focused review of a sentinel event root cause analysis

Focused Review of aFocused Review of aSentinel EventSentinel Event

Root Cause Analysis

DeterminationDetermination the Need for the Need for Focused Focused ReviewReview

• When something goes wrong, the appropriate clinical experts are in consultation– Administration– Physician leadership– Nursing leadership– Risk Management– Quality Management

DeterminationDetermination of Need for of Need for Focused Focused ReviewReview continued continued

• It is determined that the event meets the definition for sentinel events– NQF 27 Adverse Event Criteria– JCAHO Minimum Criteria

• The event is a near miss (good catch)– the event has resulted or could have resulted in

patient harm • Problems keep repeating

• Surgical Events• Product or Device

Events• Patient Protection

Events• Care Management

Events• Environmental Events• Criminal Events

NQF Adverse NQF Adverse EventsEvents

• Events resulting in an unanticipated death or major permanent loss of function, not related to the natural course of the patient’s illness or underlying condition

JCAHO JCAHO Minimum Minimum EventsEvents

• Event is one of the following (even if the outcome was not death or major permanent loss of function unrelated to the natural course of the patient’s illness or underlying condition)– Suicide of any individual receiving care, treatment or services in a

staffed around-the-clock care setting or within 72 hours of discharge– Unanticipated death of a full-term infant– Abduction of any individual receiving care, treatment or services– Discharge of an infant to the wrong family– Rape– Hemolytic transfusion reaction involving administration of blood or

blood products having major blood group incompatibilities– Surgery on the wrong individual or wrong body part– Unintended retention of a foreign object in an individual after surgery

or other procedure


• Unanticipated death or major permanent loss of function associated with a health care-acquired infection

• Severe neonatal hyperbilirubinemia (bilirubin >30 milligrams/deciliter)

• Prolonged fluoroscopy with cumulative dose >1500 rads to a single field, or any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose


• Near Misses• Repeated problems• Events which have resulted in

patient harm, or could have resulted in patient harm– “Risk thereof”

Other events Other events where RCA where RCA could be could be consideredconsidered

• Assists to prioritize safety related problems

• Applies resources (time) where they have the greatest opportunity to improve safety

• A tool intended to prioritize safety events yet not take the place of judgment

• Based on 2 dimensions

Safety Safety Assessment Assessment

CodeCode


CodeCodeSeverity:

• Based on actual and potential risk – “worst case”

• Needs to have consistent definition

• Should be determined first


CodeCode• Catastrophic

– Death or major permanent loss of function not related to natural course of illness or underlying condition

• Major– Permanent lessening of bodily function not related to natural

course of illness or underlying condition

• Moderate– Increased length of stay or level of care

• Minor– No injury, no increased length of stay or level of care


CodeCodeProbability:• More subjective, greater chance of variation• Should be reflective of the facility• Categories

– Frequent– Occasional– Uncommon– Remote

Safety Assessment Matrix

SEVERITY

Catastrophic Major Moderate Minor

Frequent 3 3 2 1

Occasional 3 2 1 1

Uncommon 3 2 1 1

Remote 3 2 1 1

Fre

qu

ency

Adapted from: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1695

Sentinel Event Sentinel Event Focused Focused Review Review

AlgorithmAlgorithmIt is determinedthat a focused

review should beconducted

The action plan isfacilitated by the

manager

RCA documentsare reviewed by

medical staff in theDepartment Meeting(includes action plan)

Manager schedulesthe RCA to be

conducted within30 days of the event

The RCA isconducted and an

action plan isestablished

Measurement planis implemented;the action plan is

evaluated foreffectiveness

• Participating in a RCA is an opportunity to learn

• Opportunity for staff to tell their story

• Emphasis is on improving the system and not correcting the individuals

Root Cause Root Cause Analysis Analysis

• Systematic process for identifying the most basic causal factor or factors for an undesirable event or problem

• Focus is on process and systems, not individuals

• Frequently ask “why “

• Confidential

• Conduct within 45 days

Root CauseRoot Cause Analysis Analysis

Root Cause Root Cause Analysis Analysis

• Who

• What

• When

• Where

• Why

• Mechanism for reporting Sentinel Events

• Investigating and evaluating causative factors

• Initiation of performance improvement

• Action plan development to prevent recurrence

Goals of a Goals of a Root Cause Root Cause Analysis Analysis

Goals of a Goals of a Root Cause Root Cause Analysis Analysis

Understand the sequence of events– Flow chart

– Cause and Effect Diagram

Chronological details can be done before to save time

Reviewing literature can help the team to differentiate between what they may or may not have within their control

• Multidisciplinary :– Key staff and departments directly

and indirectly involved in the event

– Physicians, nurses and managers

– Performance Improvement Staff

RCA TeamRCA Team

• CONFIDENTIAL

• Safe protected environment• Quality Management v.s. Risk

Management• Gain better insight into processes

involved in the event– Frequently asks “why”

• Peer Review– MN Statute §§ 145.61

• QM acts as a facilitator

Key Key AspectsAspects

• Details of the event• Human factors• Staffing• Communication• Education• Equipment• Environmental• Uncontrollable external factors• Other factors

Key ElementsKey Elements of of RCARCA

• Helps team understand event• Assures thoroughness of

investigation– Human factors/Communication– Human factors/Training– Human factors

fatigue/scheduling– Environment/Equipment– Rules/Policies/Procedures– Barriers

Triage Triage QuestionsQuestions

Minimum Scope of Root Cause Analysis for Specific Types of SentinelEvents

Detailed inquiry into these areas is expected when conducting a root cause analysis for thespecified type of sentinel event

Inquiry into areas not checked (or listed) should be conducted as appropriate to the specific eventunder review.

Suicide(24care)

MedError

ProcedureComplic

Wrong sitesurgery

Treatmentdelay

Restraintdeath

Elopementdeath

Assault,rape,hom

Transfusindeath

Infantabduction

Behavioral assessmentprocess*

X X X X

Physical assessmentprocess**

X X X X

Patient identificationprocess

X X X

Patient observationprocess

X X X X

Care planning process X X X

Staffing levels X X X X X X X X X X

Orientation & training ofstaff

X X X X X X X X X

Competency assessment/credentialing

X X X X X X X

Supervision of staff*** X X X X

Communication withpatient/family

X X X X X

Communication amongstaff members

X X X X X X X

Availability ofinformation

X X X X X

Adequacy oftechnological support

X X

Equipment maintenance/management

X X

Physical environment**** X X X X X X X

Security systems andprocesses

X X X X

Control of medications:storage/access

X

Labeling of medications X

• Root Cause Analysis Summary

• Root Cause Analysis Corrective Action Plan

• Confidential under MN Statute §§ 145.61

RCA ReportingRCA Reporting Tools Tools

To be thorough, a RCA must include:

– Determination of human and other factors

– Determine related processes and systems

– Analysis of underlying causes and effects – series of why’s

– Identification of risks and their potential contributions

Root CauseRoot Cause Analysis Analysis SummarySummary

• 5 Rules of Causation– Causal statements must clearly

show the “cause and effect” relationship

– Negative descriptors are not used in a causal statement

– Each human error must have a preceding cause

– Each procedural deviation must have a preceding cause

– Failure to act is only causal when there was a pre-existing duty to act

Determining Determining the the

Root CauseRoot Cause

HealthEast Root Cause Analysis Summary

Level of Analysis Questions/Factorsinvolved

Findings and Opportunities to Improve

What departments wereinvolved?

What happened:

What are the details of theevent?

Why did it happen:(Proximate cause)

What was the missing or weakstep in the process?

Why did that happen? What caused the missing orweak step in the process?

Why did that happen? What is currently done toprevent failure at this step?


What was the human error?

Why did that happen? Was staff performance in theprocess addressed?Was staff properly qualified?Was staffing adequate?

Why did that happen? Can orientation and inservicetraining be improved?


Was all necessary informationavailable: -when needed? -accurate? -complete?

Why did that happen? Is communication amongparticipants adequate?

Why did that happen? Are there barriers tocommunication?Is prevention of adverseoutcomes considered a highpriority?


How did the equipment fail?What broke?

Why did that happen? What is currently being done toprevent an equipment failure?

Why did that happen? What is currently being done toprotect against a bad outcome ifan equipment failure doesoccur?


What environmental factorsdirectly affected the outcome?

Why did that happen? Was the physical environmentappropriate for the process to becarried out?

Why did that happen? Are systems in place to identifyenvironmental risks?Are responses to environmentalrisks planned and tested?


Were there any uncontrollableexternal factors?

Why did that happen? Are they truly beyond theorganization’s control?

Why did that happen? How can we protect againstthem?


Were there any other factors thatdirectly influenced the outcome?

Why did that happen? What caused the breakdown atthis step in the process?

Why did that happen? How can we protect againstthem?

Type of Event:

Patient suicide Op/post-op complication Medication error Wrong-site surgery Delay in treatment Patient death/injury in restraints Patient fall Assault/rape/homicide Patient elopement Perinatal death/loss of function Transfusion error Fire

Infant abduction/wrong family Medical equipment – related Ventilator death/injury Maternal death Death associated with transfer Utility system failure Anesthesia – related Infection – related Dialysis – related In-patient drug overdose Self-inflicted injury Other (less frequent)

Root Cause(s) Identified by the RCA Team:

Check categories that apply: Behavioral assessment process Physical assessment process Patient identification process Patient observation procedures Care planning process/coordination of care Staffing levels Orientation and training of staff Competency assessment/credentialing Supervision of staff Access to care

Communication with patient/family Communication among care team members Availability of information Adequacy of technological support Equipment maintenance/management Physical environment Security systems and processes Control of medications: storage/access Labeling of medications

Additional Details:

Patient Name/Number: Where incident occurred:

Date of incident: Date Root Cause Analysis Completed:

Participants in Root Cause Analysis: Conclusions/Recommendations:

Please list references of literature search:(articles can be found in the central library)See attached bibliography.

Please attach the associated policies:(including any newly revised policies)

Questions?

Focused Review of aFocused Review of aSentinel EventSentinel Event

Developing a Corrective Action Plan

• Historically the weakest link to the process

• Often RCA teams conclude solutions based on:– Recognition of warning signs– Training/education– Asking clinicians to “be more careful”

• Creates challenges for the RCA team

Corrective Corrective Action Plan Action Plan

• Strong actions:– Physical plant changes– New device with usability testing prior to

purchase– Forcing functions– Simplifying process – remove unnecessary steps– Standardize process/equipment– Leadership is actively involved



• Intermediate actions:– Decrease workload– Software enhancements/modifications– Eliminate/reduce distraction– Checklists/cognitive aids/triggers/prompts– Eliminate look alike and sound alike– Read back– Enhanced documentation/communication– redundancy


• Weak actions:– Double checks– Warnings/labels– New policies/procedures/memorandums– Training/education– Additional study

• Do the Actions meet the following:– Address the root cause and contributing

factors– Specific– Easily understood and implemented– Developed by process owners– Measurable


• Identifies opportunities for improvement

• Assigns responsibility for actions

• Target dates are set for completion

• Looks at follow up for effectiveness by using a measurement plan

CorrectiveCorrectiveAction PlanAction Plan

Why Measure?• Confirmation that what we wanted to

accomplish did in fact occur• Measures effectiveness of action, not the

completion of the action• “All improvement will require change, but

not all change will result in improvement” G. Langley, et al

• “In God we trust. All other bring data” W.E Deming

Measure of Measure of EffectivenessEffectiveness

How will we know that the change results in improvement?

Measurement answers the question• Quality improvement measurement is for learning,

not judgment, not research• All measures have limitations• Measurement should be used to guide improvement

and test changes• Focus on the changes made in the action plans

What to MeasureOutcome Measures

• Reflect cumulative impact of multiple processes

• “Big picture” – Are we doing the right thing– Are we getting the results we

want– Did we influence the health of

the patient

• Reflect the health state of a patient resulting from our care

• Further investigation is needed to understand what processes need to be changed

Outcome Measures

• How many falls on this unit?

• How many pressure ulcers occurred on this unit?

• How many wrong site surgery events did we have?

• How many medication errors occurred on this unit

What to Measure

Process MeasuresReflect current condition of our

processes– Are they still working for us– Are we using them– Are we using the accurately

• Determine if processes are functioning effectively and efficiently

• Used to assess adherence to recommendations in clinical practice

• Able to identify specific areas of care that may require improvement

Process Measures• How many patients had the

tool to assess for risk of falls• How many patients with a

Braden score of 6 had a WOC nurse consult

• How many times was the pause for cause observed correctly

• How many nurses matched the patient’s ID band to the MAR

How to Measure

Complex and untimely

• Chart abstraction

• Financial reports

• Data obtained from existing databases and systems

Guide change, indicate progress, timely

• Tally sheets

• Checklists

• Questionnaires

• Feedback interviews

• Observation

• Daily reviews

Measurement Plan• Measures effectiveness of action,

not the completion of the action

• Defined numerator/denominator

• Defined sampling plan and time frame

• Realistic performance threshold• Plan for when initial measure did not

meet threshold


Measurement Plan Examples• % patients with risk assessment tool

used – Randomly sample 10 patients/month for 3 months. If goal of 90% not reached, discuss with staff to determine barriers and make necessary changes, then re-audit.

• % Pause for Cause observed to be correctly done by OR staff – Randomly observe 10 surgeries/month for 3 months. If goal of 90% not reached, discuss with staff to determine barriers and make necessary changes, then re-audit.


• Share with staff and Administration– Need to go beyond “share

at staff meeting” - action is not sustained

• Collaborate with other units and sites

• Report sent to Medical Department for review/comments

Spread the Spread the Success/knowledgSuccess/knowledgee

HealthEastRoot Cause Analysis

IMPROVEMENT ACTION PLAN

Type of Event:

Category of Root Cause:

Opportunity to Improve Action ResponsiblePerson

Target Date ForImplementation

CompletionDate

Measures:

Follow-up for Effectiveness:

CONFIDENTIALProtected under

Minnesota Statute §§ 145.61 et seq.

ACTION PLAN OWNER(s):HealthEast

Root Cause Analysis

IMPROVEMENT ACTION PLAN

Opportunity to Improve Action Rating

Action ResponsiblePerson

Target Date For

Implementation

Completion

DateInitials

MeasuresFollow-up for Effectiveness

Questions?

Thank You!

Rosemary Emmons RN,BSN

HealthEast Quality Management

651-232-3392 phone

651-864-2535 pager

651-232-4435 fax

[email protected]

focused review of a sentinel event root cause analysis

Documents

safety events

repeating slide

control slide

effectiveness slide

problems events

level of care slide

sentinel events nqf

reporting sentinel events