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) . . ."  

The CMS-approved Cytology Proficiency Testing (PT) Programs for calendar year 2011 are

• the College of American Pathologists,

• the State of Maryland Cytology PT Program, and

• the American Society for Clinical Pathology program.

For additional CLIA cytology PT information, refer to the links below.

Current Status of the Cytology Proficiency Testing (PT) Notice of Proposed Rule Making (NPRM)

In 2006, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) revisited the effectiveness and feasibility of the current cytology PT regulations at the request of the Clinical Laboratory Improvement Advisory Committee (CLIAC), a Secretary's Federal advisory committee.  A workgroup consisting of nationally recognized cytology experts was assembled under the auspices of the CLIAC.  The workgroup developed 16 recommendations to address the concerns of the cytology community and public.  CLIAC recommended to the Secretary that CMS and CDC develop an NPRM to include the recommendations made by the group of the experts.  In 2009, the NPRM which considered all of the CLIAC recommendations was published and public comments and input was requested to additional CMS questions.  CMS received a total of 690 submissions by the end of the public comment period which contained 6,503 individual comments from the cytology community and public.  The greater percentage of comments received in response to the NPRM conflicted with the current Clinical Laboratory Improvement Amendments of 1988 (CLIA) statute by requesting replacement of the Cytology PT program with a continuing education program.  Cytology continuing education programs do not meet the statutory requirements for the number and frequency of slides to be tested. 

In response to the public comments requesting a change to cytology PT that is in conflict with the current CLIA statute, CMS has withdrawn the NPRM and will maintain the current robust cytology PT requirements.  The Division of Laboratory Services recommends cytology laboratory continue to meet the existing CLIA regulations for enrollment and successful participation in a CMS-approved cytology PT program for the annual testing of individuals.  CMS will continue to monitory cytology PT performance and to collaborate with the cytology community on all cytology quality initiatives.