Physical Environment

As stated in the overall introduction of the reference guide, the Conditions for Coverage (CfC’s) that cover Ambulatory Surgery Cents broadly apply across a wide variety of surgical settings, including complex sterile procedures and non-sterile settings found for procedures such as endoscopy. As such, CMS has eliminated the  distinction between procedure rooms and operating rooms. There may be situations where  of endoscopic ASCs being held to operation room standards. In general, standards require endoscopy facilities to be constructed in such a way that there is safety from hazards such as fire, injury, and infection, sufficient space for operations, and adequate patient privacy. State Laws must be followed as policy. CMS requires the ASC to meet the provisions applicable to Ambulatory Healthcare Centers of the 2012 edition of the Life Safety Code of the National Fire Protection Association (NFPA 101 Life Safety Code). CMS suggests National Organizations, such as the Facilities Guidelines Institute, may be used as a source of guidance to evaluate OR design and construction in an ASC. Since ASGE is a National Organization, recommendations made in ASGE references could be adopted as policies for endoscopy units. Although ASGE has not developed a document specifically addressing the Physical Environment of the Endoscopy Unit, there are recommendations relating to the endoscopy unit in other documents:

For more in-depth information regarding interpretative guidance and surveyor procedures, access the CMS State Operations Manual, Guidance for Surveyors: Ambulatory Surgical Centers (Appendix L).¹

§416.44(a) Standard: Physical Environment

The ASC must provide a functional and sanitary environment for the provision of surgical services. (see section on Environment)

1. Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.
2. The ASC must have a separate recovery room and waiting area.

§416.44(b) Standard: Safety From Fire

(1) Except as otherwise provided in this section, the ASC must meet the provisions applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served, and must proceed in accordance with the Life Safety Code (NFPA 101 and Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-4).

(2) In consideration of a recommendation by the State survey agency or Accrediting Organization or at the discretion of the Secretary, may waive, for periods deemed appropriate, specific provisions of the Life Safety Code, which would result in unreasonable hardship upon an ASC, but only if the waiver will not adversely affect the health and safety of the patients.

(3) The provisions of the Life Safety Code do not apply in a State if CMS finds that a fire and safety code imposed by State law adequately protects patients in an ASC.

(4) An ASC may place alcohol-based hand rub dispensers in its facility if the dispensers are installed in a manner that adequately protects against inappropriate access.

(5) When a sprinkler system is shut down for more than 10 hours, the ASC must: (i) Evacuate the building or portion of the building affected by the system outage until the system is back in service, or (ii) Establish a fire watch until the system is back in service.

(6) Beginning July 5, 2017, an ASC must be in compliance with Chapter 21.3.2.1, Doors to hazardous areas.

1. A statement should be made citing the ASGE references as recommendations from a nationally recognized specialty society that were used in the development of this reference.
   
   
2. If other nationally recognized society guidelines are also being used to develop policies and procedures, it is important to review those policies and reconcile differences so that contradictory policies are not developed.
   
   
3. The Association of Operating Room Nurses (AORN) has specific policies requiring surgical attire, staffing, and restricted areas that endoscopy facilities may not wish to adopt. In the interpretive guidelines, AORN’s standards are mentioned as an example of nationally recognized standards. CMS surveyors, therefore, may hold facilities to those standards unless they have specifically adopted others.
4. Documentation of the adoption of ASGE guidelines should be referenced in the meeting minutes of the organization’s governing body. The reference should include the guideline, the portion of the guideline to be adopted, and an education plan for staff and providers as needed.

1. CMS State Operations Manual, Guidance for Surveyors: Ambulatory Surgical Centers (Appendix L). Centers for Medicare and Medicaid Services. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf.

2. Guidelines for Safety in the Gastrointestinal Unit. GASTROINTEST ENDOSC 2014; 79(3): 366-68.