14. Condition for Coverage - Infection control (Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
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.
One surveyor is responsible for completion of the Infection Control Surveyor Worksheet, Exhibit 351, which is used to facilitate assessment of compliance with this Condition. 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.
Standard: Sanitary Environment(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
The ASC must provide and maintain a functional and sanitary environment for surgical services, to avoid sources and transmission of infections and communicable diseases. All areas of the ASC must be clean and sanitary. This includes the waiting area(s), the pre-surgical prep area(s), the recovery room(s), and the operating or procedure rooms. The ASC must appropriately monitor housekeeping, maintenance (including repair, renovation, and construction activities), and other activities to ensure a functional and sanitary environment. Policies and procedures for a sanitary and functional environment should address the following:
- Ventilation and water quality control issues, including measures taken to maintain a safe environment during internal or external construction/renovation;
- Maintaining safe air handling systems in areas of special ventilation, such as operating rooms;
- Techniques for food sanitation if employee food storage and eating areas are provided;
- Techniques for cleaning and disinfecting environmental surfaces, carpeting, and furniture;
- Techniques for disposal of regulated and non-regulated waste; and
- Techniques for pest control.
These activities must be conducted in accordance with professionally recognized standards of infection control practice. 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).
Using the specific questions on the infection control survey worksheet related to environmental infection control to guide you:
- Observe throughout the ASC the cleanliness of the waiting area(s), the recovery room(s), the OR/procedure rooms, floors, horizontal surfaces, patient equipment, air inlets, mechanical rooms, supply, storage areas, etc.
- Interview staff to determine whether cleaning/disinfection takes place at the appropriate frequencies, using suitable EPA-registered agents. Ask for supporting documentation to confirm what staff say in interviews.
- Determine whether the ASC has a procedure for decontamination after gross spills of blood or other bodily fluids.
- Determine whether used sharps are disposed of properly.
- Determine whether the ASC re-uses devices marketed for single use, and if so, does it send them to an FDA-approved vendor for reprocessing?
Standard: Infection control program.(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
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 antiobiotic-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. See discussion of §416.44(a)(3).
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.
Standard: Infection control program.(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(1) Under the direction of a designated and qualified professional who has training in infection control;
The ASC must designate in writing, a qualified licensed health care professional who will lead the facility's infection control program. The ASC must determine that the individual has had training in the principles and methods of infection control. Note that certification in infection control, such as that offered by the Certification Board of Infection Control and Epidemiology Inc. (CIBC), while highly desirable, is not required, so long as there is documentation that the individual has training that qualifies the individual to lead an infection control program. The individual selected to lead the ASC's infection control program must maintain his/her qualifications through ongoing education and training, which can be demonstrated by participation in infection control courses, or in local and national meetings organized by recognized professional societies, such as APIC and SHEA.
Although CMS does not specify the number of hours that the qualified individual must devote to the infection control program, resources must be adequate to accomplish the tasks required for the infection control program. The ASC should consider the type of surgical services offered at the facility as well as the patient population in determining the size and scope of the resources it commits to infection control. The CDC's HICPAC as well as professional infection control organizations, such as the APIC and the SHEA, publish studies and recommendations on resource allocation that ASCs may find useful.
Standard: Infection Control Program.(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(2) An integral part of the ASC's quality assessment and performance improvement program; and
To reflect the importance of infection control the regulations specifically require that the ASC's infection control program must be integrated into its QAPI program. Among other things this means that infection control data and program activities are an ongoing component of the QAPI program, and that actions are taken in response to data analyses to improve the ASC's infection control performance. See the discussion related to §416.43, which articulates the ASC QAPI requirements.
Standard: Infection control program.(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(3) Responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement.
The ASC's infection control professional must develop and implement a comprehensive plan that includes actions to prevent, identify and manage infections and communicable diseases within the ASC. The plan of action must include mechanisms that result in immediate action to take preventive or corrective measures that improve the ASC's infection control outcomes. The plan should be specific to each particular area of the ASC, including, but not limited to, the waiting room(s), the recovery room(s), and the surgical areas. The designated infection control professional must assure that the program's plan of action addresses the activities discussed in the interpretive guidelines for §416.51(b), i.e.,
- Maintenance of a sanitary environment; (See discussion of §416.51(a))
- Development and implementation of infection control measures related to ASC personnel;
- Mitigation of risks associated with patient infections present upon admission;
- Mitigation of risks contributing to healthcare-associated infections;
- Active surveillance;
- Monitoring compliance with all policies, procedures, protocols, and other infection control program requirements;
- Plan evaluation and revision of the plan, when indicated;
- Coordination as required by law with federal, state, and local emergency preparedness and health authorities to address communicable and infectious disease threats and outbreaks; and
- Compliance with reportable disease requirements of the local health authority. (See discussion of §416.44(a)(3))