FMEA Applied to the Phenomenon of Retained Objects After Surgery

1
FMEA Applied to the Phenomenon of Retained
Objects After Surgery

• Project Managers
• Dr. Joan Burtner and Dr. Laura Moody
• Mercer University School of Engineering

2
Presentation Overview

• Introduction
• Motivation for the Study
• Healthcare Failure Modes and Effects Analysis
  Case Study
• Typical Results
• Select Recommendations
• Questions/Comments

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Introduction

• To Err is Human Call for action with respect to
  reducing medical errors
• Case study courses at Mercer University School of
  Engineering emphasize real-world projects
• Clients MD and RN responsible for administering
  Quality programs at a hospital in the southeast

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What is an FMEA?

• Failure Modes and Effects Analysis
• FMEA is a team-based problem-solving tool
  intended to help users identify and eliminate, or
  reduce the negative effects of, potential
  failures before they occur in systems,
  subsystems, product or process design, or the
  delivery of a service. The Certified Quality
  Engineer Handbook, page 233
• CQE Body of Knowledge (Reliability and Risk
  Management)

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What is a Healthcare FMEA?

• Motivation for the HFMEA
• Joint Commission on the Accreditation of
  Healthcare Organizations (JCAHO) Standard LD.5.2
  requires facilities to select at least one
  high-risk process for proactive risk assessment
  annually
• FMEA vs HFMEA
• HFMEA combines the detectability and criticality
  steps of a traditional FMEA
• HFMEA uses a hazard score in place of the risk
  priority number (RPN) that is associated with a
  traditional FMEA
• Hazard Score obtained from the Hazard Matrix
  Table developed by the Department of Veterans
  Affairs National Center for Patient Safety

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Project Timeline 2005-2006

• Preliminary research
• Journal articles and books
• Materials provided by southeastern hospital
• Operating room observations
• Process flow and documentation
• High-Level
• Detailed counting procedures
• Healthcare Failure Modes and Effects Analysis
• Consultation with MD and RN

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Project Team

• Clients Upper level administrators at a
  southeastern hospital
• Chief Quality Officer (Physician)
• Performance Improvement Coordinator of Surgical
  Services (Registered Nurse)
• Faculty at Mercer University
• Dr. Joan Burtner Certified Quality Engineer
• Dr. Laura Moody Human Factors Engineer
• Students enrolled at Mercer University
• Industrial Engineering Seniors
• Industrial Management Seniors

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Preliminary Research

• Factors associated with retained objects
• Emergency surgery
• Unplanned change in surgical procedure
• Patient obesity (higher mean body-mass-index)
• Most likely causes for discrepancies in counts
• Intensity/complexity of the environment
• Non-standardized methods for performing counts
• Poor communication among the Operating Room (OR)
  team members

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Site-Specific Observations

• Forms used by southeastern hospital
• Qualitative assessment of process
• Two people have to witness the count for it to be
  valid
• Lap sponges are mainly lost in cases with obese
  people and/or abdominal surgeries
• Sponges will do more damage to the patient than
  instruments if left inside the body, due to
  decomposition

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Healthcare FMEA Step 1

• Define the process that will be examined and
  define the scope
• Process - Counting of surgical tools and sponges
  prior to, during and after operations
• Goal - Provide client with possible
  recommendations for performing this task that
  will attempt to prevent surgical tools and
  sponges from being left inside patients

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Healthcare FMEA Step 2

• Assemble the Team
• ISE Students
• ISE Professors
• IDM Students
• MD
• RN
• Expertise
• Subject-matter
• Process Improvement

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Healthcare FMEA Step 3

• Graphically represent the process
• Two flows generated
• High-Level process flow
• Detailed counting procedure process flow
• Only partial graphics will be presented due to
  proprietary reasons

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Healthcare FMEA Step 4

• Conduct a hazard analysis
• Define potential failures at each step in each
  process
• Define causes for failures at each step in
  process
• Assign severity rating
• catastrophic, major, moderate, minor
• Determine probability score
• Determine hazard score
• Eliminate, control, or accept failure mode
• Actions for eliminate or control
• Who is responsible?

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Process Flow and Documentation

• High-Level Process
• Highlights overall operating room procedures
• Reviewed and approved by RN
• Detailed Counting Procedures
• Highlights the specific counting procedures for
  sponges, sharps, and instruments
• Reviewed and approved by RN

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High-Level Process Flow Excerpt
1) Equipment kits are brought into the OR
2) Sterile table is prepared for operation by
scrub nurse
3) Pre-surgical count of instruments and
sponges is conducted
4) Incisions are made
No
5a) Change in end-of-shift nurse
5b) Possible change in surgeon
5c) Possible addition of new surgical staff
members
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Sponge Decision Tree Excerpt
Are only X-ray detectable sponges being used?
Yes
No
No
Use sponges that are not X-ray detectable only
for dressings.
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Healthcare Analysis Worksheet
1 Process Step
2 Potential Failure Mode
3 Potential Cause
4 Severity
5 Probability
6 Hazard Score
7 Decision (Proceed or Stop)
8 Action (Eliminate, Control or Accept)
9 Description of Action
10 Outcome Measure
11 Person responsible
12 Management Concurrence
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Sterile Table Preparation Example
1 2) Sterile table is prepared for operation by scrub technician
2 Sterile table is not set up exactly the same by every nurse
3 There is no standard procedure
4 Moderate Severity
5 Frequent Occurrence
6 Hazard Score 8 (Hazard Scoring Matrix)
7 Decision Stop
8 Action Control
9 Initiate standard procedure for sterile table setup
10 Percent of nurses conforming to new procedure
11 Nursing administrator
12 Management concurrence undetermined at this point
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Results (High-Level)

• Accept
• Step 1 - Equipment is brought into the operating
  room
• Control
• Step 3 - Pre-surgical count of the sponges and
  instruments
• Eliminate
• Step 6 - Completion of surgical process
• Instruments, sponges, or sharps are left inside
  of a patient

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Results(Detailed Counting Procedures)

• Accept
• Step 2a - Sponges are not completely separated
  during the count
• Control
• Step 11 - Object has left sterile field,
  circulator must retrieve and verify with the
  scrub nurse
• Eliminate
• Step 10 - The scrub nurse continually counts
  needles during the procedure

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Recommendations for Future

• Review FMEA worksheets
• Institute recommendations and test
• Continue to monitor process flow periodically
• Revise as necessary

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The project managers would like to acknowledge
the exceptional efforts of the members of the
student team as well as the professionalism of
our community partners at a hospital in the
southeast.
Acknowledgements
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Questions or Comments?Dr. Joan BurtnerASQ
Certified Quality EngineerAssociate Professor
of Industrial EngineeringMercer University
Macon, GA(478) 301-4127Burtner_J_at_Mercer.edu