Getting a cancer diagnosis is life-changing. Not only does a patient begin to undergo physically taxing treatment, including chemotherapy and radiation, but the news itself is mentally and emotionally devastating. But, what is perhaps just as devastating is getting a false cancer diagnosis or a false negative. The odds are very slim, typically less than 2 percent, of an individual getting a misdiagnosis from a hospital pathology laboratory test for cancer, but it does happen. When a misdiagnosis is dished out, there’s the potential for a patient to undergo unnecessary surgical treatment, including weeks of radiation therapy, or go without treatment at all. These misdiagnoses are currently undergoing a review by The Centers for Medicare and Medicaid Services.
A national study of 6,000 cancer patients by researchers at Johns Hopkins Hospital found an error rate of 1 in every 71 histopathology results – testing which shows tissue changes. With approximately 1.3 million Americans receiving a diagnosis of cancer each year, an error rate of slightly more than 1.2 percent in lab tests can mean about 14,300 misdiagnoses. Other studies have found the rate could be as high as ten percent.
An unidentified patient of the Wake Forest Baptist Medical Center received a misdiagnosis of breast cancer last year that caused her to undergo a lumpectomy and then she “chose to undergo the more aggressive route” of a double mastectomy. A third-party review of the woman’s case, received by Wake Forest Baptist on Dec. 15, “found that the diagnosis of breast cancer was incorrect.”
This patient was one of at least 25 who received initial erroneous test results, of which 19 gained the correct diagnosis through subsequent testing. That represents a 1.7 percent error rate for the 1,422 lab results reviewed by investigators as of March 26. Three other patients faced a potential delay in cancer treatments because their lab results showed they didn’t have cancer. One of those patients was later found to have breast cancer. A total of 9,291 additional cases are set to be reviewed.
Wake Forest Baptist said the pathology lab handles about 25,000 surgical cases a year. Three of its patients were given a diagnosis of cancer and received treatment, only to be proven later to not have had cancer. Three patients did have cancer, but initial test results did not show it, so their treatment was delayed.
Dr. Kevin High, the president of Wake Forest Baptist Health, indicated that the problem was likely erroneous test results are those who had pathology specimens read at its Winston-Salem campus during the three-year period from June 2014 through August 2017 “by a specific provider who is no longer with the medical center.” He added, “Independent pathologists from outside of Wake Forest Baptist are reviewing 100 percent of these affected specimens. Medical opinions can sometimes vary. Therefore, if the independent read differs from the original, a panel of experts meets to review opinions, come to a consensus and determine any impact on treatment.”
A spokeswoman for The Centers for Medicare and Medicaid Services confirmed, “The hospital is conducting an audit of its laboratory operations and is taking steps to correct deficiencies. We will continue to monitor its progress.”