperson of the IMRB can request a RCA for any significant incident.
• DMR Strategic Leadership Center is responsible for managing and
coordinating the RCA process. Team membership includes:
•
•
•
•
Team Leader and Meeting Facilitator
Personnel familiar with the incident under review
Representatives from QA, Investigations, Management
Additional members – based on issue under study
• Each RCA should review and analyze:
•
•
•
•
•
The sentinel event
Background, context, and potential contributory factors
Risk reduction actions already taken
Recommended prevention strategies
Incidental findings, when present
Process in Connecticut
ADVERSE EVENT
Reporting, Protection,
Investigation,
Management Review
& Action
NO
Is it a
SERIOUS Event
?
1
NO
NO
Is a System
Failure Possible
Cause/Factor
?
YES
2
YES
Does
Comm,
Dep Comm, Dir QA
or IRMB Chair request
a review
YES
?
3
4
SLC assigns a
RCA TEAM
COLLECT
INFORMATION SEQUENCE
ANALYSIS
Team Identifies
CONTRIBUTORY
FACTORS &
Incidental Findings
Group Factors –
Identify
ROOT CAUSE
5
6
7
8
Team Prioritizes
Strategies & Makes
Recommendations
Report reviewed
by DMR Leadership
Leadership
Acts
Team Identifies
PREVENTION
STRATEGIES
8 STEP APPROACH FOR
ROOT CAUSE ANALYSIS
1.
ASSIGN TEAM
RCA is best conducted using a team of knowledgeable staff that
includes representation from management, quality improvement,
and the program unit where the incident under study took place.
•
Team membership will usually include:
•
•
•
•
Team Leader and Meeting Facilitator (with knowledge of RCA process)
Personnel familiar with and/or involved in the incident under review
Representatives from QA/QI, Risk Management, Special Protections,
Program Management
Additional members with special content knowledge – based on issue
under study
•
Members should be formally appointed an agency executive
•
In most instances the team will include 5-7 individuals
FORMAL ROOT CAUSE ANALYSIS WILL USUALLY REQUIRE at least 2
TEAM MEETINGS - PLUS ANALYSIS AND RESEARCH WORK INBETWEEN MEETINGS.
2. COLLECT INFORMATION
The RCA team will need detailed information about the incident
under review, organizational practices – policies - procedures, and
accepted practice standards.
•
•
Team leadership will usually assign tasks to members prior to the first
meeting.
Documentation may include the following type of information:
•
Investigation report(s) – (VERY helpful when available)
•
Autopsy or Police reports – available photographic evidence (if
available and relevant)
•
Interviews and/or staff notes/log
•
Consumer file
•
Related Incident reports
•
Related Polices and agency guidelines
•
Training records
•
Program and/or site descriptions
• Sequence Analysis
SEQUENCE ANALYSIS
Sequence Analysis provides the “raw data” for Root Cause
Analysis by objectively summarizing exactly WHAT HAPPENED
and in WHAT ORDER.
•
•
•
Sequence Analysis is a simple but essential process in RCA that helps
avoid “assumptions” by identifying what really took place and in what order.
It should be completed by personnel very familiar with the incident
Source data can come from:
FORMAT FOR SEQUENCE ANALYSIS
•
Investigation reports
DATE
TIME
WHO
EVENT or ACTIVITY
•
Program notes/logs
•
Statements/recollections
“First – This Happened.
Then – That Happened.
Then – This and This.
Followed by……”
IT IS OFTEN HELPFUL TO FLOWCHART THE
SEQUENCE ANALYSIS TO VISUALLY ILLUSTRATE
WHAT TRANSPIRED BEFORE, DURING AND AFTER
THE INCIDENT UNDER STUDY.
FLOWCHARTS
START
EVENT
Include WHO & WHEN
DECISION
POINTS
No
EVENT
Include WHO & WHEN
Yes
END
Excellent analytic tool:
• If you can’t easily show a process, it’s probably not functional
• Help visualize what happened – or what should happen
• Can compare actual event sequence with procedural requirement
• Help locate critical points to insert “barriers”
• Instructive aid when training in new procedures
3.
IDENTIFY FACTORS THAT
MAY HAVE CAUSED THE
INCIDENT
The Team will carefully review the incident, all relevant documentation
and begin the process of analysis to discover not only what happened,
but WHY it happened. This leads to a better understanding of what
factors allowed or contributed to any error.
•
•
•
•
Review the INCIDENT – provide background information
Review SEQUENCE ANALYSIS and flowchart for the actual incident
Compare to WHAT SHOULD HAVE HAPPENED
•
Develop flowchart based on agency policy/practice and/or national
practice standards
•
Identify deviations and system errors/failures
Identify the PROXIMATE CAUSE – what was or was not done
immediately before the incident that resulted in the event.
Focus is
It
IS
NOT
on BLAMING A PERSON or group!
on FACTORS that did/could have led to or contributed to any error.
REVIEW COMMON FACTORS
The team should work to identify what conditions or factors could have
CONTRIBUTED to any perceived errors by referencing the
COMMON FACTORS CHECKLIST.
•
•
The Checklist provides a series of potential
causes or contributory factors common to
DD service systems that can serve as a
prompt or cue.
Factors are categorized into clusters:
•
•
•
•
•
•
•
•
•
Staffing Factors
Consumer Factors
Communication
Equipment
Assessment/Planning
Policies
Environment
Organization
COMMON FACTORS CHECKLIST
For Identifying Causes and Contributory Factors
When attempting to identify potential causes and contributory factors related to
an incident or system failure review the following common factors. Place a
checkmark next to each factor that was or may have been present and therefore
influenced or caused the adverse incident or failure. Add additional factors
discussed by the team.
STAFFING FACTORS
P
Workload
Awareness
P
P
There were not an adequate no. of staff present to carry
out the assigned duties in the expected timelines. The
amount of work was not consistent with the duties and
assigned tasks.
Staff were not aware of what tasks they needed to do
and when those tasks were to be performed
Staff Skills
Staff did not have the necessary skills and knowledge to
perform the assigned duties – staff didn’t know how to
perform required tasks.
Prioritization
Staff or supervisors did not set priorities for multiple tasks
and responsibilities. Assumed priorities were not
consistent with organizational expectations.
Time
Allocation
Staff did not set aside sufficient time to perform priority
tasks within expected timelines.
Working with
Others
Staff were not aware of whom they needed to work with
to perform tasks and work together as a team when
required.
Staff did not have necessary experience performing the
task. If not experienced, they didn’t know whom to
access for direction and support.
Experience
Select those that are relevant
Supervision
Staff were not provided with consistent supervision from
an assigned supervisor or peer network.
•
•
Relationships
with Other
Staff
Staff did not have positive and mutually supportive
relationships with other personnel. Conflicts or poor
relationships interfered with the ability of staff to properly
complete assigned tasks in a safe and/or efficient
manner.
Staff did not have a positive and supportive relationship
with the people they were assisting.
Modify as necessary
Add additional factors
DESCRIBE FACTORS IN OBJECTIVE TERMS &
FOLLOW THE “FIVE RULES OF CAUSATION!”
P
Relationships
with
Consumers
Motivation
Staff did not have incentives for performing the required
activity, i.e., it was seen as unimportant or not
recognized by the organization. There were no clear
consequences for completing or not completing the
activity.
5 RULES OF CAUSATION
The following rules are adapted from the National Council on Patient Safety
1.
Describe the “cause and effect” relationship.
2.
Do NOT use negative descriptors.
3.
Each human error should have a preceding cause.
4.
Each procedural deviation should have a preceding
cause.
5.
• Describe the linkage between the stated cause and the adverse event or outcome.
• Do not assume others will be able to automatically understand the relationship.
• Describe how and why something led to a mistake
• Avoid shorthand statements like “inadequate” or “poorly written.”
• Include detailed explanations.
• Most adverse events involve human error - the goal of RCA is to understand WHY the
error occurred.
• Do not simply list the error. Remember, it is the cause of the error, not the error itself,
that will generate productive solutions.
• Failure to follow a prescribed procedure is not directly manageable.
• Need to understand what caused or contributed to the deviation (didn’t understand it,
forgot, not enough time, distraction, etc.)
Failure to act is not causal unless there is a clear
“duty to act.”
• Formal requirements, practice standards, or other established guidelines must have been
present.
• Must be a clear recognition in the system that there was a duty to perform.
NOTE INCIDENTAL
FINDINGS
Special concerns and practices that could lead to errors or
contribute to other types of system failures should be
documented.
•
The process of review will usually identify a
variety of concerns, issues, and factors that
could lead to other types of errors (not
directly related to the adverse event under
study). These are called INCIDENTIAL
FINDINGS – and should be:
•
Noted on a separate wall chart
•
Included in the final report for
consideration by agency leadership
•
Only BRIEFLY discussed – they are
“incidental” to the issue under review
Avoid becoming side-tracked on issues that
may be important, but are not a cause of the
incident under study.
Incidental
Findings
Note and include in final report,
but do NOT spend time
analyzing or discussing
possible solutions.
4. GROUP THE FACTORS
Once a number of contributory factors have been identified it is
helpful to group them into CLUSTERS and organize them
according to priority or importance.
•
Continue the process of asking
factors
•
Group factors (use headers in CF Checklist or develop new
•
•
“WHY” to identify additional
headers)
Develop a CONTRIBUTORY FACTORS DIAGRAM to
illustrate the relationships between factors
•
Hierarchal illustration
•
Starts with the error or failure
•
Next is proximate cause
•
Arrange Groupings according to priority – list individual factors
under headings
Go back and elicit additional reasons or factors that may have led to the
error – modify the diagram as needed
GROUP FACTORS INTO
CLUSTERS
Staff hesitant to call nurse
Client Factors
Not tested on procedure
Organizational Factors
on weekends
Training Factors
New admission – staff not
expecting noncompliance
Classroom Training only
Inexperienced staff on duty
Policy not clear on
requirements
Staff Factors
Staff felt pressured to finish –
Busy evening recreation
schedule
EXAMPLE OF CF DIAGRAM
Failure
No review or protective services
plan following a major incident.
Proximate Cause
Case Manager did not
review the incident report.
Contributory Factors
Systems deficiencies that led to failure
and proximate cause
Root Cause
Systems to assure prompt
follow-up to IR s not available
Staffing Issues
No Training in IR requirements
Limited Supervision
Lack of Experience
Environment
Limited computer access
Noisy workplace/distraction
Policy/Procedure
Old Policy- not updated
Verbal instruction contradicts policy
Lack of routing/triage protocol for IRs
IDENTIFY ROOT CAUSE
Once all of the potential contributory factors have been identified
and organized the team should zero-in on the most essential or
root cause of the error/failure.
• The ROOT CAUSE represents the most fundamental or essential reason that
the failure took place.
• May be a combination of factors (e.g., lack of clear policy and practice guidance plus
inadequate training and supervision led to staff not knowing what to do or how to do it)
• Often related to a system or process problem
• Should not be focused on an act of omission or commission by a person – but
rather what was present or absent that allowed the human error or
equipment failure to occur
FAILURE or
ERROR
PROXIMATE
CAUSE
MULTIPLE
CONTRIBUTORY
FACTORS
ROOT
CAUSE
Think About
the
7 COMMON
REASONS FOR STAFF “NONCOMPLIANCE”
1
Don’t Know
•
•
•
•
•
•
•
2
Don’t Know
ALL of the above, plus:
HOW to do it
• Using new or novel equipment
• No demonstration of how something is done
• No guidance in the program setting
3
Don’t Understand
•
•
•
•
•
Lack “big picture”
Risk seems too general, not personalized
See their situation as different from others
Don’t believe it really matters
Co-workers and supervisors do not stress importance
They
•
•
•
•
Environment is distracting
Numerous competing demands and activities
Become sidetracked with other consumers
No visible cues or prompts present
4
WHAT to do
WHY
FORGET
Incomplete instructions
Confusing or contradictory instructions
Instructions too general
Reading levels too advanced
Afraid to ask questions
Tasks are too complex
Information overload
7 COMMON REASONS
FOR STAFF “NONCOMPLIANCE”
5
Don’t Manage
•
•
•
•
Poor time management skills
Hectic work schedule
Lack structured routines
Schedule too many tasks in limited time period
6
Lack Necessary
•
•
•
•
Not enough staff on duty for type of activity
Inadequate or antiquated equipment for tasks
Limited supplies
Limited supervision or technical assistance
Don’t WANT
to do it
•
•
•
•
•
•
•
•
•
Receive little or not recognition for the activity
Task is unpleasant or boring
Task requires more effort than other tasks
Task can lead to embarrassment or injury
History of being criticized or “punished”
Interferes with more pleasant activities
Don’t like the consumer
Want to avoid interactions with others involved in task
Afraid they will make a mistake
7
TIME well
RESOURCES
Take the time to better understand WHY an error has occurred. Don’t be
satisfied with “Joe failed to……” as an adequate explanation for an adverse event.
5. IDENTIFY PREVENTION
STRATEGIES
The team should brainstorm potential solutions for each of the
identified contributory factors.
•
BRAINSTORM solutions that focus on preventing or modifying the most
important contributory factors
• Think about WHY someone did or didn’t do something - the 7 Common
Reasons (solutions usually automatically flow)
• Use Flowcharting to revise a process – make it “make sense”
Identify BARRIERS
• Equipment, technology, processes
• Automatically blocks unwanted action
• Look outside to learn about alternatives - Perform literature search
and contact other industries, agencies or state DD systems to identify
potential strategies and solutions: Find out what has worked elsewhere!
•
• PRIORITIZE SOLUTIONS according to their potential
effectiveness, feasibility and resource requirements.
• Use Efficiency Diagram to illustrate
• Assess agency “readiness” for change
EFFICIENCY DIAGRAMS
IMPORTANCE
Impact/Effectiveness
HIGH
LOW
LOW
EFFORT
Cost/Resources
HIGH
EXAMPLE
HIGH
Impact/Effectiveness
IMPORTANCE
Revise Protocol to
clarify responsibilities
Provide Training
Develop Checklist
Reduce Caseload
Develop new Information
Management System
LOW
LOW
EFFORT
Cost/Resources
HIGH
6-7. COMMUNICATE
FINDINGS
After all potential contributory factors and reasonable solutions
have been identified the team needs to develop a set of
recommendations and communicate its findings to leadership.
• FINDINGS should focus on objective information and include information
about:
• Root cause and major contributory factors that resulted in the error or failure
• Incidental findings that require follow-up
• Recommended actions to prevent future occurrence(s)
• REPORT can utilize different formats – it should always
• Be reviewed by all team members before being issued
• Incorporate changes recommended by team members (unless they conflict with
majority opinion)
• Be signed by the team leader
• FORMAL PRESENTATION of the findings and recommendations to the agency
leadership should be scheduled by the Team Leader and one or two representatives
from the team - after sharing draft report with the person who requested the RCA in the
first place.
• Focus on facts and rationale for findings
• Include pros and cons of various recommendations
• Be prepared to discuss alternative strategies
REPORTS
REPORTS CAN BE WRITTEN IN:
• Traditional Narrative Format
• RCA Form
Whatever the format, reports should include:
• Description of Adverse Event
• Purpose of the RCA
• Who requested it and Team membership
• Proximate cause of the event
• Contributory factors (grouped with explanation of how)
• Root Cause – if identified
• Corrective Actions already taken
• Potential barriers and “solutions” – prioritized
• Incidental findings
• Recommendations
• Signature of Team Leader
RCA FORM
Possible Format for Documenting Results of RCA
Adapted from a template utilized by the Australian Department of Human Services for use
by Health Care Organizations and Hospitals
AGENCY:
Sentinel Event Reference
No.:
City/Town:
Date of Event:
1.
THE EVENT – Describe what
happened and any harm that resulted.
Identify the proximate cause, if known.
2.
Date RCA Completed:
RCA Team Members:
Team Leader:
BACKGROUND & FACTORS SUMMARY– Answer the following questions (brief summary only- attach supporting
documents).
2.1
What was the sequence of events that
was expected to take place? Attach
flowchart if available.
Description:
2.2
Was there a deviation from the
expected sequence?
Yes
No
If YES, describe the deviation. Attach
flowchart if available.
2.3
Was any deviation from the expected
sequence likely to have led to or
contributed to the adverse event?
Yes
No
NK
If YES, describe with causal statement.
2.4
Was the expected sequence described
in policy, procedure, written
guidelines, or included in staff
training?
Yes
No
NK
If YES, cite source.
8. AGENCY ACTION
The team is responsible for analyzing and recommending. It is the
responsibility of Agency Leadership - NOT the RCA Team - to make final
decisions about what actions – if any – the agency should and will take.
RESPONSIBILITIES
RCA TEAM
AGENCY LEADERSHIP
• Gather information
• Review findings
• Review the incident
• Decide what action to
take
• Analyze and identify what
contributed to the problem
• Study possible solutions
• Make recommendations
• Present findings
• Assign responsibilities
• Manage any change
• Follow-up and track
FAILURE MODE &
EFFECTS ANALYSIS
A Tool for Anticipating Problems
and Correcting them Before they
Happen
WHAT IS FMEA?
Failure Mode and Effect Analysis
(FMEA) is a systematic method of
identifying and preventing failures
BEFORE they happen.
FMEA is a prospective analytic tool. It is not based on an actual
adverse event - but rather anticipates and corrects system failures
before they actually occur.
Since FMEA is not dependent upon or require the examination of
something “bad” that has already happened, it is less
“threatening” and controversial than Root Cause Analysis.
“Borrowed” from
Engineering
Like RCA, Failure Mode and Effects Analysis was used for decades in
engineering before being introduced to healthcare:
• Military and civil aviation
•
•
•
•
NASA
Nuclear power generation
Chemical processing
Automotive design and engineering
In these industries a systems failure can have catastrophic results
that include significant loss of life, serious injury, and major economic
loss.
Tools have therefore been developed to ANTICIPATE failures and
introduce product or process design changes before a problem becomes
manifest.
REACTIVE SYSTEMS
Historically in healthcare AND
in MR/DD:
 We have NOT focused much energy on
preventing human (staff) error.
 We HAVE “relied upon” errorless
performance of staff – professional and
paraprofessional alike.
 We tend to REACT to incidents,
introducing changes to practice only after
major problems have taken place.
JCAHO now requires proactive
approaches to risk management
JCAHO Standard LD.5.2









Identify and prioritize HIGH RISK PROCESSES
Annually Select ONE
Analyze potential “FAILURE MODES”
Identify the possible EFFECTS of the failure
Conduct a ROOT CAUSE ANALYSIS for the most
critical effects
REDESIGN the process to minimize risk of failure
TEST the new process
Implement MEASURES of effectiveness
Implement strategies to MAINTAIN the effectiveness
Failure Mode and Effects Analysis is becoming the “preferred”
method to meet this new standard.
FMEA v RCA
HOW ARE THEY
ALIKE?
• Teams
• Use Flow Charts
• Focus on Systems
• Avoid Blame
• Cause & Effect Analyses
• Use Brainstorming
• Focus on Prevention
• Result in Change
HOW ARE THEY
DIFFERENT?
• FMEA studies Process –
RCA looks at
Chronological sequence
• FMEA is prospective –
RCA is retrospective
• FMEA “chooses” a topic
– RCA looks at an actual
event
• FMEA asks “What If” –
RCA asks “Why”
• FMEA emphasizes
Testing the change
FMEA:
10 STEP PROCESS
1.
Identify High
a.
b.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Risk processes
Use Incident data, results of Investigations, RCA and/or Mortality Review
Select a process for FMEA
Team
Complete Process Analysis & Flow-chart
Identify all possible Failure Modes for each step
Develop RPN for each failure mode and Prioritize
Identify Improvements and prioritize them
Develop Change Plan
Identify Outcome Measures
Implement Changes
Measure and Evaluate Effects
Assemble
IDENTIFY HIGH
RISK PROCESSES
STEP 1:


Leadership, Quality Staff, Risk Managers,
Direct Support Professionals, and others
can RECOMMEND activities they believe
may be or could pose high risk of failure.
Use existing DATA to target activities





Incident reports and analysis
Mortality review results
Incidental findings from RCA
A/N Investigations
Keep the scope limited – focus on
SPECIFIC processes or activities
ASSEMBLE
TEAM
STEP 2:

Like RCA, FMEA benefits from analysis by
an “Interdisciplinary Team”



MINIMUM requirements for Team:






Different perspectives and experiences
Broadens knowledge base
Content experts (knowledge of best practices in area under study)
Persons who actually use the process
Management
QI and/or risk management staff
Person familiar with FMEA and/or RCA
Define expectations and ROLES



Team Leader
Meeting Facilitator
Note Taker
FMEA is a STRUCTURED PROCESS:
WORKSHEET
Failure Mode and Effects Analysis
SAMPLE WORKSHEET FOR CALCULATING THE RPN
Risk Prioritization Number
Process Step
Failure Mode
A
B
C
AXBXC
Impact of
Failure
Probability
Discoverability
Risk Prioritization No.
1 - 10
1 - 10
1 - 10
RPN
1 - 1000
Priority
PROCESS
ANALYSIS
STEP 3:
Process analysis is the same thing as Task Analysis in
special education. It requires you to list the steps that take
place in any given activity or process.
1. List the steps (task analysis)
2. Identify “sub-processes” for higher risk or more
complex steps
3. Flow Chart (process)
4. Label each step (1, 2, 3….)
1
2
3
4
5
Bring to
Bathing Area
Prepare
Water in Tub
Undress
Place in Seat
Bathe
• Get supplies
• Notify staff
• Check temp
• Fill halfway
• Get assistance
• Properly position
• Prep for transfer
• Check temp
• Use lift
• Position seat
• Use straps
• Lower seat
etc.
STEP 3
Process Step
Failure Mode and Effects Analysis
WORKSHEET FOR CALCULATING THE RPN
Risk Prioritization Number
Failure Mode
A
B
C
AXBXC
Impact of
Failure
Probability
Discoverability
Risk Prioritization No.
1 - 10
1 - 10
1 - 10
RPN
1 - 1000
Priority
HAZARD
ANALYSIS
STEP 4:
For each step or process, identify all of the potential Failure
Modes that could result in error. Use literature and group
experience as a guide.
1. Use Brainstorming
2. Identify ALL potential failures – mechanical and
human
3. List each failure in 2nd column on worksheet
QualityHealthCare.org has an interactive FMEA Tool on-line that
also includes the results of FMEAs performed by other users.
These examples can be informative if the process you are studying
is similar.
STEP 4
Process Step
Failure Mode
A
B
C
AXBXC
Impact of
Failure
Probability
Discoverability
Risk Prioritization No.
1 - 10
1 - 10
1 - 10
RPN
1 - 1000
Priority
STEP 5: CALCULATE THE
RPN
The Risk Prioritization Number is a simple quantitative method
for rank ordering – prioritizing – each of the failure modes, to
allow identification of the most to least critical.
RPN =
Impact X Probability X Discoverability
How bad is it if a
failure occurs?
How often will this
type of failure take
place?
What is the likelihood
we would discover
the failure and be
able to stop it?
Many different scoring methods can be used as long as they allow
differentiation of the various failures and process steps.
STEP 5A: CALCULATE THE
IMPACT SCORE
POINTS
CATEGORY
10
CATASTROPHIC
7
5
DESCRIPTION
Failure would result in the entire process failing and would have a very
negative impact on individuals or result in major economic loss. Potential
for loss of life and/or severe injury.
SEVERE
MODERATE
3
MILD
1
MINOR/NONE
Failure would result in high probability that the entire process might fail.
Potential for severe injury and/or economic loss if not detected.
Failure would result in negative impact on the entire process although
would most likely not result in complete failure. Potential for moderate
injury or compromise of a clinical or personal outcome, major disruption
and inconvenience, and/or possible economic loss.
Failure would result in mild negative impact on the process. Potential for
minor injury and only a minimal impact on a clinical or personal outcome.
Consumers and/or staff would be somewhat inconvenienced.
Negligible economic loss.
Failure does not impact the entire process. No potential for injury or
negative impact on a clinical or personal outcome. May involve minor
inconvenience. No noticeable economic loss.
STEP 5a
Process Step
Failure Mode
A
B
C
AXBXC
Impact of
Failure
Probability
Discoverability
Risk Prioritization No.
1 - 10
1 - 10
1 - 10
RPN
1 - 1000
Priority
STEP 5B: CALCULATE THE
PROBABILITY SCORE
POINTS
10
7
5
3
1
PROBABILITY
VERY HIGH
HIGH
MODERATE
LOW
VERY LOW
DESCRIPTION
Very likely to occur. High frequency (multiple times each day) is probable
and/or has been observed.
Likely to occur. Relatively high frequency (weekly) is probable. Has been
observed to take place.
Somewhat likely to occur. Estimate monthly or quarterly occurrence rate.
Sometimes observed.
Rather unlikely to occur. Estimate only yearly or every few years. Very
rarely observed in the past.
Very unlikely to occur. Estimate occurrence only every five or more years.
Has not been observed in the past.
STEP 5b
Process Step
Failure Mode
A
B
C
AXBXC
Impact of
Failure
Probability
Discoverability
Risk Prioritization No.
1 - 10
1 - 10
1 - 10
RPN
1 - 1000
Priority
STEP 5C: CALCULATE THE
DISCOVERABILITY
SCORE
POINTS
10
DISCOVERABILITY
VERY DIFFICULT
7
DIFFICULT
5
MODERATE
3
EASY
1
VERY EASY
DESCRIPTION
Very hard to detect a failure. Activity or step not seen by others. Not
followed by obvious step in process. Signs of failure or problem take
place too late to remedy or correct.
Hard to observe or detect when a failure takes place. Activity usually not
seen by others. Signs of failure probably won’t be detected until after the
activity is completed.
Somewhat difficult to detect. May be observed by others who could
intervene if vigilant. Signs of failure usually present, but only after failure
has taken place but activity is not completed.
Fairly easy to detect errors. Usually observed by others. Mistake is
rather noticeable and evident. Signs of failure are present immediately
after step is completed.
Very easy to detect errors. Always done in the presence of others.
Mistakes are very noticeable. Next steps cannot take place until error is
corrected.
STEP 5c
Process Step
Failure Mode
A
B
C
AXBXC
Impact of
Failure
Probability
Discoverability
Risk Prioritization No.
1 - 10
1 - 10
1 - 10
RPN
1 - 1000
Priority
CALCULATE RPN
RPN =
Impact X Probability X Discoverability
How Severe is the
result of Failure?
How Likely is Failure?
What is the Likelihood Failure
will be observed and stopped?
RPN will range from a
LOW
of
to a
HIGH
of
1
1000
EXAMPLES
EXAMPLE 2:
Failure to serve two vegetables to
residents of a small CLA that has at
least two staff on duty at meal time.
EXAMPLE 1:
Failure to grind food properly for a
person on a special diet who has a
significant swallowing disorder and
who lives alone with PAs sent by a
home health agency.
IMPACT
PROBABILITY
DISCOVERABILITY
Total RPN =
?
?
?
7
5
7
245
IMPACT
PROBABILITY
DISCOVERABILITY
Total RPN =
?
?
?
1
3
1
3
STEP 5d
Process Step
Failure Mode
A
B
C
AXBXC
Impact of
Failure
Probability
Discoverability
Risk Prioritization No.
1 - 10
1 - 10
1 - 10
RPN
1 - 1000
Priority
COMPLETE STEP 5:
PRIORITIES


SET
RANK ORDER FAILURE MODES
(Highest RPN is the most important or
critical – Lowest RPN is the least critical)
Evaluate STEPS or Processes for the
number of highly critical failures
Focus your prevention strategies on the failures and/or steps that
have the highest RPN and therefore pose the greatest risk of error
and harm.
IDENTIFY
IMPROVEMENTS
STEP 6:


Brainstorm POTENTIAL CHANGES &
ENHANCEMENTS that could CONTROL
or prevent the failure(s)
Evaluate options for practicality and
efficiency
Common Strategies
Process Redesign
• Build in Redundancy
• Simplify
• Reduce Reliance on Memory
• Standardize
• Use Checklists
• Install Visual Prompts/Cues
• Eliminate “Look and Sound Alikes”
• Institute “Fail-Safe” Designs
Organizational Change
• Staff “Buddy” System
• Mentoring
• Teamwork
• Increase Direct Communication
• Operational Procedures
• Reduce “Fear”
• Reward Reporting/Debriefing
• Culture of Safety
STEP 7:



CHANGE PLAN
Identify the “best” solutions
Develop and write-up a simple CHANGE
PLAN or proposal
REVIEW with agency leadership




Rationale
Options
Pros and Cons
Obstacles and Costs
Take the time to carefully “spell-out” the results of the analysis
and the reasons for proposing change. Honestly identify
obstacles and costs. Show the risk if nothing is done.
OUTCOME
MEASURES
STEP 8:



Identify series of MEASURES to assess if
proposed changes actually make a
difference
Keep it SIMPLE and “Doable”
Include staff feedback (after all they are usually the
target for intervention)

Goal = implement change and see if it has
the intended impact – Increased Safety
and Reduced Risk of Harm
Do the same thing you would for a new teaching plan or behavior
management program for people you serve. Plan, Do, Measure,
Change.
IMPLEMENT
CHANGE
STEP 9:


Consider using a Project Plan to map out
steps for implementation
Consider simulation or setting up a
PILOT before expanding to entire system



Work out the “kinks” first
Test your ideas before you roll-out the change
Make sure you follow through – DO IT!
EVALUATE
CHANGE
STEP 10:

Use identified Outcome Measures to
assess whether or not the change:







Is working
Is being accepted
Is actually being implemented
Has any unanticipated negative consequences
MODIFY as needed
REPORT BACK to leadership
Include outcome in final report or
addendum to original FMEA report
RESOURCES
for learning more about
Root Cause Analysis
and
Failure Mode & Effects Analysis
Some Helpful Resources
Bongiorno, J. (2000) Improving FMEAs. Quality Digest, 20 (10), October 2000, p.37.
Cohen, M.R., et al. Failure Mode and Effects Analysis: A Novel Approach to Avoiding Dangerous Medication Errors and Accidents. Hospital
Pharmacy, 29 (4), April, 1994, p. 319. (2000)
DeRosier, P.E., Stalhandske, E., Bagian, J.P. and Nudell, T. (2002) Using Health Care Failure Mode and Effects Analysis: The VA National
Center for Patient Safety’s Prospective Risk Analysis System. The Joint Commission Journal, May, 2002, p. 248.
Doing What Counts (2000). Doing What Counts for Patient Safety. Federal Actions to Reduce Medical Errors and their Impact. Washington
D.C. Report of the Quality Interagency Coordination Task Force, February, 2000.
To access the report go to: http://www.quic.gov/Report/
Failure Modes and Effects Analysis Tool. QualityHealthCare.org. www.qualityhealthcare.org/qhc/workspace/tools/fmea/
Hirsch, K and Wallace, D. (2001) Step by Step Guide to Effective Root-Cause Analysis. Opus Communications, Marblehead, MA
Hohmann, S.F. and Hoppes, M.M. (2003) Improving Patient Safety with Statistical Correlation. HCPro, Inc., Marblehead, MA.
Institute of Medicine (1999). To Err is Human: Building a Safer Health System. Washington D.C. National Academy Press.
To access the report go to: htttp:// www. nap.edu/books/0309068371/html
Marder, R. and Sheff, R.A. (2002) The Step by Step Guide to Failure Modes and Effects Analysis. Opus Communications, Marblehead, MA.
Morey (1994). Error Reduction as a Systems Problem. In Human Error in Medicine, Marilyn S. Bogner (Ed)., Hillsdale, NJ: Lawrence Erlbaum
Associates, Inc.
Reason, J. (1990) Human Error. Cambridge Univ Press, Cambridge, U.K.
Spath, P.L. (2000) Error Reduction in Health Care: A Systems Approach to Improving Patient Safety. Jossey-Bass, San Francisco.
Staugaitis, S.D. (2002) Root Cause Analysis: A Summary of Root Cause Analysis and its Use in State Developmental Disabilities Agencies.
Developed by Human Services Research Institute, under subcontract with the MedStat Group, Inc., for the Centers for Medicare and Medicaid
Services. HSRI, Cambridge, MA 2002. www.hcbs.org/quality/hsri/RCAManual.doc
Wachter, R. (2001) Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment No.
43, AHRQ Publication 01-E058, July 20, 2001.
ADDITIONAL WEB RESOURCES
The following resources may provide additional assistance to readers
wishing to learn more:
www.rootcauseanalyst.com
www.patientsafety.gov
www.outsights.com/systems/rca/rootca.htm
www.clinicalrisk.health.vic.gov.au/rca.htm
www.accreditinfo.com/howto/HHH/howtoex.cfm
www.va.gov/ncps/causation.html
www.va.gov/ncps/tools.html
For more information or assistance
please feel free to contact:
Steve Staugaitis at:
[email protected] or
[email protected]
Case Example






48 y/o woman – Midwest State
Severe MR – bi-polar disorder
Living in private CLA – attending full time day program
Lithium levels WNL (.9 mmol/L)
Medication packaged in blisterpak
1 week after starting new blisterpak signs of distress begin – last one
month







Repeatedly missed day program due to illness
Ongoing communication between residential and day providers
Seen by PCP multiple times






Crying and whining
Unsteady gait progressing to inability to walk or sit
Diarrhea and refusal to eat
Bruise on lower back
Annual exam
Evaluate for possible abuse (bruise)
Parents demand she be sent to hospital
Hospital finds severe dehydration, renal failure, in “grave condition,”
Lithium levels in toxic range (6.8 mmol/L)
Dies within 48 hrs of hospital admission
3 weeks later Public Health inspector discovers 300 mg Lithium packaged
in 150 mg blisterpak (double prescribed dose)
SUMMARY OF INVESTIGATION REVIEW
Sequence Analysis: Joanne Smith
Psych evaluates & inc
Lithium Rx on March 2nd Blood Levels ordered
for 8 weeks later –
WNL (.9)
3/2/03 – 5/9/03
New Lithium Rx
Picked up by Res
(30 day supply in blisterpak)
5/13/03
JS returns to
Day Program - has
continued diarrhea
Res staff notified
Home for weekend – Res
Note re: JS not eating
5/26/03
5/27-5/28/03
JS has diarrhea at
Day Program –
Needs RTW order.
Complaint of back pain –
5/23/03
JS continues to be
Sick at Day Program
Whining, unsteady, difficulty
Sitting – small bruise noted
on lower back
5/29/03
Absent from Day
Program
May have had diarrhea at
Home
(No Documentation)
5/24-5/25/03
Res staff notify PCP
Appt already scheduled for
next day
for Annual Physical Exam
5/29/03
Seen by PCP
Orders inc in fluids – call if
dec in oral intake or urination or
change in activity level or if
diarrhea –
RTW clearance issued
5/25/03
JS seen by PCP
Referral problem = bruising –
Orders x-ray and bloodwork
(No lithium levels) –
JS uncooperative for x-ray
5/30/03
6/6/03: Res Program Director resigns without notice
Res staff and Day staff
note continued
problems
Unsteady, crying, diarrhea
6/1/03
Psychiatrist Orders dec in
Zyprexia – did not see JS Told JS irritable, restless and
falling
6/1-6/2/03
Day Program notes
continued problems
and won’t accept back Calls SC who calls home –
no answer at homeoriginal RTW order provided
6/2-6/3/03
Not at Day Program
Res staff notes JS very
unstable –
Res Prog supervisors notified of
need for new RTW order
6/3-6/7/03
Res Prog Clin Dir calls
PCP Office in resp to RTW JS shows continued decline –
PCP orders inc in Levoxyl
(Diarrhea STOPS)
6/8/03
Day and Res Clinical staff did NOT directly speak
PCP Office refuses to
issue new RTW order
may believe no continued
Diarrhea
6/9/03
EMTs transport to
Hospital ER
Evaluated at ER – in grave
condition – severe dehydration –
attempt to hydrate
6/11/03
Res Prog staff and
supervisors aware of
continued decline
PCP called and asked for
X-ray – appt set for next day
6/9/03
Hospital MD reviews options –
requests nephrology consult
6/11/03
SC visits – looks very bad –
Told JS going to PCP –
JS gets x-ray
Ativan adm to presedate –
Not seen by PCP – only issue
of x-ray is reviewed
6/10/03
Lithium levels show
extreme elevation
bloodwork shows lithium level
at 6.8
6/11/03
JS very weak
staff note she needs extra
assistance – did not sleep well,
eyes moving side/side – seen
as “much worse”
6/11/03
Comfort measures
only provided
6/11-6/13/03
Parents visit home
parents alarmed at JS’s
condition – insist on
hospital visit
6/11/03
JS dies
Nephrology consult same day
as death – Cause of death
noted as renal failure and
hyperkalemia
6/13/03
Conclusions
An examination of the contributory factors reflected a pattern of misinformation
across all systems. A key finding revealed: that no one individual was
designated with the ultimate responsibility for [JS’s] health care case
management. A series of erroneous assumptions by all relevant participants
pointed to inadequate communication regarding the critically changing health
status of [JS].
The root cause of the event was acknowledged by the team to be a lack of
adequate systems to identify high-risk health situations, document target
symptoms and assure accurate communication and timely response. The RCA
team’s recommendations are intended to reduce the probability of future
communication errors in a multi-service delivery system.
From final report by RCA team to Commissioner/Director of State MR/DD agency.