2021 patient safety columns - Healthcare Hygiene magazine

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

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

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

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