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FMEA - Failure Mode & Effects Analysis Of Healthcare Processes
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Guidelines for ConductingFailure Mode and Effects
Analysis ofHealthcare Processes
Copyright 2008 Cardinal Health Inc. or one of its subsidiaries. All rights reserved.
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.
Question and Answer Session
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