Tracking Breast, Prostate Biopsies for Added Security

Multiple steps occur between taking a biopsy in the radiology suite and receiving the results - and multiple potentials for error.

To avoid any mishaps - think positive result delivered to the wrong patient - some groups are using a tracking system that uses barcodes and DNA matching for extra certainty.

“It’s an added layer of security in terms of knowing if there is a positive biopsy, it truly belongs to that specific person,” said David Dorfman, MD, a radiologist at Zwanger-Pesiri Radiology on Long Island, NY. The group started a couple years ago using the know error system, developed by a company with the same name, Know Error.

With this system, a cheek swab is used to take a reference sample of the patient’s DNA, which is sent to an independent lab. Biopsy tissue is sent in a bar-coded container to the pathology lab. If the results are positive for cancer, a DNA test compares it to the reference sample. What makes this system unique is a sample collection kit that includes barcoding, DNA testing, and chain-of-custody protocols, said Mike Harmon, vice president of marketing and communications for Know Error.

The system enhances patient safety and diagnostic accuracy, Harmon said, adding, “Errors will happen, so we want to make sure there are no adverse outcomes to patients as a result of misidentifications,” he said. Initially launched for prostate biopsies, the system was recently expanded for use with breast cancer cases, where a large share of biopsies are performed by radiologists, Harmon said.

One study referenced by Know Error found an annual biopsy switching error rate in the U.S. of 0.33 percent. That can translate to 5,200 breast biopsy specimens. Since launching in 2009, the company has documented that about 1 percent of their cases receiving a positive prostate cancer diagnosis are subject to undetected tissue transposition or contamination that would lead to the cancer diagnosis going to the wrong patient.

A recent study in the American Journal of Clinical Pathology found the mean rate of errors - either a complete transposition between patients or contamination of the tissue - to be 0.85 for physician-owned labs and 3.51 for reference labs, in reference to prostate biopsies.

The process adds about a minute and a half and fits into groups’ work flow because the kit includes everything the radiologist needs for the biopsy, Harmon said. Plus, the molecular diagnostic test is billed to insurance, and turnaround time to confirm the tissue sample with the swab on file is around 48 hours.

At Zwanger-Pesiri, one of their labs using it for prostate biopsies approached the group about the system, Dorfman said. Though they hadn’t encountered errors yet, all the physicians were on board with the added security, he said.

As with any new system, there was a learning curve, but after about a week, the physicians got the hang of it. “Now it’s such an ingrained part of our scheme, that it [adds] a few seconds to our process,” Dorfman said.

The addition of know error has become a bit of a marketing point for the group, too. Other practices don’t offer that security, so when patients hear about it, they want it, Dorfman said. “It sets us apart.”