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On Nov. 18, 2008 the Centers for Medicare & Medicaid Services (CMS) adopted the Hospital Outpatient Prospective Payment System final rule (73 FR 68502), which included revisions to the ambulatory surgery center (ASC) Conditions for Coverage (CfCs) in 42 CFR 416.2 – 416.52 that took effect on May 18, 2009. Included in the new CfCs is a rigorous focus on demonstrated infection prevention and control knowledge and practice in an ASC. In 416.51 Conditions for coverage—Infection control, an ASC must maintain an infection control program that minimizes infections and communicable diseases. The facility must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice, and the infection prevention program must include documentation that the ASC has considered, selected and implemented nationally recognized infection control guidelines, such as those issued by the Centers for Disease Control and Prevention (CDC). The program must be implemented under the direction of a designated and qualified professional who has training in infection control; it must be an integral part of the ASC’s quality assessment and performance improvement program; and it must contain 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 interpretive guidelines for the infection control conditions of coverage are as follows:
§416.51 Condition for Coverage – Infection control
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.
Survey Procedures §416.51 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. _______________________________________________________________________ Q-0241 §416.51(a) Standard: Sanitary environment
The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.
• 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). Survey Procedures §416.51(a) 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.
Interpretive Guidelines §416.51(a) 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; procedures is administered at the appropriate time, done with an appropriate antibiotic, and discontinued appropriately after surgery; - 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.
Q-0243 §416.51(b) Standard: Infection control program. [...] The program is – (1) Under the direction of a designated and qualified professional who has training in infection control; Interpretive Guidelines §416.51(b) (1) 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.
Survey Procedures §416.51(b) (1) • Determine whether a qualified individual has been designated with the responsibility for leading the infection control program. • Review the personnel file of the infection control individual to determine whether he/she is qualified through ongoing education, training, or certification to oversee the infection control program. ________________________________________________________________________ Q-0244 §416.51(b) Standard: Infection control program. [...The program is –] 138
(2) An integral part of the ASC’s quality assessment and performance improvement program; and Interpretive Guidelines §416.51(b)(2) 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. Survey Procedures §416.51(b)(2) • Determine whether the ASC’s quality assessment and performance program includes measures/indicators and activities related to infection control on an ongoing basis. • Determine whether there is evidence that the QAPI infection control activities result in specific actions designed to improve infection control within the ASC. __________________________________________________________
Q-0245 §416.51(b) Standard: Infection control program. [... The program is –] (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. Interpretive Guidelines §416.51(b)(3) 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)) 139
To access the entire interpretive guidelines document, CLICK HERE.