US · guidance
CMS SOM App. C, Tag D3011
§493.1101 Standard: Facilities
(d) Safety procedures must be established, accessible, and observed to ensure
protection from physical, chemical, biochemical, and electrical hazards, and
biohazardous materials.
Interpretive Guidelines §493.1101(d)
If you observe or obtain information regarding potential safety violations not applicable
under CLIA, notify the appropriate State or local authority. Consult with CMS or
notification to other Federal agencies such as the Occupational Safety and Health
Administration (OSHA) (https://www.osha.gov/), Environmental Protection Agency
(EPA) (www.epa.gov), or Nuclear Regulatory Commission (NRC). The appropriate
Federal, State or local authority, if warranted, will investigate and, if necessary, conduct
an on-site visit.
Probes §493.1101(d)
What safety protocols are observed and practiced in the laboratory?
How does the laboratory, including temporary testing sites or mobile units:
• Dispose of radiological, chemical, and biological wastes (including blood drawing
equipment);
• Clean up spills (chemical, biological, and radiological); and
• Determine the amount of waste that can safely be contained and the precautions
necessary to ensure that liquid waste does not spill or splash while in travel
status?
What chemical, radiological, or biological precautions are taken, if any, during the
preparation or handling of reagents?
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
32dccc4d2cb36abc84d14b74a866d7a8a6dbcd51af8d5ce665ec06795369c979
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