1. Presented to [Date] By [Insert Name] The Application of FMEA to a Medication Reconciliation Process

2. 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

3. Introduction to Failure Mode and Effects Analysis (FMEA) and Its Utilization In Healthcare

4. 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)

5. 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.

6. 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.

7. 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

8. 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.

9. Application of FMEA to a Medication Reconciliation Process Upon Hospital Admission

10. 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

11. 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

12. 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

13. 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

14. 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 Analysis TM : The VA National Center for Patient Safety’s Prospective Risk Analysis System. Journal on Quality Improvement. 2002; 28:248-267.

15. Questions and Discussion