Ann T. Moriarty, MD
Lisa Fatheree, SCT(ASCP)
Rodolfo Laucirica, MD
A new year brings new opportunities to improve cytology proficiency testing. But how did we get here? We need to trace our footsteps from CLIA ’88 to understand the current PT requirements and proposed changes in the law and regulations. Let us start at the beginning.
National gynecologic cytology proficiency testing was introduced in the Clinical Laboratory Improvement Amendments of 1988. These amendments were the government’s response to a 1987 article in the Wall Street Journal that depicted negative laboratory practices, in particular missed abnormal Pap tests and poor patient outcome. On Halloween 1988, then-president Ronald Reagan signed CLIA ’88 into law. The cytology proficiency testing provision mandated “periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions.”1
The Centers for Medicare and Medicaid Services defined PT through CLIA ’88 regulations that became effective in 1992 and were amended in 1993. It was not until 13 years after the initial regulation and 17 years after the legislation that an organization submitted a program for approval to begin in 2005.
The CMS-defined regulatory requirements for gynecologic cytology PT2 are exacting and reflect the state of cytology in 1988. Proficiency testing uses glass slides in an initial 10-slide test including at least one slide from each of four categories: unsatisfactory (category A), negative (category B), low-grade squamous intraepithelial lesions (LSIL) (category C), and high-grade squamous intraepithelial lesions and carcinoma (HSIL+) (category D). The validation standards include biopsy confirmation for slides in category C or D, and 100 percent agreement among three anatomic pathologists for the slide interpretation. Scoring for pathologists and cytotechnologists is different. Remember, cytology was different in 1988. There were no liquid-based preparations, no image-assisted screening devices, no HPV testing, and no national standard for terminology because the first iteration of the Bethesda System had just emerged. Our understanding and followup of preneoplastic cervical lesions were also different. Consensus guidelines were nonexistent, loop electrocautery excision was an evolving technology, and patients were followed based upon local and regional customs.
From the time proficiency testing was implemented in 2005, the CAP has labored on both ends of the spectrum to meet the needs of its members and participants. First, to provide field-validated slides and offer additional PT options for the cytology community, the CAP applied for and was granted PT provider status beginning in 2006. Second, the CAP has championed legislative relief from the punitive individual-based PT. Congressman Nathan Deal (R-Ga.) in 2005 introduced into the U.S. House of Representatives a CAP-endorsed bill, the Proficiency Testing Improvement Act of 2005. This legislation required the CMS to suspend the current proficiency testing program. It passed the House of Representatives in December 2005, but with the legislative session having ended, the Senate was unable to consider the House-passed legislation before adjournment.
In 2007, representatives Bart Gordon (D-Tenn.), Tom Price, MD (R-Ga.), and Deal introduced a second CAP-endorsed bill, H.R. 1237, the Cytology Proficiency Improvement Act. This bill seeks to replace the current outmoded cytology PT program with a rigorous continuing medical education requirement that would allow individual skills to be assessed using much more challenging, complex, and realistic Pap test cases. H.R. 1237 generated tremendous bipartisan support, attracted 175 cosponsors, and passed the House of Representatives in April 2008. The Senate companion bill, S. 2510, introduced by senators Mary Landrieu (D-La.) and Johnny Isakson (R-Ga.), garnered 42 cosponsors. Despite tremendous bipartisan support in both chambers, a crowded legislative calendar prevented passage of the Cytology Proficiency Improvement Act. From a legislative perspective, the CAP will begin again in the new congressional cycle to gain relief from the outdated PT. The thrust of proposed gynecologic proficiency improvement is to replace an outmoded program with an educational program that assesses cytologists ’ skills but encourages educational growth and development, all with an emphasis on patient safety.
What about changes to the old regulations? In March 2006, a working group consisting of officials of the CMS and the Centers for Disease Control and Prevention and members of the cytology profession (six cytotechnologists and six cytopathologists) were tasked to address and improve the workings of the existing regulations. This working group then presented its recommendations to the Clinical Laboratory Improvement Advisory Committee, a group chartered to provide scientific and technical advice to the secretary of Health and Human Services. CLIAC recognized the need for these revisions and recommended them to the CMS in June 2006 (Table 1) (PDF, 96 KB).3 Those regulatory changes, which addressed lengthening the interval between PT tests, increasing the number of challenges per test, and altering the grading schema, among other things, languished for two years. In November 2008, the CMS finally submitted alternatives to the cytology PT regulation to the Office of Management and Budget, or OMB, for review and approval before publication. A delegation of pathologists and CAP staff met with the OMB and U.S. Department of Health and Human Services to urge the OMB to conduct a thorough cost-benefit analysis of the PT regulatory changes. This delegation asked if cytology PT caused a reduction in false-negatives, improved patient outcomes, or included evidence of the changes in laboratory cytology practice induced by new technology and existing quality improvement instituted since CLIA ’88. Moreover, the group advised the OMB to have the CMS withdraw the proposed regulatory changes and support the legislative alternative proposed in the Cytology Proficiency Improvement Act (H.R. 1237 and S. 2510). The revised regulations will be published only if the OMB approves the CMS’ proposed regulatory changes. If the OMB rejects the proposed regulatory changes, the regulation will be sent back to the CMS for new revisions.
So where do we stand today? We still take cytology PT based upon 20-year-old tenets that do not take into consideration all of the advancements and improvements we have seen in cervical cytology screening. As such screening evolves in the era of the HPV vaccine, this outmoded PT program will be even less representative of the practice of cytology.
We look forward to successful passage of legislative initiatives to eliminate the individual punitive cytology PT programs and transform cytology PT into an educational venue that is flexible enough to keep pace with evolving technology and cancer screening programs. Today, we may be confronted with regulatory changes. The proposed regulatory changes make slight changes in PT but do not allow for flexibility in the era of rapidly changing cervical cancer screening programs. These regulatory changes were recommended in 2006 and consist of individual PT every three years, 20 “challenges” (not necessarily glass slides), and an altered grading scheme minimizing the difference between pathologist and cytotechnologist responses. If the OMB allows the CMS’ proposed changes to proceed, there will be two separate public comment periods totaling 90 days in which the cytology community can respond—and respond we should.
Where to now? Regardless of what happens this year, the CAP will need the grassroots support of its members. We will be called upon to contact our legislators as the bills are reintroduced into the House and Senate. We may need to respond to the CMS about new regulations. When the call comes, be an activist and help shape the “where” to which we are all headed.
- Clinical Laboratory Improvement Amendments of 1988 Final Rule, 42 U.S.C.§ 263a(f)(4)(B)(iv) of the Public Health Service Act, 57 Federal Register 7001–7186, 1992.
- Medicare, Medicaid, and CLIA Programs: Statutory and Regulatory Requirements Related to Laboratory Participation in Proficiency Testing and Availability of Proficiency Testing Programs in Cytology. Baltimore: Centers for Medicare and Medicaid Services; 2005.
- Clinical Laboratory Improvement Advisory Committee: Summary Report June 20–21, 2006: U.S. Department of Health and Human Services.
Dr. Moriarty, vice chair of the CAP Cytopathology Committee, is a senior pathologist at Ameripath Indiana, Indianapolis. Lisa Fatheree, CAP Cytopathology Committee staff, is a cytology technical specialist at the CAP. Dr. Laucirica, a member of the CAP Cytopathology Committee, is associate professor of pathology and head of cytopathology, Baylor College of Medicine, Houston.