By Julie Song, MPH, CPHRM, Patient Safety Risk Manager II, The Doctors Company

The following case example explores factors contributing to a wrong-site procedure in interventional radiology and highlights strategies that can help practitioners mitigate risk and increase safety.

Case Scenario

A 56-year-old female with a history of hepatitis B and cirrhosis, hypertension, and kidney transplant for end-stage renal failure with two native nonfunctioning kidneys underwent an MRI that revealed a lesion within the lower pole of the left nonfunctioning kidney. Because the lesion was concerning for renal cell carcinoma, a CT-guided cryoablation was scheduled.

The interventional radiologist began the procedure for the left renal mass with images taken at 5.0 mm slices. After initial review, he asked the technician to reconstruct the images at 3.75 mm intervals to provide a better view of the lesion. The images reconstructed by the radiology technician showed the upper pole of the kidney rather than the lower pole, where the mass was located.

Based on incorrect images, the radiologist interpreted the upper pole as having a contour irregularity consistent with a mass. The radiologist performed a standard cryoablation protocol on the upper pole of the kidney instead of the lower pole.

The radiologist told the family that the procedure had gone well. Later in the day, he reviewed the final post-procedure images and realized that the ablation had been performed at the wrong site. The mass in the lower pole of the kidney had not been removed. He waited until the next morning, however, to tell the family about the error and inform them that the patient would need a second ablation procedure.

In the hours following the procedure, the patient developed chest pain, and labs were suggestive of a heart attack. The patient was transferred to the cardiac unit and started on a heparin drip. An hour later, a CT of the abdomen and pelvis showed no evidence of bleeding and the patient’s partial thromboplastin time (PTT) was within normal limits.

The next day, the patient’s hemoglobin was normal, but the PTT was not checked as required by heparin protocol. The hospitalist noted the patient’s renal function had worsened.

Early the next morning, the patient’s BP was 110/60. Labs showed that her hemoglobin, hematocrit, and red blood cell count had all dropped, and her PTT was very high. The hospitalist ordered stopping the heparin for three hours, rechecking the PTT, and then restarting the heparin at a lower dose. When the BP was checked, however, it was 90/50. A fluid bolus was ordered, but records were unclear about the amount of fluids given.

A rapid response was called when the patient’s BP dropped to 80/40. A CT scan was obtained that revealed an intra-abdominal/retroperitoneal bleed.

The patient was transferred to the ICU and a code blue was called shortly after arrival. She was diagnosed with cardiopulmonary arrest and hypovolemic shock due to active bleeding in the abdomen and was taken to surgery for an exploratory laparotomy with evacuation of the intra-abdominal blood, left nephrectomy (pathology showed renal cancer), and splenectomy due to blood oozing from the base of the spleen.

The patient was readmitted to the ICU, placed on a ventilator, and started on hemodialysis. As a result of the prolonged code, she was diagnosed with hypoxic encephalopathy and now lives at a skilled nursing facility, where she receives tube feedings and assistance in all activities of daily living.

Case Review and Patient Safety Considerations

The patient sued the interventional radiologist, claiming wrong-site procedure with a delay in notifying the patient and family.

Informed Consent: Bleeding, a known risk of undergoing a CT-guided cryoablation, was included in the informed consent signed by the patient. Because the kidney is a highly vascularized organ, bleeding would be an elevated risk factor. In situations involving a patient who is at higher risk of experiencing a known complication due to the nature of the procedure or because of the patient’s preexisting comorbidities, the physician should emphasize the elevated risks during the informed consent discussion and document the conversation. Neither action was taken in this case.

Wrong-site procedure: The interventional radiologist’s failure to recognize that he was performing cryoablation on the wrong pole on the kidney was below the standard of care. When the technician reconstructed the images—and only showed the kidney’s upper pole instead of its lower pole—the error could have been caught if the radiologist had reviewed the image’s table location information to ensure that it matched the order. (The table location of the lower pole of the kidney would have been indicated by -175.25. The table location on the reconstructed images was, however, -115.25—indicating that the image was of the upper pole.) A comparison to previous films (not done in this case) could have also reoriented the radiologist.

Prior to conducting the cryoablation, the radiologist did not complete a preprocedural verification process to verify the correct procedure, patient, and site. If he had followed protocol and reviewed the preprocedural MRI, he would have been reminded that the lesion was located in the lower pole. This could have alerted him to the discrepancy in the technician’s reconstruction of the images that seemed to indicate that the lesion was in the upper pole.

Not having conducted the preprocedural verification process, the radiologist was susceptible to confirmation bias, a tendency to selectively gather and interpret evidence that confirms beliefs while ignoring contradictory evidence. In this case, the radiologist misinterpreted the contour irregularity to be a lesion because he was expecting the image to be the correct view, despite location information indicating it was not.

The technician’s reconstruction of the CT images—which included only the upper pole of the kidney and not the lower pole, where the cancer was located—could have resulted from communication issues between the radiologist and the technician. Any verbal order given by the radiologist should have been written down by the technician and read back to be confirmed or corrected by the radiologist. A verbal readback can stop a misunderstanding from occurring.

Error disclosure: The delay in notifying the patient and family of the wrong-site cryoablation was problematic for the claim’s defense. Jurors may think that the radiologist did not tell the patient and family earlier because he felt guilty or was attempting to cover it up. Disclose medical errors as soon as information indicates that an error has occurred.

Although the radiologist in this case may not have had all of the information necessary to answer questions, it is still important to disclose what is known and focus on the patient’s immediate care and treatment plan. Disclosure may take multiple discussions as an investigation unfolds and more information becomes available. Maintaining trust and open communication are paramount, so it is important to be proactive about informing the patient and family at regular intervals. If a medical error occurs at a hospital, disclosure to the patient and family may be provided in conjunction with a hospital risk manager.

Intra-abdominal bleed: While experts debated the cause of the intra-abdominal bleed, medical records revealed that the heparin protocol of checking the PTT at designated intervals was not followed. PTT was not checked for at least two shifts, raising a question about whether appropriate handoffs occurred during shift changes. Monitoring the PTT closely per protocol could have identified the bleed sooner and resulted in early intervention.

For more information, see our Diagnostic and Interventional Radiology Closed Claims Study, and the short video on Interventional Radiology Malpractice Claims Study. For guidance and assistance in addressing any patient safety or risk management concerns, contact the Department of Patient Safety and Risk Management at (800) 421-2368 or by email.