Failure Modes and Effects Analysis (FMEA) was developed in the late 1940’s by the U.S. military as a means of determining the effect of system and equipment failures. In the 1960’s, NASA refined the FMEA as a means to improve reliability of space hardware. FMEA was introduced into healthcare in the 1990’s. When properly completed, a FMEA identifies and mitigates potential risks.
Those of us who have lived through an accreditation survey know the frantic activities involved in preparation for the survey. This readiness flurry is in addition to our already fast and hectic pace. In this frantic preparation, we often fail to effectively complete the required FMEA.
The ECRI Institute recently issued its top 10 patient safety concerns for 2015. By my estimation, all are process safety issues. About 50% of the concerns are technology-based and the remaining 50% are human based. All concerns are related to the interface between technology and clinicians or simply between clinicians. Medication reconciliation continues to be a persistent problem and this safety concern is related to both of these interfaces.
A properly conducted FMEA consists of a moderated, multidisciplinary team, providing input on a problem-prone process, function or area. The FMEA begins once the process has been properly flow-mapped. This flow map includes the proper sequence of the process steps and each step interactions with downstream or adjacent processes. Once the proper sequencing is in place, the team begins to consider potential failures and their effects on patient care. Using a means to determine the risk in each process step and interface, you would rank the risk based on approved criteria. Typical criteria include the severity of the effects of the risk, the ability to detect the potential failure and the degree of likelihood that the potential failure will occur. Actions are then taken on those process steps that indicate the highest amount of risk. Performed correctly, this tool is extremely valuable. Many hospitals, unfortunately, do not begin with a complete flow map. This omission minimizes the potential benefit of the FMEA. A culture of risk-based thinking would ensure that the proper attention was given to complete the activity correctly.
To illustrate, my father recently had major heart surgery. He received numerous medications post-op. Upon discharge to his first acute care rehab center, his medication reconciliation tracked along correctly. Upon discharge to his sub-acute care rehab, his medication reconciliation again tracked along correctly. Upon his discharge to home from his sub-acute care facility, two (2) post-op meds reappeared and three (3) routine meds disappeared on his medication list. Somewhere along this process, there was a failure. Medication management continues to be a persistent problem, because we not conduct an effective FMEA on that process. Adjacent or downstream processes in a flow map must consider vendors and support processes to complete an effective FMEA.
Data collected from FMEAs, near misses, RCAs, etc. should be analyzed to identify trends and possible preventive actions. This additional analysis should reduce or eliminate recurring problems, such as medication management. In healthcare, once we assume a risk-based thinking posture, effective and meaningful FMEA’s will be conducted. Are FMEA’s enough to demonstrate risk based thinking? Yes, but only once we fully understand our process flow and utilize a multidisciplinary approach to complete the FMEA.
Our profession is a series of complex processes but we are still mostly unaware of potential unintended consequences in our processes. We are all very busy in our jobs. We often experience in our hospitals that we don’t have time to do “it” correctly, but we do have time to do “it” over. An anonymous author is quoted to have said, “Produce great pumpkins, pies will follow later”. Produce great FMEA’s, patient safety will follow later.
Bio:
Ted Schmidt is a Pharmacist, a Certified Enterprise Risk Manager (CERM©), and a Senior Advisor with BlueSynergy Associates, LLC. BlueSynergy Associates maximize innovation, experience and customer perspective to reduce risk and make hospitals a safer environment. He currently advises and instructs hospitals in quality, risk, safety and environmental management systems. Ted led the largest ISO 9001 implementation in healthcare at the Veterans Administration. He is a Senior Member of the American Society for Quality and a certified Lead Auditor in quality management systems by Exemplar Global. He can be reached by email at tschmidt@bluesynergyassociates.com.