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US · guidance

CMS SOM App. L, Tag Q-0241

§416.51(a) Standard: Sanitary Environment

activein force · 2026-07-22 – presentas-observed

The ASC must provide a functional and sanitary environment for the provision of

surgical services by adhering to professionally acceptable standards of practice.

Interpretive Guidelines: §416.51(a)

The ASC must provide and maintain a functional and sanitary environment for surgical

services, to avoid sources and transmission of infections and communicable diseases. All

areas of the ASC must be clean and sanitary. This includes the waiting area(s), the pre-surgical prep area(s), the recovery room(s), and the operating or procedure rooms. The

ASC must appropriately monitor housekeeping, maintenance (including repair,

renovation, and construction activities), and other activities to ensure a functional and

sanitary environment. Policies and procedures for a sanitary and functional environment

should address the following:

• Ventilation and water quality control issues, including measures taken to maintain

a safe environment during internal or external construction/renovation;

• Maintaining safe air handling systems in areas of special ventilation, such as

operating rooms;

• Techniques for food sanitation if employee food storage and eating areas are

provided;

• Techniques for cleaning and disinfecting environmental surfaces, carpeting, and

furniture;

• Techniques for disposal of regulated and non-regulated waste; and

• Techniques for pest control.

These activities must be conducted in accordance with professionally recognized

standards of infection control practice. Examples of national organizations that

promulgate nationally recognized infection and communicable disease control guidelines,

and/or recommendations include: the Centers for Disease Control and Prevention (CDC),

the Association for Professionals in Infection Control and Epidemiology (APIC), the

Society for Healthcare Epidemiology of America (SHEA), and the Association of

periOperative Registered Nurses (AORN).

Survey Procedures: §416.51(a)

Using the specific questions on the infection control survey worksheet related to

environmental infection control to guide you:

• Observe throughout the ASC the cleanliness of the waiting area(s), the recovery

room(s), the OR/procedure rooms, floors, horizontal surfaces, patient equipment,

air inlets, mechanical rooms, supply, storage areas, etc.

• Interview staff to determine whether cleaning/disinfection takes place at the

appropriate frequencies, using suitable EPA-registered agents. Ask for supporting

documentation to confirm what staff say in interviews.

• Determine whether the ASC has a procedure for decontamination after gross

spills of blood or other bodily fluids.

• Determine whether used sharps are disposed of properly.

• Determine whether the ASC re-uses devices marketed for single use, and if so,

does it send them to an FDA-approved vendor for reprocessing?

History

Rev. 56, Issued: 12-30-09, Effective/Implementation: 12-30-09

Provenance

Source
cms.gov
Retrieved
2026-07-22
Edition
som-2026-07-22
Content hash
259fa04dee061b79b6300e4cf3bfbb88ffc25862148a585b976322b756541148
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