US · guidance
CMS SOM App. C, Tag D5629
§493.1274 Standard: Cytology
(c)(5) An annual statistical laboratory evaluation of the number of--
(c)(5)(i) Cytology cases examined;
(c)(5)(ii) Specimens processed by specimen type;
(c)(5)(iii) Patient cases reported by diagnosis (including the number reported as
unsatisfactory for diagnostic interpretation);
(c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other
malignant neoplasm for which histology results were available for comparison;
(c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and
(c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen
results in reclassification as low-grade squamous intraepithelial lesion (LSIL),
HSIL, adenocarcinoma, or other malignant neoplasms.
Interpretive Guidelines §493.1274(c)(5)
For laboratories performing Non-Gynecologic Cytology Only: §493.1274(c)(5)(i),
(c)(5)(ii), and (c)(5)(iii).
For laboratories performing Gynecologic Cytology or laboratories performing both
Gynecologic and Non-Gynecologic Cytology: §493.1274(c)(5)(i), (c)(5)(ii), (c)(5)(iii),
(c)(5)(iv), (c)(5)(v), and (c)(5)(vi).
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
19f5ca48f11151c19a5ae1cb572881ce30477ff73dc61639fe0f87f5b811bce9
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