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Using Failure Modes and Effects Analysis (FMEA) Reduced Adverse Medical Events at This Hospital

After experiencing multiple adverse medical events, one large hospital system moved from the sole use of a reactive root cause analysis approach to include a proactive Failure Modes and Effects Analysis strategy, which significantly reduced adverse medical events. 

As was the strategy at the time, a large tax supported public health system relied on root cause analysis to analyze what went wrong after a patient had experienced an adverse medical event. 

After hiring an experienced Master Black Belt, the system learned about a better approach where potential process failures were addressed before tragedy struck, not after. While FMEA was commonly used in manufacturing, the healthcare industry still relied on an after-the-fact strategy of root cause analysis. 

Let’s learn how this story played out and how the transition was accomplished. 

Repeated patient adverse medical events required the hospital to rethink how they were dealing with this problem 

Mark, the executive vice president of operations, was seeing an increasing trend of patient adverse medical events, some of which resulted in the deaths of patients. Mark had read about the use of Six Sigma in the manufacturing environment but hadn’t seen many examples of how it could be applied in a hospital setting. 

After learning more about Six Sigma, Mark decided to recruit and hire an experienced Six Sigma Master Black Belt to help him solve the problem of increasing adverse events. Joel was hired to fill this role as the director of performance improvement. Joel was given the mission to examine all aspects of hospital operations with a special focus on reducing patient adverse medical events. 

Let’s first get a little background on adverse medical events.

At the time, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), later rebranded to The Joint Commission, was a non-profit organization that accredited most healthcare organizations. Without this accreditation, a healthcare organization could not receive federal funding such as Medicare and Medicaid, and the lack of accreditation could discourage patients from seeking care at an organization. This would be a significant financial burden. JCAHO had a set of standards that all healthcare organizations had to follow. After a rigorous visit from a JCAHO auditor, an evaluation was made to award accreditation or not.

One of the specific areas of focus was how to deal with an adverse medical event. The most serious event would be called a sentinel event. As of January 1, 2022, The Joint Commission’s definition of a sentinel event is 

A patient safety event (not primarily related to the natural course of the [patient’s] illness or underlying condition) that reaches a [patient] and results in death, severe harm (regardless of duration of harm), or permanent harm (regardless of severity of harm).” 

As per The Joint Commission’s standards, a sentinel event should be reported and a root cause analysis (RCA) conducted. RCA was defined as

a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of a sentinel event. A root cause is that most fundamental reason a problem―a situation where performance does not meet expectations―has occurred.”

RCA is a retrospective investigation as to what happened and why. The problem is, it is too late since the event has already occurred. Subsequently, The Joint Commission adopted FMEA as a prospective investigation aimed at identifying vulnerabilities and preventing failures in the future. It looks forward and asks, what could go wrong?

After being on the job for three months, Joel was asked to attend a senior leadership meeting in the basement conference room. He didn’t even know the room existed. When the conversation began, he soon realized something serious must have happened. As the story progressed, he understood the topic was about the occurrence of a serious sentinel event in which one patient died and another experienced serious harm.

The situation was that a husband and wife had been in a serious car accident. When they were brought to the emergency room, they both needed a blood transfusion. Protocol was to draw some blood, test for blood type, procure some blood from the blood bank and administer the transfusion. At the time, a label was put on the vial that held the blood draw that was then sent to the lab for typing. The procedure only required the use of the patient’s last name. As it turned out, the husband and wife had different blood types.

After the transfusion was performed, they realized they had given the wrong blood to each patient since there was no identification other than the last name – which was the same. As a result, the husband died, and the wife was severely harmed but eventually pulled through. This was why the group was meeting. Now that the harm was done, Joel realized he was going to be assigned the job of doing the root cause analysis.

Before the meeting broke up, Joel asked whether there were any other sentinel events in the past year. Unfortunately, there were. One incident involved the death of three infants. The synopsis of the story relayed by the Medical Director was as follows:

Three premature infants died after receiving adult doses of the blood thinner Heparin. Three other infants in the NICU also received adult doses. One needed surgery and the other two were in serious condition. Heparin is routinely used in premature infants to prevent blood clots that could clog intravenous drug tubes. An overdose could cause severe internal bleeding.

The process was that the drug arrives at the hospital in premeasured vials and is placed in a computerized drug cabinet by pharmacy technicians. When nurses need to administer the drug, they retrieve it from a specific drawer, which then automatically relocks.

Somehow, the adult doses were placed in the drug cabinet in the NICU. The adult and infant doses are similarly packaged with slightly different color blue stoppers, so the nurses didn’t catch the mixup. 

Furiously, Joel asked whether anybody had ever heard of FMEA 

While a RCA analysis might reveal what went wrong and provide some strategy for keeping it from happening again, there were still four dead patients, three of them infants. After hearing the story, Joel furiously asked if anyone in the meeting had heard of FMEA. To his surprise, no one had, despite FMEA being a common tool used in industry.

Joel went up to the flip chart and did a brief tutorial on how FMEA works and how it might have prevented such tragic outcomes. He then quickly reviewed the current sentinel event regarding the blood transfusions and showed the possibility that the blood mixup could have been predicted as a possible failure mode

Recall in an FMEA, you first identify possible failure modes and then determine severity, occurrence, and controls of that failure mode. By doing an actual FMEA on this event, Joel showed that one of the possible failure modes was mislabeling of the vials, which would have had a high severity, possibly including death. While the occurrence was low since it doesn’t happen often, there were little or no controls in place to catch or mitigate its occurrence.

As a result, Joel demonstrated that, had the hospital been using FMEA on its critical processes, this event may have been prevented.

Once explained, the leadership team understood how the process could help prevent adverse medical events

Although doing a complete FMEA can be time-consuming if you properly dive into the appropriate level of detail, the task is not too intellectually challenging.

The leadership team gave no pushback, and everyone was excited, especially Joe, that this might be the solution to one of their more serious and vexing hospital-wide problems. Joel was assigned a new task of taking on the problem of dispensing drugs to patients. There were a number of potential failure modes including wrong meds, wrong doses, wrong patients, wrong time, and Joel’s favorite: wrong route of administration (NO, it is a suppository, not an oral med!).

FMEA became a standard practice not only for dealing with adverse medical events 

Joel did the RCA on the blood transfusion event he was assigned, but also, working with the appropriate team of people, he completed a full FMEA. This was to supplement the preventive recommendations of the RCA and to reinforce the idea that adverse events can be predicted and prevented in almost every part of the hospital’s operations. 

Currently, The Joint Commission now requires the use of FMEA, along with control charts and process capability on the most important patient safety issues. This is what they say in their most current documents:

“Proactive risk reduction prevents harm before it reaches the patient. By engaging in proactive risk reduction, an organization can correct process problems in order to reduce the likelihood of experiencing adverse events.” 

3 best practices when implementing FMEA

While human and process error may always exist, the more proactive problem prevention you do, the less reactive root cause analysis will be needed. 

1. Problem resolution is a multi-step process 

In some cases, you may have to do a quick root cause analysis and put a bandaid on a problem. This may be followed by a more complete root cause analysis. But, proactively using such tools as FMEA will significantly reduce the amount of adverse events and the need to do an after the fact fix.

2. Involve the team; FMEA is not a solo activity 

No one person has the collective knowledge and experience to solve every problem by themselves. Use the synergy of a motivated team of people to do your FMEA and execute other problem-solving techniques. 

3. Even if it doesn’t happen often, a problem may still be significant 

In FMEA, you first identify a possible failure mode. Then you judge its severity, evaluate the probability of occurrence, and assess whether there are any controls currently in place to mitigate the problem. Don’t be fooled into overlooking a problem because it doesn’t frequently occur. Consider its severity and whether there are any controls in place.

Saving lives and preventing harm were the goals of this hospital’s use of FMEA 

In the case of this hospital, doing a solid root cause analysis had some benefit, but it was after someone had already been harmed. By including the use of FMEA as a standard practice, they were able to reduce the number of adverse medical events as well as improve a number of processes in administration, housekeeping, laundry, and food service.

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