CMS SOM App. C, Tag D5619

(b)(3) Nongynecologic specimens that have a high potential for cross-contamination

must be stained separately from other nongynecologic specimens, and the stains

must be filtered or changed following staining.

Interpretive Guidelines §493.1274(b)(3)

A monochromatic stain such as toluidine blue may be used to determine the cellularity of

nongynecologic specimens. Once a specimen has been concentrated, usually by

centrifugation, a small drop of specimen is placed on a slide. A drop of stain is placed

next to the specimen, allowed to mix, and coverslipped. Cellularity is evaluated

microscopically. Highly cellular specimens have a high potential for cross-contamination. One option would be for the laboratory to stain these specimens after

routine staining has been completed.

Laboratories which use automated staining methodologies must follow the

manufacturer’s instructions. Use D5411.

Probes §493.1274(b)(3)

How is the cellularity of nongynecologic specimens checked prior to cytopreparation

(staining)?

What procedure does the laboratory use to determine which specimens must be stained

separately?

§493.1274 Standard: Cytology.

(c) Control Procedures. The laboratory must establish and follow written policies

and procedures for a program designed to detect errors in the performance of

cytologic examinations and the reporting of results. The program must include the

following: