Survey Protocols for Compliance with Cytology Proficiency

6063 – Survey Protocols for Compliance with Cytology Proficiency Testing (Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20) Cytology laboratories and individuals must enroll and successfully participate in a CMS- approved cytology PT program and achieve a passing score annually. See 42 CFR §493.855. Pathologists and cytotechnologists are tested individually with test sets composed of slides exhibiting a progression of abnormality from unsatisfactory to cervical cancer. There are at least four test opportunities annually. If an individual does not score at least 90% on the first test, he/she can test a second, third, or fourth time: • Initial Test - ten slides reviewed in two hours (If the individual does not obtain a score of at least 90%, they must be retested within 45 days. The individual may continue to examine slides at this time.); • Second Test - ten slides reviewed in two hours (If the individual does not obtain a score of at least 90%, the laboratory must provide the individual with documented, remedial training and education in the area of failure, and assure every gynecologic slide examined subsequent to the notification of scoring less an 90% has been reexamined by an individual in the laboratory that has taken and scored at least 90% on their annual PT for the year until such time as the individual is retested; • Third test - 20 slides reviewed in 4 hours (if individual does not obtain a score of At least 90% they must cease testing until they obtain 35 hours of documented, formally structured continuing education in diagnostic cytopathology, and are re- tested with a 20-slide test set and score at least 90%); and • Fourth test- 20 slides reviewed in 4 hours (if the individual does not obtain a score of 90% they must cease testing and obtain an additional 35 hours of continuing education, and re-test). CMS monitors the cytology PT results and conducts appropriate follow up on enrollment and performance failures during survey reviews. During surveys, SAs must accomplish the following: • Enrollment: Confirm by review of enrollment documentation that the individuals examining gynecologic cytology slides (Pap smears and liquid based technologies) are enrolled in a CMS-approved cytology PT program for the calendar year and that all individuals at all laboratory cytology testing sites are enrolled. • Testing: Ask the laboratory director the status and outcome of each individual’s testing to ensure that the laboratory is following the regulatory protocol. Do not request copies of individual results. NOTE: Verification of Compliance: For laboratories that will not be surveyed in the current calendar year, CO will monitor their performance and provide additional guidance to the ROs. CO will also monitor the performance of individuals in accredited laboratories and CLIA-exempt laboratories and will notify the AO or approved State program of any necessary follow-up. • Approved State Programs (Exempt States) & Approved Accreditation Organizations (AOs): CLIA-exempt laboratories and accredited laboratories will be overseen by their respective State Agencies or AOs. • Systems of Testing: 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. o 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. • Systems of Re-testing: o Confirm that individuals who fail the initial proficiency test are being re-tested in a timely manner in conformance with the procedures at §493.855. o 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. Surveyors must confirm that the individual was retested within the 45 day time frame. • 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 10-slide retest: o The individual must obtain documented, remedial training in the area of test failure, which will be noted on the test results letter. Confirm via review of laboratory documentation that remedial training did occur. o All Pap smears screened by the individual subsequent to the notification of failure must be reexamined. Surveyors should review the documentation of reexamined slides, and o The individual must successfully participate in a 20-slide proficiency test within 4 hours. Confirmation of scheduled retesting must be reviewed. • If the individual fails the 20-slide test: o He/she must cease examining Pap smears immediately upon notification of failures. Surveyor confirmation of individual cessation of examining gynecologic cytology specimens is necessary; o 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. Surveyor confirmation of continuing education is necessary; and o The individual must successfully participate in another 20-slide proficiency test. Confirmation of scheduled retesting must be reviewed. • This final cycle could continue until the individual successfully participates in another 20-slide proficiency test. Enforcement Actions The RO, in conjunction with the SA, will initiate intermediate sanctions that may include Civil Money Penalties, limitation of the laboratory’s CLIA certificate for cytology, and, if applicable and serious, suspension of the laboratory’s Medicare and Medicaid payments for gynecologic cytology testing in accordance with Subpart R of the CLIA regulations if the laboratory fails to accomplish any of the following: (Also see §6250 Adverse Actions) • Ensure Enrollment: Fails to enroll all gynecologic cytology testing sites in a CMS-approved cytology PT program for each calendar year; • Ensure Testing: Fails to ensure that all individuals examining gynecologic cytology slides in the current calendar year are enrolled in a CMS-approved cytology PT program and are tested in a timely manner. The regulatory protocol under §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; • Ensure Retesting: Fails to ensure that an individual who fails a cytology PT test takes any required additional education or remedial actions, and is retested, as specified in the CLIA requirements, if such individual continues to examine slides for the laboratory; • Complete Testing: Fails to ensure that the testing for the current calendar year has been completed by April 2nd of the following calendar year. Please contact your RO in the event you identify any other questionable practices. The Survey Process