200501 brightspring pharmerica enterprise outbreak plan v5€¦ · 02/05/2020 · brightspring –...

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BrightSpring – PharMerica Enterprise Outbreak Preparedness Plan

Version 5: May 2, 2020 Introduction BrightSpring-PharMerica takes all outbreak threats very seriously. While we have had an organizational disaster and pandemic plan for many years, with the new threat posed by the novel Coronavirus and COVID-19, we have we have adopted additional tactics and committee governance to be able to respond to COVID-19 and other potential outbreaks with agility – to meet both the rapid pace of information being disseminated, and the concerns that people in the community have about COVID-19.

Outbreak Preparedness and Action Committee

We have leveraged the cross-functional expertise of a diverse set of medical, clinical, risk management, human resources, legal, communications and operations leaders throughout our organization and have formed an Outbreak Preparedness and Action Committee. The mission of the Committee is to prepare for potential outbreaks and to act when necessary to protect, support and serve our patients, clients and employees. The Committee embodies the principles of preparation, reassurance, evidence-based action, coordination, communication and support. The Committee works with operators and stakeholders to identify areas of patient, client and employee outbreak risk and prepares the organization for such threats. The Committee also serves as a means of consolidating internal and external communications regarding COVID-19 and other potential outbreaks.

Situation Summary

The virus is named “SARS-CoV-2” (Figure 1) and the disease it causes has been named “coronavirus disease 2019” (abbreviated “COVID-19”). Early on, many of the patients in the COVID-19 outbreak in Wuhan, China, had some link to a large seafood and live animal market, suggesting animal-to-person spread. Since, a growing number of patients reportedly did not have exposure to animal markets, indicating person-to-person spread. After implementing travel restrictions and robust infection control, the number of new daily cases of COVID-19 in Wuhan decreased significantly (Figure 2).

Figure 1. This transmission electron microscope image shows SARS-CoV-2, the virus that causes COVID-19—isolated from a patient in the U.S. Virus particles are shown emerging from the surface of cells cultured in the lab. The spikes on the outer edge of the virus particles give coronaviruses their name, crown-like. National Institute of Allergy and Infectious Diseases.

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Figure 2. Number of new daily cases of COVID-19 in China steadily decreased since infection control measures and travel restrictions were implemented.

Our organization is using the data that illustrate that the infection control measures taken in China and other countries are working, to sharpen our focus on our own efforts on best practices in infection control and prevention. We are also following the incidence of new daily cases in a number of countries outside of China as lessons about practices to both model and to avoid, as well as to help inform our trajectory estimate and planning for the situation in the US (Figure 3).

Figure 3. New daily cases of COVID-19 between January 21, 2020 and April 30, 2020.

Global Situation Summary

BrightSpring-PharMerica is actively monitoring the global situation daily, in order to understand transmission patterns, rate of spread, mitigation tactics, and to highlight geographies that represent high risk travel for employees or family members of employees. Our primary monitoring source is the Johns Hopkins University Coronavirus Resource Center (Figure 4), in addition to the Centers for Disease Control and Prevention (CDC) and World Health Organization’s (WHO) COVID-19 situation rooms.

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Figure 4. Johns Hopkins University Coronavirus Resource Center Dashboard.

Situation in U.S.

The Outbreak Committee monitors the situation rooms from CDC, WHO and Johns Hopkins University daily, and keeps a “Heat Map” updated so we can best direct our local operations in markets. This map is shown below, for illustrative purposes (Figure 5).

Figure 5. BrightSpring-PharMerica “Heat Map”, which shows the COVID-19 prevalence in U.S. by state, overlaid on our organization’s service line presence in each state.

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Assessment and COVID-19 Case Definition When assessing individuals with a fever and lower respiratory symptoms, such as coughing or shortness of breath, or potential exposures, we utilized the CDC’s infection control guidance for healthcare professionals about Coronavirus as shown in the below Flowchart (Figure 6). A COVID-19 case was defined as a positive nucleic acid test for SARS-CoV-2 RNA. Figure 6. BrightSpring-PharMerica COVID-19 Flowchart to Identify, Assess and Triage suspected cases of COVID-19.

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COVID-19 Case Tracking and Visualization Application In order to streamline COVID-19 case and exposure triage and reporting, we built a secure, cloud-based web application. The application leverages a QuickBase (QuickBase, Inc., Cambridge, MA) data structure to quickly capture confirmed cases as well as potential exposures from our operations sites across the U.S (Figure 7, Panel A). Entry of new patient cases auto-notified of our team of nurses. The nurses then advised the operations team at our local and regional sites to assist with triage and planning. The clinical and operational plan included reinforcement and training on necessary quarantine and isolation procedures, as well as ordering additional personal protective equipment (PPE) supply. Entry of new employee cases or exposures triggered an auto-notification to that location’s human resources partner, who then worked with the clinical team and the employee to support triage and assessment. To optimize our ability to visualize COVID-19 positive patients, clients and employees by business segment and geography, we also developed a business intelligence application, leveraging Power BI (Microsoft Corp, Redmond, WA) Figure 7, Panel B. The clinical, operations, human resources, and executive teams use the visualization tool throughout the day as a “situation room” that enabled us to deploy specific mitigation tactics as cases emerged.

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Figure 7. COVID-19 Case Tracking and Data Visualization Application. Panel A. COVID-19 tracking application that stratifies risk using CDC guidance. Panel B. COVID-19 case visualization application.

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Employee Attendance Policy To standardize support of employee cases and exposures identified through the above app, our human resources leadership has developed the below COVID-19 attendance policy (Figure 8). Figure 8. BrightSpring-PharMerica COVID-19 Attendance Policy.

Enterprise Infection Control and Prevention Policy BrightSpring-PharMerica effectuated a new Enterprise-Wide Infection Control and Prevention Policy, aimed at providing enhanced protection for the patients, clients and employees we serve (Exhibit A). Adoption of the policy is optimizing our ability to prevent and control outbreaks in all business segments. Training on the policy has been deployed through a combination of intranet resources as well as on-site and web-based live meetings. The Company has implemented nurse-leader hosted infection control and isolation protocol web meetings, occurring five days per week, open to all employees. Hundreds of employees are currently attending these sessions per week.

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Supplies The organization has aggressively acquired PPE in utilizing its large procurement team and approaching many potential global suppliers, attempting to identify reliable sources of PPE. To enable consolidated ordering and distribution of PPE to our 2,400 community living sites, we formed a new Central Supply distribution center (Figure 9). Full PPE kits were assembled and shipped to all locations, in addition to extra allotments of surgical masks, hand sanitizer, cleaning materials, and other items required to effectuate optimal infection. We have implemented the recent recommendations by CDC and the Centers for Medicare and Medicaid Services to use surgical masks for respiratory droplet precautions in non-aerosol-generating situations until the N95 supply chain is restored (Exhibit B). We have set up a dedicated email address to streamline requests at [email protected]. Current PPE inventory and order status is communicated daily between Procurement and the Outbreak Committee. PPE kits have been assembled and shipped to locations out of our new Central Supply (Figure 9), which has been set up in Louisville as a collaborative effort between the Outbreak Committee and Procurement. All locations have received full PPE kits, and none are currently undersupplied based use scenarios outlined in our Infection Control Policy. Figure 9. BrightSpring employees sorting PPE for placement into kits for shipping to all locations.

Personal Protective Equipment Conservation To optimize our supply of PPE, we have provided materials and training to our employees on appropriate steps to conserve equipment where possible. Materials and educational resources are available on our company intranet, and our nurse-led training programs reiterate PPE conservation in real time, daily. Educational Resources To enable employees across all locations to have access to the most current information, policies and training materials, we developed and deployed over one hundred COVID-19 and outbreak prevention and action resource materials for employee use. This resource library is available on our organizational intranet (Figure 10), and updates are also communicated by email to the organization three times per week.

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Figure 10. BrightSpring-PharMerica Intranet COVID-19 Educational and Practical Resources.

Our Role in Minimizing Sick Contacts and Exposures BrightSpring-PharMerica understands the importance of limiting the transmission of COVID-19 and other pathogens by having employees who are ill stay home from work. Employees who have symptoms of acute respiratory illness are directed to stay home and not come to work until they are free of fever (100.0° F [37.7° C] or greater using an oral thermometer), signs of a fever, and any other symptoms for at least 48 hours, without the use of fever-reducing or other symptom-altering medicines (e.g., cough suppressants). Employees are directed to notify their supervisor and stay home if they are sick. If an employee does come to work sick, supervisors are directed to send them home. A sick employee may return to work when free of fever or other respiratory symptoms for 48 hours. Confirmed COVID-19 Employee Cases Where repeat lab testing is available, the employee can return to work when ALL the following criteria are met:

• They no longer have a fever (without the use of fever-reducing medications) • Respiratory symptoms (e.g., cough, shortness of breath) have improved • Two consecutive negative COVID-19 test results collected ≥24 hours apart (total of two negative

specimens) Where lab testing is not available, the employee may return to work when ALL the following criteria are met:

• At least 3 days (72 hours) have passed since recovery (fever has resolved without the use of fever-reducing medications and respiratory symptoms (e.g., cough, shortness of breath) have improved)

• At least 7 days have passed since symptoms first appeared

Return to Work Practices and Restrictions We have adopted the CDC’s guidance for healthcare facilities on return to work: https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/hcp-return-work.html

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Upon returning to work, the employee who had tested positive will: • Wear a face mask at all times while at work until 14 days after illness onset (if no face mask is

available, they are not to return to work) • Be restricted from contact with those at greater risk of serious illness if infected (e.g., receiving

chemotherapy, certain cancers and other chronic illnesses) until 14 days after illness onset • Strictly follow hand hygiene and infection control protocols (e.g., cover nose and mouth when coughing

or sneezing, dispose of tissues in waste receptacles, etc.) • Continue to screen for symptoms per the usual process, and notify manager if symptoms recur

Visitor Management BrightSpring-PharMerica understands that visitors to care sites represent a potential vector of SARS-CoV-2 transmission. We have enacted a policy that limits visits by people who are sick, and have posted signs, near the entrance of our sites to remind visitors that if they are sick they should not visit until they are free of fever, cough, and shortness of breath for at least 48 hours, and are performing visitor screening at some locations. We have developed letters to inform patients, clients, guardians of the visitor management policy, and have initiated mandatory visitor logs. Employee Travel We feel it is our organizational responsibility to do our part in minimizing the spread of the virus for the protection of our patients, clients, those we support, our communities and each other. All non-essential travel has been restricted. Essential travel has been narrowly defined, and requires Executive Committee member approval. In addition, we have provided the following guidance to our employees:

• We have restricted any work-related international travel. Additionally, we strongly discourage any employee from traveling outside of the U.S. for any reason. If an employee or someone who lives in an employee’s home still chooses to travel to Europe, China, Iran, Italy, South Korea, Hong Kong and Japan or on cruises to any destination on personal time, the employee is asked to self-quarantine at home for 14 days.

• In-person group meetings are conducted, where possible, via WebEx, phone or video conference. Training and orientation is essential for our business, so when small group in-person meetings are required, we practice social distancing and the meeting space is regularly disinfected.

Employee Screening App Developed

In order to prevent well-intentioned, but ill employees from coming to work sick, BrightSpring-PharMerica developed deployed a symptom-screening app, that can be used on any device – desktop, laptop or mobile (Figure 11). All employees are asked to take their own temperature and answer simple screening questions as shown. The app better enables sick employees to stay home, as well as instills confidence in patients, clients, senior communities and referral sources – that we have an organized, scalable, and reportable model for screening employees for illness.

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Figure 11. BrightSpring-PharMerica Employee Symptom Screening App.

Cleaning and Disinfection Current evidence suggests that COVID-19 may remain viable for hours to days on surfaces made from a variety of materials – longer on plastics and steel, and shorter viability on cardboard and copper. (Figure 12). Cleaning visibly dirty surfaces followed by disinfection is a best practice measure for prevention of COVID-19 and other viral respiratory illnesses in households, clinics, offices and community settings. BrightSpring-PharMerica has implemented additional cleaning and disinfection protocols to limit the spread of COVID-19, and has a number of instructional resources available on our Company intranet. Figure 12. Doremalen N et al found that SARS-coV-2 is viable for up to 72 hours on plastics, 48 hours on stainless steel, 24 hours on cardboard, 4 hours on copper, and is detectable in aerosols for up to 3 hours. New England Journal of Medicine, March 17, 2020.

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Diagnostic Testing BrightSpring-PharMerica has procured SARS-CoV-2 diagnostic testing capabilities to enable rapid point of care (POC) testing for employees, patients and clients. Overall, we expect the testing capabilities to provide rapid access to accurate diagnosis, enhancing patient, client, caregiver and employee safety, while decreasing unnecessary isolation for non-infected employees. The Company has elected for a “two pronged” approach to POC testing:

• SARS-CoV-2 nucleic acid test to diagnose acute infection • Fingerprick test for IgM and IgG antibodies against SARS-CoV-2 to determine recent or past infection

by demonstrated immune response

Employee Testing BrightSpring-PharMerica employees who have a medium or high risk COVID-19 exposure, as documented in the Company’s tracking and exposure stratification application, will be offered diagnostic testing as per the below flow diagram (Figure 13, Panel A). After meeting exclusion and inclusion criteria, employees are tested, and test results are logged into a secure base as shown below (Figure 13, Panel B). Figure 13. Algorithm for Testing Employees for SARS-CoV-2.

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Patient and Client Testing We are currently working through POC diagnostic use cases for patient and client testing, with a goal of maximizing patient and employee safety. Antibody Testing New point of care serologic assays of SARS-CoV-2 antibodies can enable rapid testing of individuals for potential immune response to the virus. We have procured several thousand antibody tests, and are utilizing science from recent temporal studies showing the variation in IgM and IgG antibodies after SARS-CoV-2 infection (Figure 14) to inform our interpretation and response. Figure 14. Variation of the Levels of SARS-CoV-2 RNA and Antigen, IgM and IgG after infection.

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We have incorporated the below table into our clinical interpretation of the antibody testing results (Figure 15), which enables our clinical and HR advisement of employees. Figure 15. Clinical significance of SARS-CoV-2 test results. To KK, Tsang OT, Leung WS, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 Mar 23. pii: S1473-3099(20)30196-1.

Potential Therapeutics We are actively following scientific advancements in potential therapeutics for COVID-19. We have evaluated several early studies of agents with potential activity against COVID-19, including the recent report by the National Institutes of Health, of a placebo-controlled, randomized controlled trial of the investigational antiviral drug remdesivir in COVID-19 positive, hospitalized patients. Preliminary results indicate that patients who received remdesivir had a 31% faster time to recovery than those who received placebo (p<0.001). Specifically, the median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir versus 11.6% for the placebo group (p=0.059). We are also actively monitoring studies of additional antiviral medications, and other novel therapeutics. Antivirals Ampligen: AIM ImmunoTech is developing the broad-spectrum antiviral for COVID-19 in Japan. A significant survival effect was observed in a trial evaluating mice infected with the earlier Severe Acute Respiratory Syndrome (SARS) coronavirus. Chloroquine, Hydroxychloroquine: The Food and Drug Administration (FDA) has issued a safety alert stating that the use of these agents, either alone or in combination with azithromycin, should be limited to clinical trial settings or for treating COVID-19 patients under the FDA’s Emergency Use Authorization. Danoprevir: A direct-acting antiviral agent being investigated in combination with ritonavir by Ascletis Pharma to treat COVID-19. Danoprevir is currently approved in China for the treatment of chronic hepatitis C infection.

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EIDD-2801: A ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2. The FDA has approved an Investigational New Drug application (IND) that will allow Ridgeback Biotherapeutics to begin human clinical testing. ENU200: An orally delivered antiviral compound previously approved to treat other infections. In-silicomodeling conducted by Ennaid has revealed that ENU200 delivers specific antiviral activity against 2 SARS-CoV-2 proteins, S glycoprotein and Mpro. The Company believes it can quickly bring ENU200 to market by treating patients with COVID-19 in a phase 3 in-home, self-dosing clinical trial of patients with asymptomatic, mild to moderate coronavirus infections. Elsulfavirine: A non-nucleoside reverse transcriptase inhibitor (NNRTI) being investigated by Viriom in a phase 2 trial across Russia and Eastern Europe in adults with moderate manifestations of COVID-19. Favipiravir: An antiviral agent approved in Japan for influenza treatment. Fujifilm has announced the initiation of a phase 2 trial in the US. The study will enroll approximately 50 patients with COVID-19, in collaboration with Brigham and Women’s Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School. Galidesivir: An adenosine nucleoside analog that acts to block viral RNA polymerase. BioCryst Pharmaceuticals has opened enrollment into a randomized, double-blind, placebo-controlled trial to assess the safety, clinical impact, and antiviral effects of galidesivir in patients with COVID-19. Lopinavir/ritonavir: AbbVie is collaborating with select health authorities and institutions to determine the antiviral activity of the HIV drug against COVID-19. Recent trial results published in the New England Journal of Medicine showed that the combination therapy was not associated with clinical improvement in patients with confirmed COVID-19. Merimepodib: An orally-administered broad spectrum antiviral being developed by ViralClear Pharmaceuticals. A phase 2 trial will be conducted at Mayo Clinic to evaluate the drug candidate, which targets RNA-dependent polymerases. In vitro data demonstrated decreased viral production of SARS-CoV-2 by over 98%. Nitazoxanide: An investigational broad spectrum antiviral that has been shown to inhibit replication of SARS, MERS, and other coronaviruses. Romark will initiate two phase 3 clinical trials evaluating nitazoxanide for the prevention of COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers. OT-101: A TGF-β antisense drug candidate that has demonstrated potent antiviral activity against COVID-19. Mateon Therapeutics is expecting to complete the IND submission following submission of a pre-IND application to the FDA to allow the referencing of OT-101’s oncology IND. According to the Company, the mechanism of action for OT-101 against COVID-19 includes inhibition of cellular binding, inhibition of viral replication and suppression of viral induced pneumonia. Oxypurinol: XORTX Therapeutics is exploring the use of a new formulation of oxypurinol as a novel treatment for acute kidney and lung injury accompanying COVID-19 infection. Remdesivir: The broad-spectrum antiviral agent, developed by Gilead, is being investigated in a double-blinded, placebo-controlled study sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health; data is expected by the end of May. In addition, data from an open-label randomized controlled trial involving patients with severe illness is anticipated by the end of April. Results from a trial evaluating patients with moderate illness are expected by May. Leaked data from a small study in China suggested the drug may not be effective, however Gilead stated that the trial was underpowered. Ribavirin for oral inhalation: Clinical trial initiated in Canada evaluating an investigational use of the nucleoside analog ribavirin for inhalation solution (Virazole; Bausch Health), with standard of care therapy, to treat hospitalized adult patients with respiratory distress due to COVID-19. Immunotherapies and Other Investigational Therapies Acalabrutinib:A selective inhibitor of Bruton’s tyrosine kinase (BTK) being investigated by AstraZenecafor the treatment of cytokine storm associated with COVID-19 in severely ill patients. BTK inhibition reduces the production of multiple cytokines and chemokines which may potentially reduce respiratory complications of COVID-19. The Company has initiated an open-label study (CALAVI) to investigate the treatment.

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ACE-MAB: Sorrento Therapeutics is developing a bi-specific fusion protein that binds to the spike protein of coronaviruses, which is expected to block SARS-CoV-2 from binding and infecting respiratory epithelial cells or ACE2-expressing cells. ATYR1923: A fusion protein composed of the immunomodulatory domain of histidyl tRNA synthetase fused to the FC region of a human antibody. The product, which is being developed by aTyr, will be evaluated in COVID-19 patients with severe respiratory complications. Aviptadil (RLF-100): Relief Therapeutics is investigating the vasoactive intestinal polypeptide for the treatment of acute respiratory distress syndrome in patients with COVI-19 infection. The drug has now entered FDA clinical trials at Thomas Jefferson University Hospital. The multicenter trial will enroll patients who are already on mechanical ventilation to see if aviptadil can decrease mortality in this condition. Baricitinib: Lilly’s oral Janus kinase inhibitor (JAK1/JAK2) is being investigated in an NIH study for the potential treatment of hospitalized patients diagnosed with COVID-19. Brensocatib: A small molecule, oral, reversible inhibitor of dipeptidyl peptidase I currently being developed by Insmed for the treatment of bronchiectasis and other inflammatory diseases. The drug candidate will be studied in patients with severe COVID-19 in an investigator-initiated trial (STOP-COVID19). Brilacidin: A defensin-mimetic that mimics the human innate immune system and causes disruption of the membrane of pathogens, leading to cell death. It is being developed by Innovation Pharmaceuticalsand has already been tested in humans in phase 2 trials for other indications. Bucillamine: A cysteine derivative with two thiol groups that has the potential, via restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of SARS-CoV2 infection in the lungs and to help treat COVID-19 manifestations, according to Revive Therapeutics. Centhaquine: An investigational resuscitative agent that is expected to provide hemodynamic stability, improve tissue oxygenation, reduce pulmonary edema, reduce acute respiratory distress syndrome, reduce multiple organ dysfunction score and decrease mortality in patients with COVID-19. Pharmazz is approaching various regulatory agencies regarding use of centhaquine as an adjunct in the management of critically ill patients with COVID-19; the drug has already been assessed in a phase 3 study for hypovolemic shock. Convalescent plasma: Convalescent plasma therapy for COVID-19 is currently being investigated across the nation by more than 1040 sites and 950 physicians through an expanded access program led by the Mayo Clinic. In addition, several clinical trials are evaluating the safety and efficacy of the therapy. The FDA is also accepting single-patient emergency Investigational New Drug Applications for individual patients.Recovered patients are being urged to donate plasma. Dapagliflozin: A phase 3 trial evaluating the sodium-glucose cotransporter 2 (SGLT2) inhibitor as a potential treatment for patients hospitalized with COVID-19 who are at risk of developing serious complications, has been initiated by AstraZeneca and Saint Luke’s Mid America Heart Institute. DAS181: A recombinant sialidase protein that cleaves sialic acid located on the surface of epithelial cells lining the human respiratory tract. Ansum Biopharma is enrolling patients in a proof-of-concept study to evaluate the safety and efficacy of the investigational agent for severe COVID-19 infection. gammaCore: electroCore has submitted an Emergency Use Authorization application to the FDA to facilitate the study and clinical use of its gammaCore SapphireTM non-invasive vagus nerve stimulation therapy for respiratory symptoms associated with COVID-19. The hand-held therapy, which is applied at the neck, is currently approved for treating migraine and cluster headache. CD24Fc: A first-in-class biologic that fortifies an innate immune checkpoint against excessive inflammation caused by tissue injuries. OncoImmune, Inc. has received approval from the FDA for its phase 3 clinical trial evaluating the safety and efficacy of CD24Fc for the treatment of hospitalized COVID-19 patients. A cohort of 230 patients with severe clinical symptoms will be randomized and administered a single dose of CD24Fc or placebo and followed for a 14-day period. CM4620-IE: A potent and selective small molecule inhibitor of calcium release-activated calcium (CRAC) channels. According to CalciMedica, the investigational agent may prevent pulmonary endothelial damage and lessen the cytokine storm in COVID-19. A phase 2 trial is underway and is expected to enroll 60 patients with severe COVID-19 pneumonia.

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Famotidine: The H2 blocker is being investigated at Northwell Health in New York City following reports from China suggesting that the drug could potentially improve clinical outcomes in COVID-19 patients. Gimsilumab: A fully human monoclonal antibody targeting granulocyte-macrophage colony stimulating factor (GM-CSF) being developed by Roivant Sciences to treat acute respiratory distress syndrome associated with COVID-19. Gimsilumab has demonstrated a favorable safety and tolerability profile based on data collected to date. HB-adMSC: The FDA has approved a phase 2 trial evaluating the efficacy and safety of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19. The study is expected to enroll 75 patients that are either over 50 years of age, have preexisting health conditions, or are at high-exposure risk. Ifenprodil: An N-methyl-D-aspartate (NDMA) receptor glutamate receptor antagonist being developed by Algernon Pharmaceuticals. The Company is preparing for US trials based on results of an animal study that showed the investigational therapy significantly reduced acute lung injury and improved survivability in H5N1 infected mice. Inhaled nitric oxide: The FDA has granted emergency expanded access for use of the INOpulse® system(Bellerophon Therapeutics) and the Genosyl DS tankless system (VERO Biotech) for treatment of COVID-19. In a clinical study of patients infected with SARS-CoV, nitric oxide demonstrated improvements in arterial oxygenation. Ivermectin: An FDA-approved anti-parasitic agent that has shown antiviral activity against SARS-CoV-2in vitro. MedinCell has launched a research initiative on a long-acting injectable formulation of ivermectin for COVID-19. LB1148: A broad spectrum serine protease inhibitor designed to neutralize the activity of digestive proteases and preserve gut integrity during intestinal distress (eg, shock, infections, surgery). Leading BioSciences believes its mechanism of action may limit the viral load in patients with COVID-19 as the SARS-CoV-2 virus uses the ACE2 receptor, which is highly expressed in the lung and GI tract to infect epithelial cells of these organs. LEAPS peptides: CEL-SCI is developing an immunotherapy using a patented T cell modulation peptide epitope delivery technology, to stimulate protective cell-mediated T cell responses and reduce viral load. LY3127804: An investigational selective monoclonal antibody against angiopoietin 2 (Ang2) being developed by Lilly for pneumonia patients hospitalized with COVID-19 who are at high risk of progressing to acute respiratory distress syndrome. A phase 2 trial is expected to begin in late April. Mavrilimumab: Kiniksa is investigating a fully-human monoclonal antibody designed to antagonize granulocyte macrophage colony stimulating factor (GM-CSF) signaling by binding to the alpha subunit of the GM-CSF receptor (GM-CSFRα). In a prospective, interventional, single-active-arm, single-center pilot study, patients with severe pulmonary involvement of COVID-19, acute respiratory distress, fever, and clinical and biological markers of systemic hyperinflammation status were treated with a single intravenous dose of mavrilimumab. To date, 6 patients have been treated; patients showed early resolution of fever and improvement in oxygenation within 1-3 days. Multi-antibody cocktail therapy: Regeneron is developing a novel therapy that could potentially be administered as prophylaxis before exposure to SARS-CoV-2 virus or as a treatment for those already infected. It may potentially enter human trials by early summer. MultiStem therapy: Athersys will initiate a phase 2/3 study to assess the safety and efficacy of its stem cell product candidate for the treatment of acute respiratory distress syndrome induced by COVID-19. First clinical sites for the MultiStem Administration for COVID-19 Induced ARDS (MACOVIA) study are expected to open in the second quarter of 2020. Pacritinib: An investigational oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R. CTI BioPharma will evaluate the potential of pacritinib in preventing the development of an inflammatory response to COVID-19 in the phase 3 PRE-VENT study. Remestemcel-L: Mesoblast Limited is investigating its allogeneic mesenchymal stem cell (MSC) product candidate, as a treatment for patients with acute respiratory distress syndrome caused by COVID-19.

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Remestemcel-L, which is composed of culture-expanded MSCs derived from the bone marrow of an unrelated donor, is administered in a series of intravenous infusions and is believed to have immunomodulatory properties to counteract inflammatory processes. A randomized, placebo-controlled trial is being conducted at Mount Sinai hospital in New York City. Ruxolitinib: Incyte is initiating a phase 3 study evaluating the efficacy and safety of ruxolitinib, a Janus kinase inhibitor, in patients with COVID-19 associated cytokine storm. The Company intends to launch an Expanded Access Program to allow eligible patients to receive ruxolitinib, which is marketed under the brand name Jakafi in the US, while it is being investigated for COVID-19. Sargramostim: A yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) being assessed in the SARPAC trial (sargramostim in patients with acute hypoxic respiratory failure due to COVID-19) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Sargramostim is marketed under the brand name Leukine (Partner Therapeutics) in the US. Sarilumab: Regeneron and Sanofi are evaluating the interleukin-6 (IL-6) receptor antagonist in patients hospitalized with severe COVID-19 infection. The first part of the trial will evaluate the impact of sarilumab on fever and patient’s need for supplemental oxygen, while the second part will evaluate improvement in longer-term outcomes (ie, preventing death, reducing need for mechanical ventilation, supplemental oxygen and/or hospitalization). Siltuximab: A study has been initiated at the Papa Giovanni XXIII Hospital, Bergamo Italy, to investigate the use of the interleukin (IL)-6 targeted monoclonal antibody for the treatment of patients with COVID-19 who have developed serious respiratory complications (Siltuximab In Serious COVID-19; SISCO study). Interim data from the first 21 patients show that 7 patients experienced clinical improvement with a reduced need for oxygen support and 9 patients had no clinically relevant changes; worsening was seen in 3 patients and 1 patient died. In the US, siltuximab (Sylvant; EUSA Pharma) is currently approved for multicentric Castleman disease in adults who are HIV negative and human herpesvirus-8 (HHV-8) negative. ST266: A cell-free platform biologic containing hundreds of anti-inflammatory proteins. According to Noveome Biotherapeutics, its lead product candidate has the potential to treat severe inflammatory cytokine storm observed in COVID-19 patients. Human clinical trials are expected by the fourth quarter 2020. Tocilizumab: Genentech is initiating a randomized, double-blind, placebo-controlled phase 3 trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of the IL-6 receptor antagonist plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia. TAK-888: An anti-SARS-CoV-2 polyclonal hyperimmune globulin (H-IG) being developed by Takeda for high-risk individuals with COVID-19. Pathogen-specific antibodies from plasma will be collected from recovered patients (or vaccinated donors in the future) and will be transferred to sick patients to improve the immune response to the infection and increase the chance of recovery. Tradipitant: A neurokinin-1 receptor antagonist being evaluated by Vanda Pharmaceuticals for the treatment and prevention of pneumonia associated with COVID-19. The phase 3 ODYSSEY study will include 300 patients with severe infection. TD-0903: A lung-selective nebulized Janus kinase inhibitor in clinical development to assess its utility in preventing the cytokine storm associated with acute lung injury in patients hospitalized due to COVID-19, with the ultimate goal of preventing progression to acute respiratory distress syndrome. According to Theravance Biopharma, a phase 1 study is expected to begin soon in the UK. TZLS-501: The investigational therapy, being developed by Tiziana, has been shown to rapidly deplete circulating levels of IL-6 in the blood, a key driver of chronic inflammation. Excessive production of IL-6 is believed to be associated with severe lung damage observed with COVID-19 infections. Vazegepant: An intranasal, high-affinity calcitonin gene-related peptide receptor antagonist that will be evaluated in the treatment of pulmonary complications of COVID-19. Biohaven Pharmaceuticals announced that the FDA has approved a phase 2 study.

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Vaccine Development CanSino Biologics and the Academy of Military Medical Sciences China Nonreplicating adenovirus 5 (Ad5) vector carrying the gene for the SARS-CoV-2 spike protein is injected into the arm. Adenoviruses are well-established vaccine vectors, and CanSino produced an Ebola vaccine (approved (https://www.\ercepharma.com/vaccines/china-approves-self-developed-ebola-vaccine-from-2014-outbreak-virus-type) in China in 2017) using the same Ad5 platform. The company says (https://statnano.com/news/67536/China%E2%80%99s-First-Coronavirus-Vaccine-Delivered-for-Human-Trials) its Ad5- nCoV vaccine generated “strong immune responses in animal models” and has “a good safety profile.” Phase 1 clinical trial underway (https://www.dailymail.co.uk/news/article-8183931/First-people-receive-potential-coronavirus-vaccine-injections-good- health-China.html) in Wuhan, China. University of Oxford UK A chimpanzee adenovirus vaccine vector (ChAdOx1) carrying the gene for the SARS-CoV-2 spike protein is injected into the arm. A phase 1 trial (https://clinicaltrials.gov/ct2/show/NCT04170829) using the same adenovirus vector to target MERS is ongoing in Saudi Arabia. The ChAdOx1 nCoV-19 vaccine was not tested in animals before the start of the ongoing Phase 1 trial. Phase 1/2 trial underway (https://www.clinicaltrials.gov/ct2/show/NCT04324606)in the UK. Moderna and the US government USA Lipid nanoparticles containing mRNAs for the SARS-CoV-2 spike protein are injected into the arm. Moderna is developing similar vaccines against Zika and other viruses, and other companies have RNA vaccines in clinical trials as well, but to date, no vaccine of this type has been approved for use. The SARS-CoV-2 mRNA-1273 was not tested in animals (https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/) before the start of the ongoing Phase 1 trial. Phase 1 clinical trial underway (https://clinicaltrials.gov/ct2/show/NCT04283461) in Seattle; preparing for phase 2 and 3 clinical trials to begin immediately upon successful completion.

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Inovio Pharmaceuticals USA A special device administers spike protein-encoding DNA molecules through the skin. Mice and guinea pigs mounted immune responses against the virus, according to a recent preprint (https://www.researchsquare.com/article/rs- 16261/v1), and the company tells Nature (https://www.nature.com/articles/d41586-020-00798-8) that it is now testing the vaccine in monkeys. Phase 1 trial underway (http://ir.inovio.com/news-and-media/news/press-release-details/2020/INOVIO-Initiates-Phase-1-Clinical-Trial-Of-Its-COVID-19- Vaccine-and-Plans-First-Dose-Today/default.aspx)with plans to manufacture 1 million doses of its candidate this year. BioNTech and PNzer Germany RNA vaccine; details not disclosed BioNTech and Pfizer are also partnering on an RNA vaccine candidate for influenza. Expected to start clinical testing in April (https://www.reuters.com/article/us-health-coronavirus-p\zer-biontech/p\zer-biontech-to-co-develop-potential- coronavirus-vaccine-idUSKBN2140LM) CureVac Germany RNA vaccine. Curevac reported in January that a phase 1 trial of a comparable vaccine for rabies induced immune responses with just 1 microgram of mRNA, meaning it could be easy to scale up to produce mass quantities. Expected to start clinical testing in early summer (https://www.curevac.com/news/curevac-ceo-daniel-menichella-ber%C3%A4t-mit-us-pr%C3%A4sident- donald-trump-und-mitgliedern-der-corona-task-force-entwicklungsm%C3%B6glichkeiten-eines-coronavirus-impfstoffes); company says (https://www.chemistryworld.com/news/rna-vaccines-are-coronavirus-frontrunners/4011326.article) it could manufacture 10 million doses by that time. University of Pittsburgh School of Medicine USA Microneedle patch delivers pieces of the spike protein through the skin. Vaccinated mice produced antibodies specific to SARS-CoV-2 at levels that would likely neutralize the virus, according to a study published in EBioMedicine (https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(20)30118-3/fulltext) on April 2. Expected to start clinical testing in the next few months. Janssen Belgium Nonreplicating adenovirus 26 (Ad26) vector carrying undisclosed genetic material of SARS-CoV-2 is administered intranasally. Janssen is also developing other Ad26-based vaccine candidates, including its Ebola vaccine that was deployed in the Democratic Republic of Congo in November 2019. Expected to start clinical testing in September 2020 (https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark- new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use); with BARDA’s support, the company will scale up to produce up to 300 million doses of vaccine in the US each year.

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Novavax USA Nanoparticles carrying antigens derived from the SARS-CoV-2 spike protein (with Matrix-M adjuvant) In 2012, the company started development on a SARS vaccine that served as the basis for its new SARS-CoV-2 vaccine candidate. Expected to start clinical testing in May or June (https://www.technologynetworks.com/biopharma/blog/covid-19-vaccine-development-update-an- interview-with-novavax-332634). Generex Biotechnology Canada Undisclosed synthetic viral peptides are combined with proprietary Ii-Key immune system activation The company has had success with the Ii-Key technology for other infectious diseases and for cancer in clinical trials. Expected to start clinical testing “within 90 days,” the company announced (https://www.globenewswire.com/news- release/2020/02/27/1992098/0/en/Generex-Provides-Coronavirus-Update-Generex-Receives-Contract-from-Chinese-Partners-to-Develop-a-COVID-19- Vaccine-Using-Ii-Key-Peptide-Vaccines.html) on February 27 Imperial College London UK Self-amplifying RNA molecules are injected into the muscle The vaccine platform, which is designed to allow researchers to respond quickly to emerging pathogens, received $8.4 million from CEPI last December. “We cannot predict where or when Disease X will strike, but by developing these kinds of innovative vaccine technologies we can be ready for it,” CEPI CEO Richard Hatchett said (https://www.reuters.com/article/us-health-vaccines-epidemics/scientists-to-test-tailor-made-vaccine-tech- to-\ght-epidemics-idUSKBN1O9008) at the time. Expected to start clinical testing in the summer (https://www.imperial.ac.uk/news/196313/in-pictures-imperial-developing-covid-19-vaccine/) Medicago USA Virus-like particles that resemble SARS-CoV-2 are produced in a close relative of tobacco. The company has a rotavirus vaccine in clinical trials that is based on virus-like particles, and another for norovirus in preclinical studies. Expected to start clinical testing in July or August (https://www.biospace.com/article/releases/medicago-announces-production-of-a-viable-vaccine- candidate-for-covid-19/) Altimmune USA Undisclosed vaccination delivered intranasally The company is using the same technology to develop a flu vaccine that is in clinical trials. Expected to begin clinical testing in August (https://www.globenewswire.com/news-release/2020/02/28/1992600/0/en/Altimmune-Completes-First- Development-Milestone-Toward-a-Single-Dose-Intranasal-COVID-19-Vaccine.html)

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Takis Biotech and Applied DNA Sciences Italy and USA The company is exploring five DNA-based candidates based on the SARS-CoV-2 spike protein. The vaccine candidates contain PCR-produced pieces of linear DNA, as opposed to the more traditional circular plasmids, which could have several advantages including quick production. No vaccines using this approach have yet been tested in humans. Expected to start clinical testing in the fall (https://www.biospace.com/article/releases/applied-dna-and-takis-biotech-expand-covid-19-vaccine- development-program-to-include-5th-candidate/) Government Relations and Advocacy BrightSpring-PharMerica is leveraging its outstanding Government Relations team to advocate for the Company continually being deemed a vital, essential service through our diversified, community-based businesses which provide clinical care, support, medication management, and rehabilitation of the most medically, behaviorally, and socially complex individuals in society. Specific to our outbreak preparedness work, Government Relations has undertaken many initiatives, including:

• Holding a seat on the Company’s Outbreak Committee to advise and report on local, state and federal developments impacting the Committee’s work;

• Lobbying state and federal lawmakers and appointed officials, including CMS, for the funding, regulatory structures, and flexibility the Company needs to be equipped to answer the challenges of our response to this outbreak;

• Ensuring our services and are workforce are deemed “essential” during any government ordered Stay at Home or business closure periods; and

• Being a leading voice with numerous state and national associations, among other external stakeholder groups, to make our response priorities have broad support.

Business Continuity Planning BrightSpring-PharMerica has leveraged technology enablers to facilitate remote work for positions that can be effectively performed remotely. The Company has daily executive meetings where census data, COVID-19 cases, and PPE supply and demand are reviewed by business segment. Operational, human resources and governmental relations issues are also discussed. To date, the company has not experienced material business interruption to its care and service delivery or pharmaceutical management operations. We use several COVID-19 case forecast models to best enable national and state-level planning by business segment, including the University of Washington’s Institute for Health Metrics and Evaluation predictive model shown below (Figure 16).

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Figure 16. US-level COVID-19 related resource utilization predictive model (Institute for Health Metrics and Evaluation, University of Washington).

Webinars to Support Our Families The overall well-being of our team members and their families is very important to us. To help alleviate some of these stressors and provide solutions and support, we are lending the expertise of our Workforce Services division. Our workforce industry internal experts share information through a series of webinars hosted exclusively to support impacted family members of BrightSpring/PharMerica employees. Attendees find out how to access resources, find replacement income opportunities and learn coping skills for dealing with job loss. Conclusion BrightSpring-PharMerica’s Outbreak Committee reviews COVID-19 epidemiologic data in real time, linking the company’s stakeholders to this Plan to ensure optimal preparedness and action. The plan is updated frequently, and is adjusted to best serve the needs and safety of the patients, clients, employees and communities we serve.

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EXHIBIT A PROCEDURE: Isolation Precautions and PPE

SUBJECT: Infection Control

PERFORMED BY: DSP, LPT, LVN, LPN, RN, All direct care and support staff

Prepared By: E. Shauen Howard DHA, MSN, RN; VP Clinical Services Approved By: Outbreak Preparedness and Action Committee Date Written: February 2019 Last Updated February 29, 2020

Reviewed annually: See below

GENERAL: When individuals we serve have a known infection, staff must follow specific precautions to reduce the risk of cross contamination to other clients.

World Health Organization—Recommendations for standard precautions:

1. Hand hygiene technique:

• Hand washing (40–60 sec): Wet hands and apply soap; rub all surfaces; rinse hands with warm water and dry thoroughly with a single use towel; use towel to turn off faucet.

• Hand rubbing (20–30 sec): Apply enough hand sanitizer product to cover all areas of the hands; rub hands until dry.

Summary indications: • Before and after direct individual contact and between individuals we serve; whether

or not gloves are worn • Immediately after removing gloves • Before handling an invasive device • After touching blood, body fluids, secretions, excretions, non-intact skin,

and contaminated items, even if wearing gloves • During care, before moving from a contaminated to a clean body site • After contact with inanimate objects in the immediate vicinity of the individual

2. Gloves:

• Wear when touching blood, body fluids, secretions, excretions, mucous membranes, or non-intact skin.

• Change between tasks and procedures on the same individual, after contact with potentially infectious material.

• Remove after use, before touching non-contaminated items and surfaces, and before going to another individual. Perform hand hygiene immediately after removal.

3. Facial protection (eyes, nose, and mouth):

• (1) Wear a surgical or procedure mask and eye protection (eye visor, goggles)

OR

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(2) Wear a face shield to protect mucous membranes of the eyes, nose, and mouth during activities likely to generate splashes or sprays of blood, body fluids, secretions, and excretions.

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4. Gown:

• Wear to protect skin and prevent soiling of clothing during activities that are likely to generate splashes or sprays of blood, body fluids, secretions, or excretions.

• Remove a soiled gown as soon as possible and perform hand hygiene.

5. Prevention of needle stick and injuries from other sharp

instruments:

• Use care when:

– Handling and disposing needles and other sharp instruments or devices. – Cleaning used supplies.

6. Respiratory hygiene and cough etiquette. Persons with respiratory symptoms should apply control measures:

• Cover the nose and mouth when coughing/sneezing with tissue or mask, dispose of used tissues and masks, and perform hand hygiene after contact with respiratory secretions.

In aggregate care settings:

• With acutely febrile (100.4° F [37.8° C] or greater using an oral thermometer), respiratory symptomatic individuals we serve, place individuals we serve at least 6 feet away from others in common areas, if possible.

• Post signs instructing persons to practice respiratory hygiene/cough etiquette. • Make hand hygiene resources, tissues, and masks available.

7. Environmental cleaning:

• Provide routine cleaning and disinfection of environmental and other frequently touched surfaces.

8. Linens:

Handle, transport, and process used linen in a manner which:

• Prevents skin and mucous membrane exposure and contamination of clothing. • Avoids transfer of pathogens to other individuals we serve, staff, or the environment.

9. Waste disposal:

• Ensure waste handling and disposal occurs in a manner, including PPE, which protects staff and individuals we serve from exposure to pathogens.

10. Patient care equipment:

• Handle equipment soiled with blood, body fluids, secretions, and excretions in a manner that prevents skin and mucous membrane exposure, contamination of clothing, and transfer of pathogens to others or the environment.

• Clean and disinfect reusable equipment before used by another individual

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PURPOSE: To protect employees and individuals we serve from the spread of infection through contact with blood and/or body fluids in the routine or non-routine course of their job; to practice Standard Precautions in accordance with the State Department of Health rules and OSHA Standards.

EQUIPMENT: • Gloves • Gowns • Masks • Eyewear

AIRBORNE PRECAUTIONS

Airborne precautions- for individuals we serve known or suspected to be infected with pathogens transmitted by the airborne route (e.g., Coronavirus (COVID-19), tuberculosis, measles, chickenpox, disseminated herpes zoster) will be implemented for this and will include:

• Source control: put a mask on the individual. Ensure appropriate patient placement in an airborne infection isolation room- (AIIR) constructed according to the Guideline for Isolation Precautions.

In settings where Airborne Precautions cannot be implemented due to limited engineering resources, masking the individual and placing them in an individual room with the door closed will reduce the likelihood of airborne transmission until the individual is either transferred to a facility with an AIIR or returned home.

Restrict susceptible healthcare personnel from entering the room of individuals we serve known or suspected to have measles, chickenpox, disseminated zoster, or smallpox if other immune healthcare personnel are available.

Use personal protective equipment (PPE) appropriately, including a fit-tested NIOSH- approved N95 or higher-level respirator for healthcare personnel.

Limit transport and movement of individuals we serve outside of the room to medically-necessary purposes. If transport or movement outside an AIIR is necessary, instruct individual to wear a surgical mask, if possible, and observe Respiratory Hygiene/Cough Etiquette.

Staff transporting individuals we serve who are on Airborne Precautions do not need to wear a mask or respirator during transport if the individual is wearing a mask and infectious skin lesions are covered.

Immunize susceptible persons as soon as possible following unprotected contact with vaccine- preventable infections (e.g., measles, varicella or smallpox).

DROPLET PRECAUTIONS

Droplet precautions will be implemented for Diphtheria, rubella Streptococcal pharyngitis, pneumonia, scarlet fever, Mycoplasma pneumonia or sepsis, meningococcal pneumonia or sepsis.

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This will include private room, mask or respirator (N-95 mask), gown and gloves.

• Source control: put a mask on the individual.

Ensure appropriate individual placement in a single room if possible.

Aggregate Care Settings: Make decisions regarding individual placement on a case-by-case basis considering infection risks to other patients in the room and available alternatives.

Use personal protective equipment (PPE) appropriately. Apply mask upon entry into the individual room or space.

Limit transport and movement of individual outside of the room to medically-necessary purposes. If transport or movement outside of the room is necessary, instruct individual to wear a mask and follow Respiratory Hygiene/Cough Etiquette.

CONTACT PRECAUTIONS

Contact precautions (direct individual or environmental) will be implemented for multidrug resistant organisms which the such as VRE, MRSA, Clostridium Difficile (C-Diff), and other enteric pathogens, major wound infections, herpes simplex, scabies, varicella zoster.

This will include: private room, gloves and gown, eyewear if splashing is expected.

Ensure appropriate individual placement in a single individual space or room if suspected. Once diagnosis is verified, residential or community settings should make room placement decisions balancing risks to other individuals we serve.

For individuals we serve with suspected Clostridium Difficile (C-Diff) immediate isolation measures should be taken, including use of bedside commode or toilet only to be used by infected individual. Once confirmed, maintain contact precautions for at least 48 hours after diarrhea has resolved.

Restrict any unnecessary personnel from entering the home of individuals we serve known or suspected to have C-Diff.

Use personal protective equipment (PPE) appropriately, including gloves and gown. Wear a gown and gloves for all interactions that may involve contact with the individual or their environment. Donning PPE upon room entry and properly discarding before exiting the patient room is done to contain pathogens.

PROCEDURE:

1. Verify resident’s/patient’s record and physician order for isolation precautions a. Identify specific precaution required

2. Post precaution sign on resident’s/patient’s door. 3. Protective equipment will be outside of resident’s/patient’s door. 4. Wash hands before entering room and after leaving room

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5. Gather all equipment needed in resident’s/patient’s room, using resident’s/patient’s own designated equipment when possible. Keep designated equipment in resident’s/patient’s room

6. Inform individual that you are entering their room before applying PPE. 7. Apply gown, being sure to cover all outer garments, tie securely at neck and waist. 8. Apply mask next if needed, then eyewear if needed, then clean gloves bring

glove cuff over edge of gown sleeves, per specific precaution indicated above 9. If stethoscope is reused, clean ear pieces and diaphragm with alcohol swab. 10. When procedure is completed, dispose of all trash in room. 11. Leave room then remove gloves:

a. Pinch the outside of the glove about an inch or two down from the top edge inside the wrist.

b. Peel downwards, away from the wrist, turning the glove inside out c. Pull the glove away until it’s removed from the hand. Hold the inside-out glove with

the gloved hand. c. With your gloveless hand, slide your fingers under the wrist of the glove, do not

touch the outside of the glove. d. Repeat step 3. Peel downwards, away from the wrist, turning the glove inside

out. e. Continue pulling the glove down and over the first glove. This ensures that both

gloves are inside out, one glove enveloped inside the other, with no contaminants on the bare hands.

f. Dispose of the gloves in a proper bin– this may differ depending on company policies.

12. Dispose of all contaminated items. 13. Wash hands.

Limit transport and movement of individuals we serve outside of the room to medically-necessary purposes. When transport or movement is necessary, cover or contain the infected or colonized areas of the resident’s/patient’s body. Remove and dispose of contaminated PPE and perform hand hygiene prior to transporting individuals we serve on Contact Precautions. Don clean PPE to handle the individuals we serve at the transport location.

Use disposable or dedicated patient-care equipment (e.g., blood pressure cuffs). If common use of equipment for multiple individuals we serve is unavoidable, clean and disinfect such equipment before use on another individual. Prioritize cleaning and disinfection of the rooms of individuals we serve on contact precautions ensuring rooms are frequently cleaned and disinfected (e.g., at least daily or prior to use by another individual if outpatient setting) focusing on frequently-touched surfaces and equipment in the immediate vicinity of the individual.

For Individuals we serve diagnosed with C-Diff:

• Complete the Personal Waiver Regarding the use of Chlorine Bleach in a Residential Home.

• Carefully and thoroughly clean rooms and equipment used for the individuals we serve care with a C. Difficile sporicidal bleach wipe or spray (EPA List K agent).

• Wash all linens separately with an additive of bleach (EPA List K agent) to the laundry soap in hot water.

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TRAINING: All staff will be trained in Infection Control & PPE procedures upon orientation and annually. When identified for use, staff will be fitted and trained on respirator (N-95 mask). Competency will be documented. See attachments. Training by the RN or designated employee will consist of lecture and return demonstration.

POLICY REVIEW: Isolation Precautions

Review Date Signature Title 2/29/20 Chair, Outbreak

Preparedness and Action Committee

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Description Medline N95 Qualitative Fit Test Kit feature one kit tests for approximately 100 staff members. It is available as a kit with refills, and is easy to administer and instructions are found within the kit. The Medline qualitative fit test kit is to be used in conjunction with our N95 particulate respirator mask models, NON27501, NON24505, NON24506 and NON24507 as fit testing is required prior to the initial use of a respirator. It is saccharin based qualitative fit test kit that can be used for up to 100 tests.

• Type: Fit test kit • Material: Latex-free parts • One kit tests approximately 100 staff members • Refills are also available • Saccharin based fit test kit • Easy to administer and includes instructions • Available as a Kit, and refills are also available • Qualitative Fit Test Kit is to be used in conjunction with our N95 particulate respirator

masks (NON27501, NON24505, NON24506 and NON24507) • Fit testing is required prior to the initial use of a respirator • Test is easy to administer and instructions are found within the kit

Test Numerous Employees Your staff members have to go through fit testing before they can use respirators, and this Medline N95 qualitative fit test kit provides you with up to 100 tests, so everyone can get done without the need for refills. The test is easy to administer and instructions are included with this kit. Latex-Free Design Don't worry about employees having allergic reactions to this test; the parts are all latex-free, so you can be sure they're safe. The saccharin-based fit test kit is the ideal choice for all the tests you have to complete. Fits Specific Respirator Masks Make sure your fit test will work the first time with the Medline N95 qualitative fit test kit and the right respiratory mask. This kit works with the N95 particulate respirator masks with the stock numbers NON27501, NON24506, NON24505, and NON24507 for an accurate test.

Glove Use in Standard Precautions

Wear gloves when anticipating contact with a patient’s:

• Blood or body substances (i.e., fluids or solids)

• Mucous membranes (e.g., nasal, oral, genital area)

• Non-intact skin (e.g., wound or surgical incision)

• Insertion point of a patient’s invasive or indwelling device

(Siegel JD, CDC Guidelines for Isolation Precaution, 2007 )

Donning Gloves

Select correct type of glove and size

Extend to cover wrist, over isolation gown if worn

Sequence of PPE donning, gloves are often the last item to be put on

(CDC, Sequence for Personal Protective Equipment, https://www.cdc.gov/hai/pdfs/ppe/ppe-sequence.pdf)

Doffing Gloves

There are a variety of ways to safely remove gloves, one option is:

– With the gloved hand, grasp the palm area of the other gloved hand and peel off

– Hold removed glove in gloved hand; slide fingers of ungloved hand under remaining glove at wrist, peel off and discard

Sequence of PPE doffing, gloves are usually the first item to be removed

Gown Use in Standard Precautions Wear when contact between clothing or skin with patient blood or body substances is expected.

For example:

• Contact with patient’s non-intact skin (e.g., wounds)

• During procedures likely to generate a splash or spray of blood or body fluid

• Handling containers or patient fluids likely to leak,

splash or spill


Donning Gowns

Gowns should cover the torso, the legs to the knees, the arms to end of wrist and wrap around the back

Slide gowns on with the opening at the back, fasten around the back of the neck and the waist


Doffing Gowns

Unfasten gown

Pull away from neck and shoulders, touching inside of gown only

Turn gown inside out

Fold or roll into a bundle and discard

Remove gown and perform hand hygiene before leaving the patient’s environment (e.g., exam room)

Do not wear the same gown between patients


Face Mask and Eye Protection Use in Standard Precautions

Wear when anticipating potential splashes or sprays of blood/body substances during patient care

Face Masks–protect nose and mouth

Goggles–protect eyes

Face shields–protect face (i.e., nose, mouth and eyes)

Personal eyeglasses and contact lenses are not considered adequate eye protection


Donning a Face Mask or Respirator Secure ties or elastic bands at middle of head and neck

Flexible band should fit to bridge of nose

Face mask should fit snug to face and below

chin Fit-check respirator


Doffing a Face Mask or Respirator

Grasp bottom ties or elastics of the face mask/respirator, then the ones at the top, and remove without touching the front

Discard in waste container


Donning and Doffing Goggles and Face Shield

Don: • Place over face and

eyes and adjust to fit

Doff: • Remove from the back by

lifting the head band over the ear piece

• Place in designated area

for reprocessing or disposal


Key Points of PPE Removal

The key for PPE removal is to limit opportunities for environment and self-contamination

Outside front of the PPE is the area most likely to be contaminated

Perform hand hygiene after PPE removal

An example sequence of doffing PPE is as follows:

o Gloves o Face shield/goggles o Gown o Face Mask

(CDC, Sequence for Personal Protective E

EXHIBIT B DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard, Mail Stop C2-21-16 Baltimore, Maryland 21244-1850

Center for Clinical Standards and Quality/Quality, Safety & Oversight Group

Ref: QSO-20-17-ALL

DATE: March 10, 2020

TO: State Survey Agency Directors

FROM: Director Quality, Safety & Oversight Group

SUBJECT: Guidance for use of Certain Industrial Respirators by Health Care Personnel

Background

CMS is committed to taking critical steps to ensure America’s health care facilities are prepared to respond to the threat of the COVID-19 and other respiratory illness. With this announcement, health care workers in providers and suppliers certified by CMS will have a more expansive range of options to protect themselves and those receiving their care. CMS will continue to explore flexibilities and innovative approaches within our regulations to allow health care entities to meet the critical health needs of the country.

Memorandum Summary

• The Centers for Medicare & Medicaid Services (CMS) CMS is committed to taking critical

steps to ensure America’s health care facilities are prepared to respond to the threat of

the Coronavirus Disease 2019 (COVID-19) and other respiratory illnesses.

• The memo clarifies the application of CMS policies in light of recent Centers for Disease

Control and Prevention (CDC) and Food and Drug Administration (FDA) guidance

expanding the types of facemasks healthcare workers may use in situations involving

COVID-19 and other respiratory infections.

Guidance The Centers for Disease Control and Prevention (CDC) have updated their Personal Protective Equipment (PPE) recommendations for health care workers involved in the care of patients with known or suspected COVID-19. At this time, these recommendations will be considered by CMS surveyors to determine if Medicare and Medicaid providers and suppliers are complying with infection control protocols:

Based on local and regional situational analysis of PPE supplies, facemasks are an acceptable temporary alternative when the supply chain of respirators cannot meet the demand. During this time, available respirators should be prioritized for procedures that are likely to generate respiratory aerosols, which would pose the highest exposure risk to Health Care Providers (HCP).

o Facemasks protect the wearer from splashes and sprays. o Respirators, which filter inspired air, offer respiratory protection.

• When the supply chain is restored, facilities with a respiratory protection program should return to use of respirators for patients with known or suspected COVID-19. Facilities that do not currently have a respiratory protection program, but care for patients infected with pathogens for which a respirator is recommended, should implement a respiratory protection program.

• Eye protection, medical gown, and gloves continue to be recommended. o If there are shortages of medical gowns, they should be prioritized for

aerosol- generating procedures, care activities where splashes and sprays are anticipated, and high-contact patient care activities that provide opportunities for transfer of pathogens to the hands and clothing of HCP.

• Updated recommendations regarding the need for an airborne infection isolation room (AIIR).

o Patients with known or suspected COVID-19 should be cared for in a single- person room with the door closed. AIIRs should be reserved for patients undergoing aerosol-generating procedures.

• Updated information based on currently available information about COVID-19 and the current situation in the United States, which includes reports of cases of community transmission, infections identified in HCP, and shortages of facemasks, N95 filtering facepiece respirators (FFRs) (commonly known as N95 respirators), and gowns.

• Increased emphasis on early identification and implementation of source control (i.e., putting a face mask on patients presenting with symptoms of respiratory infection).

Additional information on CDC’s recommendations above can be found here: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html Further, the FDA approved the CDC request for an emergency use authorization (EUA) to allow health care personnel to use certain industrial respirators during the COVID-19 outbreak in health care settings. The FDA concluded that respirators approved by the National Institute for Occupational Safety and Health (NIOSH), but not currently meeting the FDA’s requirements, may be effective in preventing health care personnel from airborne exposure, including COVID- 19, which can cause serious or life-threatening disease, including severe respiratory illness.

This action allows the NIOSH-approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the COVID-19 outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.

PLEASE NOTE: Due to the updated CDC guidance and current supply demands of these devices (and the discards associated with testing), CMS is directing surveyors not to validate the date of the last FIT test for health care workers in Medicare and Medicaid certified facilities, until further notice.

References

1. Centers for Disease Control and Prevention. Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19). Available at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/infection-control.html. Accessed April 20, 2020.

2. County of Los Angeles Public Health. USC-LA County Study: Early Results of Antibody Testing Suggest Number of COVID-19 Infections Far Exceeds Number of Confirmed Cases in Los Angeles County. Available at: http://publichealth.lacounty.gov/phcommon/public/media/mediapubdetail.cfm?unit=media&ou=ph&prog=media&cur=cur&prid=2328&row=25&start=1. Accessed April 20, 2020.

3. Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real

time. Lancet Infect Dis; published online Feb 19. Available at: https://doi.org/10.1016/S1473-3099(20)30120-1. Accessed April 20, 2020.

4. Doremalen N, Bushmaker T, Morris DH, et al. N Engl J Med 2020; 382:1564-1567.

Available at: https://doi.org/10.1056/NEJMc2004973. Accessed April 20, 2020.

5. Earnst D. Monthly Prescribing Reference. April 2020. https://www.empr.com/home/news/drugs-in-the-pipeline/pipeline-investigational-therapies-for-covid-19/. Accessed April 30, 2020.

6. To KK, Tsang OT, Leung WS, al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020 Mar 23. pii: S1473-3099(20)30196-1.

7. Wu Zunyou, McGoogan JM. Characteristics of and Important Lessons from the Coronavirus 2019 (COVID-19) Outbreak in China. JAMA 2020; 323: 1239-1242. Available at: https://doi.org/10.1001/JAMA.2020.2648.

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