Dear FNU Community,

We hope you are all doing well as we move into the final weeks of Winter Term 2021 and begin to look forward to spring. We continue to monitor the pandemic and are encouraged by the mass vaccinations that are occurring and the seeming decrease in infection rates in some areas. We are very excited to be using our new campus as a vaccination station while we wait for the right time to bring our FNU community back to campus. Although we know we all have more work to do over the next few months, we are hoping to be able to return to our on-campus sessions by October of 2021. While our virtual programming instituted in Spring of 2020 continues to successfully both orient students to FNU and prepare students for clinical placements, we are anxiously awaiting the return to onsite sessions on our beautiful new campus in Versailles, Kentucky. 

At this time, the resolution of the pandemic continues to evolve and we continue to follow the recommendations of the CDC and other experts as to how to manage our campus operations. While we are hopeful that we will be able to return to on campus sessions this fall, we have not yet determined what the final policies will be or what the requirements for attendance on campus will be. Those decisions will be made based on CDC Guidelines, Kentucky regulations and the needs of our FNU community. 

As we plan for on campus sessions for Fall Term 2021, we are tentatively planning a PILOT on campus Clinical Bound session August 8-13. This will allow us to use our new facilities with a smaller than usual group and iron out any unexpected challenges. We will be recruiting some adventurous participants for this session from students planning to attend summer Clinical Bounds and who are willing to adhere to predetermined criteria. Attendance will be voluntary and all participants will need to understand that in the event we do not feel we can safely execute this event, we will convert the session to the virtual format. For students, if you are planning to attend Clinical Bound this summer, watch for the invitation to attend the very first onsite session on our new campus. 

As more information is available, and we begin to develop policies based on evidence and formal recommendations, we will share this with the FNU community. Your patience and flexibility as we begin to plan our transition back to on campus programming is appreciated. In the meantime stay strong, wear your mask, wash your hands and get vaccinated if you have the opportunity. To be clear, at this time we are not requiring vaccination but as the CDC guidance suggests, we are encouraging vaccination. We hope to see many of you on campus this coming fall. 

Sincerely,

Susan Stone 
President 

Dear Frontier Community,

As we approach this holiday season, I wanted to reflect on our journey through 2020. We started our year with great hope of celebrating the Year of the Nurse and Midwife as designated by the WHO. Little did we know that nurses and midwives would be challenged way beyond any expectation, but we did step in and do what needed to be done to continue progress. We created online sessions that allowed students to keep moving forward. In March we had 400 students sitting out of clinical due to the restrictions posed by the Pandemic; yet by July 95% of those students were back in clinical. All of these efforts took incredible work from our entire team of faculty and staff. We are so grateful for your commitment. Our students persevered doing their course work, their clinical work, caring for families and in most cases continuing to care for patients in their employment settings. We know that more than 85% of our students are employed as well as responsible for their families. We did not see any significant increase in withdrawals; students just kept moving forward towards the future. What an amazing group of people you are!

In June we were again struck by the reality of the deep racial, ethnic and socioeconomic inequities that exist in our country. Although we have been working to be an inclusive university for many years, the events that took place brought the reality of the outcomes front and center for all of us. We know that we must all work harder and more diligently to become a truly inclusive and equitable nation. The tragic events that occurred pushed us further and in June, we committed to the goal of becoming an antiracist university. While we have been doing much work in delving deeply into our own environment at FNU and attempting to identify the priorities, it is time to take action. I am announcing the formation of a President'sTask Force on Diversity, Equity and Inclusion for 2021. The purpose of the taskforce is to identify and implement initiatives that will address diversity, equity, and inclusion within our community and in our curriculum. The task force will work collaboratively with administration, faculty, staff, students, and our community at large.  The goal of the task force will be to enhance our caring philosophy to make equality, respect, and belonging a reality. The Task Force is specifically charged with creating an action plan and facilitating the implementation of each item on the action plan. I am excited about this and look forward to taking meaningful actions that can make our efforts even more successful and ultimately improve health care outcomes across this nation. 

As we head into 2021, we see hope on the horizon. The release of a COVID vaccine brings hope that we are making progress toward resolution of the pandemic, brings us closer to our goal of opening our new campus and most of all hope that this terrible illness will soon fade into  a tragic memory. We will continue to grow in our efforts to be a truly antiracist university and strive to make this goal apparent to all through our actions and our outcomes. Together we are on a mission to change this world, to make this world a better place. For now, I hope that you enjoy some time in the next two weeks to relax, to laugh and to enjoy your family and friends. Happy Holidays to everyone!

Warmly, 

Dr. Susan Stone 

Dear Students,

I know that there are many concerns regarding the safety of the vaccine. Right now we know a little but not a lot. Hopefully, we will know a lot more in the coming months that will make us feel safer. My message to you at this time is that we cannot convene on our campus in the current situation.  We will await more information regarding vaccines before we decide any policies. Take care of yourselves and stay safe. Let me know if you have questions. 

Sincerely,

Dr. Stone 

Dear Students, 

I hope you are managing well during this very difficult time. I know it is stressful for you to see COVID positivity rates rising, schools for our children closing to onsite sessions again, hospitals operating at maximum capacity and the constant threat of illness for you and your family. It is challenging to manage all of these stressors while also engaging in a rigorous graduate education. Please know that we are aware that you are experiencing challenges. Be sure to contact your academic or clinical advisor, your faculty member, your Department Chair or Clinical Director (whoever you feel you need to talk to) if you need to brainstorm how to manage your time and your program of study. We want to be as helpful and supportive as possible. 

It was encouraging to hear last week that the COVID vaccine is coming soon. It will be critical for our ability to reopen our campus to have our students, faculty and staff be immunized. The way that we function includes bringing students and faculty from all over the United States who travel to Kentucky for short stays. This puts our students, faculty and staff at risk without immunization. Based on this premise, we will not be able to open our campus until we are able to have widespread COVID immunization. As you know, immunization is currently required for other communicable diseases and COVID will be added to the required list. We are hoping to be able to open in fall of 2021. It is possible that we could do some Clinical Bound sessions in summer of 2021, but we will need to see where we are with immunizations. 

In the meantime, know that we are here for you. Our virtual Frontier Bound and Clinical Bound sessions have been working well. Our staff have transitioned successfully to working from home. Our student retention rate remains high speaking to your perseverance in spite of these difficulties. Do not feel alone, reach out if you need a helping hand. We are all in this together and there is a greater need for excellent nurse practitioners and nurse-midwives than ever!

Remember to take some time to take a deep breath and relax even for a few minutes. It can make a big difference. Take care of yourself and stay safe as we enter this holiday season.

Warmly,

Dr. Stone 

Dear Frontier Faculty and Staff,

We are seeing surging rates of COVID 19 in almost every state. This definitely includes Kentucky. I hope that you and your families are doing as well as possible and staying safe. 

It was encouraging to see the news this week which indicated that there is a vaccine on the horizon. While we know very few details about a vaccine at this time, we do know that there are plans in place to strive to have a large portion of the population immunized during 2021. This will be a critical factor for us to be able to start gathering on our beautiful new campus. We will all need to be immunized. As with other immunizations, if there is a valid reason why a person cannot receive the vaccine, we will have to figure out an alternative plan. Because we bring a different group of  students and faculty from all over the nation nearly every week, our risk of transmission is high. Immunization will be a critical safety factor for all of us. 

Knowing this, we will not be back on campus in the Spring term as we had hoped and most likely not for Summer term. While it’s possible that we might be able to do Clinical Bound on campus in the Summer term (July 5-September 18, 2021), we’ll  need to wait and see where we are with immunizations. I am hoping that we can be ready to resume our onsite sessions in fall of 2021. We will not require employees who work on the Versailles Campus to return to the office until the start of the term when students return. We are working to have all offices up and running by the beginning of Spring term. This will provide an opportunity for some employees to return to the campus if they wish as long as all Healthy At Work guidelines are being followed. There will be more details on the office openings at the beginning of 2021.

I know this means working at home for nearly a year ahead for most of us. I also know this can cause stress for many. Please let us know if there is anything that we can do to help you to decrease your stress. Please be careful and stay safe as we enter the holiday season. Do your very best to follow public health guidelines. Let me know if you have questions. 

Sincerely, 

Sue

Dear Students,

As you know, we have now been doing virtual Frontier Bound and Clinical Bounds since approximately April 1, 2020. The Assessment Office recently completed an evaluation of both the students and the preceptors' perception of the efficacy of these virtual sessions. Students rated the Frontier Bounds and the Clinical Bounds very highly. The majority of preceptors also rated students' readiness to start clinical as either the same as students who completed an on-site Clinical Bound or better than students who completed an on-site  Clinical Bound.  This is very good news as it does give us evidence that what we are doing is working. While we would rather be doing these sessions on-site at our new campus, we can rest assured that we are still providing a good educational experience. 

We all know that the next few months will be uncertain in terms of the Pandemic. We are concerned about a potential increase in cases and the complicating factor of the flu season which will be upon us soon as well. We are also concerned about winter travel especially with attendees arriving from multiple different states. For all of these reasons, we have decided to extend our date for return of students, faculty and staff to on-campus activities to at least the beginning of Spring Term 2021, which begins April 5, 2021. 

If you have any specific questions, please feel free to contact your advisor. I am always available for University-wide questions.

Sincerely,

Dr. Stone 

Dear All,

As you know, we have now been doing virtual Frontier Bound and Clinical Bounds since approximately April 1, 2020. The Assessment Office recently completed an evaluation of both the students and the preceptors' perception of the efficacy of these virtual sessions. Students rated the Frontier Bound and the Clinical Bound very highly. The majority of preceptors also rated students' readiness to start clinical as either the same as students who completed an on-site Clinical Bound or better than students who completed an on-site  Clinical Bound.  This is very good news as it does give us evidence that what we are doing is working. While we would rather be doing these sessions on-site at our new campus, we can rest assured that we are still providing a good educational experience for our students. 

We all know that the next few months will be uncertain in terms of the Pandemic. We are concerned about a potential increase in cases and the complicating factor of the flu season which will be upon us soon as well. We are also concerned about winter travel especially with attendees arriving from multiple different states. For all of these reasons, we have decided to extend our date for return of students, faculty and staff to on-campus activities to at least the beginning of Spring Term 2021. There are cases when faculty or staff do need to be on campus and we will follow social distance guidelines as published by the Human Resources office in those situations. 

I have not notified the students yet, but will do so soon. Please let your supervisor know if you have any questions or feel free to ask me if this is an institutional question. 

As always, thank you for your dedicated work and commitment to our mission. 

Sincerely,

Sue Stone 

Dear Faculty and Staff,

I hope that you are all doing well and are able to manage the challenging times that we are in. The world continues to try to deal with the COVID 19 Pandemic and we in our community, are doing the same. As our brand new Versailles Campus approaches completion, we had hoped to be welcoming students, faculty and staff this fall. But the pandemic continues to drive our decision making. We recently completed a review of the CDC Guidelines for Higher Education institutions and their application to FNU. Additionally we are watching the increasing number of COVID cases in some states.  It has become clear that the best decision will be to continue offering all Frontier Bound and Doctor of Nursing Practice Bound orientation sessions and Clinical Bound preparation for clinical experience virtually. This means that there will be no student sessions on the new campus prior to 2021. 

We are concerned about  bringing a group of  students and faculty from all over the country to be together for a few days. We would need to require many restrictions such as social distancing, masks and testing for some. Then that group would go home and we would need to do the same the next week with a new group. We would end up with multiple exposures to each other from across the country. Additionally, we are still worried about the traveling that would be required, particularly flying. Because we can effectively teach virtually, we believe that it is best to do so. 

The good news is that the virtual sessions have been very highly rated by students. Although it would be the ideal to be together on campus for many of the sessions, we can see through our evaluations that the students are enjoying the virtual sessions and meeting the objectives.

I will send a note out to students first thing tomorrow letting them know. Thank you for all that you do to support our students and operations at FNU.

Sincerely, Sue

HHS COVID-19 Update – June 5, 2020

Reopening Information
Opening Up America Again Testing Blueprint: Along with the White House, Ambassador Birx announced an addendum to the “Opening Up America Again Testing Blueprint”, which will focus on using tests for diagnosis and proactive surveillance. This document provides additional guidance regarding the optimal deployment and use of testing formats and testing platforms for both the diagnosis of and proactive surveillance for COVID-19. In achieving this optimization, certain testing formats and platforms are better suited for diagnosis, while others are better positioned to enable proactive surveillance (monitoring) within communities or populations known to be at high-risk of contracting the virus. Accordingly, such optimization is critical to maximizing the efficacy of States’ testing programs and determining appropriate payment mechanisms. The considerations for optimizing testing should be reflected in each State’s July through December Jurisdictional Testing Plans. A Federal peer review panel led by the Centers for Disease Control and Prevention (CDC), will assess the quality of States’ plans for using proactive surveillance to complement diagnostic testing in responding to requests for Federal financial support of their testing initiatives. These requests are due by June 15, 2020.

Contact Tracing Communications Toolkit: CDC released a Contact Tracing Communications Toolkit for Health Departments. We all need to work together with health departments to help slow the spread of COVID-19. Contact tracing and self-quarantining of people with COVID-19 and close contacts are critical to help slow transmission of COVID-19 in our communities.

Funding
$66 Million to Improve Delivery of Mental and Substance Use Disorder Treatment: SAMHSA awarded nearly $66 million in grants to provide training, education, and resources at no cost to individuals, communities, states, and the healthcare field to improve the delivery of mental and substance use disorder treatment in America’s communities. These are important grants to support those who need treatment during the COVID-19 pandemic. 

Testing 
Test Performance Data from Antibody, Serology Test Kits: FDA publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI). These results are among the first to come from a collaborative effort by the FDA, NIH, Centers for Disease Control and Prevention (CDC) and Biomedical Advanced Research and Development Authority (BARDA). Additional performance data will be made available as the FDA reviews and determines if any further actions are appropriate for those test kits prior to publication.

Diagnostic Tests vs. Antibody Tests Video: FDA issued a new video resource explaining the different categories of tests in the fight against COVID-19: diagnostic tests and antibody tests. As the video explains, diagnostic tests can tell if the tested person currently is infected. Antibody or serology tests detect if the person’s blood contains antibodies to coronavirus. The body produces antibodies when one becomes infected by the virus, and they help the immune system fight off the infection. If an antibody test finds antibodies in the blood, it likely means the person has been previously infected with the virus. Antibody tests do not detect whether a person is currently infected and should not be used to diagnose a current COVID-19 infection. The results from antibody tests can help us better understand questions about exposure to COVID-19.

EUA Authorized Serology Test Performance: FDA updated their webpage on EUA Authorized Serology Test Performance. Serology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19. Serology tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to SARS-CoV-2. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19.

Biosafety Guidelines for Handling Specimens: CDC updated their Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). The updates include the addition of anatomic pathology guidance for COVID-19 and updated Point-of-Care testing guidance for COVID-19. Related, the FAQs on biosafety and COVID-19 were also updated.

Testing Updates: During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus. To date, the FDA has authorized 124 tests under EUAs, which include 106 molecular tests, 17 antibody tests, and 1 antigen test.

Treatment
Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: FDA approved the antibiotic Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older. Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.

New Drug Application Approved for Ventilated Patients: FDA approved an abbreviated new drug application for dexmedetomidine hydrochloride in 0.9% sodium chloride injection (ANDA 209307), indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive-care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures. The most common side effects of dexmedetomidine hydrochloride injection are hypotension, bradycardia and dry mouth. This drug is listed in the FDA Drug Shortage Database. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and remains deeply committed to facilitating access to medical products to help address critical needs of the American public.

Non-Invasive Monitoring Devices: Effective immediately, new guidance issued by the FDA expands the availability and capability of non-invasive monitoring devices. These remote devices facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency. This guidance replaces the March 20, 2020, guidance, titled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The new guidance expands the scope to include additional device types (product codes) and provides additional references and standards for consideration.

Unapproved and Misbranded COVID-19 Products: As part of FDA’s effort to protect consumers, the agency issued warning letters to operators of four websites (www.roidsmall.net, www.emedkit.com, www.4nrx.md and www.chloroquineonline.com) that market unapproved and misbranded COVID-19 products. There are currently no FDA-approved drugs to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. Consumers can visit BeSafeRx to learn about how to safely buy medicine online.

Biosafety FAQ’s and Specimen Handling: CDC updated biosafety FAQs on specimen handling, specimen packing and shipping, and anatomic pathology in the midst of COVID-19. 

Moderna to Expand Domestic Manufacturing of Vaccine: BARDA is expanding an existing partnership with MODERNATX, Inc to increase the domestic manufacturing capacity of Moderna’s mRNA-1273 vaccine being developed for the prevention of COVID-19. Expansion activities are expected to begin mid-year to deliver material and could be available as soon as the end of 2020. Moderna has previously announced its new collaboration with Lonza in the United States and this funding supports that manufacturing capacity expansion.

EUA for Roche Diagnostics with Elecsys IL-6: FDA issued an EUA to Roche Diagnostics for Elecsys IL-6. Elecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative measurement of IL-6 (interleukin 6) in human serum and plasma. This assay is used to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Emergency use of this test is limited to authorized laboratories.

FDA Response to COVID-19: The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures and highlights of the agency's response efforts.

PPE
Respirators for Health Care Personnel Use: FDA announced that on Tuesday, June 9, 12:00 pm – 1:00 pm ET, the FDA will launch a webinar series on the topic of Respirators for Health Care Personnel Use during COVID-19 Pandemic. The webinar will provide FDA information and answer questions about emergency use authorizations (EUAs) for respirators, importing respirators, and overall FDA actions to help ensure that health care personnel on the front lines have the necessary supplies of respirators to meet the demand. Hear from speakers, including Stephen M. Hahn, MD, Commissioner of Food and Drugs at the FDA; Jeffrey E. Shuren, MD, JD, Director of the Center for Devices and Radiological Health (CDRH) at the FDA; William H. Maisel, MD, MPH, Director, Office of Product Evaluation and Quality (OPEQ) at CDRH; and Suzanne Schwartz, MD, MBA, Director, Office of Strategic Partnerships and Technology Innovation (OST) at CDRH. Registration is not necessary.

Information for Specific Populations
Community Related Exposure: CDC updated public health recommendations for people in U.S. communities exposed to a person with known or suspected COVID-19, other than health workers or other critical infrastructure workers. There is growing evidence of transmission risk from infected people without symptoms (asymptomatic) or before the onset of recognized symptoms (presymptomatic) and an increased community transmission in many parts of the country. Continued focus on reducing transmission through social distancing and other personal prevention strategies. Updates include the addition of exposure to people with confirmed COVID-19 who have not had any symptoms to this Guidance.

Guidance for Handlers of Service and Therapy Animals: CDC released additional guidance for animals focused on handlers of service and therapy animals. Facilities that normally use therapy animals may not allow them at this time because people in many of these settings are at higher risk for serious illness with COVID-19. If you have a service or therapy animal, follow your local guidance for acceptable business and social practices. Consider local levels of COVID-19 transmission when evaluating the risk to yourself, your animal, and the people you might come into contact with. 

Animals and COVID-19: FDA also updated a FAQ on what animal species can become infected by COVID-19. 

Resources for Limited-English-Proficient Populations: CDC created a communication toolkit to help public health professionals, health departments, community organizations, and healthcare systems and providers reach populations who may need COVID-19 prevention messaging in their native languages. The toolkit provides print resources in multiple languages and audiovisual resources. 

People Who Need Extra Precautions: CDC updated guidance for people at higher risk for severe illness with COVID-19, including those who are immunocompromised and older adults. 

Historic Preservation Compliance: FEMA released a fact sheet in accordance with 36 CFR § 800.12(a) of the Section 106 regulations and in consultation with the Advisory Council on Historic Preservation, State Historic Preservation Officers, and Tribal Historic Preservation Officers, Indian Tribes and Native Hawaiian organizations (consulting parties), developed emergency procedures to govern its Section 106 responsibilities for approval of direct Federal assistance and funding of emergency protective measures to save lives and to protect improved property and public health and safety in response to COVID-19 pandemic (COVID-19 emergency undertakings). 

Information on Trafficking Persons and COVID-19 Response: The Office of Trafficking in Person (OTIP) Director, Katherine Chon has penned a letter to anti-trafficking grantees which highlights flexibilities afforded to funding recipients, as well as efforts OTIP has taken to respond to the COVID-19 pandemic.  The two additional documents contain Qs and As regarding grant administration and provides technical assistance to grantees with implementing their grant programs. 

Research Updates
Weekly COVIDView Report: CDC released their weekly COVIDView report. Nationally, levels of influenza-like illness (ILI) and COVID-19-like illness (CLI) and the percentage of specimens testing positive for SARS-CoV-2, the virus that causes COVID-19, continue to decline or remain stable at low levels. Mortality attributed to COVID-19 also decreased compared to last week but remains elevated above baseline and may increase as additional death certificates are processed.

Clinical Laboratory Staff and Health Care Providers Using Transport Media: FDA issued a letter to clinical laboratory staff and health care providers about a safety risk with using transport media and SARS-CoV-2 testing platforms that are not compatible. There is a risk of exposure to harmful cyanide gas when certain transport media are used with an incompatible testing platform or laboratory process that uses bleach.

Postmortem Guidance: CDC updated guidance for the collection and submission of postmortem specimens from deceased persons under investigation (PUI) for COVID-19, plus recommendations for biosafety and infection control practices during specimen collection and handling, including during autopsy procedures.

Study Identifies Potential Approach to Treat Severe Respiratory Distress in Patients with COVID-19: NIH released early data from a clinical study suggesting that blocking the Bruton tyrosine kinase (BTK) protein provided clinical benefit to a small group of patients with severe COVID-19. Researchers observed that the off-label use of the cancer drug acalabrutinib, a BTK inhibitor that is approved to treat several blood cancers, was associated with reduced respiratory distress and a reduction in the overactive immune response in most of the treated patients. The findings were published June 5, 2020, in Science Immunology. The study was led by researchers in the Center for Cancer Research at the NCI, in collaboration with researchers from the NIAID, as well as the DoD’s Walter Reed National Military Medical Center, and four other hospitals nationally.

Household Cleaning and Disinfection for COVID-19 Prevention MMWR: CDC released a MMWR on knowledge and practices regarding safe household cleaning and disinfection for COVID-19 prevention. Since the onset of the COVID-19 pandemic, calls to poison centers regarding exposures to cleaners and disinfectants have increased. This report discusses how an Internet panel survey identified gaps in knowledge about safe preparation, use, and storage of cleaners and disinfectants. Approximately one third of survey respondents engaged in nonrecommended high-risk practices with the intent of preventing SARS-CoV-2 transmission, including using bleach on food products, applying household cleaning and disinfectant products to skin, and inhaling or ingesting cleaners and disinfectants.

Dear Faculty and Staff,

As we continue to address the COVID-19 Pandemic and how it affects our University operations, I wanted to clarify the employee expectations for working on campus. As long as there are no students on campus, we will continue with our current plan for all employees to work from home. At this time, we have decided to not hold any student events on campus prior to January 2021. Employees who are not essential to the physical operation of the campus will continue to work at home until at least January 1, 2021. Occasionally there will be a requirement for certain employees to be on campus for some activities and projects. When you are needed to come to campus, please observe all requirements as described in the FNU Healthy at Work for Essential Employees.  These policies apply to all employees when on campus.  Questions should be directed to your supervisor or the Human Resources Director, LaToshia Daniel. 

Thanks for your continued commitment to our goals. We appreciate all of your devoted work.

Sincerely, 

Dr. Susan Stone

Dear Faculty and Staff,

As we have examined the recommendations to keep everyone safe during the COVID 19 Pandemic, we made the decision that it would be best for all employees to remain working from home at least through October 1. Some employees may be called in to work to take care of certain issues. You will be required to follow the guidelines published by LaToshia Daniel, Human Resources Director if you are on campus. Please direct any questions to your supervisor. Thank you so much for all of your efforts. Have a wonderful weekend. 

Sincerely, 

Susan Stone 

Dear Faculty and Staff,

I hope that you are doing well. I wanted to provide a quick update regarding Telecommuting. I know we had said work at home until May 31 which is coming up very quickly. We are extending the work at home at least through the end of June. There may be requirements for a very few persons to be onsite periodically during that time for certain tasks. LaToshia Daniel, Human Resource Director is working on putting in place the requirements that will need to be followed if you are called to work on site for any reason. We will have much more information for you soon. Please check in with your supervisor if you have any questions. Thanks for all that you and I hope everyone takes some time to have a wonderful holiday weekend. 

Sincerely, Sue 

Today, HHS Secretary Azar released a strongly worded statement to the World Health Assembly, noting “a failure by this organization to obtain the information that the world needed, and that failure cost many lives.”

On Friday, an important RFI (Request for Information) was released asking for input from external audiences on HHS ASPR’s proposed strategy and structure of the Strategic National Stockpile, particularly the role of public-private partnerships in making sure the nation has the right items and quantities accessible for SNS 2.0.  Input is also being sought to understand the constraints associated with meeting pandemic demand and how the U.S. Government can contribute to improving supply availability.  Responses are due by 5/29 at 2pm.  Many of you have expertise that should be shared so we can learn from this pandemic and be better situated for the future. 

Today, HHS ASPR notified State Health Officers and other stakeholders that Gilead plans to provide an additional donation of remdesivir in June, taking the total supply of remdesivir up from 607,000 vials to a total of 940,000 vials.  This is very good news.

Testing
First At-Home Testing Kit Authorized: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used at Multiple Authorized Labs. The FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider. This allows an individual to self-collect a nasal sample at home using Everlywell’s authorized kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the Everlywell COVID-19 Test Home Collection Kit. These tests have been authorized under separate, individual EUAs. Additional tests may be authorized for use with the Everlywell at-home collection kit in the future, provided data are submitted in an EUA request that demonstrate the accuracy of each test when used with the Everlywell at-home collection kit.  

Primer on Testing Basics: The FDA issued a Consumer Update, Coronavirus Testing Basics, to provide information about the different types of tests available and the steps involved in obtaining results. The fact sheet describes the different types of tests, outlines what they do, how long it takes to get results and the limitations of each test. A diagnostic test can show if you have an active coronavirus infection and should take steps to quarantine or isolate yourself from others. An antibody test looks for antibodies that are made by the immune system in response to a threat, such as a specific virus. Because of this, antibody tests should not be used to diagnose an active coronavirus infection. At this time researchers do not know if the presence of antibodies means that you are immune to the coronavirus in the future.

Information on Serology Surveillance: CDC updated their information on COVID-19 Serology Surveillance. CDC is working with state, local, territorial, academic, and commercial partners to better understand COVID-19 in the United States. Serology tests look for antibodies in blood. If antibodies are found, that means there has been a previous infection. Antibodies are proteins that can fight off infections. The webpage includes information about CDC serology surveillance, serology surveillance surveys and information on COVID-19 testing.

Information on Serology Surveillance Strategy: CDC released new information on their COVID-19 Serology Surveillance Strategy. CDC has an overarching strategy for learning more about how many people have been infected with SARS-CoV-2, the virus that causes COVID-19, and how it is spreading through the U.S. population. This strategy includes using serology testing for surveillance to better understand how many infections with SARS-CoV-2 have occurred: At different points in time, In different locations, and Within different populations in the United States. A key CDC priority is to track COVID-19 infections to determine how much of the U.S. population is infected over time. CDC uses a variety of surveillance systems to track COVID-19 cases based on people who seek medical care. However, these systems can miss infections that occur in people who had mild or asymptomatic illness (i.e., no signs or symptoms) who did not seek medical care or get tested.

Different Seroprevalence Survey Types: CDC released information on Seroprevalence Survey Types. CDC is collaborating with public health and private partners on a variety of surveys of different sizes, locations, populations studied, and purposes. By using seroprevalence surveys, CDC can learn about the total number of people that have been infected, including those infections that might have been missed. These surveys also can help estimate how much of the population has not yet been infected, helping public health officials plan for future healthcare needs. These surveys can also track how infections progress through the population over time. This is done by taking “snap shots” of the percentage of people who have antibodies against SARS-CoV-2 (also called the seroprevalence) at different time points. The seroprevalence surveys CDC is conducting include large-scale geographic surveys, community-level surveys, and smaller-scale surveys focusing on specific populations in order to learn information about COVID-19.

Updated Information on Contact Tracing: CDC updated their information in their Contact Tracing Protocol and their  Contact Tracing Training. The protocol includes all of the contact tracer learning objectives, sample learning plans, and other resources. The sample training plan includes training topics that may be helpful for state and local public health jurisdictions to consider when designing their own training plans for COVID-19 contact tracers, case investigators, and team leads. Suggested training modalities/formats are provided, as well as information about sample existing trainings and resources. This site may be updated as new resources become available. After completing all training with the training plans, learners should be able to conduct contact tracing, case investigation or supervision of contact tracers or case investigators according to the established protocol.

Testing updates: During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus. To date, the FDA has authorized 100 tests under EUAs, which include 87 molecular tests, 12 antibody tests, and 1 antigen test.

Treatment
Updates for Children and Multi-Inflammatory Syndrome in Children (MIS-C): CDC released a health advisory for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease 2019 (COVID-19). The webpage includes  1) background information on several cases of a recently reported multisystem inflammatory syndrome in children (MIS-C) associated with coronavirus disease 2019 (COVID-19); and 2) a case definition for this syndrome. CDC recommends healthcare providers report any patient who meets the case definition to local, state, and territorial health departments to enhance knowledge of risk factors, pathogenesis, clinical course, and treatment of this syndrome. Related to MIS-C, CDC update their information and webpage on Caring for Children with the warning signs on when to seek pediatric care, added an FAQ on what is MIS-C and who is at risk in the COVID-19 and Children webpage, and added new sections on the webpages with information for pediatric healthcare providers and clinical care guidance for healthcare professionals about COVID-19. 

Role of Public-Private Partnerships to Defeat COVID-19: NIH Director Dr. Collins and Johnson & Johnson executives published an article in JAMA today on Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV).  In it, they note that to respond to the generational public health crisis caused by the global COVID-19 pandemic, a swift, coordinated effort across many sectors of society is necessary, say National Institutes of Health (NIH) Director Francis S. Collins, M.D., Ph.D., and Johnson & Johnson Vice Chairman of the Executive Committee and Chief Scientific Officer Paul Stoffels, M.D. Drs. Collins and Stoffels outline the innovative efforts of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private initiative organized by NIH and the Foundation for the NIH. ACTIV’s partners, which include at least 18 leading biopharmaceutical companies, multiple U.S. federal agencies, and the European Medicines Agency, are developing an international strategy for an integrated research response to COVID-19.

FDA Role and Progress in the Pandemic: The FDA issued an updated At-A-Glance that provides a quick look at facts, figures and highlights of agency's response efforts. Major focus areas of the FDA’s response include increasing the availability of testing, therapeutics, and devices such as ventilators and personal protective equipment, and many other important items necessary for the response. The FDA is also monitoring the human and animal food supply and taking swift action on fraudulent COVID-19 products.

FDA Resources: The FDA has also published and continues to update extensive resources on COVID-19 and medical devices to help answer questions. In addition, the FDA published Contacts for Medical Devices During the COVID-19 Pandemic, a detailed list of email addresses that may be used to ask questions about COVID-19 related to specific devices, Emergency Use Authorizations (EUAs) or guidance documents today.

Clinical Guidance Updates: CDC updated their information on Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19). The updates include new information for pediatric management as well as information about COVID-19-associated hypercoagulability and updates and resources to include new NIH treatment guidelines.  

Sepsis and COVID-19: ASPR published a blog on Raising Awareness: Many Roads Lead to Sepsis, Even for COVID-19 Patients. The blog discusses why the timely recognition and treatment of sepsis –whether bacterial or viral—is key to saving lives. The blog also highlights the interception of sepsis and COVID-19, a BARDA-sponsored partnership to develop a diagnostic for viral sepsis, a BARDA-sponsored hand-held ultrasound system to diagnose pneumonia, and the announcement of FDA EUA authorization for a BARDA-supported rapid diagnostic test. 

Expanding Remote Monitoring Capabilities: The FDA issued an EUA for the G Medical VSMS ECG Patch intended to be used by health care professionals in the hospital setting for remote monitoring of the QT interval of an electrocardiogram (ECG) in general care patients who are 18 years of age or older and are undergoing treatment for COVID-19 with drugs that can prolong QT intervals (measurements used to evaluate some of the electrical properties of the heart) and may cause life-threatening arrhythmias (such as, hydroxychloroquine or chloroquine, especially when used in combination with azithromycin). The VSMS Patch is not intended for use on critical care patients. Such remote monitoring may reduce health care professional exposure to SARS-CoV-2, the virus that causes COVID-19.

Updates on Information for Researchers Conducting Clinical Trials: The FDA added more content to the question-and-answer appendix in its guidance titled “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The new content includes information on reporting serious adverse events (SAEs) among patients with COVID-19 in certain clinical trials that are not focused on developing COVID-19 therapeutics.

Administering Naloxone During the Pandemic: CDC released information on how to safely administer naloxone during the COVID-19 pandemic. The fact sheet includes steps to respond to a suspected opioid overdose while reducing risk of COVID-19 exposure and the recommended PPE based on the situation.

Information on Alternative Care Sites: ASPR’s Technical Resources, Assistance Center, Information Exchange (TRACIE), in partnership with the HHS/FEMA Healthcare Resilience Task Force, opened registration for its May 22 webinar: “Funding Sources for the Establishment and Operationalization of Alternate Care Sites.” Alternate Care Sites (ACSs) are one of many alternate care strategies intended to provide additional hospital surge capacity and capability for communities overwhelmed by COVID-19 patients. ACS can be established by an individual hospital, a group or partnership of hospitals or health systems, a local or state health department, or the federal government. 

Warning Against Fraudulent Actors: The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. The first seller warned, Benjamin McEvoy, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of products, including dietary supplements, on the company’s website, with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. The second seller warned, White Eagle Native Herbs, offers herbal products for sale in the U.S. with misleading claims that the products are safe and/or effective for the treatment and prevention of COVID-19.

PPE Updates
State-by-State PPE Data: FEMA released State-by-State PPE Data which outlines how many respirators, surgical masks, face shields, surgical gowns, gloves, ventilators and federal medical station beds that FEMA, HHS, and private sector have coordinated the delivery of or are shipping to states. The data in the stables below are separate from the supplies delivered through Project Airbridge.

Expanding the Supply Chain: FEMA released a new fact sheet on COVID-19 Pandemic: Supply Chain Expansion Line of Effort. Manufacturing expansion is one part of a four-pronged supply chain stabilization approach for the coronavirus disease (COVID-19) pandemic response. The expansion line of effort is focused on increasing manufacturing production capacity of critical medical supplies and equipment needed to defeat the pandemic and make our Nation stronger and better prepared for future needs. The Supply Chain Task Force works with U.S. manufacturing companies to rapidly increase supply, expand domestic production of critical resources and to also increase long-term supply through two approaches: Increasing existing traditional medical supply and equipment manufacturing capabilities; and Exploring creative opportunities within the private sector to boost manufacturing capacity of critical medical supplies using non-traditional manufacturers. The fact sheet details the different avenues for manufacturing expansion.

Reopening America
CDC Role in the Pandemic and for Opening Up America Again: CDC released an updated document on CDC Activities and Initiatives for COVID-19. This document briefly summarizes CDC’s initiatives, activities, and tools in support of the Whole-of-Government response to COVID-19. It includes an overview of CDC’s Surveillance and Control Goals and Activities. The principal objectives of COVID-19 surveillance are to monitor the spread and intensity of the pandemic, to enable contact tracing to slow transmission, and to identify disease clusters requiring special intervention. Secondary objectives include understanding the severity and spectrum of disease, identifying risk factors for and methods of preventing infection, and producing data essential for forecasting. In addition to tracking the disease itself, monitoring of healthcare capacity and essential supplies through the National Healthcare Safety Network (NHSN) is critical to ensure adequacy of care.

CMS Guidance for Reopening Nursing Homes: CMS released new guidance for states and local officials to ensure safe reopening of nursing homes across the country. The guidance details critical steps nursing homes and communities should take prior to relaxing restrictions implemented to prevent the spread of coronavirus disease 2019 (COVID-19), including rigorous infection prevention and control, adequate testing, and surveillance.  The vulnerable nature of the nursing home population requires aggressive efforts to limit COVID-19 exposure and to prevent the spread within facilities. The recommendations issued today would allow states to make sure nursing homes are continuing to take the appropriate and necessary steps to ensure resident safety and are opening their doors when the time is right. This also serves to help states and nursing homes reunite families with their loved ones in a safe, phased manner. CMS is recommending that nursing homes do not advance through any phases of reopening or relax any restrictions until all residents and staff have received results from a baseline test.  In addition, CMS recommends that state survey agencies inspect nursing homes that experienced a significant COVID-19 outbreak prior to reopening.  Finally, CMS recommends that nursing homes remain in the current state of highest restriction even when a community begins to relax restrictions for other businesses, and should be among the last to reopen within the community, to ensure safety of the residents.  

Information for Specific Populations
CMS Blanket Waivers: CMS updated their list of COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers. The updates include modifications to information for hospitals, CAHs, psychiatric hospitals, Cancer Centers and Long-Term Care Hospitals on physical location as well as updates on ambulance services.

Information for Wildland Firefights: CDC has published FAQs for Wildland Firefighters as part of its information for First Responders and Law Enforcement. During fire season, members of each fire crew module should make an effort to operate and isolate as a unit. Crews should not interchange personnel or equipment between units (when possible) and should limit the number of personnel who must interact with people in the community. When personnel arrive to their duty stations, it is recommended that management provide separate spaces for the personnel to socially distance themselves from others on their crew for 14 days, if possible. After the initial 14-day period is over, fire crews and modules who work together and do not have regular interactions with other people can isolate as a unit. 

Checklist for Homeless Service Providers: CDC released a Checklist for Homeless Service Providers During Community Re-Opening. Across the United States, some states and local areas are preparing to reopen businesses and community centers after closing. Even if COVID-19 cases have decreased in your area, quick spread of this disease in homeless shelters or encampments is possible. Protection of clients and staff remains necessary. During this time, continue to refer to the guidance for homeless service providers and unsheltered homelessness. This checklist was designed to provide homeless service providers – many of whom have remained open during the COVID-19 pandemic – with a reminder of important considerations for service delivery as the surrounding community reopens.

Testing in Animals: CDC, in collaboration with USA released information on Testing for COVID-19 in Animals. Generally, routine testing of animals is not recommended. The decision to test an animal (including companion animals, livestock, and wild or zoo animals) should be agreed upon using a One Health approach between appropriate local, state, and/or federal public health and animal health officials. This document provides recommendations to guide priorities for animal SARS-CoV-2 testing given limited resources. Veterinarians are strongly encouraged to rule out other, more common causes of illness in animals before considering SARS-CoV-2 testing.

National EMS Week: This week is National Emergency Medical Services personnel week, celebrating emergency medical technicians and paramedics. HHS Secretary Azar noted: “Since the beginning of the COVID-19 pandemic, we have been especially grateful for EMS personnel, who define what it means to be on the frontlines of our response. Emergency medical technicians and paramedics have stepped up to the challenge, serving Americans in need and often putting their own lives at risk to help preserve the health of others.”

Dear Frontier Community,

I hope that everyone is doing well and staying safe and productive. I also want to reassure you that your University is doing well. We are grateful that the vast majority of our students have been able to continue their studies and all of our employees are continuing employment.  Admissions for the summer class are full and we are busy processing new applications for the fall class. 

Our latest decision related to COVID 19 is that we will be transitioning our commencement ceremony to a virtual ceremony. We will work very hard to assure that you have a wonderful and enjoyable graduation ceremony that you will be able to share with family and friends. The ceremony will occur on the same date as stated on the university calendar (September 26, 2020). For those of you who would like the opportunity to walk across the stage, in addition to this year’s virtual commencement, we plan to invite you to participate in our next onsite graduation if you would like.  

We are busy working on three options to assure that we are ready for whatever the future holds. All three of these options include our current plan to continue to host all virtual sessions until October 5th, 2020.

Plan A is that we return to business as normal in the Fall term and open the Versailles campus as scheduled to host all on-campus events, beginning October 2020. 

Plan B is that we continue Frontier and DNP Bound orientation sessions and Crossing the Bridge as virtual events but start Clinical Bound sessions on the Versailles campus beginning in October of 2020. This would allow us to have significantly fewer people on campus at the same time and maintain social distancing. 

Plan C is that during the Fall term, all sessions will be held virtually as we are currently operating.

Each of these options will require much more planning and detailed work. The goal is to have three plans in place so that we can react quickly and appropriately to the environment surrounding  us. We will make every attempt to make a decision regarding fall term by August 1, 2020 while knowing that we will need to be flexible. To be clear, there will be no on-campus sessions prior to October, 2020. We are very pleased to report that the virtual sessions, Frontier Bound, Clinical Bound and DNP Bound, have received stellar evaluations. This is encouraging and gives us the incentive to continue these sessions, to promote the safety of students, faculty and staff while making innovative improvements to make them even more effective.  

A significant challenge at this time is that we have some of our clinical sites that are not taking students. Many of the affected students have been able to be placed in other sites but there are still some on academic hiatus awaiting a return to clinical sites. Some sites that closed in March have reopened to students. That is a positive sign. We continue to work diligently to get our students back into clinical. Our goal is to keep everyone moving forward in a safe and productive way.  

We acknowledge your resilience and commitment as you continue your journey at Frontier in the face of the unique challenges we are all encountering in our personal and professional lives. If you have questions about academic or clinical issues, please talk to your Clinical Directors, Department Chairs or Advisors as appropriate. If you have questions about the operation of the university, feel free to write to me. Thank you for your passion and continued confidence in FNU.  We will continue to strive to educate nurse-midwives and nurse practitioners to serve in the regions that need them most.  

Sincerely,

Dr. Stone 

Testing

Testing Support to States: The White House released information yesterday on providing test resources to states. In addition, today, the Administration posted information on how much funding and how many swabs each state will receive as part of the effort to bolster testing capacity.

Updates on Handling Specimens: CDC updated their information on Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with COVID-19. The updates include new recommendations on point-of-care testing guidance for COVID-19.

Updates on Testing Policy: The FDA updated the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. FDA is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. The update includes EUA submission templates for molecular, antigen, and serology tests. Developers may choose to use these templates to facilitate the preparation, submission, and authorization of an EUA for various types of COVID-19 tests.

Diagnostics Update: During the COVID-19 pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus. To date, the FDA has issued 92 EUAs, which includes 12 antibody tests and 1 antigen test. The FDA has been notified that more than 245 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

Treatment

Accelerating Development of Prevention and Treatment Options: FDA released information on new actions to accelerate the development of novel prevention, treatment options for COVID-19. FDA is providing new guidance with recommendations for innovators and researchers conducting work in this area. These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19.

Coding for COVID-19: CDC released information on the ICD-10-CM Official Coding and Reporting Guidelines, April 1, 2020 through September 30, 2020. The document includes coding guidelines for all types of COVID-19 diagnoses.

Ensuring Access to Sedation while Under Mechanical Ventilation: The virus that causes COVID-19 has led to an increased number of people with severe respiratory illness. As a result, there is a shortage of FDA-approved drugs such as propofol that are used for sedation of mechanically ventilated patients. The FDA issued an Emergency Use Authorization (EUA) for emergency use of the Fresenius Propoven 2% Emulsion to maintain sedation via continuous infusion in patients older than 16 who require mechanical ventilation in an ICU during the COVID-19 public health emergency. Fresenius Propoven 2% Emulsion has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet for more information before administering it.

Additional Information on Conducting Clinical Trials: The FDA added content to the question-and-answer appendix in its guidance titled Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The updated guidance includes new content with considerations for using alternate laboratories or imaging centers, holding trial participant visits via video conference, and conducting required postmarketing clinical trials. The guidance also includes updated information about managing protocol deviations and amendments to ongoing trials, and about consulting with the FDA regarding administering investigational product infusions at home rather than at the clinical trial site.

New Drug Applications Approved: The FDA approved two Abbreviated New Drug Applications relevant to COVID-19, and both medicines are listed in the FDA Drug Shortage Database. FDA recognizes the increased demand for certain products during the novel coronavirus pandemic and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public. Cisatracurium besylate injection USP 20 mg/10 mL is indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of cisatracurium include bradycardia, hypotension, flushing, bronchospasm, and rash. Azithromycin Tablets USP, 600 mg, is indicated for mild to moderate infections caused by designated, susceptible bacteria that cause certain sexually transmitted diseases and mycobacterial infections. Side effects of azithromycin tablets include hypersensitivity, QT prolongation, diarrhea, nausea, abdominal pain, and vomiting.

Recommendations for Postmarketing Adverse Event Reporting: FDA released information on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic. This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.

Reopening America

Updates on Surveillance Inspections: FDA released information with updates on surveillance inspections during COVID-19. During COVID-19, the U.S. Food and Drug Administration will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, national and international conditions warrant, with the exception of certain mission critical inspections. Mission critical inspections are identified on a case-by-case basis and conducted with appropriate safety measures in place. The FDA is collaborating with the CDC to develop a process that would govern how and where to return to on-site facility surveillance inspections in accordance with the gating criteria outlined in the White House Guidelines for Opening Up America Again. We expect this to be a phased approach driven by scientific data. Our priority and commitment are to first protect the health and well-being of not only our own highly skilled workforce and state contract inspectors, but also the health of workers in the important industries we regulate.

Guidance for Water Parks: CDC released information on Considerations for Public Pools, Hot Tubs, and Water Playgrounds During COVID-19. As public aquatic venues open in some areas, CDC offers considerations for the safety of those who operate, manage, and use public pools, hot tubs, and water playgrounds. The considerations include promoting behaviors that prevent the spread of COVID-19, maintaining healthy environments, maintaining healthy operations, and preparing for when someone gets sick.

PPE

Fask Mask Information: FDA released information on Face Masks and Surgical Masks for COVID-19: Manufacturing, Purchasing, Importing, and Donating Masks During the Public Health Emergency. In general, masks are used by the general public and health care personnel to prevent the spread of infection or illness. This page is for people and organizations who are new to working with the FDA. To help expand the availability of face masks and surgical masks, the FDA is providing regulatory flexibility, as described in our policy for face masks and surgical masks that is in effect during the COVID-19 pandemic. The information also includes FAQs on different types of masks, process for manufacturing, importing, purchasing, and donating.

Purchasing Respirators from Another Country: CDC updated their guidance on Factors to Consider When Planning to Purchase Respirators from Another Country. Key factors to consider include evaluation of the device, evaluation of the manufacturer or seller, evaluation of the contract terms, and FDA guidance on Emergency Use Authorization.

Information for Specific Populations

Information for Pediatric Providers: CDC updated Information for Pediatric Healthcare Providers. This information informs pediatric healthcare providers of information available on children with COVID-19 and can be used when managing pediatric patients with confirmed or suspected COVID-19.

Information on Worker Safety and Supports: CDC created a new webpage for each industry sector on Worker Safety and Support. The webpage includes information on planning, preparing and responding to COVID-19 and has specific information on coping and resilience, workplace guidance, and safety steps for specific populations.

Tips for Staying Safe While Running Errands: CDC updated their information on Running Essential Errands. The information includes tips and advice for what to do when grocery shopping, picking up take-out, banking, getting gas, and doctor visits.

People with Hemoglobin Disorders at Higher Risk: CDC updated their webpage on Groups at Higher Risk for Severe Illness. The risk group added includes people with hemoglobin disorders such as sickle cell disease (SCD) and thalassemia. Living with a hemoglobin disorder can lead to serious multi-organ complications, and underlying medical conditions (such as heart disease, liver disease, diabetes, iron overload, kidney disease, viral infections, or weakened immune system) may increase the risk of severe illness from COVID-19.

Information for Title VI Grantees: ACL updated information in their COVID FAQs for Title VI Grantees. Updated information includes new details on allowable uses for the funds, information on caregiver services, disaster operations, and helpful links.

Impact of COVID-19 on Black and Latino Communities: SAMHSA released a document on Double Jeopardy: COVID-19 and Behavioral Health Disparities for Black and Latino Communities in the U.S. The coronavirus (COVID-19) pandemic has revealed deep-seated inequities in health care for communities of color and amplifies social and economic factors that contribute to poor health outcomes. Recent news reports indicate that the pandemic disproportionately impacts communities of color, compounding longstanding racial disparities.

Information for Law Enforcement on Naloxone: SAMHSA released Guidance for Law Enforcement and First Responders Administering Naloxone. It is essential that naloxone continue to be administered during this time period. SAMHSA recognizes the concerns about COVID-19 exposure and recommends intranasal naloxone administration to promote first responder safety; if law enforcement or first responders feel the use of intranasal naloxone poses too great a risk, intramuscular naloxone may be used.

Information on Unsheltered Homelessness: CDC updated information on interim guidance on unsheltered homelessness and Coronavirus Disease 2019 (COVID-19) for homeless service providers and local officials. Updates include description of “whole community” approach; clarification of outreach staff guidance; and clarification of encampment guidance.

Testing Updates 

Improving Antibody Testing Quality: FDA has revised its policy to improve antibody testing quality.  FDA is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) tests developed by laboratories and commercial manufacturers for the duration of the public health emergency. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States.  Under the new policy, FDA expects commercial manufacturers to submit Emergency Use Authorization (EUA) requests, including their validation data, within 10 days of publication of the updated policy or the date they notify FDA of their test validation, whichever is later.  Additional information can be found in a fact sheet on antibody testing oversight and use for COVID-19, as well as in a blog posting that notes the new emphasis on prioritizing access and accuracy.  

Contact Tracing Training Guidance: CDC released a training module on contact tracing. This web page contains a sample training plan including training topics that may be helpful for state and local public health jurisdictions to consider when designing their own training plan for COVID-19 contact tracers. Each heading represents the learning objective for that section. Suggested training modalities/formats are provided, as well as information about sample existing trainings and resources. This document may be updated as new resources become available.

Information on Evaluation and Testing Patients: CDC updated their guidance on evaluating and testing persons for COVID-19. The changes include updated recommendations for testing, specimen collection, and reporting patients and reporting positive test results, and specification of testing priorities.

CDC Resources for Testing: CDC released a new fact sheet on federal resources for COVID-19 contact tracing staff. This fact sheet describes several ways health departments can access additional staffing for COVID-19 contact tracing, including through State Service Commissions and AmeriCorps Programs, CDC, and FEMA.

Information for Laboratories: CDC updated their FAQ document for testing and reporting by laboratories. The FAQs include information on accessing laboratory testing, data and reporting, test developers, serology, and ordering supplies.

Treatment Updates

Symptom Based Strategy for Discontinuing Isolation: CDC released a decision memo that outlines the updated recommendations for discontinuing isolation. In the context of community transmission where continued testing is impractical, available evidence at this time indicates that an interim strategy based on time-since-illness-onset and time-since-recovery can be implemented to establish the end of isolation. Practical application of a symptom-based strategy cannot prevent all infections.

Updated Information on Discontinuing Isolation: CDC also updated their discontinuation of isolation for persons with COVID-19 not in healthcare settings. This guidance is for healthcare providers and public health officials managing persons with COVID-19 under isolation who are not in healthcare settings. This includes, but is not limited to, at home, in a hotel or dormitory room, or in a group isolation facility. Updates include extending the home isolation period based on evidence suggesting a longer duration of viral shedding and will be revised as additional evidence becomes available. The clinical care guidance for health professionals and information on what to do if you are sick was also updated to reflect this change.

Updates on Convalescent Plasma: The FDA updated its guidance on convalescent plasma and associated web page. The updated guidance provides clarification for investigators on how to submit investigational applications for COVID-19 convalescent plasma. In addition, the guidance includes updated information regarding potential donors. Previously, the FDA’s guidance noted that to qualify, individuals should have complete resolution of symptoms for 28 days or resolution for 14 and a negative diagnostic test. The revised guidance recommends that individuals  have complete resolution of symptoms for at least 14 days prior to donation. A negative lab test for COVID-19 disease is not necessary to qualify for donation. The revised guidance also clarifies that FDA does not recommend storing a retention sample from the convalescent plasma donation for single patient emergency INDs.

Expanding Dialysis Therapy Options: To help address shortages of continuous renal replacement therapy (CRRT) products during the COVID-19 public health emergency, today the FDA issued an EUA to Fresenius Medical Care for emergency use of the multiFiltrate PRO System and multiBic/multiPlus Solutions. CRRT is a type of dialysis therapy used to filter and clean the blood when the kidneys are damaged or are not functioning normally. The Fresenius multiFiltrate PRO System and multiBic/multiPlus Solutions have been authorized to provide CRRT to treat patients in an acute care environment during the COVID-19 public health emergency.

Additional Information on Remdesivir: FDA released Frequently Asked Questions on the Emergency Use Authorization for Remdesivir for Certain Hospitalized COVID-19 Patients. The FAQs cover EUA for the drug, the side effects, additional information about the uses and the study on Remdesivir and how to obtain the drug.

Convalescent Plasma Guidance and Recommendations: FDA updated their general guidance and recommendations on convalescent plasma. The guidance includes recommendations on pathways for use of plasma, patient eligibility, collection of convalescent plasma, and recordkeeping. Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product.  A health care provider must participate in one of the pathways described below. FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma.  Health care providers or acute care facilities should instead obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.

New Study on Coronavirus and Children: NIAID announced a new study to determine incidence of novel coronavirus infection in US children. The study, called Human Epidemiology and Response to SARS-CoV-2 (HEROS), also will help determine what percentage of children infected with SARS-CoV-2, the virus that causes COVID-19, develop symptoms of the disease. In addition, the HEROS study will examine whether rates of SARS-CoV-2 infection differ between children who have asthma or other allergic conditions and children who do not.

PPE and Supplies

PPE Shipments to Nursing Homes: FEMA has released additional details in a fact sheet on PPE shipments to nursing homes. Announced last week, FEMA will coordinate two shipments totaling a 14-day supply of personal protective equipment (PPE) to more than 15,000 nursing homes across the Nation. Shipments are expected to begin in the first week of May and a second shipment will occur in June. Each facility will receive an allotment of surgical masks, gloves, goggles, and gowns. Each facility will receive an allotment of all four items based on the staff size of the facility.

Funding and Resources

$40 Million to Support Education to Racial and Ethnic Minority and Vulnerable Communities: The Office of Minority Health announced a competitive funding opportunity to invest up to $40 million for the development and coordination of a strategic network of national, state, territorial, tribal and local organizations to deliver important COVID-19-related information to racial and ethnic minority, rural and socially vulnerable communities hardest hit by the pandemic. The information network will strengthen efforts to link communities to COVID-19 testing, healthcare and social services and to best share and implement effective response, recovery and resilience strategies. Applications are due by 6:00 PM Eastern Time on Monday, May 11.

30 States Receive Assistance for Crisis Counseling: FEMA announced approval of 30 states and the District of Columbia for its Crisis Counseling Assistance and Training program. The program helps fund state-provided crisis counseling services to residents struggling with stress and anxiety as a result of the coronavirus (COVID-19) pandemic. FEMA's Crisis Counseling program helps people and communities to recover from the effects of natural or man-made disasters through short-term interventions that provide emotional support, crisis counseling, and connection to familial and community support systems.

$200 Million to Local Jurisdictions for Hungry and Homeless Populations: FEMA announced $200 million in supplemental funding allocations to local jurisdictions across the country to supplement local service organizations that provide critical resources to people with economic emergencies, which include our hungry and homeless populations.

Information for General Populations:

COVID-19 At a Glance: The FDA has also posted an updated COVID-19 Response At-A-Glance Summary. It contains updates on major agency activities as well as some important facts and figures.

Tips about Grocery Shopping: Given the many questions people have about grocery shopping safety, the FDA has posted a video, 12 Tips for Grocery Shopping During the Pandemic, to advise consumers.

Information for Specific Populations:

Tips for Healthcare Systems to Operative Effectively: CDC released a new document with 10 ways healthcare systems can operative effectively during the covid-19 pandemic. This document provides practical approaches that can be used to protect healthcare personnel (HCP), patients, and communities. The tips include information on work safety and support, patient service delivery, data streams for situational awareness, facility practices and communications.

Information on Caring for Someone at Home: CDC updated their information on Caring for Someone Sick at Home or other non-healthcare setting. The guidance includes information on how to protect yourself and others. Advice includes learning what to do when someone has symptoms of COVID-19 or when someone has been diagnosed with the virus. This information also should be followed when caring for people who have tested positive but are not showing symptoms.

Information for Pediatric Healthcare Providers: CDC updated their resources for Pediatric Healthcare Providers on what to do when managing pediatric patients with suspected or confirmed COVID-19. The webpage has information on maintaining childhood immunizations during the pandemic, the burden of COVID-19 among children, the clinical presentation of COVID-19 in children, treatment and prevention for children, and additional resources.

Information for Businesses: CDC updated their FAQ document for businesses. The FAQs cover topics including suspected or confirmed cases in the workplace, reducing the spread in workplaces, healthy business operations, cleaning and disinfecting, critical infrastructure and additional resources.

Information for Dentists: CDC updated their infection prevention and control guidance for dental settings during the COVID-19 response. The key information notes that dental settings have unique characteristics that warrant additional infection control considerations and advises dentists to postpone elective procedures, surgeries, and non-urgent dental visits, proactively communicate to both staff and patients the need for them to stay at home if sick, and know steps to take if a patient with COVID-19 symptoms enters your facility. CDC recommends dentists actively screen patients and colleagues before every shift.

Information for Community and Faith-based Organizations: CDC updated their information for community and faith-based organizations in preparations for re-opening. The resources include information on ongoing mitigation guidance, prevention and support, and a webinar.

Information for Veterinarians regarding Companion Animals: CDC updated their interim infection prevention and control guidance for veterinary clinics treating companion animals during the covid-19 response. Updates were made to clarify PPE recommendations based on situational risk factors and guidance for returning to normal clinic practices.

Information for Environmental Health Practitioners: CDC posted information for specific environmental health practitioners including congregate facilities and shelters such as general population disaster shelters, correctional and detention facilities, retirement communities, childcare centers that remain open, cooling centers and more. This webpage provides information for environmental health practitioners from CDC and other trusted sources.

Dear Frontier Community,

I hope that you are all coping with the many issues confronting us with the Coronavirus  pandemic. I know that you are facing a variety of different issues such as job furloughs or lay offs, added responsibilities and stress  in your work sites, lack of child care, responsibilities for homeschooling and for some of you, illness of yourself or your family members. Through all of these stressors many of you are progressing toward your education goals as well. I want you to know that we are thinking of you and that we are here to support you in whatever path works best for you during this time. 

I wanted to bring you up to date on decisions made by FNU leadership this week. The first is that all Frontier Bound, Clinical Bound and Bridge Crossing events will be held virtually through the summer term. This means that the next on-site events will be scheduled on the Versailles Campus during fall term beginning October 5th. The dates for these events will remain the same. 

The FNU Diversity Impact Conference "Year of the Nurse and Midwife 2020: Increasing Diversity, Equity, and Inclusion" will now be offered on June 11-13, 2020 as a virtual event. FNU is extremely excited about this year's conference. The Diversity Impact Planning Ad-hoc (DIPA) Committee has been diligently working to plan an innovative, interactive, on-line version of the conference. More information can be found here: https://portal.frontier.edu/web/fnu/di-2020.

Some students and alumni have asked about our 2020 Commencement Ceremony. We plan to hold the commencement ceremony as scheduled at Rupp Arena in Lexington, Kentucky on September 26.   There are no changes in plans at this time.

Last, we are beginning efforts to assess the feasibility of more students being able  to return to their clinical rotations. Dr. Slager and I are meeting with the clinical teams to start to put together a plan to assist our students in their re-entry to clinical sites. We know that this will happen sooner in some parts of the country and for some groups than for others. We also understand that some students will be ready to return to clinical before others. Additionally, many sites will continue their policy of limiting or prohibiting student rotations for quite some time. We will keep all of these factors in mind as we strive to develop a coordinated plan. We will keep the community informed of our efforts and the results.   

Do your best to stay safe. Don’t hesitate to reach out to your faculty or advisors with any questions that you might have about your own education plan. I am always available for questions about university policy or operations. 

Sincerely,

Dr. Stone

Promising Early Results from Remdesivir Trial: The NIH announced that hospitalized patients with advanced COVID-19 and lung involvement who received Remdesivir—an investigational broad-spectrum antiviral treatment administered via daily infusion—recovered, on average, faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1063 patients. Secretary Azar noted “Through the efforts of NIH, FDA, and other parts of HHS, the Trump Administration has been working relentlessly to get promising treatments like Remdesivir to the frontlines and save lives.”

Reopening America
Reopening Cleaning Guidance: CDC has released reopening guidance for Cleaning and Disinfecting Public Spaces, Workplaces, Businesses, Schools, and Homes. This guidance is intended for all Americans, whether you own a business, run a school, or want to ensure the cleanliness and safety of your home. This document provides a general framework for cleaning and disinfection practices. Cleaning and disinfecting public spaces including your workplace, school, home, and business will require you to: develop your plan; implement your plan; and maintain and revise your plan.

Testing and Treatment
Rapid Testing Development Competition: NIH has released information about their Rapid Acceleration of Diagnostics (RADx) program. RADx aim is to speed the development and commercialization of tests that can rapidly “see” if people have been infected with SARS-CoV-2 with very high sensitivity and specificity, meaning there would be few false negatives and false positives. A key part of this effort, will be a national technology development competition that’s open to all comers. In this competition, which begins a bit like a “shark tank,” participants will vie for an ultimate share of an approximately $500 million fund that will be awarded to help advance the most-promising testing technologies.

Contact Tracing Guidance and Resources: CDC released their principles and information on contact tracing which highlights the basic principles of contact tracing to stop COVID-19 transmission, includes detailed guidance for health departments and potential contact tracers information is forthcoming. CDC also updated the information on their contact tracing resource page to include new resources and key concepts on contact tracing. CDC guidance for COVID-19 may be adapted by state and local health departments to respond to rapidly changing local circumstances. 

Serology Surveillance Strategy: CDC is working with state, local, territorial, academic, and commercial partners to better understand COVID-19 in the United States. CDC’s serology surveillance strategy includes using serology testing for surveillance to better understand how many infections with SARS-CoV-2 have occurred at different points in time, in different locations, and within different populations in the United States.

Testing Clinical Specimens: CDC released updated information on Testing Clinical Specimens from Persons with COVID-19. Updates include new information on viral transport medium (VTM) to note that some point-of-care tests advise against its use and alignment of the guidance on swab types with FDA guidance.

Ask for Contributions to Scientific Research: CMS released a letter to clinicians participating in the Merit-based Incentive Payment System. CMS is encouraging the many clinicians, including physicians, physician assistants, nurse practitioners, clinical nurse specialists, and others, who participate in the Quality Payment Program (QPP) to contribute to scientific research and evidence through clinical trials to help fight the COVID-19 pandemic. Clinicians who participate in a clinical trial and report their findings to a clinical data repository or registry may now earn credit in the Merit-based Incentive Payment System (MIPS) for the 2020 Performance Period by attesting to the new COVID-19 Clinical Trials improvement activity.

Video to Explain FDA Emergency Use Authorizations: FDA issued a new video resource explaining Emergency Use Authorizations (EUAs), one of several tools FDA uses to help make important medical products available quickly during public health emergencies like the COVID-19 pandemic. Generally, EUAs provide more timely access to drugs, diagnostic tests and/or other critical medical products that can help diagnose, treat and/or prevent COVID-19. When deciding whether to issue an EUA, the FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.

Warning to Fraudulent Actors: The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider. The first seller warned, Hopewell Essential Oils, offers essential oils and herbal products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19. The second seller warned, Santiste Labs LLC, the “DefendTM Patch,” a transdermal patch containing a “composition of botanical oils,” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention or treatment of COVID-19.

Diagnostics Update: During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, the FDA has issued 50 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 22 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). The FDA has been notified that more than 230 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

Information for Manufacturers of Generic Drugs: The FDA posted information and resources to assist manufacturers submitting generic drug applications with bioequivalence studies that may be impacted during COVID-19.

Supplies
Ensuring Food Supply Safety: Last night, President Trump announced that he was invoking the Defense Production Act to ensure that Americans have a reliable supply of products like beef, pork, and poultry. Under the order, the Department of Agriculture is directed to ensure America’s meat and poultry processors continue operations uninterrupted to the maximum extent possible. To ensure worker safety, these processors will continue to follow the latest guidelines from the Centers for Disease Control and Prevention (CDC) and the Occupational Safety and Health Administration (OSHA). This action will further ensure that vitally important food processors are able to continue to operate safely and meet the consumer needs of the American people.

Mask, Gown and Glove Conservation Strategies: FDA released an updated letter to health care providers on surgical mask and gown conservation strategies as well as an updated to their medical glove conservation strategy. Conservation strategies are outlined for conventional capacity, contingency capacity and crisis or alternate strategies. The FDA is collaborating with manufacturers of surgical masks and gowns to better understand the current supply chain issues related to the COVID-19 outbreak, and to avoid any widespread shortages of these products.

Information for Specific Populations
Extension of Employee Benefit Plans: The Department of Labor notice, jointly issued with the Department of the Treasury and Internal Revenue Service, extends certain time frames affecting participants’ rights to healthcare coverage, portability and continuation of group health plan coverage under COBRA, and extends the time for plan participants to file or perfect benefit claims or appeals of denied claims. These extensions provide participants and beneficiaries of employee benefit plans additional time to make important health coverage and other decisions affecting their benefits during the coronavirus outbreak.  

Smoking and COVID-19: As part of its work to help protect public health, FDA updated its FAQ page with information about smoking and COVID-19. Smoking cigarettes can leave smokers more vulnerable to respiratory illnesses such as COVID-19, which is why there’s never been a better time to quit smoking. FDA’s Every Try Counts campaign has supportive tips and tools to help smokers get closer to quitting for good.

Research on COVID and Older People: AHRQ published a paper on COVID-19 and the Safety of Older People. The paper highlights key patient safety problems, tools and resources for nursing homes, and professional organization resources.

Keeping Children Healthy: CDC updated their information on Keeping Children Healthy While School’s Out. The guidance includes steps to keep children healthy, signs to look for if children are sick, and how to help them continue learning. The CDC FAQ document with information for children was updated as well.

Dear Frontier Community,

I wanted to bring you up to date on a few decisions that were made this week. The first is that all Frontier Bounds and Clinical Bounds will be held virtually through summer term. This means that the next on-site events will be scheduled on the Versailles Campus during the fall term. I will be sending a message to the entire community including all students about this tomorrow so we can begin to help applicants and students plan accordingly. We will also be confirming the dates for Bounds and will get that information to you as soon as possible. 

For employees who work on the Versailles Campus, we are extending the work-at-home end date from May 8 to May 31.  As we get closer to the end of May, we will be assessing the situation to see if the plan to return to on-site work the week of June 1 is safe and workable. We want to remain flexible as we receive more information and guidance about Kentucky  "reopening". 

We have had a variety of support sessions held for faculty, staff and students. We want to thank all of you who are presenting and offering to present for your willingness to support our community. That said, there are concerns about coordinating those efforts to avoid overlap and duplication of effort and that events are announced from a central location etc.  Therefore if you desire to offer a support session, we ask that you write a very brief description including objectives indicating the target audience and email this to Amanda Bockelman who will collate the information. There is an ad hoc committee led by Dr. Calohan who will coordinate the effort.  

Lastly we are beginning efforts to assess the feasibility of students returning to clinical. Dr. Slager and I are meeting with the clinical teams to start to put together a plan to assist our students in their re-entry to clinical sites. We know that this will happen sooner in some parts of the country and for some groups than for others. As a coordinated plan develops, we will keep the community informed of our efforts and the results.   

Thank you all for your continued very hard work. We are weathering this storm together and your efforts are very much appreciated. 

Sincerely, Sue Stone

Greetings FNU Community, 

The COVID-19 Pandemic has induced a great deal of stress, anxiety, and fear of the unknown in regards to transmission of the virus and lifestyle changes.  With this pandemic upon us, I have conducted a brief environmental scan employing some great resources.  

According to The United States Department of Education (2020), xenophobia is on the rise, and educational institutions should take special care to ensure the following:  

-- all students are able to study and learn in an environment that is healthy, safe, and free from bias or discrimination (discrimination or bias can take many forms, ranging from verbal abuse to physical attacks based on race, ancestry, or misunderstandings about cultural traditions)
-- harassment based on race or ethnicity is not tolerated.

It is important to know that race or ethnicity has nothing to do with an increased risk or spread of the virus. Persons such as emergency responders, healthcare professionals, or a person who has been in an area in which the virus has been spreaded should not be subjected to bias or discirmmination.  Stigmatized groups may be subjected to:

-- Social avoidance or rejection
-- Denials of healthcare, education, housing or employment
-- Physical violence

Stigma hurts everyone by creating fear or anger towards other people. Stigma affects the emotional or mental health of stigmatized groups and the communities they live in. Stopping stigma is important to making communities and community members resilient.

Early data is showing marginalized populations are being impacted the most by COVID-19.  This is believed to be related to:

-- Health disparities
-- Health inequity
-- Social determinants of health
-- Associated chronic illnesses
-- Age 65 and older

Please note:  Ameliorating discrimination, bias, and stigma is a priority at FNU.

CDC Fact Sheet 2020

This is what I have uncovered early in the environmental scanning phase.  I will keep you abreast of any new information. Feel free to share any compelling updates at Diversity-Inclusion@frontier.edu.

Geraldine Q. Young, DNP, APRN, FNP-BC, CDE, FAANP
Chief Diversity and Inclusion Officer

Dear Clinical Students,

Please read this entire notice carefully! Clinical students may be affected differently based on region, site, etc.

As a student who attended Clinical Bound in 2019 or the Winter 2020 term, you may have been stopped from your clinical site - especially if you were rotating at a large organization/hospital. The university anticipates these rotation suspensions will be for at least 30 days.  For some organizations, it has already been 30 days since they suspended rotations.

Students Stopped from Rotations:
-- The university is collecting/maintaining organizational changes to clinical rotations daily. 

-- For students who have a rotation at one of these organizations, your end date will be revised to indicate your rotation stopped on March 23 [estimate for all students rather than the exact date of individual circumstance].

-- This “closes” the rotation in the university system. The indicator remains green but you may not return to the site without resubmitting [see below].

Students Returning to an Organization Once Suspension is Removed:
If your clinical site/preceptor notifies you that students can return to rotations, please follow the process below. Do not return to the clinical site without completing the process below! A student who returns to an organization without completing the process below risks losing the rotation and jeopardizes the relationship with FNU for future students.

-- Submit the Clinical Site  Approval Form (CSAF) with your new rotation start/end dates, estimated hours, and experiences through the Community Map.  If the site is on your plan from before March, it will be listed on the Community Map; therefore, reducing the information you’ll need to enter.

-- Once accepted by your RCF, the Credentialing Team will verify the credentialing is current and work with the site to determine if you need to re-onboard at the site. Many large organizations require extensive onboarding within a specific timeframe of your start date. This means students may need to re-onboard with a site before returning to clinicals.

-- If re-onboarding is required, your Credentialing Coordinator will work to reduce as much duplication for you as possible.  Duplication may be required in some cases.

-- If re-onboarding is not required, your Credentialing Coordinator will complete the site for your RCF to review and provide final clearance to begin, which will change the indicator to green on My Clinical Plan.

Jodi Dickey, MAHEA
Director of Clinical Credentialing

Dear Frontier Community,

Through generous donor support, Frontier has established the Frontier Emergency Scholarship Fund. Students experiencing unexpected circumstances can request financial assistance to help continue in the program. Examples of unexpected circumstances include major expenses due to a hurricane, tornado, fire, flooding, personal and/or immediate family illness (eg., significant other or child), or other unforeseen emergencies. Please note that these funds are not intended to be supplemental income for routine expenses, rather they are intended to meet unexpected emergent needs.

Applications should be submitted within 3 months of the event. These funds are available throughout the year. Funds awarded are considered part of the student’s financial aid package. If a student has already received the maximum allotment of financial aid, any award would go toward decreasing their student loan debt. In that situation, unfortunately, no award can be given since it would not be available for the emergency. Students should check with the Financial Aid Office to determine if they are eligible to receive additional funds prior to submitting a request.

If the COVID Pandemic has affected you financially, you can apply to the fund.

If you are a student and find yourself in this situation, you may submit the form (https://docs.google.com/forms/d/e/1FAIpQLSesVDb9L8pXon5X3jB34CWUte3TY_OobYiGRBQZHywDaTYwjA/viewform) linked here to request consideration for this scholarship. Your request will be answered within two weeks. This fund is designed to be expedited quickly to help students with unexpected needs without much delay. This form can also be accessed from the Portal page>Departments>Financial Aid>Frontier Scholarships>Dean's Emergency/Scholarship (https://portal.frontier.edu/web/fnu/frontier-scholarships) .

Faculty and staff, if you are aware of a student who would benefit from this assistance please refer them to the portal page to complete the request.

For students who need general financial support, our Spring and Fall Scholarship awards are announced by the Scholarship Committee and will continue to be awarded twice annually. The Financial Aid Office can answer questions and provide assistance with general financial support needs.

Frontier Emergency Fund Subcommittee

Lisa Chappell, Chair

Shirley Bush

Mickey Gillmor

Linda McDaniel

On April 1, 2020, the United States Department of Labor announced new action regarding how American workers and employers will benefit from the protections and relief offered by the Emergency Paid Sick Leave Act and Emergency Family and Medical Leave Expansion Act both part of the Families First Coronavirus Response Act (FFCRA). 

Please review the attached notification in response to the FFCRA. 

Please be mindful, federal regulations are still being written and more information is underway. 

If you are ill for any reason (unrelated or related to COVID-19) and you expect to be out more than (3) three days, please notify Human Resources as soon as possible and/or at least within three days of illness.

you can find the poster at this link

Dear FNU Preceptor,                         

We are approaching the end of our suspension of clinical rotations at Frontier Nursing University. As you may recall, we made the difficult decision to suspend clinicals for two weeks in order to evaluate the rapidly changing landscape of the COVID19 pandemic. The two week suspension has  allowed us to assess the situation and get the most up to date picture of the current status of all of our clinical students. We know that we have many students who have been suspended at the request of their clinical site. We also have students who want to continue clinical. Additionally, we are a university with students in all 50 states and we know the impact of the COVID19 pandemic is different state to state. For these multiple reasons we have decided to allow students to return to clinical sites April 6, 2020.

In preparation for return to the clinical setting, all students have completed mandatory COVID19 education related to self- monitoring, risk mitigation, proper use of PPE and reporting of any exposure.  Additionally, for students unable to return to clinical immediately, clinical simulation opportunities are available, so that upon their return they will be prepared and ready to continue their clinical learning experience.  

Lifting the clinical rotation suspension will allow many of our students to continue to advance their clinical education and contribute to meeting the need for  advanced practice nurses and midwives in the future. We recognize that not all students will be able to  return to the clinical environment for a variety of reasons, however we do support their return when our partner sites permit. Your Regional Clinical Faculty will reach out to you to discuss any questions you may have and a date your student may return to your clinical site if known. If you are not ready to have students return to your site, we completely understand. We will remain in communication to evaluate future clinical placements.  

We thank you for your continued partnership and gift of precepting. We are so grateful to you for your care and commitment  to your communities during this pandemic.

Sincerely,

Dear Frontier Community, 

We are approaching the end of another week in the midst of the COVID 19 Pandemic.  We continue to make decisions daily to assure the best experience possible for all of our students given the situation at hand. At the beginning of this week, we made the decision to suspend all students from clinical for a two week period. This allowed us to assess the situation and get the most up to date picture of the current status of all of our clinical students. We know that we have many students who have been suspended at the request of their clinical site. We also have students who want to continue clinical and we have students who would prefer to take a stop out given the impact of the pandemic on their lives. As you know FNU students and clinical sites are located across the country from New York to Florida to Mississippi to North Dakota to California. While all states are experiencing the impact of the Covid-19 Pandemic, the impact is different state to state. For these multiple reasons we have decided to move forward to allow some students to return to clinical sites as we begin the Spring Term 2020 on April 6. 

The FNU Leadership team has worked together to create a detailed plan for clinical students that will be implemented over the next week. We will be doing our best to treat clinical students individually given their situation. Students who were already in  the clinical portion of their program and were affected by the suspension of clinical experience this week will be contacted individually by their Regional Clinical Faculty (RCF). The RCF will work with each student to create an individual plan that is appropriate for that student. 

Students planning to attend Clinical Bound during the Spring Term 2020 will have the opportunity to attend a virtual Clinical Bound followed by a virtual clinical course which will enable them to complete their initial clinical hours and requirements during spring term. Department Chairs will work with students who attend Clinical Bound to design an individual plan for each student depending on their needs and clinical site availability. 

Students planning to attend Frontier Bound in the Spring Term 2020 will attend virtual Frontier Bound sessions and begin their didactic courses on schedule with no interruption. Students who are in didactic courses are encouraged to continue their coursework as scheduled. 

Any student, regardless of where they are in their program of study may decide that it is best for them to take an Academic Hiatus during Spring Term. We understand there are many unforeseen challenges confronting our students and their families as we all deal with the many consequences of the COVID 19 Pandemic. Feel free to discuss this with your Academic Advisor. 

This memo is intended to give the community an overview of our current plans. Our goal is to provide all students with a quality education. There are many details that will be provided to students as the individual plans are created. We don’t want to delay student progression unnecessarily but realize our current situation is challenging. We want to be able to assist each student to meet their goals. To do this, we all have to work together and we all have to be patient with each other.  We are all in this together. Please let me know if you have questions. 

Sincerely,

Dr. Stone
President 

Dear Frontier Staff,

As you may have seen by now, Governor Brashear released a new Executive Order today prohibiting “in-person work that is not necessary to protect or sustain life.” We are now asking all employees, except for facilities and security (as they are covered under the “Minimum Business Operations” exemption), to work from home starting Friday, March 27, 2020. Additional staff that have functions considered “Minimum Basic Operations" (see page 5 of the Exec Order) can work with their supervisor to develop a plan to complete those tasks in the office (but only if those tasks can not be completed at home). 

As before, you are still welcome to come into the office if you prefer. Please make sure to isolate yourselves, not just keeping six feet of distance but also ensuring you are not touching the same surfaces/materials as others. 

For those that don’t already have an approved telecommuting agreement, please submit one (make a copy of this template) to your supervisor before the end of the day tomorrow. In the “Work Schedule” section of the agreement, please make sure to note that this is a temporary schedule that only covers the time period of the COVID-19 Pandemic. 

The Leadership Committee continues to meet daily to discuss the effect of the pandemic on our employees, students and operations. Please reach out if you have questions or concerns. 

Take care and stay safe!

Sincerely,

Shelley Aldridge
Frontier Nursing University
Chief Operations Officer

Dear Clinical Site Leader,

I want to thank you for your important work in both caring for patients and allowing our students to learn in your facility. Given the severity of the COVID 19 situation, we have made the decision to discontinue all of our Master of Science in Nursing and Postgraduate nurse practitioner and nurse-midwife students' clinical experience at this time.

Some of our clinical sites have already discontinued clinical rotations. For those who have allowed our students to remain in clinical, Frontier Nursing University has made the decision to institute a minimum two-week hiatus as we all continue to assess the situation. While I know that you have many other issues taking up your valuable time, we did want to keep you informed and continue to communicate as the situation warrants. As conditions improve, our clinical faculty will be in touch to work with you to resume our students' clinical education rotations.

Again, thank you for being our partner in clinical education. We wish you the very best as we all continue to battle to keep people as safe as possible. If you have questions, please feel free to contact our Clinical Credentialing office at clinicalcredentialing@frontier.edu.

Very sincerely,

Dr. Susan Stone
President
Frontier Nursing University

Dear FNU Preceptor,

We know that you may have questions related to Frontier Nursing University students' continued clinical rotations during the rapidly-changing situation around COVID19. Due to the updated CDC recommendations and state responses, Frontier Nursing University has made the difficult decision to stop all clinical rotations until April 7, 2020. The situation will be reassessed at that time. Students are not to report to your clinical site after the close of business, Monday, 3/23/20.

The decision to halt clinical rotations and reassess in 2 weeks was not made lightly. We believe that allowing continued clinical rotations contradicts the recommendations of national, local and state health departments. Please rest assured that we are following the situation closely and are prepared to support our students and preceptors through this crisis. Please watch your email regularly as we communicate decisions related to clinical rotations. Your Regional Clinical Faculty will be in close communication regarding clinical rotations.

Please know that we will continue to work on solutions to ensure students’ academic progression. We thank you for your continued partnership and gift of precepting.

Sincerely,

Sincerely,

Katheryn Arterberry                   Audrey Perry                                     Susan Piper
FNP Clinical Director                 CNEP/WHNP Clinical Director            PMHNP Clinical Director

Dear Frontier Community,

As we all continue to navigate the effects of the COVID 19 virus together, I understand that everyone’s lives have been disrupted including our students, faculty staff, board of directors and our supporters. I’m sure this is causing an inordinate amount of stress for all of our community members. I hope that each and every one of you can take the time to step outside and take a deep breath of fresh air.  Know that together we will get through this.

This week at Frontier Nursing University we made the difficult decision to discontinue the clinical placement of more than 490 clinical students for the next two weeks. In reality more than 200 of those students had already been dismissed from their clinical sites due to changes in the policies of the sites, in response to the coronavirus pandemic.  During these next two weeks we will be assessing the status of and recommendations for clinical experiences for our students. We know that there is a shortage of Personal Protective Equipment and this was one reason why clinical sites were limiting students. We also know that healthcare workers are themselves at increased risk for infection. For these reasons, we felt that we needed to pause the clinical experience during this time. We continue to closely monitor the spread of the virus, the effect on the healthcare workforce and the state and national recommendations to assist us in making the best decisions possible that affect our students. 

FNU is moving forward with the start of the Spring Term on April 6, 2020. Online classes will begin as scheduled. We are also processing applications for the Summer Term which will start online classes on July 6. We plan to hold our Frontier Bound sessions as well as our Clinical Bound sessions during the spring term. We held our first completely virtual Frontier Bound orientation last week and according to student reviews, it was a great success. Our faculty is hard at work creating virtual clinical bound sessions in case we need them. We must be able to adapt to this changing situation as we receive updated information. We will keep you informed along the way. We do plan to transition back to on-campus sessions as soon as it is safe to do so. We are working hard at the goal of keeping students moving towards their goals during this challenging time.  At the same time, we understand that for some, there will be a need to stop academic progress for a period of time. We are doing our best to accommodate the varying needs of our students. The Banyan Tree Portal is being kept current with communications and updates. 

Our faculty and staff are primarily working from home with just a few essential staff on campus and those who prefer to work in offices on-campus alone. Everyone is hard at work ensuring that we accommodate the needs of our students. 

Take care yourselves. Please consider taking the time to watch this 11-minute presentation on self-care strategies by Dr. Jess Calohan, Department Chair of PMHNP.  Do whatever is the very best to keep yourself and your loved ones safe. We will come out on the other side stronger and we will have learned many important lessons.  

Sincerely,

Susan Stone, CNM, DNSc
President  

Dear FNU Clinical Students,

We know that you may have concerns about your clinical experiences and the fast-changing situation around COVID19. Due to the updated CDC recommendations and state responses, Frontier Nursing University has made the difficult decision to stop all clinical rotations until April 7, 2020. The situation will be reassessed at that time.  You are not to report to your clinical site after the close of business today, Monday, 3/23/20. Please rest assured that we are following the situation closely and are prepared to support you through this health care crisis. 

In order to support your academic progress, we encourage you to complete clinical course assignments during these two weeks. Additionally, we are increasing the number of non-face to face clinical hours from 18 to 30 hours.  Please contact your RCF to approve appropriate experiences/ education.  

Please know that we will continue to work on solutions to ensure your academic progression.  Your safety is our primary concern and the successful completion of your program of study is a close second! Your faculty, clinical directors and department chairs are available should you need us.

Sincerely,

Katheryn Arterberry                   Audrey Perry                                     Susan Piper
FNP Clinical Director                 CNEP/WHNP Clinical Director            PMHNP Clinical Director

Good Afternoon,

Many of you may have some concerns and questions in regard to some of our policies and seek guidance should there be an occurrence related to COVID-19. We recognize the hardship this epidemic has caused and we want you to know we are diligently making every effort to ensure all employees and students across the country are healthy and safe. As a result, we have created the COVID-19 Workplace Policy that is effective immediately. We will review, update, and announce any changes to the policy if needed. 

Please review the policy and if you have any questions or concerns, please contact the Human Resources Department by email or by phone. 

I hope everyone is safe and well.

Sincerely,

LaToshia Daniel, MSHRML, SHRM-CP
Frontier Nursing University
Human Resources Director

Dear Faculty and Staff,
Frontier Nursing University is following the news and recommendations of the COVID 19 Pandemic very closely. Today, the CDC recommended that for the next eight weeks there be no gatherings greater than 50 persons. Also “ that events of any size should only be continued if they can be carried out with adherence to guidelines for protecting vulnerable populations, hand hygiene, and social distancing.  When feasible, organizers could modify events to be virtual.”
 
Given this information, we have made the decision to convert all Clinical Bound sessions to online sessions through at least May 9, 2020. I will share the message that will be sent to students today. At this point, we plan to run those on the scheduled Clinical Bound dates. We will adapt as the situation unfolds. If students need to delay their Clinical Bound due to clinical site issues, we will plan extra Clinical Bound sessions in the future. We know that some students are not being allowed to attend their clinical sites. We will be in close contact with all students planning Clinical Bound and who are in clinical as this situation continues to unfold. Each student will be attended to individually to assure their needs are met to the best of our ability. 
 
Frontier Bound orientation sessions will continue to be held virtually throughout May and June 2020. 
 
Based on Governor Beshear’s closure of all dining facilities and in order to limit gatherings to less than ten people, it has also been decided to close Wendover until May 9. We are working with the staff there to develop a plan for them during this time. 
 
For you, our employees, we want to be able to care for you as well. We know that you are dealing with the stress of the many unprecedented changes and restrictions that are taking place. If you find yourself in a situation where you need to take time off due to the COVID 19 Pandemic, please talk to your supervisor or the Human Resource Director.  We will do our best to assist you. For employees who were asked to start telecommuting full-time (if approved by their supervisor) that agreement also continues through May 9. 
 
We are recommending no plane travel, no on-site site visits, no on-site case days and that you avoid large meetings as recommended by the CDC through May 9, 2020. That said, we would like to engage in a very interactive on-line work environment to support each other and to support our students. I am encouraging you all to be creative and create social situations online during the work day. This could include ZOOM meetings to share what’s happening or to have lunch together. I am sure that you can all be much more creative than that as well. 

Sincerely,
 

Susan Stone
President 

Dear Frontier Students,
 
This is an unprecedented time in our country as we are all dealing with the COVID 19 Pandemic. As health care providers we are all affected to an even greater degree. Our goal at this time is to help you continue on your educational path successfully while understanding that some of you may need to pause to attend to the collateral issues associated with the pandemic. This could be caused by increased demands of your place of employment, illness of you or a family member or another situation. Students who are in the didactic portion of the program: your faculty are here to assure that you can continue as planned with no interruption. If you find that there is a reason that you need to be away from your program because of this pandemic, please notify your Department Chair (CNEP/WHNP- tonya.nicholson@frontier.edu; FNP- lisa.chappel@frontier.edu; PMHNP- jess.calohan@frontier.edu) so that we can consider an Academic Hiatus or other arrangements specific to your needs. We will strive to be flexible to meet your needs if you encounter situations related to the pandemic that affect your academic progress.

Students who are in the clinical portion of your program: we recognize that many of you are being told that your clinical sites are now closed to students. If this affects you, you should notify your Regional Clinical Faculty to determine the next course of action. This could be relocation to another site on your clinical plan or if you need to stop out for a time, we will be flexible with timelines. We are here to assist you in your decision making. We have asked all of your Regional Clinical Faculty to cease doing on-site visits so that they can be available to you for consultations with minimal delay. They may schedule and perform virtual site visits if needed. 
 
You will be hearing from your Department Chairs, Clinical Directors and your Regional Clinical Faculty as well depending on where you are in your program. Please stay in close communication and regularly check your FNU email, as this situation continues to unfold. This is a rapidly changing daily scenario and we will be following this closely and responding to the best of our ability to assure your needs are met. We are here to help in any way that we can.
 
Sincerely,
Dr. Susan Stone
President 
 
Dr. Joan Slager
Dean

Due to concerns about the COVID19 virus, we have decided to convert the Frontier Bound/DNP Bound session scheduled for March 16-19, 2020 to an online workshop. We believe this is the best course of action at this time. We will provide an information-packed, meaningful experience that will give our Frontier Bound students the information that they need to get started in their new program, and create that sense of Community that is a core value of FNU, and distinguishes us from other distance programs.   New students attending Frontier Bound next week, stay tuned and keep your scheduled time for Frontier Bound open. You will soon be hearing from your Department Chair about the details and schedule of the Frontier Bound Online Workshop. More information about attending the required sessions for next week will be arriving soon, so watch your emails. Also, please prepare a place where you will be able to participate in the sessions without distractions or interruptions. You will need a good internet connection, laptop or computer, headset with microphone and a webcam. For students who are currently on-campus, know that we are doing our very best to take good care of you. We encourage everyone to follow normal infection prevention procedures. Two primary strategies 1. If you are sick, please notify your faculty member. This is very important. 2. Wash your hands. Ensure handwashing strategies include washing with soap and water for at least 20 seconds or using a hand sanitizer that contains at least 60% alcohol if soap and water are not immediately available. 3. Appropriately cover coughs and sneezes. These very basic public health measures can have a huge impact on the spread of any infection. We are also closely following CDC Guidelines for cleaning our facilities. 
  
Our next on-site campus session is a Clinical Bound session that starts on April 11, 2020 which is one month from now. We are not cancelling any planned on-site campus Clinical Bound sessions at this time. We will of course continue to monitor the situation and will make a different decision if necessary. I want to reassure you that we are not planning to cancel any sessions. Your very creative faculty members are busy designing an online Clinical Bound just in case we need it. To be clear, this is not our best scenario, but we can do it if it is necessary. Our goal is not to interrupt your education.  We will provide more information as it becomes available. Frontier Bound students, you will be hearing more details very soon. 

Sincerely,
Dr. Susan Stone

Dear Frontier Community,
 
Frontier Nursing University is closely monitoring the spread and the impact of the COVID 19 virus. At this point in time, the outbreak is being characterized by the Centers for Disease Control (CDC) as an ”emerging, rapidly evolving situation.” According to the CDC, there are no restrictions on travel within the United States at this time. What is important is that we take preventive actions to prevent the spread of infection including COVID 19 and INFLUENZA. Two primary strategies 1. If you are sick, please stay home. This is very important. Whether coming to an office, entering a clinical site or attending an on-campus session, it is important to stay home if you are not feeling well. 2. Wash your hands. Ensure handwashing strategies include washing with soap and water for at least 20 seconds or using a hand sanitizer that contains at least 60% alcohol if soap and water are not immediately available. 3. Appropriately cover coughs and sneezes. These very basic public health measures can have a huge impact on the spread of any infection.  The CDC is providing updates nearly daily. This one published over the weekend provides much information. I encourage you to review this. 
https://www.cdc.gov/coronavirus/2019-ncov/summary.html

In the meantime, know that we are monitoring the situation closely. We are not restricting travel at this time. We are developing alternative plans if restricted travel becomes necessary. We will keep you informed. That said, we have students and faculty all over the United States, and we cannot know the individual situation of every person. If anyone feels threatened by any required assignment in a clinical site or required travel, they should contact their Clinical Director to discuss their concern if they are in clinical or their Department Chair if they are in the didactic portion of their program. Don’t hesitate to contact your faculty members or your supervisor of any concerns as this situation continues to evolve. 

Sincerely,
Dr. Stone