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page id: 23 CMS Informational Supplement on Cytology Proficiency Testing
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CMSInformationalSupplementOnCytologyProficiencyTesting locked

E. Enrollment and Testing
E1. What are the initial cytology proficiency testing enrollment requirements?
Beginning in 2005, every cytotechnologist and pathologist examining gynecologic cytology specimens must be enrolled in a CMS-approved Cytology Proficiency Testing Program and take a proficiency test. CMS strongly recommends that laboratories enroll in one of the two CMS-approved Cytology Proficiency Testing Programs for 2005 as soon as possible.

 

E2. Where do the dates specified in the Survey and Certification Letter (SC05-11) released by CMS on December 16, 2004 come from?
CMS regrets that some confusion has arisen in regard to the dates by which laboratories must enroll and be tested in a CMS-approved cytology proficiency testing program. Laboratories generally must meet the regulatory deadline for enrollment and participation in an annual testing event, which may include retesting where necessary. Testing must be completed by December 31 of the testing year in order to comply with regulatory provisions. The dates listed in the Survey and Certification Letter were established as dates that laboratories must meet in order to avail themselves of CMS’ plans to utilize its enforcement discretion to hold in abeyance any potential sanction for as long as possible. The Survey and Certification Letter identifies internal deadlines that CMS will use when deciding whether to initiate sanctions against laboratories that fail to enroll in a CMS-approved Cytology Proficiency Testing program and complete initial testing by the close of 2005. CMS strongly encourages laboratories to enroll in one of the CMS-approved Cytology Proficiency Testing programs as soon as possible.

 

E3. Where do I take the Cytology proficiency test?
Proficiency testing may occur on-site in your laboratory or at an alternate site at least once during each calendar year. Contact the Proficiency Testing Program in which you have enrolled for specific requirements and procedures.

 

E4. I screen slides on the night shift (4:00 PM - 12:00am). When will I be tested?
To the extent practicable, testing should take place under your normal working conditions. Laboratories should contact their Proficiency Testing Program for specific information on this issue.

 

E5. If I examine only liquid based specimens at my laboratory, will I be required to take my proficiency testing with conventional Pap smear?
A CMS-approved Proficiency Testing Program will offer testing materials that are prepared in a similar manner to the patient specimens routinely examined. Contact the CMS-approved Proficiency Testing Program in which you have enrolled for specific requirements. E6. What happens if I work at more than one laboratory? Must I take the test at each laboratory where I am employed? No. If you work at more than one laboratory, you will be required to indicate one laboratory, prior to the first testing event, as the primary laboratory where you will be tested. All of the laboratories, however, must ensure that you participated in the required annual testing in order to meet their regulatory duties.

 

E7. Will Locum tenens and Temporary Employees in laboratories also need to be tested?
Yes. Any individual, including a Locum tenens or temporary employee, who examines Pap smears must participate in annual testing and score at least 90%.

 

E8. Who will proctor the proficiency test?
The CMS-approved Proficiency Testing Program will provide guidance and requirements for individuals who will proctor the proficiency test. Contact the CMS-approved Proficiency Testing Program in which you have enrolled for specific information on proctors.

 

E9. What should I do if I get a test set with a broken slide?
The test proctor should be notified immediately upon discovery of a broken slide. Proctors have specific protocols to follow when this occurs. The laboratory will be held financially responsible for any slides broken during testing.

 

E10. If the laboratory hires a new employee just prior to the scheduled proficiency test, can this individual also take the scheduled proficiency test?
Please call the Proficiency Testing Program for specific procedures.

 

E11. If I fail a test or retest, can I take the retest in my laboratory?
The Proficiency Testing program will have options for retesting. Please contact the program in which you are enrolled for additional information.

 

E12. How many individuals can be tested with one test set?
The Proficiency Testing Program will determine how many test sets are needed to test all individuals in the laboratory.

 

E13. Who in the laboratory can reexamine the Pap smears that were read by someone who has failed the first retest?
A qualified individual who has obtained a passing score in the current year is eligible to reexamine Pap smears after someone has failed.

 

E14. What should I do if I see someone sharing test results during the test?
Discussion during and after the course of testing is prohibited. Every individual who participates in a proficiency test must sign an attestation statement that they have examined the test set slides independently and did not share their results either during or after testing. If a participant observes results sharing, the proctor must be notified of the situation. The proctor will contact the proficiency testing program immediately. The program will notify CMS.

 

E15. Will instructors, researchers, and individuals who perform internal quality control or quality assessment functions be required to participate in cytology proficiency testing?
Those individuals (instructors and researchers) who do not examine gynecologic patient specimens for the purpose of making a diagnosis or providing any information to be used toward a diagnosis are not required to participate in gynecologic cytology proficiency testing. However, those individuals who review patient specimens during the course of their jobs (internal quality control/quality assessment) where a diagnosis might be changed because of their review must participate in cytology proficiency testing.


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