Effective Nov. 28, 2017, all Medicare- and Medicaid-certified nursing homes must have an antibiotic stewardship program that includes antibiotic-use protocols and a system to monitor antibiotic use as part of their infection prevention and control program (IPCP), according to §483.80 (Infection Control) of the Code of Federal Regulations. The antibiotic stewardship program is a component of the Phase 2 rollout of the Reform of Requirements for Long-term Care Facilities, and surveyors will assess compliance with this new requirement of participation under F-tag 881 during the Infection Control Facility Task that is a mandatory part of the new survey process. Note: The F881 interpretive guidance can be found in the advance copy of Appendix PP, “Guidance to Surveyors for Long-term Care Facilities,” of the State Operations Manual.
“The requirement for an antibiotic stewardship program has been incorporated into the infection prevention and control program to combat antibiotic resistance and the 40 to 75 percent of potentially inappropriate antibiotic prescriptions that researchers have estimated,” explain officials with the Centers for Medicare & Medicaid Services (CMS).
The purpose of an antibiotic stewardship program is to ensure that residents are prescribed antibiotics appropriately, say CMS officials. “This means that there is not only an indication for an antibiotic, but also that the correct antibiotic, dose, and duration [were] prescribed. Appropriate antibiotic use reduces the risk of adverse events, including the development of antibiotic-resistant organisms and Clostridium difficile infection [aka C. difficile or CDI].”
The antibiotic stewardship program applies to all antibiotics (i.e., “any dosages in any forms of antibiotics”), say officials. For example, providers need to include ophthalmic and topical antibiotics in the program. However, the regulation is very specific to antibiotics, so providers don’t have to include other antimicrobials such as antifungals or antivirals, they add.
The antibiotic stewardship program, which providers should review as needed but annually at a minimum, must include two core components, according to officials:
1. Antibiotic-use protocols. These must include information about how to identify the presence of an infection, which would be the indication for use, say officials. “The guidance requires that facilities use an infection assessment tool or management algorithm as part of antibiotic-use protocols.” In other words, providers should have a system to assess residents for infection using standardized tools and criteria.
For example, when residents have suspected urinary tract infections (UTIs), facilities must use standardized tools and criteria for making determinations about when to start an antibiotic. With UTI, one standardized tool option would be the Agency for Healthcare Research and Quality’s (AHRQ) Suspected UTI Situation, Background, Assessment, and Request (SBAR) form, say officials.
Additionally, providers may choose to use the Loeb’s minimum criteria for initiating antibiotics for skin and soft-tissue infections, respiratory infections, UTIs, and fever where the focus of infection is unknown, say officials. Note: A two-page pocket reference card with these criteria is available from the Minnesota Antibiotic Resistance Collaborative.
Other options for assistance in developing standardized tools and criteria for antibiotic-use protocols (not all specifically mentioned by CMS officials) include the following tools and toolkits:
· The AHRQ toolkit, Determine Whether It Is Necessary To Treat a Potential Infection With Antibiotics:
o Minimum Criteria for Antibiotics Tool
o Toolkit 1. Suspected UTI SBAR Toolkit
o Toolkit 2. Common Suspected Infections: Communication and Decision-making for Four Infections
o Toolkit 3. Minimum Criteria for Three Infections Toolkit
· INTERACT V4 SBAR communication form and progress note and care paths
“Whatever tools and system are used by nursing homes, antibiotic-use protocols must include review of laboratory reports for susceptibility and also whether there is a need to change the current antibiotic, for example, whether it can be de-escalated to one with a narrower spectrum,” say officials.
2. A system to monitor antibiotic use. “The antibiotic stewardship program must also contain a system of reports related to monitoring antibiotic usage and resistance data with feedback to prescribing providers,” said officials.
A provider’s antibiotic stewardship program needs to have “protocols for how it will assess antibiotic use in its facility,” they explain. “This includes the frequency and mode of review and feedback to providers. Monitoring by the facility may include review of: medical records for compliance with antibiotic-use protocols; laboratory tests ordered and results; prescription documentation, including the indication for use, dosage, and duration; and clinical justification [for] the use of an antibiotic beyond the initial duration order. Other examples of monitoring may include summarizing antibiotic use from pharmacy data, such as the rate of new starts or types of antibiotics prescribed, as well as summarizing antibiotic resistance based on laboratory data and tracking measures of outcomes related to antibiotic use, e.g., infections from Clostridium difficile and multidrug-resistant organisms.”
In addition, the antibiotic stewardship program needs to have education protocols, which include mode and frequency requirements, for educating prescribing clinicians, as well as nursing staff, about the program and its protocols, say officials. Note: For more detailed information about program requirements, see Chart 1, “Antibiotic Stewardship Program Protocols: The Must-Have’s,” at the end of this article. See Chart 2, “The Bottom Line on F881 Noncompliance and Deficiency Examples,” to review the Elements of Noncompliance and examples of deficiency categorizations at all four levels.
Steps to compliance
Once directors of nursing services (DNSs) have read the roughly five pages of interpretive guidance for F881 in Appendix PP, what are the key steps they should prioritize for a compliant antibiotic stewardship program come November? James Marx, PhD, RN, CIC, FAPIC, an infection preventionist with Broad Street Solutions in San Diego, CA, and faculty for the EPI in Long-term Care certificate series offered by the Association for Professionals in Infection Control and Epidemiology (APIC), offers these suggestions:
* Review the Core Elements of Antibiotic Stewardship for Nursing Homes
CMS references the Core Elements toolkit developed by the Centers for Disease Control and Prevention (CDC) in the F881 interpretive guidance. The toolkit defines seven elements that are critical to a successful antibiotic stewardship program (leadership commitment, accountability, drug expertise, action, tracking, reporting, and education) and walks providers through practical ways to implement strategies from each element a step or two at a time.
“There are a lot of great tools here,” stresses Marx. “For example, DNSs can start by conducting a baseline assessment of where they stand using the CDC’s checklist to accomplish the core elements for antibiotic stewardship in nursing homes.”
Note: Within the next few months, CMS is expected to publicly release all facility tasks, including the Infection Control Facility Task, which also could be used to assess facility readiness.
* Seek out expertise
“For the core element of drug expertise, the question the CDC asks is, ‘Does the facility have access to an individual with antibiotic stewardship expertise?’” notes Marx. “That could be a consultant pharmacist, a physician, or someone with specialized training in antibiotic stewardship and practical knowledge on how to oversee and implement programs.”
Having someone with drug expertise on the antibiotic stewardship team is critical, says Marx. “Nursing homes may have to reach outside their normal realm to find that expertise. For example, they may need to partner with hospitals that know how to manage strong antibiotic/antimicrobial stewardship programs. For example, hospitals have antibiotic pharmacists who understand the indications for antibiotic use and potential interactions.”
Another option for finding the required expertise may be to contact the local public health department, he suggests. “Some health departments have epidemiology units that monitor antibiotic resistance and can help providers understand the resistance patterns for very specific problems in their location.”
* Focus on teamwork
In addition to failing to find appropriate expertise, another common mistake nursing homes make is assigning sole responsibility for the antibiotic stewardship program to an individual rather than a team, says Marx. “Often, they even combine the two mistakes, assigning it, for example, to a single nurse who doesn’t have that specific expertise. DNSs need to make sure that the responsibility for antibiotic stewardship is assigned to a team with expertise so that the appropriate protocols, policies, and procedures can be developed and implemented effectively.”
In addition, the F881 interpretive guidance states that, per the CDC’s Core Elements, leadership should be involved in the development of the antibiotic stewardship program to ensure leadership support and accountability. Specifically, the guidance cites “the participation of the medical director, consulting pharmacist, nursing and administrative leadership, and [the] individual with designated responsibility for the infection control program if different.”
* Assess orders for compliance
The F881 investigative summary of the Infection Control Facility Task instructs surveyors to “determine whether the facility’s antibiotic stewardship program includes antibiotic use protocol(s) addressing antibiotic prescribing practices (i.e., documentation of the indication, dose, and duration of the antibiotic; review of laboratory reports to determine if the antibiotic is indicated or needs to be adjusted; an infection assessment tool or management algorithm is used when prescribing) and a system to monitor antibiotic use (i.e., antibiotic use reports, antibiotic resistance reports).”
When it comes to documenting the indication, dose, and duration, “prescribers in nursing homes often fail to write the indication when ordering antibiotics,” says Marx. “Antibiotic stewardship requires the right antibiotic for the right indication at the right dose and the right duration. Knowing the indication is critical to the successful implementation of policies and procedures that fulfill the antibiotic-use protocol requirement, so it’s not enough for the indication to be implied based on laboratory tests and signs and symptoms. The actual order should say what the antibiotic is for.”
* Be sure to address nursing policies
Nurses have a significant role to play in antibiotic stewardship, so DNSs should make sure staff have policies and procedures that implement standardized tools or algorithms as indicated by the F881 interpretive guidance—and that they receive ongoing education on these policies, says Marx. “For example, nurses need to be properly scripted when reporting a change of condition to a physician. It can be time-consuming when a physician doesn’t order an antibiotic right away. Consequently, when nurses think an antibiotic might be warranted, they often steer the physician toward an antibiotic as the first response so they don’t have to make another phone call to the physician if the resident’s condition changes again. So the nurses should be scripted (e.g., with an SBAR), and the prescribing physicians should be familiar with the process so they understand that they may be receiving that second phone call if necessary.”
Another common mistake is not developing a nursing policy for microbiology reports, says Marx. “When nurses receive a microbiology report, they need to understand how to interpret it so they can make sure that it is consistent with the antibiotic that the resident is receiving. In addition, if the antibiotic the resident is receiving isn’t effective in treating that specific organism, there needs to be a process in place to address that with the prescribing clinician.”
* Work on monitoring
The F881 interpretive guidance makes clear the importance of monitoring antibiotic usage and resistance data and using that information to improve prescribing practices, says Marx. “For example, one great way to obtain data about antibiotic resistance patterns is to work with the lab to develop a facility-specific antibiogram, which gives prescribing clinicians information about the typical resistance patterns in the facility for the common causes of issues like urinary tract infections and pneumonia.”
In addition to monitoring use and resistance, it’s also important for providers to monitor for adverse effects that could result from inappropriate antibiotic use, suggests Marx. “This could include monitoring for C. difficile diarrhea, as well as for the potential interaction of antibiotics with the many other medications that nursing home residents take.”
The following resources can help nursing homes develop monitoring reports:
· Appendix B, “Measures of Antibiotic Prescribing, Use, and Outcomes,” of the Core Elements
· The AHRQ toolkit Implement, Monitor, and Sustain an Antimicrobial Stewardship Program:
o Toolkit 1. Start an Antimicrobial Stewardship Program
o Toolkit 2. Monitor and Sustain Stewardship
· The AHRQ toolkit Help Prescribing Clinicians Choose the Right Antibiotic:
o Toolkit 1. Working With a Lab To Improve Antibiotic Prescribing
o Toolkit 2. Using Nursing Home Antibiograms To Choose the Right Antibiotic (Concise Antibiogram Toolkit)
o Toolkit 3. The Nursing Home Antibiogram Program Toolkit: How To Develop and Implement an Antibiogram Program
· The National Nursing Home Quality Improvement Campaign’s C. Difficile and Antibiotic Stewardship resource hub
Editor’s note: Comments from CMS officials come from two sources: (1) the July 25 MLN National Provider Call on the Revised Interpretive Guidance for Nursing Homes and New Survey Process. Access the call slides, as well as the transcription and recording (when available) here, and (2) the surveyor training video Infection Control.
Antibiotic stewardship program protocols: The must-have’s
The antibiotic stewardship program protocols shall describe how the program will be implemented and antibiotic use will be monitored, consequently protocols must:
· Be incorporated in the overall infection prevention and control program;
· Be reviewed on an annual basis and as needed;
· Contain a system of reports related to monitoring antibiotic usage and resistance data. Examples may include the following:
o Summarizing antibiotic use from pharmacy data, such as the rate of new starts, types of antibiotics prescribed, or days of antibiotic treatment per 1,000 resident days;63
o Summarizing antibiotic resistance (e.g., antibiogram) based on laboratory data from, for example, the last 18 months; and/or63
o Tracking measures of outcome surveillance related to antibiotic use (e.g., C. difficile, MRSA, and/or CRE). 63
· Incorporate monitoring of antibiotic use, including the frequency of monitoring/review. Monitor/review when the resident is new to the facility; when a prior resident returns or is transferred from a hospital or other facility 63; during each monthly medication regimen review when the resident has been prescribed or is taking an antibiotic, or any antibiotic regimen review as requested by the QAA committee. In addition, establish the frequency and mode or mechanism of feedback (e.g., verbal, written note in record) to prescribing practitioners regarding antibiotic resistance data, their antibiotic use and their compliance with facility antibiotic use protocols.63 Feedback on prescribing practices and compliance with facility antibiotic use protocols may include information from medical record reviews for new antibiotic starts to determine whether the resident had signs or symptoms of an infection; laboratory tests ordered and the results; prescription documentation including the indication for use (i.e., whether or not an infection or communicable disease has been documented), dosage and duration; and clinical justification for the use of an antibiotic beyond the initial duration ordered such as a review of laboratory reports/cultures in order to determine if the antibiotic remains indicated or if adjustments to therapy should be made (e.g., more narrow spectrum antibiotic);
· Assess residents for any infection using standardized tools and criteria 63 (e.g., SBAR tool for urinary tract infection (UTI) assessment 67, Loeb minimum criteria for initiation of antibiotics 68); and
· Include the mode (e.g., verbal, written, online) and frequency (as determined by the facility) of education for prescribing practitioners and nursing staff on antibiotic use (stewardship) and the facility’s antibiotic use protocols. NOTE: Prescribing practitioners can include attending physicians and non-physician practitioners (NPP) (i.e., nurse practitioners, clinical nurse specialists, and physician assistants).
63 Centers for Disease Control and Prevention. (2015). The core elements of antibiotic stewardship for nursing homes. Accessed on June 9, 2017 from https://www.cdc.gov/longtermcare/prevention/antibioticstewardship.html
67 Agency for Healthcare Research and Quality. (2016). Toolkit 3. Minimum criteria for common infections. Accessed on June 9, 2017 from http://www.ahrq.gov/nhguide/toolkits/determine-whether-to-treat/toolkit3minimum-criteria.html
68 Loeb, M., Brazil, K., Lohfeld, L., McGeer, A., Simor, A., Stevenson, K., Zoutman, D…..Walter, S.D. (2005). Effect of a multifaceted intervention on number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes: Cluster randomised controlled trial. BMJ, 331, 669.
Accessed on June 9, 2017, from http://www.bmj.com/content/bmj/early/2004/12/31/bmj.38602.586343.55.full.pdf.
Source: F881, Appendix PP (advance copy), State Operations Manual.
The bottom line on F881 noncompliance and deficiency examples
KEY ELEMENTS OF NONCOMPLIANCE
To cite deficient practice at F881, the surveyor’s investigation will generally show that the facility failed to do any one or more of the following:
· Develop and implement antibiotic use protocols to address the treatment of infections by ensuring that residents who require antibiotics are prescribed the appropriate antibiotics;
· Develop and implement antibiotic use protocols that address unnecessary or inappropriate antibiotic use thereby reducing the risk of adverse events, including the development of antibiotic-resistant organisms; and/or
· Develop, promote and implement a facility-wide system to monitor the use of antibiotics.
An Example of Severity Level 4 Non-Compliance: Immediate Jeopardy to Resident Health or Safety includes but is not limited to:
• The facility failed to develop and implement an antibiotic use protocol which included reporting results of laboratory data to the ordering practitioner. Medical record review indicated the prescribing practitioner had ordered a culture and sensitivity for a resident and prescribed an antibiotic for treatment of pneumonia prior to receipt of the results of the lab test. The facility received the results of the lab test which indicated that the bacteria was resistant to the antibiotic prescribed, however, they did not provide this information to the practitioner. As a result, the antibiotic was not adjusted accordingly and the resident was hospitalized for complications related to the pneumonia.
An Example of Severity Level 3 Non-Compliance: Actual Harm that is not Immediate Jeopardy includes but is not limited to:
• The facility did not develop a protocol for antibiotic use, and did not develop or implement a system to monitor antibiotic use. Based on record review, two residents were currently being treated with antibiotics without an appropriate indication for use. The two residents had indwelling urinary catheters and were asymptomatic for UTIs. There was no established criteria for use in the facility for when to treat a catheter-associated urinary tract infection. As a result of the antibiotic therapy, the two residents developed numerous watery, foul-smelling stools, elevated temperature, nausea, and decreased appetite. The medical record revealed that stool cultures identified positive bacteria for antibiotic-related colitis (C. difficile). The two residents were treated for antibiotic-related colitis, but did not require hospitalization and fully recovered.
An Example of Severity Level 2 Non-Compliance: No Actual Harm with Potential for more than Minimal Harm that is not Immediate Jeopardy includes but is not limited to:
• The facility failed to implement its protocol for antibiotic use and failed to monitor actual antibiotic use. Record review indicated that the facility developed a protocol which indicated “residents with MDROs are not to be treated with antibiotics for colonization.” However, record review revealed one resident colonized with an MDRO receiving an antibiotic to eliminate colonization. As a result, the potential exists for residents to develop antibiotic resistance.
An Example of Severity Level 1 Non-Compliance: No Actual Harm with Potential for Minimal Harm includes but is not limited to:
• The facility failed to implement their protocol to monitor the rate of new starts of antibiotics monthly. On review, the monitoring was not completed for 6 weeks. There were no findings of increased MDROs or CDI in the facility.
Source: F881, Appendix PP (advance copy), State Operations Manual.
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