The trusted source for
healthcare information and
SDS Accreditation Update: Use FMEA to find and fix problems before they happen
Joint Commission adds failure mode effect and analysis requirement for ambulatory programs
Ambulatory programs accredited by the Joint Commission on Accreditation of Healthcare Organizations soon will be required to perform at least one failure mode effect and analysis (FMEA) per year.
An FMEA enables providers to find potential problems that affect patient safety before an incident occurs.
The Joint Commission has required all hospital organizations to conduct one FMEA each year since July 2001.
Ambulatory programs will join them in this requirement in 2004. The Wilmette, IL-based Accreditation Association of Ambulatory Health Care (AAAHC) does not require the use of a tool such as FMEA for accreditation.
Addressing problems with multiple causes
FMEA can be an effective way to address ongoing problems that have multiple causes, says Colleen J. Trask, RN, CNOR, director of perioperative services at the Greenville (SC) Hospital System.
Trask’s organization handles between 90 and 100 cases each day and were seeing an average of 94 cases each week delayed or canceled because there was information missing on the chart or because of other reasons such as jewelry on the patient.
"After performing an FMEA and implementing our action plan, the number of delayed or cancelled cases dropped to 25 in five weeks," she says.
While an FMEA can satisfy the requirement for a performance improvement project, it is different from a traditional quality improvement study, points out Richard J. Croteau, MD, executive director for strategic initiatives for the Joint Commission.
"A performance improvement study relies upon collection and analysis of a significant amount of data," he says.
It also is a reactive process in which an organization identifies problems and solutions after looking at what has happened, Croteau points out.
FMEA is a proactive approach to improvement during which the organization looks at a process and identifies the points at which something could happen to harm a patient, he explains.
There are many issues in the same-day surgery process that can be successfully studied through the FMEA process, according to Croteau.
"Surgical site identification, patient education, medication administration, and delay of surgery are just a few," he says.
Once you’ve chosen the process you want to study, put together a multidisciplinary team that represents all areas involved in the process, he suggests.
"Depending on the process, your team might include nursing staff, admitting personnel, anesthesiologists, surgeons, lab personnel, medical records staff, and housekeeping," he says.
Pick a straightforward first project
For your first FMEA study, be sure to choose something doable, says Croteau. Although FMEA can be applied to an entire process, it makes sense to choose a part of the process to produce real solutions in a shorter period of time so team members don’t get frustrated with their first attempt, he suggests.
For example, rather than evaluate the entire process of preparing the patient for surgery, look at one piece of the preparation, such as surgical site identification, Croteau adds.
Managers at Youngstown, OH-based Surgery Center at Southwoods chose site validation for their FMEA, says Suzanne Fornelli, RN, BSN, administrator.
"In our recent survey, the surveyor focused on patient safety issues, and surgical site identification is a key element of patient safety for same-day surgery programs," she points out.
Once you’ve decided the process you will study, define the process in detail using flowcharts, says Croteau. Produce two flowcharts, he advises.
"The first flowchart should define the process as it is suppose to happen according to policies and procedures," he says. "The second flowchart should define the process as it really happens on a day-to-day basis."
Comparing the two flowcharts helps the team identify potential failure points, he explains.
The next step is to define the failure mode, says Croteau.
"What can go wrong?" is the question the team members ask as they go through the process systematically, he explains.
"This is a brainstorming effort by the whole team; and in most cases, you will identify multiple failure points for any process," he adds.
Multiple failure points is what the same-day surgery staff at Greenville Hospital System found when they studied the reasons for delay or cancellation of surgery on the day of surgery, says Trask.
"Missing history and physicals, nonexistent lab reports, jewelry on the patient, and surgical sites not marked according to policy are just a few of the reasons surgeries are delayed," she says.
Because there are so many reasons for surgical delays, it was helpful to identify them all in one study so an effective solution could be developed, she adds.
Before you develop your solutions, be sure to complete the analysis of the effects each failure mode can produce, warns Croteau.
"Go back to the beginning of your failure mode list and evaluate how the failure would affect the patient," he says.
As you evaluate the effect, ask yourself how often it might occur and how serious is the effect, Croteau suggests. For seriousness, assign a numerical score or use low, medium, or high to differentiate each effect, he says.
If you’ve done a good job with your analysis, you’ll have a large number of effects, Croteau says.
"Prioritize the failure modes that you want to target based upon the seriousness of effects associated with the different failure modes, and address the failure modes that have the greatest likelihood of occurring and affecting the patient," he suggests.
Ask yourself, "What would allow this to happen?" and look at all systems that contribute to the failure, Croteau says.
For example, if equipment breakdown would cause a surgery to be delayed significantly, make sure you have access to extra equipment, he continues.
Test plans before implementation
After you develop an action plan, conduct a pilot test, especially if you are introducing a new process, suggests Croteau. The pilot test should involve reevaluation of the same information you developed in the original FMEA to produce your action plan, he says.
After studying their process to find failure modes for surgical site identification, Fornelli’s staff focused on the "time-out" in the operating room as a key element in ensuring that the surgical site is correct. Not only did staff education sessions emphasize the importance of the circulator stopping the surgeon just before the first incision to confirm that the surgical site is the site for which the patient was scheduled and for which the physician ordered, but large, red signs that say "Time Out" are permanently placed in the operating rooms as a reminder, says Fornelli.
Using an individual approach
Trask’s "surgery stoppers" study produced a more individual approach to solving problems.
"Any time we have surgery delayed or cancelled because of missing information on the chart, jewelry, or incorrect site identification, the surgery department personnel send a note with a stop sign on the top of the page to the manager of the department that was responsible for the information or activity that resulted in the problem," she says.
The note says, "We were not able to provide the service we promised to our patient because . . . ," and the reason is described.
"This note is much more effective than an incident report for several reasons," Trask says. The note has no punitive overtones, so employees are more willing to send one to a manager, she points out.
The manager receives the note, talks with the employee involved to make sure that policies and procedures are understood, and points out the effect of the staff member’s actions on the patient’s experience, she adds.
Trask says the program is effective.
"The one-on-one education is received positively because the focus is on improvement of service to the patient rather than punishment of the employee," she says.
For more information on failure mode effect analysis, contact:
• Richard J. Croteau, MD, Executive Director for Strategic Initiatives, Joint Commission on the Accreditation of Healthcare Organizations, One Renaissance Blvd., Oakbrook Terrace, IL 60181. Telephone: (630) 792-5000. Fax: (630) 792-5005. E-mail: email@example.com.
• Colleen J. Trask, RN, CNOR, Director of Perioperative Services, Greenville Hospital System, 701 Grove Road, Greenville, SC 29605. Telephone: (864) 455-3224. E-mail: firstname.lastname@example.org.
• Suzanne Fornelli, RN, BSN, Administrator, Surgery Center at Southwoods, 7525 California Ave., Youngstown, OH 44512. Telephone: (330) 758-1954.
For an example of a failure mode effect analysis presentation that includes examples of flowcharts, severity ratings, and specific steps, see the "Failure Mode Effects Analysis on Wrong Site Surgery" presentation on the Association of periOperative Registered Nurses Patient Safety First web site. To access the document, go to: www.patientsafetyfirst.org/Information_Resources/Document_Share.asp.