# Presentation: 766149

## Healthcare Failure Mode and Effect AnalysisTM

## Aimed at prevention of adverse events
Doesn’t require previous bad experience or close call
Makes system more robust
JCAHO requirement

- Aimed at prevention of adverse events
- Doesn’t require previous bad experience or close call
- Makes system more robust
- JCAHO requirement

**Notes:**
NCPS developed HFMEA to give facilities a tool that could be used to proactively evaluate our systems before an adverse event or close call occurs.  Proactive analysis gives us the opportunity to get upstream of adverse events and close calls.  The point is to take an objective look at our systems without guilt and shame being a factor as they sometimes are in retrospective analysis of an adverse event.  When done correctly a prospective analysis will identify system vulnerabilities in many parts of the process that when corrected will make our systems more robust and fault tolerant.

The new JCAHO Patient Safety Standards include a requirement for prospective analysis.  NEXT SLIDE

## 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

**Notes:**
The JCAHO Standard LD.5.2, which can be found in the Hospital Accreditation Program Standards, requires Leaders to ensure that there is an ongoing and proactive program for identifying risks to patient safety 
Components of the program include identifying and prioritizing high risk processes, selecting at least one of these high risk processes each year, and performing a prospective analysis on the process.  The goal is to identify failure modes and their effects and implement corrective actions.  

JCAHO doesn’t come out and use the term Failure Mode Effect Analysis but they do talk in terms of failure modes and their effects.

##  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

-  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

**Notes:**
FMEA has been in used for over 40 years in a number of industries to evaluate products and processes for making products.  In the traditional FMEA multidisciplinary teams, with a clearly identified scope of work.  Each identified failure mode is scored using a 10 point scale, for Severity, Occurrence and Detection.  These 3 numbers are then multiplied together to create the Risk Priority Number.  When all of the RPNs are known the team picks a cutoff and then corrects everything that has scored higher.  Once the team is finished and corrections are made the process is repeated.  The definitions used in the process are very general in nature. The top or worst score is a 10 and for severity this is anything that could result in death or injury....

## HFMEATM Components and Origin

- Traditional Failure Mode Effect Analysis
- Hazard Analysis and Critical Control Point
- VA Root Cause Analysis

## Why HFMEATM?

- HFMEATM conceptually easier for process evaluation
- Definitions are healthcare-specific (patient-centric)
- Triages vulnerabilities (hazard matrix)
- Process simplified by decision tree
- Closure with actions, outcomes and management concurrence

## 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

## Step 4: Hazard Analysis

**SEVERITY RATING:  **

**Step 4: Hazard Analysis**

| Catastrophic Event
(Traditional FMEA Rating of 10 - Failure could cause death or injury)  | Major Event
(Traditional FMEA Rating of 7 – Failure causes a high degree of customer dissatisfaction.)  |
| --- | --- |
| Patient Outcome:Death or major permanent loss of function (sensory, motor, physiologic, or intellectual), suicide, rape, hemolytic transfusion reaction, Surgery/procedure on the wrong patient or wrong body part, infant abduction or infant discharge to the wrong family
 Visitor Outcome: Death; or hospitalization of 3 or more.
 Staff Outcome: * A death or hospitalization of 3 or more staff
 Equipment or facility:  **Damage equal to or more than $250,000
 Fire: Any fire that grows larger than an incipient  | Patient Outcome:Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, increased length of stay for 3 or more patients, increased level of care for 3 or more patients
Visitor Outcome: Hospitalization of 1 or 2 visitors
Staff Outcome:  Hospitalization
of 1 or 2 staff or 3 or more staff experiencing lost time or restricted duty injuries or illnesses 
Equipment or facility:  **Damage equal to or more than $100,000
Fire: Not Applicable – See Moderate and Catastrophic  |

## PROBABILITY RATING:

**Step 4: Hazard Analysis**

_**PROBABILITY RATING:**_

**Occasional - **Probably will occur (may happen several times in 1 to 2 years)

**Uncommon - **Possible to occur (may happen sometime in 2 to 5 years)

**Remote - **Unlikely to occur (may happen sometime in 5 to 30 years)

**Frequent - **Likely to occur immediately or within a short period (may happen several times in one year)

## 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

**HFMEA****TM**** Decision Tree**

## ICU Alarm Example

*ICU Alarm Example*

## ICU Alarm Example

*ICU Alarm Example*

## ICU Alarm Example

## In Summary...

- Builds upon others work in proactive risk assessment (FMEA, HACCP, RCA)
- Only healthcare-specific analysis model in use
- Meets JCAHO criteria for prospective assessment
- Detailed description of the process to be published in the May 2002 JCAHO Journal on Quality Management

**Notes:**
TO summarize what we have covered today.  
This is an extension of the current patient safety activities; many of the components are similar or the same to what we are doing with RCAs.  The focus is on interdisciplinary teams, asking why questions, and uncovering system and process issues.
We have been in discussion with JCAHO and have their approval that this fully complies with the patient safety standard involving proactive risk assessment.  (Standard LD5.2. Select at least one high risk process for proactive risk assessment each year)
 We will assist you with this venture.  We have provided this video training,and have developed forms and educational material to assist in performing your HFMEA. As always, we are also here as points of reference and consultants on your endeavors.
We will provide additional examples of HFMEA in the Fall.  Currently you have the examples of the PSA testing and also the BCMA example.  We realize that these are not full, in-depth HFMEAs, and look forward to sharing more examples later this year.
 You only need to do one this year.  Our patient safety performance measure for 2002 requires facilities to develop a BCMA contingency plan; you may choose to make this your 2002 proactive risk assessment.  Additional information will be provided by the national BCMA committee Chaired by Jim Bagian.  
 If we’re not making mistakes, we’re not trying new things.  We anticipate that there will be some enhancements and modifications to our process and hazard matrix as you apply it to your individual situations.  We encourage and expect you to provide us with this feedback and suggested improvements.  
That is the end of the videotaped portion of our presentation.  We look forward to your questions during the next segment of our live interactive portion.  Thank you.