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US · guidance

CMS SOM App. C, Tag D5681

§493.1276 Standard: Clinical cytogenetics

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

(a) The laboratory must have policies and procedures for ensuring accurate and

reliable patient specimen identification during the process of accessioning, cell

preparation, photographing or other image reproduction technique, photographic

printing, and reporting and storage of results, karyotypes, and photographs.

Interpretive Guidelines §493.1276(a)

When there are condition-level deficiencies identified in Clinical Cytogenetics in any or

all phases of testing, use D5034.

Determine which of the following services may be provided:

• Tissue Cultures (e.g., skin, lung, product of conception);

• Bone Marrow Cultures;

• Solid Tumors;

• Lymph Nodes;

• Chorionic Villus Samples (CVS);

• Peripheral Lymphocyte Cultures;

• Amniotic Fluid Cultures;

• High resolution chromosome analysis;

o Special techniques (e.g., Fragile “X” Studies, Chromosome Breakage

analysis);

• Karyotype analysis (photographic and/or computer methods);

• Transplant studies;

• Chromosome staining (banding techniques) such as:

o Quinacrine fluorescence (Q Banding);

o Giemsa/trypsin (G Banding);

o Sodium phosphate/acridine or giemsa/heat (R Banding);

o Barium hydroxide/heat (C Banding);

o Nuclear Organizing Region - Silver Stain (NOR);

o Distamycin A/4-6-diamidino-2-phenylindole (DA/DAPI); or

o Giemsa 11 (pH 11.0 for heterochromatin) (G 11).

NOTE: The above listing is not intended to be all-inclusive.

Review a sample of patient case files to determine if it is possible to go from the

accession number to the patient’s file with karyotypes, report and observation records, the

microscope slide, photographs, or requisition forms.

Probes §493.1276(a)

When photographs are taken, are the coordinates of the microscope noted for each cell

selected? If not, how does the laboratory identify the cell for future reference?

What system does the laboratory use to ensure that records reflect accurate patient

identification when:

• Photographing chromosome spreads;

• Using computer systems to assist in karyotyping; or

• Storing photographic images of chromosomes and chromosomes spreads?

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
6aaff8bfd9310babbd18c8185fea449a539831d6b2f159e77c55da02afee5eba
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