US · guidance

CMS SOM App. C, Tag D5665

§493.1274 Standard: Cytology

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

(g) Automated and semi-automated screening devices. When performing

evaluations using automated and semi-automated screening devices, the laboratory

must follow manufacturer’s instructions for preanalytic, analytic, and postanalytic

phases of testing, as applicable, and meet the applicable requirements of this

subpart K.

Interpretive Guidelines §493.1274(g)

Some automated devices, such as instruments where only a portion of the slide is

reviewed, may have a higher workload limit than 100 slides. This must be stated in the

manufacturer’s product insert to be applicable. However, the maximum workload limit

for those slides which require 100% manual review (as a result of automated or semi-automated analysis OR in the routine workload) remains 100 slides.

Probes §493.1274(g)

When technology (automated/semi-automated devices) is introduced into the laboratory,

how does the laboratory ensure its operation is within the specifications of previous

methods used by the laboratory?

Some automated devices remove a percentage of the slides from the workload. How

does the laboratory ensure that the correct slides are archived?

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: 9d0bccf5d82bf9ea13989f3fdf6649618596caab1d1ae68b2da1f429a81f9647

View the official source →

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.

Coverage · API docs