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

1. ANALYTIC APPROACHES TO MANAGING RISK:The I-D-Q Approach • AN INTRODUCTION: Two Analytic Risk Management Tools: • RootCauseAnalysis • FailureMode & EffectsAnalysis 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 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.

4. RISK is all around us In one NE state, if you receive residential services from the MR/DD agency you have a: 1 in 40 chance of suffering a severe injury 1 in 50 chance of experiencing abuse or neglect And, you will probably experience 1½ unusual incidents each year. Or, if you have mental retardation and are served by the state agency, and you are: Mobility dependent - you are 6X as likely to die as a person who is mobility independent. On the other hand, if you are: Female, you are 1.06X as likely to die as a male served by the state agency. And, if you are: Over 85-yrs of age, you have a 50:50 chance of dying, but less than a 5% chance if you are younger than 65. Are these risks “reasonable?” Problem: We don’t know unless we use data & develop benchmarks!

5. Today’s Presentationwill 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 • 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 2.5chance 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 ofdata 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. 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 is an ANALYTIC Process and can help create a HOLISTIC view by using RETROSPECTIVEanalyses that look at the CONTEMPORARYanalyses that look at the PROSPECTIVEanalyses that look toward the PRESENT FUTURE PAST 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. 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 ANALYTIC METHODS SYSTEM Services Policies Practices Standards I-D-Q is an INTERACTIVE PROCESS Then use results of prospective analyses to enhance Systems and methods for Retrospective and Contemporary Analyses

15. 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 The Purpose of I-D-Q: CONTINUOUS IMPROVEMENT SYSTEM IMPROVEMENT • Changes in Policy • Protocol Development • Practice Standards • Focused Training • Better Design

16. QUALITY FRAMEWORK Quality Management Functions Design Discovery Remediation Improvement Focus 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. 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 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! AHRQ = Agency for Healthcare Research & Quality www.ahrq.gov • 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 However,NO ANALYSIScan result in evenGREATER RISKof harm to people - and - failure of our systems!

19. PRACTICAL IDEAL BALANCEIS 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.

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. Omaha World Herald July 11, 1998 Peoria Journal Star February 27, 1999 Deaths Spur An Inquiry at Facility Iowa officials are investigating procedures at Woodward State Hospital- School…. Six Doctors Charged with Mistreating Patients at Hospital for Retarded…… The Daily Record November 1, 1997 The Milwaukee Journal Sentinel April 3, 2002 The Day November 3, 2003 Norwich Nursing Home Cited in Man’s Death State Inquiry Finds Hamilton Neglected Retarded Patient, 36 Charges Filed in Group Home Neglect Case AG Prosecuting Former Caregivers for Neglect of Mentally Retarded Adults The Hartford Courant October 11, 1998 The Cincinnati Enquirer2001 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. Deadly Restraint: A Nationwide Pattern of Death 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. 1975 USFDA mandated IR for blood transfusion reactions 1978 1997 Cooper introduced IR to anesthesiology JCAHO mandates Root Cause Analysis for sentinel events 1990s 1995 CDC included IR in National Nosocomial Infection Surveillance System New York State introduced IR into NY Statewide Transfusion System JCAHO mandated hospital-based surveillance system for reporting sentinel events (voluntary reporting to JCAHO) 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:

28. 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: Only1,152events in6 years! And, 76% of these were untimely deaths. • Existing U.S. research studies suggest: • only1.5%of all adverse events are reported • 6%of ADE are identified through IR systems • only5-30%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 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% decreasein 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 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 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 toDiscover • 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. 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 evaluatewhether or not their intervention is working. • If it isn’t, they will make revisions – until change takes place.

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

38. 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

39. RCA is just like FA FUNCTIONAL ANALYSISincludes 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. Both use SYSTEMATIC ANALYSIS Like FA, ROOT CAUSE ANALYSISalso includes an examination of thesequenceof 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 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 toREDUCE THE FUTURE PROBABILITYof 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. 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. USEROOT 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 incidentthat causes harm or calls into question the adequacy of care. BARRIER.Represents a process, environmental change, or system that canpreventor reduce the probabilityof an adverse event. CONTRIBUTORY FACTOR.Additional reasons, beyond the root cause, that an adverse event has occurred. They increase risk bysetting the stagefor or contributing to the probability of an adverse event. INCIDENTIAL FINDING.Problems, inefficiencies or failures in a process or system thatdid not contributeto the incidentunder considerationbut which require attention by the organization in order to prevent other types of adverse events. PROXIMATE CAUSE.Mostobvious reasonan adverse event occurred. Immediately precedes the incident. Usually identified in investigations. ROOT CAUSE.Most basicand fundamental or underlyingcauseof 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 eventthat isunexpected and that leads directly to or places someone at risk ofdeath 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 selectedSENTINEL 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. 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 Recommendations Report reviewed by DMR Leadership Leadership Acts

47. 8 STEP APPROACH FOR ROOT CAUSE ANALYSIS

48. 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 memberswith 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. 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 “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.