US · guidance
CMS SOM App. C, Tag D5607
§493.1273 Standard: Histopathology
(d) Tissue pathology reports must be signed by an individual qualified as specified
in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer
report is generated with an electronic signature, it must be authorized by the
individual who performed the examination and made the diagnosis.
Interpretive Guidelines §493.1273(d)
The laboratory must ensure that only those individuals qualified to evaluate
histopathology specimens can release his or her electronic signature for reporting
purposes.
The tests in histopathology include both gross examination (macroscopic) and
microscopic examination of the slide(s) with evaluation and diagnostic interpretation, and
diagnostic findings reported.
In the event of a computer-generated signature, the laboratory must ensure that the
system is protected from use by unauthorized individuals.
If the technical supervisor who performed the examination and diagnosis is not available
to sign the report, an individual, also qualified as a technical supervisor in
Histopathology, must reexamine and diagnose in order to sign out the report.
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
b87c9d1b61b76e3749e4453f3bc22b901a49c32571da0f2ea6c40da41901d7f2
The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.
Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.