Finding and fixing large-scale laboratory errors

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• What caused the error to occur?
• What is the scope of the testing error?
• What is its clinical significance?

Remedial action for patient care

• Do reports need to be revised?
• Notification: who, how, and by whom?
• Offer retesting?
• What is urgency or time frame?

Remedial action to manage risk beyond patient care

• Are there other stakeholders?
• Are there other implications associated with the error (within and outside institution)?
  (Example: Do previous patient charges have to be credited?)
• What is likely to happen once providers/clients/patients know about this error?
• Does error need to be reported internally? Externally?

Long-term adequacy of corrective action

• Can this type of error occur again?
• Can its root cause affect other operations or cause other types of errors?
• Are there system issues outside the lab that need to be addressed?

In the case of the erroneous chloride results, Mayo elected to alert its clinicians via a newsletter communication to the clinical staff. “We stated exactly what the interference was, how it was impacting results, and that there might be a delay in reporting results,” Dr. Baumann says. “We also did retrospective data review and looked for spuriously elevated chloride results in patients known to be taking the medication. For those patients, we did do targeted physician notification and approached from a risk management perspective, asking, ‘Were any decisions made based on this result that may have changed the clinical management for this patient?’”

Laboratories should think as well about the potential impact outside the lab’s walls. One of the first questions Dr. Santrach asks herself is, What is likely to happen once providers or clients or patients know about this error? “Is this going to be considered a non-event and no big deal, or is this going to generate a ton of buzz, and is it likely to get outside of the organization? Does the chief quality officer need to know? Does the quality unit need to understand what’s happened? What about risk management, and legal? Do you need to notify regulatory agencies? Do you need to notify accreditation entities?” And how about payers, Medicare/Medicaid, insurers, the FDA?

Knowledge of a particular error, Dr. Santrach notes, can quickly spread from the laboratory to the rest of the hospital and beyond. “You have to ask yourself as an organization: ‘Am I just going to react, or should I be proactive and actually disclose this as soon as I can, so that we can kind of control the message?’ The other thing is, do you need to develop contingency plans to deal with the feedback? This could involve public relations.” In one circumstance in which Mayo had erroneous test results, it disclosed the problem publicly. “We actually had a 1-800 number to call for patients who had concerns, and we had counselors available for them, and then we facilitated re-testing. Again, over-notification and over-communication is always probably the best approach,” Dr. Santrach says.

The last step of Mayo’s checklist: Assess the long-term adequacy of the corrective action. “Once you fix it, you need to be disciplined in thinking about: Can this type of error occur again, and how often, and do we have a good mechanism to detect it?” Dr. Santrach says. “We may have solved it for now, but is there a more effective preventive solution that we could put in place down the road? Another question is, ‘Could the root cause of this error impact other operations or cause other kinds of errors?’”

In dealing with the chloride errors, says Dr. Baumann, the laboratory realized the errors could indeed happen again. “We had a short-term safety net, but we needed to evaluate the effectiveness of that safety net, and we found it was quite robust.” The laboratory directors also considered whether the root cause of the error could affect other operations or cause other errors. This provides the laboratory the opportunity to think about how it could have been more proactive. It is a good time to ”re-evaluate how we’re using our quality assurance tools in the laboratory, and make sure communication with clinicians happens continually.”

Dr. Baumann says it’s vital for laboratories to take seriously the role of physicians in detecting errors. “The case that we presented—it was all initiated based on a physician discovering a result that didn’t make sense and bringing it to the lab’s attention,” she says. “Most of the time, a physician will ask, ‘Can you repeat this test?’ Or they’ll just order a second test and see how it compares with the first. I think it is important to utilize our clinicians as error detectors, because they’re really good at it.”

The question, she says, is how laboratories react when a physician questions test results. “One must always consider that a single error may potentially be uncovering something large-scale. Taking clinician inquiries seriously is important. We can count numerous examples where it’s been a very astute clinician who has questioned a result on a particular patient and, importantly, communicated with the laboratory. We dive in and troubleshoot and investigate, but if you stop there and don’t look beyond that single inquiry, you can miss a systematic issue that affects far more than just that one patient.”
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Anne Ford is a writer in Evanston, Ill.