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Issuing a new set of safety standards with which health care institutions must comply is all well and good, but offering those institutions creative tools to aid that compliance is perhaps even more significant. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has approved new standards that focus directly on patient safety and medical/health error reductions in hospitals, setting July 1, 2001, as the date they will take effect. In the Feb. 27, 2001, issue of Sentinel Event Alert, JCAHO published a proactive risk-assessment model that uses the Failure Mode, Effects, and Criticality (FMECA) approach.
Although this particular illustration outlines a process to evaluate the preparation and administration of medications, the FMECA model can be used in almost any area of health care, asserts Rick Croteau, MD, JCAHO’s executive director for strategic initiatives. "It’s a well-tested and proven analytical model for identifying risk points and for aiding in redesigning processes so they will be safer," says Croteau, whose background includes not only general surgery but aerospace engineering. "It’s been proven in a number of high-risk fields — not including health care. It probably has been used to greatest effect in the aerospace, nuclear power, and chemical industries, but the principles are translatable to virtually any process, including the health care process."
The model is created by first listing the processes being evaluated at the top of the chart. In the rows below, each of the headings is cross-referenced with the following items:
Like root-cause analysis, FMECA has come to the health care arena out of fields that are more heavily based in engineering, manufacturing, and production environments, says Croteau. "And that’s the premise we are working on." The principles upon which FMECA is based are:
"Some of these approaches to redesigning systems to optimize performance through fail-safe design, redundancy simplification, and a looser coupling of processes are all opportunities to notice why things go wrong," Croteau explains. "This is an opportunity to marry two disciplines, to use a lot of what we’ve learned in aerospace and apply it as appropriate to the health care process."
Can the FMECA process outlined for drug administration be readily adapted to other health care processes? "Absolutely," Croteau insists. "Certainly, we recognize that medical safety is one of the main areas that needs to be addressed, but we are looking at things much more broadly. In surgical areas, in particular, with respect to complications and wrong-site surgery, a lot of work needs be done, and it is very amenable to the kinds of approaches we are talking about."
To create a FMECA chart, start by deciding what process you want to analyze, Croteau explains. "From a surgical standpoint, for example, if you’re concerned about wrong-site surgery, the process you wish to study is really pre-op preparation — from admission up to the point where the surgery begins. This will be fairly elaborate, but like any process, it can be flowcharted. You then work along between each step and each linkage, asking yourself what can go wrong."