Published on February 28, 2007
Contact: Gretchen Schaefer
Phone: 202-354-7131 or 202-236-4410
Representatives Gordon and Price Introduce Bill to Modify Controversial Cytology Proficiency Testing Requirements to Make Program Educational Rather Than Punitive
Washington, D.C.—Legislation was introduced today by U.S. House of Representatives Bart Gordon (D-TN) and Tom Price (R-GA) to modify the controversial federal regulations requiring annual proficiency testing of pathologists and laboratory professionals who screen for cervical cancer. The legislation makes the program educational rather than punitive. The Cytology Proficiency Improvement Act of 2007, H.R. 1237, suspends the current regulation that subjects those professionals to annual proficiency testing and instead requires annual continuing medical education that would provide opportunities for improving screening and interpretation skills. The legislation tracks recommendations made by the College of American Pathologists (CAP) to model federal cytology quality assurance standards after the Mammography Quality Standards Act of 1994 (MQSA).
“We applaud Representatives Gordon and Price for proposing a constructive alternative to this seriously flawed regulation that will provide laboratory professionals meaningful educational opportunities to improve screening and interpretive skills in a non-punitive environment,” said Thomas M. Sodeman, MD, FCAP, and president of CAP. “The legislation builds upon the existing, stringent federal quality control requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and provides the laboratory director with an additional tool to evaluate ongoing performance, but does so constructively. This is a better, more effective way to ensure quality because it allows the laboratory director to correlate continuing medical education results with actual day-to-day performance and take corrective action if necessary.”
The legislation modifies CLIA, which required the Secretary of Health and Human Services to establish standards for ensuring quality cervical cancer screening. The regulation, promulgated in 1992, was first implemented by the Centers for Medicare and Medicaid Services (CMS) in 2004. The legislation resolves the controversy over the statutory requirement, which CMS interprets as mandating an annual proficiency test for all professionals screening for cervical cancer.
“The government has twice rejected individual proficiency testing of professionals’ interpretive skills for breast cancer because its impact upon clinical outcomes has not been demonstrated, just as it has not been demonstrated to improve interpretive performance in cytology, to reduce false negatives or positives, or to reduce the incidence of cervical cancer,” Sodeman said.
Consistent with the FDA’s initial consensus in 1994 that proficiency testing for interpreting physicians was “excessive, unnecessary, costly, impractical, and duplicative of examinations already in place,” the Institute of Medicine, in preparation for a second reauthorization of MQSA projected to occur in 2007, recently concluded that it would not recommend mandatory proficiency testing for interpreting physicians, because it determined that PT had “not been proven to have a direct positive impact on interpretative performance in clinical practice.”
In 2005, the House passed H.R. 4568, The Proficiency Testing Improvement Act of 2005, which called upon CMS to suspend the current program and to implement specific changes to the program. A federal advisory panel last June recommended revisions to the current regulation, including significant revisions to the scoring and the frequency of the test. However, CMS and the Centers for Disease Control blocked discussion of any alternatives that required changes other than adjustments to the existing regulatory framework. Testimony presented to the federal advisory panel indicated that under the newly proposed regulation some individuals who were reported to have failed in 2005 would not have failed had the revised grading system been in place.
A CMS official recently said during a Clinical Laboratory Improvement Advisory Committee meeting that a proposed rule to modify the current regulation will be published “sometime this year.” CMS initially announced the rule would be published in February of 2007 and later moved that time to July of 2007. Laboratory professionals will again be tested in 2007 under the current regulation.
“The proposed revisions are neither timely or adequate, and they will have a short shelf life before they become out of date because the cumbersome federal rulemaking process cannot keep pace with changing standards of care and practice. It is time for Congress to drop the punitive approach, which doesn’t work, and to modify this program to make it beneficial to laboratory professionals and to patients,” Sodeman said.
The College of American Pathologists (CAP) is a medical society serving about 16,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high quality and cost-effective patient care.