Healthcare Failure Mode and Effect AnalysisSM

Edward J. Dunn, MD, MPH

VA National Center for Patient Safety

edward.dunn@med.va.gov www.patientsafety.gov

Location in our VA NCPS Curriculum Toolkit

Content- Patient Safety Introduction

- Human Factors Engineering

-HFMEA ppt & exercise

Alternative Education Formats- Pt Safety Case Conference (M&M)

- Pt Safety on Rounds (Modulettes)

- HFMEA participation- Etc…

Instructor Preparation

-Swift and Long Term Trust

- “Selling the Curriculum”

- Etc…

Aimed at prevention of adverse events Doesn’t require previous bad experience (patient

harm) Makes system more robust JCAHO requirement

Why use prospective analysis?

JCAHO Standard LD.5.2Effective July 2001

Leaders ensure that an ongoing, proactive program for identifying risks to patient safety and reducing medical/health care errors is defined and implemented.

Identify and prioritize high-risk processes Annually, select at least one high-risk process Identify potential “failure modes” For each “failure mode,” identify the possible effects For the most critical effects, conduct a root cause analysis

Who uses failure mode effect analysis?

Engineers worldwide in:AviationNuclear powerAerospaceChemical process industriesAutomotive industries

Has been around for over 40 years Goal has been, and remains, to prevent accidents from

occurring

Healthcare Version - HFMEASM

Combines:– Traditional Failure Mode Effect Analysis– Hazard Analysis and Critical Control Point– VA Root Cause Analysis

Adapted and Tested in Healthcare Settings– 163 VA hospitals (with some success)– Still a complex process/time commitment (see NIH)

The Healthcare Failure Mode Effect Analysis Process

Step 2 - Assemble the Team

Step 3 - Graphically Describe the Process

Step 4 - Conduct the Analysis

Step 5 - Identify Actions and Outcome Measures

Step 1- Define the Topic

HFMEATM Hazard Scoring Matrix

Probability

Severity Catastrophic Major Moderate Minor

Frequent 16 12 8 4

Occasional 12 9 6 3

Uncommon 8 6 4 2

Remote 4 3 2 1

   

HFMEATM Decision Tree

Does this hazard involve a sufficientlikelihood of occurrence and severity to

warrant that it be controlled?

(e.g. Hazard Score of 8 or higher)

Is the hazard so obvious and readilyapparent that a control measure is not

warranted?(Detectability)

STOP

NO

YES

YES

PROCEED TO HFMEASTEP 5

NO

Does an Effective Control Measure exist for the

identified hazard?

YES

NO

Is this a single point weakness in theprocess?

(e.g. failure will result in system failure)(Criticality)

YES

NO

ICU Alarm Example

Patient is beingTransferred to ICU

Isolation Room

Monitoring Patient Alarms in ICU Isolation Room

Connect to necessaryphysiological monitor

and equipment

Provide care andmonitor Alarms

Intervene asappropriate

1 2 3 4

Sub Process StepsA. Apply transferacceptance checklistB. Determine type ofisolation and postC. Determineparameters to bemonitoredD. Gather and calibratemonitor andaccessories (e.g.transducers)

Sub Process StepsA. Don PersonalProtective EquipmentB. Connect to ventilatorif appropriateC. Connect monitoringdevices to patientD. Set Alarm parametersas appropriateE. Test Alarm Broadcast

Sub Process StepsA. Periodically checkmonitor statusB. Respond to alarms

Sub Process StepsA. Verify validity ofalarmB. Reconnectequipment (ifnecessary)C. Medically intervene(if necessary)D. Silence alarmE. Readjust alarmparameters (ifnecessary)

ICU Alarm Example

Periodically checkmonitor status

Respond toalarms

3A 3B

Failure Modes3A1 Did not check status3A2 Misread or misinterpret3A3 Partially check

Failure Modes3B1 Did not respond3B2 Respond slowly or late

Se

ve

rity

Pro

ba

bil

ity

Ha

z

Sc

ore

Sin

gle

Po

int

We

ak

ne

ss

?

Ex

isti

ng

C

on

tro

l M

ea

su

re ?

De

tec

tab

ilit

y

Pro

ce

ed

?

Ca

tas

tro

ph

ic

Fre

qu

en

t

16 N N Y

3B1a Ignored alarm (desensitized)

Ca

tas

tro

ph

ic

Fre

qu

en

t

16 N N Y C

Reduce unw anted alarms by: changing alarm parameter to f it patient physiological condition and replace electrodes w ith better quality that do not become detached

Unw anted alarms on f loor are reduced by 75% w ithin 30 days of implementation.

Nu

rse

Ma

na

ge

r Yes

3B1b Didn't hear; care giver lef t immediate

area

Ca

tas

tro

ph

ic

Oc

ca

sio

na

l

12 N N Y C

Alarms w ill be broadcast to Central Station w ith retransmission to pagers provided to care staf f .

A larms w ill be broadcast to the central station w ithin 4 months; complete by mm/dd/yyyy B

iom

ed

ica

l E

ng

ine

er

Yes

3B1c Didn't hear; alarm volume too low

Ca

tas

tro

ph

ic

Oc

ca

sio

na

l

12 N N Y E

Set alarm volume on isolation room equipment such that the low est volume threshold that can be adjusted by staf f is alw ays audible outside the room.

Immediate; w ithin 2 w orking days; complete by mm/dd/yyyy

Bio

me

dic

al

En

gin

ee

r

Yes

3B1d Didn't hear alarm; remote location

(doors closed to isolation room)

Ca

tas

tro

ph

ic

Fre

qu

en

t

16 N N Y C

See 3B1b See 3B1b

3B1e Caregiver busy; alarm does not broadcast to

backup

Ca

tas

tro

ph

ic

Oc

ca

sio

na

l

12 N N Y C

Enable equipment feature that w ill alarm in adjacent room(s) to notify caregiver or partner(s).

Immediate; w ithin 2 w orking days; complete by mm/dd/yyyy

Bio

me

dic

al

En

gin

ee

r

Yes

Actions or Rationale for Stopping

Outcome Measure

3B1 Don't respond to alarm

HFMEA Subprocess Step: 3B1 - Respond to Alarms

Scoring Decision Tree AnalysisHFMEA Step 5 - Identify Actions and OutcomesHFMEA Step 4 - Hazard Analysis

Pe

rso

n

Re

sp

on

sib

le

Ma

na

ge

me

nt

Co

nc

urr

en

ce

Failure Mode: First

Evaluate failure mode before determining

potential causes

Potential Causes

Ac

tio

n T

yp

e

(Co

ntr

ol,

Ac

ce

pt,

E

lim

ina

te)

ICU Alarm Example

“Blow-up” of One Line

Ignored alarm (desensitized)

Catastrophic

Frequent Reduce unwanted alarms by: changing alarm parameter to fit patient physiological condition and replace electrodes with better quality that do not become detached

Unwanted alarms on floor are reduced by 75% within 30 days of implementation

Failure Mode: 3B1a - Crucial Alarm Ignored and Patient Decompensated

Failure ModeCause Severity Outcome MeasureFrequency Action

HFMEA & RCA

Interdisciplinary teamDevelop flow diagramSystems focusActions & Outcome measuresScoring matrix (severity/probability)Triage questions, cause & effect diag., brainstorming

Preventive v. reactiveAnalysis of Process v. chronological caseChoose topic v. caseProspective (what if) analysisDetectability & Criticality in evaluationEmphasis on testing intervention

Similarities Differences