Taking the lead to address a worrisome problem, U.S. Rep. Tom Price (R-Ga.) has introduced a bill that would suspend controversial, punitive regulatory requirements for annual cytology proficiency testing under the Clinical Laboratory Improvement Amendments of 1988. The Cytology Proficiency Testing Improvement Act addresses a cluster of problems with current regulations and presents a nonpunitive, constructive alternative.
The existing regulations, developed in 1992 but not implemented until 2005, were an attempt to address long-resolved problems with the so-called Pap mills of the late 1980s. Rep. Price’s legislation (H.R. 6133) would replace those regulations with nonpunitive requirements for continuing medical education.
The Price bill is consistent with dramatic advances in science and cultural understanding about patient safety and laboratory error since the CLIA regulations were written 14 years ago. It underscores the importance of continuing medical education and integrates seamlessly within CLIA quality control requirements. Perhaps most important, this bill acknowledges the necessity of knowing what you’re looking for before you begin to test for it.
The Cytology Proficiency Testing Improvement Act would give laboratory directors another tool to monitor, evaluate, and improve the skill of the laboratory team. It would institutionalize a motivating, morale-boosting mechanism to help strengthen individuals’ screening and interpretive skills. It would enhance the current practice of cytology. We think it’s a good bill.
The Price bill is consistent with recommendations the CAP made, which are based on the Mammography Quality Standards Act of 1994. The mammography act reflects what we know about the usefulness of proficiency testing to evaluate subjective interpretive skills. The Food and Drug Administration, which regulates mammography, wrote in 1994 that PT for interpretive skills such as mammography was "excessive, unnecessary, costly, impractical, and duplicative of examinations already in place." After deciding that it would not call for proficiency testing in mammography as part of the 2007 reauthorization of the mammography act, the FDA went to an outside, independent scientific body, the Institute of Medicine, to reaffirm its thinking. That body concurred, saying that PT for interpreting physicians had "not been proven to have a direct positive impact on interpretative performance in clinical practice."
The quasi-licensure aspect of the existing regulations is a huge worry. In what amounts to federal credentialing of pathologists, a passing grade is required for continued practice. If allowed to stand, pathology would become the first medical specialty to be licensed by the federal government.
We have a number of additional concerns. The scientific premises are archaic and the underlying assumptions are inconsistent with good laboratory medicine. They assess and monitor the performance of individuals acting in a vacuum, rather than a team of laboratory professionals who collaborate and consult.
Many Pap smears are ambiguous. Screening is a blunt instrument; a significant number of slides are referred to a pathologist for a second opinion. When a slide is set aside for review by the pathologist, the exercise moves away from screening and becomes a medical decision. The pathologist will not only examine the clinical evidence but also check the patient’s reports from the previous five years, including any biopsy findings. He or she may then consult with another pathologist, request a second Pap test, call for a biopsy, or do all three. This is not public health screening; it is the practice of medicine.
The current regulatory PT scheme permits no such histological or clinical review and consultation; individuals examine the slides once, alone, and their findings are reported to regulators at the Centers for Medicare and Medicaid Services. Under the Price bill, individual results would be recorded and reviewed upon inspection for laboratory accreditation.
If Congress approves the new legislation, quarterly cytology PT would continue to be a requirement of laboratory accreditation programs. The laboratory director would still be expected to correlate proficiency testing results with day-to-day performance and take corrective action as required. As always, if the laboratory director failed to see that all staff members were qualified to conduct all testing assigned to them, the laboratory could lose its accreditation.
As a nonpunitive program, the CAP program gives participants a full range of slides, creating a rich learning experience and providing important opportunities for mentoring. Regulatory cytology PT, on the other hand, must exclude rare, highly complex, and extremely difficult cases that are intellectually stimulating and wonderful for teaching but unfair for testing. Data show that sophisticated technologists may interpret highly complex slides differently; this is why we collaborate and sometimes request another sample, if not a biopsy. Properly structured gynecologic PT presents opportunities for exposure to highly complex slides that will challenge and build skill.
The Cytology Proficiency Testing Improvement Act would also put to rest controversies regarding the outdated grading scheme in the current program. When the regulations were written in 1992, it was believed that gynecologic screening should emphasize the distinction between high-grade and low-grade squamous intraepithelial lesions (HSIL and LSIL). Fourteen years later, we know the distinction is often not clear-cut and that, because of the risk of undetected high-grade disease in biopsies of patients with LSIL Paps, both sets of patients require colposcopy. Moreover, there appears to be no significant correlation between the ability to distinguish HSIL and LSIL and clinical proficiency.
In June, a federal advisory panel recommended significant changes to the current regulations. The CMS has announced that they would not be published for public comment before 2007, which would mean lab professionals would again be tested in 2007 under the current scheme. Testimony presented to the federal panel indicated that some of the very few individuals who reportedly failed the 2005 examination would not have failed under the proposed improved grading scheme. What purpose is served by another year of testing under the outdated requirements? The CAP believes Congress should suspend the program in 2007 to allow full consideration of alternative approaches like the Price bill.
Advances in molecular medicine and the advent of a vaccine for human papillomavirus, now known to play a significant role in cervical cancer, will further affect how screening and other preventive measures evolve. A few years from now, cytology PT as we now know it may be replaced by dramatically revised approaches to screening. Either way, our patients are best served when we follow best practices unencumbered by regulations that cannot begin to keep pace with the changes in medicine. We must educate our legislators. I want to call on pathologists and cytotechnologists to support the CAP and congressman Price’s efforts for reform.