Baylor reviews inaccurate Pap smears

Lab failed to diagnose malignancies in more than 200 screenings

Baylor College of Medicine has launched a full review into the diagnostic accuracy of Pap smears it sends to an Austin pathology laboratory that missed signs of malignancies in more than 200 Irish women later found to have cervical cancer.

Baylor’s review follows one announced Monday by the Irish government, which outsourced tests to Clinical Pathology Laboratories Inc. in Austin as part of a free government screening program. In the past week, the media in Ireland have extensively reported on the consternation caused by the false negatives.

“We have reached out to Clinical Pathology Laboratories Inc. to ascertain the accuracy of diagnoses for our patients and will do what is necessary to ensure the safety of our patients,” Baylor officials wrote in a statement following a Houston Chronicle inquiry.

The statement said it is unknown at this time how many of Baylor’s patients could have been impacted by the company’s possible inaccurate reading of Pap smears. It said any affected will be contacted.

Baylor contracts with Clinical Pathology Laboratories, in addition to other laboratories, to read Pap smears collected by family doctors at its Baylor Clinic. Baylor obstetrician-gynecologists have clinics at Texas Children’s Pavilion for Women, which sends Pap smears to a different lab.

But Baylor’s relationship with the company goes beyond sending Pap smears. CPL contracts with Baylor to provide laboratory director services to its clinical testing facilities in the Houston and Victoria areas, overseeing tests such as the analysis of blood, body fluid and urine specimens. In addition, Baylor’s chairman of pathology is listed on CPL’s website as one of its pathologists.

It was unclear Tuesday what other Houston institutions or doctors might send Pap smears to Clinical Pathology Laboratories, one of the largest such private endeavors in the nation and now in its 70th year. MD Anderson Cancer Center, Houston Methodist, UTHealth Physicians and Memorial Hermann, as well as Baylor affiliates St. Luke’s and Ben Taub, all said they do not use the company.

Clinical Pathology Laboratories did not respond to Chronicle phone calls and an email.

The inaccurate readings became public last week when court proceedings showed that

CPL reached a $3 million settlement with 43-year-old terminally ill Irish woman Vicky Phelan, who was diagnosed with cervical cancer in 2014. A review found that a 2011 Pap smear that CPL reported as negative actually strongly indicated the presence of cancer.

“If she had been diagnosed in 2011, there would have been a 95 percent chance of a cure,” her lawyer, Cian O’Carroll, said in the New York Times. “Instead, she is left with what is now an incurable cancer.”

In January, Phelan was told she has only six months to live, O’Carroll said.

CPL’s settlement with Phelan did not involve an admission of liability.

About 1,400 women who participated in the Irish government’s screening program developed cervical cancer despite Pap smears that came back negative between 2010 and 2014. The tests were accurate in most cases — the cancer developed later — but for 208 women, subsequent reviews found clear signs that early-stage cancer should have been spotted.

At least 17 of the women have died, though officials in Ireland said they could not confirm the causes of death.

Much of the controversy in Ireland involved the failure to tell some patients about the 2014 review that found inaccurate readings. According to emails released in the Phelan case, program officials argued that providing such information would not affect patients’ current treatment.

Ireland’s Prime Minister Leo Varadkar said Monday he was “very angry” and “saddened” by the case and said the government would investigate “appalling communication failures,” the Times reported.

The Times also reported that the government is setting up phone help lines and emergency testing and considering a plan to automatically compensate survivors of the deceased women so they do not have to go through the courts.

It was not clear whether Clinical Pathologies Laboratory was the only company associated with the erroneous test results.

The New York Times contributed to this report.