Laboratory Error Results In Mistaken Mastectomy

NY Dept. of Health determines that lab tech cut corners with tissue samples, causing wrong diagnosis

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CEO SUMMARY: In New York, because of a laboratory error and wrong diagnosis, a woman underwent a needless double mastectomy. In reporting the case, New York newspapers discovered another case of lab error and both women are suing the labs involved. Each case is a reminder that the public and state healthcare regulators are becoming increasingly intolerant of preventable laboratory errors.

ONCE AGAIN, AN ERROR IN AN ANATOMIC PATHOLOGY LABORATORY is generating national media attention with the news that, acting on a mistaken laboratory diagnosis, a New York woman underwent unnecessary and life-altering surgery.

In a lawsuit filed by the patient this summer, CBLPath, Inc., of Ocala, Florida, is accused of mislabeling tissue samples resulting in the misdiagnosis. As a result of the misdiagnosis of invasive lobular carcinoma (breast cancer), Darrie Eason, 35, a single mother from Long Beach, New York, had a double mastectomy in May 2006. Two months later, Eason learned that she was incorrectly diagnosed because of a laboratory error.

“Cut Corners By Batching”

A report issued by the New York Department of Health in August 2006 said a CBLPath technician in the company’s Rye Brook, New York, laboratory, had handled Eason’s test and admitted to supervisors that he “occasionally cut corners by batching,” samples, meaning processing more than one tissue sample at a time, and did not always verify patients’ initials when labeling them.

“This is a system failure,” said Eason’s attorney James Baydar. “Somewhere along the line—because someone cut corners— Darrie has to live with the consequences of the scars and the emotional turmoil that she continues to go through.” Baydar was quoted in The Journal News, a newspaper in White Plains, New York. Eason filed a suit last month in State Supreme Court in Mineola seeking undisclosed damages.

New York newspapers also reported the case of another woman who underwent a needless mastectomy as a result of a laboratory error. According to New York Newsday, a newspaper in Melville, New York, Lynne Yurosko, a 57-year-old consultant in Garden City, New York, was told she had cancer and had a lumpectomy and 25 radiation treatments in 2005 before she learned that she never had cancer. Newsday said the misdiagnosis was the result of a mistake at a laboratory of Quest Diagnostics Incorporated.

Both women have brought suits in State Supreme Court in Mineola. Eason is suing CBLPath and Yurosko is suing Quest Diagnostics and her doctors. Yurosko’s case is scheduled for trial next year.

While such errors are limited in number, they are, nonetheless, very high profile cases when the public learns the details. Inevitably, the facts of these cases and the names of the laboratories involved get reported in newspapers nationwide.

Another High Profile Case

Long-time clients and readers of THE DARK REPORT will remember the national media uproar caused by the Linda McDougal case in February 2003. In May 2002, McDougal, a 47-year-old accountant and mother of three, responding to a pathology report which diagnosed her as having an aggressive form of breast cancer, underwent a double masectomy at United Hospital in St. Paul, Minnesota (owned by Allina Hospitals and Clinics).

When no malignancy was found in the amputated breast tissue, an investigation revealed that McDougal’s diagnosis of breast cancer was inaccurate—the result of a laboratory error. While reading McDougal’s slides, the pathologist mismatched the specimen slides and paperwork of McDougal and another female patient, both of which were kept in the same folder. The pathology group admitted it was common for several patients’ slides and paperwork to be placed in a single folder to be read by a pathologist. (See TDR, February 10, 2003.)

In the New York cases, CBLPath and Quest Diagnostics cited patient confidentiality when they declined to comment to newspaper reporters. William Curtis, CBLPath’s CEO, did issue a statement saying, the “case involving Ms. Eason is one we have taken very seriously.” When the mistake was reported more than a year ago, Curtis added, the company “completed a thorough investigation in cooperation with New York State authorities to confirm all appropriate training, protocols, and procedures were and are in place to ensure patient care and safety.”

In its August 2006 report, the New York Department of Health said a technician admitted cutting corners while labeling tissue specimens. Even though the state report found “no systemic problems” at CBLPath, Eason’s attorney, Steven E. Pegalis, said the lab must be held accountable. “You kind of assume that if a lab diagnoses you as having cancer, you’ve got it,” Pegalis told Newsday. “How do you have faith and trust in systems that are supposed to be infallible?” Pegalis also told Newsday that he and his client chose not to sue Eason’s doctors because the physicians were working with flawed information from CBLPath.

At the time of the McDougal case, THE DARK REPORT noted that the national publicity was a sign of the ongoing evolution in public opinion toward medical errors and physician incompetence. Increasingly, news of any type of serious medical error has consequences for the provider responsible for making the mistake.

Quality Bar Is Rising

For clinical labs and anatomic pathology groups, such failures raise the bar on quality. The consequences of laboratory errors and misdiagnoses can literally put a laboratory out of business.

It is for this reason that progressive laboratories and pathology groups are turning toward quality management systems such as Lean and Six Sigma to error-proof workflow and clinical practices. These quality management systems are based on a “system of prevention” mind-set—that individual work processes are organized so that they can produce the desired outcomes.

That is why the laboratory errors in the cases of Eason and Yurosko are a timely warning for the lab profession. Many patients, working in companies that use Lean and Six Sigma, now understand how these methods—when used in labs—can reduce errors. The result is that the public and healthcare regulators have little tolerance for the types of preventable lab errors that brought distress to Eason, Yurosko, and McDougal.

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