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

D. Regulatory Requirements
D1. Who must take this proficiency test?
All individuals (physicians and cytotechnologists) who examine or interpret gynecologic cytology specimens (Pap smears) must enroll and participate in one testing event annually.

 

D2. If I only screen non-gynecologic cytology specimens, must I participate in this cytology proficiency test?
At the present time, only those individuals who examine gynecologic specimens must enroll and participate.

 

D3. What is considered a passing score on a proficiency test?
A passing score on all cytology proficiency tests is 90%. Once you have achieved a passing score for a calendar year, you have met your cytology PT obligation for that year.

 

D4. Will my proficiency test be unannounced or will I know in advance when to anticipate my proficiency test?
Under most circumstances, your Cytology proficiency test will be an announced event. Proficiency testing programs are required to notify laboratories at least 30 days prior to testing for announced proficiency testing. Approved programs must also have the capability of providing unannounced proficiency testing when requested by CMS.

 

D5. What happens if I miss the testing event in my laboratory?
If a test is missed due to an unexcused absence, the individual receives a test score of “0”.

 

If the test is missed for an excused absence, laboratories must contact the proficiency testing program to determine when and where the make-up examination will take place. Examples of “excused” absences include prior scheduled leave, natural disasters, hospitalization, death in the family, etc.

 

D6. If I fail a proficiency test, will I have to stop screening Pap smears?
Individuals have multiple opportunities to take the proficiency test and any retest, if necessary. Initially, individuals are required to take a 10–slide test, within 2 hours provided in sets.
  • If an individual passes the first 10-slide test, he/she has successfully participated for the year and need not be tested again until the following year.
  • If the individual fails the first 10-slide test, he/she must take a 10-slide retest within 45 days after notification of test failure.
  • When an individual passes the second 10-slide test, he/she has successfully participated for the year and need not be tested again until the following year.
    • If the individual fails the second 10-slide retest:
      • The individual must obtain documented, remedial training in the area of test failure, which will be noted on the test results letter.
      • All Pap smears screened by the individual subsequent to the notification of failure must be reexamined, and
      • The individual must successfully participate in a 20-slide proficiency test within 4 hours.
  • If the individual fails the third 20-slide test:
    • He/she must cease examining Pap smears immediately upon notification of failure;
    • The individual must obtain at least 35 hours of documented, formally structured, continuing education in diagnostic Cytopathology which focuses upon the examination of gynecologic cytology; and
    • The individual must successfully participate in another 20-slide proficiency test.
    • This final cycle would continue until the individual successfully participates in another 20-slide proficiency test. Please see Attachment A at the end of this document for an overview of the testing process.

 

D7. How much time will I have to take a 10-slide test? A 20-slide test?
Each individual (physician or cytotechnologist) will be allowed a total of 2 hours to complete a 10-slide test and 4 hours to complete a 20-slide test.

 

D8. How will cytotechnologists and physicians be tested?
Every individual will be tested independently. Each cytotechnologist will receive atest set of referenced slides, examine each slide, identify the diagnostic areas in the same manner as they do patient specimens (by dot or circle), and write their diagnosis on their score sheet. Physicians who perform any primary screening (screen slides which have not been pre-screened by a cytotechnologists) must be tested in the same manner as a cytotechnologist. Physicians who examine slides after they are pre-screened by a cytotechnologist may choose to screen a set of test slides that have been previously screened and dotted by cytotechnologists or they may examine a set of slides that have not been previously screened and dotted. If the physician chooses to examine a pre-screened set, the cytotechnologist’s diagnosis will accompany the test set.

 

D9. Who will receive a copy of my test results and will they be kept confidential?
CMS will receive all testing results from each CMS-approved Proficiency Testing Program. The laboratory director of your laboratory will receive a summary of the test results for all the participants in the laboratory within fifteen days after the proficiency testing event. The notification will include whether each individual passed or failed the test, their score, and, if appropriate, the area of failure. In addition, each participant will receive a letter with his/her individual test results, including whether he/she passed or failed the test, the score, and, if appropriate, the area of failure. If an individual works at more than one laboratory, a copy of the individual’s test results will be sent to each laboratory director where the individual is employed.

 

CMS will make every attempt to maintain the confidentiality of the test scores. See Section H, Confidentiality, of this document for further details on the recordkeeping system.

 

D10. How are the slides referenced by the proficiency testing program?
All slide preparations must have 100% consensus agreement among a minimum of three physicians certified in anatomic pathology. Additionally, non-negative slide preparations must be confirmed by tissue biopsy, either by comparison of the reported biopsy results or reevaluation of biopsy slide material by a physician certified in anatomic pathology.

 

D11. Will the test sets be comparable?
Yes, each of the test sets, whether 10-slide or 20-slide, will be comparable. Each test set must include at least one slide representative of each of the diagnostic categories listed in the CLIA regulations. Test sets must also be equivalent to each other. Several times a year, each slide must be evaluated for staining, breakage, and diagnostic agreement by the CMS-approved Proficiency Testing Program.

 

D12. What diagnostic categories are used in the test sets?
The diagnostic categories for Pap smears in the test sets include at least one slide from each of the following categories:
  • Unsatisfactory samples (i.e., scant cellularity, air drying, and obscuring material (blood, inflammatory cells or lubricant));
  • Normal or Benign Changes (i.e., normal, negative, or otherwise within normal limits, infections other than Human Papilloma virus (HPV) (e.g., Trichomonas vaginalis, changes or morphology consistent with Candida spp., Actinomyces spp., or Herpes simplex virus),
  • Low Grade Squamous Intraepithelial Lesions – includes: Cellular changes associated with HPV, Mild Dysplasia/CIN-1,
  • High Grade Squamous Intraepithelial Lesion and Carcinoma – includes moderate dysplasia/CIN-2 and severe dysplasia/carcinoma in-situ/CIN-3, Squamous Cell Carcinoma, Adenocarcinoma and other malignant neoplasms.

 

NOTE: These diagnostic categories are consistent with those listed in the 2001 Bethesda Conference report.

 

D13. Are cytotechnologists and physicians scored the same way?
No. Cytotechnologists and physicians are not scored the same way. Physicians are scored more stringently because they are ultimately responsible for all diagnoses made in the laboratory. For the 10-Slide Test, the scoring grids are listed below:

 
Cytotechnologists:

Participant Diagnosis
Correct DiagnosisABCD
A10055
B51055
C501010
D0-51010

 
Technical Supervisors (Pathologist):

Participant Diagnosis
Correct DiagnosisABCD
A10000
B51000
C50105
D0-5510

 

The highlighted areas (in bold) on the grids demonstrate those diagnostic categories where the cytotechnologist’s and technical supervisor’s score would differ. The red highlighted areas demonstrate where there is interpretive agreement with the Correct Diagnosis and that of the Participant. To determine the final score of a testing event, each slide is given a numerical value, as specified on the scoring grids. Cytotechnologists receive a score based on the “Cytotechnologist Grid” and the Technical Supervisor’s score is based on the “Technical Supervisor Grid”. The Cytotechnologist’s and Technical Supervisor’s diagnosis can be found along the X-axis. The Proficiency Testing Program diagnosis, based upon 100% consensus of at least 3 physicians board certified in anatomic pathology and tissue biopsy confirmation of cases in the premalignant and malignant categories can be found along the Y-axis. Both Cytotechnologists and Technical Supervisors begin with a score of zero. Points are accumulated based on the accuracy of their diagnosis to the diagnosis specified by the Proficiency Testing Program.

 

D14. If I miss a high-grade lesion or a cancer, will I pass the test?
No. Individuals (cytotechnologists or physicians) will not obtain a passing score if a slide determined by the proficiency testing program to exhibit a high-grade lesion or cancer is identified as “Normal or Benign Changes” during the testing event.

 

D15. What would happen in a laboratory if the cytotechnologist passes the test and the technical supervisor fails the test?
In this instance, the cytologist would have completed their testing for that year under CLIA, and the technical supervisor will need to be retested as described in Question C6.

 

D16. May I enroll in another cytology proficiency testing program when one becomes available?
Individuals must remain in the CMS-approved cytology proficiency testing program for one calendar year. Participants will be provided with their own unique Proficiency Testing Registration Number. This number will be used to identify each individual’s enrollment. After that time, individuals are welcome to participate in any CMS-approved program.


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