Pap Smears: Improving Readings Puts Legislature to Test

For four years Loretta Embree was told that her Pap smear tests were normal. Although her tests had been sent to three Southern California laboratories, it was not until Embree’s slides were sent to a fourth lab that her Pap smear was read as abnormal, eventually requiring cryosurgery, a process in which the abnormal cells are destroyed by freezing.

Critics of the medical lab industry blame such occurrences on high-volume, high-pressure working conditions for cytotechnologists, who examine Pap smear slides. Medical experts say the error rate in these tests can range as high as 20%.

At the heart of the problem, critics say, is a weak state law governing the number of slides a cytotech should be allowed to examine. The law limits to 75 the number of slides a lab can ask a cytotech to read each day. But many labs get around the law by paying technicians on a per-slide basis. The law does not bar technicians from voluntarily reading more than 75 slides a day, and many jump at the chance to earn extra money.

‘Hard to Say No’

“When someone is holding out money in front of you, it’s hard to say no,” said Donald York, president of the California Assn. of Cytotechnologists. “In that situation I think we can even convince ourselves that we are doing a good job.”

Legislative efforts to strengthen the law have proved difficult. Five Assembly bills dealing with quality control for Pap smears were sent to the Assembly Health Committee last month. They were combined into one compromise bill, which passed out of the committee by the narrowest of margins. It would limit the number of gynecological slides a cytotech could read to 80 per day and 19,000 per year. The latest version of the bill, authored by Democratic Assemblywomen Sally Tanner of El Monte and Jackie Speier of South San Francisco, is awaiting a vote in the Ways and Means Committee.

Named for Dr. George N. Papanicolaou who developed the test in the 1920s, the Pap smear is recommended for sexually active women or women over the age of 18. The Pap smear is often done as part of a routine gynecological exam. A physician or nurse practitioner takes a specimen of cervix cells, which are examined on a stained slide for signs of irregularities.

Readings of Pap slides range from Class I, which is normal, to Class V, which marks the presence of cervical cancer. Most slides are examined in licensed laboratorys, of which there are about 2,000 in California. Other slides are read in doctors’ offices.

Embree’s Pap smear tests were re-examined by another pathologist who said that in at least four instances since 1984, the slides were misdiagnosed. Embree said the pathologist told her that in three of those cases, slides originally classified as normal should have been designated abnormal.

Filed Complaint

Embree eventually filed a complaint with the Department of Health Services. Department spokesman William Argonza confirmed that the agency is reviewing the allegations.

A major issue for the lab industry is the limit that would be imposed by the Tanner-Speier bill. Michael Arnold, spokesman for the California Clinical Labs Assn., said the daily and yearly limits are arbitrary and do not take into account the individual ability of each cytotech.

“I think 80 to 100 (a day) is reasonable (as a legislative limit),” said Virginia Cardin, president of Cancer Screening Services in North Hollywood. Cardin said 80 to 100 slides per day were usual for full-time cytotechs at Cancer Screening Services. She likened the Pap screening process to reading a book and said “comprehension” is the most important element. A flat limit, Cardin said, would penalize the person who takes a longer time with the slides.

“What is the incentive to hire (a person who does fewer slides per day) when you could get another who could reliably screen 80 per day?” she asked.

Cancer Screening Services, unlike some labs, also has a rescreen policy--10% of the normal slides screened by each cytotech each day are reviewed again by a supervisor cytotechnologist. With this policy, Cardin said, Cancer Screening has discovered that 5% to 6% of slides originally interpreted as normal are misdiagnosed.

While the industry opposes the bill’s limits in slides, it embraces other provisions that would require a proficiency test for cytotechs, that screening be done only in licensed laboratories and that out-of-state labs receiving slides from California physicians be licensed by the state of California.

Legislators on the Senate Business and Professions Committee have already bowed to industry pressure and removed the daily slide limit from a bill in the Senate. The bill, introduced by Sen. Milton Marks (D-San Francisco), is awaiting a hearing before the Senate Appropriations Committee, and a consultant to the senator said she hopes to win industry support for placing a limit back into the bill.

The California Medical Assn., which opposed the Marks bill in the Senate Business and Professions Committee, is reviewing the Tanner-Speier compromise. The California Medical Assn. has contributed more than $1 million to California political campaigns in the last three years, and its support or opposition could make a difference in the Legislature.

‘No Way to Outlaw It’

Bill Cleveland, spokesman for the California Medical Assn., said supporters of the Pap smear legislation have not shown “major evidence” of a Pap smear screening problem in California. “There will always be false positives and false negatives,” Cleveland said. “There’s no way to outlaw it; you can only try to minimize it.”

According to Betsy Hite of the American Cancer Society, 13,000 women in the United States are expected to be diagnosed as having cervical cancer in 1988. Seven thousand are expected to die from it. In California, the society estimated that in 1988 there will be 5,000 cases of cervical cancer diagnosed and 900 women are expected to die from it. According to the American College of Obstetricians and Gynecologists, the survival rate for women whose cervical cancer is detected early is between 80% to 90%.

“The number of deaths from cancer of the cervix has decreased 70% in the last 40 years,” said Charlotte Newhart of the American College of Obstetricians and Gynecologists. “This is largely the result of women having Pap smears.

“Unfortunately, the majority of women who died from cervical cancer have not had a Pap smear on an annual basis to detect the abnormalities.”

According to Dr. John Whitelaw, legislative representative for the American College of Obstetrics and Gynecology, the usual error rate for the Pap smear varies from 5% to 20%, depending upon the skill of the person collecting the specimen and the ability of the person reading the slide.

Accuracy Tied to Volume

“A lab that does the occasional Pap smear is not where you want your Pap smear to go,” Whitelaw said, adding that labs that process a higher volume of Pap smears are more likely to have the experience to read the slides correctly.

However, Whitelaw said, “There is a point--and the laboratory people will tell you this--where the quality begins to drop off.’

Even if a lab adheres to the state regulation, there is nothing to prevent cytotechs from working more than one job. York, president of the statewide cytotech association, estimated that in the Los Angeles area alone there are about 150 cytotechnologists working two jobs. These moonlighting cytotechs, York said, average 150 to 250 slides per day.

Also, a shortage of cytotechnicians in the state adds to the problem. Relatively low wages for cytotechnologists--full-time starting salaries range from roughly $14,000 to $26,000--have discouraged people from entering the profession. An estimated 20% of positions available for cytotechs statewide remain empty.

Lack of Enforcement

Another problem is a lack of enforcement. Every two years, 920 Medicare-certified labs are inspected by the Department of Health Services. The remaining 1,080 licensed laboratories are inspected at intervals of one to five years. Labs exempt from state licensing laws, primarily those in physicians’ offices, are not regulated or inspected by the state.

California also has a shortage of facilities to train cytotechs. Lack of interest in the field has caused many schools to close down their programs, leaving only three certification programs in California: at Loma Linda University, Sharp Memorial Hospital in Los Angeles and USC. Interest is so low that only nine students statewide were training to be cytotechs this year.

Wage increases, which cytotechs say are necessary to bring people back into the field, have been slow to develop. Two weeks ago, 15 to 20 part-time cytotechs at Cancer Screening Services--a lab that processed 855,000 Pap smears last year--went out on strike and won pay increases of 80 cents to $1 per slide.

The shortage of cytotechs could reach alarming proportions, considering California’s growing population and the increasing demand for Pap smears. Cytotechnologists as a group are also getting older, adding pressure to train younger technicians who can competently handle a heavy workload. Dr. Eileen King, a professor of medicine at UC San Francisco who has been studying the shortage of cytotechnologists, calls the current situation a crisis.

“We don’t have the manpower to do it,” King said. NORMAL AND ABNORMAL PAP SMEARSDr. William H. Kern, director of the pathology department at the Hospital of the Good Samaritan in Los Angeles, provided The Times with the four slides below. The slides were chosen because they show pronounced changes in cell structure that the untrained eye can easily discern in a photograph. Kern stressed that many Pap smear slides show less discernible changes in cell structure and can be much more difficult to interpret.