US · guidance
CMS SOM App. C, Tag D3000
§493.1100 Condition: Facility administration
Each laboratory that performs nonwaived testing must meet the applicable
requirements under §§493.1101 through 493.1105, unless HHS approves a
procedure that provides equivalent quality testing as specified in Appendix C of the
State Operations Manual (CMS Pub. 7).
Interpretive Guidelines §493.1100
To determine which tests are categorized as waived or nonwaived (i.e. moderate or high
complexity tests), refer to the following web link for the FDA categorization database
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0). Test
systems, assays, and examinations not yet classified are considered high complexity.
Significant deficiencies cited under this condition may also indicate deficiencies under
personnel responsibilities.
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
31533ac969efdcb11b322c020e00a6879d1888958ddc11a6b1800a0d2caa4a54
The link goes to the issuing authority’s own document — the one we read to produce this record. Where a source publishes whole titles rather than sections, your browser may need a moment to jump to the provision.
Unofficial copy of government-published law, reproduced from official sources with full provenance. Not an official publication; verify against official sources before relying on it in a filing. Records in the 'guidance' corpus, and only that corpus, are sub-regulatory (interpretive guidelines, survey procedures) and are not binding law. Validity bounds follow each jurisdiction's declared temporalBasis.