a snapshot of the root cause analysis process cindy bednar, rn, bsn director of licensing programs...

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.


• 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.


• 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 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


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.

• 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



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?


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?


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?


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?


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?


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?


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).


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”


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



• 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.



• 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.



• 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



• 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.


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?


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


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)


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

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


laying on the floor




posey


Patient treatedand transferred to local burn unit


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


laying on the floor




posey

Patient inlocked ward

Patient treatedand transferred to

local burn unit


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.


in wheelchair


lighter



laying on the floor




posey



local burn unit


Short Staffed


Lack of restraint alternative devices resulted in the patient being tied into his wheelchair, which decreased his ability to escape in an emergency.


in wheelchair


lighter



laying on the floor




posey



local burn unit


Short Staffed


The policy of providing patients with lighters to ignite cigarettes increased the likelihood that the patient or others could be injured by fire.


in wheelchair


lighter



laying on the floor




posey

Patient in locked

ward


local burn unit


Short Staffed


Inadequate staffing resulted in unsupervised smoking, increasing the likelihood that patients could be injured by fire.


in wheelchair


lighter



laying on the floor




posey



local burn unit


Short Staffed


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.

[email protected]

• 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

Questions?

A “Snapshot” of the Root Cause

Analysis Process

a snapshot of the root cause analysis process cindy bednar, rn, bsn director of licensing programs...

Documents

rca process

treasury slide

root cause analysis

close calls close calls

health system

effective root cause

s us manufacturing

basic principles