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.
The duodenoscope situation is part of a larger focus by the sterile processing and central service community on quality improvement. Steve Adams, RN, BA, CRCST, IAHCSMM president-elect and nurse manager of sterile processing at Greater Baltimore Medical Center, says there are numerous issues that hospitals need to address in relation to their CS departments, including general knowledge about the responsibility and role of the CS department in a hospital setting. “It is unfortunate to say, but not all hospital executive leadership teams, physicians and hospital staff have a good understanding of the role that a CS department truly plays in the daily operations of the facility,” Adams says. “When asked, most individuals may be able to tell you that CS is a department in the basement, a non-revenue-generating department on the balance sheet and, perhaps, the department that takes care of the instruments and supplies. Most hospital personnel have no idea about the numerous steps and critical attention to detail that the CS staff must commit to when performing the steps of cleaning, decontamination, inspection, assembly, packaging, sterilization, storage and provision of supplies. I am also not convinced, unless a facility has experienced issues that would stop CS operations, that many individuals realize how many different areas of the hospital are affected by the CS department. CS leaders need to reach out to their hospital administrators, OR teams and other customer departments. CS leaders need to explain the critical nature of their department and the direct impact we have on providing safe patient care.”
Adams points to CS departmental practices as another area of concern. “We have to ask if our hospital administrators are confident that the CS department is following the most current standards, guidelines and recommended practices from AAMI, AORN, SGNA, APIC, the Joint Commission, etc.,” he says. “CS departments should be assessed to ensure that best practices are in place (not only to be compliant, but most importantly, to ensure that the patients and hospital personnel are safe). Poor and sloppy practices in the CS department can lead to widespread cross contamination very quickly. A good working relationship with Infection prevention personnel and CS leadership will help alleviate concerns and improve confidence.
He adds that the needs of CS personnel should be addressed as well. “Typically, when we speak about staffing, many CS personnel will immediately indicate they are overworked and underappreciated. I think most professional staff in any line of work would easily state the same concerns. Although these are important not to overlook, there are many other characteristics that define CS personnel.”
Adams continues, “First and foremost, each team member’s work ethic should be assessed. Human resources and CS managers should work closely when reviewing and interviewing new candidates for hire. If an individual does not exhibit the characteristics needed to help make the CS department and organization, as a whole, successful, then it’s time to move on to another candidate. Current staff should also be assessed to ensure they are still engaged. Secondly, what education and training does each CS team member have? Today’s CS departments can no longer support hiring individuals without some classroom training about CS. On-the-job training isn’t enough. This profession has become so much more technical than in years past. No longer are CS technicians only preparing the basic scissor, clamp and needle holder for surgery, but they are working with instruments across every service line that support this high-tech age of minimally invasive surgery. Manufacturers’ instructions for use (IFU) need to be followed in order to properly handle, inspect and process these items for surgery.”
Adams emphasizes that CS technicians must be certified in their profession. “Certification is a measure of acquired baseline knowledge, but maintaining certification also requires technicians to engage in continuing education to keep current with changing practices and trends. Keep in mind, as quickly as surgical techniques change is as quick as the CS technicians need to change and adjust to the new instruments that support these new techniques. Lastly, departments need to be assessed for appropriate staffing levels. Hospital administrators need to understand the time and attention to detail required to process surgical instruments correctly. There are CS technicians who will tell you they can assemble a major orthopedic or spine set in two to five minutes. Frankly, I would not want that set used on my loved ones. Some of these ortho and spine sets may have well over 100 instruments. At best, each instrument only gets a quick three-second glance. Is that instrument properly inspected, checked for cleanliness and functionality in a three-second glance? Probably not. Having your CSP staff rush their work and expect 100 percent error-free results is not going to happen. The CS team must have enough time to perform their job tasks in a way that aligns with IFU, standards, requirements and best practices to produce high-quality sets.”
Adequate resourcing is high on the list of priorities, according to Adams, who explains, “CS departments need to have the proper tools and equipment to perform their job properly. This departments’ major equipment is typically expensive and requires planning to acquire as part of the budgeting process. Major equipment, such as washers, ultrasonic cleaners and sterilizers, should be up to date and well maintained. There should also be strong service support so broken equipment is not out of service for long periods of time. Service personnel also need to provide ongoing education to the CS staff. Other daily supplies, such as brushes, cleaning chemistries, biological and chemical indicators, and many others, need to be selected based on the needs and services provided, ease of use by staff and, of course, cost (supplies should not, however, be chosen based on cost alone or what is used by other facilities). Every department is unique in regard to water and steam quality, for example, which will have an impact on outcomes.”
However, the best equipped departments can’t operate at peak performance with collaborative relationships between CS and end-user departments, Adams says. “The last thing we need are adversarial relationships between CS and any department it provides its services. Hospitals need to ensure that there is a healthy working relationship between CS and their customers. For some reason, the OR and CS have had a history of poor working relationships and typically point the finger at each other to place blame. This is, fortunately, not the case in all facilities, but even those that have good working relationships are sometimes challenged to effectively maintain those relationships. All efforts need to be made to partner and share experiences that both departments can learn from and work to make improvements. Teamwork is so important in order to achieve consistent positive outcomes for the surgical patients. Both CS and end user departments need to put differences aside and always place the patient first. If we place ourselves in the shoes of the patients, it’s amazing how quickly we can change our perceptions.”
Adams adds, “The important take away is that the CS staff overall are people that really care about their jobs and want to do what is best for patient safety at all times. Effective teamwork and communication, and the availability of vital resources for the staff, can lead to a very productive CS department that offers the highest quality of care to patients.”
The CRE outbreaks related to poorly reprocessed instruments and scopes highlight the need for a national agenda for improving practice in the CS/SPD as well as improvement efforts at the institutional level. “Based upon the CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices, I believe it will be important for sterile processing departments to take a good look at their practices, as well as the information they have internally on training and competencies,” says Mark Duro, CRCST, FCS, the CS manager at New England Baptist Hospital in Boston, chairman of IAHCSMM’s Orthopedic Council and an IAHCSMM executive board member. “This CDC/FDA health alert really focuses on training, education and competencies, as well as having and following device manufacturers’ instructions for use. To improve our processes, sterile processing must be able to comply with IFU, standards and requirements; however, in many cases, sterile processing departments aren’t able to do so. The use of IFU just became hot within the last 10 years and even hotter in the last three to five years. Many reprocessing departments are working with equipment and work spaces that are far older than that. Moving forward, there may need to be an emphasis on departmental capacity and available reprocessing technologies.”
Many experts in the sterile processing and CS communities believe that certification of technicians can help address underperformance that can lead to breaches in protocol and best practices. Josephine Colacci, JD, the government affairs director of IAHCSMM, reviews the organization’s ongoing efforts to champion certification. “Our Connecticut certification legislation became law this year, and we will continue to focus our legislative efforts in the northeastern part of the country. Currently, we have legislation pending in Massachusetts and Pennsylvania. Massachusetts and Pennsylvania run on two-year legislative cycles, which means they start their legislative session in January 2015 and end in December 2016.”
Colacci continues, “Our Massachusetts legislation had a Joint Public Health Committee hearing in September 2015, where the committee took public testimony on our issue. IAHCSMM members and I testified before the committee. This committee has until March 2016 to pass the bill. If we are successful in passing out of the Joint Public Health Committee, then we may have to go through three more committees. We have been working on our Pennsylvania bill since 2011 and have not been successful in moving the bill forward. In October 2015, IAHCSMM hired a lobbyist to help better position our bill. I, along with IAHCSMM members, have been meeting with legislators to educate on the issue in hopes of getting a House Health Committee hearing. For 2016, we will continue to work on Massachusetts and Pennsylvania. We will not introduce any new states for 2016; however, we will begin discussing our issue with Rhode Island legislators during 2016 in hopes of introducing legislation in Rhode Island in 2017.
Duro says he was able to witness the Connecticut governor’s bill-signing ceremony: “A lot of time and effort was put in by the Connecticut group and Josephine Colacci to make this happen, and their success should be applauded,” he says. “In Massachusetts, I and other members of the Massachusetts chapter testified alongside Karen Nauss and Colacci at the state house. Legislatively, it is important that we continue to work on this certification issue on a state by state basis. We must pursue required certification of CS technicians to ensure all healthcare facilities have well-educated, trained and competent reprocessing professionals to serve our healthcare customers and patients. Patient safety is at the very heart of these legislative initiatives.”
IAHCSMM is joined by other associations in watching the reprocessing issues carefully. “We’re noticing that disinfection and sterilization of instruments and medical devices seems to be rising to the top of the healthcare priority list of issues by continuing to be spotlighted when outbreaks occur,” says APIC’s Hailpern. “The FDA and others are looking at that issue closely and it will continue to be a big issue because it’s worrisome to all healthcare stakeholders.”
Terri Link, MPH, RN, CNOR, CIC, product manager of Guideline Essentials for the Association of periOperative Registered Nurses (AORN), says that device-related infections is one of the top issues of concern, adding that the organization is in the process of finalizing a guideline for flexible endoscopes. “We must not only look at processes and manufacturers’ instructions for use, but validating of the cleaning process — we must have proof that it works before we select a product or train personnel on how to perform the cleaning and disinfection processes. In addition, facilities may use automated endoscope reprocessors (AERS) that have their own, additional manufacturers’ instructions for use, and we must make sure that they all work together.”
Link emphasizes that proper reprocessing is a shared responsibility among OR nurses and other healthcare stakeholders. “It’s not just nurses, but also techs, IPs, manufacturers, organizations — we are all challenged equally to get it right,” she says. It also requires effective resource management and skillfully making the business case for resourcing needs to the institution’s C-suite. “It’s a challenge to be able to present a compelling business case so that you can get the right equipment and personnel needed,” Link says. “Education and training of personnel have a direct impact on care outcomes — we can’t expect performance by staff if people don’t get the appropriate training and support they need to succeed.”
AORN offers a number of tools and resources for its members, including its AORN Guidelines and Tools for the Sterile Processing Team, that may be helpful for improving sterile processing performance. AORN also offers Guidelines Essentials developed by Terri Link to help clinicians implement AORN’s guidelines. These electronic tools are published with each AORN guideline, with seven in place by February 2016, and feature bulleted points and pictures demonstrating key protocols as a handy reference, Link says. There are also gap analysis for facility compliance and audit tools to help evaluate competencies. “We’re very excited about this suite of tools for nurse managers and educators,” Link says.
Cleaning and disinfection isn’t limited to devices and instruments; Link emphasizes that perioperative nurses need to continue to work with IPs in addressing the importance of the role of the environment and disinfection of high-touch surfaces. “We have to be looking more closely at not just how we clean but what we are using to clean with and the training involved, as well as issues such as disinfectant dwell time,” Link says. “We also must examine the knowledge and implementation gaps that exist and ensure personnel use tools such as checklists, or perform cleaning monitoring and feedback to determine if surfaces have been cleaned because they are significant reservoirs of contamination.”
Link says negative outcomes such as device-related infections are learning tools. “I think we have learned so much this year and although there have been a lot of alarming things that have happened, such as the CRE outbreaks related to endoscopes, the positive thing about it is that we now know about it and we can act on it, and learn from when bad things happen and help us do better. The takeaway message is the importance of getting back to basics on principles of cleaning, disinfection and hand hygiene — these are not new concepts but we must make sure we do them right.”
Policy and Regulatory Issues
Infection prevention as a condition of participation for Medicare is heating up in several healthcare sectors and should play a major role in shaping care in years to come.
A proposal announced last July at the White House Conference on Aging would make major changes to improve the care and safety of the nearly 1.5 million residents in the more than 15,000 long-term care facilities (LTCFs) or nursing homes that participate in the Medicare and Medicaid programs. If finalized, unnecessary hospital readmissions and infections would be reduced, quality of care increased, and safety measures strengthened for the more than 1 million residents in these facilities. Many of the proposals build on improvements that nursing homes have already made since 1991, the last time these conditions of participation were comprehensively updated. This rule would bring these best practices for resident care to all facilities that participate in Medicare or Medicaid and implement a number of important safeguards that have been identified by patient advocates and other stakeholders, and include additional protections required by the Affordable Care Act. Changes include:
- Updating the nursing home’s infection prevention and control program, including requiring an infection prevention and control officer, and an antibiotic stewardship program that includes antibiotic use protocols and a system to monitor antibiotic use.
- Making sure that nursing home staff is properly trained on caring for residents with dementia and in preventing elder abuse.
- Ensuring that nursing homes to take into consideration the health of residents when making decisions on the kinds and levels of staffing a facility needs to properly take care of its residents.
- Ensuring that staff members have the right skill sets and competencies to provide person-centered care to residents. The care plan developed will take the resident’s goals of care and preferences into consideration.
- Improving care planning, including discharge planning for all residents with involvement of the facility’s interdisciplinary team and consideration of the caregiver’s capacity.
The Centers for Medicare & Medicaid Services (CMS) published its recommended reforms in proposed rule CMS-3260-P, in the July 16, 2015 Federal Register.
APIC’s Hailpern says she is seeing a number of issues related to transitions of care. “We had the CMS proposed rule revising the long-term care requirements, and just recently CMS put out a proposed rule on discharge planning. In addition, the Agency for Healthcare Research and Quality (AHRQ) recently released a draft technical brief on patient care in nursing homes for comment recently, and the National Quality Forum featured discharge planning issues in their care coordination measures report. I think as CMS continues to move toward pay for performance, the continuum of care is going to be a bigger issue.”
Hailpern says alternative-care settings will continue to receive more attention from CMS and other organizations. “We are seeing many more places where infection prevention is needed and this deficit is being noticed,” she says. As we see more emphasis on infection prevention and control in more alternative-care settings, there will be a greater realization that more people are needed to do it — what we’re hoping is that it doesn’t take tragedies before facilities realize they need to better resource their programs. Hopefully they will realize this is part of healthcare regulation and other requirements coming up from accrediting organizations and federal entities. We must continue to have IPs to relay this to administrators so that it is better understood how the role of infection prevention is fitting into the big picture in terms of healthcare payment and reimbursement policies.”
Hailpern adds, “I see infection prevention being inserted into a lot of areas where it previously might not have been. Infection prevention is being thought of not so much as separate but more a part of everything that is going on in healthcare these days, and that is providing us with opportunities to get the word out about what IPs do and the need to better resource them and that infection prevention is a huge part of patient safety and healthcare quality.”
Greene concurs, saying that she thinks proposed conditions for participation for long-term care will gain traction. “Some people are against them primarily because of the costs involved, but aside from that I think we are going to see more traction at a national level in terms of long-term care and infection prevention. Healthcare reform is impacting long-term care through the proposed recommendation to have an infection preventionist whose primary job was infection prevention, but in LTCFs they wear multiple hats — the projected impact from a cost perspective may be prohibitive at this point, but certainly there will be movement. They may be even required to report C. difficile, for example, and maybe some of those outcome metrics may become reportable. We are acting in tandem, in that patients go back and forth from the LTCF to the hospital — I don’t think we have done a very good job at connecting those dots, but as we begin to tackle these things there will be greater transparency than ever before and it will uncover new opportunities in infection prevention and control.”
A move toward even greater levels of reporting will necessitate better resourcing and improved technology, Greene notes. “Lack of appropriate technology is a very big concern, especially as NHSN continues with its plan to transition to algorithmic surveillance in the next five years. I frequently hear that hospitals don’t have the technology support they need and those that do, part of the problem is moving into the many other high-level priorities in healthcare IT. There is much more yet to be done in surveillance and extracting information from the electronic health record, and yet for many organizations, these issues are put on the back burner. For example, when we are required to report the VAE, that’s information that can easily be extracted by electronic systems instead of pulling information manually. But many hospitals aren’t prepared for that.”
Until hospitals catch up on technology, collaboration between IPs and healthcare epidemiologists may be the answer. Dembry emphasizes the value that epidemiologists bring to institutions, including leadership and management skills. “We’re in a unique position where we are kind of responsible for everything and yet we have little to no authority with a lot of responsibility,” Dembry says. “So we have to develop collaborative relationships, solidifying them and then taking them to the next level. We also don’t want to get diluted in all of the healthcare reform pieces, such as pay for performance, value-based purchasing, and the growth of quality initiatives — these all require data collection. So it’s about building teams, strengthening collaboration, trying to build in efficiencies, but also trying to push the agenda of doing what’s right based on the evidence as we know it today, and being guided by science. We do have regulatory aspects, which those aren’t going away and they are only going to grow. What are the areas of gaps and what should we do, and letting people know that may change. We are like consultants, working with multiple stakeholders and trying to achieve consensus.”