US · guidance
CMS SOM App. C, Tag D5400
§493.1250 Condition: Analytic systems
Each laboratory that performs nonwaived testing must meet the applicable analytic
systems requirements in §§493.1251 through 493.1283, 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 analytic systems and correct identified problems as
specified in §493.1289 for each specialty and subspecialty of testing performed.
Interpretive Guidelines §493.1250
Significant deficiencies cited under this condition may indicate deficiencies under
personnel. Use D5400 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.
Refer to §§493.1261 - 493.1278 for additional requirements for Bacteriology,
Mycobacteriology, Mycology, Parasitology, Virology, Routine Chemistry, Hematology,
Immunohematology, Histopathology, Cytology, Clinical Cytogenetics, and
Histocompatibility.
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
4928f579b0a71456043faf60e820b87b10184265aa5db1b7ee03dbd725734416
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