CMS SOM App. A, Tag A-0725

offered.

Interpretive Guidelines §482.41(d)(3)

Physical facilities must be large enough, numerous enough, appropriately designed and

equipped, and of appropriate complexity to provide the services offered in accordance with

Federal and State laws, regulations and guidelines and accepted standards of practice for that

location or service.

Survey Procedures §482.41(d)(3)

Verify through observation that the physical facilities are large enough and properly equipped for

the scope of services provided and the number of patients served.

0726

(Rev. 238; Issued: 03-20-26; Effective: 09-05-25; Implantation: 09-05-25)

§482.41(d)(4) - There must be proper ventilation, light, and temperature controls in

pharmaceutical, food preparation, and other appropriate areas.

Interpretive Guidelines §482.41(d)(4)

There must be proper ventilation in at least the following areas:

• Areas using ethylene oxide, nitrous oxide, gluteraldehydes, xylene, pentamidine, or other

potentially hazardous substances;

• Locations where oxygen is transferred from one container to another;

• Isolation rooms and reverse isolation rooms (both must be in compliance with Federal

and State laws, regulations, and guidelines such as OSHA, CDC, NIH, etc.);

• Pharmaceutical preparation areas (hoods, cabinets, etc.);

• Food preparation areas;

• Laboratory locations; and

• Operating rooms.

There must be adequate lighting in all the patient care areas, and food and medication

preparation areas.

Temperature, humidity and airflow must be maintained within acceptable standards to inhibit

microbial growth, reduce risk of infection, control odor, and promote patient comfort. In

operating rooms and associated ancillary rooms (e.g., pre-op, post-op, storage, sterilization,

etc.), ventilation standards may permit the reduction of relative humidity levels as low as 20%,

but hospitals must consider sterile supply and medical equipment manufacturer instructions for

use regarding required humidity levels prior to any humidity level adjustment. Failure to

maintain manufacturer required humidity levels may void sterile packaging and result in medical

equipment malfunction or failure.

In addition, ventilation standards typically require hospital operating rooms to maintain the

upper range of RH at 60 percent or less, as excessive humidity is conducive to microbial growth

and again may compromise the integrity of supplies and medical equipment. Hospitals must

maintain records that demonstrate they are maintaining the required temperature, humidity, and

airflow levels.

Each operating room should have separate temperature control. Acceptable standards such as

from the Association of Operating Room Nurses (AORN) or the Facilities Guidelines Institute

(FGI) should be incorporated into hospital policy.

The hospital must ensure that an appropriate number of refrigerators and/or heating devices are

provided and ensure that food and pharmaceuticals are stored properly and in accordance with

nationally accepted guidelines (food) and manufacturer’s recommendations (pharmaceuticals).

Survey Procedures §482.41(d)(4)

• Verify that all food and medication preparation areas are well lighted.

• Verify that the hospital is in compliance with ventilation requirements for patients with

contagious airborne diseases, such as tuberculosis, patients receiving treatments with

hazardous chemical, surgical areas, and other areas where hazardous materials are

stored.

• Verify that food products are stored under appropriate conditions (e.g., time,

temperature, packaging, location) based on a nationally-accepted source such as the

United States Department of Agriculture, the Food and Drug Administration, or other

nationally-recognized standard.

• Verify that pharmaceuticals are stored at temperatures recommended by the product

manufacturer.

• Review monitoring records for temperature to ensure that appropriate levels are

maintained.

• Review temperature, humidity and airflow maintenance records for operating rooms and

associated ancillary rooms to ensure acceptable parameters are being maintained. If

monitoring determined temperature, humidity or airflow levels were not within

acceptable parameters, confirm corrective actions were performed in a timely manner to

achieve acceptable levels.