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CMS Finalized New Conditions of Participation for Hospitals and Critical Access Hospitals

On September 30th, 2019, the Center for Medicare and Medicaid Services finalized a new set of Conditions of Participation for hospitals and critical access hospitals (CAH) that were originally proposed in June 2016.  These regulations are intended to ensure hospitals and CAH conform to current practice standards and support improvements in quality of patient care.  As part of this final rule, the requirement for hospitals and CAH to establish antibiotic stewardship program (ASP) was added.  Sections §482.42(b)(1-4), §482.42(c)(1), and §482.42(c)(3) specifically address ASP standards for hospitals. The standards for CAH can be found under Sections §485.640(b)(1-4), §485.640(c)(1), and §482.42(c)(3).

According to the new COP, the facility governing body should appoint individual(s) with education, training, or experience in infectious diseases and/or antimicrobial stewardship as ASP leader(s) based on recommendations from medical staff and pharmacy leadership.  The facility governing body should also ensure that systems are in place to monitor antibiotic use (in addition to infection prevention, control and surveillance activities) in order to demonstrate the implementation, success and sustainability of these activities.  Furthermore, facility leadership should work in collaboration with quality assurance/performance improvement (QAPI) leadership to address antibiotic use issues identified by the ASP.

The responsibilities of ASP leader(s) outlined in the new COP include

  • Development and implementation of facility-wide ASP based on national guidelines to track and improve antibiotic use
  • Documentation of all ASP activities
  • Communication and collaboration with facility medical, nursing and pharmacy leadership, infection prevention and control program, and QAPI program
  • Competency-based training and education on the application of antibiotic stewardship policies and procedures

Under the guidance of facility leadership and ASP leader(s), ASP should

  • Demonstrate coordination with hospital stakeholders (e.g., medical, nursing, pharmacy services) responsible for antibiotic use and resistance
  • Document evidence-based antibiotic use in all departments
  • Document improvements in antibiotic use
  • Follow nationally recognized guidelines and best practices to improve antibiotic use

CMS estimates that leadership from 0.4 full-time equivalent (FTE) of physician and 1.0 FTE of clinical pharmacist (both with the appropriate training and/or experience) are necessary to initiate and maintain an antibiotic stewardship program in an average-sized hospital (~124 beds).  For a 25-bed CAH, CMS estimates that leadership from 0.45 FTE of clinical pharmacist and 0.19 FTE of physician are necessary to initiate and maintain an antibiotic stewardship program in this setting.

This new CMS COP to establish ASP in hospitals and CAH must be implemented by March 30th, 2020.  For additional details, please refer to the new CMS COP.   Be sure to browse the Acute Care Section of this website for free resources for ASP implementation in hospitals and CAH.  Feel free to contact us if you have any questions regarding implementation of ASP in hospitals or CAH.

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