Medicare-certified ambulatory surgery centers (ASCs) must maintain an ongoing infection prevention and control (IPC) program to prevent, control, and investigate infections and communicable diseases. An integral part of the facility’s data-driven quality assurance and performance improvement (QAPI) program, an IPC program should provide a plan to immediately implement effective corrective and preventive measures. The ASC must measure, analyze, and track quality and patient safety indicators (i.e., postoperative infections, infection control breaches).
While reciting the Medicare requirements is easy, bringing these requirements to life in everyday ASC operations is not. In fact, deficiencies associated with IPC programs and practices are the most common citation issued by Medicare surveyors. The IPC program should include a written plan that defines which organizations will be used to establish best practices (i.e., CDC, AORN, APIC), how the IPC activities will be documented and reported, and delegations of authority and responsibility by the Governing Body to the Infection Control Coordinator (ICC).
Here, I provide guidance for ensuring you have a sufficient infection control plan.
Utilizing recognized best practices
The IPC program must be based on nationally recognized guidelines and standards of practice, or best practices. These best practices include:
- Measures taken to protect patients from healthcare-associated infections, or HAIs, such as surgical attire and traffic patterns
- Instrument processing
- Barriers such as drapes and gowns
- Surgical hand scrubs and site preparations
- Environmental cleaning and disinfection
- Hand hygiene
- Standard precautions.
Establishing and implementing best practices for each of these measures begins with consideration and adoption of the guidelines into official policies and procedures. In example, the instrument disinfection and sterilization program should not only be based upon the manufacturer’s instructions for use (MIFU) but also evidence-based industry and specialty-specific standards. Instrument processing staff must be familiar with the guidelines they are following and have access to the MIFU for each instrument and device used. This is not limited to the MIFU for instruments — it includes devices used as well (i.e., sterilizers, washers, detergents, etc.).
Documenting infections
IPC program documentation should include monthly written surgeon queries to validate the absence or presence of postoperative infections or complications identified with their patients. In the event a postoperative infection is identified, a comprehensive infection investigation must occur, documenting all the relevant information associated with the event. The findings of the infection investigation, the incident and surgeon reports, and patient’s medical record should be reviewed by the QAPI and Peer Review committees and then reported to the Governing Body. Follow-up documentation to an infection should include the corrective actions taken by the QAPI committee to achieve improvement (i.e., staff training, revision in procedure).
Infection control compliance should be monitored quarterly through an infection control compliance surveillance audit tool. Also, initial, annual, and as-needed infection control training should be documented for all staff.
Delegating authority
The IPC program must be under the direction of a written Governing Body-designated and qualified professional who has IPC training. The ICC must have documented education and ongoing infection control training and may voluntarily opt for certification. Certification in infection control is offered by the Certification Board of Infection Control and Epidemiology and the Board of Ambulatory Surgery Certification. The ICC should be a confident communicator and leader, ethical, knowledgeable, detail-oriented, organized, and a critical thinker.
The Governing Body maintains accountability for and direct oversight over the ASC’s QAPI program. The IPC program is a required component of the QAPI program. The QAPI program must be well defined, establish priorities and include mechanisms for evaluation, and specify data collection methods, frequency, and type. These functions are documented in QAPI and Governing Body meeting minutes. Quarterly QAPI meeting minutes should include analysis of the required documentation and these minutes should be provided to the Governing Body for formal review and approval, at least annually. The Governing Body should conduct a documented formal annual appraisal of the effectiveness of the QAPI program, which must include the IPC program.
Staying up to date on regulations and standards
ASC regulations, standards, and best practices are a moving target. For example, in June 2022, Medicare provided the explanation that multi-dose eyedrop bottles are not subject to the injection practices standards associated with multi-dose vials, discarding within 28-days of opening and upon entering an immediate patient care area. In August 2023, ANSI / AAMI released a new standard on water quality, the ST108:2023 Water for the processing of medical devices, which provides water quality testing specifications for utility, critical, and steam water used in instrument processing. Most recently, in November 2023, the USP updated the <797>, providing revised immediate-use provisions for sterile preparations, including extending the maximum preparation to administration timeframe from 1 hour to 4 hours, and highlighting the importance of documented training and competency for staff using aseptic technique.
An important and less obvious component of the IPC program is ventilation and maintaining safe air handling systems in operating rooms. Contracting with an HVAC vendor that has healthcare environment experience is critical. Requirements go well beyond documenting temperature and humidity in the operating rooms and include minimum total air exchanges per hour and pressure relationships to adjacent areas. CDC, ANSI, ASHRAE, and ASHE guidelines state that HVAC design parameters for an operating room should accomplish 20 total air exchanges per hour, maintain a temperature of 68-75°F, humidity of 20-60%, and a positive pressure relationship to adjacent areas.
Using resources
The requirements of the IPC program are provided by Medicare in Conditions for Coverage sections §416.43 Quality Assessment and Performance Improvement and §416.51 Infection Control. ASCs are also encouraged to use Medicare Exhibit 351 ASC Infection Control Surveyor Worksheet to conduct a self-assessment for compliance with the Medicare regulations. Finally, facilities should review their state regulations and accrediting organization standards to confirm there aren’t any additional mandates that supersede Medicare requirements.
Conclusion
As you set out for IPC program success, remember this program must be ongoing and data-driven. Track and trend information collected monthly to determine which areas of the program are functioning well and which require your attention. The tools used to accomplish this don’t have to be lengthy or complex — they just have to exist and show the ongoing efforts set forth to keep patients safe and free from infection.
The IPC has a great deal of requirements and moving parts, but translating those into meaningful action items is where the rubber meets the road. Don’t just collect the data — do something with it to continue to drive performance and quality in your ASC. OP
