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US · guidance

CMS SOM App. C, Tag D5625

§493.1274 Standard: Cytology

activein force · 2026-07-22 – presentas-observed

(c)(3) For each patient with a current HSIL, adenocarcinoma, or other malignant

neoplasm, laboratory review of all normal or negative gynecologic specimens

received within the previous 5 years, if available in the laboratory (either on-site or

in storage). If significant discrepancies are found that will affect current patient

care, the laboratory must notify the patient’s physician and issue an amended

report.

Probes §493.1274(c)(3)

How does the laboratory track previous cases on an individual patient?

What criteria does the laboratory use to determine discrepancies when reviewing normal

or negative slides from the past five years? How does the laboratory document the

review?

How does the laboratory use the retrospective review to assess the analytic system and

communicate findings to the appropriate staff? Use D5793

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
95350cee0f43de82af84b509bae000cf4db50121516fb679f5ebb55ad9f5b4e6
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