Pap Smear Doctors Defend Know-How

A national physicians group is leading an effort in Congress to halt annual competency tests of doctors and laboratory technicians who read Pap smears, even as the results of the first such test indicate significant problems with the way the slides are interpreted.

Legislation to place a moratorium of at least one year on the proficiency exams recently passed the House and is now before the Senate.

It is supported by the College of American Pathologists, which accredits laboratories nationwide.

Data compiled from the first competency test, given this year, showed failure rates of 9% to 41% among various categories of medical personnel, according to the Centers for Medicare and Medicaid Services, the federal agency responsible for regulating laboratory testing

The 41% failure rate is especially troubling to federal officials because it represents doctors who regularly read Pap smears without their being screened by cytotechnologists -- medical technicians with special training in identifying cellular abnormalities. The cytotechnologists had a 9% failure rate. Physicians whose slides were screened by cytotechnologists had a 13% failure rate.

Because it can show changes in the cervix that can be treated before cancer develops -- as well as cancerous cells in their earliest, most curable stages -- the Pap smear is considered the first line of defense against cervical cancer. The American Cancer Society estimates that at least 10,000 women will be diagnosed with the disease this year.

Early this month, the Los Angeles Times reported on rising concerns about the adequacy of hospital laboratory testing, and allegations of faulty tests -- many involving Pap smears -- have triggered a flurry of lawsuits.

The bill before the Senate, the Proficiency Testing Improvement Act of 2005, would bar the federal government from requiring the proficiency testing more often than every two years and order revisions in the test “to reflect changes in laboratory operations and practices” since the law requiring proficiency exams was enacted.

It also calls for the revised test to “reflect the collaborative clinical decision-making” process that the College of American Pathologists contends is utilized in most laboratories. The physicians’ group also argues that pathologists are being unfairly singled out for proficiency testing.

The original law was passed 17 years ago, but the initial competency tests were given only this year. After the testing requirement was signed into law, it took four years to agree on regulations to implement it. That was followed by a lengthy search for an organization to oversee the testing.

In brief debate in the House prior to the bill’s passage by voice vote on Saturday, supporters of the measure echoed claims by the pathologists’ organization that the test was outdated and ineffective.

“This situation is unacceptable, and these professionals who are performing vital services deserve better,” said Rep. Nathan Deal (R-Ga.).

Opponents of the testing have also noted that a single agency, the Midwest Institute for Medical Education, is approved to administer the test nationwide. Maryland has been conducting its own testing program for more than a decade, but the test prepared by the Midwest Institute, a nonprofit in Indiana that develops pathology and cytotechnology education programs, was approved late last year for nationwide use.

The College of American Pathologists, despite its vocal opposition to the program, recently had its own version of the test approved. It is expected to be available next year.

In recent reports to its members, the pathologists’ group has taken credit for leading a “grass-roots effort” to halt the current testing program. That effort included a plea for delayed implementation, also signed by other pathology groups, to Dennis G. Smith, who heads the Centers for Medicare and Medicaid Services office that regulates laboratory testing. Smith denied the request in an Aug. 16 letter and responded to the pathologists’ objections in detail.

Smith noted that those who fail the test initially are given three more chances to pass it, and only after a third failure are restrictions imposed.

“We regard these as important public protections that are well warranted after an individual has failed to demonstrate proficiency three times,” Smith wrote. “We cannot agree that these are arbitrary.”

A person who fails the test three times is prohibited from reading Pap smears until he or she takes a 35-hour course and scores at least 90 on a retest.