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It examines each component of a particular system to determine the number of ways in which each component could fail and, not only this but the effect of a particular failure on the stability of the entire system (Spath, 2003).
One of the major concerns in the healthcare industry is safety. The assurance that a patient is in reliable hands and that the treatment being done or service being offered is safe and up to quality standards. For patient safety and wellbeing, healthcare service providers must adopt a set of rules or standards to abide by. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) assumed responsibility for the certification of hospitals in 1951, back then, the standards continued to uphold a safe environment. Because of increasing public concern with the problem of medical errors and patient injuries, JCAHO reinforced its commitment to patient safety. Commencing in 1996, JCAHO introduced several new standards that are intended to maintain continuous improvement in the safety of the services provided to the public (Spath, 2003).
In addition to adopting well-defined processes used in healthcare services and assuring that the personnel performing the processes are competent, there is a need for more safety and precautionary measures. The solution to this lies in other industries. This is when JCAHO executives considered standard changes to adopt a more proactive approach to risk reduction, they researched many other techniques to improve safety used in other high-risk industries to find one that would be adaptable to health care services as well (Spath, 2003).
So, FMEA is a proactive approach and it consumes little time and resources when compared to the return on investments. The National Center for Patient Safety website developed by the Veterans Affairs devised a set of steps applying the traditional FMEA to healthcare. The process is as follows:
- Choose a process to study. JCAHO requires the justification for the choice of topic to perform FMEA on, with supporting arguments and rationale.
- Assemble a team. The team is a vital part of the process and should have members well-versed in a variety of disciplines. The team must have a capable leader. The commencing and ending dates must also be determined through cooperation.
- Organize information about the process. During this stage, the team collaborates and comes up with useful information which is represented clearly and precisely in the flow diagram. All information should be clear and understandable and organized into sub-processes.
- Conduct a hazard analysis. In this stage, each sub-process is looked into individually. Failure modes for each component of the sub-process are assessed determining the hazard severity. (i.e., catastrophic, major, moderate, minor) Then, the probability of each hazard is determined (i.e., occasional, uncommon, remote) and all the data is organized into the scoring matrix. The team members can further assess the hazards by making decision trees for each case and defining repetitive steps.
- Develop and implement actions and outcome measures. In this step, the members finalize the causes for each failure case and decide whether to control, accept, or eliminate the cause. The controlling and eliminating ways and steps are set with their outcomes. The whole process is then reviewed and tested thoroughly (Spath, 2003).
The Joint Commission has not specified the processes that had to be used; however, an FMEA would efficiently satisfy the requirements. However, according to the Joint Commission’s standard LD.5.2, the following steps must be taken care of:
- Redesign the process to minimize the risk of that failure mode or to protect patients from its effects.
- Test and implement the redesigned process.
- Identify and implement methods to measure effectiveness.
- Implement a strategy for maintaining the effectiveness of the redesigned process.
The Joint Commission also specifies that all healthcare facilities practicing the standard must choose one high-risk process annually to perform a risk assessment. The choice depends on internal patient safety requirements or JCAHO sentinel event alerts (Spath, 2003).
Since FMEA is a proactive preventive measure that involves analyzing every process and sub-process in detail, sudden unexpected scenarios like sentinel events can be handled in a calm and organized manner. Since such cases are common in healthcare, such as serious injuries, psychological conditions, trauma, and death. FMEA’s detailed and thorough method of creating an organized set of steps for dealing with every type of possible event that might occur, as well as any failures involved in it, makes catering to sentinel events even more efficient. If such an emergency or unfortunate event takes place, thanks to FMEA, the personnel around will have a pre-determined set of steps, processes, or a case ready to relate it to. This would save precious time, effort, and in many cases, lives.
By providing sufficient preparation, proper forms, and a keen group of patient advocates, FMEAs easily can be conducted in the healthcare sector. The most important part of the process is the development of a system that monitors the ongoing changes to ensure that they have improved and continue to do so. FMEA can make a positive contribution to providing safe and quality healthcare services to the public.