From: Robyn Nisi mailto:ASCPStar@ascp.org
Sent: Friday, February 25, 2005 5:17 PM
Subject: Future of Cytology Proficiency Testing Regulations
To ASCP Members
The ASCP Board of Directors met earlier this month and asked that the Society continue to urge the federal government to modernize the regulations regarding the current CLIA approach to cytology proficiency testing (PT). ASCP officials have also met directly with CMS to express the many concerns of the cytopathology community around the implementation of this nationwide PT program.
At the February 15, 2005 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC) in Atlanta, ASCP presented the following statement regarding the future of cytology testing. CLIAC is an advisory body that includes a variety of experts in the laboratory field as well as representatives of federal agencies including CMS and CDC. What follows is a copy of ASCP's public statement:
The American Society for Clinical Pathology (ASCP) appreciates the opportunity to provide this statement to the Clinical Laboratory Improvement Advisory Committee (CLIAC).
ASCP and the vast majority of members of the cytopathology laboratory community are concerned with the recent Centers for Medicare and Medicaid Services (CMS) decision to implement a nationwide cytology proficiency testing (PT) requirement through the approval of the Midwest Institute for Medical Education (MIME).
The CMS decision to approve MIME is in accordance with the role and responsibility of the agency. However, for more than a decade professional societies, including ASCP, have asked that these regulations be updated to reflect the current science and everyday operations of the nation's laboratories that provide cytology services. The decision to approve MIME
was made late in the 2004 calendar year and caused a great deal of disruption among laboratories, with no apparent consideration for the significant budgetary implications of this action.
For many years the Society has had an ongoing dialogue with the federal government about ASCP's concerns about the science behind the CLIA Cytology PT requirements and how these programs were to be implemented. The years of communication with the federal government regarding CLIA cytology PT regulations raise a broader concern. While ASCP and other scientific
organizations have expressed concern about these regulations and have written letters and appeared before federal advisory bodies such as the Clinical Laboratory Improvement Advisory Committee, we do not believe that sufficient attention has been paid to address the integrity, validity and scientific questions surrounding CLIA's approach.
Attached to this statement are a number of communications between ASCP and the federal government related to our concerns. These letters document our long held belief that the CLIA Cytology PT requirements, as written, need to be modified in order to better protect women's health and reflect the scientific and everyday operations of our nation's laboratories.
Since the original release of the regulations governing cytology proficiency testing, there have been a number of important scientific, medical and technological advances that bear directly on the practice of cytopathology and the ability of cytology proficiency testing programs to protect patient health. Medical providers increasingly view the Pap smear as a screening tool, rather than a diagnostic tool. In addition the 2001 Consensus Guidelines for the Management of Women With Cervical Cytological Abnormalities has had an important impact on the practice of cytopathology.
Given our long held belief that these regulations need to be updated, ASCP requests that the federal government immediately reopen the regulations under CLIA governing cytology proficiency testing. In a letter to Dr. Robert
Martin at CDC dated February 25, 1999, ASCP asked that our nation implement a multifaceted approach to cytopathology proficiency testing. Six years later we reiterate that request and ask that work on a modernized cytology
proficiency testing regulation begin immediately.
To begin this process we recommend that CLIAC form a working group to provide CMS with advice regarding the scientific framework, proposed timeline and process for release of a new regulation.
While ASCP remains concerned about the integrity, validity and science of the CLIA approach to cytology proficiency testing, we are also a nonprofit dedicated to serving the nation's patients as well as the Society's members and customers. To that end, ASCP looks forward to working with CMS on approval of the ASCPSTAR program for 2006. Given your very busy schedules, ASCP also wants to thank both CDC and CMS in advance for your willingness to work with us on an approval of our program.
Thank you for the opportunity to provide this statement to the distinguished committee.
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