A “Snapshot” of the Root Cause Analysis Process Cindy Bednar, RN, BSN Director of Licensing Programs Health Facility Licensing & Compliance Division Texas Department of Health Presentation originally developed for TMF training with the Alliance of Community and Rural Hospitals

Objective The learner will be able to demonstrate an understanding of the basic principles behind an effective root cause analyses.

Root Cause… An identified reason for the presence of a defect or problem.The most basic reason, which if eliminated, would prevent recurrence.

What is a Root Cause Analysis (RCA)? It is a process for identifying the contributing causal factors that underlie variations in performance associated with adverse events or close calls. It focuses on systems and processes rather than individual performance and outcomes.

What is a Root Cause Analysis (RCA)? It identifies changes that can be made in the system through either re-design or development of new processes or systems that would reduce the risk of recurrence of the event or close call.

What is a Root Cause Analysis (RCA)? It is an inter-disciplinary process, involving experts from the frontline services, those most closely involved in the processes/ systems and those who are the most familiar with the situation. It requires participation by the leadership of the organization.

What is a Root Cause Analysis (RCA)? It focuses on prevention, not blame or punishment. Basic premise is that no one comes to work intending to make a mistake or hurt someone

The top down approach doesn’t work in health care.” “The organizing principles of a health system should be the individual patient: you start with the patient and work back. The top down approach doesn’t work in health care.” Paul O’Neill former US Secretary of the Treasury

Where did the RCA process originate? US Military (1949) to determine effect of system and equipment failures NASA for Apollo space program (1960s) US manufacturing (1960s-70s) US Auto Industry (1990s) Nuclear industry and chemical plants

The RCA process should answer the following questions... What happened? (or almost happened) Why did it happen? What happened that day? What usually happens? (norms) What should have happened? (policies) What are we going to do to prevent it from happening again? (actions/outcomes)

When should an RCA be done? Required for those occurrences specified in the rules. JCAHO designated “sentinel events.” (if you are an accredited facility) Any event or close call a facility decides merits that level of attention.

When should an RCA be done? Selected Close Calls Serious & fundamental system implications Potential for patient harm Aggregated minor incidents or close calls Close calls occur dozens to hundreds of times more frequently than the adverse event they are the harbinger of … it makes sense to learn from close calls, instead of waiting for a catastrophe to occur.

When is RCA NOT appropriate? Intentionally unsafe acts. Criminal acts. Situations involving alcohol/ substance abuse by employees.

Basic steps of the RCA process... Part I: What happened? - Demographics (date, location, etc.) - Description of the event/close call - Listing of immediate actions taken - Notation of prior similar events/close calls and action taken - Due dates

Basic steps of the RCA process... Part II: Why did it happen? What happened that day? What usually happens? What should have happened? - Brainstorming and Flow Charting - Safe simulation of the event/close call - Document review - Interviews - Literature review - Development of Root Cause statements - Feedback to the “reporter” - Lessons Learned

Basic steps of the RCA process... Part III: What are we going to do to prevent it from happening again? Development of actions and outcome measures CEO/Administration concurrence

Determining what happened... Map out the flow of the team’s initial understanding of what happened and when it happened. Use the flow chart to help the team determine what additional information is needed. Gather more information to fill in the blanks. Finalize the flow diagram.

Determining why it happened... Simulate the events if necessary. Interview those staff that the team has determined may have information about the event or circumstances at the time. Use triggering and triage questions to help you drill down to the true root causes. Keep asking why until there are no more questions and no more possible answers!

Determining why it happened... Suggested key areas to focus on during the drill down process: Human Factors - Communication Human Factors - Training Human Factors – Fatigue/Scheduling Environment / Equipment Rule/Policies/Procedures Barriers

Determining why it happened... Human Factors is: The science of designing tools, tasks and work systems to be compatible with the abilities of human users Both physical and cognitive Both knowledge and experience

Determining why it happened... Human Factors – Communication Issues related to communication, flow of information and availability of information Were issues related to patient assessment a factor in this situation? Was a lack of information or misinterpretation a factor? Was communication a factor?

Determining why it happened... Human Factors – Training Issues related to routine job training, special training & continuing education Were issues related to staff training or competency a factor in this event? Was equipment involved in this event in any way?

Determining why it happened... Human Factors – Fatigue/Scheduling Issues regarding the influence of stress and fatigue which may result from change, scheduling, staffing issues, or environmental distractions such as noise. Were personal issues or staffing a factor in this event?

Determining why it happened... Environment / Equipment Issues related to the use and location of equipment; fire protection and disaster drills; codes and regulations; general suitability and condition of the environment. Equipment failures as they may relate to human factors issues, policies & procedures questions and training needs: Was equipment involved in this event in any way? Were there environmental concerns related to this event?

Determining why it happened... Rules/Policies/Procedures Issues related to the existence and accessibility of directives, including technical information for assessing risk, mechanisms for feedback on key processes, effective interventions developed following previous events and compliance with policies, codes, standards and regulations. Were appropriate rules/polices/procedures (or lack thereof) a factor in this event?

Determining why it happened... Barriers Issues related to the effectiveness of barriers intended to protect people and property from adverse events. Was the failure of a barrier designed to protect the patient, staff, equipment or environment a factor in this event?

Determining why it happened... Finalizing and documenting your root causes and contributing factors... Root Causes should synthesize the team’s findings about what must be fixed. In selecting Root Causes, it’s useful to ask: If we control or eliminate “X,” will we prevent or minimize future events? Remember that your Root Causes will guide everything else that follows (task assignment, actions, outcome measures).

Determining why it happened... Finalizing and documenting your root causes and contributing factors... Strong root causes set up success. Weak root causes undo everything … Two examples of an ineffective RCA process: “do-overs” “no root cause”, ”everything that should have been done, was done”

Determining why it happened... Tips for Root Cause Statements... Clearly show the “cause and effect” relationship. You should clearly show the link between the root cause and the adverse outcome

Determining why it happened... Tips for Root Cause Statements... Use specific and accurate descriptors for what occurred rather than negative and vague words. Words like “carelessness” and “complacency” are bad choices and do little to describe the actual conditions or behaviors that led to the event.

Determining why it happened... Tips for Root Cause Statements... Identify the preceding cause(s), not the human error. Many adverse events have a set of events & errors For every human “error” in your causal chain, you should have a clear and obvious preceding cause.

Determining why it happened... Tips for Root Cause Statements... Identify the preceding cause(s) for procedural violations. Violations of procedure are NOT root causes Only the cause of the procedural violation can be managed

Determining why it happened... Tips for Root Cause Statements... Failure to act is only causal when there was a pre-existing duty to act. The “duty to act” may be defined by standards and guidelines for practice, or other regulatory duties to provide patient care Failure to act can only be judged based on the duty to act at the time the error occurred

How do we prevent it from happening again? Developing action plans First, decide to either eliminate, control or accept the root cause. Determine what actions will be taken Be specific, concrete and clear Specifically address the root cause/ contributing factor Give them to a cold reader and confirm that they understand the actions and would know how to go about implementing them Designate who is responsible.

How do we prevent it from happening again? Developing action plans Actions are developed to prevent or minimize future adverse events or close calls. How can we decrease the chance of the event or close call form occurring? How can we decrease the injury if the event does occur? How can involved devices, software, work process or work space be redesigned using a human factors approach?

How do we prevent it from happening again? Developing action plans Stronger actions Architectural/physical plant changes Simplify the process and remove unnecessary steps Standardize equipment or process New device with usability testing before Tangible involvement & action by leadership in support of patient safety

How do we prevent it from happening again? Developing action plans Intermediate actions Checklists/cognitive aids Increase in staffing/decrease in workload Readback Enhanced documentation/communication Software enhancements/modifications Eliminate look and sound-a-likes Eliminate/reduce distractions (sterile medical environment)

How do we prevent it from happening again? Developing action plans Weaker actions Redundancy/double checks Warnings and labels New procedure/memorandum/policy Training Additional study/analysis

- Pay More Attention - More Training Put “Knowledge in the World” through re-design instead of relying on memory and vigilance!

Measuring Success... Establishing outcome measures Must be specific and quantifiable with defined numerators, denominators and thresholds Define the sampling strategy and the timeframe for the measurement Whenever possible, measure the effectiveness of your actions, not the steps in the process related to the action Set realistic thresholds for acceptable performance levels

Let’s try one together...

Event Reported: A patient in a locked ward was found on the floor in his room with 3rd degree burns to his chest and arm. The patient had been last seen requesting a cigarette. A partially burned posey was still attached to the patient’s wheelchair.

Initial Flow Diagram Sample A B C Our Example Patient was wearing posey in wheelchair Posey ignited, burns and breaks Patient falls out of his wheel-chair Patient found burned, laying on the floor

Intermediate Step - Working Diagram Patient was wearing posey in wheelchair Posey ignited, burns, and breaks Patient falls out of his wheel-chair Patient found burned, laying on the floor Why? Why was a restraint device used? Why wasn’t a less restrictive device used? ???? Why? What was the ignition source? How was the ignition source obtained? Was this patient a known fire risk? Why was a combustible posey used?

Final Flow Diagram Patient in locked ward Patient is a fall hazard & needs assistance to stay in wheelchair Posey used to maintain position in wheelchair Patient requests cigarette and lighter Posey burns, breaks and Patient slips out of chair Patient uses lighter to ignite posey Short Staffed Staff provide smoking materials Patient found burned, laying on the floor Patient treated and transferred to local burn unit

Final Flow Diagram Patient in locked ward Patient is a fall hazard & needs assistance to stay in wheelchair Posey used to maintain position in wheelchair Patient requests cigarette and lighter Staff did not receive training on the use of restraints No restraint alternative devices are available Posey burns, breaks and Patient slips out of chair Patient uses lighter to ignite posey Staff provide smoking materials Short Staffed If posey had been fire retardant or treated with fire retardant, smaller fire & potentially less injury Procedures used to light cigarettes not assessed Too busy to supervise smoking area Patient found burned, laying on the floor Patient treated and transferred to local burn unit

Final Flow Diagram / Root Causes Patient in locked ward Patient is a fall hazard & needs assistance to stay in wheelchair Posey used to maintain position in wheelchair Patient requests cigarette and lighter Lack of staff competency in restraint use lead to the patient being tied into his wheelchair, which decreased his ability to escape in an emergency. Staff provide smoking materials Patient found burned, laying on the floor Posey burns, breaks and patient slips out of chair Patient uses lighter to ignite posey Short Staffed Patient treated and transferred to local burn unit

Final Flow Diagram / Root Causes Patient in locked ward Patient is a fall hazard & needs assistance to stay in wheelchair Posey used to maintain position in wheelchair Patient requests cigarette and lighter Staff provide smoking materials Lack of restraint alternative devices resulted in the patient being tied into his wheelchair, which decreased his ability to escape in an emergency. Patient found burned, laying on the floor Posey burns, breaks and patient slips out of chair Patient uses lighter to ignite posey Short Staffed Patient treated and transferred to local burn unit

Final Flow Diagram / Root Causes Patient in locked ward Patient is a fall hazard & needs assistance to stay in wheelchair Posey used to maintain position in wheelchair Patient requests cigarette and lighter The policy of providing patients with lighters to ignite cigarettes increased the likelihood that the patient or others could be injured by fire. Staff provide smoking materials Patient found burned, laying on the floor Posey burns, breaks and patient slips out of chair Patient uses lighter to ignite posey Short Staffed Patient treated and transferred to local burn unit

Final Flow Diagram / Root Causes Patient in locked ward Patient is a fall hazard & needs assistance to stay in wheelchair Posey used to maintain position in wheelchair Patient requests cigarette and lighter Staff provide smoking materials Inadequate staffing resulted in unsupervised smoking, increasing the likelihood that patients could be injured by fire. Patient found burned, laying on the floor Posey burns, breaks and patient slips out of chair Patient uses lighter to ignite posey Short Staffed Patient treated and transferred to local burn unit

Final Flow Diagram / Root Causes Patient in locked ward Patient is a fall hazard & needs assistance to stay in wheelchair Posey used to maintain position in wheelchair Patient requests cigarette and lighter The highly combustible nature of the restraint device increased the likelihood that the posey would ignite and burn. Staff provide smoking materials Patient found burned, laying on the floor Posey burns, breaks and patient slips out of chair Patient uses lighter to ignite posey Short Staffed Patient treated and transferred to local burn unit

Tools & Methods dcannon@chepinc.org NCPS has partnered with the Chesapeake Health Education Program (CHEP), located in Perry Point, Maryland. The NCPS Triage Cards™ booklet is available through the CHEP. E-mail Debbie Cannon for additional information. dcannon@chepinc.org

Tools & Methods Ishikawa fishbone diagram process: Brainstorm causes Put into pre-defined categories Vote on which most likely to cause problems Generate solutions (Problem: Doesn’t always encourage asking the deeper “why” questions)

Tools & Methods JCAHO http://www.jcaho.org/accredited+organizations/hospitals/sentinel+events/forms+and+tools/index.htm

Resources Center for Disease Control http://www.cdc.gov/sharpssafety/pdf/AppendixA-9.pdf VA National Center for Patient Safety http://www.patientsafety.gov/tools.html Stratos Institute http://www.stratosinstitute.com/forms/ONT-rootcauseanalysis.pdf

Resources National Quality Forum www.qualityforum.org Agency for Healthcare Research & Quality www.ahrq.gov Institute for Healthcare Improvement www.ihi.org

www.tdh.state.tx.us/hfc/PatientSafety.htm

A “Snapshot” of the Root Cause Analysis Process Questions?