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

Content
- Patient Safety Introduction

Location in our VA NCPS Curriculum Toolkit Preparation Instructor

-Swift and Long Term Trust - Selling the Curriculum - Etc

- Human Factors Engineering

-HFMEA ppt & exercise

Alternative Education Formats

- Pt Safety Case Conference (M&M) - Pt Safety on Rounds (Modulettes)

- HFMEA participation
- Etc

Why use prospective analysis? Aimed at prevention of adverse events Doesnt require previous bad experience (patient harm) Makes system more robust JCAHO requirement

JCAHO Standard LD.5.2 Effective 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: Aviation Nuclear power Aerospace Chemical process industries Automotive 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

The Healthcare Failure Mode Effect Analysis Process Step 1- Define the Topic Step 2 - Assemble the Team Step 3 - Graphically Describe the Process Step 4 - Conduct the Analysis Step 5 - Identify Actions and Outcome Measures

HFMEATM Hazard Scoring Matrix Severity

Catastrophic 16 12 8 4 Major 12 9 6 3 Moderate 8 6 4 2 Minor 4 3 2 1

Probability

Frequent Occasional Uncommon Remote

Does this hazard involve a sufficient likelihood of occurrence and severity to warrant that it be controlled? (e.g. Hazard Score of 8 or higher)

NO

HFMEATM Decision Tree

NO

YES

Is this a single point weakness in the process? (e.g. failure will result in system failure) (Criticality) YES Does an Effective Control Measure exist for the identified hazard?

YES STOP

NO Is the hazard so obvious and readily apparent that a control measure is not warranted? (Detectability)

YES

NO

PROCEED TO HFMEA STEP 5

ICU Alarm Example

Monitoring Patient Alarms in ICU Isolation Room 1 2 Connect to necessary physiological monitor and equipment 3 4

Patient is being Transferred to ICU Isolation Room

Provide care and monitor Alarms

Intervene as appropriate

Sub Process Steps A. Apply transfer acceptance checklist B. Determine type of isolation and post C. Determine parameters to be monitored D. Gather and calibrate monitor and accessories (e.g. transducers)

Sub Process Steps A. Don Personal Protective Equipment B. Connect to ventilator if appropriate C. Connect monitoring devices to patient D. Set Alarm parameters as appropriate E. Test Alarm Broadcast

Sub Process Steps A. Periodically check monitor status B. Respond to alarms

Sub Process Steps A. Verify validity of alarm B. Reconnect equipment (if necessary) C. Medically intervene (if necessary) D. Silence alarm E. Readjust alarm parameters (if necessary)

ICU Alarm Example

3A 3B

Periodically check monitor status

Respond to alarms

Failure Modes 3A1 Did not check status 3A2 Misread or misinterpret 3A3 Partially check

Failure Modes 3B1 Did not respond 3B2 Respond slowly or late

ICU Alarm Example

HFMEA Subprocess Step: 3B1 - Respond to Alarms
HFMEA Step 4 - Hazard Analysis

HFMEA Step 5 - Identify Actions and Outcomes Action Type (Control, Accept, Eliminate) Decision Tree Analysis Single Point Weakness? Existing Control Measure ? Detectability

Probability

Haz Score

Frequent

3B1 Don't respond to alarm 3B1a Ignored alarm (desensitized)

Catastrophi Severity c

16

Proceed?

Evaluate failure mode before determining potential causes

Potential Causes

Actions or Rationale for Stopping

Outcome Measure

16

Catastrophic Catastrophic Catastrophic Catastrophic

Occasional

3B1b

12

Occasional

3B1c

12

Frequent

3B1d

Didn't hear alarm; remote location (doors closed to isolation room) Caregiver busy; alarm does not broadcast to backup

See 3B1b

16

Occasional

12

Biomedical Engineer

3B1e

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

Biomedical Engineer Yes

Didn't hear; alarm volume too low

Set alarm volume on isolation room equipment such that the low est volume threshold that can be adjusted by staff is alw ays audible outside the room. See 3B1b

Biomedical Engineer Yes

Didn't hear; care giver left immediate area

Reduce unw anted alarms by: changing alarm parameter to fit patient physiological condition and replace electrodes w ith better quality that do not become detached Alarms w ill be broadcast to Central Station w ith retransmission to pagers provided to care staff.

Alarms w ill be broadcast to the central station w ithin 4 months; complete by mm/dd/yyyy Immediate; w ithin 2 w orking days; complete by mm/dd/yyyy

Nurse Manager

Catastrophic

Frequent

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

Management Concurrence
Yes Yes

Person Responsible

Failure Mode: First

Scoring

Blow-up of One Line

Failure Mode: 3B1a - Crucial Alarm Ignored and Patient Decompensated
Failure Mode Action Outcome Measure Cause Severity Frequency Ignored alarm Catastro Frequent Reduce unwanted Unwanted alarms on (desensitized) phic alarms by: changing floor are reduced by alarm parameter to fit 75% within 30 days patient physiological of implementation condition and replace electrodes with better quality that do not become detached

HFMEA & RCA

Similarities
Interdisciplinary team Develop flow diagram Systems focus Actions & Outcome measures Scoring matrix (severity/probability) Triage questions, cause & effect diag., brainstorming

Differences
Preventive v. reactive Analysis of Process v. chronological case Choose topic v. case Prospective (what if) analysis Detectability & Criticality in evaluation Emphasis on testing intervention