Lab Closed by State Told to Pay for New Pap Tests

The state Department of Health Services on Monday ordered Central Pathology Services Medical Group of Tarzana to contact hundreds of thousands of women whose Pap smears were diagnosed as normal by the lab over the last five years and offer to pay for new tests.

Central Pathology, which last week was ordered shut down by the state for allegedly misdiagnosing too many Pap smears, processed nearly 700,000 smears last year, more than half of all smears done in Southern California. The lab also did Pap smears under the name Central Diagnostic Laboratory.

“In order to protect the public health and safety, it is necessary that all women, not just those residing in California, receiving Class I or equivalent reports (indicating no abnormalities) from either Central Pathology or Central Diagnostic within the last five years, need to be offered the opportunity for a repeat Pap smear,” according to the health department’s written order delivered to the lab Monday.

The lab was given 30 days to contact the women and recommend that they see physicians about retaking the tests.

In announcing the action, Dr. Kenneth Kizer, health services director, said Monday that a March inspection of the lab found that 21% of its Pap smears had been misdiagnosed.

“It was a sloppy operation,” he said in an interview with The Times. “It was totally unacceptable that they had such a high error rate.” The Pap smear is a routine test that physicians use to detect cervical cancer and other medical abnormalities.

“We have not worked out the mechanics of how they will pay for the testing,” said state health spokesman Norm Hartman.

If Central Pathology does not comply, the state will take “further legal action to protect the health and safety of women from erroneous Pap smear reports,” the order said. Kizer also said his department will send out teams of inspectors to 10 other Pap smear laboratories in California during the next six weeks. “We need to get an idea of the other labs’ error rates and set some kind of standard,” he said. Kizer would not identify any of the other labs.

Kizer said the state will also begin to require continuing education courses for cytotechnologists who read Pap smears. And he said he would work with the Legislature on legislation requiring the licensing of cytotechnologists along with a cap on the number of slides they can read per day.

Permanently Closed

Central Pathology said Monday that it has permanently closed and is referring Pap smear business to other labs. The company said in a statement that it was “a 27-year-old facility with a perfect inspection record to this point” and that it had recently instituted what it considers to be “the most stringent quality-control standards in the nation.”

The Times reported last month that the state health department had sent a team of 20 inspectors to Central Pathology after the federal government found in a January inspection that the lab had failed to detect a range of diseases from herpes to cervical cancer, according to an internal government report. The federal government had found an error rate of as high as 12% in a random sampling of 1,258 Pap smears.

The federal Department of Health and Human Services decertified the lab from its Medicare and Medi-Cal programs because, among other things, the lab’s error rate failed to meet federal quality control standards. Those two agencies stopped paying for Pap smears processed at Central Pathology.

State inspectors examined 1,103 Pap smears and found 234 alleged errors. Central Pathology was given only 24 hours Monday to contact those 234 women or their physicians to notify them of the alleged errors.

The industry average for Pap smear errors is about 5%, but some pathologists say top labs make even fewer mistakes.

Kizer said Monday that Central Pathology issued results for slides that were blank or contained too few cells for an accurate diagnosis to be made. Company officials have denied that charge.

Volume Criticized

Federal and state officials have criticized the high volume of Pap smears that Central Pathology processed--about 2,600 a day. Central Pathology, according to company spokesman Martin Cooper, required its full-time cytotechnologists to read 100 slides a day, which is above the recommended level of the industry’s trade group.

Some cytotechnologists at Central Pathology read in excess of 100 slides a day because the company pays $1 extra for every case above 100 examined during one workday. Paying per slide encourages speed over accuracy, according to some pathologists.

Founded in Early ‘60s

Central Pathology was founded in the early 1960s by Dr. Allen N. Levy, a pathologist. Levy, through a holding company called Amsterdam International, also owns Tarzana-based Central Diagnostic Laboratory, which performs a variety of medical tests including blood and urine analyses.

Dr. Cyrus Milani, Central Pathology’s director, blamed Central Pathology’s closure in a statement on “the less-than-forthcoming attitude of government employees, their refusal to provide specific guidance for corrective action and . . . media distortions and inaccuracies.”