Failure Mode and Effects Analysis (FMEA) is an ongoing quality improvement process that is carried out in healthcare organizations by a multidisciplinary team. Unlike root cause analysis (RCA), which is carried out retrospectively in response to a sentinel event, FMEA is a proactive process that acknowledges that errors are inevitable and predictable. It anticipates errors and designs a system that will minimize their impact. FMEA might reveal that an error is tolerable or that the error will be intercepted by the system of checks and balances that is part of a health system's quality improvement system. In other cases, FMEA reveals that specific steps must be put in place to address potential errors with significant impact-errors that are intolerable.
Although FMEA is now a requirement under the JCAHO Patient Safety Standards (LD.5.2), modified processes and creative methods can and should be used to regularly examine potentially dangerous processes and medical product use including drugs and devices. For example, adverse events reported to both the USP-ISMP Medication Errors Reporting Program and the JCAHO Sentinel Event Reporting Program routinely describe patient safety issues with information about the failure modes and root causes that led to these events.
Why should you attend: The problem with The Joint Commission requirement is that everyone knows something about risk management but few people know how to properly use tools such as FMEA. It is unlikely and impractical to require every hospital to acquire this expertise. The two big issues are failing to quantify risks using scientific approach and failing to use robust solutions to avoid harm to patients.
It is unlikely that each hospital will obtain the commitment to adequately staff FMEA process proactively. One can also question whether Joint Commission inspectors have the knowledge to adequately evaluate each hospital's results. The result is that some hospitals perform an activity to achieve a checkmark in a box, rather than actually eliminating risks.
Areas Covered in the Session: