The Washington Hospital is reviewing at least 500 Pap smear slides analyzed by its laboratory after a woman claimed in a lawsuit that one of the hospital's pathologists misread her tests for five consecutive years before she was diagnosed with cervical cancer, according to the attorney who filed the case.
While refusing to answer specific questions about the case, the hospital said in an emailed statement that it takes "these allegations very seriously."
"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," the hospital in Washington, Pa., also said. "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."
Among the groups investigating the allegation are the Pennsylvania Department of State, the federal Centers for Medicare and Medicaid Services, and accrediting organizations such as The Joint Commission and the College of American Pathology.
None of those agencies has completed its investigation, although the hospital's pathologist accused of misreading the five Pap smear slides, Richard Pataki, said Thursday that the Centers for Medicare and Medicaid Services has conducted its onsite review.
"I was concerned" about the review, said Dr. Pataki, 74, who has worked at The Washington Hospital for nearly 50 years and has been the lab's medical director since 1975. "But we did very well" in the review, he said.
Lorraine Ryan, spokeswoman for the centers, said in an email that the centers asked the American Society of Cytotechnology to do a "survey to rule out potential harm due to lack of quality practices in cytology," but it was not yet completed.
The reviews were initiated after Jennifer Beiswenger, 30, of Canonsburg, filed a medical malpractice lawsuit Oct. 1 against the hospital, the hospital's pathology lab and eight doctors, including her obstetrics and gynecological doctors, and Dr. Pataki.
She was diagnosed with cervical cancer in late May 2011, two months after giving birth. Ms. Beiswenger responded well to treatment and was found free of cancer by November 2011. A follow-up test Wednesday found that she remains cancer free.
"It was very good news," said Ms. Beiswenger, an online math tutor.
Concerned that her case might not be the only one in which Pap smears were misread, Ms. Beiswenger's attorney, Deborah Maliver, sent letters to various government and accrediting organizations telling them what happened to her client.
"It can't be random that her tests were misread for five straight years," said Dr. Maliver, a former physician now practicing law. "There's a potential public health risk here."
It is not known how many other women had their slides reviewed by The Washington Hospital's laboratory.
But Dr. Maliver said she was told by a hospital official that the hospital turned over 500 slides -- a sampling of potentially thousands of tests -- from other women from the past five years to the pathology laboratory at Magee-Womens Hospital of UPMC for an outside review. Ms. Beiswinger's five slides also were sent there.
Magee's cytopathology department includes R. Marshall Austin, one of the leading experts on Pap smears and cervical cancer screening. Dr. Austin said Thursday he could not comment on the case.
The Pap smear, a test named for its inventor, George Papanicolaou, involves taking a sampling of cells from the cervix and analyzing those cells on a slide under a microscope. In the 75 years since it was first used, the death rate from cervical cancer has dropped by 80 to 90 percent for women who undergo regular Pap smears, medical experts say.
Over the past decade, the analysis of those slides has increasingly been aided by computers, which identify questionable Pap smears for closer examination and confirmation by cytotechnologists and then a pathologist. It is not known if The Washington Hospital uses a computer to aid in the analysis of its Pap smears.
The Washington Hospital asked for the review of its Pap smear slides because, among other missteps by her doctors, Ms. Beiswenger charges in the lawsuit that for at least five years -- 2006 to 2010 -- Dr. Pataki misread her Pap smear slides.
Instead of concluding that the slides showed abnormal cells, which would have required further testing, and then a growing cancer, Dr. Pataki found the tests were either normal or that no endocervical cells were present, according to the lawsuit.
Multiple pathology experts hired by Ms. Beiswenger's attorney reviewed those same Pap smear slides and, according to the lawsuit, concluded that those five years of tests showed a clear progression from pre-cancerous cells to an invasive carcinoma.
That was the same conclusion Dr. Pataki and two of his colleagues came to on May 26, 2011, when, after learning that Ms. Beiswenger was diagnosed with cervical cancer, they reviewed the five years of her Pap smear slides that they had in their possession, according to the lawsuit.
According to hospital records obtained by Ms. Beiswenger, they wrote in part in their review: "We reviewed the Pap smears from 2006 to 2010 and we had multiple AGUS ...," an acronym for a finding of "atypical glandular cells of undetermined significance."
Such a finding "should have been a red flag for a biopsy or other additional testing," Dr. Maliver said.
But at least in the last four years of that period, Ms. Beiswenger never had additional testing that would have confirmed what the diagnostic Pap smear test seemed to find: that cervical cancer was growing inside her.
In 2006, she also was tested for human papillomavirus, or HPV, and it came back positive. Some strains of HPV can lead to cervical cancer. That same year Dr. Pataki found that her Pap smear was abnormal, showing "atypical squamous cells of uncertain significance" -- a finding known as ASCUS.
Those two findings in 2006 -- as well as a finding in 2003 of AGUS in her Pap smear by a different pathologist -- also should have resulted in additional testing by her obstetrics and gynecological doctors when they were given those results, the lawsuit charges.
Those test results were seized Thursday by Dr. Pataki, who noted: "Earlier we did say she had AGUS and ASCUS and nothing was done."
Asked if he was attempting to place blame on Ms. Beiswenger's ob-gyns -- who are also named in the lawsuit -- Dr. Pataki said: "I'm not dumping on anyone."
Dr. Pataki said because his practice was aware of those prior findings, "We had quite a few people look at [the slides in 2007 to 2010], and we just didn't think [a finding of abnormal cells] was there."
As for the experts Dr. Maliver hired to look at the slides who found a clear indication of a growing cancer in Ms. Beiswenger's slides from 2006 to 2010, Dr. Pataki didn't put much credence in their review.
"You can always look back and find something once you know the result," he said.
Sean D. Hamill: firstname.lastname@example.org or 412-263-2579.