CMS SOM App. C, Tag D5649

(e)(1) A technical supervisor confirms each gynecologic slide preparation

interpreted to exhibit reactive or reparative changes or any of the following

epithelial cell abnormalities:

(e)(1)(i) Squamous Cell

Interpretive Guidelines §493.1274(e)(1)(i)

NOTE: This requirement is in addition to the review and confirmation by a technical

supervisor of all nongynecologic preparations as described under §493.1274(e)(3).

Probes §493.1274(e)(1)(i)

How does the laboratory ensure that the technical supervisor confirms every slide

containing cells exhibiting reactive, reparative, atypical squamous/glandular cells, LSIL,

HSIL, and all carcinomas?

(e)(1)(i)(A) Atypical squamous cells of undetermined significance (ASC-US) or

cannot exclude HSIL (ASC-H).

(e)(1)(i)(B) LSIL-Human papillomavirus (HPV)/mild dysplasia/cervical

intraepithelial neoplasia 1 (CIN 1).

(e)(1)(i)(C) HSIL-moderate and severe dysplasia, carcinoma in situ (CIS)/CIN 2 and

CIN 3 or with features suspicious for invasion.

(e)(1)(i)(D) Squamous cell carcinoma.

(e)(1)(ii) Glandular Cell

(e)(1)(ii)(A) Atypical cells not otherwise specified (NOS) or specified in comments

(endocervical, endometrial, or glandular).

(e)(1)(ii)(B) Atypical cells favor neoplastic (endocervical or glandular).

(e)(1)(ii)(C) Endocervical adenocarcinoma in situ.

(e)(1)(ii)(D) Adenocarcinoma endocervical, adenocarcinoma endometrial,

adenocarcinoma extrauterine, and adenocarcinoma NOS.

(e)(1)(iii) Other malignant neoplasms.