Closed Claims—Open Insights: Specimen Management Error

Background

A 52-year-old man with a known prostate nodule was referred to a urology practice for a transrectal ultrasound and prostate biopsy. Upon arrival, a technician escorted him to the procedure room, verbally confirmed his name and date of birth, and provided a consent form, which he signed. The physician then performed an ultrasound-guided prostate biopsy, and the tissue specimens were placed into a container labeled with the patient’s identifying information.

At a follow-up visit, the patient was informed that the biopsy showed an aggressive form of prostate cancer. The urologist discussed treatment options and ordered additional imaging, which indicated no evidence of metastatic disease. Based on the reported biopsy results, the patient underwent a robotic-assisted radical prostatectomy with pelvic lymph node dissection. Pathological examination of the lymph nodes showed no malignancy, and the removed prostate was submitted for further examination.

Five days later, the original biopsy results were received and showed no evidence of cancer. It was then discovered that the pathology specimens for this patient and another patient seen on the same day had been mistakenly switched at the urologist’s office. The error occurred because the technician wrote the patients’ names on the consent forms rather than using preprinted labels with verified identifying information. The patient inadvertently signed a consent form bearing another patient’s name. Although the biopsy specimens were initially labeled correctly, they were packaged with the incorrect consent forms.

When the pathology lab identified a discrepancy between the labeled specimens and the handwritten consent forms and returned them for clarification, the technician improperly resolved the discrepancy by switching the specimen labels, resulting in misidentification. Subsequent DNA testing confirmed that the biopsy samples had been confused, and the patient and his wife were informed of the error.

As a result of the mislabeling and erroneous diagnosis, the patient underwent an unnecessary prostatectomy. He was left with permanent erectile dysfunction, urinary incontinence, and chronic pelvic and leg pain attributed to the surgery. This significantly limited the patient’s ability to work as a machinist, a role that required prolonged standing, affecting both his health and livelihood.

Allegations

• Failure to follow proper specimen labeling and verification protocols
• Inadequate staff training and supervision
• Lack of documented competency for delegated tasks
• Failure to ensure the informed consent process was accurate

Case Review Insight

• This case highlights the need for redundant identity verification systems—including standardized labeling, barcode scanning, and strict two-factor identifier checks at each step.
• Reliance on manual processes and individual judgment creates vulnerability points that can expose the practice, clinician, and staff to significant legal risk.
• Pathology specimen mislabeling can lead to incorrect diagnoses, unnecessary procedures, delayed treatment, and irreversible harm. Although labeling errors occur in only a small percentage of laboratory workflows, they account for a disproportionate number of malpractice claims due to their severity and impact on patient outcomes. These claims often involve multiple defendants, including the ordering clinician, clinical staff (e.g., technicians or MAs), the medical practice, and the pathology laboratory.
• Because these events typically arise from failures in basic patient identification procedures, they are often viewed as clear deviations from expected standards of care. As a result, claims frequently involve substantial damages due to the preventable and permanent nature of the injuries.

Resolution

The case was settled against the organization.

Lessons Learned

• This case illustrates how a single breakdown in the specimen labeling and consent verification process—such as using handwritten identifiers instead of preprinted labels—can cascade into an incorrect cancer diagnosis and unnecessary major surgery. Minor workflow deviations can result in major and irreversible clinical consequences, including permanent disability.
• Discrepancies in specimen identification should always prompt immediate escalation and re-verification of patient identity. In this case, when the pathology lab flagged the mismatch between the labeled specimens and the consent forms, the discrepancy was incorrectly resolved by switching labels rather than investigating the source of the error.

Risk Management Tips

• Use standardized, preprinted patient identification labels at every step, ensuring that all specimens, requisitions, and consent forms use two patient identifiers (e.g., name and DOB) pulled directly from the EHR or a verified label source.
• If labels, consent forms, or specimen information do not match exactly, staff must immediately stop, escalate the issue to a supervisor, and re-verify patient identity before any specimen is transferred, processed, or corrected. No “workarounds” or relabeling should occur without full investigation.
• Maintain chain‑of‑custody documentation for all specimens. Track specimen handling from collection to lab pickup using documented checkpoints, including who labeled the specimen, who verified it, and when it was handed off. This creates accountability, reduces gaps, and facilitates early error detection.
• Provide annual training and competency assessments for all staff handling specimens.
• Ensure technicians, MAs, nurses, and providers receive regular education on identification procedures, labeling rules, and escalation pathways.

Resources

• AORN Guideline for Specimen Management (Updated August 2025)
• CLIA / CMS Requirements (42 CFR 493.1242 – Updated January 2026)

Disclaimer

Curi’s risk mitigation resources and guidance are offered for educational and informational purposes only. This information is not medical or legal advice, does not replace independent professional judgment, does not constitute an endorsement of any kind, should not be deemed authoritative, and does not establish a standard of care in clinical settings or in courts of law. If you need legal advice, you should consult your independent/corporate counsel. We have found that using risk mitigation efforts can reduce malpractice risk; however, we do not make any guarantees that following these risk recommendations will prevent a complaint, claim, or suit from occurring, or mitigate the outcome(s) associated with any of them.