US · guidance
CMS SOM App. C, Tag D5800
§493.1290 Condition: Postanalytic Systems
Each laboratory that performs nonwaived testing must meet the applicable
postanalytic systems requirements in §493.1291 unless HHS approves a procedure,
specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides
equivalent quality testing. The laboratory must monitor and evaluate the overall
quality of the postanalytic systems and correct identified problems as specified in
§493.1299 for each specialty and subspecialty of testing performed.
Interpretive Guidelines §493.1290
Significant deficiencies cited under this condition may indicate deficiencies under
personnel responsibilities. Use D5800 when deficiencies are identified that are:
significant and have the potential to, or adversely affect, patient testing, are systemic and
pervasive throughout the laboratory, and are not limited to any one specialty or
subspecialty.
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
296f27901acc82f3d63f9191fdb2a9131c38dcd2d50bea376f943eee25945ddd
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