By Kelly M. Pyrek
Infection preventionists (IPs) continue to be consumed with keeping up with evolving infection prevention imperatives, according to an online survey conducted by ICT that asked respondents what they believed were the most important issues facing the entire infection prevention and hospital epidemiology community in 2016. Other top issues on their minds for the new year included addressing antibiotic/antimicrobial resistance, advancing quality improvement and patient safety, addressing emerging pathogens and infectious diseases, and evolving the evidence base to answer unresolved issues.
These concerns are shared by a number of experts in infection prevention and hospital epidemiology who have identified priorities that range from domestic to international, and affect the entire healthcare delivery continuum. Let’s explore some of these issues that are on the radar of healthcare stakeholders.
Antibiotic Stewardship and Other Clinical Issues
On June 2, 2015 the Obama Administration convened the Antibiotic Stewardship Forum at the White House to tackle antibiotic resistance with a focus on antibiotic stewardship. As part of the initiative, the Society for Healthcare Epidemiology of America (SHEA) has committed to address needs across all healthcare settings to create, implement and sustain antibiotic stewardship programs through a variety of programming, educational and stakeholder opportunities. Antibiotic stewardship programs and interventions help ensure that patients get the right antibiotics at the right time for the right duration. In addition to improving patient care, there is also potential for significant cost savings.
“We are encouraged that the Administration has taken a proactive role in helping find solutions to stem antibiotic resistance, one of the most pressing issues we face in healthcare,” says Anthony D. Harris, MD, MPH, professor of epidemiology and public health at the University of Maryland School of Medicine.
“Overuse and misuse of antibiotics by healthcare professionals contributes significantly to the problem of antibiotic resistance. A key piece is to launch successful antibiotic stewardship programs, which serve as integrated, coordinated efforts to manage antibiotics across the healthcare spectrum, including hospitals, long-term care institutions, and primary care settings. Leaders of antimicrobial stewardship programs require specific education and training to create programs that are successfully implemented and sustained. Additionally, success lies in creating an overarching culture of understanding where, when and how antibiotics should be used and creating a team available for expert consultation to clarify misunderstandings and direct appropriate use institution-wide.”
Harris adds, “Without real action, antibiotic resistance will continue to threaten patients, increase healthcare costs and eliminate valuable drug interventions setting modern medicine back decades. Healthcare systems must invest in making strong antimicrobial stewardship a way to practice and deliver care based on a team-approach. This is an all-hands-on-deck moment. We all need to unite – public organizations, private entities, academic and research institutions, federal, state and local officials, and patient advocates – to address the issue head on, and implement evidence-based interventions such as stewardship in all clinical settings to improve care and preserve the efficacy of trusted antibiotics.”
For infection preventionists, that message is an essential one for 2016.
“You’d have to be living in a vacuum if you didn’t know that antimicrobial stewardship is a huge issue in healthcare,” says Linda R. Greene, RN, MPS, CIC, manager of infection prevention at Highland Hospital in Rochester, N.Y. and an Association for Professionals in Infection Control and Epidemiology (APIC) board member. “It’s critical that IPs understand and play a role in AS programs in their hospitals. They can assist in many ways, including reporting resistance data, making sure the infection control committee and/or antimicrobial use committee is analyzing that data, and looking beyond traditional surveillance for mandatory reporting.”
Nancy Hailpern, APIC’s regulatory affairs director, confirms that antibiotic stewardship is one of the top issues that APIC is monitoring, and concurs that IPs can assist healthcare stakeholders to better implement and manage these programs in their institutions. “While the actual actions required in antibiotic stewardship is not part of the role of IPs, they have purview over the results when these actions are not taken. What IPs bring to the table is coordination of quality improvement and infection control committees in their facilities which brings everyone together, including pharmacists and physicians. And IPs will remain essential in the planning to ensure that antibiotic stewardship stays at the top of the institutional agenda.”
“All healthcare facilities can improve patient outcomes and antibiotic resistance trends by focusing on efforts to eliminate unnecessary antibiotic therapies and raising the patients’ understanding of this issue,” says Sara Cosgrove, MD, MS, chair of SHEA’s Antimicrobial Stewardship Committee. “Implementing comprehensive programs to help providers optimize antibiotic use across healthcare settings is of great importance. At the same time, we must educate and engage patients in understanding when antibiotics are needed and when they are not.”
Louise-Marie Dembry, MD, MS, MBA, president-elect of SHEA, says that although the tenets of stewardship have been recognized for the last several years, it is only now that the real work has begun on education about antibiotic overuse and misuse, the introduction of strategies such as antibiotic stewardship, expanded surveillance of antibiotic resistance, as well as investment in new drug development and diagnostic testing that can help reverse antibiotic resistance trends. “I think 2015 was still a period of organizing and setting goals, and now we need to start implementing antibiotic stewardship programs on a national level. Not just in all patient-care settings, but AS programs in animal husbandry and agriculture, as antibiotic resistance is an all-encompassing threat.”
Dembry acknowledges the significant workload that AS programs require of hospital staff as well as staff in other patient-care settings, and advises epidemiologists and others to take advantage of the numerous tools, courses and resources offered by SHEA and others. “Networking also helps,” she says. “Set reasonable goals at the local level, and have plans how to reach them. Engage leadership as well. If the program is struggling, assess the barriers, as maybe the program took on too much too soon. Define what you want the AS program to focus on, such as vulnerable or problem areas, examine what resources you have and start setting up those priorities of what you can address, how you address them, and a collaborative strategy all the way from administration to the bedside. It’s admirable to have big goals for an AS program but take it in increments — go after the low-hanging fruit, get some wins, get people excited and on board and then you can start looking at the program elements that are more challenging. Keep forging ahead, be tenacious. It takes time, so set priorities, have reasonable timelines and agreed-upon metrics, measure them, and circle back when things aren’t working and don’t wait too long to do that. You want to intervene quickly if things aren’t working.”
AS programs at the local and national levels require additional resourcing and funding, so the passage of the Bipartisan Budget Act of 2015 by Congress in November was considered to be a step in the right direction by healthcare experts. The compromised budget is a critical step toward allowing Congress to complete work on fiscal year (FY) 2016 appropriations bills and reinvest in public health and health research that directly influence the lives of all Americans. SHEA says the funding increases will address key issues for its members by providing support for programs on healthcare-associated infections, infection prevention, and antibiotic stewardship to improve patient outcomes. Additionally, the budget will support programs on disease prevention; as well as build a national healthcare outbreak response infrastructure; educate the next generation of scientists, healthcare providers, and public health professionals; develop new cures; improve health workforce training; and more. Even with the successful passage of the Bipartisan Budget Act of 2015, SHEA strongly believes that funding for public health and health research is too low. Current funding remains well below historical levels. SHEA says it is hopeful that the budget sets the stage for more appropriate funding for healthcare programs in FY 2016 and beyond, as lawmakers understand the necessity and value of addressing pressing health issues.
Dembry says she hopes this funding can help researchers address unresolved issues or those requiring more and better evidence from quality studies. “We need to remember that we don’t know everything or have definitive evidence on how to get to zero infections,” she says. “We certainly have clinical interventions we know will help us decrease the risk of infections but to get to zero, there is still much research that has to be conducted. There has been a great deal of focus on antibiotic-resistant organisms and that will and should continue, however there are antibiotic-sensitive organisms that also can cause devastating HAIs, so I think we need to identify the gaps in our knowledge. Some of them are technical and some of them relate to how to implement and sustain those interventions which studies have been shown to be beneficial. There is a difference when one studies an issue in a research setting — which is usually in a relatively confined, controlled environment — as opposed to a real-world setting, and when we try to disseminate that across the spectrum of healthcare delivery, it’s not so easy. So I think those issues focusing on implementation and sustainability are huge for the future. And then there are the things we don’t know, the issues that still generate a lot of questions, such as the use of contact precautions — what really should we do — does one policy fit all, or is a different strategy required in different settings and patient population? Those issues still need to be researched further.”
Dembry points to other research and evidence deficits. “There is the huge issue of high-level disinfection and medical devices. We need more research in order to better understand what we need to do to keep patients safe with each of these devices — for example, do they need to be sterilized or is high-level disinfection (HLD) okay? How do we do HLD — when and with what? Do we need to look at those recommendations further? We have learned some things from outbreaks and other things we have known for a while — the devices are getting increasingly complex and more challenging to reprocess and I think the cleaning and disinfection hasn’t kept pace.”
Another issue is hand hygiene, Dembry says. “What works best, and how do we achieve compliance? To me, the big unanswered question around hand hygiene is how good is good enough — and we may never be able to be answer that question. Do we have to be 100 percent compliant all of the time? Or does it depend on the patient, the organism or the situation?. We don’t know, so we keep pushing for 100 percent and inevitably we are all going to fall short. That’s what we don’t know — should perfection be the goal? It might be, but I don’t think we know that yet.”
A number of experts in the infection prevention and healthcare epidemiology community cited Ebola and other emerging pathogens as a significant ongoing concern for 2016.
“Global threats will still be an issue, along with continued domestic threats,” says Greene. “We learned many things from the MERS outbreak and the Ebola outbreak, including the importance of having our ears to the ground and applying lessons learned from Ebola to other issues and pathogens.”
Dembry concurs, noting, “Many lessons came out of SARs and Ebola but we forget those lessons when those outbreaks go away, issues like PPE and what really do healthcare personnel need in order to be safe. How do we determine that? How do we make it such that they can do their work in this PPE and do it safely? I think we are learning a lot about that through Ebola but I don’t think it is a question that has been completely answered. There will be other infections of high concern, and we never know when the next one will come along.”
These concerns are borne out by the results of a survey of infection preventionists conducted late last year by APIC which delivered both good and bad news about U.S. institutions’ state of readiness. The survey found that healthcare facilities are more prepared to confront Ebola compared to last year, with 9 out of 10 infection control leaders (92 percent) reporting that their facilities are better prepared today than a year ago to receive a patient with a highly lethal infectious disease such as Ebola, but more than half (55 percent) say their facilities have not provided additional resources to support their infection prevention and control programs as a result of the Ebola crisis.
The survey polled APIC members to determine their ongoing needs a year after the first Ebola patient was admitted to a U.S. hospital. Respondents included 981 U.S.-based IPs working in acute-care hospitals. Half of respondents (53 percent) reported that there is fewer than one or just one full-time infection preventionist at their organization. Of these, 45 percent work in facilities with more than 100 beds. As a result of the Ebola crisis, 10 percent of respondents received additional personnel from their facilities, and a third (37 percent) received support for staff training programs on infection control protocols.
“We are encouraged to learn that our members feel their facilities are more prepared to handle patients with highly lethal infectious diseases, and to know that some infection prevention and control departments have obtained additional staff and resources,” says Susan Dolan, RN, MS, CIC, president-elect of APIC and hospital epidemiologist at Children’s Hospital Colorado. “But with the ongoing threat of emerging infectious diseases and antibiotic-resistant organisms, we remain concerned that many facilities are lagging behind in providing adequate support to protect patients and healthcare workers. We urge healthcare leaders to assess the needs of their infection prevention programs and dedicate the necessary staff, training, and technology resources to this critical area.”
Dolan adds, “Compared to last year, most of the IPs told us their facilities were more prepared this year, however, when you actually look at the question of how prepared they are, the majority felt they weren’t well prepared. I think Ebola raised awareness of the need to be prepared, and some IPs did actually receive additional resources — at least that’s a start. The majority did not receive additional resources and that’s an opportunity for healthcare leaders and administrators to reach out to their IPs and see what is needed in their institution’s infection prevention and control program in terms of resources. They need to assess staffing, training and PPE needs with the IPC team. I was struck by the data that showed that 1 in 4 IPs felt they did not have enough PPE in their facility to meet the CDC guidelines for Ebola care. If you are trying to impact patient safety and you don’t have the PPE you need, how do you develop staff trust about having adequate protection?”
Dolan emphasizes that the survey shined a spotlight on the resources that are needed to maintain institutional preparedness, adding that healthcare professionals have valuable take-away lessons from the H1N1 pandemic and the Ebola outbreak. “During both events there was a big burst of energy and a lot of activity, but we have to stop and reflect on what these events taught us — not only do we need to be prepared for future threats, but we have to use it as a great opportunity to return to the basics of how to put on and take off your PPE and how to perform adequate travel and symptom screening with each patient encounter,” she says. “HAI prevention is an everyday priority, so I think we need to utilize those moments to really ingrain in staff the infection control priorities. We need to develop and maintain a system not just for initial training of new employees, but for ongoing training of existing personnel because these are skill sets that can be used every single day.”
Training was a priority identified by IPs in the survey, with almost two-thirds of respondents (62 percent) reporting that they are continuing to educate and train staff on the management of patients with Ebola. But without resources, that readiness will erode.
“One of the things the survey did show was the number of IPs that could not continue to do ongoing training for PPE,” Dolan says. “That’s concerning — if you can’t maintain the training, then you are not going to be in a ready state when the next event occurs, or you won’t consistently be using the processes needed on a daily basis to fight HAIs.”
Dolan adds, “IPs can use the survey data to show members of their institution’s C-suite that they are still not where they need to be in terms of resources that are necessary in order to not only implement day-to-day HAI prevention efforts but to be in a ready state to deal with future serious emerging threats.”
“Though progress has been made toward addressing unanticipated, deadly threats like Ebola, there is still more to do to address infection prevention programs overall,” says Katrina Crist, MBA, CAE, chief executive officer of APIC. “We can’t wait for the next crisis to get ready. APIC recently undertook a ‘mega survey’ of the infection preventionist profession and looks forward to sharing key data in 2016 to better inform the dialogue about infection prevention staffing and resource levels.”
Dolan concurs. “The mega survey should highlight these issues for us and inform the industry on what exactly an IPC program needs and will be a perfect complement when an IP approaches his or her C-suite to present a business case for future program plans and additional resources. Infrastructure is critical as we face both continued emerging threats and current day-to-day HAI prevention and research efforts.
According to the Ebola survey, 34 percent of respondents say their facilities have made a commitment to providing additional infection prevention and control resources as a result of the Ebola crisis, while 55 percent say their institutions have not and 11 percent were unsure. For those who did secure a commitment, assistance came in the form of additional personnel, additional resources to train healthcare workers to prepare for potential Ebola patients and others with highly lethal infectious diseases, as well as technology and equipment (such as infection surveillance, tracking, and monitoring technology to ease the surveillance burden).
Dolan points to the survey data on the low number of IPs per facility versus the number of beds in the institution, and how it can impact surveillance and readiness. “When you see that there was just one IP in a facility with more than 100 beds, you immediately think of the usual IP work-load, the regulatory requirements involved with surveillance and required reporting, and then these emerging threats on top of it. Many IPs don’t have enough time to be out on the front lines, observing and educating personnel, assessing for areas that are not in compliance, sharing best practices, and looking for gaps where an organization could maybe drive the data that is still lacking. There are multiple things that IPs need to be doing and then we put Ebola or the next emerging threat on top of it, and you can see how this important work can be negatively impacted. We need to have staff maintaining competency in the basics of PPE and develop process for assessing those competencies regularly. Developing program consistency and stability is essential to ensure future infection prevention program reliability, as we cannot always accurately predict when the next event will arrive and we need staff to be prepared.”
Outbreak concerns of another kind were building here in the U.S. the last several years, capitulating in a widely publicized outbreak when major healthcare systems in around the country acknowledged patient deaths from Carbapenem-resistant Enterobacteriaceae (CRE) caused by improperly cleaned and disinfected duodenoscopes. Recent media reports described instances of patients being notified that they may be at increased risk for infection due to lapses in basic cleaning, disinfection, and sterilization of medical devices. These events involved failures to follow manufacturers’ reprocessing instructions for critical and semi-critical items and highlight the need for healthcare facilities to review policies and procedures that protect patients.
Outbreaks of CRE infections related to improperly reprocessed endoscopes drove headlines for much of 2014 and 2015, leading the ECRI Institute to identify this issue as No. 1 on its 2016 Technology Hazards List, an annual list of top 10 health technology hazards created to help hospitals prioritize technology safety efforts that warrant their attention and to reduce risks to patients. The fatal CRE infections, combined with ECRI Institute’s own studies into endoscope cleaning and disinfection practices, prompted ECRI safety engineers to elevate flexible endoscope reprocessing to the top of the 2016 list. This year’s top hazard specifically addresses the need to adequately clean flexible endoscopes before disinfection to help prevent the spread of deadly pathogens.
The CDC issued several alerts stemming from the CRE infections, including the admonition that “Healthcare facilities should arrange for a healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer.” The CDC outlined imperatives related to training, auditing and feedback, and infection control protocols.
The FDA issued alerts of its own after undertaking a comprehensive investigation into infections associated with reprocessed reusable medical devices, working with federal partners, manufacturers, and other stakeholders to better understand the critical factors contributing to device-associated patient infection and how to best mitigate them. Last March, the FDA issued a guidance document, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” that included recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices. Also in March, the CDC developed an interim protocol for facilities that wanted to test their duodenoscopes for contamination with bacteria, including CRE, after the cleaning and disinfection process.