[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR416.44]



[Page 814-815]

 

                         TITLE 42--PUBLIC HEALTH

 

                    CHAPTER IV--CENTERS FOR MEDICARE

                          & MEDICAID SERVICES,

                        DEPARTMENT OF HEALTH AND

                             HUMAN SERVICES

 

PART 416_AMBULATORY SURGICAL SERVICES--Table of Contents

 

               Subpart C_Specific Conditions for Coverage

 

Sec. 416.44  Condition for coverage--Environment.



    The ASC must have a safe and sanitary environment, properly 

constructed, equipped, and maintained to protect the health and safety 

of patients.

    (a) Standard: Physical environment. The ASC must provide a 

functional and sanitary environment for the provision of surgical 

services.

    (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.

    (3) The ASC must establish a program for identifying and preventing 

infections, maintaining a sanitary environment, and reporting the 

results to appropriate authorities.

    (b) Standard: Safety from fire. (1) Except as otherwise provided in 

this section, the ASC must meet the provisions applicable to Ambulatory 

Health Care Centers of the 2000 edition of the Life Safety Code of the 

National Fire Protection Association, regardless of the number of 

patients served. The Director of the Office of the Federal Register has 

approved the NFPA 101 [reg] 2000 edition of the Life Safety 

Code, issued January 14, 2000, for incorporation by reference in 

accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is 

available for inspection at the CMS Information Resource Center, 7500 

Security Boulevard, Baltimore, MD and at the National Archives and 

Records Administration (NARA). For information on the availability of 

this material at NARA, call 202-741-6030, or go to: http://

www.archives.gov/federal--register/code--of--federal--regulations/ibr--

locations.html. Copies may be obtained from the National Fire Protection 

Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in 

this edition of the Code are incorporated by reference, CMS will publish 

notice in the Federal Register to announce the changes.

    (2) In consideration of a recommendation by the State survey agency, 

CMS may waive, for periods deemed appropriate, specific provisions of 

the Life Safety Code which, if rigidly applied, 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 must be in compliance with Chapter 21.2.9.1, Emergency 

Lighting, beginning on March 13, 2006.

    (5) Notwithstanding any provisions of the 2000 edition of the Life 

Safety Code to the contrary, an ASC may place alcohol-based hand rub 

dispensers in its facility if--

    (i) Use of alcohol-based hand rub dispensers does not conflict with 

any State or local codes that prohibit or otherwise restrict the 

placement of alcohol-based hand rub dispensers in health care 

facilities;

    (ii) The dispensers are installed in a manner that minimizes leaks 

and spills that could lead to falls;

    (iii) The dispensers are installed in a manner that adequately 

protects against access by vulnerable populations; and

    (iv) The dispensers are installed in accordance with the following 

provisions:

    (A) Where dispensers are installed in a corridor, the corridor shall 

have a minimum width of 6 ft (1.8m);

    (B) The maximum individual dispenser fluid capacity shall be:

    (1) 0.3 gallons (1.2 liters) for dispensers in rooms, corridors, and 

areas open to corridors.

    (2) 0.5 gallons (2.0 liters) for dispensers in suites of rooms;

    (C) The dispensers shall have a minimum horizontal spacing of 4 ft 

(1.2m) from each other;

    (D) Not more than an aggregate 10 gallons (37.8 liters) of ABHR 

solution shall be in use in a single smoke compartment outside of a 

storage cabinet;

    (E) Storage of quantities greater than 5 gallons (18.9 liters) in a 

single



[[Page 815]]



smoke compartment shall meet the requirements of NFPA 30, Flammable and 

Combustible Liquids Code;

    (F) The dispensers shall not be installed over or directly adjacent 

to an ignition source; and

    (G) In locations with carpeted floor coverings, dispensers installed 

directly over carpeted surfaces shall be permitted only in sprinklered 

smoke compartments.

    (c) Standard: Emergency equipment. Emergency equipment available to 

the operating rooms must include at least the following:

    (1) Emergency call system.

    (2) Oxygen.

    (3) Mechanical ventilatory assistance equipment including airways, 

manual breathing bag, and ventilator.

    (4) Cardiac defibrillator.

    (5) Cardiac monitoring equipment.

    (6) Tracheostomy set.

    (7) Laryngoscopes and endotracheal tubes.

    (8) Suction equipment.

    (9) Emergency medical equipment and supplies specified by the 

medical staff.

    (d) Standard: Emergency personnel. Personnel trained in the use of 

emergency equipment and in cardiopulmonary resuscitation must be 

available whenever there is a patient in the ASC.



[47 FR 34094, Aug. 5, 1982, amended at 53 FR 11508, Apr. 7, 1988; 54 FR 

4026, Jan. 27, 1989; 68 FR 1385, Jan. 10, 2003; 69 FR 18803, Apr. 9, 

2004; 70 FR 15237, Mar. 25, 2005]