Failure Mode and Effects Analysis in Health Care,By Allyson Doan, Verica Saveski, Jere Sims, and Dallisa Williams,April 27,2010,Objectives,Understand what Healthcare Failure Mode and Effect Analysis Method is. Know the history of the Failure Mode and Effect Analysis Method. Know FMEA terms. Know how to use the FMEA method. Know when this method is used and by whom. Know the steps to use the method.,What is a Healthcare Failure Mode and Effect Analysis (HFMEA)?,The process of evaluation to identify where and how a design inadequacy might fail by assessing the impact of difference failures, and identifying the parts of the process that are in most need of change.,History of FMEA,Developed in the U.S. Military 11/9/1949. Titled Procedures for Performing a Failure Mode, Effects, and Critical Analysis Failures were classified according to their impact on mission success and personnel/equipment safety,Cayman Business Systems, 2004,FMEA Terms,Failure Mode The way in which a process can fail Effect The impact on the process or customer requirements as a result of the failure Severity The impact of the effect on the customer or process Root Cause The initiating source of the failure mode Occurrence (or frequency) How often the failure is likely to occur Detection The likelihood that the failure will be discovered in a timely manner, or before it can reach the customer,iSix Sigma, 2010,Methods or steps used include review of:,Steps in the process Failure Modes What could go wrong? Failure causes Why would failure happen? Failure effects What would be the consequences of each failure?,Institute for Healthcare Improvement, 2010,Two ways to use FMEA Tool,Analyze and evaluate processes for potential impact of considered changes Discuss and analyze steps of a process Consider changes Calculate Risk Priority Number (RPN) Obtained by multiplying values assigned to severity, occurrence, and detection. Track improvement over time calculate the total RPN for a process track the RPN over time to see if changes have lead to improvement,Institute for Healthcare Improvement, 2010,When Failure Mode and Effects of Analysis is used and by who,All health facilities that are accredited by JCAHO use the FMEA method. A FMEA is performed at least once a year for all accredited health facilities. The JCAHO standards are used by hospitals, physicians, nurses, pharmacists and other health care organizations, as a means to improve quality of care in the organization. The JCAHO is used to accredit and certify medical organizations.,http:/medicalhealthcarefmea.com/,Several standards in the chapter on “Medication Management” apply to the use of medications in emergencies:,Standard MM.2.20 Medications are properly and safely stored. Standard MM.2.30 Emergency medications and/or supplies are consistently available, controlled, and secured. Under the Code Documentation and Quality Review of Codes, there are standards like:,Several standards in the chapter on “Medication Management” apply to the use of medications in emergencies:,Standard PI.1.10 The hospital collects data to monitor the performance of potentially high-risk processes, e.g. resuscitation and its outcomes. Standard PI.2.10 Data are systematically aggregated and analyzed.,Several standards in the chapter on “Medication Management” apply to the use of medications in emergencies continued,Data are analyzed and compared internally over time and externally with other sources of information when available. Comparative data are used to determine if there is excessive variability or unacceptable levels of performance when available.,Several standards in the chapter on “Medication Management” apply to the use of medications in emergencies continued,Standard PI.2.20 Undesirable patterns or trends in performance are analyzed. Standard PI.3.10 Information from data analysis is used to make changes that improve performance and patient safety and reduce the risk of sentinel events”. JCAHO standards are also used for medical restraints, administering medication and conscious sedation.,There are several benefits of using the JCAHO standards,Leads to improved patient care Demonstrates the organizations commitment to safety and quality Offers a consultative and educational experience Supports and enhances safety and quality improvement efforts May substitute for federal certification surveys for Medicare and Medicaid Provides a competitive advantage Fulfills licensure requirements in many states Recognized by insurers and other third parties Strengthens community confidence,Healthcare FMEA Process Teaching Example 1,Step 1. Define the Scope of the HFMEA along with a clear definition of the process to be studied: FMEA is focused on ICU Monitors and response time. Step 2. Assemble the team and define goals: Team Members: Management, Physicians, Nursing Staff, Respiratory Therapists, Biomedical Engineer Goal: To reduce response time to ICU Monitor Alarms,Healthcare FMEA Process Teaching Example 1,St