.04 Cytology — Departmental Requirements.

A. The Secretary may not issue a license to operate a laboratory that examines gynecologic cytology specimens if the laboratory does not enroll and participate satisfactorily in a cytology PT program operated or approved by the Secretary.

B. The OHCQ shall conduct annual PT for each pathologist and cytotechnologist who examines gynecological cytology slides acquired in the State.

C. The OHCQ or an agent of the Department shall hand carry test materials for first-event testing in a PT cycle to a laboratory and shall conduct and supervise all testing.

D. The OHCQ shall:

(1) Conduct announced and unannounced on-site testing for individuals during an annual PT cycle; and

(2) Schedule and conduct a retesting event for an individual who has failed the annual PT testing event not more than 45 days after receipt of the notification of the PT testing event failure by the:

(a) Individual who failed the annual PT testing event; and

(b) Laboratory director of the individual who failed the annual PT testing event.

E. The OHCQ may conduct unannounced PT at any time during normal laboratory working hours when the testing is conducted as part of routine PT, a complaint investigation, a follow-up certification, or a regulatory compliance survey.

F. The OHCQ shall conduct announced retesting within an annual PT cycle at a site selected by the Department.

G. The OHCQ shall schedule an individual who misses a laboratory's annual PT event to make up the missed test.

H. The OHCQ shall evaluate an individual's PT performance as set forth in 42 CFR §493.945.