In 2019, CDC advocated more action be taken to protect people from antibiotic resistance threats, reporting at least 2.8 million infections and 35,000 deaths were caused by antibiotic-resistant bacteria in the United States each year. In 2020, CMS acted by overhauling Conditions of Participation §482.42 for acute care hospitals and §485.640 for critical care hospitals. In this article we explore CMS requirements and CDC recommendations for leading a successful antibiotic stewardship program (ASP) to improve antibiotic use.
Appointing a Leader
CMS clearly states, the hospital’s governing body must ensure that an ASP is implemented and operational which includes monitoring and improving antibiotic use. If you are a part of a hospital system, CMS allows for a unified ASP to be implemented at the system level; however, the program must address the unique differences of each hospital individually and demonstrate that the program is managed at each facility. Each individual hospital must also appoint a leader for the program with expertise in infectious diseases and/or antibiotic stewardship. This appointment must be made by the governing body and based on the recommendations of medical staff and pharmacy leadership.
The ASP leader(s) must be an individual (or individuals) who is/are qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship. Training and/or certification may be obtained through the American Board of Internal Medicine (for internists), the American Board of Pediatrics (for pediatricians), and the Society for Infectious Disease Pharmacists (for pharmacists).
It is recommended to appoint co-leaders, such as a physician and pharmacist responsible for program management and outcomes. If a non-physician is the leader of the program, the hospital should designate a physician champion for the program; after all, prescribing practices are a function of the medical staff.
ASP Leadership Responsibilities
The ASP leader(s) is/are responsible for the development and implementation of the overall, hospital-wide antibiotic stewardship program, based on nationally recognized guidelines, to monitor and improve the use of antibiotics. Specific responsibilities include the following:
- Communicate and collaborate with medical staff leadership, pharmacy leadership, and nursing leadership.
- Coordinate with the hospital’s overall Infection Prevention and Control program to address healthcare acquired infections and antibiotic resistance.
- Communicate and collaborate with the hospital’s Quality Assurance and Performance Improvement (QAPI) program.
- Document all program activities which includes documented evidence-based use of antibiotics in all departments and services of the hospital; and any improvements, including sustained improvements in proper antibiotic use.
- Implement policies and activities dictated by a unified system program and communicate activities at their hospital with the system.
- Provide competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the hospital, on the practical applications of antibiotic stewardship guidelines, policies, and procedures.
- Monitor and report the effectiveness of antibiotic stewardship interventions through data collection and analysis.
Establishing Guidelines
Developing and implementing evidence-based, nationally recognized guidelines for the diagnosis and treatment of the hospital’s most common indications for antibiotic use can significantly improve prescribing practices. Facilities are required to develop and implement treatment guidelines that provide recommendations for antibiotic selection and duration of therapy in accordance with nationally recognized antibiotic stewardship guidelines and/or recommendations which include but are not limited to the following:
- The Society for Healthcare Epidemiology of America (SHEA)
- The Infectious Diseases Society of America (IDSA)
- The American Society for Health System Pharmacists (ASHP)
- The Society for Infectious Disease Pharmacists (SIDP).
ASP Education
There must be competency-based training and education of hospital staff, including medical staff, and contracted staff (as applicable) regarding the hospital’s antibiotic stewardship guidelines, policies, and procedures. Survey Tip: Lack of ASP education is becoming a frequent survey finding. Be survey-ready by having documentation of ASP training and education easily accessible to demonstrate compliance.
As for the ASP team, members must maintain ongoing education and training through participation in antibiotic stewardship courses. If you are in need of course suggestions, organizations that provide ongoing training and education include the Society for Healthcare Epidemiology of America (SHEA), and the Infectious Diseases Society of America (IDSA) and the Society for Infectious Disease Pharmacists (SIDP).
ASP Performance Data & Reporting
Prospective review and preauthorization are two popular approaches for improving and tracking antibiotic prescribing practices. Prospective review consists of conducting a review of prescribed antibiotics and use by an expert along with providing suggestions to the prescriber. According to the CDC, prospective review is the most effective approach. Preauthorization requires the prescribers to obtain approval prior to use of certain antibiotics.
Suggested performance measures for antibiotic stewardship include the following:
- Tracking the types and reactions from prospective audit and feedback interventions
- Monitoring conditions and timeliness of preauthorization interventions
- Monitoring adherence to facility-specific treatment guidelines, preferably by provider
- Tracking antibiotic use as days of therapy (DOTs) per days present to monitor antibiotic usage.
ASP Performance data must be shared regularly with the Infection Prevention & Control Committee, report up to the hospital Quality Assurance & Performance Improvement Committee, medical staff, and ultimately to the governing body. Survey Tip: Be survey-ready by having dated excerpts from meeting minutes to substantiate reporting occurs. You may want to consider a committee reporting flow diagram to provide a visualization of how information is shared with the governing body.
References:
1. Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States (2019). Atlanta, GA: U.S. Department of Health and Human Services.
2. Centers for Disease Control and Prevention. (2019). Core Elements of Hospital Antibiotic Stewardship Programs. Atlanta, GA: US Department of Health and Human Services. Retrieved from: cdc.gov
3. Centers for Medicare and Medicaid Services. (2023). State Operations Manual, Appendix A – Survey Protocol, Regulations, and Interpretive Guidelines for Hospitals. Retrieved from
2. Centers for Disease Control and Prevention. (2019). Core Elements of Hospital Antibiotic Stewardship Programs. Atlanta, GA: US Department of Health and Human Services. Retrieved from: cdc.gov
3. Centers for Medicare and Medicaid Services. (2023). State Operations Manual, Appendix A – Survey Protocol, Regulations, and Interpretive Guidelines for Hospitals. Retrieved from