US · guidance
CMS SOM App. C, Tag D5200
§493.1230 Condition: General laboratory systems
Each laboratory that performs nonwaived testing must meet the applicable general
laboratory systems requirements in §§493.1231 through 493.1236, 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 general laboratory systems and
correct identified problems specified in §493.1239 for each specialty and
subspecialty of testing performed.
Interpretive Guidelines §493.1230
Significant deficiencies cited under this condition may indicate deficiencies under
personnel responsibilities. Use D5200 when significant deficiencies are identified that
have the potential to adversely affect patient testing, are systemic and pervasive
throughout the laboratory, and are not limited to any one specialty or subspecialty.
The requirements in this section address those general operational functions that are not
specific 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
b1f2f94a696c540d0166e7416f90061e025c7bb01332de873a0f04277658cac6
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