Sec. 10.10.06.10. Quality Control — Cytology

A. Primary Standard. A licensee of a laboratory offering to perform or performing tests in the subdiscipline of gynecologic cytology shall ensure that the laboratory:

(1) Limits the number of slides an individual may examine as set forth in 42 CFR §493.1274;

(2) Limits slide examination to the laboratory premises;

(3) Establishes a quality assurance program and follows written quality control procedures to monitor and evaluate the quality of cytological procedures and testing processes;

(4) Does not pay for the examination of cytology slides on a piecework basis;

(5) Reviews not less than 10 percent of all negative gynecologic slides before reporting results on those slides;

(6) Employs an individual who qualifies as a supervisory cytotechnologist or a technical supervisor in gynecologic cytology to review negative gynecologic slides;

(7) Does not allow the evaluation of a slide that shows evidence of unsatisfactory preparation;

(8) Reports as to whether a slide is satisfactory or unsatisfactory for evaluation;

(9) Maintains records for 5 years of slides reported as unsatisfactory;

(10) Maintains and stores for 5 years from the date of examination any slide that was examined;

(11) Retains cytology reports for at least 10 years;

(12) Does not send gynecologic cytology slides to a laboratory not holding a State license; and

(13) Requires cytotechnologists and pathologists to obtain continuing education.

B. Standards.

(1) General. A licensee shall ensure that the laboratory complies with the applicable requirements in 42 CFR §493.1221.

(2) Continuing Education.

(a) A cytotechnologist or pathologist who is employed by a laboratory and who performs primary gynecologic screening shall obtain at least 20 credit hours per calendar year of continuing education in cytology. A credit hour is 1 hour of active participation in the educational activity.

(b) An individual may obtain cytological continuing education in a formal or informal educational activity, such as reading journal articles, reviewing case histories, and attending lectures or workshops. This activity provides the individual with increased medical or technical knowledge of cytopathology or exfoliative cytology.

(c) A licensee shall ensure that the laboratory annually compiles records of the continuing education for each cytotechnologist and pathologist and retains them for at least 2 years.