US · guidance
CMS SOM App. C, Tag D8301
§493.1777 Standard: Inspection of laboratories that have requested or
have been issued a certificate of compliance.
(a) Initial inspection. (a)(1) A laboratory issued a registration certificate must
permit an initial inspection to assess the laboratory’s compliance with the
requirements of this part before CMS issues a certificate of compliance.
Interpretive Guidelines §493.1777(a)
If for any reason a facility denies entry to or does not permit you to conduct a survey,
take the following steps:
• Explain your authority to conduct the survey and the consequences of failure to
permit a survey;
• If necessary, consult with your supervisor or CMS; and
• For failure to permit entry into or an inspection of the laboratory, use D8101.
If the laboratory continues to refuse a survey, refer to Subpart R – Enforcement
Procedures beginning at §493.1800 and the Adverse Action section of the SOM at 6250.
(a)(2) The inspection may occur at any time during the laboratory’s hours of
operation.
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
16a605d619011722809989cfa05b939a2a865a8866b5a286cd2c81aa1907cc0a
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.