Few Lab-Related Medical Errors Are Caused by Lab Operations

When an error occurs involving patient diagnostics, the laboratory itself is rarely at fault directly.

That is the finding of an extensive survey of diagnostic-related errors by the patient safety division of the ECRI Institute. The Pennsylvania-based medical quality think tank analyzed more than 2,400 incidents related to laboratories that occurred between 2011 and the middle of last year. They were categorized into 14 different types.

According to data gathered by ECRI, laboratory-related errors are the fourth-leading cause of medical errors, accounting for about 10 percent of the 287,000 reported to the organization by providers between 2009 and the middle of last year. However, they are the second most-cited error in medical malpractice lawsuits, with awards averaging more than $395,000 between 2008 and 2012.

Mislabeled specimens were the leading cause of the incidents, occurring 31 percent of the time. The largest number of errors, 626, or 26 percent of the total, took place in inpatient general care areas of hospitals, particularly in the emergency department.

Of the laboratory-related incidents, only 4 percent—or fewer than 100—occurred within the physical walls of the laboratory. Most of the errors—74 percent in total—occurred during the preanalytic phase, when tests are being ordered and specimens are being collected and transported.

Data on how much harm the errors caused to patients were incomplete, with the impact of only 42 percent of the events recorded. Among those fully traced incidents, four were harmful enough to lead to a patient’s hospitalization. Another 24 resulted in temporary harm that required medical intervention.

The report recommended a variety of ways to reduce errors, most of them related to technology. They included using standardized measures for identifying patients and specimens and keeping them aligned through the use of electronic bar coding and radio frequency identification tags.

As for less technologically oriented solutions, the report recommended that labs build a process map or flowchart to understand the sequence of events required to test a specimen and that it be used in conjunction with root cause analysis to pinpoint the origin of any issue.

To that end, the report recommended that staff be educated regarding compliance and patients be reminded about the importance of their involvement in the testing process. It also suggested creating a series of team-building exercises designed to break down barriers between the laboratory and patient care staff.

“Strategies to reduce diagnostic errors involving laboratory testing must entail all phases of the laboratory testing process and engage all stakeholders in that process,” said Karen P. Zimmer, M.D., medical director of ECRI’s patient safety operations.

Takeaway: Although they can be extremely costly, laboratory-related errors rarely take place within the four walls of a laboratory, and most do not rise to the level of causing patient harm.


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