By Gary Evans, AHC Media Senior Staff Writer
Infection preventionists have drawn key supporting roles in a proposed rule by CMS requiring antibiotic stewardship programs in hospitals to rein in drug-resistant bacteria and stop the rise of Clostridium difficile.
CMS directly linked infection preventionists to antibiotic stewardship, but called for program leadership at a level comparable with a physician/pharmacist. How big a priority has antibiotic stewardship become? CMS is incorporating the term into its current “infection control” Conditions of Participation (CoP) 482.42. CMS proposes a change to the title of this CoP to “Infection Prevention and Control and Antibiotic Stewardship Programs.”1
“The beauty of that is the incorporation of antimicrobial stewardship and changing the wording to infection ‘prevention’ and control,” says Sue Dolan, RN, MS, CIC, president of the Association for Professionals in Infection Control and Epidemiology (APIC). “They are not mutually exclusive and they shouldn’t be working in silos. They are integral to one another — it’s truly a two-way street. This overall arching theme of having them together and working in sync makes a lot of sense.”
The proposed rule is open for comment until Aug. 15, 2016. (See editor’s note at the end of this story.) As a first step toward regulation requiring antibiotic stewardship, earlier this year CMS sent out a proposed rule calling for hospitals to send their drug utilization and resistance data to the CDC’s National Healthcare Safety Network (NHSN) Antimicrobial Use module.
(https://federalregister.gov/a/2016-09120) CMS will then include the data on its Hospital Inpatient Quality Reporting (IQR) Program.
In addition, the proposed antibiotic stewardship rule would require that the hospital governing body ensure that systems are in place and are operational for the tracking of all infection surveillance, prevention and control, and antibiotic use activities. Moreover, problems identified by the respective programs must be addressed. This section of the rule speaks to the need for resources to fulfill the requirements, meaning antibiotic stewardship should not fall into the dreaded “unfunded mandate” category.
“The APIC public policy committee will be taking a more critical look at the document and providing comments,” Dolan says. “So it is hard for me to predict [APIC’s formal response], but certainly, I can see that there would be a trend toward [program] support for a lot of the recommended changes. We have been working with policy makers to educate them and support funding resources to help with the implementation of such programs, especially those in the NHSN. We need that system so we can have reporting to the antibiotic utilization module and the antibiotic resistance module. These efforts are going to continue on the advocacy side of APIC.”
In addition to antibiotic stewardship, the CMS proposed rule revised and reiterated some of the general requirements for infection control — raising questions by some IPs about whether their duties were being expanded. For example, CMS proposes that the infection preventionists “be responsible for preventing and controlling healthcare-associated infections (HAIs), including auditing of adherence to infection prevention and control policies and procedures by hospital personnel.”
In an early comment to the CMS proposed rule docket, an unidentified IP in Indiana objected to this seemingly perfunctory description to IP duties.
“I don’t think the infection preventionists should be responsible for control and preventing HAIs,” the IP told CMS. “My rationale is that while my title includes the words ‘control’ and ‘prevention,’ I do not work at the patient bedside. It is the healthcare workers who are directly at the bedside that control and prevent infections by their actions. I can create/recommend policies and protocols based on evidence-based practice and I can audit adherence to the policies. The verbiage should be the ‘infection preventionist is responsible for implementing evidenced-based policies and procedures to prevent and control infections, including auditing adherence to the policies and providing feedback to hospital leadership and personnel.’”
Another unidentified IP from Alabama expressed a similar concern in comments submitted on the proposed rule.
“As a busy, dedicated infection preventionist in a large medical center, it is unrealistic to make already overwhelmed IPs responsible for auditing adherence to IP & C policies and procedures by hospital personnel,” the IP wrote in comments to CMS. “We do audits, provide guidance, tools, corrective actions, and standards but ultimately leadership of the multitude of areas should have responsibility auditing adherence. IP & C has a role but should not have primary responsibility since it has no line authority to ensure compliance. The proposed rule refers several times to leadership involvement and responsibility.”
However, an unidentified IP from California, who was among the early commenters on the rule, took the view that CMS was empowering infection prevention programs.
“As an infection preventionist for the past 10 years and certified by CBIC, I have read the proposed rule [and] support it to its fullest,” the IP wrote to CMS. “IPs are constantly requested to provide evidence of rules and regulations when attempting to make a positive impact on preventing HAIs. With antiquated verbiage and lack of regulatory processes it has been a hardship to get the ‘buy-in’ from leadership within the hospitals. This is definitely a great step in the right direction.”
In more specific comment on hand hygiene, an unidentified IP from Kansas said CMS could help IPs and protect patients by specifically banning artificial nails, which can harbor bacteria.
“As an infection preventionist, I know that hand hygiene is the best preventive method to reduce or prevent healthcare-associated infections,” the IP says to CMS. “Unfortunately, the statement that, ‘Hospitals must follow hand hygiene guidance as suggested by the CDC or WHO’ does not help healthcare facilities to enforce [bans of] artificial, gel, acrylic nails or nail polish as the CDC and WHO guidelines are very open to interpretation and outdated. … I feel that it would benefit every patient in the United States and reduce the cost of healthcare if the statement was concrete and stated: ‘Healthcare workers shall not wear artificial, gel, or acrylic fingernails while having direct contact with patients in the healthcare setting.’”
By adding the word “prevention” to the CoP name, CMS is promoting larger, cultural changes in hospitals so “that prevention initiatives are recognized on balance with their current, traditional control efforts,” the agency states. Adding “antibiotic stewardship” to the title emphasizes the important role that hospitals should play in combatting antimicrobial resistance with implementation of a robust stewardship program that follows nationally recognized guidelines for appropriate antibiotic use, CMS explained.
According to CMS, the rule “would require a hospital to develop and maintain an antibiotic stewardship program as an effective means to improve hospital antibiotic-prescribing, [and] curb … potentially life-threatening, antibiotic-resistant infections.” This would promote better alignment of hospital infection control and antibiotic stewardship efforts with nationally recognized guidelines and “heighten the role and accountability of a hospital’s governing body in program implementation and oversight,” CMS states.
As outlined by CMS, the following goals for an antibiotic stewardship program would have to be met:
- Demonstrate coordination among all components of the hospital responsible for antibiotic use and factors that lead to antimicrobial resistance, including, but not limited to, the infection prevention and control program, the Quality Assurance & Performance Improvement (QAPI) program, the medical staff, nursing services, and pharmacy services.
- Document the evidence-based use of antibiotics in all departments and services of the hospital.
- Demonstrate improvements, including sustained improvements, in proper antibiotic use, such as through reductions in C. diff and antibiotic resistance in all departments and services of the hospital.
As proposed in the new CMS rule, IPs would be responsible for the development and implementation of hospitalwide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines.
IPs would also “be responsible for communication and collaboration with the antibiotic stewardship program,” CMS states. “Based on the evidence provided by CDC, IDSA, SHEA, and others, we believe that collaboration between the hospital’s infection prevention and control and antibiotic stewardship programs will provide the optimal approach to reducing HAIs and antibiotic resistance.”
The CMS proposed requirement for leadership responsibilities of a stewardship program calls for “the hospital, with the recommendations of the medical staff leadership and pharmacy leadership, to designate an individual, who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship … who would serve as the counterpart to his or her colleague(s) leading the hospital’s overall infection prevention and control program.”
There was some concern expressed during past discussions of antibiotic stewardship that infection preventionists would be given responsibility beyond their authority, as only physicians can prescribe antibiotics. CMS acknowledges this issue and draws a clear line between infection control and antibiotic stewardship.
“The skills needed to lead each program are different,” CMS states. “Infection prevention programs are often led by nursing staff who do not prescribe antibiotics. Antibiotic stewardship programs are led by physicians and pharmacists who have direct knowledge and experience with antibiotic prescribing.”
The programs have the shared goal of preventing both infections and antibiotic resistance, so “close collaboration” is essential even though each has its own distinct structure and leadership responsibilities, CMS notes. After the rule is finalized, CMS will develop interpretive guidelines to instruct surveyors how to determine hospital compliance.
The responsibilities listed for antibiotic stewardship leadership — and presumably some of these tasks could be done in collaboration with IPs depending on the hospital — include the following
- the development and implementation of a hospitalwide antibiotic stewardship program, based on nationally recognized guidelines, to monitor and improve the use of antibiotics.
- all documentation, written or electronic, of antibiotic stewardship program activities,
- communication and collaboration with medical staff, nursing, and pharmacy leadership, as well as the hospital’s infection prevention and control and Quality Assurance Performance Improvement (QAPI) programs, on antibiotic use issues, and
- the 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.
Barbarians at the Gates
The CMS move to enforce antibiotic stewardship was inevitable given an executive order to do so from the White House last year, which followed the CDC’s increasingly urgent warnings about the looming prospect of untreatable infections. The most recent example came in a CDC alert about a multidrug-resistant fungal infection with high mortality emerging on four continents.2 (See related story in this issue.)
That comes on the heels of the first U.S. case of horizontal genetic transfer of a novel plasmid mcr-1, which confers resistance to the last-line drug colistin in Escherichia coli. Unnecessary and indiscriminate use of antibiotics selects out such strains, a pattern that has been recurring since bacteria resistant to penicillin appeared more than a half-century ago.
“[CMS is] proposing revisions that would require a hospital to develop and maintain an antibiotic stewardship program as an effective means to improve hospital antibiotic-prescribing practices and curb patient risk for possibly deadly C. diff infections, as well as other future, and potentially life-threatening, antibiotic-resistant infections,” the proposed rule states. “We would promote better alignment of a hospital’s infection control and antibiotic stewardship efforts with nationally recognized guidelines and heighten the role and accountability of a hospital’s governing body in program implementation and oversight.”
As part of the antibiotic stewardship program, hospitals would be required to improve their internal coordination among all components responsible for antibiotic use and reducing the development of resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, nursing services, and pharmacy services, CMS states.
CMS aims in the new rule to “enhance the accountability” of hospital leadership for the infection prevention and control and antibiotic stewardship programs. This accountability would extend all the way to the governing body level of the institution. “We wish to promote a hospitalwide culture of safety and quality, and we are proposing these regulatory changes to introduce a catalyst at the leadership level,” CMS states in the rule.
For example, CMS endorsed an Executive Walk Rounds program developed at Brigham & Women’s Hospital in Boston. The goals of the rounds are to ensure safety is a high priority for senior leadership and get information from staff about safety issues.
“In addition to consultation with nursing leadership, we would also require hospital governing body consultation with medical staff, pharmacy leadership, the infection preventionist(s), and the leader of the antibiotic stewardship program,” the CMS rule reads. “We believe these changes would provide hospitals with greater flexibility and open up the process and expand accountability and involvement at all levels.”
In general, infection preventionists and healthcare epidemiologists can provide support and guidance to antibiotic stewardship programs through surveillance for syndromes of interest, implementing interventions to guide the delivery of evidence-based practices, and translating data and infection rates to healthcare workers, nursing units, and administrators, says Dolan, hospital epidemiologist at Children’s Hospital in Aurora, CO.
Frontline interventions can quickly identify multidrug-resistant organisms, but the rigor needed for all steps of the process is immediately underscored.
“Yes, we can provide early identification of organisms, but even before that we need to make sure our staff knows how to get the right specimen and do it properly,” she tells Hospital Infection Control & Prevention. “That’s a huge piece and we can really impact there.”
IP involvement will be critical to get patients into the appropriate level of isolation while drug susceptibilities and resistance factors are determined. Compliance with precautions and core measures like hand hygiene are then important to protect other patients from cross transmission, she notes. IPs could also be involved in using electronic surveillance data to inform risk assessment and action plans, development and implementation of clinical algorithms for treating infections, creation of evidence-based bundles, checklists, and real-time electronic reminders on antibiotic ordering for providers, Dolan explains.
Education is another obvious role for IPs, as they can underscore prudent and appropriate use of antibiotics for providers and explain to consumers and patients when antibiotics are not needed. Though CMS involvement may raise compliance issues and attendant anxieties for IPs, regulations rooted in financial incentives and penalties could also empower infection control to reduce more patient infections and preserve the efficacy of antibiotics. A speaker at the recent APIC conference in Charlotte, NC, observed that IPs were perfectly positioned to join the fight to stave off a post-antibiotic era.
“You appreciate the importance of antibiotic resistance,” says Rita Olans, DNP, RN, CPNP, APRN-BC, assistant professor at the MGH Institute of Health Professions in Boston. “You are used to working the systems using the multidisciplinary linkages that you have created in your hospitals. You know your hospitals. You’re everywhere. You are experienced at operationalizing critical interventions. When do they call you — when there’s a critical need, right?”
Editor’s note: To comment on the CMS proposed rule, refer to file code CMS-3295-P. To submit electronic comments on the CMS regulation, visit http://www.regulations.gov. Follow the “Submit a comment” instructions. Alternatively, you can mail written comments to the following address: entries for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3295-P, P.O. Box 8010, Baltimore, MD 21244. Comments must be received no later than 5 p.m. on August 15, 2016.
- CMS. Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care. Proposed Rule. Fed Reg June 16, 2016: http://1.usa.gov/291FtIc.
- CDC. Global Emergence of Invasive Infections Caused by the Multidrug-Resistant Yeast Candida auris.iJune 24, 2016: http://bit.ly/28ZiJqz.
- McGinn P, Snesrud E, Maybank R, et al. Escherichia coli Harboring mcr-1 and blaCTX-M on a Novel IncF Plasmid: First report of 2 mcr-1 in the USA. Antimicrob Agents Chemother doi:10.1128/AAC.01103-16. Published online May 26, 2016: