Claims Case Study: A Biopsy Mix-Up

Biopsy specimen management is one of the areas of greatest risk for medical practices, but also one where effective processes can significantly help reduce the likelihood of adverse outcomes. In this case study, we examine how one practice’s specimen-management practices led to a patient receiving an unnecessary prostatectomy, and we offer tips to help other practices avoid a similar outcome.

The Case:

A 52-year-old male patient with a prostate nodule was referred to a urology practice for a trans-rectal ultrasound and prostate biopsy. At the practice, a technician escorted him to the procedure room and verbally confirmed his name and date of birth. The technician then gave him a consent form, which he signed. The physician performed an ultrasound-guided needle/punch biopsy of the patient’s prostate. The specimens were placed in a container, and a label with the patient’s information was attached.

When the patient returned to the practice to discuss the biopsy results, he was told that he had an aggressive form of prostate cancer. Various treatment options were discussed with the patient. Additional radiology studies were ordered and showed that the patient’s cancer had not metastasized.

The patient ultimately underwent a robotic-assisted radical prostatectomy and pelvic lymph node dissection. The lymph node dissection demonstrated no evidence of cancer. The prostate was removed and submitted for pathology. Five days after the procedure, the results of the prostate biopsy were received, and they did not reveal the presence of cancer.

At this point, it was discovered that the pathology specimen from this patient and another patient who was being seen on the same day had been switched at the urologist’s office. The technician had hand-written the two patients’ names at the top of each consent form, rather than using pre-printed labels with the patients’ names and identifying information from a secure packet. She then picked up the wrong consent form for this particular patient, and he signed a form with another patient’s name at the top. After the biopsy, the tech used the correct name labels to identify both patients’ pathology specimens. She then packaged the correctly labeled specimens with the incorrectly signed consent forms. The incorrect consent forms and correctly labeled specimens were picked up by the pathology lab. The lab returned the specimens to the practice, noting that the consent forms did not match the labeled specimens. However, rather than investigate further, the technician simply switched the labels on the specimens, which resulted in the error.

DNA samples were then taken from the patients to confirm that samples had been confused. The patient and his wife were informed of the error.

The patient underwent an unnecessary prostatectomy. He was left with permanent erectile dysfunction and urinary incontinence. He also developed issues with pelvic and leg pain that were attributed to the prostatectomy. Due to his leg and pelvic pain he was unable to continue his work as a machinist, which involved standing for long periods of time.

Risk Management Takeaways:

It is essential for practices to establish and follow written policies for collecting, processing, and tracking laboratory specimens. Curi’s Risk Management team recommends the following to help prevent cases like the one above:

• Practices should ensure that all equipment is up-to-date and in working order to reduce the possibility of errors.
• Practices should establish a policy for labelling specimens and verifying them once the specimen has been retrieved. This can be accomplished using a two-identifier (or two-person) verification system. This process should be completed prior to leaving the procedure room to prevent any mix-up of specimens.
• Staff should work within their scope of practice as defined by state law or specialty, and all staff members must have documented competency and proficiency on file to perform delegated skills and tasks.
• Delegating tasks to unlicensed staff may place a practice at greater risk, particularly if the tasks are not delegated to competent staff that is supervised closely. A licensed staff member or clinical manager should be responsible for processes such as lab-error notification.
• Physicians are responsible for discussing procedures and informed consent with their patients to ensure they understand. This process should always be documented. Practices should also use procedure-specific consent forms, which could help decrease the potential for performing an incorrect or unnecessary procedure. Members of Medical Mutual can find and download procedure-specific consent forms here.

For further guidance on this issue, Curi members are encouraged to reach out to our Claims and Risk Management Departments at 800.662.7917.