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2016 Outlook: The Infection Prevention Imperatives

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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.”

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