By Mark Tosczak
Nobody — not her dentist, her primary care doctor or even an ear, nose and throat specialist — had been that concerned with the patch of raw, painful tissue inside Vickie Murphy’s lower lip.
But Dr. Ewain Wilson, the ENT specialist at Wake Forest Baptist Health ENT and Sleep Medicine in North Wilkesboro removed a bit of tissue anyway and sent it off to the pathology lab at Wake Forest Baptist Health in Winston-Salem, just to be sure.
A few days later, Murphy got an urgent call. “He called me and said ‘I need you to come in,’” she said.
When she saw him in his office, he had some grave news.
“The hardest part was when Dr. Wilson said ‘I don’t want to scare you, but I’m really concerned — it came back cancer,’” she said. “He said, ‘I think we need to get it out as soon as we can.’”
The only problem? She didn’t have cancer. The diagnosis from the pathology lab was wrong. But Wilson didn’t learn that until after he had operated on his patient.
Nine months later, Murphy is still bothered by the effects of the surgery.
“I’ve got a lot of scar tissue there and it hurts,” she said “It hurts when I eat, hurts when I brush my teeth.”
North Carolina Health News reviewed Murphy’s medical records related to the diagnosis and surgery for this story.
Wilson’s office manager directed media inquiries to Wake Forest Baptist’s public relations office. Officials there have declined to comment on Murphy’s situation or to provide any new information regarding the hospital’s pathology lab, which has been under scrutiny from federal officials this year.
The Centers for Medicare and Medicaid Services earlier this year threatened to cut the Winston-Salem hospital off from Medicare reimbursements after internal complaints turned up problems in the pathology lab.
State investigators first reviewed the situation in February, then followed up with an on-site inspection in March. By then, the hospital had identified 9,291 tissue pathology cases it planned to review and completed assessments of 1,422 cases. That effort turned up 25 erroneous pathology reports — an error rate of about 1.8 percent. Ten of those patients had their care affected by the errors, according to the inspectors’ report.
No one knows how frequently mistakes happen in pathology, but studies suggest an error rate of 2-4 percent said Dr. Mark Graber, a senior fellow in health care quality and outcomes at Research Triangle Institute and founder of the Society to Improve Diagnosis in Medicine.
“The vast majority of those will be inconsequential,” Graber said.
The government’s April report details the experiences of four of those patients — three women who were told they had breast cancer when they didn’t, and a fourth who was told she didn’t when she did.
Two of those women subsequently had breast tissue removed in lumpectomies and then underwent radiation therapy. A third woman chose to have a double mastectomy. The fourth woman later started treatment for breast cancer, more than a year after the mistaken pathology report.
The fact that women had both surgery and radiation treatment that turned out to be unnecessary raised questions for Dr. Barbara Dull, a cancer surgeon at UNC’s Rex Hospital in Raleigh.
“The whole Wake Forest thing is pretty uncommon in terms of someone being diagnosed with a cancer and then it turns not to be that,” she said. Radiation therapy after a lumpectomy is fairly common — when patients actually have cancer, she said.
After surgeons remove tissue in a lumpectomy or other procedure, the tissue is sent to a pathology lab and pathologists examine it again to determine the true size of the cancer and whether or not there was cancer around the edges of the excised tissue — an indication follow-up surgery might be required to remove more cancerous tissue.
If no cancer was detected in the tissue that was removed, Dull said, there would be no reason for radiation therapy, as two of the patients at Wake Forest Baptist had.
“Somewhere there was a failure,” she said.
Breast surgery and radiation therapy can have both short and long-term consequences. In the short term, there can be pain around the surgery site and radiation therapy can cause peeling and burning of the skin. Long-term physical consequences, such as chronic pain, heart conditions or even, very rarely, new cancers, are relatively rare.
For most women who undergo breast surgery, the long-term effects can be cosmetic — to the appearance and symmetry of their breasts — and psychological.
“For many women, much of their identity is associated with having those breasts,” she said.
It’s not clear if Murphy was among the 10 patients the hospital had identified, as of March, as being affected by incorrect diagnoses. The government’s inspection report doesn’t identify patients or physicians by name, only by a number.
But the report says that in an interview Feb. 5, Wake Forest Baptist’s chief medical officer, Dr. Russell Howerton, told investigators that the hospital was reviewing all the breast cancer cases handled in the pathology lab and that “there was no evidence to date that the organization had a problem other than the work by MD #7, ‘who is now gone.’”
MD No. 7 is the previous head of the pathology department; that person isn’t identified by name.[sponsor]
In Murphy’s case, the pathologist who prepared the report is listed on the health system’s website as a 2017-2018 dermatopathology fellow, and the doctor who signed off on the report is listed as the director of that fellowship program.
The pathology report that found no cancer in the tissue removed during surgery was done by Piedmont Pathology Associates in Hickory.
Government investigators also discovered problems with maintenance, training and expired lab supplies when they inspected the lab. Hospital officials are now working against a June 12 deadline to fix problems with the lab.
Graber says there are a number of ways that health systems and pathology labs are working to reduce errors. The best way to reduce mistaken diagnoses, he said, is to have tissues checked by more than one doctor.
At least some pathology labs, he said, are prioritizing so-called “dual reads” on types of tissues that are more susceptible to errors.
“I don’t know any place that is doing a second read of everything,” he said. “The downside is it’s expensive.”
Wake Forest Baptist told the inspection team it was instituting dual reads on all breast cancer cases and hoped to do so for other cancers.
In some types of diagnoses, computer software is starting to supplement human doctors. Mammograms, for example, are now routinely read by both a radiologist and computer software.
Technology is also being used in some places to reduce system errors that result, for example, when a lab report isn’t seen by the physician treating the patient. Some electronic health record systems notify physicians if new lab reports have been viewed.
But the best intervention, Graber said, is sending lab reports directly to patients, who are motivated to follow-up with their doctors if they have questions.
“There’s a movement in medicine to do more of that,” he said, but added there still challenges in how exactly to implement direct-to-patient reporting while still protecting patients’ privacy.
Waiting for ‘Sorry’
Nine months after her unnecessary surgery, Murphy continues to deal with physical and financial consequences.
The inside of her mouth sometimes hurts after eating or talking for a long time, and it’s affected her relationship with her husband of 39 years. “We’re having to learn how to re-kiss each other,” she said.
She and her husband are still making monthly payments on out-of-pocket costs for the surgery that her state employee retiree health insurance didn’t cover. As of this week, they still owed $1,947.42 on the bill.
They can afford to pay it off bit-by-bit, she said, but they’d rather spend the money on their grandchildren or their disabled adult son, who lives with them.
Wilson, her doctor, has been great, Murphy said. He’s told her he’ll continue to help her and treat her for the surgery’s after effects. He has told Murphy that he’s hopeful that over time the pain and numbness will go away, though there is no guarantee.
Her doctor learned of the pathology error last September and he in turn told her, but Murphy didn’t hear from the hospital until this spring. She has gotten two phone calls from a hospital official, but no apology.
“An official apology would be nice and not to have to pay the rest of that bill would be nice,” she said. She also wishes hospital officials would be more forthcoming about what steps they’ve taken to prevent similar misdiagnoses in the future.
“Just ‘We’ve made a mistake,’” she said. “And this is what we’re doing so this doesn’t happen in the future. This is what our plan is.”