The Application of FMEA to a Medication

Reconciliation Process
Presented to

[Date]

By
[Insert Name]
 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
Introduction to Failure Mode and Effects
Analysis (FMEA) and Its Utilization In
Healthcare
 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)
 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.
 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.
 HealthCare Process FMEA Steps
1. Select a high-risk process and assemble a team.
2. Diagram the process.
3. Brainstorm potential failure modes
4. Estimate the severity of the failure
5. Estimate the probability of occurrence
6. Estimate the probability of detection
7. Calculate the risk priority number
8. Prioritize failure modes
9. Identify contributing factors of failure modes
10. Redesign process
11. Analyze and test the new process
12. Implement and monitor the redesigned process
 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.
Application of FMEA to a Medication
Reconciliation Process Upon Hospital
Admission
 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
 Examples of Rating Failure Modes
Failure Mode: Independent medication histories throughout medical record with conflicting information about patient’s 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
 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
 Lessons Learned / Closing Comments
Hospital leadership, the team’s time and commitment and effective, appropriate follow through are essential
•

Flowcharting the process is a vital piece of the team’s 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
•
 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/resources/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; 28:331-339.
– DeRosier, J et al. Using Health Care Failure Mode and Effect AnalysisTM: The VA National
Center for Patient Safety’s Prospective Risk Analysis System. Journal on Quality Improvement.
2002; 28:248-267.
Questions and Discussion