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Cytology Proficiency Testing
The Clinical Laboratory Improvement Amendments (CLIA) regulations at Section 493.855(a) state: "The laboratory must ensure that each individual engaged in the examination of gynecologic preparations is enrolled in a proficiency testing (PT) program approved by the Centers for Medicare & Medicaid Services (CMS) . . ."
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The ASCT presented two documents to the Centers for Medicare & Medicaid Services (CMS) in response to the Notice of Proposed Rule Making (NPRM) for the “Proposals to Improve Cytology Proficiency Testing Required by the Clinical Laboratory Improvement Amendments of 1988".
The first document is the ASCT organizational response, which is represented by a summary of the ASCT membership responses that were gathered using a web-based survey sponsored by the ASCT. To view a PDF of this document, click here.
In keeping with the mission of the ASCT to be the collective voice of our profession, the ASCT also offered cytotechnologists who are not members of the ASCT the opportunity to participate in our web-based survey regarding this NPRM. These responses were also submitted to the CMS in a document containing the survey question results and summary of comments from all respondents (members and non-members). To view a PDF of this document, click here.
The ASCT is proud to represent our members’ position on legislative and regulatory issues, and to support the practice of all cytotechnologists.
ASCT Again Urges Expedited Rule Making at CLIAC Meeting
Cytotechnologist Scope of Practice
Cytotechnologist State Licensure
Proposal to State Legislatures
Endorsed by ASCT and ASCP
ASCT Hears Positions on Proficiency Testing
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Cytology Legislation Reintroduced in the House of Representatives
Cytology Legislation Introduced in the House Legislation was introduced by U.S. Rep. Bart Gordon (D-TN) and Tom Price (R-GA) to modify the controversial federal regulations requiring annual proficiency testing of pathologists and laboratory professionals who screen for cervical cancer. H.R. 1237http://thomas.loc.gov/cgi-bin/query/z?c110:H.R.1237: mirrors legislation introduced last year and makes the program educational rather than punitive by suspending the current regulation that subjects those professionals to annual proficiency testing and instead requiring annual continuing medical education.
ASCP e-Policy News Volume 4, Issue 3 March 2007
ASCP Urges Fast Track for Revised Cytology PT Regulations Matthew Schulze, Senior Manager of Federal and State Affairs in ASCP's Washington Office was among those urging the federal government to fast track revisions to the CLIA cytology proficiency testing regulations. Schulze and others made comments before the Clinical Laboratory Improvement Advisory Committee (CLIAC) on February 14, 2007.Schulze complimented the Committee for holding a consensus meeting to discuss and provide a comprehensive set of recommendations for the revision of the CT proficiency testing rules. But he noted that, despite initial assurances from CMS that rules revision would be handled in an expedited manner, they have not yet been released for public comment - nor have they been submitted for regulatory approval by the Office of Management and Budget (OMB), a process that can take months.Schulze also expressed ASCP's disappointment with CMS' inability to make greater progress on the rules revision and stated that the delay is unacceptable. In his testimony Schulze asked CLIAC to urge CMS to fast track its revision of this rule and to publish it as soon as possible and reiterated ASCP's willingness to work with CLIAC and CMS to secure the speedy publication of a revised cytology proficiency testing regulation.
PT Update from CMS
Cytology PT Rule from CMS Delayed Until July
A notice w as published in Monday’s Federal Register from the Centers for Medicare and Medicaid Services (CMS) indicating...Click here to read full story
The CLIAC met on September 20 and 21 in Atlanta . Most of the agenda focused on laboratory w orkforce issues. Cheryl Wiseman presented an update on PT and also reported on specialized surveys for Cytology labs (a contract held by ASCT Services). The year 2005 showed initial test results of 91% (12,831 participants) making the 90% score. At the half w ay point of 2006, 95% are scoring at 90% (5947 participants) on initial test.
The ASCT legislative consultant presented public comment highlighting results from the recent member survey on the PT Workgroup/CLIAC June recommendations. The summary report of the June 2006 CLIAC is no w available in both HTML and PDF formats: http://www.phppo.cdc.gov/cliac/. The Proficiency Testing Workgroup presentation and public comments are included in those minutes.
On behalf of the American Society for Cytotechnology (ASCT), representing cytotechnologists, we respectfully request that the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) consider our comments and suggestions for the implementation of a more cost effective, valid, equitable and educational Cytology Proficiency Testing (PT) program. Assuming that the PT program continues, we additionally request that the PT program continue to be conducted on an educational basis and without punitive sanctions until consensus and regulatory revisions are achieved. Read the entire statement here...
Early reports from the June CLIAC meeting state that CLIAC has adopted many of the recommendations made by the cytology proficiency testing workgroup. Some of the more significant recommendations include three-year testing intervals, unified scoring for cytotechnologists and pathologists, elimination of automatic failure (-10) for failure to distinguish between negative and HSIL and a 20-slide test rather than 10-slide test if the test interval is more than a one-year interval. ASCT is waiting for the official minutes of the CLIAC, which will be posted on the CDC website in the near future. Next steps? CMS will be issuing an official notice of proposed rule making (NPRM). Once this announcement is made, it is critical that cytotechnologists respond in writing to CMS / CDC stating what they like and dislike about the current regulations as well as CLIAC’s recent recommendations. ASCT will announce on our website when the CLIAC recommendations are available on the CDC website. We will also announce when CMS issues the official notice of proposed rule making. Guidelines and resources for writing letters to CMS /CDC will be available on the ASCT website after the NPRM is issued. Stay tuned….
The cytotechnologist membership of the American Society for Cytotechnology (ASCT) wishes to thank CLIAC for allowing this process to move forward and Dr. Soloman and the PT Workgroup for their recommendations. We request that the PT program continue to be conducted on an educational basis and without punitive sanctions until consensus has been reached.
Read the statement here.
SCIENTIFIC ISSUES RELATED TO THE CYTOLOGY PROFICIENCY TESTING REGULATIONS
This document has been developed by the Cytopathology Education and Technology Consortium (CETC) to provide guidance to CMS and other regulatory bodies regarding revisions of the Cytology Proficiency Test Regulations. Click here to open the printable .pdf document.
ASCP acquires complete cytology product line of the Midwest Institute for Medical Education (MIME) and ensures that ASCP proficiency testing (PT) will be valid, fair and overseen by cytopathologist and cytotechnologist experts... Read the press release here.
Statement to the clinical laboratory Improvement Advisory Committee regarding a more cost effective, valid, equitable and educational Cytology Proficiency Testing program...
Read the statement here.
CMS Suspends Cytology PT Penalties for 2006: Laboratories still must ensure pathologists, cytotechnologists tested - Click here to read full story
From the LA Times:
Pathologist Exam Delayed for a Year
Federal health officials head off a congressional confrontation over the proficiency test.
By Walter F. Roche Jr.
Times Staff Writer
January 25, 2006
WASHINGTON - Faced with the threat of congressional intervention, federal health officials have agreed to delay for another year the implementation of a 17-year-old testing requirement for pathologists and technicians who read Pap smears.
Although data from the first proficiency test given last year showed what health officials called alarming failure rates, pathologist organizations have challenged the adequacy of the test and asked Congress to impose a moratorium.
The House unanimously approved such a measure late last year, and similar action was pending in the Senate. But federal health officials acted first.
In a letter this week to state health regulators and laboratory directors, officials of the Centers for Medicare and Medicaid Services said they would not impose penalties, such as fines or decertification, on licensed laboratories as long as they took steps to ensure that individual technicians and pathologists enrolled in and took a proficiency test.
"In 2006 we are continuing the educational approach to national testing. In the educational approach, laboratories will not have deficiencies cited or have sanctions imposed" provided they meet the enrollment and testing requirements, Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services, wrote in the letter to state health regulators.
The decision to withhold some penalties represented a partial victory for the College of American Pathologists and other groups who had charged that the approved test was inadequate and out of date, contentions disputed by federal officials.
The College of American Pathologists asked for congressional intervention after federal health officials turned down a request to suspend and redesign the competency test.
In opposing legislation, federal health officials cited preliminary data from the testing program. Results showed one group of pathologists who read Pap smears without having them first screened by a cytotechnologist had a failure rate of 41%. For cytotechnologists, the failure rate was 9%.
In December, The Times reported on concerns about the adequacy of hospital laboratory testing and widespread allegations of faulty test results, including misread Pap smears.
Judy Yost, a division director for the Centers for Medicare and Medicaid Services, said regulations barring technicians and pathologists who failed the tests would remain. For instance, a person who failed the test three times would not be allowed to read Pap smears until he took a 35-hour course and scored at least 90 on a fourth test.
In addition to delaying penalties on laboratories, federal officials say they will meet with the pathologists group and other interested parties to review the test requirements, including the provision for annual testing.
Competency testing for those who read Pap smears was mandated by Congress in 1988 after reports of widespread errors in interpreting the tests, which are considered a first line of defense against cervical cancer.
Last year, federal officials approved for nationwide use a test designed by the Midwest Institute for Medical Education. More recently, they approved a testing program developed by the College of American Pathologists. Maryland has its own program, which has been in place for more than a decade. A fourth testing program is under review by federal officials.
December 2005: House Votes to Suspend Cytology PT - Click here to read full story
Additional Information on PT Testing: