ANALYTIC APPROACHES TO MANAGING RISK: The I-D-Q Approach

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ANALYTIC APPROACHES TO MANAGING RISKThe 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
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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 everyones 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 dont 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 someones
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.
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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.
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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 5050 chance of dying, but less than
a 5 chance if you are younger than 65.
Are these risks reasonable? Problem We dont
know unless we use data develop benchmarks!
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Todays 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

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CONTENTS

• 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

QUESTIONS WELCOMED
FOCUS Today
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GENERAL OVERVIEW
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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 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.

• Learn from previous mistakes
• Change organizational processes dont just
  blame people
• RCA, IR FMEA are good tools for doing this

IOM must focus on reducing faulty SYSTEMS to
improve patient safety.
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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.

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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!
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I-D-Q INFORMATION DRIVEN QUALITY requires
procedures that analyze
One way of looking at solutions.
INFORMATION ABOUT WHAT
THAT CAN HELP US LEARN based on the
HAS HAPPENED
PAST
IS HAPPENING
PRESENT
WILL (MOST LIKELY) HAPPEN
FUTURE
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I-D-Q is an ANALYTIC Process and can help create
a HOLISTIC view by using
RETROSPECTIVE analyses that look at the
CONTEMPORARY analyses that look at the
PROSPECTIVE analyses that look toward the
PRESENT
FUTURE
PAST
Investigation Mortality Review Root Cause
Analysis Trends Analysis Comparative
Analysis Audits
Incident Management Personal Outcomes Monitoring/S
ite Reviews
FMEA (Failure Mode Effects Analysis) TCA (Task
Criticality Analysis) Predictive Statistics
and can help meet the expectations within the
CMS QUALITY FRAMEWORK
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I-D-Q is an INTERACTIVE PROCESS
Use retrospective and contemporary analyses to
initiate prospective analyses.
IR Incident Management LIC Licensing
INV Investigations IR Incident Data MR Mortality
Review RCA Root Cause Analysis
FMEA Failure Mode Effects Analysis TCA Task
Criticality Analysis PS Predictive Statistics
RETROSPECTIVE
CONTEMPORARY
PROSPECTIVE
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I-D-Q is an INTERACTIVE PROCESS
Then use results of prospective analyses to
enhance Systems and methods for Retrospective and
Contemporary Analyses
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The Purpose of I-D-Q CONTINUOUS IMPROVEMENT
SYSTEM IMPROVEMENT

• Changes in Policy
• Protocol Development
• Practice Standards
• Focused Training
• Better Design

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QUALITY FRAMEWORK
Quality Management Functions
Improvement
Design
Discovery
Remediation
Focus
Participant Access
ANALYTIC approaches to performing QUALITY FUNCTION
S can apply to most FOCUS AREAS
Participant-Centered Service Planning and Delivery
Provider Capacity and Capabilities
Participant Safeguards
Participant Rights and Responsibilities
Participant Outcomes and Satisfaction
System Performance
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Examples of HOW Data and Analytic Methods can
address Framework Functions
TYPE OF ACTIVITY
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
DESIGN

• 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

DISCOVER

• 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

REMEDY

• Methods to Use Results of Data Analyses to
• Establish Improvement Objectives
• Design/change Policy
• Modify Practices
• Inform Consumers/Families
• Adjust Consumer Plans/Services

IMPROVE
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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),
• 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

AHRQ Agency for Healthcare Research
Quality www.ahrq.gov
However, NO ANALYSIS can result in even GREATER
RISK of harm to people - and - failure of our
systems!
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BALANCE IS ESSENTIALDo 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.
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.
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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. Policies and Procedures
2. Identification
3. Notification
4. Triggers Response

1. Documentation Follow-up
2. Analysis
3. Reporting
4. Quality Improvement

Data is a NECESSARY BUT NOT SUFFICIENT CONDITION.
You need it. BUT, it must be logically
integrated into the overall MANAGEMENT PROCESS.
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ROOT CAUSE ANALYSIS
A Tool for Retrospective Analysis Designed to
Reduce Risk of Harm
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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 1990s
• 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

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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
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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 dont even know
about.
We Must Ask 2 BIG Questions
ARE WE DOING ENOUGH TO REDUCE REASONABLE RISK 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.)
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Managing Risk. Or, failing to!
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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.
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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
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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
Data represents significant UNDER Reporting in
Health Care
JCAHO Only 1,152 events in 6 years! And, 76 of
these were untimely deaths.

• 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

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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/distributio
  n
• 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

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SPECIAL NOTE Be prepared for debate!
Adapted
POLITICALLY RIGHT
Inevitable intersection on the road of IDQ
FISCALLY RIGHT
Structured analytic processes can expose
weaknesses in your systems that may pose moral
clinical - fiscal programmatic political
and especially legal DEBATE!
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Introduction to ROOT CAUSE ANALYSIS
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TRADITIONAL APPROACH to significant adverse events
PROCESS INVESTIGATION
TYPICAL QUESTIONS What happened? Did anybody
do something wrong? If so, who messed up? What
disciplinary or enforcement action is needed?
PURPOSE To Identify WHAT happened WHO was
responsible
FOCUS is often on INDIVIDUAL fault
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RCA APPROACH to significant adverse events
PROCESS ANALYSIS
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?
PURPOSE To Identify WHY it happened HOW to
prevent its reoccurrence
FOCUS SYSTEMS change
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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 peoples 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

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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.

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WOULDNT 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 isnt, they will make revisions until
   change takes place.

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GOOD program development for treating challenging
consumer behavior is an analog for GOOD
management of adverse events.
CONSUMER
INCIDENT
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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.

• Consumer, and people who
• Know the consumer
• Special knowledge of behavior analysis
• Will implement the intervention

IDT

• 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
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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.
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Both use SYSTEMATIC ANALYSIS
Like FA, ROOT CAUSE ANALYSIS also includes an
examination of the sequence of events that were
associated with the adverse incident.
A B - C
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.
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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 strive to
REDUCE THE FUTURE PROBABILITY of certain
behaviors. The foundation of 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.
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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. There are REPEATED PROBLEMS that are
ascribed to human error. A sentinel event
results in DEATH or SERIOUS INJURY. There is
TIME to gather Information, use a Team Process
and Think before Acting.
To review EVERY INCIDENT or potential system
failure. As a SUBSTITUTE for Investigation. If
the reason is OBVIOUS. When there is NOT TIME to
go through a Formal Process of discovery.
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PROCESS OF ROOT CAUSE ANALYSIS
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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.
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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

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Process in Connecticut
Reporting, Protection, Investigation, Management
Review Action
ADVERSE EVENT
NO
NO
NO
Is it a SERIOUS Event ?
Does Comm, Dep Comm, Dir QA or IRMB Chair
request a review ?
Is a System Failure Possible Cause/Factor ?
YES
YES
YES
1
2
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 Identifies PREVENTION STRATEGIES
Team Prioritizes Strategies Makes Recommendatio
ns
Report reviewed by DMR Leadership
Leadership Acts
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8 STEP APPROACH FOR ROOT CAUSE ANALYSIS
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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 IN-BETWEEN MEETINGS.
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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

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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
• Investigation reports
• Program notes/logs
• Statements/recollections

FORMAT FOR SEQUENCE ANALYSIS
DATE TIME WHO EVENT or ACTIVITY








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.
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FLOWCHARTS
DECISION POINTS
EVENT Include WHO WHEN
EVENT Include WHO WHEN
No
START
Yes
END

• Excellent analytic tool
• If you cant easily show a process, its
  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

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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 NOT on BLAMING A PERSON or group! It IS
on FACTORS that did/could have led to or
contributed to any error.
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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
• Select those that are relevant
• Modify as necessary
• Add additional factors

DESCRIBE FACTORS IN OBJECTIVE TERMS FOLLOW THE
FIVE RULES OF CAUSATION!
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5 RULES OF CAUSATION
The following rules are adapted from the National
Council on Patient Safety

• Describe the cause and effect relationship.
• 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
• Do NOT use negative descriptors.
• Avoid shorthand statements like inadequate or
  poorly written.
• Include detailed explanations.
• Each human error should have a preceding cause.
• 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.
• Each procedural deviation should have a preceding
  cause.
• Failure to follow a prescribed procedure is not
  directly manageable.
• Need to understand what caused or contributed to
  the deviation (didnt 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.

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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

Incidental Findings
Note and include in final report, but do NOT
spend time analyzing or discussing possible
solutions.
Avoid becoming side-tracked on issues that may be
important, but are not a cause of the incident
under study.
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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 WHY to identify
  additional factors
• Group factors (use headers in CF Checklist or
  develop new 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

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GROUP FACTORS INTO CLUSTERS
Staff hesitant to call nurse on weekends
Client Factors
Training Factors
Not tested on procedure
New admission staff not expecting noncompliance
Organizational Factors
Classroom Training only
Policy not clear on requirements
Inexperienced staff on duty
Staff Factors
Staff felt pressured to finish Busy evening
recreation schedule
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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
ROOT CAUSE
MULTIPLE CONTRIBUTORY FACTORS
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Think About the 7 COMMON REASONS FOR STAFF
NONCOMPLIANCE
1
2
3
4
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7 COMMON REASONS FOR STAFF NONCOMPLIANCE
Dont Manage TIME well

• Poor time management skills
• Hectic work schedule
• Lack structured routines
• Schedule too many tasks in limited time period

5
Take the time to better understand WHY an error
has occurred. Dont be satisfied with Joe
failed to as an adequate explanation for an
adverse event.
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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 didnt 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

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EFFICIENCY DIAGRAMS
HIGH
HIGH
HIGH
VERY GOOD
GOOD
IMPORTANCE
IMPORTANCE
IMPORTANCE
Impact/Effectiveness
Impact/Effectiveness
Impact/Effectiveness
POOR
LOW
LOW
LOW
LOW
HIGH
LOW
HIGH
LOW
HIGH
EFFORT
EFFORT
Cost/Resources
Cost/Resources
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EXAMPLE
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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

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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

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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 AGENCY Sentinel Event Reference No. Sentinel Event Reference No.
City/Town City/Town Date of Event Date of Event Date RCA Completed Date RCA Completed Date RCA Completed Date RCA Completed Date RCA Completed Date RCA Completed
1. THE EVENT Describe what happened and any harm that resulted. Identify the proximate cause, if known. RCA Team Members Team Leader RCA Team Members Team Leader RCA Team Members Team Leader RCA Team Members Team Leader RCA Team Members Team Leader RCA Team Members Team Leader RCA Team Members Team Leader RCA Team Members Team Leader
2. BACKGROUND FACTORS SUMMARY Answer the following questions (brief summary only- attach supporting documents). BACKGROUND FACTORS SUMMARY Answer the following questions (brief summary only- attach supporting documents). BACKGROUND FACTORS SUMMARY Answer the following questions (brief summary only- attach supporting documents). BACKGROUND FACTORS SUMMARY Answer the following questions (brief summary only- attach supporting documents). BACKGROUND FACTORS SUMMARY Answer the following questions (brief summary only- attach supporting documents). BACKGROUND FACTORS SUMMARY Answer the following questions (brief summary only- attach supporting documents). BACKGROUND FACTORS SUMMARY Answer the following questions (brief summary only- attach supporting documents). BACKGROUND FACTORS SUMMARY Answer the following questions (brief summary only- attach supporting documents). 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 Description Description Description Description Description Description Description
2.2 Was there a deviation from the expected sequence? Yes No If YES, describe the deviation. Attach flowchart if available. If YES, describe the deviation. Attach flowchart if available. If YES, describe the deviation. Attach flowchart if available. If YES, describe the deviation. Attach flowchart if available. If YES, describe the deviation. Attach flowchart if available. If YES, describe the deviation. Attach flowchart if available. 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. If YES, describe with causal statement. If YES, describe with causal statement. If YES, describe with causal statement. If YES, describe with causal statement. If YES, describe with causal statement. 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. If YES, cite source. If YES, cite source. If YES, cite source. If YES, cite source. If YES, cite source. If YES, cite source.
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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
AGENCY LEADERSHIP
RCA TEAM

• Gather information
• Review the incident
• Analyze and identify what contributed to the
  problem
• Study possible solutions
• Make recommendations
• Present findings

• Review findings
• Decide what action to take
• Assign responsibilities
• Manage any change
• Follow-up and track

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FAILURE MODE EFFECTS ANALYSIS
A Tool for Anticipating Problems and Correcting
them Before they Happen
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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.
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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.
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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.

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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.
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FMEA v RCA
HOW ARE THEY DIFFERENT?
HOW ARE THEY ALIKE?

• 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

• Teams
• Use Flow Charts
• Focus on Systems
• Avoid Blame
• Cause Effect Analyses
• Use Brainstorming
• Focus on Prevention
• Result in Change

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FMEA10 STEP PROCESS

• Identify High Risk processes
• Use Incident data, results of Investigations, RCA
  and/or Mortality Review
• Select a process for FMEA
• Assemble 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

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STEP 1 IDENTIFY HIGH RISK PROCESSES

• 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

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STEP 2 ASSEMBLE TEAM

• Like RCA, FMEA benefits from analysis by an
  Interdisciplinary Team
• Different perspectives and experiences
• Broadens knowledge base
• MINIMUM requirements for Team
• 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

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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 Priority
Process Step Failure Mode Impact of Failure 1 - 10 Probability 1 - 10 Discoverability 1 - 10 Risk Prioritization No. RPN 1 - 1000 Priority


















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STEP 3 PROCESS ANALYSIS
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
Prepare Water in Tub
Undress
Place in Seat
Bring to Bathing Area
Bathe

• Check temp
• Fill halfway

• Get assistance
• Properly position
• Prep for transfer

• Get supplies
• Notify staff

• Check temp
• Use lift
• Position seat
• Use straps
• Lower seat

etc.
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Failure Mode and Effects Analysis WORKSHEET FOR
CALCULATING THE RPN Risk Prioritization Number
STEP 3
Process Step Failure Mode A B C AXBXC Priority
Process Step Failure Mode Impact of Failure 1 - 10 Probability 1 - 10 Discoverability 1 - 10 Risk Prioritization No. RPN 1 - 1000 Priority


















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STEP 4 HAZARD ANALYSIS
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.
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STEP 4
Process Step Failure Mode A B C AXBXC Priority
Process Step Failure Mode Impact of Failure 1 - 10 Probability 1 - 10 Discoverability 1 - 10 Risk Prioritization No. RPN 1 - 1000 Priority


















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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.
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STEP 5A CALCULATE THE IMPACT SCORE
POINTS
CATEGORY
DESCRIPTION
10

• CATASTROPHIC 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 Failure would result in high probability
  that the entire process might fail. Potential
  for severe injury and/or econom