A federal agency is investigating cell-testing practices at Washington Hospital following complaints that came to light after a Canonsburg woman filed a lawsuit claiming a doctor misread her Pap smears for five years before she was diagnosed with cervical cancer.
Lorraine Ryan, spokeswoman for the federal Centers for Medicare & Medicaid Services, said in an email that the agency called on the American Society of Cytotechnology to investigate and a surprise survey was completed Wednesday at the hospital to “rule out potential harm due to lack of quality practices in cytology.” She said the surveyors have 10 days to send their findings to the lab, which then has the same amount of time to respond with a plan of correction.
Holli Senior, spokeswoman for the state Department of Health, said the department’s Bureau of Laboratories reached out to its partners at the centers after being notified of the compliant last month and will review the findings to determine whether further action is needed.
Meanwhile, Dr. Deborah Maliver, the attorney for the woman, said a hospital official told her that 500 Pap smear slides obtained over the past five years from numerous women were sent to Magee-Womens Hospital of UPMC in Pittsburgh for review after the suit was filed.
In a written statement, Washington Hospital said it is taking the allegations “very seriously” but could not comment on the suit.
“Immediately upon learning of this complaint, the hospital consulted with independent experts to evaluate the claims at issue, and is working diligently to identify any patient safety concerns,” reads the hospital’s statement. “The hospital is also cooperating with independent agencies to evaluate the quality of pathology services, and preliminary results have not identified any widespread deficiencies in Pap smear interpretation. In the event that patient safety concerns are identified or verified, the hospital is prepared to follow up with individual patients and their physicians.”
The hospital also stated that it is not aware of any similar past or present claims.
According to the suit filed Oct. 1 in Washington County Court, 30-year-old Jennifer Beiswenger was diagnosed with cervical cancer in May 2011, about two months after giving birth to her daughter. She underwent treatment and was determined to be cancer-free last November, which her attorney said was reaffirmed Wednesday by a test.
Named as defendants in the suit are Washington Hospital, Pathology Associates Inc., Washington OB/GYN Associates, Washington Physicians Group and eight doctors, including Dr. Richard Pataki, the medical director of the pathology lab at Washington Hospital since 1975, who allegedly misread Beiswenger’s Pap tests over a five-year period.
The suit claims abnormal cells were first present in a 2003 Pap test, which was signed by an OB/GYN doctor not specifically named in the complaint then “filed away and completely ignored.”
A 2006 Pap test also contained abnormalities, which Pataki reported, but he incorrectly documented that no endocervical cells were present in the sample, the suit claims.
The complaint also claims none of Pataki’s reports from 2007 to 2010 flagged the “ongoing, immediate need for a proper workup” of Beiswenger’s previous abnormal tests.
Reached at his office by phone Friday, Pataki declined to comment on the suit.
The suit also details other alleged oversights by doctors who failed to take measures to address the abnormal test results.
Beiswenger and her husband, Eric Beiswenger, who is also a plaintiff in the suit, are seeking monetary damages against the hospital and the other defendants.
According to Maliver, who is a former internal medicine physician turned attorney, only about 1 percent of Pap slides containing cells removed from the cervix and endocervix are sent from cytologists to pathologists, such as Pataki, for further review due to abnormalities.
“This can’t be one person making a mistake over and over five times in a row,” she said.
This led Maliver to send a letter to all of the members of the hospital’s board as well as several governmental and accrediting agencies alerting them to the issue.
“I have a moral obligation to warn other people,” she said.
Maliver said she hopes she’s wrong and that Pataki and his colleagues didn’t make any other mistakes, but she’s concerned the issue could extend to other women tested at the lab.
“If it were me, I’d go get a Pap test,” she said.