College of American Pathologists
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cap today

New take on mistakes—stopping errors sooner

June 2004
Ed Finkel

Clinical laboratories are getting increasingly systematic—and forward-thinking—about how to reduce errors in testing, and those that have not done so need to jump on the bandwagon.

So says Elizabeth A. Wagar, MD, laboratory medical director at the University of California, Los Angeles, David Geffen School of Medicine, who spoke April 13 at a CAP Virtual Management College teleconference.

Dr. Wagar says this trend toward more conscious attempts to map processes is driven by greater awareness of the need and stronger focus on the subject from the Joint Commission on Accreditation of Healthcare Organizations, which in the past couple of years has expanded from an emphasis on after-the-fact "root cause" analysis to more prospective "failure mode and effects" analysis.

This more purposeful process mapping will provide myriad benefits, Dr. Wagar says. "We do a lot better job of teaching our residents, and they’ll be better prepared for the job market," she says. "For another thing, it will be a lot less haphazard, and we’ll probably do a better job of correcting the errors. We won’t be doing patchwork processes."

Laboratory managers always have sought answers to why errors occur, Dr. Wagar says, but they have not typically made it a conscious part of their daily routines. "We’ve gone back to looking at what we do and realizing that this is something we step around," she says. "We spend a lot of time doing this sort of analysis instinctively."

This need not be seen as an extra burden, Dr. Wagar says. "If you look inside a clinical laboratory, you have to do this anyway," she says. "Clinical laboratories need to be proud of their ability to solve these problems. For years we’ve brushed them under the rug. We need to be proud that we’re on the leading edge of this kind of thinking." She adds, "You need to discuss your process changes openly. . . . It’s incredibly important to give yourself visibility for the improvements you make."

Emphasizing the "what" rather than the "who" is critical to gaining employee buy-in, Dr. Wagar says. "Deemphasize the blame," she says. "As soon as your employees see that you’re more interested in solving the problem than blaming someone, amazing information rises to the surface and provides a lot of insight into what happened."

While some laboratory managers might feel they can’t possibly find the time to be more systematic about error detection and correction, Dr. Wagar says leadership is key to making it happen. "By recognizing it as an important part of our day, it becomes easier to encourage people to do it," she says. "If you don’t make that kind of leadership message apparent, then they feel it’s just extra work, or busywork."

The typical laboratory processes to examine are ordering tests, encountering or registering a patient, processing a specimen for testing, analyzing specimens, reporting results, and consulting with physicians, she says. For example, ordering a test involves several steps: The physician thinks of a needed test and writes an order, a nurse draws a blood specimen, the order and specimen are transferred to the lab, a clerk at the lab inputs the entry, and the specimen is transferred to the processing bench. "This all happens well before you even begin processing the specimen," Dr. Wagar says.

"What seems like a simple process involves at least five different categories of people: patient, physician, nurse, unit secretary, lab personnel," she says. "Multiple decisions are made in the process: which test, which tube, how many tubes. The geographical locations are multiple. . . . The point being that the reason we need to learn a little bit about process analysis and examining for dysfunction is that nothing we look at is really as simple as it seems."

To get started, laboratory managers must identify and make a "quick list" of the types of problems and complaints most frequently encountered, Dr. Wagar says. Labs can choose where to focus based on the severity, probability, and detectability of various problems. Create a diagram of the process you want to analyze, and involve personnel from the affected areas in doing so.

"You really need to go to the person who brought the specimen down, the individual who drew the blood, the individual performing the test, to do appropriate process analysis," she says. "Also, don’t forget to talk to your customers in this evaluation. Talk to the clinicians who ordered the test. Talk to the patients."

To evaluate how the process can be improved, sit around the table with this group of people and brainstorm, identify process changes, then implement them. "Sometimes that’s the hard part, and there will be resistance to change; it’s universal," Dr. Wagar says. "Think about how you might do it in a stepwise process. And then evaluate the success of the process changes."

Failure mode and effects analysis, or FMEA, attempts to foresee problems before they happen using the "Swiss cheese model." Dr. Wagar explains: "If a hazard occurs, and a hazard is represented by each slice of Swiss cheese, and multiple hazards line up so that you can go right through three or four slices of Swiss cheese, that’s when patient error occurs," she says. "Your hospital administrator may be asking you if you do FMEA before your next Joint Commission inspection."

Root cause analysis is performed after an error already has occurred. "It’s a systematic process of gathering and ordering all data relevant to an event," Dr. Wagar says. "It’s a repeat of the question, ’Why? Why? Why?’ It creates visibility for internal operations and error checkpoints, it helps to analyze costs and benefits of the prevention options, and it uses process analysis."

Dr. Wagar identifies three "hot spots" where weak points and signs of dysfunction can be detected in lab processes: tests, personnel issues, and procedures.

One group of "hot spot" tests are those for sexually transmitted infections such as Chlamydia and Neisseria. "Positive results for these organisms are reportable to public health agencies. That’s one factor," she says. "They tend to be socially sensitive test results affecting personal relationships. That’s an important factor. Third, physicians are especially sensitive to patient confidentiality for STD testing."

Dr. Wagar shares an example from her lab: A 21-year-old college student tests positive for chlamydial infection. The laboratory reports the result to the public health agency the same day it becomes available and faxes it to the physician. A couple days later, the physician calls the laboratory very upset because the patient was contacted by the public health agency—but the physician had not known the result.

It turns out the physician’s fax number had been incorrectly recorded in the laboratory, and the fax had never arrived. "There weren’t any technical aspects to be identified," Dr. Wagar says. "The consequences, however, were a strained relationship between a physician and a patient, and between a physician and the lab. The lesson is that some types of sensitive tests only require one piece of Swiss cheese."

One type of personnel issue that can arise is fragmented employee loyalty, where employees identify with their lab sub-sections rather than the lab as a whole, she says. Dr. Wagar shares an example in which a specimen labeled "chest drainage" was forwarded to both the hematology and chemistry areas.

"The hematology and chemistry areas cancel the test because they do not test ’drainage,’" she says. "A call to the floor clarifies the specimen type as a pleural effusion. The test orders are reactivated." But by then eight hours have elapsed, and "when an upset floor nurse calls the receiving and the chemistry labs, employees in each section point fingers at the other section for causing the delay."

A process analysis identifies such problems as delays from receiving to the individual test areas due to short staffing, poor communication from the physician regarding the test type that should have been caught earlier and clarified, and employees’ balkanized loyalties within the lab to their areas. "They were most worried about chemistry, or hematology, instead of whether the patient’s test was being performed," Dr. Wagar says. "Employees spent a lot of time finger-pointing and blaming."

In addition to deemphasizing the blame game in such situations, laboratory managers must "reinforce the larger goal of patient care on a routine and regular basis," she says. "The process should be fully explored for problems and solutions, and leadership should emphasize, always, the importance of supporting other lab employees."

An example of a process issue could be the need to immediately communicate critical lab values to the physician. "There usually are strict responses to procedures," Dr. Wagar says. "It often occurs at inconvenient hours in the middle of the night."

For example, an 82-year-old woman with low-grade fever and shortness of breath is found through a sputum culture and preliminary blood work to have a potassium level higher than the lab’s defined critical value. But an attempt to page the physician at 1 AM is unsuccessful, and the contact directory does not list an answering service.

"A critical value was identified, and a caregiver was not notified of the result. That’s major," Dr. Wagar says. "The clinical laboratory did not have a backup contact information system for the clinician, and the clinical laboratory did not have a specific procedure for handling contacts that are not immediately available."

The solutions could be understanding how clinicians of various specialties want critical values to be handled and what they consider to be critical values. "You also need to write a comprehensive procedure for handling critical value notification, including non-response calls," Dr. Wagar says. "This is an incredibly important area, and will be primary in your Joint Commission inspections with the new patient safety standards."

Ed Finkel is a writer in Evanston, Ill.