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Mastectomy Mistake Brings Up Spectre Of Labs Not Scrutinized

We ran two pieces, Why The Secrecy On Inspection Agency Lab Results? and Inspection Agencies Could Assist In Traceability, dealing with the way the Canadian Food Inspection Agency dealt with the testing it did in its investigation of Dole product that was eventually recalled.

We criticized the CFIA for its secrecy:

Logically, we would look to the quality of the testing: Did the CFIA use approved methods of testing? What method was used? Was there, in fact, a confirmed positive? Has CFIA looked within its own lab and sampling method to see if there might be a possible cross contamination?

Unfortunately, the CFIA won’t give out any information. They will not share test results or the PFGE strips. They just repeat like a mantra that they took 40 bags, and broke them into 8 samples of 5 bags each.

This is a very serious matter. Reputations, businesses, whole industries can be destroyed based on government reports on these matters.

It is too important a matter to allow for possibly self-serving secrecy.

Both the companies involved and the public at large are entitled to complete transparency so that the possibility of error or malfeasance can be considered.

How do we know that CFIA isn’t covering up for the incompetence of its own lab? Perhaps one day a lab technician will be paid off by a competitor. The process has to be transparent or people will lose confidence.

There is not a reason in the world why CFIA doesn’t release the PFGE strips and the test results so other experts can at least review them for anomalies.

We had been sensitized to the issue of lab error after our piece, Church Brothers/True Leaf Recalls, Then “Unrecalls” Spring Mix/Arugula After Testing Mishap, in which a lab error caused all kinds of problems. Yet what really got us concerned about that situation was how easy it would be for a lab to cover up its failures — easier than admitting them.

Now news like this hits the airwaves:

Mastectomy Mistake: ‘You Don’t Have Cancer’
Woman Told She Has Breast Cancer,
But Learns After Operation Her Biopsy Slide Was Mixed Up

Darrie Eason, a 35-year-old single mother from Long Island, N.Y., underwent a double mastectomy after she was told she had breast cancer. But after the surgery, she learned the unthinkable — she never had cancer at all.

“I remember the words, ‘You don’t have breast cancer, you never did’,” Eason said today on “Good Morning America.”

The news was stunning.

“I have a philosophy that you have to laugh to keep from crying, so I try to laugh as much as I can,” Eason said.

A state report blames Eason’s mix-up on a former technician at CBLPath lab who mislabeled her biopsy results. The report said the technician “cut corners.”

Yet interestingly enough it appears that the State found no systemic problem at the lab:

But in a statement, CBLPath Medical Lab said, “The New York State Department of Health found no systemic problems and no deficiencies were cited against the lab.”

Eason filed a lawsuit last month against the laboratory, seeking an undisclosed sum. Her attorney, Steven Pegalis, said they hope to learn whether or not the error was a system failure.

“Was that an isolated act by one individual who never before made a mistake?” Pegalis asked on “GMA. “I doubt it. It’s possible. But we’ll try to find out.”

You can read the entire article here. The piece goes on to recommend that people always get a second biopsy. Although that advice seems questionable considering the expense, the risk of the procedure, etc.

Remember that there is another woman who actually had cancer but was not told of it in a timely manner. You can never tell the consequence of this.

The State’s finding that the lab had “no systemic problems and no deficiencies” would indicate that the state does not expect labs to have systems in place to check for the occasional human error. In other words, it is acceptable that some frequency of misdiagnosis will occur due to human error. Otherwise they would require internal verifications.

One feels horrid for this woman and revulsion at the sense of fatalism that holds that every once in a while a woman will lose her breasts needlessly due to human error in the lab. The piece quotes a safety expert as explaining the situation this way:

Wachter said there have to be backup systems that anticipate human error. “You have to create technologies that anticipate that humans will blow it from time to time and catch the errors before they kill someone,” Wachter said.

One of the most important back-ups is that labs must operate under the scrutiny of interested parties.

United, PMA and CPMA should be bringing this issue up with the regulatory authorities.

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