CMS SOM App. L, Tag Q-0242

The ASC must maintain an ongoing program designed to prevent, control, and

investigate infections and communicable diseases. In addition, the infection control

and prevention program must include documentation that the ASC has considered,

selected, and implemented nationally recognized infection control guidelines. […]

Interpretive Guidelines: §416.51(b)

The ASC must maintain an ongoing program to prevent, control, and investigate

infections and communicable diseases. As part of this ongoing program, the ASC must

have an active surveillance component that covers both ASC patients and personnel

working in the facility. Surveillance includes infection detection through ongoing data

collection and analysis.

The ongoing program must be based on nationally recognized infection control

guidelines that the ASC has selected, after a deliberative process. 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).

The ASC should select one or more sets of guidelines that enable it to address the

following key functions of an effective infection control program:

• Maintenance of a sanitary ASC environment (see requirements of §416.51(a));

• Development and implementation of infection control activities related to ASC

personnel, which, for infection control purposes, includes all ASC medical staff,

employees, and on-site contract workers (e.g., nursing staff employed by

associated physician practice who also work in the ASC, housekeeping staff, etc);

• Mitigation of risks associated healthcare-associated infections:

• Identifying infections;

• Monitoring compliance with all policies, procedures, protocols and other infection

control program requirements;

• Program evaluation and revision of the program, when indicated;

The following provides a more detailed overview of the types of activities related to these

key functions.

ASC staff-related activities:

• Evaluating ASC staff immunization status for designated infectious diseases, for

example, as recommended by the CDC and its Advisory Committee on

Immunization Practices (ACIP);

• Policies articulating the authority and circumstances under which the ASC screens

its staff for infections likely to cause significant infectious disease or other risk to

the exposed individual, and for reportable diseases, as required under local, state,

or federal public health authority;

• Policies articulating when infected ASC staff are restricted from providing direct

patient care or required to remain away from the facility entirely;

• New employee and regular update training in preventing and controlling

healthcare-associated infections and methods to prevent exposure to and

transmission of infections and communicable diseases; and

• Methods to evaluate staff exposed to patients with infections and communicable

diseases.

Mitigation of risks contributing to healthcare-associated infections (HAI):

For the purposes of its surveillance activities in an acute care setting, the CDC defines an

HAI as a localized or systemic condition resulting from an adverse reaction to the

presence of an infectious agent(s) or its toxin(s). There must be no evidence that the

infection was present or incubating at the time of admission to the ASC.

HAIs may be caused by infectious agents from endogenous or exogenous sources.

Endogenous sources are body sites, such as the skin, nose, mouth, gastrointestinal (GI)

tract, or vagina that are normally inhabited by microorganisms. Exogenous sources are

those external to the patient, such as patient care personnel, visitors, patient care

equipment, medical devices, or the health care environment.

HAI risk mitigation measures include:

Surgery-related infection risk mitigation measures:

• Implementing appropriate prophylaxis to prevent surgical site infection (SSI),

such as protocol to assure that antibiotic prophylaxis to prevent SSI for

appropriate procedures is administered at the appropriate time, done with an

appropriate antibiotic, and discontinued appropriately after surgery; and

• Addressing aseptic technique practices used in surgery, including sterilization or

high-level disinfection of instruments, as appropriate.

• Other ASC healthcare-associated infection risk mitigation measures:

• Promotion of hand hygiene among staff and employees, including utilization of

alcohol-based hand sanitizers;

• Measures specific to the prevention of infections caused by organisms that are

antibiotic-resistant;

• Measures specific to safe practices for injecting medications and saline or other

infusates;

• Requiring disinfectants and germicides to be used in accordance with the

manufacturers’ instructions;

• Appropriate use of facility and medical equipment, including air filtration

equipment, UV lights, and other equipment used to control the spread of

infectious agents;

• Educating patients, visitors, and staff, as appropriate, about infections and

communicable diseases and methods to reduce transmission in the ASC and in the

community.

Identifying Infections

The ASC must conduct monitoring activities throughout the entire facility in order to

identify infection risks or communicable disease problems. The ASC should document

its monitoring/tracking activities, including the measures selected for monitoring, and

collection and analysis methods. Activities should be conducted in accordance with

recognized infection control surveillance practices, such as, for example, those utilized by

the CDC’s National Healthcare Safety Net (NHSN). Monitoring includes follow-up of

patients after discharge, in order to gather evidence of whether they have developed an

infection associated with their stay in the ASC.

The ASC must develop and implement appropriate infection control interventions to

address issues identified through its detection activities, and then monitor the

effectiveness of interventions through further data collection and analysis.

Monitoring Compliance

It is not sufficient for the ASC to have detailed policies and procedures governing

infection control; it must also take steps to determine whether the staff of the ASC adhere

to these policies and procedures in practice. Are staff washing their hands prior to

providing care to patients? Do personnel who prepare injections comply with all

pertinent protocols? Is equipment properly sterilized or disinfected? Is the facility clean?

The ASC must demonstrate that it has a process in place for regularly assessing infection

control compliance.

Program Evaluation

See the guidance for §416.51(b)(2), which requires that the infection control program

must be an integral part of the ASC's quality assessment and performance improvement

program.

An ASC presents different challenges for infection control as patients at varying levels of

wellness are gathered in waiting or recovery areas, including the elderly, immuno-compromised patients, pre- and post-operative patients, and individuals with active or

incubating infectious and communicable diseases. The length of stay for such individuals

can range from brief to all day. Additionally, as ASCs are performing more invasive

procedures, the level of risk for developing and transmitting infections and

communicable diseases for patients and heath care workers increases. The ASC should

design its infection control program with these challenges in mind. For instance, the

ASC should take appropriate control measures for those individuals who may present risk

for the transmission of infectious agents by the airborne or droplet route. When such

individuals are identified, the ASC could, for example, implement such prevention

measures that would include prompt physical separation, implementation of respiratory

hygiene/cough etiquette protocols, and appropriate isolation precautions based on the

routes of transmission of the suspected infection.

Survey Procedures: §416.51(b)

• Use the infection control tool to assist in assessing compliance with this standard.

• Determine that there is an ongoing program for the prevention, control, and

investigation of infections and communicable diseases among patients and ASC

personnel, including contract workers and volunteers.

• Determine whether the policies and procedures of the program of the infection

control program are implemented correctly. Specifically, surveyors should

determine whether the ASC:

• Mitigates risks contributing to healthcare-associated infections (for example,

observe whether staff exhibit good hand hygiene);

• Performs monitoring/tracking activities to identify infections; and

• Monitors compliance with all infection control program requirements.

• Review the parameters of the program to determine whether it is consistent with

nationally recognized infection control guidelines. Is there documentation that

the ASC has developed the procedures and policies of the program based on

nationally recognized infection control guidelines?