U.S. Decertifies Pap-Smear Lab in Fullerton

Federal health officials said Monday that they have decertified National Cancer Screening Laboratories, which has serviced some Planned Parenthood chapters around the United States, for allegedly misdiagnosing too many Pap smears.

The Health Care Financing Administration informed National Cancer in a letter dated March 30 that Medicare and Medi-Cal programs would no longer pay for Pap smears done at the company. The firm shut down operations last week.

Harry Barba, HCFA’s associate regional administrator in San Francisco, said the number of alleged misdiagnoses at National Cancer was unacceptable by federal quality-control standards. He refused to release specifics until the lab has an opportunity to study the government’s findings, but said the percentage of misdiagnoses is “a substantial number--a very high number.”

The Pap smear is a medical test regularly used by doctors to detect cervical cancer.

National Cancer owner Neil Gregory, 46, said he stands behind the quality of the Pap smear tests done his firm “100 percent” and accused federal and state officials of harassment. “There is a lot of politics involved in this,” Gregory said. “It’s a witch hunt.”

He said he closed National Cancer last week because the company was no longer profitable. “Over the last 10 months, we’ve been winding down the business,” Gregory said. “The business is very, very competitive, and the profit margins are very narrow.”

National Cancer is the second Pap-smear lab in California to be decertified by the federal government. Central Pathology Medical Services in Tarzana, the nation’s largest Pap-smear lab, lost Medicare and Medi-Cal funding early last year and was subsequently shut down by the state.

“This is not a common occurrence,” said Barba.

Under a state law that went into effect Jan. 1, the state Department of Health Services will now be required to suspend National Cancer’s medical license.

The lab, which has been operating for more than 10 years, was inspected last month by a team of lab technicians from a trade group called the American Society of Cytotechnologists. HCFA, a division of the U.S. Department of Health and Human Services, employs the group to do surveys of Pap-smear labs nationwide.

Federal and state officials said National Cancer processed about 100,000 Pap smears a year, including many from Planned Parenthood chapters outside Southern California. Gregory said the number of Pap smears processed at National Cancer had dwindled recently to around 25,000 a year, but confirmed that Planned Parenthood was a major client. The company charged $6.95 a test.

Planned Parenthood facilities in Los Angeles and Orange County have never sent Pap smears to National Cancer, officials said. The Los Angeles affiliate opened its own lab last year, Planned Parenthood spokeswoman Marie Paris said.

Central Pathology diagnosed nearly 700,000 Pap tests a year. Federal authorities found an error rate of about 12% at that lab, but a later state inspection claimed about 21% of Pap smears there were misdiagnosed. The industry average is about 5%.

HCFA alleged that Central Pathology had failed to detect a range of diseases from herpes to full-blown cervical cancer in a random sampling of 1,258 Pap smears.

The state health department said it tried to begin an inspection of its own at National Cancer but was ordered off the premises last June. The company was one of 10 labs randomly selected for inspection by state officials after Central Pathology’s closure in order to determine the extent of misdiagnoses in the Pap-smear industry.

But state inspector Gloria Walker maintains in a complaint that Gregory threatened her with what she thought was a gun. Walker fled the lab, and the state did not make any follow-up visits.

Gregory is scheduled to go to trial in Orange County Municipal Court on April 9 on a misdemeanor charge of “drawing and exhibiting a replica firearm,” according to Deputy Dist. Atty. Doug Brannan.

Gregory has denied the charge and has accused Walker of using “Gestapo” tactics against him.

National Cancer was last inspected by state health officials in November, 1988, and passed.

The reading of Pap smears--which is still done manually with use of a microscope--has generated a great deal of concern in recent years, particularly about the number of specimens that cytotechnologists are expected to review.

In some labs, sometimes called Pap mills, technologists read four times as many specimens as medical experts recommend to ensure accuracy. Some companies pay technologists on a per-specimen basis, which can encourage carelessness, health officials said.

The American Cancer Society says about 60,000 women a year get cervical cancer and nearly 7,000 die of the disease annually.