The odds are very slim — typically less than 2 percent — of an individual getting a misdiagnosis from a hospital pathology laboratory test for cancer, according to national research studies.
However, when it occurs, there’s the potential for a patient to undergo unnecessary surgical treatment and weeks of radiation therapy, or have a delay in beginning treatment.
In either case, the patient likely experiences emotional, physical and often financial anguish from getting such life-changing news.
A national study of 6,000 cancer patients by researchers at Johns Hopkins Hospital found an error rate of 1 in every 71 histopathology test results. Histopathology is the study of changes in tissues caused by diseases, such as cancer.
With about 1.3 million Americans receiving a diagnosis of cancer each year, even a 1.2 percent error rate on cancer lab tests can mean about 14,300 faulty results. Other studies suggest the error rate could be as high as 10 percent.
In the case of an unidentified Wake Forest Baptist Medical Center patient, a misdiagnosis of breast cancer last year led her to undergo first a lumpectomy and then she “chose to undergo the more aggressive route” of a bilateral (double) mastectomy, according to a federal Medicare investigation of the medical center’s pathology lab. She didn’t receive radiation therapy.
An external review of the patient’s case, received by Wake Forest Baptist on Dec. 15, “found that the diagnosis of breast cancer was incorrect,” the Medicare report determined. The patient was told of the misdiagnosis, but what happened since is unclear because of patient health privacy laws.
The patient was one of at least 25 who received initial erroneous test results, of which 19 gained the correct diagnosis through subsequent testing, according to a 54-page Medicare report.
At 25 cases, that represents a 1.7 percent error rate for the 1,422 lab results reviewed as of March 26 as part of the investigation. A total of 9,291 cases were identified as requiring review.
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, thus delaying their treatment.
Dr. Kevin High, the president of Wake Forest Baptist Health, said Friday that patients possibly affected by erroneous test results are those who had pathology specimens — a biopsy or surgical removal of tissue — read at its Winston-Salem campus from June 2014 through August 2017 “by a specific provider who is no longer with the medical center.”
That individual, identified in the CMS report as “MD No. 7,” was the one responsible for the erroneous test on the patient who chose to undergo the bilateral mastectomy.
“Independent pathologists from outside of Wake Forest Baptist are reviewing 100 percent of these affected specimens,” High said.
“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.”
High said less than 1 percent of test results have required a change in treatment. Patients are notified promptly if a change in treatment is recom mended, he said.
“We encourage patients who have received care during the time frame, and who have concerns about their status, to contact us,” High said.
Dr. Otis Brawley, the chief medical officer for American Cancer Society, is among several medical officials who recommend that patients insist on getting a second pathology lab test opinion from an expert pathologist.
“The cost to the member can vary based on their benefits, and may include application of deductible and coinsurance,” said Austin Vevurka, a spokesman for Blue Cross and Blue Shield of North Carolina.
“We would also cover the member if they seek a second opinion — whether that is simply a second reading of the pathology slides, or a visit to another oncologist or surgeon for a repeat biopsy,” Vevurka said.
Brawley, an expert in prostate cancer test screening, said he is familiar with the Medicare investigation into the Wake Forest Baptist pathology lab.
Brawley said reviewing biopsies is often “a very subjective mission in which six pathologists may look at the same tissue sample and each comes up with a different answer on whether it is cancer or not, or the stage of the cancer.”
The most common misdiagnosis issue tends to be mislabeling of the biopsy by lab officials, or putting the test results into the wrong patient case file, Brawley said.
Reviewing a biopsy “is lot more of a gray area rather than strictly black or white,” he said.
“Lung cancer tends to be a relatively simple cancer to diagnosis properly, while prostate cancer is very challenging, and breast cancer is somewhere in between. Sixty percent of prostate cancer can be safely watched, and many of those patients will never be definitively treated with surgery.
“But you have to know the grade of the cancer to properly determine whether to treat or watch,” Brawley said.
The National Coalition on Health Care co-sponsored a 2013 study titled “Exploring Diagnostic Accuracy in Cancer,” which surveyed 400 cancer specialists nationwide.
The study determined that oncologists underestimated how often they incorrectly diagnose cancer in patients, said Larry McNeely, the policy director for the Washington-based coalition.
“Any misdiagnosis, even just one time, is too frequent,” McNeely said. “So, cancer misdiagnosis is a bigger problem than most recognize.”
That study determined that the top-five cancers for misdiagnosis were, in order, lymphoma, breast, sarcomas, melanoma and what was cited as “cancer of unknown primary site.”
Other studies have shown the odds are higher for a misdiagnosis of a biopsy for tissue from the skin, prostate, breast and female reproductive tract.
CMS has given Wake Forest Baptist until June 12 to resolve the issues with the pathology lab or face suspension of inpatient Medicare billing privileges. The medical center was supposed to submit an updated corrective plan or a new plan on Thursday.
The corrective plan is aimed at resolving concerns raised during a CMS investigation Feb. 5-8. The investigation was prompted by internal complaints.
The billing privileges had been in “immediate jeopardy” status until CMS rescinded, at least temporarily, that move on April 9, retroactive to March 26. Immediate jeopardy is a federal designation that means missteps have caused or are likely to cause injury or death.
Medicare and Medicaid beneficiaries represented about 44 percent of Wake Forest Baptist’s gross receivables in fiscal 2016-17, according to its fiscal 2017 report to bond holders.
“Wake Forest Baptist continues to be a full participant in the Medicare program, providing the full range of clinical treatment and services,” High said April 9.
High said the medical center “expects a CMS survey team to return within the next few months to confirm compliance with the processes and procedures that have been put in place.”
CMS spokeswoman April Washington said on April 11 that “the hospital is conducting an audit of its laboratory operations and is taking steps to correct deficiencies.”
“We will continue to monitor its progress.”
The national studies show that some erroneous tests come from having pathologists not being experts in the types of cancer they’re asked to examine.
Misjudging how fast or how far the cancer had spread can dramatically affect a patient’s care, according to Johns Hopkins medical officials.
“That can change whether a patient gets no treatment vs. surgery vs. radiation,” Dr. Jonathan Epstein of Johns Hopkins told ABC News. “If they get surgery or radiation, which type?”
Brawley said it requires significant amount of experience, as well as properly set-up technology, to make a precise diagnosis.
The Medicare report on the Wake Forest Baptist pathology lab was summed up by saying “laboratory staff failed to provide oversight of laboratory services and ensure laboratory specimens were appropriately processed with accurate results for medical interventions, in particular the subspecialty of histopathology.”
The laboratory director was cited for “failing to provide overall management and direction” for the laboratory, and “failed to ensure delegated duties were performed as required ... failed to ensure testing personnel were trained prior to testing patients, and failed to ensure policies and procedures were established and followed for monitoring testing personnel competency.”
Dr. Russell Howerton, Wake Forest Baptist’s medical officer, was quoted in the CMS report as telling regulators during the February review that the hospital was “re-reviewing 100 percent of the breast cancer cases.”
“We’ve had a workflow/workforce imbalance. ... We are deep in the midst of a complex and deep review to see if we have a quality issue,” Howerton said. “We have internally and externally reviewed and found our care did not meet our standards.”
Brawley said he expects that most, if not all, of the six Wake Forest Baptist erroneous tests fall into the gray category, and the pathologist “called it black when other would have called it white.”
Brawley said pathologists sometimes are under pressure from physicians and the patient and family members “for a yes or no diagnosis when there is no immediate certainty from the lab result.
“Oftentimes, the pathologist seeks a second opinion without the patient knowing it,” he said.