CMS SOM App. L, Tag Q-0240

The ASC must maintain an infection control program that seeks to minimize

infections and communicable diseases.

Interpretive Guidelines: §416.51

This regulation requires the ASC to maintain an active program for the minimization of

infections and communicable diseases. The National Institute of Allergy and Infectious

Diseases (NIAID) defines an infectious disease as a change from a state of health to a

state in which part or all of a host’s body cannot function normally because of the

presence of an infectious agent or its product. An infectious agent is defined by the

NIAID as a living or quasi-living organism or particle that causes an infectious disease,

and includes bacteria, viruses, fungi, protozoa, helminthes, and prions. NIAID defines a

communicable disease as a disease associated with an agent that can be transmitted from

one host to another. (See NIAID website glossary)

The ASC’s infection control program must:

• Provide a functional and sanitary environment for surgical services, to avoid

sources and transmission of infections and communicable diseases;

• Be based on nationally recognized infection control guidelines;

• Be directed by a designated health care professional with training in infection

control;

• Be integrated into the ASC’s QAPI program;

• Be ongoing;

• Include actions to prevent, identify and manage infections and communicable

diseases; and

• Include a mechanism to immediately implement corrective actions and

preventive measures that improve the control of infection within the ASC.

The ambulatory care setting, such as an ASC, presents unique challenges for infection

control, because: patients remain in common areas, often for prolonged periods of time;

surgical prep, recovery rooms and ORs are turned around quickly; patients with

infections/communicable diseases may not be identified; and there is a risk of infection at

the surgical site. Furthermore, due to the short period of time patients are in an ASC, the

follow-up process to identify infections associated with the ASC requires gathering

information after the patient’s discharge rather than directly. It is essential that ASCs

have a comprehensive and effective infection control program, because the consequences

of poor infection control can be very serious. In recent years, for example, poor infection

control practices related to injections of medications, saline or other infusates in some

ASCs have resulted in the transmission of communicable diseases, such as hepatitis C,

from one patient infected with the disease prior to his/her ASC visit to other ASC

patients, and a requirement to notify thousands of other ASC patients of their potential

exposure.

Infection Control Breaches

Some types of infection control breaches, including, but not limited to, medication

injection practices and disinfection and sterilization of medical devices and equipment,

pose a risk of blood borne pathogen transmission that may warrant engagement of public

health authorities to conduct a risk assessment and, if necessary, to implement the process

of patient notification.

Survey Procedures: §416.51

• One surveyor is responsible for completion of the Infection Control Surveyor

Worksheet. However, each member of the survey team, as he or she conducts

his/her survey assignments, should assess the ASC’s compliance with the

Infection Control regulatory requirements.