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Risk Management

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What is Failure Mode and Effects Analysis (FMEA)

Failure mode and effect analysis (FMEA) is an approach included in probabilistic risk assessment. FMEA can be defined as a risk control technique used to prevent the occurrence of loss by analyzing a situation that might create risk as a later time, such as a new morphine pump that has been purchased but not been placed in use (Krenc, 2010). The purpose of FMEA is to identify ways in which that process might potentially fail. The goal of failure mode and effects analysis is to eliminate or reduce the likelihood or outcome severity of a failure.  Krenc (2010) asserts that FMEA is used before an adverse event or incident occurs, and it is considered a successful technique for proactive risk management.

According to Chang & Sun (2009) FMEA is used by risk managers in health care to attempt to understand system failures and identify opportunities to enhance patient safety. Healthcare providers need to adopt failure mode and effects analysis (FMEA) to reduce errors in healthcare (Chang & Sun, 2009). FMEA can be used at the process conceptualization, design and or assessment stages. FMEA can also be consistently applied for continuous quality improvement in care processes from planning through performance monitoring (Krenc, 2010).  

How FMEA is used in Risk Management to Improve Processes in Healthcare Organizations

FMEA is used by healthcare organizations accredited by The Joint Commission to respond to any sentinel event and also to select high-risk process for proactive risk assessment. Healthcare organizations should identify other patient safety events and high risk processes for which a FMEA would be valuable. Shirouyehzad, Dabestani & Badakhshain (2011) says that FMEA is an effective risk management strategy used to understand and reduce medical errors. FMEA assists risk managers and others in driving change before it can do harm by forecasting potential failures and proactively applying loss control techniques to those potential failures.

Applied to healthcare, FMEA is one patient safety tool that provides risk managers with the opportunity to get ahead of the curve and favorably impact the patient care environment. Shirouyehzad, Dabestani & Badakhshain (2011) noted that in health care organizations FMEA is conducted to identify potential risks that can cause accidents and adverse events. Lighter (2010) says that healthcare organizations will choose a process for FMEA that is associated with high risk of patient harm, identified by data using some of the decision tools that have been described previously by brainstorming with process experts. Through FMEA, risk management professionals will serve their organizations well by tracking regional and national loss trends even if those types of incidents have not occurred or been reported in the organization (Briner et al, 2010).      

The Impact of FMEA on Preventing Sentinel Events

FMEA can be used to investigate sentinel events in order to determine and correct its causes and thus to prevent the sentinel event or decrease the likelihood that the event will occur. Stewart (2011) noted that FMEA can be performed for all sentinel events whether the event is infection related or not. FMEA investigates the potential for sentinel events that have not yet occurred, preventing patient harm before it happens (Shirouyehzad, Dabestani & Badakhshain, 2011). An FMEA analysis is similar to a root cause analysis, but is proactive rather than reactive. Stewart (2011) noted that rather than reacting to sentinel event, an FMEA analysis is performed before a negative outcome occurs. Since FMEA is a proactive tool its impact on sentinel events is huge preventing it from occurring. In the course of FMEA and specifically during analysis of these events and assesses the impact of various potential failures/errors actually occurring (Rodrguez-Prez & Pea-Rodrguez, 2012).   

FMEA can be used to identify weaknesses in a system design and predict what is likely to happen as a result of those weaknesses. Rodrguez-Prez & Pea-Rodrguez (2012) says that FMEA is especially useful in analyzing a new design or redesign such as that which might be proposed following root causes analysis of a sentinel event. The impact of FMEA in this case is that it is used in judging the effect of an uncontrollable external failure. The impact of FMEA in sentinel events is to prevent them from occurring by attempting to identify all the ways a process could fail, estimate the probability and consequences of each failure and then take action to prevent the potential failures from occurring (Shirouyehzad, Dabestani & Badakhshain, 2011).  

What are JCAHO's Requirements in FMEA

JCAHO has developed more stringent patient safety standards in the last ten years. The major focus of JCAHO is prevention of errors. Rodrguez-Prez & Pea-Rodrguez (2012) says that effective in 2002; JCAHO required health care organizations to perform at least two FMEA annually. JCAHO requires organizations first to identify a high-risk process or population. The JCAHO standards require analysis of high-risk processes to reduce risk for error and FMEA has been commonly used to comply with this standard.  JCAHO requires an action plan that identifies the strategies the organization intends to implement to reduce the risk of similar events occurring in the future (Burnaby, Hass & O’ Reilly, 2011).

Currently, JCAHO FMEA guidelines require the selection of one high-risk process that is most frequently occurring types of sentinel events and patient safety risk factors (Stewart, 2011). Secondly, failure mode analysis is conducted on the event. Thirdly, JCAHO that FMEA pinpoints undesirable variation with adverse effects on patients. The fourth step requires redesigning, testing and implementation processes to be carried out. Finally, the effectiveness of change is measured (Burnaby, Hass & O’ Reilly, 2011).  JCAHO requires FMEA to recalculate the criticality index for each failure after implementation of the improvement. Each failure mode should be re-evaluated because improvement is one part of a process may cause improvements in other parts of the process (Briner et al, 2010).

Response to the Stated Questions Concerning FMEA

FMEA is applied to existing or proposed processes to anticipate errors and to design systems to avoid mistakes and help in risk mitigation. Risk assessment tools such as FMEA used by risk managers have evolved over time to fit in healthcare organizations. This implies that in a healthcare setting FMEA is a fundamental tool whose application cannot be overlooked. In this hospital FMEA will provide a means of performing important analysis about where a failure may occur and what effect that failure will have on the process or an outcome in the hospital (Stewart, 2011).  The advantage of FMEA derives from the use of a system of quantifying the three most important attributes of a failure mode which include severity, occurrence and ability of the hospital to detect the failure (Stewart, 2011).

In this hospital FMEA can be used in a number of areas such as reduction of medical errors, reducing the risk from blood transfusions and improving the reliability of maintenance of biomedical instruments. Shirouyehzad, Dabestani & Badakhshain (2011) assert that since the method can anticipate and eliminate potential causes of errors, FMEA serves an important function in the improvement of quality in the hospital. In this hospital, FMEA can be used in minimizing waste and rework through elimination of process steps or items that are not used or that do not add value to the process such as multiple data entry into the hospital management system (Briner et al, 2010).  FMEA can be used before an adverse event or serious incident occurs, and is considered as a proactive risk management process and tool.

FMEA is crucial to the hospital and it should be embraced by all staff. This is because it is fundamental in identifying processes for proactive risk assessment (Shirouyehzad, Dabestani & Badakhshain, 2011). The risk management team can develop a list of high-risk processes in the hospital, from which one or more processes of FMEA can be carried out. FMEA will assist risk management department to drive significant changes before they do harm by forecasting potential failures and proactively applying loss control techniques to those potential failures. 

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