Tool offers preventive approach to tackling safety-related issues
Tool offers preventive approach to tackling safety-related issues
JCAHO puts seal of approval’ on aerospace industry tool
It’s an old story with a new twist: A safety tool that has been used in other industries for approximately 30 years has been "discovered" by the health care profession. Failure mode and effect analysis (FMEA), a tool first used by aerospace engineers to institute a proactive approach to safety, remains a mystery to many quality professionals.
But that’s changing now. The Joint Commission on Accreditation of Healthcare Organizations has required that one failure mode analysis project be designated as of Oct. 1, 2001, and completed by July 1, notes Patrice L. Spath, of Forest Grove, OR-based Brown-Spath & Associates. (The Joint Commission refers to the process improvement technique as FMECA, or failure mode, effects, and criticality analysis.) FMEA, as it is more widely known, is a team-based tool. It involves the identification and prioritization of "failure modes" (likely areas of process breakdown) using a point system. Three factors — occurrence, severity, and detection — are rated from one to 10 by the team for each mode. (See sample rating scales, below.)
The resulting numbers then are multiplied, creating a risk priority number, or RPN. The higher the number, the higher priority a particular mode is assigned. The team then determines a course of action, and when that action is completed, the RPN is recalculated. "It seems that for a lot of the organizations, this is all brand-new," notes Mike Rudolf, director of performance improvement at VHA-East Coast in Cranbury, NJ. "The good news is that everyone is now aware of it. I just did an orientation session for our Quality Council, comprised of the chief qualify officers of all of our hospitals." The not-so-good news, he says, is that very few of them have done anything with FMEA, "but that’s all changing. A couple of us are going to one of our member systems in New Jersey, for example. They want us to work with them and show them how they can really do this."
A proactive approach
Quality professionals who have worked with FMEA are most impressed with its proactive nature. "It allows you to create a guideline, if you will, for determining where your weak spots are, rather than saying I know we have them,’ and reacting to whatever difficulties arise in your process," says David L. Snow, RPh, MBA, quality management facilitator at the M.D. Anderson Cancer Center in Houston. "It sounds generic, but in health care, we have very complex systems intertwined like a ball of yarn, and it’s difficult to tell in advance where the problems are going to arise," he says.
"The detection piece has been a real eye-opener," says Tina Maund, MS, RN, director for performance improvement at Atlantic Health System/Overlook Hospital in Summit, NJ. "How critical is it to know at the time of failure that there is a failure? FMEA has brought us to process changes that we might not have focused on otherwise," she adds.
"Failure mode analysis is much more proactive than, say, root-cause analysis," Rudolf adds. "It allows me in the hospital setting to choose something that’s really vital to safety and to the smooth process flow of the services we provide." When root-cause analysis is employed, Rudolf continues, "the event becomes my issue; it happened in my unit. You start to preclude yourself from being able to borrow from other folks. With failure mode, I’m very optimistic that people will be able to share." In addition, he says, "FMEA is a planning tool, while root-cause analysis is retrospective."
Because of this, FMEA can be a "dynamite tool" in assessing potential new service lines, Rudolf adds. "We have a lot of hospitals that are either renovating their emergency departments or expanding outpatient capabilities, and FMEA allows you to look at the key aspects of those processes," he explains.
"Another major strength is that FMEA allows you to apply objectivity in analyzing the safety of your process and look at individual process components and assess them with some objectivity," Maund says. "Also, because it allows you to do this with a group of people who know the process well, it really involves the participants. And by looking closely at the three components, it allows you to very specifically see where the vulnerabilities are, and what you need to focus on," she says.
Another strength of FMEA, Spath says, is that "it forces you to look at the human factors in a process, which is something we’ve not done before. You now have to look not only at the process and how it works, but at how people interact with it." Maund agrees. "FMEA can be very helpful in improving processes to reduce both human error and the errors built into the processes themselves," she asserts.
No process is perfect . . .
For all of its strengths, FMEA has its drawbacks as well. And knowing those weaknesses is as important to your ultimate success as knowing its strengths, the experts note. The complexity of health care itself is one of the potential problems, says Snow. "It’s difficult to see all the potential problems that might arise; you have to break things down into very small bits of process — smaller elements — and then put the blocks together and see if things work better. What one team may be working on in one area or process can intertwine or interface with what others are doing, and you may be able do a good FMEA on one part of the process but it can be hard to tell how it will impact others. For example, diagnostic imaging processes might overlap with outpatient services. To apply FMEA to a widget factory is one thing; to apply it to the complex issue of health care is another."
In addition, he notes, health care is very soft; we often don’t have hard results that tell us if a process has a failure mode in it. "You can look at a process, and it seems to be fine, but one day you get an event; it had a weak spot, but we never could have prevented it," he says. For example, Snow notes, his staff conducted an FMEA on the medication process, from ordering and preparation to dispensing and patient monitoring. "We looked at 14 different locations; we found one underlying single process that had 145 different variations. To analyze this from . . . the point of view of the hematology service, you can go through the whole analysis and find the process is good for them but it has error-prone gaps for another type of patient care. So you actually need to have variations on the theme."
Spath has similar concerns. "The tool was originally designed to be used during the design phase of a process," she explains. "It’s been used mostly in the computer industry, to test software before it’s released. When you test something like software, you can pretty accurately predict the chance of failure. In the construction industry, you have a pretty good idea of the chances of a bridge falling down; we really don’t have that kind of data. In FMEA, when you brainstorm all the things that could go wrong, the next step is to determine probability — and that will be a pretty subjective decision. It can be done, but it’s not as statistically valid as in other industries."
There are possible legal risks, as well. "Let’s say it’s determined that the chances of giving the wrong chemotherapy are slim; your team determines that they don’t think it will happen," Spath offers. "One month later, a patient gets the wrong medicine and dies. The case goes to court, and the opposing attorney sees that we knew about the problem but didn’t do anything about it. People have to be willing to take the risk of not doing something about every possible risk they might find."
Despite these potential concerns, Spath says, "On balance [FMEA] is positive because it gets us to focus on something we have not done before." Snow agrees. "I don’t think the weaknesses should have any impact on its acceptance," he says. "Failure mode analysis can be applied anywhere, and the concept is easy to understand."
Raising the odds of success
While recognizing the potential pitfalls of FMEA, you can increase the likelihood of success by paying close attention to the key elements of the process, says Maund. "One key is to definitely have the people who are consistently involved in carrying out the target process doing the FMEA," she says. "In addition, you have to do your homework first. You need to come to this discussion with a thorough understanding of the process, detailed process flowcharts, and some cause-and-effect work done on the process. This does take time.
"You also need to help people understand FMEA before they apply it," she continues. "At the beginning of the analysis session, you go through and explain what it is, show examples of how it is used, explain the different scales, and allow for practice time. Discuss hypothetical cases and how FMEA might be used." Snow says that staff perceptions also must be addressed. "Since so few people know about FMEA, the hang-up in health care is the terminology," he notes. "When I explained the basic approach to a small group by saying that FMEA involves analyzing in advance what could go wrong with our process, they clearly grasped the concept."
Here to stay?
What does the future hold for FMEA in health care? The outlook is mixed, say the experts, but the bottom line is that FMEA, or something like it, has a place in the profession. "I think it has to catch on, and it will," Snow predicts. "After all, 30 years ago, not many people knew what root-cause analysis was. FMEA will end up in the same boat."
"I’d be prepared for it to take awhile," says Rudolf, who also has some misgivings about how FMEA will fare as part of the accreditation process. "The Joint Commission is getting some recommendations to focus on severity and occurrence more than on detection, and that’s really where the scoring will come into play; I don’t know if I agree," he says. "One thing we in health care don’t have in place is a preventive process that is well-documented." Since the Joint Commission began requiring the use of root-cause analysis, he notes, it has become a mandated exercise, "and in many ways, we have missed the goal of getting better. Many organizations just did it to get it done. And since one person did it all, it never fed through the organization to make things better. The same could happen with FMEA."
"I think the concept of identifying what can go wrong, of anticipating problems and fixing them before things go wrong, is a concept that has a future in health care," Spath predicts. "It’s essentially proactive error management. This concept, if not necessarily this specific tool, will continue."
Maund is even more enthusiastic. "I anticipate that hospitals will use FMEA consistently with problem processes, for setting priorities for improvement, for evaluating improvement, and also proactively as they build new processes. For example, we are revising some aspects of our medication administration processes. One application will be to look at these revised processes, to do some FMEAs on them, and to identify and improve the weaker areas even before putting the new processes in place. This will work especially well in high-risk areas," she says.
Need more information?
• David L. Snow, RPh, MBA, M.D. Anderson Cancer Center, Houston. Telephone: (713) 792-8890.
• Tina Maund, MS, RN, Atlantic Health System/ Overlook Hospital, 99 Beauvoir Ave., Summit, NJ 07902-0229. Telephone: (908) 522-4912. E-mail: [email protected].
• Mike Rudolf, VHA-East Coast, 68-A S. Main St., Cranbury, NJ 08512. Telephone: (610) 296-2558. E-mail: [email protected].
• Patrice L. Spath, Brown-Spath & Associates, P.O. Box 721, Forest Grove, OR 97116. Tele-phone: (503) 357-9185. E-mail: [email protected].
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