Lab blames Irish rules for missed cancers

Austin’s CPL says U.S. Pap smear protocols make catching false negatives more likely

The Austin laboratory that missed early signs of cervical cancer in Irish women uses a more reliable screening method for U.S. patients, the company said Wednesday, a hopeful sign for Houston women concerned about its readings of their tests.

In its first statement on the controversy raging in Ireland over the false negatives, Clinical Pathology Laboratories noted the contract with the government-run program did not include the level of scrutiny required under U.S. standards. During a four-year period, the program mistakenly cleared more than 200 Irish women who later received cancer diagnoses.

“These screens have been performed through manual examinations of individual slides, without the benefit of computer-based imaging and a separate HPV (human papilloma virus) test, which together comprise the clinical standard in the U.S. and many other countries for cervical cancer screening,” read a part of the statement.

The company, one of the largest such private enterprises in the U.S., is used by Baylor College of Medicine for some of its testing, including Pap smears. Family medicine doctors at the Baylor Clinic send such smears to CPL. Those taken by Baylor obstetrician-gynecologists at

Texas Children’s are sent to a different lab.

Baylor announced last week it is conducting a review of the accuracy of CPL’s Pap smears, emphasizing it “will do what is necessary to ensure the safety of our patients.” It said then that it doesn’t know how many of Baylor’s patients could have been impacted by CPL’s potentially inaccurate readings.

Dr. Thomas Wheeler, chairman of pathology at Baylor, said the review is still ongoing but confirmed that the fact the Irish program’s standards were less than those for the U.S. should allay local patients’ concerns about their Pap smear readings returned by CPL.

“I would have confidence to send Pap smears of my wife or daughter or other loved ones to Clinical Pathology Laboratories,” said Wheeler, listed on CPL’s website as one of its doctors. “The standards utilized in the Irish program are not those employed in the U.S. In terms of Baylor’s patients, everything looks fine for the quality of screenings we’ve reviewed.” Higher standards

Wheeler said Baylor will take a fresh look at the screenings of any Baylor Pap smear patient who makes such a request.

Wheeler, who called Pap smears the most regulated test in all of medicine, noted the U.S.’s higher standards require the use of an imaging system that works like facial recognition software to distinguish abnormal cells, invaluable assistance considering only a handful of such cells sometimes exist within 100,000 normal cells; and complementary testing for HPV, the sexually transmitted infection that is the most common cause of cervical cancer and which signals the need for greater scrutiny if detected. The Irish program’s contract didn’t require either.

U.S. regulations allow for follow-up reviews every three years instead of annually, acceptable given the additional tests, Wheeler noted. But without such safeguards, he added, annual reviews would be valuable to catch occasional missed false negatives. The Irish program’s contract only required follow-ups every three years.

Clinical Pathology Laboratories’ statement also expressed regret about Vicky Phelan, a 43year-old terminally ill Irish woman who was diagnosed with cervical cancer in 2014, after a review found that a 2011 Pap smear that CPL reported was negative actually strongly indicated the presence of cancer. CPL settled with Phelan, whose doctors have given her six months to live, for 2.5 million euros (about $3 million).

“What has happened to Mrs. Phelan and her family is tragic, and we deeply regret the outcome,” said the statement. “We hope this settlement will allow Mrs. Phelan to gain additional treatment and an improved prognosis and quality of life.” Other labs contracted

CPL’s settlement with Phelan did not involve an admission of liability. The case’s court proceedings exposed problems with the Irish program.

About 1,400 women who participated in the 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 Irish officials said they could not confirm the causes of death.

In its statement, Clinical Pathology Laboratories said “no screening program is 100 percent effective,” but noted its Pap smear accuracy rate, monitored by accrediting agencies, is “well above accepted rates.”

Besides CPL, a 70-year-old company affiliated with more than 150 pathology departments in the Southwest, the Irish government also contracted with Quest Diagnostics, a New Jersey laboratory, and Irish companies MedLabs and Sonic Healthcare. The percentage of tests each company read is unknown.

Other major institutions in the Texas Medical Center contacted by the Chronicle last week said they did not send Pap smears to CPL.