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Mix Ups In Biopsy Tests Result in Legal Cases Related to Prostate Cancer Surgeries

Posted Aug 15 2010 12:47am

Both situations are sad and the man who had surgery to cure what he was told was prostate cancer is even sadder now that he lives with some not so nice side effects that came along with the surgery.  In the meantime, the other man didn’t have his prostate cancer found as earlier as it could have been.  image

Doctors make decisions on suggested treatments based on the pathology reports and when there’s a breakdown at that end with tissues and patient identification being mixed up, well the results are not good.  At least nobody passed away over the mix up, but there are some long term issues that each man will live with as a result.  I think the pathologists as well as the doctors upon finding and reacting to such errors cant’ help but feel agony and sorrow as the situation could happen to anyone. 

The article mentions bar codes as a system to help prevent such mix ups and I am high on that solution myself, but it doesn’t cover all area and the one hospital is making sure that a “time out’ is taken before the analytical process.  I would guess too that it would be prohibitive to even think about having 2 tissues open for analysis at once too to avoid such mix ups.  image

The use of bar coding will track the process and the tissue results through out the entire process.  Recently, Dendreon who has the new prostate cancer vaccine recently approved by the FDA uses bar codes and even may be expanding to a more complex bar code tracking system.  In their case blood is taken from the man with prostate cancer, send to the facility for incubation and then returned to be injected into the patient so we would not want a patient receiving someone' else's blood.  Actually part of the their approval was justifying to the FDA that a good tracking system was in place for safety. 

Other labs are beginning to use some type of bar coding system and with using something like Microsoft Tags bar codes the tag could also even be stored in the medical record and the personal health record.  There’s all different types of design to explore here but bar code attached to the patient chart, the tissue sample itself there’s a far less chance for mix ups.  One lab mentioned in this article states the lab was in the process of installing such a system.  Bar coding is being used in hospitals with prescriptions to avoid the same type of issue, with cutting down or eliminating mix ups. 

Again, I see the use of the Bar Code Tags having many solutions in healthcare to include being able to located and find FDA recalls with consumers simply using a cell phone to scan as well as use in finding devices that have been recalled as all hospitals and other outpatient facilities may not have sophisticated RFID systems to assist them.  Without all the particulars of the situation with these 2 men its hard to tell exactly how the mix ups occurred with the handling by the pathologists.  image

Tracking Medical Device Recalls – Sounds Like A Good Place for a Microsoft Tag Data Base at the FDA

Again it’s too late to reverse what happened here but if we can improve and look into ways where technology can help make such issues more fool proof, we will all benefit.  There are stories to where patients have been implanted with devices that were recalled by the FDA but missed from being removed from the supply area and when the devices failed, the patients died, again not on purpose but the recalled items were missed from being returned and used unintentionally in surgery.  In essence there’s an unlimited supply of scanners with cell phones and if it saves one life from an error of such, it’s all worth the effort.  Drug recalls get missed too if not on the appropriate page at the FDA.

The Unknown FDA Recall of Bayer's Yaz Contraceptive Pills (And Some Prempro Too)

Not too far off in the distance is the ability to use a cell phone to take documented information and use a cell phone to place into your personal health record too.  The Tag Bar Codes can be stored in the cloud with audit trails and monitored in real time.  From the consumer side of all of this, it’s the perfect solution to involve the patient as everyone want the empowerment to scan with their phones, it’s a hands down once you simply demonstrate and show someone how simple the process is.  BD 

Manuel Barros lifted his shirt in the steaming heat inside his Dorchester home to show a scar near his navel from prostate surgery he had in March. Also visible at the top of his pants was the edge of an adult diaper the 60-year-old Cape Verdean native wears as a result of incontinence, a consequence of the procedure.

Barros said he could have tolerated that side effect, as well as erectile dysfunction that resulted from the surgery, if he hadn’t gotten startling news from the doctor who operated on him at Beth Israel Deaconess Medical Center soon afterward: He never had cancer.

The Beth Israel pathologist who analyzed his biopsy in November had mistaken his slides for those of another patient who did have prostate cancer, according to a report Beth Israel filed with the state.

Thomas Cloutman, 53, also had a biopsy of his prostate last year, and his specimen was analyzed by Strata Pathology Services. The lab results came back negative, to his great relief, he said.

About eight months later a second biopsy, examined at a different lab, revealed that he had cancer after all, he said. A Strata technician had mixed up his slides with those of another patient, according to an apologetic “letter of disclosure’’ he received from Strata in November.

“Labs are a pretty important part of the whole medical thing,’’ Cloutman said. “And to have them screw up a fairly simple thing like that makes me wary.’’

As egregious as such blunders are, he said, hospitals and labs should learn from them. One way to prevent mix-ups with biopsy tissue, for example, is to use bar codes to match specimens and slides, he said. Strata said in its letter of apology to Cloutman that it had begun to set up that kind of system when the mix-up occurred.

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