Pathologist Exam Delayed for a Year

Faced with the threat of congressional intervention, federal health officials have agreed to delay for another year the implementation of a 17-year-old testing requirement for pathologists and technicians who read Pap smears.

Although data from the first proficiency test given last year showed what health officials called alarming failure rates, pathologist organizations have challenged the adequacy of the test and asked Congress to impose a moratorium.

The House unanimously approved such a measure late last year, and similar action was pending in the Senate. But federal health officials acted first.

In a letter this week to state health regulators and laboratory directors, officials of the Centers for Medicare and Medicaid Services said they would not impose penalties, such as fines or decertification, on licensed laboratories as long as they took steps to ensure that individual technicians and pathologists enrolled in and took a proficiency test.

“In 2006 we are continuing the educational approach to national testing. In the educational approach, laboratories will not have deficiencies cited or have sanctions imposed” provided they meet the enrollment and testing requirements, Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services, wrote in the letter to state health regulators.

The decision to withhold some penalties represented a partial victory for the College of American Pathologists and other groups who had charged that the approved test was inadequate and out of date, contentions disputed by federal officials.

The College of American Pathologists asked for congressional intervention after federal health officials turned down a request to suspend and redesign the competency test.

In opposing legislation, federal health officials cited preliminary data from the testing program. Results showed one group of pathologists who read Pap smears without having them first screened by a cytotechnologist had a failure rate of 41%. For cytotechnologists, the failure rate was 9%.

In December, The Times reported on concerns about the adequacy of hospital laboratory testing and widespread allegations of faulty test results, including misread Pap smears.

Judy Yost, a division director for the Centers for Medicare and Medicaid Services, said regulations barring technicians and pathologists who failed the tests would remain. For instance, a person who failed the test three times would not be allowed to read Pap smears until he took a 35-hour course and scored at least 90 on a fourth test.

In addition to delaying penalties on laboratories, federal officials say they will meet with the pathologists group and other interested parties to review the test requirements, including the provision for annual testing.

Competency testing for those who read Pap smears was mandated by Congress in 1988 after reports of widespread errors in interpreting the tests, which are considered a first line of defense against cervical cancer.

Last year, federal officials approved for nationwide use a test designed by the Midwest Institute for Medical Education. More recently, they approved a testing program developed by the College of American Pathologists. Maryland has its own program, which has been in place for more than a decade. A fourth testing program is under review by federal officials.