Baylor Is Investigating Whether an Austin Lab Improperly Screened Pap Smears

The review of diagnostics at Clinical Pathology Laboratories comes after hundreds of Irish women with cervical cancer were issued false negatives. Baylor Clinic sends patients' pap smears to the same facility.

By Abby Ledoux May 4, 2018

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A public health crisis in Ireland tied to a laboratory in Austin has prompted a Baylor College of Medicine review, the Chronicle reported yesterday. Officials are working to determine the accuracy of pap smears collected at Baylor Clinic and outsourced to Austin-based Clinical Pathology Laboratories Inc. for diagnostics, now at the nexus of international controversy after the lab was found to have mistakenly issued more than 200 false negatives to Irish women who went on to develop cervical cancer.

One of those women, 43-year-old Vicky Phelan, is dying. Her case, which wound its way through Ireland's High Court, busted open the medical scandal when court proceedings revealed CPL mistakenly cleared 208 women between 2010 and 2014 despite early indications of malignancies. Those women, Phelan included, received free cervical screenings through an Irish government program that, like Baylor, contracted with CPL to read its tests. Phelan's 2011 pap smear came back negative, the New York Times reported. A second test in 2014 found cervical cancer, which prompted a review of the 2011 test. It turned out the first test "strongly indicated the presence of cancer" after all. Phelan first learned of the false negative last September; four months later, doctors gave her six to 12 months to live.

Last week, CPL settled with Phelan for about $3 million. Ireland's clinical director of the screening program resigned last weekend, and the government announced an investigation into the tragic debacle on Monday. Irish officials said at least 17 of the 208 women mistakenly cleared by CPL have since died.

"I could be another one of those women," Phelan told an Irish radio show on RTÉ Radio One. "By God, I'm going to take these guys on. I think it's disgraceful what they've been doing to the women of Ireland."

Baylor's inquiry for the women of Texas comes right on the heels of the Irish government's. In a statement to the Chronicle, Baylor officials said they don't know how many of their patients might be affected by inaccurate CPL readings but will contact any that are found to be.

That's a point of contention in Ireland–Phelan was diagnosed with terminal cancer a full three years before she was even told about her inaccurate pap smear; all told, 162 women who received false negatives were not informed of theirs. The Times reported a dispute between doctors and the government screening program over who was responsible for telling the affected patients; Prime Minister Leo Varadkar has since deemed the ordeal full of "appalling communication failures."

Houston patients should know that MD Anderson Cancer Center, Memorial Hermann, and Houston Methodist told the Chronicle they don't send their pap smears to CPL, but individual doctors might. Baylor OBGYNs at Texas Children's Pavilion for Women send their tests to a different lab.

Though headquartered in Austin, CPL has labs across the southwest, including a number in Houston. Baylor provides medical direction for CPL's operations in the greater Houston area.

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