The Need for Speed: Infection Prevention is a Quality-Oriented Sport

By Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, CIC, LTC-CIP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the May 2023 issue of Healthcare Hygiene magazine.

Infection prevention and control (IP&C) plays a critical role in healthcare delivery, aiming to minimize the risk of healthcare-associated infections (HAIs) among patients, visitors, and healthcare workers. HAIs are a leading cause of morbidity and mortality, resulting in increased healthcare costs and prolonged hospital stays. As medical professionals, it is crucial to deliver high-quality healthcare, which encompasses preventing and controlling infections. This article will discuss the integration of healthcare quality into IP&C, offering a comprehensive approach to healthcare service improvement.

Healthcare quality encompasses the ability of healthcare providers to deliver safe, effective, patient-centered, timely, efficient, and equitable care. By integrating healthcare quality into IP&C, we can promote a more comprehensive approach to preventing HAIs and delivering excellent patient care.

Patient Safety: Ensuring patient safety is at the heart of healthcare quality. In the context of IP&C, this includes reducing the risk of HAIs, implementing evidence-based practices, and promoting a culture of safety in the setting of a just culture. By integrating IP&C and quality improvement initiatives, we can develop a more effective and systematic approach to preventing infections and improving patient outcomes.
Effectiveness: Integrating healthcare quality into IP&C means using evidence-based practices and guidelines to prevent and control infections. Medical professionals should stay up-to-date with the latest IP&C guidelines and research, such as those provided by the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). This will ensure that the most effective interventions are implemented, ultimately leading to better patient outcomes.
Patient-centeredness: A patient-centered approach to IP&C involves engaging patients, their families, and their caregivers in infection prevention strategies. This includes providing them with information about the risks and benefits of different interventions and involving them in shared decision-making. By focusing on the needs and preferences of patients, we can tailor IP&C efforts to better address their individual needs.
Timeliness: Prompt identification and management of potential infections are crucial in preventing the spread of pathogens within healthcare facilities. Integrating healthcare quality into IP&C involves implementing timely interventions, such as rapid diagnostics and appropriate isolation measures, to minimize the risk of transmission and improve patient outcomes.
Efficiency: By incorporating healthcare quality into IP&C, medical professionals can optimize the use of resources, reduce waste, and enhance the overall efficiency of healthcare delivery. This includes minimizing the overuse and misuse of antibiotics, streamlining IPC processes, and identifying cost-effective interventions.
Equity: Ensuring equitable access to IP&C measures is essential in delivering high-quality healthcare. Integrating healthcare quality into IP&C means addressing disparities in the implementation of IPC interventions, such as access to vaccinations, infection prevention education, and resources for underprivileged populations.

Strategies for Integrating Healthcare Quality into IP&C

To effectively integrate healthcare quality into IP&C, medical professionals should consider implementing the following strategies:

Develop a Multidisciplinary Team: Establish a team of professionals from different disciplines, including physicians, nurses, pharmacists, and infection preventionists, to collaboratively address IP&C and healthcare quality. This team should regularly meet to review IP&C data, discuss best practices, and identify areas for improvement.
Establish a Culture of Continuous Improvement: Encourage a culture of continuous improvement by setting clear expectations, promoting transparency, and fostering open communication about IP&C and healthcare quality. This includes discussing IP&C successes and challenges, learning from errors, and continuously striving to improve processes and outcomes.
Use Data to Drive Improvement: Collect and analyze IP&C data to identify trends and areas for improvement. By using this information to drive change, medical professionals can implement targeted interventions to improve patient outcomes and reduce the risk of HAIs.
Implement Standardized Protocols and Checklists: Develop and implement standardized protocols and checklists for key IP&C practices, such as hand hygiene, surgical site infection prevention, invasive device maintenance bundles and antimicrobial stewardship. These tools can help ensure consistency in IP&C practices across healthcare settings and promote adherence to evidence-based guidelines.
Provide Education and Training: Offer ongoing education and training for healthcare workers on IP&C best practices and the importance of integrating healthcare quality. This includes addressing knowledge gaps, enhancing compliance by ensuring understanding of the why behind recommendations, and fostering a commitment to continuous learning and improvement.
Engage Patients and Families: Involve patients and their families in IP&C efforts by providing them with education about infection prevention and control, their role in preventing infections, and the importance of healthcare quality. Encourage them to ask questions and voice concerns to promote shared decision-making and ensure a patient-centered approach to care.
Utilize Technology: Leverage technology, such as electronic health records and surveillance systems and data analytics, to support IP&C and healthcare quality efforts. These tools can help monitor IP&C performance, identify areas for improvement, and streamline communication among healthcare providers.

Measuring the Impact of Integrating Healthcare Quality into IP&C

To assess the impact of integrating healthcare quality into IPC, medical professionals should measure key performance indicators (KPIs) and outcomes. Examples of these indicators include:

Incidence of HAIs: Monitor the rate of HAIs, such as surgical site infections, catheter-associated urinary tract infections, and ventilator-associated pneumonia. A reduction in HAI rates indicates the success of IP&C efforts and the effectiveness of integrating healthcare quality.
Adherence to IP&C Guidelines: Measure adherence to evidence-based IP&C guidelines and protocols, such as hand hygiene compliance, appropriate use of personal protective equipment, and antimicrobial stewardship. Increased adherence to these practices indicates the successful integration of healthcare quality into IP&C.
Patient Satisfaction: Assess patient satisfaction with IP&C efforts and their overall healthcare experience. High patient satisfaction scores can indicate that IP&C measures are patient-centered and effectively integrated with healthcare quality.
Length of Hospital Stay and Readmission Rates: Monitor the length of hospital stay and readmission rates for patients with HAIs. A decrease in these metrics may suggest that integrating healthcare quality into IP&C has led to improved patient outcomes and more efficient care.
Financial Impact: Evaluate the financial impact of IP&C efforts, including cost savings associated with a reduction in HAIs and the potential decrease in penalties related to poor performance on quality measures. Improved financial outcomes can signal the successful integration of healthcare quality and IP&C.

Integrating healthcare quality into infection prevention and control is essential for medical professionals to provide safe, effective, and patient-centered care. By implementing a multidisciplinary approach, fostering a culture of continuous improvement, and utilizing data-driven strategies, healthcare providers can effectively integrate healthcare quality into their IP&C efforts. Monitoring key performance indicators and outcomes will allow medical professionals to assess the impact of this integration, ultimately leading to improved patient outcomes and a safer healthcare environment. Infection prevention and control is a true team sport that truly executes upon the Institute for Healthcare Improvement Quadruple Aim concept.

Hudson Garrett is president and CEO of Community Health Associates, LLC. He has an appointment as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a Fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com.

The Impetus to Drive Change Across the Healthcare Continuum to Reduce Healthcare-Associated Infections

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, LTC-CIP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the March 2023 issue of Healthcare Hygiene magazine.

In healthcare settings, healthcare-associated infections (HAIs) are a persistent problem, leading to morbidity, mortality, and increased healthcare costs. In order to address this issue, change leadership is needed to promote and implement effective infection control practices. This article will discuss the need for change leadership in reducing HAIs in healthcare, the benefits of effective change leadership, and strategies for implementing change.

HAIs are infections that patients acquire during the course of receiving healthcare treatment, either in a hospital, outpatient clinic, or long-term care facility. They are caused by a variety of pathogens, including bacteria, viruses, and fungi, and can result from a failure to adhere to proper infection control practices. HAIs can lead to prolonged hospital stays, increased healthcare costs, and even death. According to the Centers for Disease Control and Prevention (CDC), HAIs affect 1 in 31 hospital patients and result in an estimated 99,000 deaths each year in the United States alone. These infections are widely recognized as mostly preventable, but the advancement of evidence-based practices to every single patient’s bedside has been a limiting factor for many years for infection preventionists and other patient safety professionals.

Change leadership is necessary to reduce HAIs in healthcare because it involves implementing new practices and processes that will require significant changes to the way healthcare is delivered. Effective change leadership involves engaging and empowering staff members to embrace these changes and take ownership of the new practices. It also involves identifying and addressing the barriers to change, such as lack of resources, resistance to change, and competing priorities.

Effective change leadership can bring about a number of benefits for reducing HAIs in healthcare. First, it can help to establish a culture of safety and accountability within healthcare organizations. When healthcare workers understand the importance of infection control practices and are empowered to take ownership of these practices, they are more likely to adhere to them consistently. This can result in a decrease in the incidence of HAIs.

Second, effective change leadership can help to improve the quality of care that patients receive. When infection control practices are consistently followed, patients are less likely to acquire infections during their hospital stay. This can lead to improved patient outcomes, such as shorter hospital stays, reduced morbidity and mortality, and decreased healthcare costs.

Finally, effective change leadership can lead to improved staff satisfaction and retention. When staff members are engaged in the change process and feel that their input is valued, they are more likely to feel a sense of ownership and commitment to the new practices. This can lead to increased job satisfaction and retention rates.

Implementing change to reduce HAIs in healthcare requires a multifaceted approach that addresses the root causes of these infections. One key strategy is to implement evidence-based infection control practices, such as hand hygiene, environmental cleaning, and appropriate use of personal protective equipment. These practices must be consistently reinforced and monitored in order to ensure adherence.

Another strategy is to provide staff members with the education and resources needed to effectively implement these practices. This may involve providing regular training sessions, disseminating educational materials, and ensuring that staff members have access to the necessary equipment and supplies.

It is also important to engage staff members in the change process by soliciting their input and feedback, and involving them in the development and implementation of new infection control practices. This can help to build a sense of ownership and commitment to the new practices, and can also help to identify and address any barriers to change.

Reducing healthcare-associated infections in healthcare requires effective change leadership. Change leadership can help to establish a culture of safety and accountability, improve the quality of care that patients receive, and improve staff satisfaction and retention. Implementing evidence-based infection control practices, providing staff members with education and resources, and engaging staff members in the change process are key strategies for reducing HAIs in healthcare. By embracing change leadership, healthcare organizations can take a significant step towards improving patient safety and reducing the incidence of HAIs.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, LTC-CIP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE is president and CEO of Community Health Associates, LLC and also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. He is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. He is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com.

A New Era of Healthcare Risk Management Collaboration to Reduce HAIs Across the Continuum of Care

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the February 2023 issue of Healthcare Hygiene magazine.

Infection control is a critical aspect of healthcare delivery, and it is essential that all healthcare providers understand the importance of infection control measures. Healthcare risk management (HRM) plays a significant role in ensuring that the healthcare facilities are providing safe care to patients. Collaboration between infection control and HRM is crucial in developing effective strategies to prevent and control infections in healthcare settings.

Healthcare-associated infections (HAIs) pose a significant risk to healthcare systems. HAIs are infections that patients acquire while receiving treatment for another condition in a healthcare setting. They are caused by bacteria, viruses, or other pathogens and can spread from person to person through contact with contaminated surfaces, medical equipment, or from healthcare workers who carry the pathogens on their hands or clothing.

HAIs can lead to increased patient morbidity and mortality, prolonged hospital stays, and higher healthcare costs. In addition, HAIs can cause patients to have greater trust issues with healthcare providers and can lead to negative publicity for the healthcare system, which can harm its reputation and reduce patient satisfaction.

One of the biggest risks associated with HAIs is the development of antibiotic-resistant strains of bacteria. When patients are treated with antibiotics, they can kill off susceptible bacteria, but resistant strains can persist and continue to spread. This leads to a growing population of bacteria that are resistant to multiple antibiotics, making it increasingly difficult to treat infections effectively. This can result in longer hospital stays, higher healthcare costs, and increased patient morbidity and mortality.

Another significant risk associated with HAIs is the transmission of infectious diseases from one patient to another. This can occur when contaminated medical equipment or surfaces are not properly disinfected, or when healthcare workers fail to follow proper infection control procedures. This can result in outbreaks of infections, such as methicillin-resistant Staphylococcus aureus (MRSA) or Clostridium difficile (C. diff), which can spread rapidly through a healthcare facility and result in significant harm to patients.

HAIs also create risks for healthcare systems by increasing healthcare costs. The cost of treating HAIs is significant, as patients often require extended hospital stays, additional treatments, and sometimes, specialized care. This can increase the overall cost of healthcare and put a strain on healthcare systems that are already facing budget constraints.

Healthcare-associated infections pose significant risks to healthcare systems. They can result in increased patient morbidity and mortality, prolonged hospital stays, higher healthcare costs, and decreased patient trust. To minimize these risks, healthcare systems must implement and enforce strict infection control procedures, improve hygiene practices, and invest in technology and equipment to prevent the spread of infectious diseases.

Infection control involves practices, policies, and procedures aimed at preventing the transmission of infectious diseases between healthcare providers and patients. The goal of infection control is to protect patients, healthcare providers, and the community from the spread of infections. Some of the common infection control measures include hand hygiene, use of personal protective equipment, decontamination of equipment, and isolation of infected patients.

HRM is responsible for identifying and managing the risk of adverse events that may occur in healthcare facilities. In the context of infection control, HRM must assess the risks associated with infections and develop strategies to mitigate these risks. This includes developing policies and procedures to ensure that healthcare providers are adhering to infection control measures, as well as conducting regular audits and inspections to monitor compliance.

Collaboration between infection control and HRM is essential in ensuring that healthcare facilities are providing safe care to patients. By working together, infection control and HRM can identify and prioritize areas for improvement, and develop strategies to minimize the risk of infections in healthcare settings. This collaboration can take the form of regular meetings, joint trainings, and shared information systems, among others.

One key area of collaboration between infection control and HRM is in the development of infection control policies and procedures. These policies and procedures should be developed with input from both infection control and HRM to ensure that they are evidence-based and address the specific risks associated with the healthcare facility. The policies and procedures should also be regularly reviewed and updated to ensure that they are current and reflect best practices.

Another important area of collaboration is in the implementation of infection control programs. HRM can provide support in the implementation of these programs by providing resources, training, and support to healthcare providers. HRM can also work with infection control to monitor compliance with infection control policies and procedures, and address any areas of non-compliance.

Infection control and HRM play a critical role in ensuring that healthcare facilities are providing safe care to patients. Collaboration between these two areas is essential in developing effective strategies to prevent and control infections in healthcare settings. By working together, infection control and HRM can ensure that healthcare facilities are providing safe care to patients and minimizing the risk of adverse events.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE, is president and CEO of Community Health Associates, LLC. He is an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com.

A New Era of Leadership to Prevent HAIs: Raising the Bar

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the January 2023 issue of Healthcare Hygiene magazine.

The past three years have been extremely taxing on the entire global healthcare system, but particularly frontline healthcare providers. The pandemic has exposed critical vulnerabilities in the continuity of care, most notably with healthcare staffing and personnel. The Institute for Healthcare Improvement (IHI) developed a Triple Aim concept years ago that was designed to serve as the pillars for healthcare quality improvement. The traditional IHI Triple model includes population health, per capita costs, and experience of care. As a result of the pandemic, the time to evolve to the Quadruple Aim is now. The Quadruple Aim adds a fourth pillar which is that of the Healthcare Provider Experience:

Population Health Management impacts:

Risk management through pooling
Preventative Care
Socio-Economic Cost Reduction

Reducing Costs of Care Delivery impacts:

Productivity
Sustainability
Cost Effective
Comparatively effective

The Patient’s Experience impacts:

Patient Satisfaction
Clinical Outcomes and Quality
Patient Safety

Provider Experience:

Provider satisfaction
Work/Life Balance
Workflow Optimization

While healthcare continues to ensure daily stressors, the need for present leadership in healthcare has never been greater than today. Frontline healthcare workers are at all-time high level of stress and burnout, which is not only impacting clinical performance, but it also jeopardizing patient safety. A recent study published in the Mayo Clinic Proceedings indicated frightening statistics of registered nurses are likely to leave healthcare altogether in the next twenty-four months. This alarming data point must serve as a wake-up call for healthcare executives of looming staffing challenges of epic proportions. Healthcare truly is enduring a leadership crisis as many leaders are only managing and not truly leading. Most leaders are not able to create new leaders, which means that our rate of growing leadership teams is significantly limited.

The pandemic, for many different reasons, has also greatly eroded trust between healthcare providers and patients and healthcare providers and healthcare employers alike. This can only be rebuilt over time and through repeated trust-building activities where leaders earn this trust back. Leaders must be visible, present, and empower their teams to reach new levels of success. This approach will strengthen clinical outcomes, reduce preventable costs, and optimize operational efficiencies.

The great author and leadership expert, John Maxwell, outlined 5 Principal Thoughts of Change:

“We” is more important than me
Who is more important than how
What unites us is more important than what divides us
What I have is more important than what I lack
Collaboration is more important than cooperation

The concept of a team dynamic in healthcare settings would certainly help healthcare facilities better achieve the IHI Quadruple Aim, but it does admittedly take a tremendous amount of attention and resources. One thing is certain, healthcare will not survive much longer in is current state. Organizations such as the American College of Healthcare Executives can serve as excellent resources for growing one’s leadership skillset and help to prepare new and seasons leaders for the dynamic challenges present in today’s healthcare market.

Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE, is president and CEO of Community Health Associates, LLC. He has an appointment as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. He is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

Implementation of Antibiotic Stewardship Across the Continuum of Care

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the December 2022 issue of Healthcare Hygiene magazine.

Recently, the Centers for Disease Control and Prevention (CDC) released a new and concerning report on the state of antibiotic-resistant pathogens and antibiotic stewardship within the United States. The findings in this report should alarm all healthcare professionals and leaders, particularly as a result of the impact of the COVID-19 pandemic on existing antibiotic stewardship progress:

Resistant hospital-onset infections and deaths both increased at least 15% during the first year of the pandemic.
In a 2021 analysis, CDC also reported that, after years of steady reductions in healthcare-associated infections (HAIs), U.S. hospitals saw significantly higher rates for four out of six types of HAIs in 2020.
Many of these HAIs are resistant to antibiotics or antifungals.

As you can see, the progress that was being made prior to the pandemic has largely been subjected to major declines as a result of the scattered focus and now staffing challenged being faced across the entire healthcare industry. These declines in progress have now put the class of medications of antibiotics at severe risk and subsequently patients are in harm’s way, particularly with serious multidrug resistant pathogens.

The patient is an important part of the the antibiotic stewardship program. Key messaging to patients must be incorporated in any program in order to achieve success. Patient messaging can focus on the following core measures:

Antibiotics can save lives. When a patient needs antibiotics, the benefits outweigh the risks of side effects and antibiotic resistance.
Antibiotics do not treat viruses, like those that cause colds, flu, or COVID-19. Other medications, like antivirals, can treat viruses.
Antibiotics are only needed for treating certain infections caused by bacteria, but even some bacterial infections get better without antibiotics. Antibiotics aren’t needed for many sinus infections and some ear infections.
An antibiotic will not make you feel better if you have a virus. Respiratory viruses usually go away in a week or two without treatment. Ask your healthcare professional about the best way to feel better while your body fights off the virus.
When antibiotics aren’t needed, they won’t help you, and the side effects could still cause harm. Side effects range from minor to very severe health problems. When you need antibiotics for a bacterial infection, the benefits usually outweigh the risk of side effects.
Taking antibiotics can contribute to the development of antimicrobial resistance. Antimicrobial resistance occurs when germs like bacteria and fungi develop the ability to defeat the drugs designed to kill them. If antibiotics and antifungals lose their effectiveness, then we lose the ability to treat infections, like those that lead to sepsis.
If you need antibiotics, take them exactly as prescribed. Talk with your healthcare professional if you have any questions about your antibiotics.
Talk with your healthcare professional if you develop any side effects, especially severe diarrhea, since that could be a Clostridioides difficile(difficile or diff) infection, which needs to be treated immediately.
Do your best to stay healthy and keep others healthy by cleaning hands by washing with soap and water for at least 20 seconds or using a hand sanitizer that contains at least 60% alcohol; covering your mouth and nose with a tissue when you cough or sneeze; staying home when sick; and getting recommended vaccines, such as the flu vaccine.
Antibiotics aren’t always the answer. Everyone can help improve antibiotic use. Improving the way we take antibiotics helps keep us healthy now, helps fight antimicrobial resistance, and ensures that these life-saving antibiotics will be available for future generations.

When discharging patients or residents from a healthcare facility, careful attention must be paid to the proper transfer of information related to antibiotics, particular the following:

Information communicated across transitions of care may include:
- Diagnosis and treatment plan
- Antibiotic therapy
  - List inpatient antibiotic(s) and total number of days received in the hospital.
  - Specify if antibiotic therapy was completed in the hospital or if continued therapy post-discharge is needed.
  - For a post-discharge prescription, list the planned antibiotic, dose, and end date.
- Results of relevant diagnostic tests (including pending tests)
- Instructions for follow-up medical care, including contact information for additional questions

In some cases, the patient may be discharged back to their traditional home environment, and therefore the patient and their caregiver team must be educated about how to continue the proper care protocols including the indication and planned antibiotic course; instructions for follow-up medical care; signs and symptoms of worsening infection, and sepsis; and signs and symptoms of antibiotic-associated adverse events, including Clostridioides difficile infection. One of the best partners for patients being cared for in the home environment is a community-based pharmacist as they can easily review the patient’s entire medical history and work to prevent adverse drug events.

Antibiotics stewardship is a true team sport that involves the patient, the prescriber, nursing, pharmacy colleagues, and relies upon a collaborative care model to ensure that as healthcare providers we are appropriately protecting this critical class of medications. A vertical and horizontal approach to antibiotic stewardship across the entire continuum of care is needed if healthcare as an industry wants to move the needle substantially in the reduction of Multidrug resistant organisms. Together, we can save lives, reduce unnecessary antibiotic use, and reduce preventable healthcare costs.

Garrett is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a Fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. He is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

Infection Prevention Perspectives for Healthcare Value Analysis

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the November 2022 issue of Healthcare Hygiene magazine.

In today’s complex healthcare environment, the evaluation of infection prevention and control products can be a daunting task. As part of the clinical value analysis process, Infection Preventionists and Value Analysis leaders must objectively evaluate new products and technologies using a standardized methodology. The Institute for Healthcare Improvement (IHI) has defined three core elements to define overall healthcare value which includes the experience of care, population health, and per capita cost.

One of the first steps in product evaluation is centered around determining the appropriate regulatory body that is responsible for oversight of the product being evaluated. For example, hand sanitizers such as alcohol-based hand sanitizers are used on the hands and because they are used on the human body, they are regulated by the Food and Drug Administration (FDA).

The FDA regulates:
• Medical devices
• Drugs (OTC and Rx)
• Blood
• Biologics
• Vaccines
• Food
• Sterilization
• High-level disinfection

The Environmental Protection Agency (EPA), on the other hand, regulates:
• Low-level disinfectants
• Intermediate-level disinfectants
• Cleaning agents

Product Evaluation for most infection control-related products can be reviewed through three unique lens:
• Efficacy: Does it work? Is it going to kill the relevant microorganisms?
• Safety: Is it safe for the patient, healthcare team and environment?
• Compatibility: Will the product work with my other medical items, technologies, etc.?

This approach can easily be leveraged with a variety of products including hand hygiene, disinfectants, cleaning agents, certain medical devices, and personal protective equipment. The product evaluation process should be multidisciplinary and may differ by product type to ensure the relevant expertise (i.e., pharmacy, vascular access, etc.) is an active part of the product evaluation process.

Many infection control products must demonstrate their ability to be “broad spectrum”, they must be effective against a wide range of pathogens including:
• Broad Spectrum for bacteria
• Viruses (non-enveloped and enveloped)
• Multi-Drug Resistant Organisms (Drug Resistant Strains)
• Pathogenic Fungi (Candida)
• Bloodborne Pathogens (HIV, HBV, HCV)
• Emerging Pathogens (Novel viruses, etc.) as applicable

Evidence-based medicine remains an important part of infection control product evaluation, but there is a necessary prioritization in most situations. First, healthcare facilities must fall regulation as that is considered the law and is enforceable. Next, healthcare facilities should review and follow applicable national evidence-based guidelines and guidance from reputable governmental agencies such as the Centers for Disease Control and Prevention (CDC) or the Association of periOperative Registered Nurses (AORN). Third, there may be practice or specialty-specific professional society guidelines or recommendations which can be helpful to consider such as gastroenterology standards for a new disposable endoscope. Finally, the lowest level of consideration is that of expert opinion, as this is not considered to be evidence-based.

The CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) has developed an Infection Prevention Product Review Worksheet that healthcare facilities, infection preventionists, and healthcare value analysis professionals with an objective methodology to evaluate any product related to infection prevention and control. Before introducing a new product into a healthcare, a complete and thorough review must be performed to ensure patient and healthcare team safety.

A comprehensive value analysis process that incorporates assessment of evidence-based practices, patient and healthcare worker safety, population health management, patient satisfaction, and cost of care delivery will mitigate many risks associated with infection control product introduction across the continuum of care.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, MSL-BC, CPPS, CPHQ, CPXP, CVAHP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

Is Monkeypox the Next Global Pandemic?

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the October 2022 issue of Healthcare Hygiene magazine.

As global cases of Monkeypox quickly approach 60,000, many healthcare professionals are carefully monitoring this outbreak in fear of it becoming a global pandemic. Luckily, monkeypox does not share the same routes of transmission as COVID-19 and is primarily spread through close skin-to-skin contact.

The incubation period of Monkeypox can vary widely but is typically between three to 17 days. During this time, a person does not have symptoms and may feel fine. The illness typically lasts two to four weeks, but lesions may take additional time to heal.

The signs and symptoms of Monkeypox include:
• Lesions are firm or rubbery, well-circumscribed, deep-seated, and often develop umbilication (resembles a dot on the top of the lesion).
• During the current global outbreak:
• Lesions often occur in the genital and anorectal areas or in the mouth.
• Rash is not always disseminated across many sites on the body.
• Rash may be confined to only a few lesions or only a single lesion.
• Rash does not always appear on palms and soles.
• Rectal symptoms (e.g., purulent, or bloody stools, rectal pain, or rectal bleeding) have been frequently reported in the current outbreak.
• Lesions are often described as painful until the healing phase when they become itchy (crusts).
• Fever and other prodromal symptoms (e.g., chills, lymphadenopathy, malaise, myalgias, or headache) can occur before rash but may occur after rash or not be present at all.
• Respiratory symptoms (e.g., sore throat, nasal congestion, or cough) can occur.

Unlike in previous clinical guidance from the Centers for Disease Control and Prevention (CDC), the most current Monkeypox guidance specifies who healthcare professionals are to ensure that consistency in infection control practices is adhered to. Healthcare personnel (HCP) refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel). Finally, healthcare settings refers to places where healthcare is delivered and includes, but is not limited to, acute care facilities, long-term acute-care facilities, inpatient rehabilitation facilities, nursing homes, home healthcare, vehicles where healthcare is delivered (e.g., mobile clinics), and outpatient facilities, such as dialysis centers, physician offices, dental offices, and others.

Given the many lessons learned from COVID-19 about the appropriate use of personal protective equipment (PPE), healthcare professionals can remain confident that PPE is protective against Monkeypox transmission when properly utilized. Current CDC guidance for the care of patients with Monkeypox recommends the use of:
• Gown
• Gloves
• Eye protection (i.e., goggles or a face shield that covers the front and sides of the face)
• NIOSH-approved particulate respirator equipped with N95 filters or higher

The widespread availability of diagnostic testing and vaccinations has significantly decreased cases in the United States, but the momentum towards this reduction must be maintained. Monkeypox has very low mortality, but it can cause scarring lesions and significant pain to infected patients. As such, our goal as a healthcare community must be in the prevention of the disease through a multi-modal infection control and public health strategy.

Given the limited transmission routes for Monkeypox, it is unlikely that the outbreak will reach pandemic proportions. That said, a concerted effort toward educating high-risk individuals and offering pre-exposure vaccination can significantly curb Monkeypox cases globally. As with any ongoing outbreak, healthcare professionals and public health departments must carefully monitor case counts and severity of illness and adjust infection control efforts as needed. By working collaboratively, Monkeypox and other emerging infectious disease threats can be mitigated.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE, is president and CEO of Community Health Associates, LLC. He serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

Sniffles, Snorts, Coughs, and Hacks: The Era of Modern Respiratory Infectious Diseases

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE

This article originally appeared in the September 2022 issue of Healthcare Hygiene magazine.

Currently, the most common respiratory infections include COVID-19, influenza, pneumococcal disease, and colds. Some pathogens follow a more seasonal distribution pattern, such as influenza and RSV, and can even target the most vulnerable patient populations, such as newborns and the elderly. For respiratory pathogens to infect patients in healthcare settings, only a few things need to happen to result in transmission. Luckily, with basic and consistent infection prevention measures, many of these infections can be mitigated successfully. The chain of infection transmission includes:
• Infectious Agent: the bacteria, fungi, or virus that is pathogenic
• Source: people, equipment, water
• Exit: such as aerosols and splatter
• Means of Transmission: contact, inhalation, airborne, or vector-borne
• Portal of Entry: mucous membranes, respiratory tract, or broken skin
• Susceptible Host: a patient with a compromised immune system.

There are several primary routes for infection transmission, which include:
• Contact: This isolation level requires hand hygiene, gloves, and a gown.
• Droplet: This level of isolation requires a surgical mask and preferably eye protection.
• Airborne: This level of isolation requires the use of a NIOSH-approved respirator.

In addition to the patient-specific issues regarding respiratory infections, healthcare providers must also consider patient exposure, symptoms, the availability of laboratory testing, the availability of efficacious treatment options, and vaccines.
• Patient exposure
• Symptoms
• Availability of laboratory testing
• Availability of efficacious treatment options
• Vaccines

RSV is a common respiratory infection that has historically infected the infant population and has caused many outbreaks in neonatal intensive care settings. RSV can be problematic and deadly to premature infants or those with severely compromised immune systems. Luckily, with good adherence to core infection control measures such as hand hygiene, appropriate use of personal protective equipment, particularly masks, and frequent environmental cleaning and disinfection, healthcare professionals can normally stop outbreaks in their tracks.

While some respiratory pathogens have prophylactic vaccines available, these vaccines have varying levels of efficacy, particularly that of the annual Influenza vaccine. The development of vaccines, in and of itself, is an extraordinarily complex science that requires tremendous research and development. Vaccines, however, have significantly reduced overall mortality and morbidity in many instances.

Given the ongoing threat posed by the COVID-19 pandemic, healthcare facilities should also be given special consideration to the risks associated with aerosol-generating procedures or AGPs. According to the current Centers for Disease Control and Prevention (CDC) guidance, AGPs include but are not limited to:
• open suctioning of airways
• sputum induction
• cardiopulmonary resuscitation
• endotracheal intubation and extubation
• non-invasive ventilation (e.g., BiPAP, CPAP)
• bronchoscopy
• manual ventilation

Even though AGPs can heighten the risk of transmission to healthcare staff, adherence to proper personal protective equipment practices can effectively eliminate this risk. Other measures such as using anti-viral filters in circuits can trap potentially infectious aerosols and prevent them from escaping into the air. There will always be inherent risks of infection transmission in healthcare, but with aggressive infection prevention efforts, many of these can be mitigated.

Respiratory pathogens are here to stay, but by consistently following infection control best practices, healthcare facilities can substantially reduce the risk for infection in both patients and healthcare staff members alike. There are many lessons to be learned from the COVID-19 pandemic and most can be applied to the general prevention of respiratory infections. As we continue to experience respiratory pathogens such as COVID-19, RSV, and seasonal influenza, now is the time to formalize the infection prevention core measures to decrease risks, improve clinical outcomes, and remove preventable costs from healthcare.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, FACHE, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

A New Era of Safety in the Operating Room: Truly Treating Surgical Smoke

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This article originally appeared in the August 2022 issue of Healthcare Hygiene magazine.

Surgical smoke in the operating room remains a regular health and safety risk for both patients and healthcare staff. The Association of periOperative Registered Nurses (AORN) defines surgical smoke as “the vaporous and gaseous by-product of the use of surgical energy devices (e.g., electrosurgical units, lasers, ultrasonic devices, high-speed powered instruments).” Furthermore, the Occupational Safety and Health Administration (OSHA) directs that Under the General Duty Clause, Section 5(a)(1) of the Occupational Safety and Health Act of 1970, employers are required to provide their employees with a place of employment that is “free from recognizable hazards that are causing or likely to cause death or serious harm to employees.” Even though OSHA’s General Duty Clause can be leveraged as a catch-all standard for healthcare surgical smoke initiatives, there is not a specific OSHA regulatory standard that addresses surgical smoke in the perioperative setting.

Surgical smoke is sometimes referred to as smoke plume, surgical plume, bio-aerosols, lung-damaging dust, and laser-generating airborne contaminants. Surgical smoke is known to contain particles and can contain certain substances including aromatic hydrocarbons, volatile organic compounds (VOCs), polycyclic aromatic hydrocarbons (PAHs), hydrogen cyanide, inorganic gases such as hydrogen monoxide, nitriles, viruses, bacteria, blood, and potentially viable cancer cells.

The need for mitigating surgical smoke is not a new recommendation, but rather one where the true consequences for patients and perioperative staff have been poorly misunderstood until recent data highlighted the widespread impacts. The overarching goal for the perioperative environment is to create a smoke-free environment. This will require a multi-modal approach consisting of the use of air purification and disinfection technologies that have multiple stages to mitigate surgical smoke. Technologies that treat contaminated air beyond traditional HEPA filtration will be more effective in reducing the negative consequences of surgical smoke when used according to the device's instructions for use.

The hierarchy of controls can be used as a systematic approach to identify the most effective method of risk reduction:

- eliminating the hazard (e.g., avoiding use of smoke-generating surgical devices)

- substituting the hazard (e.g., using alternative devices)

- using engineering controls (e.g., surgical smoke evacuation and filtration, room ventilation of 20 total air exchanges per hour, work practices)

- using administrative controls (e.g., policies and procedures, education and training)

- wearing personal protective equipment (PPE) (i.e., respiratory protection)

When managing the risks associated with surgical smoke, healthcare facilities should utilize a variety of methods to mitigate the potential impacts and evaluate effectiveness. As part of the surgical plan, if surgical smoke is anticipated, the team should discuss mitigation steps to be taken during the case.

Current AORN Guidelines for Surgical Smoke recommend that healthcare facilities use smoke evacuation and filtration (i.e., local exhaust ventilation) in addition to room ventilation. This combination approach will most effectively treat the contaminated air and remove harmful particles from the operating room. Additionally, AORN has revised its guidelines to recommend healthcare facilities “Use a smoke evacuator system that contains an ultra-low particulate air (ULPA) filter with an activated carbon filter when surgical smoke is anticipated. When using a medical-surgical vacuum system, place an in-line ULPA filter with an activated carbon filter between the suction wall connection and the suction cannister. An ULPA filter demonstrates an efficiency of no less than 99.999 percent at a most penetrating particle size (MPPS) (e.g., 0.12 μm). An activated carbon filter adsorbs odors and gases (e.g., volatile organic compounds) in surgical smoke.”

In addition to the need for air filtration technologies to mitigate surgical smoke, perioperative departments must also establish policies and procedures regarding surgical smoke and communicate these policies to all impacted team members. Perioperative team members, including surgeons, should receive training on surgical smoke mitigation strategies at the time of initial hire, annually, and anytime a process or procedure changes. This training should be role-specific and competency-driven. In addition to training, perioperative leaders should engage with the facility quality, safety, engineering, and infection prevention teams on surgical smoke initiatives.

Surgical smoke in the perioperative setting continues to be a true safety concern, but luckily some technologies will mechanically treat the contaminated air and render it safe through multi-modal filtration. This safety threat requires constant attention from perioperative leadership and healthcare facility leadership. The time for action is now as our patients and healthcare team members deserve a safe healthcare environment that is free of these preventable airborne risks. For more information on surgical smoke prevention, visit the AORN website at www.aorn.org.

Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

What Are Medical Devices and How Are They Regulated?

By J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This article originally appeared in the July 2022 issue of Healthcare Hygiene magazine.

Infection preventionists are routinely consulted for guidance on medical device products and infection control risk assessments. Medical devices are used across all of healthcare and range from non-complex to extremely complex and high-risk devices. Basic devices such as blood pressure cuffs are routinely used during patient care and their safety is taken for granted by patients and healthcare providers. Food and Drug Administration (FDA)-cleared medical devices, however, have been repeatedly implicated in both infection outbreaks and also patient harm. Healthcare facilities must perform a rigorous risk assessment before implementing any medical device and monitor device utilization even after usage begins. The FDA is the federal regulatory agency responsible for medical device regulation in the United States.

FDA is the oldest comprehensive consumer protection agency in the U.S. federal government. Our mission is to promote and protect public health. This scope is broad and covers foods, drugs, biologics, cosmetics, animal and veterinary medicines, tobacco, and, of course, medical devices and radiation-emitting products, the last two of which are regulated by the Center for Devices and Radiological Health, (CDRH). FDA's authority to regulate medical devices originates from the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1976. The agency has continued to evolve its laws to ensure that it regulates these products in the most efficient way as our scientific knowledge advances over time. Starting in 2002, CDRH began implementing a medical device user fee program in which the regulated device industry provides user fees to CDRH with the goal of advancing regulatory decision-making.

The 1976 Amendments provide us with the definition of a medical device. The full definition is found in Section 201(h) of the FD&C Act. In summary, a device is an instrument, apparatus, machine, implant, or in vitro reagent that diagnoses, cures, treats or prevents a disease or condition. It does this by affecting the structure or function of the body but doesn't achieve its purpose through chemical metabolism or as a drug. This definition excludes certain software functions, mostly involved with the administrative data storage and support, and transmission of electronic patient records.

Innovative products may feature aspects of devices as defined in the prior slide, as well as components such as drugs or biologics. The FDA refers to these as Combination Products, which, by definition, involve at least two regulatory component types of drugs, devices and biologics. An example of a drug-device combination product is a drug-eluting cardiovascular stent, whose two components work together to keep an artery open and prevent restenosis. Combination products involve the applicable regulatory responsibilities from all the components involved. One FDA Center will usually take the lead and the Agency's Office of Combination Products helps facilitate product jurisdiction.

Our federal laws are intentionally written to be broad. We elaborate on the details and specifics of Laws in regulations. The regulations that are specific to medical devices are found in 21 Code of Federal Regulations, Parts 800 - 1050. Parts 800 - 861 mostly address broad regulations that apply to most types of devices, and Parts 862 - 1050 largely address device-specific requirements. For example, 21 CFR 812 addresses Investigational Device Exemptions, a requirement that is applicable to all medical devices; whereas 21 CFR 876 provides classification information and requirements specific to gastroenterology or urology. In addition, 21 CFR Parts 1- 99 contain general regulations that apply to all medical products regulated by FDA, including medical devices. As a result, depending on your specific device, you may have regulatory responsibilities outlined in all these sections.

Sometimes, the FDA Laws and Regulations are not sufficiently detailed to describe how FDA intends to regulate a device policy. In such cases, FDA will publish a guidance document that describes what FDA is thinking. A guidance document is not binding, but it does reflect FDA's current thinking, so it can often be an excellence source of detailed information and clarification on a particular policy. FDA may initially issue a draft guidance document that describes the Agency's proposed thinking on a topic. During this period, the public is invited to provide comments on the proposal. At the completion of the comment period, FDA will evaluate the public feedback and issue a final guidance document, which reflects the Agency's current thinking.

FDA classifies devices, or more accurately, device types, to identify the degree of regulation for that product area. Classification is largely based on two factors: the device description, that is, its physical characteristics, and the intended use. As a result, to fully understand your device's classification, you need to identify both the device description and intended use. FDA classifies devices into Class I, II, or III. The class of a device generally increases with its degree of risk. In addition, each device type is assigned a product code, which refers to a three-letter coding. This allows FDA to group similar devices and intended uses. Note that the same device with a different intended use may have a different classification, product code, and Class.

Source: Food and Drug Administration

This table describes the key characteristics of each class of medical devices. Moving from left to right, we describe each Class according to the general risk of devices, controls necessary, and submissions required. As the risk of the device increases, so does the regulatory control to ensure its safety and effectiveness. Controls may be general, special, and PMA. Devices may be exempt from submission to FDA, or require 510(k) or PMA, with some alternatives. For example, Class I devices generally present the lowest level of risk. They are subject to general controls only and most are exempt from premarket submission, but some may require a 510(k).

So, what are regulatory controls? These are requirements that apply to a product area, or product code. They provide consistent requirements to predictably foster safe and effective medical devices with the appropriate level of regulatory burden or oversight. Regulatory controls are usually broad, but some may be specific to a product area.

For example, one fundamental general control is labeling. 21 CFR Part 801 provides details involving labeling, which, broadly speaking, requires providing information about the device to ensure its safe and effective use. Another example is establishment registration. As described in 21 CFR 807, businesses are required to register with FDA on an annual basis. Even with these regulatory controls, the system is not perfect, and users of medical devices often fail to follow the manufacturer’s instructions for use which can lead to danger to patients and the user.

While it is impossible to mitigate every risk associated with medical device utilization, it should remain our goal to prevent patient and healthcare team harm. Infection preventionists and other healthcare leaders such as clinical value analysis professionals must become well versed in medical device regulation and evaluation criteria to ensure the safe use of these devices in our healthcare systems. While medical devices provide truly lifesaving diagnostic and therapeutic functions, they carry inherent risks. Through risk mitigation, careful oversight, and proper usage, medical devices can provide an invaluable service to patients.

To learn more about FDA-regulated medical devices, visit www.fda.gov/devices.

Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC and also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a Fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com.

Breaking Down Barriers in Healthcare Communication: Applying the TeamSTEPPS Methodology for Quality Improvement

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the June 2022 issue of Healthcare Hygiene magazine.

Multiple data points suggest that breakdowns in communication are major source for healthcare errors that may cause patient harm. TeamSTEPPS, Team Strategies and Tools to Enhance Performance and Patient Safety, is a collaborative education initiative between the Agency for Healthcare Research and Quality (AHRQ) and the Department of Defense. The TeamSTEPPS program focuses on strengthening the specific knowledge, skills, and attitudes of teamwork and can be tailored to meet the needs of any team in any setting both inpatient and outpatient.

The program is based on more than 40 years of research and evidence from high-risk fields and provides specific tools and strategies for:
• Improving communication in teamwork
• Reducing the chance of error
• Enhancing patient safety
• Outcomes of a high-performing team are adaptability, accuracy, productivity, efficiency, and safety

TeamSTEPPS can be used with any member of the healthcare team and is not limited strictly to clinical practitioners. For healthcare communication to be as effective as possible, it must be complete, clear, brief, and timely. The communication is complete when it includes and communicates all relevant information regarding the situation. It is clear when the information is plainly understood and not riddled with complex medical jargon. Healthcare communications need to be brief, concise and focused on the topic at hand. Finally, for these communications to be actionable, they must be timely so that there is still an opportunity to positively influence any potential clinical outcome.

TeamSTEPPS can create several benefits for any healthcare facility and include:
• Significant improvement in communication and supportive behavior
• Significant increase in perceptions of teamwork after training
• Reductions in turnover rate
• Increases in employee satisfaction

Healthcare leaders play a pivotal role in forming highly performing teams and should consider 1) who their team members are and their skillsets, 2) when they need to interact and with whom, 3) how do they currently exchange critical patient information, and 4) what, if anything, would you want to change about your current team structure and performance? Proper leadership and autonomy can create highly resilient teams throughout the entire continuum of care. The TeamSTEPPS model is built on three core tenets: 1) Performance, 2) Attitudes, and 3) Knowledge. Most would argue that attitudes are the most critical component as knowledge can typically be taught and performance can be managed by proper leadership. At the core of the TeamSTEPPS model is a focus on the patient themselves. Engaged frontline leadership is necessary to implement this type of change management program and sustain the positive momentum created.

Since most errors in healthcare involve human beings and breakdowns in healthcare communication, the transfer of care between settings such as hospitals and skilled nursing facilities or even within hospital departments can be risky. When transferring patient care or conducting even something such as an outbreak investigation, a proper handoff can be very helpful in ensuring continuity of care. A proper handoff includes the following components:
• Responsibility: The person is aware of assuming responsibility
• Accountability: You are accountable until both parties are aware of the transfer
• Uncertainty: Clear up all ambiguity before the transfer is complete
• Communicate verbally
• Acknowledged: Ensure that the handoff is understood and accepted
• Opportunity: Evaluate the situation for both safety and quality

By using a standardized tool such as a handoff, healthcare providers can more effectively transfer the care of any patient. Another TeamSTEPPS tool that is extremely helpful is Situation Monitoring. Situation Monitoring is the process of actively scanning behaviors and actions to assess elements of the situation or environment. It also enables team members to identify potential issues or minor deviations. The benefits of Situation Monitoring include fostering mutual respect and team accountability, providing a safety net for team and patient, and finally Includes cross-monitoring.

A shared mental model is an organized knowledge structure of relevant facts and relationships about a task or situation that are commonly held by team members. Team effectiveness will improve if team members have a shared understanding of the situation. In healthcare, if the wrong plan is developed, potentially all actions that follow are wrong, and the patient and caregiver are at risk. The use of the TeamSTEPPS model combined with a shared mental model and engaged healthcare leaders can dramatically reduce patient harm, medical errors, and improve clinical outcomes.

J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

The Journey to Zero CLABSI and CAUTI Infections: Is It Possible?

By J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the May 2022 issue of Healthcare Hygiene magazine.

Millions of indwelling central venous and urinary catheters are inserted in both acute care and non-acute care healthcare settings annually across the globe. While in many instances, these devices play serve as a critical medical treatment delivery tool, there are unfortunately scenarios where these catheters are not medically necessary and can result in patient harm and associated mortality and morbidity. A new resource guide was released in April by the Agency for Healthcare Research and Quality (AHRQ) directly targeting core interventions to reduce the incidence of catheter-associated urinary tract infection (CAUTI) and central line-associated bloodstream infections (CLABSI). CAUTIs account for 75 percent of all healthcare-associated urinary tract infections.[1] CLABSIs significantly increase the risk of death.[2]

There are some important questions that must be asked by the healthcare team to ensure that all possible preventable risks are mitigated:

Understanding the Science of Safety

Identifying Defects
Engage the Senior Executive
Learn from Defects
Implement Teamwork and Communication

The new recommendations from AHRQ are broken into two tiers, both of which are equally important. Tier 1 is focused on standardizing products, procedures, and bedside processes and Tier 2 which is focused on enhanced practices. Together, these interventions provide healthcare providers and facilities with the most sustained approach to infection control to reduce CAUTIs and CLABSIs.

Tier 1 Interventions Tier 2 Interventions

Tier 1 interventions are technically focused, evidence-based actions that should occur with every patient, every time.	Tier 2 interventions are team-based strategies that extend beyond the bedside and can enhance the Tier 1 interventions.
The interventions in Tier 1 will aid in driving the consistent application of evidence-based practices.
Tier 1 interventions are technically focused, evidence-based actions that should occur with every patient, every time.

Part of reducing preventable CLABSI and CAUTI infections is frequent, unit-based rounding. Some of the best practices for catheter rounds include:

Identify key practices to observe or check during planned rounds and specific goal(s) of rounds. This will vary over time as barriers or needs are identified and may vary by ICU.
Identify nurse experts to round and a nurse champion to lead the rounds.
Observe insertions, if the opportunity to observe an insertion occurs.
Develop or adapt a rounding checklist to record findings.
Provide direct, constructive feedback to staff during rounds to educate, compliment, seek information, etc. per goals of rounds, and as opportunities arise.
Aggregate findings from rounds and provide feedback to the ICU and individuals as appropriate.

CAUTI Infection Control Interventions:

Source: AHRQ Safety Program for Intensive Care Units: Preventing CLABSI and CAUTI

Regardless of the infection type, there are some important commonalities in reducing the incidence of CLABSI and CAUTI. These strategies can not only reduce the risk for infections but can also improve overall patient safety and reduce the length of stay:

Improve Communication patterns and unit culture relative to urinary catheter use
Increase Nurse comfort with urinary catheter removal protocols
Improve Staff knowledge and skills
Create Respect among nurses and providers
Dedicate personnel to review, remind, and reinforce best practices and analyze infection rates
Use the AHRQ Safety Program Playbook for Intensive Care Units: Preventing CLABSI and CAUTI
Utilize Information technology support for data collection
Provide Feedback using data on catheter use to frontline staff
Celebrate the ICU team’s recognition of the hazard of urinary and central venous catheters

Frontline staff plays a pivotal role in the success of any infection control intervention, but building staff competency in the proper placement, maintenance, and removal of indwelling urinary and central venous catheters. To build competency, the established competencies should be role-specific to the individual clinician type performing the care such as a registered nurse or nursing assistant. Healthcare Facilities should identify what an employee’s role will be related to urinary catheters (insertion, maintenance, transport of patients with urinary catheters, etc.). Then, there should be education and competency are offered to those with the responsibility of insertion. Finally, infection preventionists and unit managers can educate employees on hospital policies, procedures, and expectations for performance.

Sharing data about CAUTI and CLASBI back to frontline staff in real-time can optimize the appropriate use and care of indwelling catheters. This feedback encourages the use of alternatives to catheters, which can greatly reduce the risk of infection and mitigate the risk of future CAUTIs. Strategies to feed data back to staff include but are not limited to multidisciplinary catheter rounds with real-time feedback, and an in-depth review of CAUTIs to identify contributing factors to the infection.

With a sustained, interprofessional approach to infection control, achieving and maintaining zero CAUTI and CLABSI infections is possible. Healthcare leaders must champion these infection control efforts at the highest levels of the organization to remove obstacles and empower frontline staff. At every step on the infection journey, there are opportunities for improvement and together healthcare professionals can solve this ongoing patient safety threat.

Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

References:

[1] Catheter-associated Urinary Tract Infection (CAUTI). Centers for Disease Control and Prevention.

[2] Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. Epub 2014 Oct 21. doi: 10.1007/s15010-014-0689-y. PMID: 25331552.

The Road to Safer Flexible Endoscopies: Elimination of Medical-Device Associated Risks

By J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the April 2022 issue of Healthcare Hygiene magazine.

Millions of endoscopies are performed annually across the world to both diagnose and treat a wide variety of medical conditions in many different anatomical sites within the human body. Surgical site infection (SSI) risk factors can mostly be controlled, but they are the top cause of nosocomial infections in the perioperative setting. These infections are preventable, and the reprocessing of reusable flexible endoscopes has been repeatedly implicated in both outbreaks and unfortunately patient deaths due to reprocessing failures. Sadly, based on published reports of device-related outbreaks and also FDA MAUDE reports, thousands of patients have contracted infections from these devices and some patients have died because of flexible endoscope contamination.

There are some important questions that must be asked by the healthcare team to ensure that all possible preventable risks are mitigated:
• What does the patient bring to the table at the time of the procedure in the form of
microorganism colonization or active infection? What about existing comorbidities?
• What risks can we as the Healthcare Team mitigate or engineer out of the reprocessing process?
• What risks are there to perioperative and reprocessing personnel? Have these risks increased
due to the ongoing COVID-19 pandemic?
• Does our facility currently assess the cleanliness of our flexible endoscope fleet?

Recently, the Food and Drug Administration (FDA) has published three different safety alerts for flexible endoscopes used in gastroenterology, pulmonology, and urology healthcare settings. These safety alerts must serve as an important alarm for healthcare facilities that are reprocessing these devices and the inherent risk associated with reprocessing. These recent FDA analyses have identified several core trends that, as a profession, must be addressed to maintain patient safety. First, Post-market design changes that do not account for how they impact the ability to properly clean and disinfect the device. There is a general lack of communication between manufacturers and/or between manufacturers and device users when medical devices/equipment used for reprocessing are modified and instructions are revised. Third party servicing and accessories that are not typically validated by the Original Equipment Manufacturer (OEM) of the flexible endoscope or inspected by the FDA. Finally, there may be a lack of standardized Clinical Value Analysis processes for complex medical devices in
some healthcare settings.

During the analysis of the FDA’s Medical Device Adverse Event reports for flexible endoscopes, the FDA and Centers for Disease Control and Prevention (CDC) have compiled a list of problematic design aspects of most reusable flexible endoscopes. These potential hazards include:
• Long, narrow interior channels (lumens), including those with internal surfaces that are not
smooth, have ridges or sharp angles, or are too small to permit a brush to pass-through
• Hinges
• Sleeves surrounding rods, blades, activators, inserters, etc.
• Adjacent device surfaces between which debris can be forced or caught during use
• O-rings
• Valves that regulate the flow of fluid through a device (stopcocks)
• Devices with these or other design features that cannot be disassembled for reprocessing
to successfully and reliably mitigate risks associated with the reprocessing process for flexible
endoscopes, healthcare leaders should prioritize the three P’s: People, Process, and Product. This comprehensive approach provides the best possible outcomes when it is rigorously followed. This three-tiered approach can assist healthcare leaders with identifying risks associated with reprocessing and in decreasing potential patient and healthcare team safety issues.

1) People:
• Do I have the right team members performing the role for which they are most qualified?
• How do I ensure the competency of my perioperative personnel?
• Are my personnel able to meet the demands of our clinical practice with instrument/device
reprocessing?
• Do I have a highly functional team culture within my OR and facility?

2) Process:
• How is my reprocessing process validated and how often?
• How often does the device vendor validate our reprocessing capability?
• What other devices does our facility use that may contribute to reprocessing failures?
• How would I know if I have a reprocessing failure and how many patients would be impacted?

3) Product:
• Do I want to continue to take the known risks associated with reprocessing and the risks for
SSIs?
• How old is my fleet of reusable devices and how often are they inspected, serviced, and
assessed by the actual OEM device manufacturer?
• What other third-party devices might be used through the surgical device that could result in
damage to the device and create a pathway for potential device contamination?

Patients who are readmitted following endoscopies are typically experiencing chief complaints of pain, bleeding, or infection. These are widely preventable complications that increase length of stay and the cost of care delivery. In addition, the patient’s overall experience will be negatively impacted when they contract a device-related infection. There are now FDA-cleared sterile, disposable flexible endoscopes that are readily available in the U.S. market and can assist healthcare professionals and systems with eliminating device-related infections by removing the reprocessing process from the equation completely.

See the April 2022 issue of HHM for a table that compares the use of traditional reusable flexible endoscopes and
sterile, disposable flexible endoscopes. These differences are important to note when evaluating a
facility’s infection prevention and control program as well as overall reprocessing processes.

The FDA has strongly advised healthcare facilities to begin using sterile, disposable flexible endoscopes where available to reduce the risk for device-related infections to patients. As more flexible endoscopes become 510(k)-cleared through the FDA, the use of sterile, single-use devices should become the absolute standard of care to eliminate device-related infections. By eliminating the risky part of the flexible endoscopy procedure, reprocessing the device, the overall infection risk for the patient can be virtually eliminated. Patients expect safe, reliable, and evidence-based care. They don’t expect to contract an infection from a device that is being used to provide clinical care to them. Healthcare systems must carefully evaluate medical-device related risks and take all available steps to mitigate and preferably eliminate these risks in the interests of protecting both patients and the healthcare team alike. To learn more about the FDA’s work in advancing the safety of medical devices, visit: https://www.fda.gov/medical-devices/medical-device-safety.

J. Hudson Garrett Jr. is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine; is a fellow with the Institute for Healthcare Improvement; and has earned designation as a fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

The Hopeful End of a Pandemic, the Beginning of the Endemic

By J. Hudson Garrett Jr., Ph.D., MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the March 2022 issue of Healthcare Hygiene magazine.

The recent trends for the COVID-19 pandemic continue to show overall decreases in cases; the transition to a more endemic virus has commenced in many locations worldwide. The Centers for Disease Control and Prevention (CDC) continues to update its healthcare guidance regarding testing, appropriate levels of personal protective equipment, and vaccination. As this guidance evolves, there are impacts on the healthcare team at multiple levels. A recent analysis by multiple independent staffing agencies and the American Hospital Association demonstrates an impending crisis in maintaining safe levels of healthcare provider staffing to deliver the safest level of care. This challenge is being felt in the acute-care environment and equally so in other healthcare environments, most notably skilled nursing facilities. Staffing crisis, combined with increasing regulatory and accreditations standards related to COVID-19 and infection prevention and control, have caused further unintended consequences for healthcare personnel and systems.

As the acuity of patient care across U.S. healthcare facilities has not decreased, the need for specialized healthcare professionals is more significant now than ever. Many technical healthcare professionals are stepping away from direct patient care or even leaving the healthcare sector altogether. The loss of this experience within the workforce has exponential impacts across all healthcare, especially in specialized settings such as skilled nursing facilities and intensive care settings. In addition, during the pandemic, the availability of training and development opportunities for healthcare professionals has decreased, resulting in varying competency levels for healthcare personnel.

Several mechanisms can be utilized to improve the current healthcare staffing crisis, which includes:
• Basic ventilator management training for all bedside personnel that might need to care for a ventilated patient during crisis levels of care. Expert respiratory therapists can facilitate this training to bolster the essential skillset across the continuum of care. Healthcare professionals in step-down units, outpatient settings, and skilled nursing can benefit from this type of just-in-time training. The Society for Critical Care Medicine has made ventilator training programs available for healthcare professionals at no charge during the pandemic. To view these free training tools and resources, visit: https://covid19.sccm.org.
• Use of retirees for critical public health functions: Thousands of retired healthcare professionals with a wealth of knowledge may serve in paid or volunteer roles. During the height of pandemics or large-scale outbreaks, these retired healthcare professionals can be tremendous assets to mass vaccination or testing clinics and reduce the workload burden on already taxed acute care environments.
• Just-in-time training delivery and competency assessment program for critical skills and utilize furloughed HCPs to supplement other workstreams: When elective procedures were canceled, many healthcare professionals were furloughed rather than being redeployed to other areas with need. One rationale for not redeploying this personnel was due to lack of specialized training such as Intensive Care or Ventilator care standards of care. This can be alleviated as mentioned above by frequent cross-training opportunities.
• Agency personnel resources and staffing supplementation: While additional healthcare professionals are vital to staffing healthcare facilities, improperly trained healthcare professionals can be problematic. Staffing agencies should cross-train staff to ensure that they are ready for emergency deployment to different patient-care environments.

The CDC has provided detailed guidance on best practices to address healthcare staffing focused on three levels: conventional (normal staffing operations), contingency (staffing challenges are mild to moderate), and finally crisis (staffing is severely compromised). This tiered approach to guidance can provide healthcare facilities with some much-needed flexibility during staffing challenges and potentially put patients and other healthcare clinicians at risk for unnecessary exposure to COVID-19 and other infectious diseases.

While the COVID-19 pandemic has taught the healthcare industry many lessons, one of the most significant impacts of the pandemic is only beginning to be felt by healthcare facilities-the staffing crisis! Without tremendous investments in reinvigorating our healthcare teams, the ability to staff America’s hospitals and healthcare facilities will be in grave peril. The American Hospital Association and other clinical associations have published resources to assist healthcare leaders and administrators with meeting staffing requirements. Still, these efforts alone cannot be sustainable without actual changes in how healthcare personnel staffing is currently addressed across the continuum of care. Without highly competent and engaged frontline healthcare clinicians, the patients could be at risk for healthcare-associated infections, medical errors, and other potential adverse events. The time for action is now, and every healthcare executive must fully engage in resolving the next pandemic of healthcare staffing. Maintaining appropriate staffing in healthcare facilities is essential to providing a safe work environment for healthcare providers and safe patient care.

A Needed Change in Communications From the CDC

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the February 2022 issue of Healthcare Hygiene magazine.

The COVID-19 pandemic continues to rage on, and its impacts are widespread and far-reaching across all industries, not just healthcare. During the pandemic, the Centers for Disease Control and Prevention (CDC) has offered often conflicting guidance that has led to confusion within the healthcare community. While evidence-based practice demands an evolution of clinical guidance, the delivery of the message must be carefully scripted to be pragmatic and follow a logical path.

Unfortunately, this is not the type of messaging that has been regularly disseminated from the CDC. During this unprecedented pandemic, both healthcare providers and the public are desperate for an understanding of what best practice should consist of from important topics such as the appropriate use of personal protective equipment to how healthcare professionals can safely deliver clinical care during a pandemic. In addition, healthcare facilities are struggling to maintain adequate staffing levels and also the ability to continuously delivery safe patient care.

According to the healthcare communications experts at the CDC, there are some basic principles that healthcare facility leadership should follow to best optimize communications during an emergency such as a facility fire or a more global event such as an infectious disease pandemic. Below are important caveats that healthcare leaders and infection preventionists should adhere to during any communications activities.

Basic Tenants of Crisis Communications:
• Don’t over reassure. The objective is not to placate, but to engender, calm concern.
• Acknowledge uncertainty. Offer what you know versus what you don’t know. Show your distress and acknowledge your audience’s distress regarding the uncertainty of the situation. “It must be awful to hear we can’t answer that question right now . . .”
• Express that a process is in place to learn more. “We have a system (plan, process) to help us respond (find answers, etc.).”
• Give anticipatory guidance. If you are aware of future negative outcomes, let people know what to expect. Example: side effects of antibiotics. If it’s going to be bad, tell them.
• Be regretful, not defensive. Say “we are sorry . . .” Or “we feel terrible that . . .” when acknowledging misdeeds or failures from the agency. Don’t use “regret,” which sounds like you’re preparing for a lawsuit.
• Acknowledge people’s fears. Don’t tell people they shouldn’t be afraid. They are and they have a right to their fears. Don’t tell them they are idiots for their misplaced fear; acknowledge that it’s normal, human to be frightened. They aren’t experts.
• Acknowledge the shared misery. Some people will be less frightened than they are miserable, feeling hopeless and defeated. Acknowledge the misery of a catastrophic event and then help move them toward hope for the future through the actions of your agency and actions they too can take.
• Express wishes. “I wish we knew more.” “I wish our answers were more definitive.”
• Stop trying to allay panic. Panic is less common than imagined. Panic doesn’t come from bad news, but from mixed messages. If the public is faced with conflicting recommendations and expert advice, they are left with no credible source to turn to for help. That level of abandonment opens the door to charlatans and mass poor judgment. Candor protects your credibility and reduces the possibility of panic because your messages will ring true.
• At some point, be willing to address the “what if” questions. These are the questions every person is thinking about and wants to hear answers from experts. It’s often impractical to fuel “what ifs” when the crisis is contained and not likely to affect wide numbers of people; it is reasonable to answer “what ifs” if the “what if” could happen and people need to be emotionally prepared for it. However, if you do not answer the “what if” questions, someone with much less at risk regarding the outcome of the response will answer them for you. If you are not prepared to address “what ifs,” you lose credibility and the opportunity to frame the “what if” questions with reason and valid recommendations.

When dealing with a crisis such as a pandemic, always try to be first and quickly share both the information that you do know, but equally important is to share the information that you don’t know. Next, it is critical to be “right” and establish credibility with your target audience whether that be internal healthcare personnel or external patients and the local community. Healthcare spokespersons should take all necessary steps to remain credible and communicate clear messaging that can be practically implemented. During all communications, a visible display of respect must be noticeable for all parties both healthcare personnel and patients. When delivering recommendations, we must ensure that they are able to be understood by the target audience and that they provide actionable guidance on what steps to take to remain safe.

Ironically, the CDC offers a world-class training curriculum to help healthcare facilities navigate the challenging nuisances of communication during crises such as a pandemic. This CDC-sponsored training is called Crisis and Emergency Risk Communication (CERC) training and can be accessed online via the CDC website: https://emergency.cdc.gov/cerc/training/index.asp. The cause of most medical adverse events is breakdowns and communication, and now more than ever we need our federal public health officials to lead, deliver evidence-based science, and provide clear guidance to keep our healthcare colleagues and patients safe during this extremely challenging time.

J. Hudson Garrett Jr. is president and CEO of Community Health Associates, LLC. He also has an appointment as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. He is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

Is it Time to Ditch Reusable Bronchoscopes Due to Reprocessing Failures? The Future of Medical Device Safety is in the Balance

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

This column originally appeared in the January 2022 issue of Healthcare Hygiene magazine.

Reusable endoscopes are widely utilized by healthcare professionals and facilities in both inpatient and outpatient settings globally. These devices are lifesaving and provide for both diagnostic and therapeutic benefits to the patient’s medical care, but there is one major underlying safety issue related to these reusable endoscopes -- potential contamination of the device itself.

Recent Food and Drug Administration (FDA) studies and analysis of device-related adverse events have identified hundreds of incidents of potential reusable endoscope contamination and subsequent patient harm. These reusable devices have complex cleaning and reprocessing instructions that are difficult to adhere to in a fast-moving reprocessing department. In some instances, reusable endoscopes are not even capable of being properly reprocessed due to a combination of factors including:
• Device design
• Reprocessing failures (human)
• Reprocessing failures (equipment)
• Device maintenance issues
• Device damage issues

While there’s no question that discussions in healthcare around infection control have gained new urgency over the past 18 months as the novel coronavirus upended life across the globe, this important conversation has been happening in flexible endoscopy for some time now at both a regulatory and clinical level. The Food and Drug Administration (FDA) has recently analyzed Medical Device Reports (MDRs) for duodenoscopes, ureteroscopes, and most recently bronchoscopes, and discovered some staggering statistics related to infection risk.

Twice this year, the FDA has issued guidance on reprocessing flexible endoscopes. In June 2021, it updated a safety communication reminding clinicians and healthcare facilities about cleaning and appropriately caring for bronchoscopes. The announcement followed an April 1 letter to healthcare providers focusing on preventing device-related infections associated with reprocessed urological endoscopes; a sharp reminder to healthcare providers that the discussion about infection control is far from over.

Just as there are answers to slowing the spread of SARS-CoV-2 — vaccinations and non-pharmaceutical interventions such as masks and social distancing — there is an evidence-based solution for cross-contamination from medical devices that eliminates potential human factors-related issues. That answer is sterile, single-use, disposable endoscopes. In fact, in its June letter the FDA advised healthcare providers to “consider using a single-use bronchoscope in situations where there is increased risk of spreading infection.”

The use of a sterile device eliminates the need for reprocessing and the associated errors identified in this process. There is no need to reprocess these devices nor to follow lengthy and confusing decontamination steps. There is no searching for an available scope to complete the procedure. They are ready when needed and are also cost-effective.

The cystoscope, for example, is the urologist’s “stethoscope” — it is the primary tool to diagnosis bladder cancer. More than 83,000 Americans are expected to be diagnosed with bladder cancer in 2021 and an estimated 600,000 U.S. patients have at least an annual cystoscopy for bladder cancer surveillance. Some of the common reasons to perform a cystoscopy include hematuria, overactive bladder, and dysuria. Many of these procedures are performed in outpatient settings where reprocessing personnel have minimal if any formal training on how to care for these endoscopes.

The FDA revealed in April that it was investigating “numerous” medical device reports (MDRs) describing patient infections and other possible contamination issues possibly associated with reprocessed urological endoscopes, including cystoscopes and ureteroscopes. Three patients developed Pseudomonas aeruginosa infections after procedures (outside of the U.S.) and later died. One involved a cystoscope, which the report said did not pass a leak test, a preventive maintenance measure required to ensure the device isn’t damaged. The two other deaths were associated with a forceps/irrigation plug, an accessory component used to control water flow and enable access to the endoscope’s working channel.

The FDA is investigating potential causes and contributing factors associated with the reported infections and contamination issues. Some reports have indicated issues with inadequate reprocessing or maintenance. Other potential issues the FDA is evaluating include device design and reprocessing instructions on labeling. The FDA believes the risk of infection is low based on available data. Two manufacturers were cited in reports; the agency, however, “has not concluded that such risks are limited to a particular manufacturers’ devices nor that any specific manufacturer or brand of these devices is associated with higher risks than others.”

In its June safety communication, the FDA updated years of investigation into MDRs related to bronchoscope-associated infection. The agency collected 867 MDRs between July 2015 and January 2021, an almost eightfold increase compared with the 109 bronchoscope-related MDRs from January 2010 to June 2015. According to public FDA reports, there were seven patient deaths reported in that time, but it’s not known if the deaths were causally related to contaminated bronchoscopes.
While the risk of device-related infection is considered rare, the FDA previously determined in its 2015 safety communication that bronchoscopes “pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed.” Flexible endoscopes are notoriously hard to clean — either through high-level disinfection or sterilization — given their long channels and delicate nature. This has been vividly illustrated in the ongoing study of duodenoscopes and the FDA’s recommendations to transition to disposable components and “innovative designs.”

Industry guidelines for reprocessing endoscopes can include more than 100 steps, and the process can take more than two hours to complete. Hospitals have spent millions of dollars building infrastructure to clean and house endoscopes, and yet device contamination and reprocessing failure continues to remain a daily threat to patient safety.

Bronchoscopies and urological procedures requiring the use of an invasive scope occur in various settings with a variety of oversights, potentially increasing the risk of cross-contamination. And whether reprocessing is ultimately effective depends, in part, on the individual following the steps and deciphering the instructions.

A sterile, single-use endoscope relieves the hospital personnel charged with those tasks of the responsibility for infection control. In addition, disposable endoscopes can reduce costs as well as downtime for repairs, and they prevent hospital staff from being exposed to chemicals and other infectious diseases risks such as SARS-CoV-2 during reprocessing.

The FDA said it received more than 450 MDRs between Jan. 1, 2017, and Feb. 20, 2021 describing post-procedure patient infections or other potential contamination issues involving reprocessed endoscopes. These risks are nothing new to the medical community. They exist and will continue to exist as long as endoscopes are manually cleaned by reprocessing personnel and used again on patients with the known variability that exists in reprocessing between different reprocessing personnel. Self-regulating to perfection is an unfair ask of healthcare facilities and providers. Guidelines and instructions for use are constantly changing, and staffing challenges posed by the COVID-19 pandemic only compound the problem. The time to evaluate the use of single-use endoscopes is now. By using these sterile devices, the risk of device-related contamination is eliminated, patient safety is improved, and the costs of care is decreased and optimized.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, FSHEA, FIDSA, is president and CEO of Community Health Associates, LLC. He also has an appointment as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. He is a Fellow in the National Academies of Practice, Society for Healthcare Epidemiology of America, and Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

The Participative Approach to Leadership

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, BC-MSLcert™, NCEE, NREMT, MSL-BC, DICO-C, TR-C, CPPS, CPHQ, CPXP, FACDONA, FAAPM, FNAP, FSHEA, FIDSA

Editor's note: This column originally appeared in the December 2021 issue of Healthcare Hygiene magazine.

The ongoing COVID-19 pandemic has taught healthcare a variety of lessons about both exemplary and also less than ideal leadership at all levels of the pandemic response. Healthcare leaders must adapt their leadership styles to meet the ever-changing needs of their teams and clinical environments.
There are many different kinds of leadership, and the style you choose could increase your chances of success. Research shows that participative leadership is usually more productive than authoritative models.

What is participative leadership exactly? It’s a form of governance that shares power and encourages input. Management studies show that it can enhance outcomes and increase job satisfaction and morale. It’s the difference between giving orders and building consensus.

For example, consider two different approaches to an office move. The CEO of a more autocratic hospital might pick the new location and give employees a list of tasks to complete.

On the other hand, a participative leader would form a committee to review possible patient safety issues and give employees the opportunity to discuss the project ideas and coordinate logistics.

Learning to be a more collaborative leader can help your relationships and your career. Put these suggestions to work for you.

Maximizing the Advantages of Participative Leadership:

1. Earn trust. For a participative workplace to flourish, colleagues need to trust their leader and each other. That requires confidence in each other’s character and abilities. Sincerity and transparency are essential.

2. Pull together. Close communication draws a team together. Employees are more likely to develop strong and healthy professional relationships and maybe even socialize more outside of work.

3. Increase engagement. According to recent Gallup polls, employee engagement is the lowest it’s been in 20 years. Fifty-four percent of employees say they are psychologically unattached to their work and do the minimum. Giving employees a greater voice can increase their commitment.

4. Celebrate diversity. One of the greatest strengths of participative leadership is welcoming contributions from team members with a variety of talents and backgrounds. Approaching challenges from many different perspectives usually creates more effective solutions.

5. Reward innovation. The free flow of ideas is another benefit. When you create a safe environment for discussion, employees are more likely to propose ideas that can help your business.

Overcoming Obstacles to Participative Leadership:

1. Clarify your vision. Motivating and inspiring your team becomes even more important when you expect them to make greater contributions. You need a clear mission that appeals to employees’ emotions and core values. Scheduling regular one-on-one time and providing adequate resources also helps.

2. Teach communication skills. With so much focus on discussion, employees may need to work on their communication skills, including active listening and sharing constructive feedback. Offer training sessions and post helpful reminders around the office. Use games and exercises to make learning fun and memorable.

3. Plan for delays. Another common drawback is the way group decisions usually take longer. You may need an alternative process when you’re dealing with time sensitive matters.

4. Provide structure. Planning ahead can also speed up discussions. Circulate an agenda before meetings, so attendees will come prepared and stick to the subject. Hire a professional facilitator or use a staff member. Nobody likes to attend meetings that are not producing meaningful outcomes!

5. Set boundaries. The participative model works best with issues where your staff has at least a minimum level of expertise. You may have to limit input on some matters to those who meet certain qualifications. This is especially true when dealing with specific medical specialties.

6. Deal with dissent. After your team votes, what do you say to the members who were in the minority? Make it clear from the start that each employee needs to be fully committed to backing the final decision.

7. Be decisive. Even in the most democratic workplace, there will be stalemates or decisions that are ill-suited to group deliberations. You’ll still need to take responsibility for resolving sensitive issues that affect the future of your organization.

You can develop your participative leadership skills with practice. Use them to advance your career and make your work more meaningful. Whatever your role is within your healthcare organization, leadership is the critical pinch point in the success or frankly the failure of challenging circumstances such as pandemics or other major events. Invest in yourself as a leader, invest in your teams as frontline providers, and never lose focus of the patients that we have the privilege to serve.

J. Hudson Garrett Jr. is president and CEO of Community Health Associates, LLC. He has an appointment as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine, is a fellow with the Institute for Healthcare Improvement, and has earned designation as a Fellow with both the Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

Building Consistency Within Infection Control Practices: Post-Pandemic Practices to Improve Clinical Outcomes and Reduce HAIs

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, NCEE, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, FSHEA

This column originally appeared in the November 2021 issue of Healthcare Hygiene magazine.

The ongoing impacts of the COVID-19 Pandemic are both substantial and far-reaching. Many healthcare personnel are approaching critical levels of stress and at significant risk for burnout. Patients continue to flow in and out of healthcare facilities at record paces, and the need for reinvestment across healthcare is of paramount importance. Unfortunately, the human body can only maintain itself at critical levels of stress for a short-extended period. Over the last few months, many healthcare facilities are reporting observations of healthcare workers becoming complacent with basic infection control practices such as hand hygiene, disinfection of surfaces, and appropriate use of personal protective equipment (PPE).

These practices are largely being driven by healthcare worker fatigue across the entire healthcare continuum of care. Recent data analysis from the Centers for Disease Control and Prevention (CDC) has revealed rising rates of antibiotic resistant pathogens and elevations in healthcare-associated infections (HAIs) in healthcare. With the recent focus of healthcare systems being on pandemic care management, attention towards HAI reduction efforts may have been sidelined due to a lack of resources or sheer time to focus on these initiatives.

As healthcare hopefully emerges from the most dramatic impacts of the ongoing COVID-19 pandemic threat, there is a need to readdress and prioritize Infection Control efforts in both inpatient and outpatient settings. Hand hygiene, environmental surface disinfection, proper use of gloves, etc., are all important core interventions that are known to reduce the risk for cross contamination, mitigate HAI risk, and decrease exposure to healthcare workers. A renewed focus on basic infection prevention and control measures cannot be driven by the facility’s infection preventionist alone but requires frontline leaders and staff engagement vertically and horizontally across the facility or health system. Only through this collaborative, team-based approach can sustained success against HAIs be achieved. Because HAIs have no boundaries, the approach to infection prevention must equally be multi-faceted and must reach all stakeholders deep within the organization. The approach must also be customized for frontline healthcare workers vs. those not in clinical environments or in support or leadership roles. This technique will build higher relevance for each stakeholder in the infection prevention and control process.

Whether during a pandemic or simply in normal operating circumstances, the CDC recommends an intense focus on core infection control interventions which include:
• Hand Hygiene
• Aseptic Technique
• Safe Injection Practices
• Standard and Transmission-Based Precautions
• Training and Education of Perioperative Personnel
• Patient and Family Education
• Environmental Hygiene
• Leadership Support
• Monitoring of Clinical Practice
• Employee and Occupational Health
• Early Removal of Invasive Devices

These Infection Control Core Practices outline a comprehensive approach to mitigating the risks of HAIs, but more importantly, consider the personnel and organizational challenges that might impede progress towards our goal of zero infections. Each organization might have unique challenges that must be addressed head-on, and then using a quality-based framework to continuous improvement will ensure compliance with current evidence-based practices for HAI prevention.

Healthcare leaders, infection preventionists and other executives must fully resource infection prevention and control (IP&C) programs, ensure that staffing is sufficient, and frontline staff are held accountable to facility policies and procedures. Now is not the time to take our foot off the gas of driving down HAIs, but rather a time to reflect on the lessons learned from the past two years, and strengthen the existing IPC program, leadership, and build momentum toward prevention efforts of the future.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, NCEE, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, FSHEA, is president and CEO of Community Health Associates, LLC. He also has an appointment as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

What is Healthcare’s Level of Readiness for the ‘Next Pandemic’ of Staffing Shortages?

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, NCEE, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, FSHEA

This column originally appeared in the October 2021 issue of Healthcare Hygiene magazine.

While healthcare facilities and professionals have endured the multiple impacts of the ongoing COVID-19 pandemic, there is another pandemic brewing in our midst that must be immediately addressed: healthcare personnel resilience and staffing. Think back to the first statement that we often hear on any commercial aircraft: In the event of an emergency, first place the oxygen mask on yourself before attempting to help others. This statement resonates directly with ongoing threats posed by the COVID-19 pandemic. If healthcare providers are not emotionally, mentally and physically well themselves, then they cannot adequately care for their patients.

The continuing impacts of the pandemic have created the “next pandemic” which is an immediately looming healthcare professional staffing crisis. At a time when healthcare demand is high and the need for experienced healthcare personnel is significant.

Chronic stress leads to increases in cortisol, which is recognized as the body’s stress hormone. When the body is subject to constant stress, this can negatively impact the human body, particularly the body’s immunity. Healthcare professionals experiencing significant stress or burnout can reach a point of compassion fatigue, which is defined as a state of exhaustion and dysfunction (biologically, psychologically, and socially) because of prolonged exposure to secondary trauma or a single intensive event. In this case, the prolonged exposure is due to the ongoing impacts of the COVID-19 pandemic. Stress can manifest itself in symptoms such as helplessness, feeling incapable of effecting successful patient outcomes, confusion, isolation, exhaustion, and the feeling of being overwhelmed by work.

Burnout can present quite differently in each individual, but infection prevention leaders and healthcare executives should observe for the following signs which may be quite subtle:
• Physical, emotional, and mental exhaustion caused by long term involvement in emotionally demanding situations
• Role overload – expectations of others exceed one’s ability to perform
• Role conflict – forced to make a choice about which demand to satisfy

Burnout, when not recognized or treated, can lead to emotional exhaustion, a feeling of low personal accomplishment, and depersonalization of the patient. Burnout can be resolved with the proper resources and treatment modalities. During the ongoing pandemic, and also after it has subsided, healthcare professionals and especially those directly caring for COVID-19 patients will continue to be at risk for stress and burnout. Healthcare facilities should make available onsite and complimentary stress management services such as Critical Incident Stress Debriefing and also access to professional counseling services as necessary.

Resilient people generally have several key characteristics which include: a strong family connection, a robust social support infrastructure, a fulfilled spiritual life, meaningful personal connections with others, an optimal physical environment such as one’s home, and a sense of inner wisdom. Building personnel resiliency is not a one-time, term-limited activity, but rather must remain an ongoing and concerted effort across the entire healthcare system

Healthcare executives and leaders must take immediate action to ensure that frontline healthcare personnel have all necessary tools and resources to properly care for their patients but also take care of themselves. Frontline personnel such as nurses, patient-care technicians, EMS personnel, respiratory therapists, physicians, and other support personnel continue to be directly in the bullseyes of the COVID-19 pandemic and are at most risk for burnout. As such, the time is now to invest in frontline personnel and ensure leadership throughout healthcare is well-prepared to support these ongoing demands for the foreseeable future.

Pandemics and Beyond: An Evidence-Based Approach to Resiliency in the Perioperative Environment

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP

Editor's note: This column originally appeared in the August 2021 issue of Healthcare Hygiene magazine.

Over the past year and a half, perioperative clinicians and service lines have been challenged with addressing many challenges as a result of the ongoing COVID-19 pandemic. These challenges included cancelled surgical procedures, staffing shortages and furloughs, delays in care, and generalized fear of the unknown viral pathogen. This pandemic has served as a tremendous learning opportunity for both healthcare institutions and perioperative personnel. Impacts of the ongoing pandemic threat include:

• Fear and worry about your own health and the health of your loved ones
• Changes in sleep or eating patterns
• Difficulty sleeping or concentrating
• Worsening of chronic health problems
• Worsening of mental health conditions
• Increased use of alcohol, tobacco, or other drugs
• General Irritability due to chronic stress and anxiety

Currently, the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) COVID-19 Module tracks patient impatient and hospital capacity, healthcare worker staffing, and healthcare supply chain. There is an important element missing from this module, however, which is the impact to the actual healthcare personnel. Perioperative clinicians are continuously making efforts to catch up with previously postponed procedures, which can greatly stress existing perioperative staffing models.

To reduce the incidence of burnout, there are several key tips that can be followed to protect patients, perioperative clinicians, and healthcare institutions:

1. Create a Culture of Resiliency: Build a culture that is focused on excellence, being part of something meaningful, and allow perioperative staff to have autonomy.
2. Build a Personal Pandemic Plan: Perioperative clinicians must have a personal pandemic plan that is focused on how to address their family’s protection, living circumstances during a period of isolation or quarantine, access to personal medications and toiletry items.
3. Prepare Your “Go” Bag: This bag should be always ready to grab at a moment’s notice and should include your personal favorite items such as snacks, lip balm, and other creature comforts.
4. Maintain Your Normal Routine: Managing chronic stress such as that during long working shifts can be effectively managed with exercise, spending time with friends, family, and coworkers outside of the hospital, protective one’s sleep hygiene, and remaining engaged in personal activities such as hobbies or faith-based activities.
5. Accept a Culture of Learning and Focus on Failures: The perioperative environment is a fast-paced and complex clinical care setting, which is bound to have periodic errors. With every error comes an opportunity to reduce a Surgical Site Infection or other adverse event in the perioperative setting.
6. Implement a Hierarchy of Controls Approach to Preventing Surgical Site Infection: Focusing on Elimination as the highest intervention will help substantially reduce risk. Next, risks can be substituted. A third option is utilizing Engineering Controls. Administrative controls are an additional option. Finally, the use of personal protective equipment (PPE) is the last line of defense in protecting both the perioperative clinician and the patient themselves.

Whether during a pandemic or simply in normal operating circumstances, the CDC recommends an intense focus on core infection control interventions which include:
• Hand hygiene
• Aseptic technique
• Safe injection practices
• Standard and transmission-based precautions
• Training and education of perioperative personnel
• Patient and family education
• Environmental hygiene
• Leadership support
• Monitoring of clinical practice
• Employee and occupational health
• Early removal of invasive devices

The impact of adverse events such as surgical site infections or wrong-site surgeries are widespread to the patient and healthcare facility. A vigilant focus on improving patient safety and infection control will yield substantial results for clinical outcomes. Perioperative clinicians are instrumental in not only improving patient safety, but also must ensure that they practice self-care. The impacts of reduced staffing, pandemics, high throughout, etc. can be detrimental to even the most seasoned perioperative clinicians. A team-based approach to resilience will improve the workplace culture, reduce errors, and improve staff morale.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. He may be reached at: Hudson.garrett@chaassociates.com

Breaking Down the FDA EUA Vaccine Review Process

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP

Editor's note: This column originally appeared in the July 2021 issue of Healthcare Hygiene magazine.

Over the past year and a half, there has been a tremendous amount of media coverage regarding the currently three Emergency Use Authorized (EUA) COVID-19 vaccines available in the United States. Understandably, many consumers and healthcare practitioners are not familiar with the relatively new EUA process that is orchestrated by the Food and Drug Administration (FDA).

There are multiple phases of clinical trials that exist beginning at Phase 1 through Phase 4. Phase 1 trials focus on whether or not the medication is safe. Phase 2 trials add to the findings of Phase 1 trials by determining whether there is truly efficacy or effectiveness of the medication. Phase 3 trials then combine the safety and efficacy clinical outcomes in a larger study population, especially one that is representative of the disease in question. After Phase 3 trials have concluded and the data has been analyzed, the medication is submitted to the FDA for review and consideration of licensing. Prior to FDA’s final decision being reached regarding new medication approval, the FDA utilizes the services of it’s external Advisory Board for further independent review of the medication’s safety and efficacy profile based on submitted clinical data. In addition, once the FDA issues its approval of a new vaccine, the CDC’s Advisory Committee on Immunization (ACIP) then makes formal recommendations regarding vaccine administration practices, which was the case for the recent three EUA COVID-19 vaccines.

The FDA’s medication review process is quite intensive by design and is charged with identifying any significant safety and/or efficacy concerns that might exist with the new medication. Phase 4 trials take place after the new medication is distributed in the market and serve the purpose of ongoing surveillance and monitoring for safety related concerns such as unexpected adverse events. In addition to the ongoing Phase 4 trials, the Centers for Disease Control and Prevention (CDC) has also launched an additional safety tracking mechanism specific to the COVID-19 vaccine, which is called vSAFE, which serves as a direct communication tool between public health experts at the CDC and the actual individual vaccine recipients.

The Emergency Use Authorization approval process is a multi-step process for any potential new medication and begins with the presence of a confirmed public health emergency. In order for an EUA to be granted by the FDA, four basic criteria must be met:
1) The presence of a serious or life-threatening condition must be present
2) Evidence of effectiveness of the new medication demonstrating benefit for the specific targeted disease
3) The risk-benefit analysis for safety must be substantial, and
4) There are no other alternatives that exist to treat the condition or disease

Once the declaration of the public health emergency is made ferally, then drug manufacturers that have potential products that would be relevant to the public health threat can request a pre-EUA submission meeting with the Food and Drug Administration. This collaborative type of meeting with the FDA facilitates a much more productive dialog and expedites the submission of a new product to the agency for EUA consideration. The new medication can then be submitted to the FDA for consideration of EUA approval, followed by the agency’s determination to either approve or reject the submission. Finally, the EUA approval is terminated once the declared public health threat is over and the public health emergency declaration is rescinded. Once an declared public health emergency is over, the drug manufacturer is expected to work with the FDA to submit the medication for full FDA licensing approval.

The COVID-19 pandemic has required the engagement of multiple federal, state, and local public health agencies, the assistance of private industry partners, and the continued collaboration with researchers, clinicians, practitioners, and many more across the entire healthcare continuum of care. While the vaccine regulation process in the United States may not be perfect, it is still the most robust system of its type globally and provides significant oversight to new medications being considered for use in the country. The next step in the COVID-19 vaccination process is widespread education of frontline healthcare providers on the various types of COVID-19 vaccines and frequently asked questions that patients may commonly ask. Regulatory review and approval, ongoing clinical research regarding safety and clinical outcomes, and healthcare provider education on vaccines will help curb the ongoing pandemic threat.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is president and CEO of Community Health Associates, LLC, and also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

A Needed Time for Recharging: Resetting Resilience During and After a Pandemic

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP

This column originally appeared in the March 2021 issue of Healthcare Hygiene magazine.

The COVID-19 pandemic has created some of the most significant and far-reaching consequences on modern healthcare in history. As such, healthcare worker resiliency is extremely low due to the ongoing demands of the pandemic. Most healthcare professionals have never experienced a pandemic, much less a national outbreak in their careers. This novel pathogen has exploited the many vulnerabilities within the global healthcare system. Luckily, pandemics are not normally long-range events and therefore our heightened state of response is hopefully coming to an end very soon. The level of stress created during a pandemic is not normal and likely can cause anxiety in even the most resilient healthcare providers. A key to maintaining one’s resilience is proper recognition of both acute and chronic stress, despite the specific cause.

The stresses resulting from the pandemic can include subtle changes in healthcare provider’s including:
• Difficulty sleeping
• Changes in appetite, energy, desires and interests
• Difficulty concentrating and making decisions
• Irrational feelings of anger, fear, worry, numbness or frustration
• Worsening of chronic health conditions
• Increased use of alcohol, drugs, and/or tobacco Items
• Physical pain such as back pain or nausea

There are several recommended stress-management techniques that can be used to help healthcare workers maintain some semblance of “normalcy.” These techniques assist healthcare personnel with balancing personal physical, mental, and emotional needs during the ongoing challenges associated with the pandemic.

• Maintain a normal schedule as much as possible.
• Eat a healthy and balanced diet.
• Build a solid support structure of colleagues, friends, and family to help protect your mental health.
• Engage in outdoor activities when permissible with local weather conditions.
• Exercise at least 30 minutes a day.
• Ensure adequate sleep.
• Schedule time to unwind.
• Take frequent breaks as possible.
• Engage in alternative medicine stress reduction techniques such as meditation or acupuncture.

The Centers for Disease Control and Prevention (CDC) has created unique capacity categories related to the use of personal protective equipment (PPE) during a pandemic. There are three basic classifications: Conventional, Contingency, and Crisis. These levels of PPE availability and need can be extrapolated to the management of healthcare worker resilience:
• Conventional: “All systems are operating as normal” as they say with no significant changes in patient acuity, volume, or infection transmission risk to healthcare personnel. In this capacity setting, healthcare workers are not experiencing abnormal levels of stress, and therefore no specific risk mitigation is necessary to decrease the impacts of stress.
• Contingency: In this response mode, healthcare systems and personnel are being subjected to increased patient censuses and resilience begins to decrease acutely.
• Crisis: In crisis mode, all normality is absent of the situation and healthcare professionals are forced to operate in a climate of “uncharted territory.” Healthcare personnel may be operating without proper PPE and experience concern of potential transmission from themselves to family and friends. The human body is not designed to endure a sustained and constant stress response, therefore preventative measures are helpful in reducing the risk for negative impacts

Healthcare facilities, specifically healthcare executives must support frontline healthcare workers in making mental and physical health resources readily available. Healthcare personnel can serve as collaborative support systems for one another and help to reduce any cumulative impacts of pandemic stress. While the full impacts of this pandemic have not been fully appreciated, they will likely be far-reaching and have a significant impact on healthcare for many years to come. Mitigation techniques to reduce stress can substantially improve healthcare personnel resiliency, decrease the impacts of stress on the human body, and ensure continued clinical continuity of healthcare delivery.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is president and CEO of Community Health Associates, LLC, and also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

What is Our Responsibility With the COVID-19 Vaccine as Healthcare Providers?

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP

This column originally appeared in the January 2021 issue of Healthcare Hygiene magazine.

With the recent Emergency Use Authorizations (EUA) from the Food and Drug Administration (FDA) for two COVID-19 vaccines, there is finally true hope in curbing the transmission of the highly transmissible SARS-CoV-2 virus. FDA defines EUA as “an expedited authorization and use of an unapproved product or the off-label use of an already approved product in a declared emergency involving a chemical, biological, radiological, or nuclear (CBRN) agent.” These medical countermeasures can include drugs, devices or biologics that have potential to “diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a CBRN agent when there are no adequate, approved, and available alternatives. FDA established four criteria that must be met for an EUA to be granted which include:
1. Presence of a serious or life-threatening condition
2. Evidence of effectiveness
3. Risk-benefit analysis for safety
4. No other alternatives to address the life-threatening condition

While the FDA is the responsible federal agency for the regulation of drugs and vaccines, FDA scientists and career regulatory officials work extremely closely with the Centers for Disease Control and Prevention (CDC) to develop clinical recommendations for both healthcare providers and the general public related to vaccine prioritization and administration. Healthcare providers are in a unique position given their professional role in caring for likely immunocompromised patients. Published data from the CDC and other public health authorities has demonstrated that immunocompromised persons and those with significant comorbidities are at higher risk for experiencing elevated poor clinical outcomes. As such, healthcare providers need to serve as ambassadors for the COVID-19 vaccines not only within their healthcare institution but also in their community involvement in places of worship, athletics, etc.

By setting an example and being stewards of infection prevention and control, we can help build the needed community heard immunity to stop the widespread and ongoing community transmission that is plaguing communities across the globe. Infection preventionists must be trusted by the patients and also our colleagues, and with this trust comes a deep responsibility to advocate for public health including vaccines for all eligible patient candidates.

Healthcare leaders and infection preventionists should be properly trained and deemed competent on several core issues related to vaccine safety, administration, and monitoring. The skills below are critical to ensuring the safety and efficacy of the vaccine:
• Storage and handling of vaccine
• Preparation of vaccine
• Administration of vaccine
• Emergency response preparedness
• Documentation
• Immunization Information System (registry) data entry
• Patient education
• Staff education
• Adverse event monitoring

Additionally, the vaccine manufacturers in collaboration with FDA and CDC have created vaccination information documents for both vaccine recipients and also healthcare providers administering the vaccine. These handouts provide answers to the most frequently asked questions, and can be helpful in answering questions from patients, healthcare colleagues, and family members regarding the vaccines. It is expected that additional vaccines will be issued an EUA in the first quarter of 2021, which will allow for more widespread distribution of the vaccine to community settings.

As further data is collected, analyzed, and submitted to the FDA for review and approval, other groups of potential vaccine candidates such as pediatrics and pregnant women may be potentially added if the science supports the use of the vaccine in these unique patient populations. Vaccination, combined with a continued emphasis on infection control interventions, will help curb the tide of this pandemic and allow us to move forward.

For more information on the available COVID-19 vaccines, visit the CDC website at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

Strategies to Reduce the Transmission of Respiratory Infections During a Pandemic

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP

This column originally appeared in the December 2020 issue of Healthcare Hygiene magazine.

With the ongoing COVID-19 pandemic, healthcare professionals and facilities must maintain vigilance in the prevention of common and seasonal transmissible respiratory infections such as Influenza, rhinovirus, and RSV. Respiratory infections are primarily spread via infectious respiratory droplets that enter the human body through mucous membranes or via indirect contract with contaminated environmental surfaces or the hands of healthcare personnel. These droplets can survive on environmental surfaces such as overbed tables, wheelchairs, IV poles, call light/TV remotes, bedrails, and other surfaces for varying timeframes from hours to days in some cases depending upon the specific microorganism.

Basic infection control and prevention measures such as hand hygiene, cleaning and disinfection of the clinical environment of care, and proper respiratory etiquette practices will greatly reduce the spread of these infections in both healthcare and community settings. Certain patient populations, such as those with chronic comorbidities as chronic obstructive pulmonary disease, hypertension, type 2 diabetes, and congestive heart failure, are typically at increased risk for developing severe complications such as pneumonia and sepsis from respiratory infections. It is critically important for healthcare facilities to take extra precautions to protect these vulnerable patient populations that have high-risk healthcare conditions.

The Centers for Disease Control and Prevention (CDC) guidance provides several core recommendations which will reduce the potential transmission of both COVID-19 as well as other common transmissible respiratory infections.

• Cough Etiquette: Covering your cough or sneeze with your elbow or a tissue will reduce the spread of infectious respiratory droplets into the air which could expose others in the immediate vicinity to these droplets. The CDC has several educational campaigns that can assist healthcare facilities with reminding patients, visitors, and healthcare personnel about these basic respiratory protection and infection control.
• Hand Hygiene: Hand hygiene may be performed with either soap and water or an alcohol-based hand rub with an alcohol concentration between 60 percent to 90 percent. It is also important that any alcohol-based handrubs be properly cleared through the Food and Drug Administration to ensure both safety and efficacy. Alcohol-based handrubs are highly effective against a wide variety of bacteria and viruses and are an important element for both patients and healthcare personnel to break the chain of infection transmission. Hand hygiene remains the single most important infection prevention intervention that is in our arsenal as healthcare providers.
• Disinfection: Disinfection of high-touch surfaces with an Environmental Protection Agency (EPA)-registered disinfectant greatly reduces the presence of viable virus on environmental surfaces and medical devices. The EPA has published a new List N which identifies all EPA-registered disinfectants that are deemed effective against SARS-CoV-2 virus on hard, non-porous surfaces. Disinfectants used should be broad-spectrum and have a low overall contact time to ensure that room turnover is not compromised. They should also be compatible with commonly used healthcare surfaces and devices to ensure that degradation of the clinical environment does not occur due to incompatibility between the disinfectant and the actual healthcare environment itself. Due to product supply challenges, disinfectants may be available in a variety of different formats including ready-to-use wipes, liquids, sprays, or also distributed thru novel technologies such as electrostatic spraying modalities.
• Face Coverings or Masks: The CDC continues to recommend the use of a universal face coverings for the general community and the use of FDA-cleared masks for healthcare providers to create universal source control when addressing potential spread of COVID-19 infection. In the healthcare settings, healthcare providers should wear FDA-cleared medical masks and follow their institutional policies and procedures for the appropriate use of Personal Protective Equipment.
• Universal Screening: Screening of both healthcare providers and also patients/visitor for potential infectious respiratory diseases. This screening includes temperature, symptoms of common respiratory infections, travel history, and recent exposure history (usually within the last 14 days). This screening should be conducted each time a patient/visitor or healthcare provider enters the healthcare facility.
• Social Distancing: Remaining at a distance of six feet or greater will help reduce the potential dispersal of contaminated droplets from one person to another particularly with COVID-19 infection, but also can be helpful with common respiratory infections. More importantly, if a healthcare provider is ill, they should not report to work and stay home to avoid exposing their colleagues and patients to potential infection.
• Vaccines: Certain vaccines, such as the annual Influenza vaccine, are not only effective at mitigating the potential spread of common respiratory infections, but also in many instances can reduce the potential severity of illness in affected patients or healthcare personnel. The CDC publishes annual guidance on appropriate vaccines for both healthcare personnel as well as patients that should be used to guide best practices for infection prevention and control.

While the COVID-19 pandemic is now entering a new phase with vaccine availability, healthcare personnel and facilities must continue to adhere to the CDC’s recommended infection control practices to prevent the transmission of these respiratory infections. This involves a comprehensive approach that addresses risks of patients, visitors, and healthcare personnel together to reduce potential spread of these infections. While vaccines are playing a larger role in the reduction of common respiratory infections such as Influenza, core infection control practices remain the mainstay for reducing transmission, improving outcomes, and ensuring the continuity of clinical operations during both pandemic and normal seasonal respiratory infection periods.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

CDC Releases New Guidance on Potential Additional Routes of COVID-19 Transmission

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP

Editor's note: This column originally appeared in the November 2020 issue of Healthcare Hygiene magazine.

Recently, the Centers for Disease Control and Prevention (CDC) released new guidance specific to the modes of transmission of COVID-19. This new guidance, which was released on Oct. 6, 2020, details an additional route of potential infection transmission: “airborne.” It is important to note that the term “airborne” transmission within healthcare settings has specific connotations regarding the appropriate level of respiratory protection and personal protective equipment (PPE) required for personnel protection.

In this new guidance update, the CDC has provided additional details regarding the potential of low-frequency potential spread of COVID-19 infection in environment where air flow is stagnant, and ventilation is inadequate. SARS-CoV-2 virus, which causes COVID-19 infection, can be spread via aerosols in the air in certain environments. COVID-19 remains a highly transmissible virus and spreads most often during close and prolonged contact with an infected person. Respiratory droplets, containing SARS-CoV-2 virus can be spread when a person sneezes, coughs, or sings. These small droplets can be transmitted in aerosols for longer distances before eventually falling to the floor.

The new CDC Guidance states the following points regarding the potential airborne transmission of COVID-19:

• Some infections can be spread by exposure to virus in small droplets and particles that can linger in the air for minutes to hours. These viruses may be able to infect people who are further than 6 feet away from the person who is infected or after that person has left the space.
• This kind of spread is referred to as airborne transmission and is an important way that infections like tuberculosis, measles, and chicken pox are spread.
• There is evidence that under certain conditions, people with COVID-19 seem to have infected others who were more than 6 feet away. These transmissions occurred within enclosed spaces that had inadequate ventilation. Sometimes the infected person was breathing heavily, for example while singing or exercising.
• Under these circumstances, scientists believe that the amount of infectious smaller droplet and particles produced by the people with COVID-19 became concentrated enough to spread the virus to other people. The people who were infected were in the same space during the same time or shortly after the person with COVID-19 had left.
• Available data indicate that it is much more common for the virus that causes COVID-19 to spread through close contact with a person who has COVID-19 than through airborne transmission.

This new CDC guidance is similar to recommendations for several other highly transmissible respiratory infections where aerosols may remain suspended in the air for an extended period of time, especially in indoor environments where the air circulation is inadequate. However, it is important to note that this route is not the most common mode of the transmission of COVID-19. The CDC’s core infection control recommendations have not changed and include fundamental interventions which aim to reduce the presence of viable virus in the environment, protect healthcare personnel and patients, and mitigate the potential spread of the SARS-CoV-2 virus. The CDC’s Core Recommendations to assist with mitigation of COVID-19 include:
• Hand Hygiene: Hand Hygiene may be performed with either soap and water or an alcohol-based hand rub with an alcohol concentration between 60-90%. It is also important that any alcohol-based hand rubs be properly cleared through the Food and Drug Administration to ensure both safety and efficacy. Hand Hygiene remains the single most important infection prevention intervention that is in our arsenal as healthcare providers.
• Face Coverings or Masks: CDC continues to recommend the use of a universal face coverings for the general community and the use of FDA-cleared masks for healthcare providers to create universal source control.
• Universal Screening: Screening of both healthcare providers and also patients/visitor for potential infectious respiratory diseases
• Social Distancing: Remaining at a distance of six feet or greater will help reduce the potential dispersal of contaminated droplets from one person to another.
• Disinfection: Disinfection of High-Touch Surfaces with an Environmental Protection Agency (EPA)-registered disinfectant greatly reduces the presence of viable virus on environmental surfaces and medical devices. The EPA has published a new List N which identifies all EPA-registered disinfectants that are deemed effective against SARS-CoV-2 virus on hard, non-porous surfaces.

Fighting COVID-19 requires a persistent and interprofessional approach to infection prevention and control. The development of additional diagnostic testing, therapeutics, and most recently vaccines to fight COVID-19 will help healthcare providers to further reduce the impacts of the ongoing COVID-19 pandemic. Operation Warpspeed and the core infection control practices such as hand hygiene, proper use of PPE, and the routine disinfection of the healthcare environment will all directly help curb the spread of COVID-19.

For more information, visit: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

Vetting Infection Control Technologies: Ensuring Safe and Efficacious Usage in Healthcare Settings

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP

This column originally appeared in the September 2020 issue of Healthcare Hygiene magazine.

Anytime there is a pandemic threat or large-scale outbreak of an infectious disease, there is a predictable entry of “novel” infection control products and technologies into the U.S. marketplace. Many of these technologies claim to solve the specific pandemic or outbreak-related threat yet may not hold the necessary product registrations from the government nor have independent efficacy validation to substantiate claims or safety instructions. Most infection prevention and control products will be regulated by either the Environmental Protection Agency (EPA) or the Food and Drug Administration (FDA). In most cases, products must first be approved by these agencies prior to being marketed to customers. Healthcare facilities should carefully review all product information prior to instituting product evaluations/trials or implementing new products/technologies.

Here are a few best practices to ensure that any products utilized meet the stringent requirements for safety and efficacy:
1. Review the product’s registration or approval classification. For products that are used on humans or given as medications, they will be regulated by the FDA or the EPA. To determine whether a product hold these regulatory approvals, healthcare providers can visit www.fda.gov or www.epa.gov. All product registration information indicating product approval or registration is available to the public.
2. Review the product’s technical data specific to efficacy, claims, and safety. It is imperative that healthcare users evaluate products to ensure that they are safe for the patient, healthcare team, and environment, and also are efficacious and deliver upon their clinical claims (e.g., microbe-kill claims, etc.).
3. It is important to note how long an infection control product takes to work such as an environmental surface disinfectant may take 5 minutes to fully inactive all microorganisms. While, in this example, that would be appropriate for disinfecting an animate surface, this timeframe would be far too long for healthcare professionals to wash their hands. Therefore, products must have reasonable contact times to achieve efficacy so that compliance with use remains as high as possible.
4. Ideally, utilize products that are broad spectrum and demonstrate validated efficacy against the following key microorganisms:
a. Gram-positive bacteria
b. Gram-negative bacteria
c. Enveloped viruses
d. Nonenveloped viruses
e. Pathogenic fungi
f. Bloodborne pathogens (minimum of hepatitis B virus and HIV) for environmental surface disinfection especially
g. Bacterial spores as appropriate
5. Speak with colleagues in other healthcare institutions that are current users of the product to determine their experience with the product or technologies. This type of personal experience can be invaluable.
6. Review the product’s safety data sheet to conduct a risk assessment about potential risks that might be relevant to either the patient or the healthcare team.
7. Involve your facility infection preventionist (IP) upfront in the product evaluation checklist. The IP must be an integral partner in evaluating any new technology to ensure that it meets the current evidence-based standards and guidelines related to infection prevention and control.
8. In addition to vetting the safety and efficacy of infection control-related products, healthcare facilities should ensure the compatibility of certain products such as environmental disinfection agents with common surfaces specific to the facility (e.g., overbed tables, counter tile, stainless steel, etc.).

Emerging infectious disease challenges and threats create a sense of urgency in the clinical practice arena, but also can create risks associated with non-vetted products that might endanger patients. Following a standardized process, involving the facility IP, and thoroughly vetting each product will significantly mitigate the risks associated with these new market entrants. IPs bring unique expertise to the table related to product evaluation and are an integral part of the value analysis process in both inpatient and outpatient settings.

While we cannot stop every outbreak or pandemic, through a proactive and comprehensive approach to infection control, we certainly can be ready and able to respond to the next infectious disease threat that might land at our front doors.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is the president and CEO of Community Health Associates, LLC. He also is an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Dr. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He can be reached at: Hudson.garrett@chaassociates.com

A Time for Collaboration: A Needed Paradigm Shift in Interprofessional Communication to Reduce Healthcare Associated Infections

By J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP

This column originally appeared in the August 2020 issue of Healthcare Hygiene magazine.

COVID-19 has exposed many vulnerabilities in our healthcare delivery system, most notably issues with availability of Personal Protective Equipment and compliance with established core practices in infection prevention and control, but there are other major opportunities to improve safety. Patients and microbes really know no formal boundaries, and therefore our efforts as a healthcare team must be agile and very comprehensive in nature.

Healthcare facilities such as long-term care facilities and acute-care hospitals have been dramatically impacted by surges of COVID-19 patients, and this can create communication challenges even among the top-rated healthcare facilities in the country. These ongoing challenges require a collaborative, transparent, and comprehensive approach to ensuring that all patient information is handed off during every patient transfer event.

Now more than ever, healthcare providers must take the necessary time to clearly communicate all clinical issues relevant to the patient’s clinical care. Clinical patient care may be delivered by a wide variety of stakeholders such as registered nurses, providers (physicians, nurse practitioners, clinical nurse specialists, and physician assistants), nursing technicians, and emergency medical services professionals. Each of these healthcare team members is exposed to potential infectious disease threats and must be fully integrated in the clinical care of the patient to optimize the clinical outcomes of each patient as well as maintain personal safety.

During the COVID-19 pandemic, inter-facility transfers, especially from acute care hospitals to long term care facilities are quite common and require transportation by skilled Emergency Medical Services (EMS) providers. During these transfers, EMS providers are often faced with unique infection control challenges such a small, cramped patient-care environment, limited ventilation capabilities, and ongoing shortages of personal protection equipment (PPE). It is important for acute-care nursing professionals to fully communicate the entire “clinical picture” of the patient, especially infectious diseases that might threaten the health and safety of other healthcare providers as well as patients in the receiving facility.

Here are a few best practices to break down barriers in patient hand-offs to improve safety and reduce the risk for occupational exposure:

1. Review ALL isolation precautions and rationale for these precautions with any member of the healthcare team that will be taking over patient care.
2. Ensure that all necessary PPE is available to ensure compliance with Centers for Disease Control and Prevention (CDC) guidelines and recommendations.
3. The sending facility must communicate with the receiving facility all current infection control and infectious diseases issues associated with the patient prior to transferring the patient.
4. If EMS professionals must transport a patient wearing PPE, then sending hospitals should provide a “clean escort” for the EMS crew all the way to the transport unit to minimize potential contamination during the movement of the patient out of the sending facility.
5. Before transferring a patient, the sending facility must confirm that the receiving facility has all the necessary capabilities (e.g. trained staff, PPE, laboratory testing etc.) to properly care for the patient’s infectious disease (s).
6. If transporting an patient that has an active infectious disease requiring isolation precautions, carefully follow all CDC recommendations to minimize exposure to others and potential occupational transmission to the healthcare providers transporting the patient.

Pandemics and outbreaks always present healthcare providers and facilities with difficult challenges, but we have the capability to stop infection transmission in its tracks if we focus on adoption of core practices of infection prevention and control such as hand hygiene, environmental surface disinfection, and the appropriate use of PPE combined with enhanced communication regarding patient clinical care and needs. There are widely available evidence-based communications tools and programs such as TeamSTEPPS and Just Culture that can enhance interprofessional healthcare communication and break down silos. Together, we can significantly reduce the risk of transmission of infectious diseases and ensure workplace safety.

J. Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, IP-BC, PLNC, CFER, AS-BC, VA-BC, MSL-BC, CPPS, CPHQ, NREMT, CADS, FACDONA, FAAPM, FNAP, is the president and CEO of Community Health Associates, LLC, and also is an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

The Need for Change in Infection Prevention and Control: Protecting Our Most Vulnerable Populations

By Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, PLNC, AS-BC, IP-BC, VA-BC™, CFER, CPPS, NREMT, FACDONA, FAAPM, FNAP

This column originally appeared in the July 2020 issue of Healthcare Hygiene magazine.

Over the last few months during the COVID-19 pandemic, the tremendous infection control vulnerabilities that exist in many of America’s long-term care facilities (LTCFs) have been exposed. During the course of the pandemic, LTCFs have been under tremendous pressure to care for COVID-19 patients as well as prevent transmission within the facilities. Because most LTCFs are not built with the necessary engineering controls and physical space to care for patients with transmissible infections, this has created significant infection control challenges. In addition, the widespread lapse of general infection control practices in these facilities has been repeatedly demonstrated in Centers for Medicare and Medicaid Services (CMS) regulatory surveys. Patients are commonly crowded together into small rooms, staff are frequently moving between multiple areas within the facility, and personal protective equipment (PPE) may not be readily available.

These unique logistical challenges play a substantial role in potential transmission of infectious pathogens not only for the residents and staff, but also external stakeholders such as the staff member’s families if proper precautions are not followed. Both the Centers for Disease Control and Prevention (CDC) and Centers for Medicare and Medicaid Services (CMS) have released extensive and detailed infection control guidance documents, recommendations, and requirements. CMS and CDC staff have also regularly provided infection control risk assessments through virtual means to increase the awareness of these practices in LTCFs. While these additional assessments are helpful, there continue to be large gaps with following basic infection control practices such as performing hand hygiene.

There are a few basic steps that LTCFs that can to ensure that they are ready for the next pandemic:
1. Appoint a full-time, properly trained infection preventionist that is dedicated to managing the facility’s infection prevention and control program. This individual should have extensive training and/or board certification in the specialty of infection prevention and control.
2. Frontline clinical care staff must receive role-specific, mandatory training on the CDC core elements of infection control with psychomotor competency evaluation. Common topics that should be included include hand hygiene, environmental disinfection, safe injection practices, and the proper use of personal protective equipment.
3. Facility leadership must take an active role in the resourcing of the infection prevention and control program and support a full-time position for the Infection Preventionists. Commonly, in LTCFs, the infection preventionist role is one small part of the individual’s overall scope of responsibilities. With the recent challenges identified by COVID-19 patients in these facilities, it is imperative that the program be strengthened and appropriately resourced.
4. Reasonable accommodations should be made to allow relatives to visit their loved ones so that social isolation does not have negative impacts on both the residents and their families. These accommodations could include an outside meeting point with social distancing, the use of video technology, or other innovative means. Isolating residents long term is not a sustainable solution and can lead to significant deterioration of their existing conditions.
5. Staff members and residents should have access to hand hygiene throughout the facility and perform hand hygiene in accordance with hand hygiene recommendations from the CDC.
6. Staff should receive competency driven and hands on training regarding the proper use of PPE. PPE should not be reused unless supply chain shortages exist requiring reuse. Facilities should carefully follow the existing PPE reuse recommendations published by the CDC.

While LTCFs serve a vital role in caring for America’s senior citizens and rehabilitation patients, they must dramatically increase their infection prevention and control efforts. Facility administrators, medical directors, and directors of nursing must be actively engaged in the infection control program, ensure that staff accountability exists for following infection control procedures, and actively engage the residents in the process when necessary. Thru interprofessional collaboration across all healthcare disciplines, infection risk can be substantially reduced to both residents and also the facility staff. The COVID-19 pandemic has created awareness around infection control vulnerabilities and the time to hardwire sustainable infection control practices is certainly right now.

Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, PLNC, AS-BC, IP-BC, VA-BC™, CFER, CPPS, NREMT, FACDONA, FAAPM, FNAP, is the president and CEO of Community Health Associates, LLC. He also serves as an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

A Post-COVID World: Hardwiring Core Practices for Infection Control and Patient Safety

By Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, PLNC, AS-BC, IP-BC, VA-BC™, CFER, CPPS, NREMT, FACDONA, FAAPM, FNAP

This column originally appeared in the June 2020 issue of Healthcare Hygiene magazine.

The ongoing COVID-19 pandemic has reminded healthcare professionals of the tremendous value of adhering to core practices for infection prevention and control. To protect both healthcare workers and staff from future infectious diseases and pandemics, healthcare leaders must ensure that every facility has a robust and well-supported infection prevention and control (IP&C) program.

Regardless of where patient care may be delivered, the core expectations of safe clinical care remain the same. In an effort to assist healthcare facilities with adhering to evidence-based strategies for IP&C, the Centers for Disease Control and Prevention (CDC) developed the Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings - Recommendations of the Healthcare Infection Control Practices Advisory Committee. These core practices represent the most important infection control interventions necessary to keep both patients and healthcare staff safe from infectious pathogens.

The Core Practices include:
1. Effective Leadership and Support: IP&C starts and ends with the chief executive officer (CEO). Leadership must resource the program which may include personnel, technology, or program resources.
2. Education and Training of Healthcare Personnel on Infection Prevention: Training must extend beyond basic training techniques and be focused on role-specific competency. This competency-driven approach assists healthcare staff members with safely performing their role.
3. Patient, Family and Caregiver Education: Education goes well beyond the healthcare team and extends to both families and caregivers, especially in outpatient settings such as home care.
4. Performance Monitoring and Feedback: IP&C practices must be continuously assessed in order to monitor for compliance. If infection control practices are not being properly followed, then clinicians must be afforded immediate constructive feedback specific to improvement strategies.
5. Standard Precautions: Standard Precautions represent specific basic practices that should be followed when caring for each patient. These practices make the assumption that all patients might have an infectious disease and also protects the patient and healthcare team from potential transmission.
a. Hand Hygiene: Hand hygiene remains the single most important infection control intervention that we have in our toolkit against infectious diseases. The regular practice of hand hygiene with either soap and water or an alcohol-based handrub can help stop the transmission of germs in their tracks.
b. Environmental Cleaning and Disinfection: The use of an EPA-registered disinfectant on potentially contaminated environmental surfaces will remove bioburden and potential microbes from the clinical environment of care.
c. Injection and Medication Safety: The reuse of needles and syringes continues to plague our healthcare system, especially in some outpatient settings. Healthcare professionals must carefully follow the manufacturer’s instructions for use for single-use and disposable injection devices to prevent potential transmission of bloodborne pathogens.
d. Risk Assessment with Appropriate Use of Personal Protective Equipment: While personal protective equipment (PPE) is routinely used in healthcare to stop the spread of infectious diseases, PPE is the last line of defense in transmission. Other measures such as engineering controls should serve as the primary mode of intervention.
e. Minimizing Potential Exposures: Healthcare professionals should avoid unnecessary exposures to infectious diseases and use only the core personnel necessary to safely deliver clinical care.
f. Reprocessing of Reusable Medical Equipment: Medical equipment should be cleaned, disinfected, and reprocessed according to the manufacturer’s instructions for use. This may include a range of reprocessing options flow low-level disinfection with an EPA-registered disinfectant up to sterilization.
6. Transmission-Based Precautions: Transmission-based precautions focuses on infection control interventions centered on the pathogen’s route of transmission.
7. Temporary Invasive Medical Devices for Clinical Management: Early and prompt removal of invasive devices should be part of the plan of care and included in regular assessment. Healthcare personnel should be knowledgeable regarding risks of the device and infection prevention interventions associated with the individual device and should advocate for the patient by working toward removal of the device as soon as possible.
8. Occupational Health: Protecting the health and wellness of healthcare workers is a crucial aspect of the infection prevention program. Sick healthcare workers must stay home when sick and the healthcare employer must support these employees refraining from actively working while ill.

As with any clinical outcomes program, infection control requires a commitment from the CEO is critical to the program’s overall success. IP&C requires a focused effort from all stakeholders that is yearlong in duration. Patients expect to receive safe clinical care, whether during a pandemic or on any other day, and the CDC Core Practices assist healthcare systems with implementing sustainable infection control solutions designed to protect both patient safety and the entire healthcare team.

Human Factors and Medical Device Safety: A Clinical Perspective to Improve Patient Safety and Reduce Cross-Contamination

By Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, PLNC, AS-BC, IP-BC, VA-BC™, CFER, CPPS, NREMT, FACDONA, FAAPM, FNAP

This column originally appeared in the April 2020 issue of Healthcare Hygiene magazine.

With recent outbreaks associated with reprocessed medical devices, both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have placed tremendous emphasis on improving medical device safety. Medical devices are routinely used in clinical settings for both diagnostic and therapeutic purposes. Medical devices must be reprocessed according to the manufacturer’s instructions for use (IFU).

The FDA regulates high-level disinfection and sterilant products, while the Environmental Protection Agency (EPA) regulates low- and intermediate-level disinfectants. Medical devices are categorized into three classifications: noncritical, semi-critical, and critical items. Noncritical items are those most frequently used in healthcare settings and include blood pressure cuffs, stethoscopes, etc. These items are used on intact patient skin and include environmental surfaces as well. Noncritical items require the use of a low or intermediate level disinfectant for reprocessing. Semi-critical items are those that contact mucous membranes of the patient and include examples such as laryngoscopes and endoscopes. Semi-critical items must undergo a minimum of high-level disinfection. Finally, critical items are those that enter sterile body cavities such as surgical instruments. Critical items require sterilization.

Recent guidance from the FDA requires many medical manufacturers to conduct human factors validation of their IFU and demonstrate the ability for users to safety and consistently reprocess these medical devices to ensure patient safety and reduce the risk for cross transmission. Reprocessing steps must be concise, easy to follow for users, and validated to be reliability achieved with all user populations. For example, if a flexible endoscope is going to be used in a gastroenterology setting, then all users, which would include nurses, technicians, physicians, and reprocessing professionals, would need to be properly trained on their roles in reprocessing. This validation must be performed under strict clinical research controls to ensure the integrity of the process. This rigorous process validates that properly trained clinical users can reliably reprocess reusable medical devices. Incorporating Human Factors-validated clinical training in healthcare facilities is a critical element for ensuring patient safety and reducing the risk for outbreaks associated with medical devices.

Healthcare facilities should focus on a three-step process that addresses people, processes, and products across the entire continuum of care. This unique approach begins with intense focus on personnel and ensuring that the entire healthcare team involved in the process has received standardized and role-specific training for all associated tasks. In addition, training does not equate to competency with healthcare professionals. Healthcare Leaders must take the necessary responsibility to ensure proper competency management of their direct reports so that breaches in medical device reprocessing are mitigated. While many processes can be automated to reduce the risk for error in reprocessing, some processes still require human interaction, and these can introduce variability and result in patient-safety risk. This is evidenced by the multiple outbreaks associated with breaches in medical device reprocessing.

Recent advancements in human factors engineering has demonstrated a high reliability in validated and standardized reprocessing efforts for flexible endoscopes with properly trained reprocessing personnel and appropriate resources to execute the overall reprocessing process. If healthcare medical device reprocessing processes are highly reliable, then errors will be tremendously reduced. Processes should be independent of specific individuals and the outcomes must be replicated to document success.

Finally, healthcare facilities should have rigorous processes in place to evaluate commercial products prior to them being introduced into the healthcare facility. This process must include disposable and reusable devices and items. Training on new products should be conducted at the time of conversion and then annually thereafter to ensure that each product is correctly used and reaches its desired state of efficacy.

While medical devices are used millions of times daily across the U.S. healthcare system, they are not without risk. Healthcare executives must ensure staff competency with all associated reprocessing processes. Regulators must screen new medical device applications carefully to ensure that the product can be appropriately used by the intended users. This is validated by conducted human factors studies with the input of actual simulated clinical users. Finally, medical product manufacturers play a pivotal role in collaboration and own the product development pipeline to address healthcare’s complex needs. Patients deserve the opportunity to receive healthcare in a safe environment that is free of preventable harm. Interprofessional collaboration is a strategic imperative for all stakeholders in healthcare and requires an intense and ongoing focus on patient safety, infection prevention and control, and ensuring healthcare staff competency.

Hudson Garrett Jr., PhD, MSN, MPH, MBA, FNP-BC, PLNC, AS-BC, IP-BC, VA-BC™, CFER, CPPS, NREMT, FACDONA, FAAPM, FNAP, is president and CEO of Community Health Associates, LLC. He also is an adjunct assistant professor of medicine in the Division of Infectious Diseases at the University of Louisville School of Medicine. Garrett is a frequent lecturer globally on patient safety, infectious diseases, and medical device reprocessing and safety. He may be reached at: Hudson.garrett@chaassociates.com

2019-n-CoV: Lessons Learned from the SARS Outbreak

By Kathy Warye

This column originally appeared in the February 2020 issue of Healthcare Hygiene magazine.

In February 2003, Severe Acute Respiratory Syndrome (SARS), a unique respiratory illness erupted in China. SARS was caused by a coronavirus never before seen in humans. An unusual mutation in the virus enabled ease of transmission. Air travel propelled the spread of SARS rapidly throughout Asia and to 29 other countries including Canada and the U.S. In total, 8,096 people developed SARS and 774 of them died. SARS also wreaked more damage to the global economy than the September 11th terrorist attacks in the U.S. Over a six-month period, SARS cost the world economy approximately $40 billion. Then it disappeared. Since the initial outbreak there have been no reported cases anywhere in the world.

On Dec. 31, 2019, the Chinese health authority notified the World Health Organization (WHO) of a “pneumonia” of unknown cause in the Wuhan, Hubei province with an epidemiological link to a cluster of people who had frequented the Huanan Seafood Wholesale Market where there was sale of live animals.

Health authorities in Hong Kong, Macau, and Taiwan stepped up border surveillance and concern that a novel and serious threat to public health had emerged.

By the third week of January, more than 830 cases had been confirmed worldwide and an additional 8,420 people reported to be under observation. The 2019-nCoV appears to be clinically milder than SARS in terms of severity, case fatality rate and transmissibility.1

While the current situation presents a serious threat to public health, much has changed since the SARS outbreak in 2003.

What’s different between 2003 and 2020?

• Most significant has been the response of the Chinese government to the 2019 n-CoV. China initially denied the SARS outbreak, then downplayed the magnitude of the threat delaying response and handicapping the ability of the global health community to implement appropriate measures. It took months for the true implications of SARS to be exposed. In contrast to 17 years ago, with the current outbreak the Chinese health authority promptly notified the WHO of a cluster of infections of concern and took comprehensive public health measures including closure of the markets implicated in the outbreak, intensive surveillance and prohibition on travel from affected geographies.

• The advent of and use of rapid genetic sequencing also represents a significant advantage. Chinese microbiologists were immediately able to rule out SARS-CoV, MERS-CoV, avian influenza and other respiratory viruses. Most importantly they were able to quickly isolate 2019-nCoV from a patient and perform gene sequencing. On Jan. 12, the Chinese health authority transmitted the genetic sequence of the 2019-nCoV to the WHO. Because of this, public health laboratories around the world have been able to produce rapid diagnostic PCR tests to detect 2019-nCoV infection.

• More robust and connected surveillance globally, supported by communications protocols established during the SARS outbreaks has enabled early response by health authorities and infectious disease experts around the world.

• In the U.S., the coordination between the Department of Homeland (DOH) security and the Centers for Disease Control and Prevention (CDC) since notification of the outbreak is also unprecedented. DOH set up surveillance of arrivals at key U.S. airports and took the additional step of rerouting planes originating from Wuhan through these airports. The routing and surveillance is enabling early detection of individuals potentially infected with n-CoV.

While the eventual trajectory and impact of 2019 n-CoV cannot be known at this time, the lessons learned from the SARS outbreak were many and led to significant reforms in China, new surveillance and response measures throughout Asia and a more robust overall global infrastructure to protect the public health from novel infectious disease outbreaks.

Kathy Warye is the founder and CEO of Infection Prevention Partners where she provides strategic guidance on the commercialization of solutions that detect, prevent or manage infection.

Reference: Hui DS, et al. The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health — The latest 2019 novel coronavirus outbreak in Wuhan, China. International Journal of Infectious Diseases, Vol. 91, 264-266.

20 Years After the Patient Safety Revolution

By Kathy Warye

This column originally appeared in the January 2020 issue of Healthcare Hygiene magazine.

November of 2019 marked the 20th anniversary of To Err is Human, the groundbreaking report from the prestigious Institute of Medicine on the state of patient safety in U.S. hospitals. Developed by a panel of highly credible leaders from across the spectrum of care, the report found that approximately 44,000 to 98,000 people died each year from preventable healthcare harm. It was nothing short of a clarion call for transparency and improvement.
At the institutional level, the code of silence around preventable error had been broken.

Prior to the report, "the general belief was that medical errors came about because of impaired physicians," said William C. Richardson, PhD, MBA, president-emeritus of Johns Hopkins University. But, in contrast to that belief, To Err Is Human shed light on the systems of care, finding that medical errors occur because of problematic healthcare systems or "non-systems" as the report stated, marked by a combination of factors including decentralization, fragmentation, faulty processes and conditions that caused healthcare workers to make mistakes.

Notable is the fact that the report gave scant attention to healthcare-associated infections (HAIs). Several years after publication of the report, estimates of HAIs alone eclipsed the estimate of total number of medical errors. While progress has been made, HAIs still present a formidable challenge to safety. Due in part to the application of systems thinking, reduction of central line bloodstream infections (CLABSI) represents an improvement bright spot. In 2018, CDC reported a 45 percent reduction in CLABSIs nationwide. According to the Agency for Healthcare Research and Quality (AHRQ) National Scorecard, healthcare-associated conditions (HACs) decreased overall by 21 percent between 2010 and 2015. This represented a total of 3.1 million fewer HACs contracted by hospitalized patients over five years, saving an estimated 125,000 lives and $28 billion. Together, these findings represent substantial progress.

However, the data around SSIs and other forms of harm paints a very different picture. AHRQ reported no reduction in the set of SSIs reported to the National Healthcare Safety Network between 2015 and 2018. And new challenges have emerged such as those related to ambulatory care.

Almost two decades after the research was conducted that formed the basis of the report, a study in the Journal of Patient Safety estimated the true number of premature deaths associated with preventable harm at more than 400,000 per year.1 And serious harm was estimated to be 10- to 20-fold more common than harm resulting in death.

In 2015, a panel of top health leaders gathered at the National Academy of Sciences to review the progress since To Err Is Human was released, and to discuss challenges and opportunities in patient safety. The group issued nine specific recommendations:

1. Establish a federal agency for safety in medical care similar to the Federal Aviation Agency (FAA)
2. Include patients and families in efforts to improve patient safety. CMS now involves patients and families in all its quality measurement and development work
3. Ensure that medical facility CEOs and boards of directors make patient safety and quality care top priorities
4. Develop agreement on how much and what needs to be reported in order to standardize quality-of-care metrics and transparency
5. Extend efforts to improve quality and safety beyond hospitals to ambulatory and long-term care settings
6. Ensure non-punitive, supportive cultures that foster patient safety, including incorporating nurses in the planning and implementation of patient safety efforts
7. Establish more coordination of care to prevent medical errors, including interoperability of electronic medical records
8. Use a systems-engineering approach to health care delivery, which aims to prevent errors through safety-oriented design
9. Take advantage of healthcare workers’ intrinsic motivation to improve patient safety and quality of care.

To the list above, I would add one more recommendation. By shining a spotlight on our healthcare institutions, the media played a critical role in driving new standards of transparency and accountability. For a decade after the release of To Err is Human, there was considerable media attention to the problem of healthcare-associated infections and medical harm in general. In the intervening decade, however, our national attention has turned primarily to the issue of insurance, the uninsured, underinsured, the fate of the Accountable Care Act and finding a sustainable solution to access and cost. Other than occasional, mostly negative headline worthy incidents, preventable harm and HAIs are no longer in the news. While there is perhaps no more important challenge in healthcare today than access to affordable care, as patient safety advocates, we need to keep the issue of preventable harm in the forefront of our national healthcare dialog. With the emergence and growth of resistant organisms, few issues are of greater consequence; and while much progress has been made since 1999, there is still much to be done.

Kathy Warye is the founder and CEO of Infection Prevention Partners where she provides strategic guidance on the commercialization of solutions that detect, prevent or manage infection.

Reference:
1. James JT. A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. J Patient Saf. Vol. 9, No. 3. September 2013.

Combating AMR: The Importance of Transparency in Reporting

By Kathy Warye

This column originally appeared in the December 2019 issue of Healthcare Hygiene magazine.

The recent update to the Center for Disease Control and Prevention (CDC)’s AMR Threat Report, published in early November, has garnered considerable attention. It contains both good news and bad news in the battle against resistant organisms and healthcare-associated infections (HAIs) in general. but the key message is not a good one. Since the last report in 2013 AMR has been rising far more rapidly than previously understood.

While significant progress has been made in reducing rates of MRSA, C. difficile and certain device-related HAIs, rates of the one of the most serious emerging organisms, Carbepenem resistant Enterococci (CRE), was underestimated by 50 percent. In an interview with The Washington Post, Micheal Craig, CDC senior advisor, stated that, “A lot of progress has been made, but the bottom line is that antibiotic resistance is worse than we previously thought.” This situation is not without precedent.

In 2006, the Association for Professionals in Infection Control and Epidemiology (APIC) conducted the first, national study of MRSA prevalence. The study found significantly higher rates of MRSA in U.S. hospitals than had been previously estimated. With the emergence of a community-associated strain and reports of deaths from MRSA among those with no previous hospitalization, the study generated considerable attention from the media and contributed to pressure on policy-makers to ensure more accurate tracking.

Beginning in 2009, hospitals were required to report MRSA bacteremia to the National Healthcare Safety Network (NHSN), a comprehensive HAI database managed by the CDC, as a condition of participation in Medicare and Medicaid. The federal policy had two important, features: the requirement for acute-care hospitals to routinely submit data on MRSA bacteremia to the NHSN, and transparency. In addition to the tracking provision, rates of MRSA by institution were made available to the public. Prior to enactment of this policy, the real burden of MRSA was largely unknown to national healthcare leadership and little information on MRSA rates and deaths was available to the public.

In most countries with well-developed healthcare systems, reporting of organisms of concern is a key component of broader programs to protect public health. In 2006, with MRSA on the rise, the United Kingdom made reporting of MRSA bloodstream infections to the National Health Service mandatory. Reporting was the initial phase of a more comprehensive strategy to prevent transmission and deaths which resulted in a drop of close to 40 percent in MRSA isolates. Across Europe, The European Centre for Disease Prevention and Control (ECDC) promotes the transparent reporting of outbreaks and organisms of concern. Reporting is viewed as an important catalyst in driving attention to the problem, an effective component of a larger reduction effort and a foundation for regional coordination.

While it could be argued that public reporting is burdensome for hospitals, accurate tracking of resistant organisms is critical if we are to have the data upon which to base containment and other strategies. And if CRE or another resistant organism yet to emerge mutates into a community-associated strain, as with flu outbreaks, the public will have the right to know where it is emerging.

More importantly, it is well accepted in management and quality circles that what gets measured, gets managed. In the context of MRSA, the federal reporting mandate enabled not only more accurate measurement of the burden of MRSA but made the problem of MRSA front and center on the healthcare leadership radar. The public availability of hospital specific data drove leadership accountability and initiated a decade long improvement in infection prevention resourcing and infrastructure in U.S. hospitals.

Currently, only two resistant organisms are subject to reporting, MRSA bacteremia and C. difficile. CRE was designated by CDC in the 2013 CDC AMR Report as an “urgent” threat and described by the Director at the time as the “nightmare, triple threat bacteria.” Unlike MRSA and C. difficile, there is no federal requirement for reporting of CRE or repository of data on the emerging resistant organisms of greatest concern. This obstructs efforts at comprehensive national surveillance and leads to a less than accurate picture of the magnitude of the problem.

More importantly, without accurate estimates and transparency, healthcare institutions may downplay the threat and de-prioritize the investments in infection prevention and laboratory capacity that will be needed to prevent transmission, morbidity and mortality and future growth in resistance.

It is time for CRE and Candid auris, another rapidly growing resistant organism, to be added to federal reporting requirements because what gets measured, gets managed. Transparency drives accountability. And accountability drives the attention and resources that infection prevention programs at the institutional and regional levels must have if they are to effectively act as the front line in defense against these threats to public health.

Kathy Warye is the founder and CEO of Infection Prevention Partners where she provides strategic guidance on the commercialization of solutions that detect, prevent or manage infection.

Learning from the Past to Protect the Future

By Kathy Warye

This column originally appeared in the October 2019 issue of Healthcare Hygiene magazine.

It has been approximately 20 years since the publication of To Err is Human, the landmark study that gave birth to the patient safety movement. And while there has been much progress made in the management of healthcare associated infections, we are facing a growing crisis that will demand that we do even better.

While the threat of antimicrobial resistance is well known, in the practice of infection prevention, and the delivery of healthcare in general, there is often a wide gap between knowledge and action. There are many reasons for this, from insufficient resources to resistance to change to imperfect evidence.

Whatever the factors, when confronted with the rise in healthcare-associated MRSA in the late 1990s, the U.S. was late to act in comparison to other countries. And when the action did occur, it was not as comprehensive as other developed nations and lacked regional coordination. When confronted with a rapid rise in MRSA early in the decade, the UK took decisive action at a national level. The UK plan was comprised of a combination of integrated components which addressed the entire system of infection prevention from elevation of IP leaders to positions of greater influence, to mandatory reporting of MRSA to universal screening of patients via newly available rapid diagnostic technology.

In 2001, the rates of MRSA isolated from infections in the U.S. and the UK were almost identical, but over the next 15 years, the two different strategies produced dramatically different results. From 2001 to 2015, the UK achieved a decline in MRSA isolates from 45 percent in 2001 to just over 10 percent in 2015. Over the same period of time, in the US rates of MRSA isolates increased to approximately 55 percent before returning to just under 45 percent.¹ While it must be noted that the U.S. has achieved significant reduction in MRSA-related bloodstream infections and deaths since 2005, MRSA is endemic in our healthcare institutions.

The emergence of Carbapenem-resistant or Carbapenemase-producing entererococci (CRE), a family of organisms that is highly resistant to antibiotics, poses a new and potentially far more dangerous threat. Carbapenemases, which include the KPC enzyme which has been most prevalent in the U.S., are plasmid-mediated. This attribute makes horizontal transfer easier and the spread of resistance and infection faster than with either MRSA or C. difficile. Estimates of mortality with CRE-related bloodstream infection are as high as 50 percent. In 2015, the combination of resistance to antibiotics and the potential for community-associated strains of CRE to emerge led then-director of the CDC, Tom Frieden, to refer to CRE as the “nightmare bacteria.”

Today, the CDC estimates that there are approximately 100 patients colonized with CRE for every infected patient. This means that standard infection control practice, which relies on clinical cultures from patients suspected of harboring MDROs to trigger intervention, will miss the vast majority of CRE colonization. Since addressing the tip of the iceberg alone will not contain the spread of CRE, CDC is recommending that hospitals establish screening programs for high-risk patients to identify what would otherwise be a hidden reservoir of CRE colonization.² This is a notable departure from CDC’s approach to MRSA, wherein little, if any, guidance was provided on optimization of detection methods to prevent transmission. New technologies are also entering the market which will make detection of MDROs, such as CRE, on the front line of healthcare and in the first episode of care possible for the first time. Placed in units where risk is highest, these technologies promise will make active surveillance faster, easier and more affordable.

In parts of Europe, South America and Asia where CRE is tracked, rapid increases have been observed. While rates in the U.S. are still low, we know they are on the rise. If past is prologue, the consequences for public health could be dire. While the CDC has raised the alarm and encouraged a coordinated regional approach to prevention, screening protocols for CRE are inconsistent across U.S. hospitals allowing a potentially large percentage of CRE to go undetected and unmanaged. In many hospitals, infection prevention still struggles for resources and leadership support. And in hospitals across the country, new, potentially life-saving technologies face increasingly high bars for adoption. While much has been learned from MRSA, there is still much to do to close the gap between knowledge of CRE’s emergence and the actions that must be taken to limit the consequences of this nightmare bacteria to public health.

References:

Resistance Map, Center for Disease Resistance and Policy, Washington, DC. UK: European Antimicrobial Resistance Network (EARSNet) U.S.: The Surveillance Network (TSN) 1999-2012; National Healthcare Safety Network (NHSN) 2013-14.
CDC CRE Toolkit, 2015.

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Vetting Infection Control Technologies: Ensuring Safe and Efficacious Usage in Healthcare Settings

A Time for Collaboration: A Needed Paradigm Shift in Interprofessional Communication to Reduce Healthcare Associated Infections

The Need for Change in Infection Prevention and Control: Protecting Our Most Vulnerable Populations

A Post-COVID World: Hardwiring Core Practices for Infection Control and Patient Safety

Human Factors and Medical Device Safety: A Clinical Perspective to Improve Patient Safety and Reduce Cross-Contamination

2019-n-CoV: Lessons Learned from the SARS Outbreak

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Combating AMR: The Importance of Transparency in Reporting

Learning from the Past to Protect the Future