* Enroll all affected individuals (i.e., cytotechnologists and pathologists) in a CMS approved testing program for the CY 2006 testing cycle, and

* Ensure that all such individuals are tested in a timely manner within 2006, in accordance with the regulatory protocol. The regulatory protocol under 42 CFR 493.855 identifies the extent to which additional testing, education, or limitations must be put in place with regard to individuals who do not pass the test initially. ..."

Instructions to continue the educational approach have already been issued to the nation’s surveyors, effective January 1, 2006, and will be available on the CMS website: http://www.cms.hhs.gov/CLIA/02_CytologyProficiencyTesting.asp(external link). (Editor's Note: This link had not yet been posted at the time of this article submission. Here is a link to that letter:http://cytopathnet.org/tiki-download_file.php?fileId=196.)

2005 Follow-up on Testing
In the first year of testing (2005), laboratories had until April 2, 2006 to ensure that all affected individuals were tested at least once for the 2005 testing cycle. According to CMS, only 4% of laboratories have needed the extra time to achieve this goal. "...If you have not undertaken testing in 2005 with a program approved to conduct the 2005 testing, you will need to do so by April 2, 2006. The laboratory will then also need to enroll for the CY 2006 testing cycle. If the educational approach fails, and you have not enrolled or undertaken PT testing by April 2, 2006 for the 2005 testing cycle, the laboratory will be subject to sanctions that may include: Civil Money Penalties of up to $10,000; limitation on the laboratory’s CLIA certificate, and/or suspension of Medicare payment for cytology testing. These are outcomes we would all like to avoid. ..."

Consideration of Future Program Improvements
In accordance with their 2005 Program objectives, CMS will be 1) evaluating the 2005 testing results data, and 2) considering Program improvements based on these results and ideas brought by the professional community. The following is planned for 2006:

  • CLIAC Workgroup: agenda topics will include:
    • Frequency of Testing
    • Scoring
    • Diagnostic Categories
  • Cytology PT Informational Supplement: (Expected by end of January). This update will elaborate on how CMS maintains confidentiality of testing.

Please visit http://www.cms.hhs.gov/clia(external link) for additional information.

CMS is furthering their efforts to "...work with laboratory professionals and key professional organizations to promote and protect the health and safety of women in this country. ..."

For additional information regarding Cytology PT, please refer to ProficiencyTesting, http://cytopathnet.org/tiki-index.php?page_ref_id=6. To find out how you can contribute to CYTOPATHNET's efforts towards a "Commitment to Quality", read more at http://cytopathnet.org/tiki-index.php?page=CommitmentToQuality.