FAILURE MODES AND EFFECT ANALYSIS: A TOOL TO MANAGE PATIENT SAFETY PROACTIVELY

Introduction Latent Failures – These are likely to be removed in time and space from the focal event, but nevertheless act as The safety of a patient depends on each health contributory factors. Latent failures, also sometimes professional’s ability to “do the right thing.” As a health known as error-provoking conditions, include poor professional continuously works at improving quality, management, poorly maintained equipments, unworkable individual performance shifts to “doing the right thing procedures or short-sighted policies. Researchers found well.”1 Assuring the safety of the patient to whom services that active failures contribute only to 15% of all errors and are provided is an essential dimension of professional the balance 85% contribution is from the latent failures. performance. The Institute of Medicine (IOM) published a James Reason’s Swiss cheese model, shown in figure 1, report in year 2000 entitled To Err is Human: Building a offers a widely cited and elegant depiction of the effects of Safer Health system.2 This report describes the risks of latent failures. medical care in the United States and the documented harm that has occurred because of unsafe practices in the Figure 1: The Swiss Cheese Model of Organizational healthcare systems. Safety4


Introduction
Latent Failures -These are likely to be removed in time and space from the focal event, but nevertheless act as The safety of a patient depends on each health contributory factors. Latent failures, also sometimes professional's ability to "do the right thing." As a health known as error-provoking conditions, include poor professional continuously works at improving quality, management, poorly maintained equipments, unworkable individual performance shifts to "doing the right thing procedures or short-sighted policies. Researchers found well."1 Assuring the safety of the patient to whom services that active failures contribute only to 15% of all errors and are provided is an essential dimension of professional the balance 85% contribution is from the latent failures. performance. The Institute of Medicine (IOM) published a James Reason's Swiss cheese model, shown in figure 1, report in year 2000 entitled To Err is Human: Building a offers a widely cited and elegant depiction of the effects of Safer Health system.2 This report describes the risks of latent failures. medical care in the United States and the documented harm that has occurred because of unsafe practices in the A Patient Safety Practice application reduces the probability of adverse events resulting from exposure to the healthcare system across a range of diseases and procedures1. The delivery of care and its mode of delivery should have the least potential to cause patient harm and the greatest potential to result in an optimal outcome for the patient. Patients assume that this is what we do when we take care of them.

Systems Approach to Patient Safety Management
With respect to patient safety, there is a growing recognition that an understanding of the nature and frequency of error is a prerequisite for effective error management. However, several researchers have pointed Hence, it is the systems development that is much needed out that achieving a good understanding of failure in for patient safety improvement. It is therefore necessary to healthcare is hampered by the fact that there is no standard understand patient safety culture to tune the systems way of defining errors in healthcare, and therefore no towards patient safety. Figure 2 shows the evolution of standardized classification system3. safety culture. Anyhow, according to Reason (2000), the systems Figure 2: Evolution of Patient Safety Culture5 approach to patient safety management adopts a more sophisticated perspective, focusing not only on the individual, but also on the role of organizational factors. It is acknowledged that in order to understand the roots of individual errors, it is necessary to consider the physical, social and organizational environment in which the individual operates. From the systems perspective, a crucial distinction is made between active and latent failures.4 Active Failures -These are the proximal causes of adverse events. They nearly always involve individual error or violation and have an immediate negative effect.
The above figure indicates that the safety culture must 3. Diagram the Process -It is essential to select only 5 -8 move from reactive to proactive. In reactive culture, the highly important activities. The diagram must be linear organization takes safety seriously and does Root Cause as far as possible and it is recommended to avoid 'if X, Analysis (RCA) only after the occurrence of an incident. In then y splits'. Each activity should describe something proactive culture, the organization finds the potential which has been done (For example: Medical Officer adverse events before its occurrence. One of the tools to examines the patient, Consultant writes the operation identify such adverse events proactively is Failure Modes notes) and Effect Analysis. This article briefly describes such 4. Brainstorm -The team analyses each activity to method.
identify where the error can occur and ranks each into A methodology called Failure Modes and Effect Analysis three categories : (FMEA) is a very helpful tool to proactively identify and • What is the severity of the error when it occurs? prioritize errors that could occur in the process, rather than • What is the likelihood of occurrence? reacting after the incident. FMEA was originally developed by the U.S. military in 1949 to proactively • How difficult is it to detect the error? anticipate potential failures and became more widely used Each category gets a score on a 1-10 scale (low to high) and in the automotive industry in the 1970s. In some countries, the scores are multiplied together to give a Risk Priority FMEA already tends to be used in hospital transfusion Number (RPN) for each failure mode. To help prioritize medicine and pharmacy settings, but can be used to our improvements (assuming we cannot fix everything at improve any process.6 once), we sort the failure modes by their RPN score. The

Failure Modes and Effects Analysis (FMEA)
failure modes with the highest scores should receive our initial attention. If a failure mode is very likely to occur An FMEA document is typically built in a spreadsheet and (score 10), is very hard to detect (score of 10), and would is based on team brainstorming about what could go wrong cause a patient death (score of 10), the RPN score would be in their process. As with standardized work (with the 1000. Table 1 illustrates this. Table 1 initiation of 5S and Kaizen), FMEA is most effectively done by the people who actually work in the process, 5. Complete the FMEA form -The form which was although the FMEA could be facilitated by someone developed must be completed finalizing the ranks of experienced with that methodology6.
the activities according to the RPN score. Then use the RPN to determine where to focus your limited The following steps are used in the FMEA process.
resources. To start we are looking for failures that are 1. Select a Process -When we select a process that most severe, occur often, and are hard to detect. Of all process must be of high importance to the organization. the activities which scores highest RPN ranks 1, the 2. Assemble a Team -The team must contain all activity which scores second highest RPN ranks 2 and categories of staff who are actively involved in the so on. The highest priority must be given to the activity process. Preferably there should be 8 -10 members in that ranks 1 and take necessary action. A sample form is the team shown below.

5.
Hudson P, Applying the lessons of high risk industries 7. Analyze and test the new processes -A pilot study to health care, Quality Safety Health Care should be carried out and analyzed before adapting, 2003;12(Suppl. 1):i7-i12 institutionalizing and standardizing the process. The team must be flexible to make changes in the plan if 6. Graban Mark, Lean Hospitals, CRC Press, 1st edition, there is a necessity.
2009, pp 130-131 8. Implement & monitor redesigned process -Then the redesigned process must be implemented and monitored. The process must be reviewed routinely to improve further.
Using an FMEA is in keeping with the Lean Concept that we have to be open in talking about problems in our work place. FMEA is just a tool. Leadership must take responsibility for creating an environment of openness in the name of patient safety and error prevention.

Conclusion
For many years, healthcare organizations have relied primarily of people performing their jobs correctly to protect patients from unintended harm. Decades of research, mostly from other industries, especially from airline industry, has proven that most accidents are caused by capable but fallible people working in dysfunctional systems. Healthcare organizations are now borrowing techniques from other industries and using systems approach to improve patient safety.
Patient safety includes the same basic quality management c o m p o n e n t s : m e a s u r e m e n t , a s s e s s m e n t , a n d improvement. One of the important models is FMEA which is now often used to reduce the chance that harmful mistakes will occur. If this model can be introduced to Sri Lankan hospitals, a large sum of money due to failures can be saved.