The pathology laboratory at Wake Forest Baptist Medical Center, which has had at least 25 tests with erroneous results, is back in compliance with Medicare’s conditions of participation, the agency said Friday.
Medicare notified Dr. Julie Ann Freischlag, the medical center’s chief executive, of the decision in a short letter.
Wake Forest Baptist submitted in mid-April a corrective plan aimed at resolving lab test concerns raised during a Medicare investigation of Feb. 5-8. The investigation was prompted by internal complaints.
The notification comes four days after the N.C. Survey Agency conducted a follow-up review Monday. The agency was assigned by the state Department of Health and Human Services on Medicare’s behalf.
Medicare had until June 12 to conduct the follow-up review and until June 21 to make its review recommendations.
“We are removing your facility from state survey agency jurisdiction,” wrote Linda Smith, an associate regional administrator for Medicare’s Division of Survey & Certification. “Your hospital’s ‘deemed status’ as a facility accredited by the Joint Commission has been restored.”
Dr. Kevin P. High, president of Wake Forest Baptist Health, expressed satisfaction with Medicare’s decision.
“We welcomed the opportunity to work with the surveyors,” High said. “Thanks to the culture of safety that exists at the medical center, which encourages all of our employees to speak up if they see something that is important to patient care and safety, we were able to recognize and rectify this situation, improving the quality of care that we provide.”
The center’s inpatient Medicare billing privileges had been in “immediate jeopardy” status until Medicare rescinded that move April 10. Immediate jeopardy is a federal designation that means missteps have caused or are likely to cause injury or death.
The center has defined the review period as June 2014 to August 2017.
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. Medicare did not provide Friday a follow-up report addressing the review of the remaining cases.
Wake Forest Baptist said the pathology lab handles about 25,000 surgical cases a year.
At least 25 patients were affected by faulty pathology laboratory test results, including two who underwent lumpectomies and radiation only to be told later they didn’t have cancer, according to an expanded report released April 11 on cancer misdiagnoses at the center.
In the case of an unidentified female 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 the Medicare investigation. She didn’t receive radiation therapy.
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.
Another 19 patients had erroneous test results, but regulators determined their “treatment was not impacted.”
An initial 23-page report, issued March 22, identified only four patients who were possibly misdiagnosed.
The amended 54-page report, released April 11, addressed histopathology test results. Histopathology is the study of changes in tissues caused by diseases such as cancer. The pathology laboratory handles about 25,000 surgical cases a year.
Medicare and Medicaid beneficiaries represented about 44 percent of the hospital’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,” Dr. Kevin High, president of Wake Forest Baptist, said April 11.
Medicare spokeswoman April Washington has said that “it’s important to note that most facilities take steps to correct deficiencies prior to termination of its provider agreement.”