Making A Title Slide

1
The Application of FMEA to a Medication
Reconciliation Process
Presented to Date By Insert Name
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Presentation Overview

• Introduction to Failure Mode and Effects Analysis
  (FMEA) and Its Utilization In Healthcare
• Application of FMEA to a Medication
  Reconciliation Process Upon Admission to the
  Hopsital
• Pilot Data Collection
• Lessons Learned / Closing Comments
• Questions and Discussion

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Introduction to Failure Mode and Effects Analysis
(FMEA) and Its Utilization In Healthcare
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What is FMEA?

• This method, used by other high-risk industries,
  is defined as follows
• An FMEA can be described as a systematic group
  of activities intended to (a) recognize and
  evaluate the potential failure of a
  product/process and the effects of that failure,
  (b) identify actions that could eliminate or
  reduce the chance of the potential failure
  occurring, and (c) document the entire process.
  It is complementary to the process of defining
  what a design or process must do to satisfy the
  customer. All FMEAs focus on the design, whether
  it be of the product or process.

From Potential Failure Mode and Effects Analysis
(FMEA) 3rd Edition. Reference manual developed
by the FMEA teams at Chrysler, Ford and General
Motors working under the auspices of the
Automotive Division of the American Society for
Quality Control (ASQC) and the Automotive
Industry Action Group (AIAG)
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Why Utilize FMEA in Healthcare?

• The Joint Commission on Accreditation of
  Healthcare Organizations (JCAHO) Standard LD 5.2
  requires healthcare organizations to perform
  annually at least one proactive assessment of a
  high-risk process.
• FMEA has been proven to be effective in other
  high risk industries such as nuclear power,
  aviation and automotive.
• Historically, healthcare has assessed issues,
  once an incident occurred, using a Root Cause
  Analysis (RCA). FMEA is a prospective approach.

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RCA versus FMEA

• Retrospective
• Reactive. RCA is utilized after a near-miss or
  sentinel event and is impacted by hindsight bias.
• RCA team may not engage those directly involved
  in the incident. The environment may appear as
  punitive and may be emotional due to the
  situation at hand.

• Prospective
• Proactive. FMEA is utilized to prevent a
  near-miss or sentinel event from occurring by
  identifying potential problems that exist and
  correcting the process.
• FMEA team is multi-disciplinary and includes
  front-line personnel. It is conducted in a
  non-punitive environment with the ultimate goal
  to create a safer system or process.

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HealthCare Process FMEA Steps

• Select a high-risk process and assemble a team.
• Diagram the process.
• Brainstorm potential failure modes
• Estimate the severity of the failure
• Estimate the probability of occurrence
• Estimate the probability of detection
• Calculate the risk priority number
• Prioritize failure modes
• Identify contributing factors of failure modes
• Redesign process
• Analyze and test the new process
• Implement and monitor the redesigned process

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Calculating a Risk Priority Number

• Each severity (S), occurrence (O) and detection
  (D) can be ranked using a scale from 1 to 10,
  with 1 corresponding to low risk and 10
  corresponding to high risk.
• The Risk Priority Number (RPN) can be determined
  by the following equation
• Severity Rank (S) x Occurrence Rank (O) x
  Detection Rank (D) RPN
• The RPN directs the team to areas of greatest
  potential for harm. Recommendations for
  corrective actions can be developed and
  prioritized based on results.

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Application of FMEA to a Medication
Reconciliation Process Upon Hospital Admission
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Failure Modes Identified

• Inaccurate , incomplete and/or missing
  information on patients admission medication
  histories
• No formalized approach for obtaining and
  documenting medication histories within patients
  medical records
• Inconsistencies between histories obtained by
  various disciplines and documented throughout
  patients medical records

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Examples of Rating Failure Modes

• Failure Mode Independent medication histories
  throughout medical record with conflicting
  information about patients medication history
• 10 (S) x 10 (O) x 7 (D) 700 RPN
• Failure Mode Inaccurate medication history
  obtained
• 10 (S) x 8 (O) x 7 (D) 560 RPN
• Failure Mode Incomplete and/or incorrect
  medication orders upon admission
• 10 (S) x 9 (O) x 8 (D) 720 RPN

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Medication Reconciliation Upon Admission

• Recommendations made by FMEA team
• Create single, shared medication list accessible
  to all authorized health care providers
• Obtain an accurate and complete medication list
  upon admission
• Consider use of pharmacy resources for obtaining
  medication histories in appropriate cases
  (pharmacy consult)
• Develop a formalized process for medication
  reconciliation
• Incorporate medication reconciliation into an
  advanced clinical information system

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Lessons Learned / Closing Comments

• Hospital leadership, the teams time and
  commitment and effective, appropriate follow
  through are essential
• Flowcharting the process is a vital piece of the
  teams work
• The process of medication reconciliation upon
  admission is time-consuming. Obtaining staff
  buy-in to incorporate a new process into workflow
  design can be challenging
• The FMEA process promotes positive cultural
  change within the organization

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Resources

• Failure Mode and Effects Analysis (FMEA)
• Stoll, HW. Product Design Methods and Practices.
  New York Marcel Dekker, Inc., 1999.
• From Potential Failure Mode and Effects Analysis
  (FMEA) 3rd Edition. Reference manual developed
  by the FMEA teams at Chrysler, Ford and General
  Motors working under the auspices of the
  Automotive Division of the American Society for
  Quality Control (ASQC) and the Automotive
  Industry Action Group (AIAG)
• Strategies and Tips for Maximizing Failure Mode
  and Effect Analysis in your Organization. White
  Paper prepared by the American Society for
  Healthcare Risk Management, July 2002. Available
  at http//www.hospitalconnect.com/ashrm/resource
  s/files/FMEAwhitepaper.pdf. Accessed December 6,
  2002.
• Burgmeier, J. Failure Mode and Effect Analysis
  An Application in Reducing Risk in Blood
  Transfusion. Journal on Quality Improvement.
  2002 28331-339.
• DeRosier, J et al. Using Health Care Failure
  Mode and Effect AnalysisTM The VA National
  Center for Patient Safetys Prospective Risk
  Analysis System. Journal on Quality Improvement.
  2002 28248-267.

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Questions and Discussion