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Rate of occult specimen provenance complications in routine clinical practice
1Dept of Pathology and Immunology, Washington University School of Medicine, St Louis, MO 63110, USA.
Abstract:
Occult specimen provenance complications (SPCs), which occur when there is an absence of any direct or indirect indication that a specimen switch or contamination may have occurred, constitute a significant patient safety and medical-legal problem because they can lead to misdiagnosis. However, the rate at which occult SPCs occur is unknown because, by definition, this category of errors is not identified by standard laboratory practices. In this study, we evaluated a data set comprising almost 13,000 prostate biopsies that were prospectively tested for specimen provenance errors as part of routine clinical practice. The frequency of occult type 1 errors (a complete transposition between patients) and type 2 errors (contamination of the patient's tissue with 1 or more unrelated patients) was 0.26% and 0.67%, respectively; every urology practice setting and surgical pathology laboratory type with a representative sample size experienced at least 1 type 1 and 1 type 2 error during the study period. Overall, the mean frequency of SPCs across practice settings was 0.22% for type 1 errors and 1.69% for type 2 errors. The type 1 rate showed no correlation with a surgical pathology laboratory setting or urologic practice group setting; the type 2 rate correlated solely with a surgical pathology laboratory setting. The occult SPC rate in this limited data set provides an estimate of the scope of the problem of potential misdiagnosis as a result of occult specimen provenance errors in routine clinical practice.
Insights
Occult specimen provenance complications (SPCs) are undetected errors in patient samples that can lead to misdiagnosis. This study found these errors occur in 0.26% (type 1) and 0.67% (type 2) of prostate biopsies, highlighting a significant patient safety issue.
Area of Science:
- Urology
- Pathology
- Patient Safety
Background:
- Occult specimen provenance complications (SPCs) are undetected errors in specimen handling, posing risks for misdiagnosis.
- The frequency of these errors is unknown due to their inherent stealth, challenging standard laboratory detection methods.
- SPCs represent a significant patient safety and medical-legal concern.
Purpose of the Study:
- To evaluate the frequency of occult specimen provenance errors in prostate biopsies.
- To assess the occurrence of type 1 (transposition) and type 2 (contamination) errors.
- To determine the impact of practice settings on SPC rates.
Main Methods:
- Prospective evaluation of nearly 13,000 prostate biopsies.
- Testing for specimen provenance errors as part of routine clinical practice.
- Analysis of error rates across different urology and pathology settings.
Main Results:
- Occult type 1 errors occurred in 0.26% of cases; type 2 errors occurred in 0.67%.
- All practice settings with sufficient sample size encountered at least one type 1 and type 2 error.
- Overall mean SPC rates were 0.22% for type 1 and 1.69% for type 2 errors.
- Type 2 error rates correlated with surgical pathology laboratory settings.
Conclusions:
- Occult SPCs are a prevalent issue in prostate biopsies, occurring across various practice settings.
- These errors contribute to the risk of misdiagnosis, underscoring the need for improved detection.
- The findings provide an estimate of the scope of occult SPCs in routine clinical practice.
