In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards
Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP
Article Posted 14 April 2023
In 2014 CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals increase infection cure rates while reducing treatment failures, C. difficile infection, adverse effects, antibiotic resistance, hospital costs, and hospital length of stay. In the time since the Core Elements were released, institutional leaders quickly became familiar with them, as they were a focus for the first regulatory standards on antimicrobial stewardship by The Joint Commission (MM.09.01.01), which went live in January of 2017. As a matter of fact, many stewardship programs have maintained a regulatory preparedness binder that is divided into the sections of the Core Elements, which has served many people well in ensuring compliance with these initial standards.
In the same year the initial Core Elements were published, President Obama released executive order 13676, which established an interagency Taskforce on Combating Antimicrobial Resistant Bacteria. Today this Taskforce is known as The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, or PACCARB. PACCARB provides advice, information, and recommendations to the Health and Human Services Secretary (HHS) regarding programs and policies intended to support and evaluate the implementation of U.S. government activities related to combating antibiotic-resistant bacteria.
Among other things, PACCARB was initially charged with developing a 5-year National Action Plan for the President outlining specific actions to be taken to facilitate the monitoring and implementation of a National Strategy for Combating Antibiotic-Resistant Bacteria. In 2015 a National Action Plan for Combating Antibiotic Resistant Bacteria was released, known as CARB. The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. CARB implements the National Strategy for Combating Antibiotic-Resistance Bacteria, which is released periodically by The White House.
CARB sets forth goals that identify governmental response plans to the problem of antimicrobial resistance. Within the goals are more granular objectives. CARB’s objectives flag various federal departments and agencies which are responsible for assisting with reporting on progress. The regulatory body the Center for Medicare and Medicaid Services (CMS) is one of these departments. CMS is flagged for 7 different objectives, the details are as follows and often they are not the only agency listed.
- Goal 1, Objective 2.2: Develop new or expanded educational training guidelines, outreach, and awareness activities to educate stakeholders, such as consumers, healthcare providers, and industries, on best practices for using antibiotics responsibly, stopping the spread of antibiotic resistance, and preventing infections.
- CMS is charged with increasing and expanding outreach activities each year
- Goal 1, Objective 3.3: Support national and State policies that improve the use of antibiotics across healthcare settings and communities.
- CMS is charged to develop and optimize interpretative guidance for the antibiotic stewardship requirements within the conditions of participation for Medicare and Medicaid programs.
- Goal 1, Objective 4.1: Support further prevention of healthcare-associated infections (HAIs) prioritized in the National HAI Action Plan.
- CMS is charged with helping to meet the targets of the National HAI Action Plan
- Note: In the National HAI Action Plan, Phase 4 is focused on antimicrobial stewardship.
- Goal 1, Objectives 4.2: Support national and State policies to help prevent HAIs and stop the spread of antibiotic resistance within and between settings and communities.
- CMS is charged to develop and optimize guidance for improving infection control standards across healthcare settings.
- Goal 2, Objective 3.1: Expand the number of sources for and quantity of antibiotic resistance surveillance data collected from inpatient healthcare facilities.
- CMS is charged to explore interagency collaborations to examine options for increased reporting to the CDC National Healthcare Safety Network (NHSN) Antibiotic Resistance Option.
- Goal 2, Objective 4.1: Expand the number of sources for and quantity of surveillance data on the use of antibiotics from inpatient and outpatient healthcare facilities to improve understanding and implementation of the optimal use of antibiotics.
- CMS is charged to explore interagency collaborations to examine options for increased reporting to the CDC National Healthcare Safety Network (NHSN) Antibiotic Resistance Option.
- Goal 4, Objective 4.2: Examine changes in new technology add-on payments under the CMS Inpatient Prospective Payment System (IPPS) Final Rules, starting with the FY 2020 IPPS/long- term care hospital prospective payment system final rule, to inform potential additional actions.
- CMS is charged to report the number of applications, approvals, and renewals for new technology add-on payments and the estimated amount of those payments.
CMS regulations on antimicrobial stewardship for acute care (QSO-22-20-Hospitals) went into effect mid-2022. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023. The numbering on the updated regulations is a bit odd (it doesn’t start at 1), but there are both new and updated items. An important accompanying document for Joint Commission standards are Critical Access Hospital Accreditation Survey Activity Guide, for which the January 2023 guide can be found here. You can also browse the FAQ section of The Joint Commission’s website to find helpful information, searching for “antimicrobial stewardship” as a key term. The Core Elements are an important reference for both regulatory requirements.
Given all of the new and emerging interest in the area of antimicrobial stewardship regulations, I thought it might be nice to attempt to outline where we are today as well as highlight some helpful points and resources. If you got this far you have reviewed some of the former, now let’s dive into the latter. Here are five things to know about antimicrobial stewardship regulatory standards…
1. It is essential to have partnerships between infection prevention and control (IPC) programs, quality assurance performance improvement (QAPI) programs, and antimicrobial stewardship (AS) programs
The Joint Commission may have antimicrobial stewardship listed under a Medication Management standard that is owned by the pharmacy department, but that is not how it is with CMS and expect antibiotic stewardship to be discussed in Joint Commission meetings related to the infection prevention and control programs.
To achieve their goals, CMS needs different hospital IPC, QAPI, and AS programs to work together to address the problem of antimicrobial resistance. Folks from these groups need to be presenting at the same meetings, sharing information, and aligning their work to maximize organizational efficiency. Expect that regulators will want to see collaboration demonstrated and that the members of one program can speak to some of the fundamental work of the others.
I often say “teamwork makes the dream work” and I really believe this is the case with combating antibiotic resistance. For years educational regulators have been pressing for inter-professional education by including it within their standards. It’s no surprise this type of collaboration is also key in practice. For antimicrobial stewardship, inter-professional collaboration is paramount.
This topic alone could be a whole series of blog posts, so I will cut it here, but ask you to consider – should antimicrobial stewardship programs live within pharmacy departments as they so often do today?
2. Not all the experts agree on how to interpret current antimicrobial stewardship regulations
I have listened to several webinars from experts attempting to break down the latest regulations and provide cross-walks on how to prepare to demonstrate adherence to them, but there are some gray areas.
For example, Joint Commission Element of Performance (EP) 15 states “The antibiotic stewardship program documents the evidence-based use of antibiotics in all departments and services of the hospital.” Given that we cannot be everywhere all the time, how can this be demonstrated? My current take on this is that institutions should have system-wide protocols, policies, and guidelines that apply to all areas. They should also be able to demonstrate that the best practices set forth by their stewardship program (based on national standards) are put into place so that they apply in all areas. If there is a particular department or area that the rules of the stewardship program do not apply for, I could see that maybe being an issue on EP15.
Another gray area is with EP 19, which states “The antibiotic stewardship program evaluates adherence (including antibiotic selection and duration of therapy, where applicable) to at least one of the evidence-based guidelines the hospital implements.” What level of detail is needed to satisfy this requirement, what must the scope of such an assessment be, and how often should it be performed? My take on this is that approximately annually hospitals should be performing a medication use evaluation on adherence to a common infectious diseases guideline.
I suppose the ultimate answers will come in time as facilities are surveyed on the new standards.
3. Competency-based training for staff, including medical staff are now included in acute care antimicrobial stewardship regulations from The Joint Commission and Centers for Medicare and Medicaid Services
Education is one thing, competency-based training is another. Depending on the size and scope of an organization, this may be a particularly tall order. If regulators want to see competency training, that would mean they are looking for a skills assessment and not just a passive flyer on antibiotic resistance.
It’s notable that this is also including medical staff, which can be harder cats to herd as compared to pharmacy or nursing staff, as they may not be fully employed by the organization.
I think one key to addressing this standard relates back to point number 1 above. IPC programs are also charged by CMS to have competency-based training. It makes a lot of sense for IPC and AS programs to collaborate and also work with QAPI partners to push out competency-based training for staff.
4. Mandatory reporting to the National Healthcare Safety Network Antibiotic Use and Resistance Module is coming in 2024
The National Healthcare Safety Network (NHSN) Antibiotic Use and Resistance (AUR) Module is an online platform which can capture and summarize information transmitted by participating facilities. These data allow for tracking and trending by the federal government. NHSN can also send helpful benchmark data back to the participating facilities.
Setting up NHSN AUR can require a lot of resources (especially from informatics) and takes time, so this is a task that should not be pushed back until the last minute. If you are not sure about the consequences of not reporting to NHSN AUR, I recommend talking to your colleagues in QAPI to get more information. From what I gather, not reporting can carry a steep financial penalty.
This is a really nice blog post from Nebraska Medicine that gives more details about NHSN AUR. You can learn more about enrolling in NHSN here, but it’s likely your IPC folks are already using NHSN so a phone-a-friend on this one may be the best starting point.
5. Antimicrobial stewardship regulatory standards are not just for acute care
A lot of us get caught up in the hospital side of things, but it is important to note there are also antimicrobial stewardship regulatory standards outside of the hospitals too. COVID-19 wasn’t the only thing to come to us in 2020. The same year, Joint Commission released medication management standards for antimicrobial stewardship in ambulatory health care. They are not as sophisticated as the acute care standards, but they apply to some ambulatory health organizations.
While preparing for those hospital surveys, don’t forget about any regulatory items in other care areas. If working on stewardship in the ambulatory space, a word to the wise is squeeze more out of your acute care efforts by picking projects which meet needs in both areas. Things like fluoroquinolone prescribing, penicillin allergies, and durations of therapy are just a few good examples of topics which touch both areas heavily.
Closing Comments
Antimicrobial stewardship regulatory standards are a bit complicated, but are also a tremendously important topic given this is one of our few ways of fighting the progression of antimicrobial resistance.
In order to achieve success, it is not just important to maintain an awareness of current standards, it is also essential that organizational cultures promote teamwork and communication which can foster the growth of fruitful programs. Indeed, checking the boxes at a regulatory assessment is important, but we must also remember to build programs which truly elevate patient care.
Disclosure: The views and opinions in this article are that of the author and do not necessarily reflect the opinion or policy of any former, current, or potential future employer.
RECOMMENDED TO YOU
