10.10.05.05

.05 Cytology — Laboratory and Individual Standards.

A. Primary Standard. A pathologist or cytotechnologist who examines gynecological cytology specimens from individuals in this State shall participate satisfactorily in an annual cytology PT program approved by the Secretary.

B. Laboratory Standards.

(1) A licensee operating under a permit to examine gynecologic cytology specimens shall ensure that each pathologist and cytotechnologist who examines gynecologic cytology specimens participates in a cytology PT program conducted by the Department or approved by the Secretary.

(2) An in-State laboratory shall participate in the Department's PT program.

(3) An out-of-State laboratory shall participate in either the Department's PT program or another equivalently rigorous cytology PT program approved by the Secretary.

(4) A licensee employing an individual who has failed a second testing event in an annual PT cycle shall:

(a) Prohibit the individual from examining gynecologic specimens and provide or secure remedial training and education in gynecologic cytology for the individual, which training and education includes examination by the individual of gynecologic specimens in the individual's area of failure; and

(b) Document the individual's completion of education and training using a form provided by the OHCQ.

(5) A licensee employing an individual who has failed a first or subsequent PT event and who does not obtain mandated retesting or retraining, or both, shall:

(a) Immediately remove that individual from a position of examining gynecologic cytology specimens for the purpose of reporting diagnostic test results to a health care provider; and

(b) Provide written notice to the OHCQ within 30 days after being informed of the individual's last test failure that the individual is no longer examining gynecologic cytology specimens for the purpose of reporting diagnostic test results to a health care provider.

C. Individual Standards.

(1) A cytotechnologist or pathologist who examines gynecological cytology specimens shall participate in an annual PT event that involves the examination of a 10-slide or 20-slide test set as set forth in 42 CFR §493.945.

(2) An individual passes a testing event and performs satisfactorily in PT when the individual scores at least 90 percent on a 10-slide or 20-slide test set.

(3) An individual fails a testing event and performs unsatisfactorily in PT if the individual:

(a) Scores less than 90 percent on a 10-slide or 20-slide test set; or

(b) Fails to take a scheduled retest without prior Department approval.

(4) An individual who fails the annual testing event shall take a second test with another 10-slide test set:

(a) Within 45 days after receiving notice of a test failure; or

(b) At a later date with prior Department approval.

(5) An individual who fails a second test shall:

(a) Cease examining gynecologic specimens immediately upon being notified of the second failure;

(b) Complete at least 40 hours of remedial training and education in gynecologic cytology that includes examining gynecological specimens in the area of failure;

(c) Complete the required training and education in a laboratory that operates under a:

(i) State permit for in-State laboratories; or

(ii) Certificate issued by CMS in the subdiscipline of gynecologic cytology for out-of-State laboratories;

(d) Document the required remedial training and education when completed, using a form provided by the OHCQ, and submit the completed form to the OHCQ;

(e) Schedule and take a third test with a 20-slide test set within 30 days of completing the required remedial training and education; and

(f) Begin examining gynecologic cytology specimens only after the OHCQ informs the individual that the individual obtained a passing score on the third test.

(6) An individual who fails a third or subsequent test shall:

(a) Complete at least 35 hours of documented, formally structured, continuing education in diagnostic cytopathology that focuses on the examination of gynecologic preparations;

(b) Document the education when completed, using a form provided by the OHCQ, and submit the completed form to the OHCQ;

(c) Schedule and take a subsequent test with a 20-slide test set within 30 days of completing the required continuing education; and

(d) Begin examining gynecologic cytology specimens only after the OHCQ informs the individual that the individual obtained a passing score on the test required under §C(6)(c) of this regulation.

(7) An individual who fails a first or subsequent testing event in an annual PT cycle and who chooses not to complete mandatory retesting or remedial training, or both, shall:

(a) Immediately cease examining gynecologic cytology specimens and notify the OHCQ of this in writing; and

(b) Reenter the PT process at the point where the individual previously chose to withdraw from the testing process, if the individual decides at a later date to satisfy PT requirements.