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CYTOPATHNET: Online Resource for Cytopathology > 42_CFR_493
page id: 40 Sec. 493.855 Standard; Cytology: gynecologic examinations. (Cached) CLIA > ProficiencyTesting
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42_CFR_493

To participate successfully in a cytology proficiency testing
program for gynecologic examinations (Pap smears), the laboratory must
meet the requirements of paragraphs (a) through (c) of this section.
(a) The laboratory must ensure that each individual engaged in the
examination of gynecologic preparations is enrolled in a proficiency
testing program approved by CMS by January 1, 1995, if available in the
State in which he or she is employed. The laboratory must ensure that
each individual is tested at least once per year and obtains a passing
score. To ensure this annual testing of individuals, an announced or
unannounced testing event will be conducted on-site in each laboratory
at least once each year. Laboratories will be notified of the time of
each announced on-site testing event at least 30 days prior to each
event. Additional testing events will be conducted as necessary in each
State or region for the purpose of testing individuals who miss the on-
site testing event and for retesting individuals as described in
paragraph (b) of this section.
(b) The laboratory must ensure that each individual participates in
an annual testing event that involves the examination of a 10-slide test
set as described in Sec. 493.945. Individuals who fail this testing
event are retested with another 10-slide test set as described in
paragraphs (b)(1) and (b)(2) of this section. Individuals who fail this
second test are subsequently retested with a 20-slide test set as
described in paragraphs (b)(2) and (b)(3) of this section. Individuals
are given not more than 2 hours to complete a 10-slide test and not more
than 4 hours to complete a 20-

[[Page 920]]

slide test. Unexcused failure to appear by an individual for a retest
will result in test failure with resulting remediation and limitations
on slide examinations as specified in (b)(1), (b)(2), and (b)(3) of this
section.
(1) An individual is determined to have failed the annual testing
event if he or she scores less than 90 percent on a 10-slide test set.
For an individual who fails an annual proficiency testing event, the
laboratory must schedule a retesting event which must take place not
more than 45 days after receipt of the notification of failure.
(2) An individual is determined to have failed the second testing
event if he or she scores less than 90 percent on a 10-slide test set.
For an individual who fails a second testing event, the laboratory must
provide him or her with documented, remedial training and education in
the area of failure, and must assure that all gynecologic slides
evaluated subsequent to the notice of failure are reexamined until the
individual is again retested with a 20-slide test set and scores at
least 90 percent. Reexamination of slides must be documented.
(3) An individual is determined to have failed the third testing
event if he or she scores less than 90 percent on a 20-slide test set.
An individual who fails the third testing event must cease examining
gynecologic slide preparations immediately upon notification of test
failure and may not resume examining gynecologic slides until the
laboratory assures that the individual obtains at least 35 hours of
documented, formally structured, continuing education in diagnostic
cytopathology that focuses on the examination of gynecologic
preparations, and until he or she is retested with a 20-slide test set
and scores at least 90 percent.
(c) If a laboratory fails to ensure that individuals are tested or
those who fail a testing event are retested, or fails to take required
remedial actions as described in paragraphs (b)(1), (b)(2) or (b)(3) of
this section, CMS will initiate intermediate sanctions or limit the
laboratory's certificate to exclude gynecologic cytology testing under
CLIA, and, if applicable, suspend the laboratory's Medicare and Medicaid
payments for gynecologic cytology testing in accordance with subpart R
of this part.

57 FR 7146, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 59
FR 62609, Dec. 6, 1994


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