PAP/NGC Programs Review
Marianne U. Prey, MD
Have you ever wondered what the CETC is? What is its purpose? Does it have members? Is it affiliated with professional organizations?
The CETC is the Cytopathology Education and Technology Consortium. It is an independent consortium of national and international organizations that have an interest in diagnostic cytopathology. These interests include education of cytopathology professionals, technological advancements, legislative and regulatory issues affecting individuals and institutions involved in cytopathology, and education of other medical professionals and the public about the role of cytopathology in health care. The primary goal of the CETC is to foster activities that are beneficial to diagnostic cytopathology and that can be accomplished best by group action rather than by the individual action of any constituent organization.
The CETC began in 1990 with the formation of the Cytology Education Consortium, or CEC. The American Society of Cytopathology, American Society for Clinical Pathology, and American Society for Cytotechnology founded the CEC. It was established as an independent policymaking consortium, such policy to be subject to the approval of the constituent organizations. Its primary goal was to foster activities beneficial to diagnostic cytology that could be accomplished best by the collective action of multiple professional societies. Such activities were to include the development of educational programs, projects, and courses designed to fulfill current or future regulatory requirements.
To qualify for membership in the CEC an organization must have been a national association based in the U.S., had education as a primary societal function, had participative membership that included active practitioners of diagnostic cytology (diagnostic cytology was interpreted to include both cytotechnology and cytopathology), placed strong emphasis on diagnostic cytology services, and supported personnel standards for all levels of cytology practice. Constituent organizations were to have two representatives each, selected by each organization by a method of its choice. Representatives of each organization had staggered three-year terms arranged so that no more than one member became ineligible in any year.
At the inception of the CEC the ASCP provided basic staff support at its own expense. The operational plan was that programs developed under the CEC would generate sufficient funds to recover the cost of its activities.
The attendees at the inaugural meeting were representatives of the three collaborating organizations: Patricia Ashton, CT, represented the ASCT; Scott Jordan, MD, and Zuher Naib, MD, represented the ASC; and Sandra Bigner, MD, Thomas Bonfiglio, MD, and Ernest Tucker, MD (the CEC’s first chairman), represented the ASCP. Also present were Karen Ireland, MD, Robert Dietrich, MD, and George Stevenson, MD, who at the time was the ASCP’s senior vice president of education.
In 1990 the various cytopathology organizations were independent groups with disparate memberships, and for the most part there was little intersociety communication. The CEC embodied a new concept of intersociety cooperation and established a forum for professional organizations to exchange information and ideas and to develop educational programs and consensus policies to enhance cytopathology practice.
At the core of the initial CEC activity was a sense of urgency to develop a diagnostic cytology slide registry, driven primarily by the relatively new CLIA regulations for proficiency testing. At the time, the CEC planned to offer review examinations and review courses that individuals could partake of as preparation for proficiency testing, and the slide registry was to provide the material for these courses. The CEC developed a detailed plan for the registry that included the acquisition of slides, target numbers for individual slides and slide sets, type of slides with tissue confirmation, and a tracking mechanism for returning slides to donors if needed.
The CEC’s first major accomplishment was cosponsorship, with the Centers for Disease Control and Prevention, of a cytology proficiency test symposium in Atlanta in November 1993. The participants explored alternative approaches to cytology proficiency testing because of the difficulties at the time of implementing a glass-slide-based program. Thirteen years ago digitized computer imaging was thought to hold great promise as a less expensive and more efficient proficiency testing modality.
The original requirement for participant organization memberships to include cytotechnologists and cytopathologists was relaxed in 1995 when the CAP joined the CEC. The consortium continued its activities in 1996 by preparing “Understanding Your Pap Smear,” a patient education program developed for use by cytopathology professionals to increase public awareness of the importance of gynecologic cytology in promoting women’s health. An alternative proposal for cytology proficiency testing was also produced in 1996. In 1997 the CEC sponsored another symposium titled “CDC’s Role in Cytology Proficiency Testing—An Update.” The CEC’s final activity was in 1998 when it participated in the CDC discussion panel titled “A Comparison of Cytologists’ Work Performance Screening Pap Smears with Their Performance on Glass Slide and Computer-based Proficiency Tests.”
The Intersociety Working Group for Cytology Technologies, or IWGCT, formed around the time the FDA approved the first computerized screening device. Landmark technological advancements were now commercially available to cytology laboratories across the U.S., yet there were no consensus guidelines that addressed evaluating and using such devices in routine cytology practice. The IWGCT’s first meeting was in Boston in April 1996. In attendance were representatives from the CAP, ASC, ASCP, ASCT, Papanicolaou Society of Cytopathology, and International Academy of Cytology. This was a busy group that immediately tackled the difficult subject of practice guidelines for automated primary screening devices. Martha Hutchinson, MD, was instrumental in developing the first IWGCT publication in 1997, “Proposed Guidelines for Primary Screening Instruments for Gynecologic Cytology.” A second document, “A Proposed Methodology for Evaluating Secondary Screening (Rescreening) Instruments for Gynecologic Cytology,” was produced in 1998. Both documents were intended for use by manufacturers and the FDA in developing and approving this new technology. In a similar manner to the CEC, the IWGCT wrote a patient educational piece, “What Women Should Know About Pap Smear Technologies.”
For several years the CEC and the IWGCT worked in parallel producing information for cytotechnologists and cytopathologists, the public, and the government. Then in 2000, the two groups merged. With the merger, the International Academy of Cytology and the Papanicolaou Society of Cytopathology joined as member organizations. The goals of this new organization were a compilation of the two merged entities and were:
- To develop educational programs, projects, and courses designed to fulfill
current or future regulatory requirements.
- To guide the effective use
of new approaches and technology in gynecologic cytopathology.
- To serve
as a resource for educating the public and the profession about new approaches
to cervical cytology screening.
- To establish benchmarking parameters for
use in evaluating new approaches to cervical cytology screening.
The merger was the next logical evolutionary step in the integration of new technologies into daily cytopathology practice. The two consortia had overlapping goals and interests and overlapping participation of several professional organizations. The CETC’s formation allowed for a single voice representing cytotechnologists and cytopathologists for interacting with manufacturers of the new technologies and the government agencies that implemented regulatory requirements and approved new technologies.
The CEC and IWGCT held their first joint meeting on Nov. 8, 2000, in conjunction
with the ASC annual meeting in Philadelphia. The initial plan was for the two
groups to maintain their individual names, but, by October 2001, it was decided
that the new name would be the Cytopathology Education and Technology Consortium.
Dr. Bonfiglio was the first chairman.
The CETC is not incorporated as a legal entity. The participating organizations receive information on CETC activities through their designated representatives. Meeting minutes and all documents the CETC develops are distributed to the representatives for subsequent communication throughout the respective participating organizations.
The CETC may independently draft policy guidelines or recommendations related to cytopathology for consideration by the participating organizations’ members and governing boards. Alternatively, the CETC may develop policy guidelines or recommendations on the basis of a consensus of the participating organizations with approval of their governing boards.
Member organizations provide funding for their representatives to attend CETC meetings, a maximum of two meetings per year in the continental U.S., and incidental representative support such as conference telephone calls. Each of the member organizations, at their own expense, provide staff support for the CETC during the period their representative is the chair of the consortium.
The CETC has produced two significant documents since its formation in 2000. In 2003 the consortium released “Daily Workload Guidelines for Cytotechnologists Utilizing Automated Assisted-Screening Technologies.” The CETC believed that daily workload performance should be included for assessment in pivotal clinical trials used by medical device manufacturers to support FDA premarket approval applications. With this in mind, the CETC wrote a comprehensive guide that described how a pivotal clinical trial should be designed, how workload data should be collected and calculated during a trial, and how instruments should be labeled specifically as to workload.
Recently, the CETC completed a document titled “Scientific Issues Related to the Cytology Proficiency Testing Regulations” in which the consortium describes in detail the concerns of the participating organizations and the cytotechnologists and cytopathologists represented. This document was written for the Centers for Medicare and Medicaid Services to urge it to reconsider federally mandated cytology proficiency testing.
The CETC continues to be a notable voice in cytopathology. The participating organizations represent professionals from every aspect of cytopathology practice. The organization’s strength continues to be its ability to achieve consensus among participants for unified interaction with industry and regulatory agencies.
Dr. Prey, a member of the CAP Cytopat ology Committee, is laboratory medical director, Quest Diagnostics, St. Louis, Mo. She would like to extend a special thanks to the following people for providing historical documents and their personal recollections of the origins of the CETC: Teri Somrak, Sue Zaleski, Diane Davey, and Beth Jenkins.