Citing Public Safety, State Shuts Down Pap Test Lab

In an unprecedented action, the state Department of Health Services on Friday ordered Central Pathology Services Medical Group to “cease operations immediately . . . in order to protect the public health” because the lab allegedly had misinterpreted the results of too many Pap smears.

Dr. Kenneth Kizer, the state health department’s director, issued the order based on the results of a state inspection last month of the Tarzana laboratory, which processes more than half the Pap smears in Southern California.

In a letter to the lab, Kizer said he was “appalled” by the results of the inspection. Although specific findings from that inspection have not been released, a source involved in the investigation said the laboratory missed “substantial numbers” of cases in which precancerous lesions were present.

Will Comply

Central Pathology’s attorney, Allan Browne, said Friday that the facility will comply with any order issued by Kizer.

The Pap smear is a routine test that physicians use to detect cervical cancer and other abnormalities in women. Central Pathology processes almost 700,000 Pap smears a year.

State health officials had dispatched a team of 20 inspectors to Central Pathology last month after a federal government inspection in January showed that the lab failed to detect a range of diseases from herpes to cervical cancer, according to an internal government report. The federal government had looked at a random sampling of 1,258 Pap smears.

The U.S. Department of Health and Human Services dropped Central Pathology from its Medicare and Medi-Cal programs because, among other things, the lab’s error rate of as much as 12% failed to meet federal quality control standards. Those two programs no longer will pay for Pap smears processed at Central Pathology.

After examining more than 1,000 randomly selected Pap smears, the state concluded Friday that the lab’s error rate was nearly twice what the federal government had alleged.

Typically, laboratories have an error rate of about 5% on Pap smears, but some pathologists say top-flight labs make even fewer mistakes. Browne insisted Central Pathology’s error rate is only about 3%.

State health spokesman Norm Hartman said he believes the order against Central Pathology is the first such action against a lab in California. “As far as I know, this is unprecedented,” he said.

State officials refused to disclose the details of their findings until Central Pathology’s executives have an opportunity to review them.

But a source involved in the inspection said the state shares the federal government’s concerns about the way Central Pathology does business.

High Volume Criticized

Federal health officials have criticized the lab for the high volume of Pap smears it processed--about 2,600 a day. Central Pathology, according to company spokesman Martin Cooper, requires 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 even more than 100 slides a day because the company pays $1 extra for every extra slide examined during one workday, Cooper said. During its inspection, the federal government had found that Central Pathology issued results for slides that were blank or contained too few cells to diagnose a disease. Company officials have denied that charge.

Central Pathology also issued diagnoses on severely broken slides, a practice it has since modified, according to the company’s written response to the federal government’s allegations.

Founded by Pathologist

Central Pathology was founded in the early 1960s by pathologist Allen N. Levy. Through a holding company called Amsterdam International, Levy also owns Tarzana-based Central Diagnostic Laboratory, which performs a variety of medical tests including blood and urine analyses. Central Diagnostic is the largest privately owned laboratory in the United States, according to court records.

Last month, Cooper said the number of slides being sent to Central Pathology had fallen by about 10% after disclosure of the federal government’s findings. A number of doctors said they had stopped using the laboratory because of the allegations.