Patient Safety & Quality

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.

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

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:

  1. 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.
  2. CDC CRE Toolkit, 2015.