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Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient
1, Paul N Valenstein, Stephen S Raab
1Department of Pathology, St Joseph Mercy Hospital, Ann Arbor, Mich 48106-0998, USA. paul@valenstein.org
Context:
Misidentified laboratory specimens may cause patient injury, but their frequency in general laboratory practice is unknown.
Objectives:
To determine (1) the frequency of identification errors detected before and after result verification, (2) the frequency of adverse patient events due to specimen misidentification, and (3) factors associated with lower error rates and better detection of errors.
Design:
One hundred twenty clinical laboratories provided information about identification errors during 5 weeks.
Results:
In aggregate, 85% of errors were detected before results were released; one quarter of laboratories identified more than 95% of errors before result verification. The overall rate of patient identification errors involving released results was 55 errors per 1,000,000 billable tests. A total of 345 adverse events were reported. Most of the adverse events caused material inconvenience to the patients but did not result in any permanent harm. On average, adverse events resulted from 1 of every 18 identification errors. Extrapolating the adverse event rate observed in this study to all United States hospital-based laboratories suggests that more than 160,000 adverse events per year result from misidentification of patients' laboratory specimens.
Conclusions:
Identification errors are common in laboratory medicine, but most are detected before results are released, and only a fraction are associated with adverse patient events. Even when taking into consideration the design of this study, which used imperfect case finding, institutions that did a better job of detecting errors within the laboratory released a smaller proportion of results that involved specimen misidentification.
Insights
Laboratory specimen identification errors are frequent but mostly caught before release. While most errors cause inconvenience, over 160,000 adverse events may occur annually in US labs due to misidentification.
Area of Science:
- Clinical Laboratory Science
- Patient Safety
- Medical Diagnostics
Background:
- Misidentified laboratory specimens pose a risk of patient harm.
- The actual frequency of specimen misidentification in clinical practice is not well-documented.
Purpose of the Study:
- To quantify the frequency of laboratory specimen identification errors before and after result verification.
- To determine the incidence of adverse patient events linked to specimen misidentification.
- To identify factors influencing error rates and detection efficacy.
Main Methods:
- A 5-week data collection period involving 120 clinical laboratories.
- Information gathered on identification errors and associated adverse events.
Main Results:
- 85% of identification errors were detected prior to result release.
- The rate of patient identification errors in released results was 55 per million tests.
- Approximately 1 in 18 identification errors led to an adverse event, potentially exceeding 160,000 annually in US labs.
Conclusions:
- Identification errors in laboratory medicine are common, yet most are intercepted before results are issued.
- A small proportion of errors result in adverse patient events, though most cause minor inconvenience.
- Improved internal error detection correlates with a lower rate of misidentified specimens being released.
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