1. 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

2. 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.

3. 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 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 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 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 Americans die each year as a result of preventable errors in their hospital care.

4. RISK is all around us Are these risks “reasonable?”
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.
Are these risks “reasonable?”
Problem: We don’t know unless we use data & develop benchmarks!

5. 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

6. CONTENTS Retrospective Analysis: ROOT CAUSE ANALYSIS FOCUS Today
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

7. GENERAL OVERVIEW

8. 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 – don’t just “blame” people
RCA, IR & FMEA are good tools for doing this
IOM: must focus on reducing faulty SYSTEMS to improve patient safety.

9. 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.

10. 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!

11. INFORMATION DRIVEN QUALITY requires procedures that analyze
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

12. I-D-Q PAST PRESENT FUTURE CMS QUALITY FRAMEWORK 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
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

13. I-D-Q is an INTERACTIVE PROCESS
Use retrospective and contemporary analyses to initiate prospective analyses.
INV
Investigations IR
Incident Data MR
Mortality Review
RCA
Root Cause Analysis IR
Incident Management
LIC
Licensing
FMEA
Failure Mode & Effects Analysis
TCA
Task Criticality Analysis PS
Predictive Statistics
RETROSPECTIVE
CONTEMPORARY
PROSPECTIVE

14. I-D-Q is an INTERACTIVE PROCESS
Then use results of prospective analyses to enhance
Systems and methods for Retrospective and Contemporary Analyses IR
Incident Management
LIC
Licensing
INV
Investigations
Incident Data MR
Mortality Review
RCA
Root Cause Analysis
FMEA
Failure Mode & Effects Analysis
TCA
Task Criticality Analysis PS
Predictive Statistics
ANALYTIC METHODS
Policies
Practices
Standards
Services
SYSTEM

15. The Purpose of I-D-Q: CONTINUOUS IMPROVEMENTIR
Incident Management
LIC
Licensing
INV
Investigations
Incident Data MR
Mortality Review
RCA
Root Cause Analysis
FMEA
Failure Mode & Effects Analysis
TCA
Task Criticality Analysis PS
Predictive Statistics
RETROSPECTIVE
PROSPECTIVE
CONTEMPORARY
SYSTEM
IMPROVEMENT
Changes in Policy
Protocol Development
Practice Standards
Focused Training
Better Design

16. Quality Management Functions
FRAMEWORK
Quality Management Functions
Focus
Design
Discovery
Remediation
Improvement
Participant Access
ANALYTIC
approaches to
performing
QUALITY
FUNCTIONS
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

17. Build into your QI system the use of data and analytic procedures
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

18. FACE VALIDITY ONLY Flawed analysis can result in:
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
However, NO ANALYSIS can result in even GREATER RISK of harm to people - and - failure of our systems!

19. BALANCE IS ESSENTIAL Do not over-emphasize data!
IDEAL
PRACTICAL
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.

20. 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:
Policies and Procedures
Identification
Notification
Triggers Response
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.

21. ROOT CAUSE ANALYSIS A Tool for Retrospective Analysis
Designed to Reduce Risk of Harm

22. 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

23. 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

24. 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 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.)

25. Risk. Managing The Day The Cincinnati Enquirer 2001
November 3, 2003
Norwich Nursing Home Cited in Man’s Death
State Inquiry Finds Hamilton Neglected Retarded Patient, 36
Peoria Journal Star
February 27, 1999
Six Doctors Charged with Mistreating Patients at Hospital for Retarded……
The Daily Record
November 1, 1997
AG Prosecuting Former Caregivers for Neglect of Mentally Retarded Adults
Omaha World Herald
July 11, 1998
Deaths Spur An Inquiry at Facility
Iowa officials are investigating procedures at Woodward State Hospital- School….
The Milwaukee Journal Sentinel
April 3, 2002
Charges Filed in Group Home Neglect
Case
The Hartford Courant
October 11, 1998
Deadly Restraint: A Nationwide Pattern of Death
The Cincinnati Enquirer 2001
Ohio’s Secret Shame
In Dayton, a mentally retarded woman is so severely dehydrated she curls up on an old couch and dies of thirst.
In Cincinnati, a mentally retarded man having a seizure dies after a caregiver hangs up on 911 operator offering help.
In Columbus, a mentally retarded man on a dairy-free diet chokes to death of a “golf ball-sized wad” of bread and cheese.
Whether by neglect, incompetence or accident, these are three of at least 12 people who died in questionable circumstances inside a state system that’s supposed to protect them.
Managing
Risk.
Or, failing to!

26. 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.

27. 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

28. RESEARCH Incident Reporting
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

29. RESEARCH Root Cause Analysis
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

30. 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!

31. Introduction to
ROOT CAUSE ANALYSIS

32. TRADITIONAL APPROACH INVESTIGATION WHAT happened & WHO was responsible
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

33. RCA APPROACH ANALYSIS WHY it happened & HOW to prevent SYSTEMS change
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

34. 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

35. WOULD YOU ACCEPT: 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.

36. WOULDN’T YOU EXPECT
A systematic process to change the conditions that promote and maintain the problem behavior?
A team of people who know the consumer and have expertise in modifying behavior will meet to develop an intervention plan.
They will analyze the situation to gain an understanding of what antecedents and consequences are maintaining the target behavior(s).
Then they will implement strategies to modify those antecedents and consequences.
They will evaluate whether or not their intervention is working.
If it isn’t, they will make revisions – until change takes place.

37. Prevention Strategies
GOOD program development for treating challenging consumer behavior is an analog for GOOD management of adverse events.
CONSUMER
INCIDENT
TEAM APPROACH
IDT
People with knowledge of the person/incident and content expertise
RCA Team
SYSTEMATIC ANALYSIS
Functional Analysis
Systematically evaluate environmental and personal characteristics related to the target behavior/incident.
Root Cause Analysis
INTERVENTION
Behavior Support Plan
Develop a plan to modify environmental antecedents and consequences that promote and maintain the behavior/incident.
Prevention Strategies
EVALUATION
Track Target Behavior(s)
Establish method to collect data and track impact or effectiveness of intervention.
Track Incidents
REVISION
Modify the Support Plan
Plan for changing the intervention if evaluation indicates it isn’t having the desired effect.
Modify Prevention Strategies

38. TEAM APPROACH IDT RCA Consumer, and people who: Know the consumer
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

39. A – B - C 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.

40. A – B - C 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.

41. USE THE SAME APPROACH TEAM APPROACH SYSTEMATIC ANALYSIS
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.

42. USE ROOT CAUSE ANALYSIS WHEN:
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.

43. PROCESS OF
ROOT CAUSE ANALYSIS

44. 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.

45. 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

46. 1 2 3 4 5 6 7 8 Process in Connecticut ADVERSE EVENT
Reporting, Protection,
Investigation,
Management Review
& Action
ADVERSE EVENT NO NO NO
Is it a
SERIOUS Event ?
Is a System
Failure Possible
Cause/Factor ?
Does
Comm,
Dep Comm, Dir QA
or IRMB Chair request
a review ?
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
Recommendations
Report reviewed
by DMR Leadership
Leadership
Acts

47. 8 STEP APPROACH FOR
ROOT CAUSE ANALYSIS

48. 1. ASSIGN TEAM Team membership will usually include:
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.

49. 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

50. FORMAT FOR 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.

51. FLOWCHARTS Excellent analytic tool:
DECISION
POINTS
EVENT
Include WHO & WHEN No
EVENT
Include WHO & WHEN
START
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

52. 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.

53. REVIEW COMMON FACTORS P
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
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
Workload
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.
Awareness
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.
Experience
Staff did not have necessary experience performing the task. If not experienced, they didn’t know whom to access for direction and support.
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.
Relationships with Consumers
Staff did not have a positive and supportive relationship with the people they were assisting.
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. P
DESCRIBE FACTORS IN OBJECTIVE TERMS & FOLLOW THE “FIVE RULES OF CAUSATION!”

54. 5 RULES OF CAUSATION Describe the “cause and effect” relationship.
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 (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.

55. 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.

56. 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

57. 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

58. EXAMPLE OF CF DIAGRAM

59. IDENTIFY ROOT CAUSE 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

60. Think About the 7 COMMON REASONS FOR STAFF “NONCOMPLIANCE”
Don’t Know WHAT to do
Incomplete instructions
Confusing or contradictory instructions
Instructions too general
Reading levels too advanced
Afraid to ask questions
Tasks are too complex
Information overload 1 2
Don’t Know HOW to do it
ALL of the above, plus:
Using new or novel equipment
No demonstration of how something is done
No guidance in the program setting 3
Don’t Understand WHY
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 4
They FORGET
Environment is distracting
Numerous competing demands and activities
Become sidetracked with other consumers
No visible cues or prompts present

61. 7 COMMON REASONS 5 6 7 FOR STAFF “NONCOMPLIANCE”
Don’t Manage TIME well
Poor time management skills
Hectic work schedule
Lack structured routines
Schedule too many tasks in limited time period 5
Lack Necessary RESOURCES
Not enough staff on duty for type of activity
Inadequate or antiquated equipment for tasks
Limited supplies
Limited supervision or technical assistance 6
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
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.

62. 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

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

64. EXAMPLE

65. 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

66. 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

67. 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:
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: 2.
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? NK
If YES, describe with causal statement.
2.4
Was the expected sequence described in policy, procedure, written guidelines, or included in staff training?
If YES, cite source.

68. 8. AGENCY ACTION RESPONSIBILITIES AGENCY LEADERSHIP RCA TEAM
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 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

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

70. 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.

71. “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.

72. 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.

73. 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.

74. FMEA v RCA
HOW ARE THEY DIFFERENT?
HOW ARE THEY
ALIKE?
Teams
Use Flow Charts
Focus on Systems
Avoid Blame
Cause & Effect Analyses
Use Brainstorming
Focus on Prevention
Result in Change
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

75. FMEA: 10 STEP PROCESS Identify High Risk processes Assemble Team
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

76. Use existing DATA to target activities
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

77. Like RCA, FMEA benefits from analysis by an “Interdisciplinary Team”
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

78. 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
Impact of Failure
1 - 10
Probability
Discoverability
Risk Prioritization No.
RPN

79. 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.
List the steps (task analysis)
Identify “sub-processes” for higher risk or more complex steps
Flow Chart (process)
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.

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

81. STEP 4: HAZARD ANALYSIS Use Brainstorming
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.
Use Brainstorming
Identify ALL potential failures – mechanical and human
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.

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

83. 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.

84. 10 7 5 3 1 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 economic loss if not detected.
MODERATE 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.
MILD 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.
MINOR/NONE 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. 7 5 3 1

85. Risk Prioritization No.
STEP 5a
Process Step
Failure Mode A B C
AXBXC
Priority
Impact of Failure
1 - 10
Probability
Discoverability
Risk Prioritization No.
RPN

86. 10 7 5 3 1 STEP 5B: CALCULATE THE PROBABILITY SCORE
POINTS
PROBABILITY
DESCRIPTION 10
VERY HIGH Very likely to occur. High frequency (multiple times each day) is probable and/or has been observed.
HIGH Likely to occur. Relatively high frequency (weekly) is probable. Has been observed to take place.
MODERATE Somewhat likely to occur. Estimate monthly or quarterly occurrence rate. Sometimes observed.
LOW Rather unlikely to occur. Estimate only yearly or every few years. Very rarely observed in the past.
VERY LOW Very unlikely to occur. Estimate occurrence only every five or more years. Has not been observed in the past. 7 5 3 1

87. Risk Prioritization No.
STEP 5b
Process Step
Failure Mode A B C
AXBXC
Priority
Impact of Failure
1 - 10
Probability
Discoverability
Risk Prioritization No.
RPN

88. 10 7 5 3 1 STEP 5C: CALCULATE THE DISCOVERABILITY SCORE
POINTS
DISCOVERABILITY
DESCRIPTION 10
VERY DIFFICULT 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.
DIFFICULT 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.
MODERATE 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.
EASY 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 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. 7 5 3 1

89. Risk Prioritization No.
STEP 5c
Process Step
Failure Mode A B C
AXBXC
Priority
Impact of Failure
1 - 10
Probability
Discoverability
Risk Prioritization No.
RPN

90. CALCULATE RPN LOW of 1 HIGH of 1000 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 1
to a
HIGH of 1000

91. EXAMPLES 7 1 5 3 3 245 EXAMPLE 2: EXAMPLE 1:
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 ?
IMPACT ?
PROBABILITY ?
DISCOVERABILITY ? 7 5 1 3 3
245
Total RPN =
Total RPN =

92. Risk Prioritization No.
STEP 5d
Process Step
Failure Mode A B C
AXBXC
Priority
Impact of Failure
1 - 10
Probability
Discoverability
Risk Prioritization No.
RPN

93. Evaluate STEPS or Processes for the number of highly critical failures
COMPLETE STEP 5: SET PRIORITIES
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.

94. Evaluate options for practicality and efficiency
STEP 6: IDENTIFY IMPROVEMENTS
Brainstorm POTENTIAL CHANGES & ENHANCEMENTS that could CONTROL or prevent the failure(s)
Evaluate options for practicality and efficiency
Common Strategies
Organizational Change
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
Staff “Buddy” System
Mentoring
Teamwork
Increase Direct Communication
Operational Procedures
Reduce “Fear”
Reward Reporting/Debriefing
Culture of Safety

95. Identify the “best” solutions
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.

96. Keep it SIMPLE and “Doable”
STEP 8: OUTCOME MEASURES
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.

97. Consider using a Project Plan to map out steps for implementation
STEP 9: IMPLEMENT CHANGE
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!

98. Use identified Outcome Measures to assess whether or not the change:
STEP 10: EVALUATE CHANGE
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

99. for learning more about Failure Mode & Effects Analysis
RESOURCES
for learning more about
Root Cause Analysis
and
Failure Mode & Effects Analysis

100. 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 (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:
Failure Modes and Effects Analysis Tool. QualityHealthCare.org.
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/ /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
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.

101. For more information or assistance please feel free to contact:
ADDITIONAL WEB RESOURCES
The following resources may provide additional assistance to readers wishing to learn more:
For more information or assistance
please feel free to contact:
Steve Staugaitis at: or

102. 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
Crying and whining
Unsteady gait progressing to inability to walk or sit
Diarrhea and refusal to eat
Bruise on lower back
Repeatedly missed day program due to illness
Ongoing communication between residential and day providers
Seen by PCP multiple times
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)

103. 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)
New Lithium Rx
Picked up by Res
(30 day supply in blisterpak)
JS has diarrhea at
Day Program –
Needs RTW order.
Complaint of back pain –
Absent from Day
Program
May have had diarrhea at
Home
(No Documentation)
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
3/2/03 – 5/9/03
5/13/03
5/23/03
5/24-5/25/03
5/25/03
JS returns to
Day Program - has
continued diarrhea
Res staff notified
Home for weekend – Res
Note re: JS not eating
JS continues to be
Sick at Day Program
Whining, unsteady, difficulty
Sitting – small bruise noted
on lower back
Res staff notify PCP
Appt already scheduled for
next day
for Annual Physical Exam
JS seen by PCP
Referral problem = bruising –
Orders x-ray and bloodwork
(No lithium levels) –
JS uncooperative for x-ray
5/26/03
5/27-5/28/03
5/29/03
5/29/03
5/30/03
6/6/03: Res Program Director resigns without notice
Res staff and Day staff
note continued
problems
Unsteady, crying, diarrhea
Psychiatrist Orders dec in
Zyprexia – did not see JS -
Told JS irritable, restless and
falling
Day Program notes
continued problems
and won’t accept back -
Calls SC who calls home –
no answer at home-
original RTW order provided
Not at Day Program
Res staff notes JS very
unstable –
Res Prog supervisors notified of
need for new RTW order
Res Prog Clin Dir calls
PCP Office in resp to RTW -
JS shows continued decline –
PCP orders inc in Levoxyl
(Diarrhea STOPS)
6/1/03
6/1-6/2/03
6/2-6/3/03
6/3-6/7/03
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
Res Prog staff and
supervisors aware of
continued decline
PCP called and asked for
X-ray – appt set for next day
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
JS very weak
staff note she needs extra
assistance – did not sleep well,
eyes moving side/side – seen
as “much worse”
Parents visit home
parents alarmed at JS’s
condition – insist on
hospital visit
6/9/03
6/9/03
6/10/03
6/11/03
6/11/03
EMTs transport to
Hospital ER
Evaluated at ER – in grave
condition – severe dehydration –
attempt to hydrate
Hospital MD reviews options –
requests nephrology consult
Lithium levels show
extreme elevation
bloodwork shows lithium level
at 6.8
Comfort measures
only provided
JS dies
Nephrology consult same day
as death – Cause of death
noted as renal failure and
hyperkalemia
6/11/03
6/11/03
6/11/03
6/11-6/13/03
6/13/03

104. 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.