REGULATORY REQUIREMENTS

The Conditions of Participation (CoP) for Center for Medicare and Medicaid Services (CMS) was revised in October 2016 for long-term care facilities (LTCF).  The current regulations require LTCF to develop an Infection Prevention and Control Program (IPCP) that includes an Antimicrobial Stewardship Program (ASP).  The ASP must, at a minimum, includes antibiotic use protocols and a system to monitor antibiotic use.  To view the full updated CoP, visit https://www.gpo.gov/fdsys/pkg/FR-2016-10-04/pdf/2016-23503.pdf.

The interpretive guidance for the new CMS CoP was published on June 30th, 2017.  To view the full document, visit https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html.  The following are excerpts from the 696-page document relevant to ASP in LTCF.

42 CFR 483.80(a)(3)–pertaining to antibiotic stewardship program

Intent of the regulation is to ensure facility

• optimizes treatment of infection through use of protocols
• reduces risk of adverse events from antibiotic use
• monitors facility-wide antibiotic use

ASP should include leadership support and accountability via the participation of

• the medical director
• consulting pharmacist
• nursing
• administrative leadership, and
• individual with designated responsibility for the infection control program if different.

ASP protocols must

• be incorporated in the infection prevention and control program
• be reviewed on an annual basis
• contain a system of reports to monitor antibiotic usage and resistance data
• incorporate monitoring of antibiotic use
• assess residents for suspected infection using standardized tools and criteria
• include mode and frequency of prescribers and nursing education on ASP

Review by surveyor will determine if facility’s ASP includes

• antibiotic use protocol(s) to address antibiotic prescribing practices such as
  • documentation of indication, dose, duration of antibiotic
  • review of laboratory reports to determine if antibiotic is indicated or needs adjustment
  • use of an infection assessment tool or management algorithm
• system to monitor antibiotic use such as
  • antibiotic use reports
  • antibiotic resistance reports