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Published on March 18, 2009

Contact: Jodi Greenblatt
Phone: 1-800-392-9994, ext. 7102

College Critical of Proposed Cytology PT Regulation

Urges Consideration of Meaningful Alternatives

Washington, D.C.—The College of American Pathologists expressed concern earlier this week that the January 2009 proposed rule on federal cytology proficiency testing requirements fails to protect women’s health, and called on the Centers for Medicare and Medicaid Services (CMS) to withdraw the proposed regulation so that meaningful and more effective alternatives can be considered.

CAP has long been a critic of the current cytology proficiency testing regulation, which requires federal cytology proficiency testing for every pathologist and cytotechnologist who reads pap test specimens, because the program is not scientifically or statistically valid, cannot measure competency or improve quality.

In a letter to CMS released yesterday, CAP President Jared N. Schwartz, MD, PhD, FCAP said “CAP believes the current regulation and recently proposed revisions to the federal proficiency testing requirements continue to demonstrate problems with embedding professional standards into federal regulations,” and that “CMS’s efforts to regulate in this manner have resulted in a program that fails to measure competency, is not supported by science, and does not support improved health outcomes.”

Schwartz called the current program “costly and statistically flawed...unable to test and measure proficiency, improve locator or interpretive skills, maintain pace with science and technology, or protect women’s health.”

In January 2009, CMS proposed revisions to the 1992 cytology proficiency testing regulation that would make minor adjustments such as increasing the number of Pap test challenges from 10 to 20 per test, and decreasing test frequency from once each year to once every two years.

CAP has advocated for an alternative testing model proposed in legislation that won passage in the 110th Congress House of Representatives, and garnered 43 cosponsors in the Senate before the session ended. It was also endorsed by Cytology Proficiency Improvement Coalition, a group of more than 60 organizations representing pathologists, laboratory professionals, women’s health and cancer prevention groups.

CAP, along with the Cytology Proficiency Improvement Coalition, continues to support this alternative and indicated it could be achieved through regulatory changes if CMS desires to do so.

The alternative advocated by CAP includes the following requirements:

  • All individuals involved in screening and interpreting PAP tests must participate in a federally mandated annual CMS testing program in gynecologic cytology;
  • All CMS PT programs must be approved by the Accrediting Council for Continuing Medical Education or the American Academy of Continuing Medical Education;
  • All cytology testing programs must incorporate the interpretation of Pap test with glass slides (or equivalent technologies);
  • All cytology testing programs must provide an educational opportunity to interpret a broad range of cases, including complex and ambiguous conditions;
  • Each laboratory must maintain a record of each individual’s cytology test results;
  • Each laboratory director must use results from the annual test, along with other CLIA required metrics, to assess individual performance and if necessary, take appropriate action in terms of remedial training or further continuing medical education;
  • Each lab director must share individual testing results with the lab’s accrediting organization so that individual performance can be reviewed and monitored by the accrediting organization on an ongoing basis;
  • Accrediting organizations must review the testing results as part of conducting laboratory inspections and accreditation under CLIA;
  • Each lab director must transmit assessment results and improvements to the accrediting body of the lab for quality assurance.

According to CAP, if CMS were to withdraw the proposed regulation and work with stakeholders to take a fresh look at the CLIA statute, the regulatory attributes of CAP’s alternative could provide the foundation for a bona fide regulatory model.

The College of American Pathologists is a medical society serving more than 17,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of board certified pathologists and is widely considered the leader in laboratory quality assurance. The College is an advocate for high-quality and cost-effective medical care. .