American Association for Clinical Chemistry
Better health through laboratory medicine
Taking Aim at Medical Errors

Special Edition


Taking Aim at Medical Errors
Sessions Focus on Preventing Lab Mistakes
By Deborah Levenson

Labs are not immune to the widespread problem presented by hospitals’ medical errors, the eighth leading cause of death in the U.S., according to a 2000 landmark Institute of Medicine report on patient safety. Research suggests that 12.5% of incorrect and delayed lab test results adversely affect patient health (Clinical Chemistry 2002; 48: 691–698). According to experts on patient safety, lab-related errors result from multiple sources, including poor communication and system failures triggered by multitasking. Many labs have initiated programs to reduce lab errors and improve patient safety, and this week Annual Meeting attendees will have the opportunity to learn strategies employed by these labs, as well as how labs can reduce errors by using standards for medical device manufacturers that emphasize constant attention to risks.

Communication Matters

More effective communication among laboratories, physicians, and patients is an important goal in improving quality in the laboratory, especially as labs handle increasingly complex assays like genetic tests, according to Devery Howerton, PhD, Chief of the Laboratory Practice and Genomic Branch at the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta, Ga. Howerton was moderator of a Monday symposium titled “Communication: A Key Ingredient for Improving Laboratory Utilization and Improving Patient Safety.”

The symposium included a presentation by Kim Riddell, MD, Chief of Clinical Pathology at Group Health Cooperative Labs in Seattle, Wash., on a physician report card project that changed physician ordering practices to improve test utilization. While laboratorians know they are partners in patient care, the rest of the hospital doesn’t always see them as such, Howerton noted. “Labs have traditionally been relegated to the basement, where they aren’t seen. Laboratory staff need to interact with clinicians, but often they don’t have a mechanism for doing so,” she pointed out.

Related issues, including persistent institutional attitudes that still don’t consider laboratorians a crucial part of the patient care team, pose barriers to communication. Information technology problems can affect patient safety, especially when the lab isn’t involved in the design of an institution’s information systems. In hospitals located in cities with large immigrant populations, patient-provider communication issues can exacerbate quality problems as well. Too many institutions also lack a defined process for discussing lab errors, Howerton added.

Focusing on the Wrong Things

Too often, laboratories focus on ineffective means of error prevention or those that don’t require much work, according to Michael Astion, MD, PhD, Professor and Director, Reference Laboratory Services in the Department of Medicine at University of Washington in Seattle. Astion, a member of AACC’s Patient Safety Task Force, was a speaker at a Sunday AACC University session titled “How to Avoid Errors in Laboratory Medicine.” “There’s a tendency in medicine in general to choose weak interventions for preventing error,” he noted. These efforts include providing extra training, telling staff to be more careful, warnings and labels posted on equipment, and protocols that emphasize double-checks. “These interventions are generally easy and allow us to complete our incident reports, but they rarely lead to sustained error reductions,” he added.

On a more fundamental level, these strategies don’t deal with the majority of errors, which are non-cognitive and result from failure to complete a task that is normally automatic and doesn’t require deep thought. “You can’t train your way out of a typical data entry error. It’s related to how the job and work area are set up,” Astion explained. “The majority of lab errors are systems errors, just like most of the errors made in the rest of the hospital.”

But labs are better positioned than other areas of the hospital to correct problems. “We can put in stronger interventions than areas like nursing, because we have more automation,” Astion pointed out. Calling interfaces between lab instruments and laboratory information systems “one of the biggest triumphs in error reduction in the last 30 years,” he added, “You can’t make a data entry error when you don’t enter data.”

Astion identified several “strong” interventions that reduce the number of steps needed to complete tasks and associated chances to make errors. One is establishment of automation zones in which lab processes “are completely automated for high-volume tests.” This intervention is especially good for avoiding centrifuging, aliquoting, and routing errors, according to Astion. Analyzer consolidation, in which an automated instrument runs a variety of formerly manual assays, is another good way to remove steps and possible errors. Standardization of lab equipment is another effective strategy. “If you use only one brand of point-of-care glucometer in a healthcare system, you are likely to have not only fewer errors but also to need less staff training,” he pointed out. Autovalidation limits the need to look at results on paper “and deletes half the work.”

The Downside

These strategies all involve some financial risk and uncertainty that may create unforeseen problems, especially if the lab is part of a large teaching hospital or other institution that can afford to be the first in the nation to use a piece of equipment. “If you’re the first to use something, there’s lots you don’t know. But for the rest of us, doing your homework can reduce risk,” Astion said. He suggested lab directors take crucial steps like visiting labs that handle similar tests in similar volumes, checking the literature, and performing usability tests. “You’ve got to compare apples to apples,” he explained.

One important, but often overlooked problem associated with error reduction efforts involving automation is flagging employee morale that often accompanies the introduction of major pieces of equipment. Most employees are concerned about layoffs, but most labs won’t need to cut positions because of staff shortages and attrition of older workers, according to Astion. He suggested allaying these concerns and emphasizing the positive effects of such changes on employees’ jobs, like the opportunity to do more high-level, critical thinking and to spend less time on mundane tasks like routing, capping, storage, and data entry.

Taking a Lesson from Manufacturers

Another approach that can help laboratories reduce errors is embracing the systematic management process used by in vitro diagnostic device manufactures. Don Powers, PhD, a consultant on quality management systems in Pittsford, N.Y., suggested that lab directors turn to a standard from the International Organization for Standardization, ISO 14971, to learn how diagnostic companies avoid errors. Powers is the moderator of the Wednesday symposium titled “Quality Management Approach to Improving Patient Safety.”

ISO 14971, a sophisticated international standard on risk management for manufacturers of medical devices, advocates a risk-management process involving specific tools to estimate risks from the consequences of a device failure. Labs’ use of the standard would involve an approach that requires identifying, controlling, and monitoring risk over the life cycle of a testing process. Powers emphasized that the standard relies on quality management as a solution to ongoing problems. “You’ve got to constantly monitor how a process is performing and address any new problems as soon as they are identified,” he said.

The risk management process described in ISO 14971 can fit well into labs’ work, Powers emphasized. Like manufacturers, labs have suppliers, complex processes, and their own products, which are test results. “Many labs already follow a quality management system approach and have corrective and preventive action processes, which integrate naturally with a proactive risk management approach,” he explained.

During the Wednesday symposium on use of the standard, attendees will hear a presentation by D. Joe Boone, PhD, Acting Director of the CDC’s Division of Laboratory Systems, National Center for Preparedness, Detection, and Control of Infectious Diseases that highlights risks posed to patients created by laboratory testing errors, where they occur, their causes, and how risk management strategies can make laboratory testing much safer. Presentations by Christina Krenc, Manager, Core R&D Life Sciences of Abbott Laboratories in Waukegan, Ill. and Richard Miller, Staff Scientist at Dade Behring, Inc. in Newark, Del., will explain how hazard analysis methods used by diagnostics manufacturers can prevent lab errors. Shirley Weber, Director of Clinical Labs at University of Kansas Hospital, Kansas City, Kansas will describe how her laboratory has used these tools, including Process Mapping and Failure Mode and Effect Analysis, to identify the critical steps in a process and then reduce both the number of those steps and the opportunities to make an error.

“These strategies are very common in the in vitro diagnostics industry and there’s no reason why they can’t be applied to clinical lab operations. But they aren’t very common yet,” Powers observed. “Manufacturers consider possible failure modes when they design their devices and take steps to prevent them. Labs can do the same thing when they are implementing new tests.”

Strategies entailed in the standard can also help labs meet a Joint Commission patient safety goal that requires labs to become more proactive about avoiding risk. “Labs have access to the experts needed to comply with the Joint Commission requirement and to identify risks to patient safety,” Powers said. He suggested forming a cross functional team to identify which errors are important. Such a team, he said, should include lab technologists who actually run the tests, physicians who use the results, and clinical chemists who know how tests work, their optimal use, and which errors are benign. “Having a team explore how processes fail is more powerful than just one person doing it,” Powers concluded.