Guidelines for ConductingFailure Mode and Effects

Analysis ofHealthcare Processes

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PROPRIETARY2

Joint Commission Patient Safety Standards

• Ongoing, proactive program for identifying risks and reducing unanticipated adverse events and safety risks to patients is defined and implemented (PI.3.20)– At least one high-risk process assessed annually

– A failure mode and effects analysis is performed and the criticality of effects on patients determined

– The process is redesigned to minimize risk

– Redesigned process is implemented and monitored for effectiveness

PROPRIETARY3

Failure Mode & Effects Analysis (FMEA)

• Engineering process

• Used extensively in the airline and automobile industries

• Main applications:– Quality & safety of goods/services

– Safety of processes

• Application to healthcare is recent

PROPRIETARY4

Definition of FMEA

• Systematic analysis of a process

• Identifies

– ways process might fail (failure modes)

– effects or results of failures

– possible causes of failures

• Actions are taken to reduce potential for failure

– prevent or minimize possibility of occurrence

– minimize consequences of failure

• An ongoing process of improvement

PROPRIETARY5

FMEA vs. Root Cause Analysis

• FMEA– Proactive technique

– Identifies and addresses problems before they occur

– Incorporates some features of RCA

• Root Cause Analysis (RCA)– Retrospective technique

– Used to address problems after they occur

– FMEA may be used during RCA to identify actions for improvement

PROPRIETARY6

Objectives of FMEA in Healthcare

To proactively identify and reduce risk points in healthcare processes that may negatively impact outcomes for patients, caregivers, and healthcare organizations.

• Additional benefits:– Increase effectiveness

– Increase efficiency

– Cost avoidance

PROPRIETARY7

Obstacles

• Resistance to change

• Lack of personnel time to participate in FMEA

• Lack of resources to implement improvement strategies

• Reluctance to replace immediate, convenient systems with safer, but more time-consuming ones

• Lack of support from leadership

PROPRIETARY8

FMEA Process

• Choose a process

• Form a team

• Analyze the process

• Identify strategies for improvement

• Implement strategies

• Evaluate effectiveness of actions taken

PROPRIETARY9

Choose a Process

• High-risk or error-prone processes

• New processes/procedures– In planning stage

– After implementation

• Use of equipment

• New or renovated facility design

• Other aspects of healthcare system– including non-clinical processes

PROPRIETARY10

What to Analyze

High-Risk Medications

• Anticoagulants

• Chemotherapy agents

• Insulin

• Lidocaine

• Midazolam

• Parenteral calcium

• Parenteral magnesium

• Parenteral narcotics

• Parenteral potassium

• Parenteral NaCl>0.9%

• Vasoactive agents

• Neuromuscular blockers

PROPRIETARY11

What to Analyze

Error-prone Procedures

• Examples– Dose calculations and measurements

– Telephone/oral transmission of orders

– Handwritten and pre-printed orders

– Choosing proper items from storage locations

– Use of infusion control devices

PROPRIETARY12

What to Analyze

Changes in Processes/Procedures

• Examples– New or changed medication use processes

– New diagnostic procedures

– New or changed treatment protocols

– Formulary drug reviews

– Policy and procedure development

PROPRIETARY13

What to Analyze

Incidents/High-risk processes reported in the literature

• Examples– ISMP Medication Safety Alert!

– Hospital Pharmacy

– American Journal of Health-System Pharmacy

– American Journal of Nursing

– Journal of Healthcare Risk Management

PROPRIETARY14

What to Analyze

Incidents/High-risk processes reported by healthcare

organizations and regulatory agencies

• Such as– JC (Sentinel Event Alerts. www.jointcommission.org)

– FDA (www.fda.gov/cder/drug/MedErrors)

– USP (www.usp.org)

– ASHP (www.ashp.org)

– NCCMERP (www.nccmerp.org)

– NAHQ (www.nahq.org)

– NPSF (www.npsf.org)

PROPRIETARY15

What to Analyze

Incidents/High-risk processes identified at your facility

• Through– voluntary reporting of incidents

– observation of high-risk processes

– review of patient medical records

– surveys of practitioners and patients

– performance improvement data

– evaluation of missing/unadministered doses

PROPRIETARY16

Form a Team

• Most effective when conducted by a multidisciplinary team

• Include all disciplines involved in the process being analyzed

Helpful Tip:– A team of ten or fewer members is generally the

most effective and efficient

PROPRIETARY17

Form a Team

• Team composition– Pharmacists

– Nurses

– Physicians

– Risk Managers

– Others such as• Pharmacy technicians Unit secretaries

• Materials management Dieticians

• Information systems Laboratory

• Radiology Respiratory therapy

PROPRIETARY18

Analyze the Process

• Understand the process– Track process from beginning to end

– A process flow diagram is a helpful tool

• Identify potential failure modes at each step in process

• Identify the effects of each potential failure

• Identify any checks/controls that increase likelihood of detection

PROPRIETARY19

Analyze the Process

Helpful Tips:– Ensure that the project is manageable

– For complex processes focus on an area in the process

– Develop flow diagrams of sub processes in the chosen area

– Use a system of numbering or lettering for process and sub process steps

PROPRIETARY20

Analyze the Process

Helpful Tips:– Process flow diagrams can be prepared in

advance

– The team then reviews the diagram and makes necessary revisions

– A time saver for complex processes

PROPRIETARY21

Analyze the Process

• Prioritize failure modes by estimating– Probability of each failure occurring

– Severity of effects of each failure

– Probability of each failure being detected

• Estimates made– Using ranking scales

– Considering documented reports from the literature and from the hospital’s incident reporting system

PROPRIETARY22

Analyze the Process

Helpful Tips:– Ranking scales should be meaningful to the team

and to the process under analysis

– Keep the scales simple

– Develop definitive criteria for each ranking score

– Ranking scales are a qualitative assessment tool used to prioritize areas of focus

PROPRIETARY23

Example Severity Ranking Scale

Ranking Category Criteria

1 No Harm No harm to patient

2 Minor Temporary harm to patient;monitoring or minorintervention required

3 Moderate Temporary harm to patient;initial or prolongedhospitalization

4 Major Permanent harm to patient

5 Severe Terminal injury or death

PROPRIETARY24

Analyze the Process

• Calculate Criticality Index (CI) for each failure mode

CI= O X S X D

where:O = frequency of occurrence ranking score

S = severity of effects ranking score

D = probability of detection ranking score

Criticality Index is sometimes referred to as the

Risk Priority Number (RPN)

PROPRIETARY25

Analyze the Process

• Assign priority ranking for each failure mode in decreasing order of CI– Also may want to assign priority to those with high

severity scores even though CI is low

Helpful Tips:– Keep clear, detailed documentation

– Worksheets or forms can be helpful in recording and compiling ideas and ranking scores as the analysis proceeds

PROPRIETARY26

Analyze the Process

• Identify root causes of potential failure modes– Critical to identify all root causes

Helpful Tips:– Begin with failure modes with highest CI values

– Address remaining failure modes later in descending order

– Solutions to failures with highest CI values may be solutions to less significant failures

– Cause & effect (fishbone) diagram is a helpful tool

PROPRIETARY27

Identify Strategies for Improvement

• Identify actions that could reduce the CI

• Include actions that:– decrease likelihood of occurrence

– decrease the severity of effects

– increase probability of detection

Helpful Tip:– Don’t reinvent the wheel! Look at strategies

implemented or recommended by other organizations

PROPRIETARY28

Identify Strategies for Improvement• Decide which strategies can be implemented

Factors to consider:– Likelihood that failure will be prevented

– Likelihood of a long-term vs. short-term solution

– Reliability of strategy/action (i.e., will it always work)

– Impact on other processes, resources, schedules

– Practicality

– Barriers to implementation

– Cost of implementation

– Time needed to implement

– How improvement can be measured

PROPRIETARY29

Types of Strategies for Improvement

• Redundancies

• Fail-Safes

• Eliminate item or procedure

• Limit use or access

• Location

• Appearance

• Tactile clues, special packaging

• Warning signs, labels

• Technology

• Audible alarms

• Protocols, procedures

• Documentation

• Education

• Minimize/eliminate possibility of error

• Minimize consequences of error

Cohen MR, Senders J, Davis NM, Hosp Pharm 1994, 29:319-24, 326-28, 330

PROPRIETARY30

Implement Strategies for Improvement

• Develop an action plan

• Develop process and outcome measures, as appropriate

• Complete baseline measures of key processes as necessary

• Implement action plan

Helpful Tip:– Conduct a pilot test in a selected area before facility-

wide implementation

PROPRIETARY31

Evaluate Effectiveness of Actions

• Recalculate CIs of failure modes

• Conduct process/outcome measures and reassess key processes and compare to baselines

• Improvement shown if reduction in CI values, favorable process/outcomes measures, and improvement over baseline measures

• If improvement not demonstrated, continue with FMEA

• Continue to improve the process even if improvement is shown

PROPRIETARY32

Resources

• JC Failure Mode and Effects Analysis in

Healthcare: Proactive Risk Reduction, 2007

• VA National Center for Patient Safety (NCPS)

– www.patientsafety.gov/HFMEA.html

• JC Perspectives on Patient Safety

• Cohen MR, ed. Medication Errors. APhA, 2007

PROPRIETARY33

Resources

• Hospital Pharmacy, April 1994 – 3 articles

• McNally, Page, Sutherland. Am J Health-Syst

Pharm. 1997; 54:171-7

• Fletcher CE. J Nur Admin. 1997; 27(12):19-26

• Barker D, et al. J Healthc Risk Manage. 2002; 22:9-12.

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