a snapshot of the root cause analysis process cindy bednar, rn, bsn director of licensing programs...
TRANSCRIPT
A “Snapshot” of the Root Cause
Analysis Process
Cindy Bednar, RN, BSNDirector 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.
• 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
What is a Root Cause Analysis (RCA)?
“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’Neillformer US Secretary of the Treasury
• 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
Where did the RCA process originate?
• 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)
The RCA process should answer the following questions...
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
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
Basic steps of the RCA process...
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.
• 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...
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
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
Determining why it happened...
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 changesSimplify the process and remove unnecessary stepsStandardize equipment or processNew device with usability testing beforeTangible 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 workloadReadbackEnhanced documentation/communicationSoftware enhancements/modificationsEliminate look and sound-a-likesEliminate/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
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
A B C
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
Sample
Our Example
Intermediate Step - Working Diagram
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?
Why?
Why was a restraint device used?
Why wasn’t a less restrictive device used?
????
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
Posey used to maintain
positionin wheelchair
Patient requests
cigarette and lighter
Posey burns, breaks and
Patient slips out of chair
Patient found burned,
laying on the floor
Patient is a fall hazard & needs
assistance to stay in wheelchair
Patient uses lighter to ignite
posey
Patient in locked ward
Patient treatedand transferred to local burn unit
Staff provide smoking materials
Short Staffed
Final Flow Diagram
Posey used to maintain
positionin wheelchair
Patient requests
cigarette and lighter
Posey burns, breaks and
Patient slips out of chair
Patient found burned,
laying on the floor
Patient is a fall hazard & needs
assistance to stay in wheelchair
Patient uses lighter to ignite
posey
Patient in locked ward
Patient treatedand transferred to local burn unit
Staff provide smoking materials
Short Staffed
Final Flow Diagram
Staff did not receive training on the use of
restraints
No restraint alternative devices are
available
Procedures used to light
cigarettes not assessed
Too busy to supervise
smoking area
If posey had been fire retardant or treated with fire
retardant, smaller fire & potentially less injury
Posey used to maintain position
in wheelchair
Patient requests cigarette and
lighter
Posey burns, breaks and patient slips out of chair
Patient found burned,
laying on the floor
Patient is a fall hazard & needs
assistance to stay in wheelchair
Patient uses lighter to ignite
posey
Patient inlocked ward
Patient treatedand transferred to
local burn unit
Staff provide smoking materials
Short Staffed
Final Flow Diagram / Root Causes
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.
Posey used to maintain position
in wheelchair
Patient requests cigarette and
lighter
Posey burns, breaks and patient slips out of chair
Patient found burned,
laying on the floor
Patient is a fall hazard & needs
assistance to stay in wheelchair
Patient uses lighter to ignite
posey
Patient in locked ward
Patient treatedand transferred to
local burn unit
Staff provide smoking materials
Short Staffed
Final Flow Diagram / Root Causes
Lack of restraint alternative devices resulted in the patient being tied into his wheelchair, which decreased his ability to escape in an emergency.
Posey used to maintain position
in wheelchair
Patient requests cigarette and
lighter
Posey burns, breaks and patient slips out of chair
Patient found burned,
laying on the floor
Patient is a fall hazard & needs
assistance to stay in wheelchair
Patient uses lighter to ignite
posey
Patient in locked ward
Patient treatedand transferred to
local burn unit
Staff provide smoking materials
Short Staffed
Final Flow Diagram / Root Causes
The policy of providing patients with lighters to ignite cigarettes increased the likelihood that the patient or others could be injured by fire.
Posey used to maintain position
in wheelchair
Patient requests cigarette and
lighter
Posey burns, breaks and patient slips out of chair
Patient found burned,
laying on the floor
Patient is a fall hazard & needs
assistance to stay in wheelchair
Patient uses lighter to ignite
posey
Patient in locked
ward
Patient treatedand transferred to
local burn unit
Staff provide smoking materials
Short Staffed
Final Flow Diagram / Root Causes
Inadequate staffing resulted in unsupervised smoking, increasing the likelihood that patients could be injured by fire.
Posey used to maintain position
in wheelchair
Patient requests cigarette and
lighter
Posey burns, breaks and patient slips out of chair
Patient found burned,
laying on the floor
Patient is a fall hazard & needs
assistance to stay in wheelchair
Patient uses lighter to ignite
posey
Patient in locked ward
Patient treatedand transferred to
local burn unit
Staff provide smoking materials
Short Staffed
Final Flow Diagram / Root Causes
The highly combustible nature of the restraint device increased the likelihood that the posey would ignite and burn.
Tools & Methods
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.
• Ishikawa fishbone diagram process:Brainstorm causesPut into pre-defined categoriesVote on which most likely to cause problemsGenerate solutions
(Problem: Doesn’t always encourage asking the deeper “why” questions)
Tools & Methods
Tools & Methods
JCAHOhttp://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
Patient Safety
Welcome to the Texas Department of Health's Patient Safety WebPage!
Patient Safety is a critical component of quality. We cannot improve patient
safety simply by punishing healthcare workers f or human errors. The problem is seldom the f ault of the individual - it is the f ault of the
system. To truly improve patient safety, we must f ocus on creating systems that minimize the opportunities f or human errors and mistakes - systems
that f ocus on prevention, not punishment. Establishing a culture of safety where people are able to report adverse events and close calls without f ear
of punishment is the key to making patient safety a reality.
Background Information on the Patient Safety Program and Medical Error Reporting Legislation
Patient Safety Program Requirements
Reporting Requirements
Reporting Forms and Rules
Training Aids and Resources
Patient Safety Links
Questions and Answers (coming soon!)
Contact Information
www.tdh.state.tx.us/hfc/PatientSafety.htm