State Probing Allegations of Lab’s Pap Smear Errors

The California Department of Health Services has sent a team of 20 inspectors to Central Pathology Services Medical Group to investigate allegations that the Tarzana laboratory is misdiagnosing too many Pap smears, The Times has learned.

Pap smears are widely used to detect cervical cancer and Central Pathology diagnoses nearly 700,000 tests a year, including more than half of all taken in Southern California.

The state’s inspection comes a month after federal authorities alleged that Central Pathology misdiagnoses Pap smears as much as 12% of the time, including some that contain evidence of life-threatening disease.

The federal Department of Health and Human Services found in a January inspection that the lab had failed to detect a range of diseases from herpes to full-blown cervical cancer in a random sampling of 1,258 Pap smears, according to an internal government report.

Central Pathology disputes the government’s findings. “We are a high-quality laboratory,” said Dr. Cyrus Milani, Central Pathology’s medical director. “We are not second to anyone.” Milani said he would feel completely at ease having his daughter’s Pap smears examined at Central Pathology.

The industry average for Pap smear errors is about 5%, but some pathologists say first-rate labs have even fewer misdiagnoses. Dr. Conley Lacey, a former professor of gynecologic oncology at UC San Francisco, said top-flight Pap smear labs “only miss about 2%” of their cases.

“Services at Central Pathology Services Medical Group pose an immediate threat to patient health and safety,” concluded Peter Summers, acting chief of standards and certification for the Department of Health and Human Services, in a letter he sent to Central Pathology.

His office last month dropped Central Pathology from the approved vendor lists of both Medicare and Medi-Cal because, among other things, the lab’s error rate of as much as 12% failed to meet federal quality control standards. Those two agencies will no longer pay for Pap smears done by Central Pathology. “We took the most severe action we could take,” said Summers.

Wolfgang Fuhs, chief of laboratories for the state, said its ongoing investigation into Central Pathology is a follow-up on the federal government’s allegations. But company spokesman Martin Cooper said Central Pathology executives are under the impression the investigation is part of a routine annual visit.

Volume a Concern

The federal government’s concerns about Central Pathology include the high-volume of Pap smears it processes. The lab reviews about 2,600 Pap smears daily. To process so many specimens, Cooper said the company requires its full-time cytotechnologists to read 100 slides a day, which is above the recommended level of the industry’s trade group.

Some Central Pathology cytotechnologists read more than 100 slides per day because the company pays $1 extra for every slide a technician reads in excess of 100 in a workday. The practice of paying per slide encourages speed over accuracy, according to Dr. Dorothy Rosenthal, chief of the cytology division at UCLA Medical Center, and other pathologists.

The federal government’s action has prompted some doctors to stop using the lab. One of them is Reinhold Ullrich, an associate clinical professor of obstetrics and gynecology at UCLA who has his own practice in Torrance. Based upon the government’s findings, Ullrich said Central Pathology could be described by “the generic term Pap mill” and last month he stopped sending his patients’ Pap smears there.

Central Pathology’s officials claim two independent consultants concurred with Central Pathology’s diagnoses on all but a few of the suspect slides. The company declined to release the name of either consultant.

Director’s Response

“We can give you, maybe, the names of many doctors who have called us since this problem and have told us they don’t understand what this fuss is about,” said medical director Milani. “They are willing to support us to any length.”

Central Pathology later declined to release a list of doctors and hospitals using the lab.

Dr. Boyd Cooper, a Hollywood gynecologist contacted by The Times, said he was quite happy with the lab’s work. Cooper said he has sent about 1,000 Pap smears to Central Pathology in the last year and received accurate diagnoses in return. “I have no reason to believe they are not doing their job properly,” Cooper said.

Pap smears have become part of a routine checkup for many women. About 60,000 women will get cervical cancer this year and about 7,000 will die from it, according to the American Cancer Society. However, the illness usually can be stopped if caught in time.

Central Pathology challenged the federal government’s decertification in February, but its appeal was denied. Only about 10% of Central Pathology’s business was from Medicare and Medi-Cal patients, so the lab continues to do substantial business, some of which is reimbursed by private insurance carriers.

Owned by Founder

The man who founded Central Pathology is Dr. Allen N. Levy, a 62-year-old pathologist. Central Pathology’s parent company is Central Diagnostic Laboratory, also based in Tarzana, which performs a variety of medical tests, including blood and urine analyses. Central Diagnostic does not do Pap smears.

Levy owns 100% of Amsterdam International, a holding company that owns all of Central Diagnostic. Central Diagnostic is described in court records as the largest privately-owned laboratory in the United States. The firm and its subsidiaries employ about 1,200 people nationwide, and its revenues exceed $100 million a year, the company said.

Both Central Pathology and Central Diagnostic were started in the early 1960s by Levy, who was earning only $75 a month at the time as a medical intern.

In the last eight years, Levy has spent about $30 million building a two-acre Malibu compound nicknamed the Whale on Encinal Bluffs that is expected to become the most expensive home in that exclusive community when it is finished. Levy is also a classic car collector, whose holdings include a 1955 Bentley sedan with the personalized license plate “A HERO.”

Levy declined several requests for an interview.

The Times has learned that last December, Central Diagnostic was ordered by the state health department to stop performing certain kinds of blood tests and that directive is still in effect.

Samples Omitted

Central Diagnostic failed to comply with a state requirement to submit quarterly samples of blood work for a routine review so the state can verify the accuracy of the test results. Levy’s attorney, Allan Browne, said the missing results were “an inadvertent omission.” Central Diagnostic failed to send in samples for seven consecutive quarters in 1987 and 1988.

And last year a complaint was filed with the state health department by a Kern County public health official who alleged Central Diagnostic had misdiagnosed the AIDS virus infection in four patients. Ronald Talbot, the county’s lab director, said his tests showed the patients were not infected with the AIDS virus. Records indicate the state investigated the claim and found Central Diagnostic may have erred because it was using an older testing method. The company has since updated its testing method.

But the most serious allegations against Levy’s businesses are in the federal government’s inspection report on Central Pathology’s Pap smear lab. The survey--part of a new nationwide federal inspection program--was conducted by members of the American Society for Cytotechnology, a trade group with most of its operations in Durham, N.C.

The survey team said that about 150 of the 1,258 slides they examined were either misdiagnosed, or were diagnosed based on incomplete cell samples. The team said that cytotechnologists had missed malignant tumor cells, plus several related conditions.

Team’s Conclusions

Forty-five of those cases, the team concluded, were clearly misdiagnosed by Central Pathology. The federal government ordered the lab to contact the physicians who submitted those specimens so they could conduct patient follow-ups.

Central Pathology laid the blame for those 45 cases on four of its cytotechnologists in a letter it wrote to the federal government. The company said one cytotechnologist resigned and that the others are being retrained.

Besides failing to detect various forms of cancer and precancerous cells, the survey team said that Central Pathology also missed the presence of herpes in some cases.

Pregnant women infected with the herpes virus need accurate test results. Those women who give birth vaginally with an active herpes virus risk exposing their newborns to the virus. The infants can go blind or even die. If a physician knows that the woman’s herpes is active, the doctor will invariably perform a Caesarean section.

Through the state’s Public Records Act, The Times has obtained a complaint filed with the state health department in 1988 accusing Central Pathology of further misdiagnoses in the cases of several patients treated at a single medical practice.

Included in the complaint is a March, 1988, letter from a woman who alleged Central Pathology was misreading Pap smears, including her own. The woman--whose name is blackened in state records--had a July, 1987, Pap smear diagnosed by Central Pathology as free of cancer. Eight months later, she said she underwent surgery because of cervical cancer.

Concern for Others

“My concern is for other women, who may not have regular Pap smears, receive false negative results when they do get a Pap smear, and are thereby lulled into a false sense of security,” the woman wrote health officials.

She said that she took her original Pap smear slide to a pathologist at Daniel Freeman Marina Hospital in Marina Del Rey and was told it had been misread by Central Pathology. State records indicate the woman’s doctor stopped using Central Pathology in November, 1987 because, according to the doctor’s office, the lab was misdiagnosing Pap smears “two to three times a week.”

Health officials and physicians agree that reading Pap smears is not an exact science. While many lab tests are now computerized, the Pap smear is still performed manually by cytotechnologists who stare at thousands of cells through a microscope. Two competent and highly-experienced technologists can examine a slide and still come up with two different diagnoses.

“The idea that there is an empirical mathematical way that everyone would read the same slide the same way is simply incorrect,” said Levy’s attorney Browne.

But federal authorities say that a difference of opinion usually only applies in borderline cases. Furthermore, the government’s inspection report alleges the lab failed to meet basic requirements that can affect test results.

Some Slides Blank

For instance, the federal survey team found that Central Pathology issued results for slides that were blank or contained too few cells for an accurate diagnosis to be made. “Rendering a diagnosis of normal or anything else on an acellular specimen is better known as sink testing,” said Patricia Ashton, a director of the cytotechnology association whose survey team inspected Central Pathology. “It’s like taking a specimen of urine and pouring it down the sink and still giving a diagnosis or test report. It’s creating data.”

Central Pathology denies the charge. “We don’t believe,” said attorney Browne, “there were any slides that were read that were acellular and we have independent studies to demonstrate that.”

Faulty Pap smears usually happen when a physician does not take a large enough cell sample. But pathologists say labs are responsible for returning an unsatisfactory specimen rather than proceeding with a diagnosis.

Central Pathology even diagnosed severely broken slides, the inspection team reported. “The piece you don’t have may be the piece that has the abnormal cells on it,” said Ashton.

The company says it has recently modified some of its practices. “If slides are broken to pieces, we report them as unsatisfactory,” Central Pathology said in a written response to the federal government.

The federal inspection team also cited Central Pathology for failing to take the time to provide monthly in-service sessions. “There should be some kind of forum in the laboratory to review difficult cases along with new developments,” said Rosenthal of UCLA Medical Center.

‘Form Over Substance’

Beginning Feb. 10, Central Pathology held its first in-service class. “Dr. Milani provided for this in-service training on an individual basis,” said attorney Browne. He said the federal requirement of classroom instruction is “a matter of form over substance.”

Pathologists say the 100-slide daily minimum Central Pathology imposes on its full-time technologists increases the possibility of error. The American Society for Cytotechnology suggests a 90-slide limit.

Cytotechnologists can volunteer to do more, a choice many make because of the industry’s low wages. Central Pathology recently raised the starting salary of its full-time technologists to about $2,000 a month.

Employees there can earn far more because they get paid $1 extra for every case above 100 that they read per day. They often work late into the night and early morning hours, a company spokesman said. Although Central Pathology does not have general guidelines on the maximum number of slides that can be read in one day, it does set individual limits on some cytotechnologists, according to spokesman Martin Cooper.

One cytotechnologist at Central Pathology claims to have read as many as 180 slides in one day. “Nobody can work under those conditions and not miss cases of abnormalities,” the technologist said. “You’re tired and worn out and your eyes hurt.”

Lab’s Requirements

Central Pathology spokesman Martin Cooper reiterated that the lab does not require technicians to read more than 100 slides per day.

Central Pathology contends that it has corrected any alleged deficiencies and is now the most accurate Pap smear lab in the country. “At the present time, the lab has more safety nets and safety precautions to prevent any misdiagnosis than any other laboratory in the country,” said attorney Browne.

Central Pathology plans another appeal to try and get the federal government to reinstate it as a Medicare and Medi-Cal-approved lab. But the Department of Health and Human Services remains unconvinced. “We are talking about a dead issue as far as I’m concerned,” said Summers.