Biosafety

Different outside perspectives and guidance were initially provided about the level of biosafety needed for EVD. Ebola viruses have a very low infectious dose, 1–10 aerosolized organisms, in nonhuman primate models [12] and can reach extremely high levels in blood (up to 10¹⁰ RNA copies per ml of serum [13]), stool, sweat, and other body secretions. Exposure of health care workers to infected body fluids via emesis, sweat, urine, saliva, diarrhea, or blood is a significant concern. There was also initial concern that this strain was not behaving epidemiologically as expected and the personal protective equipment (PPE) guidelines in Africa were not fully effective in prevention of transmission. Further, we had to demonstrate our ability to safely manage these patients.

To achieve the lowest risk to health care personnel, the highest level of biosafety was initially employed. This included MAXAIR powered air-purifying respirators (PAPRs), fluid-resistant body suits along with cover aprons, double gloves and shoe covers, and wiping down all surfaces with US Environmental Protection Agency (EPA)-registered disinfectants (no spraying) when doffing PPE. Other key biosafety SOPs developed were autoclaving within the unit for waste management, followed by disposal of regulated medical waste off-site after it had been autoclaved; decontamination; and handling of laboratory samples and waste. The consequences of transmission stressed the need for the highest level of biosafety.

The importance of the EHSO office in reinforcing the prior training of personnel and monitoring the clinical staff for consistency and adherence to biosafety from training sessions to practices in real-time clinical care cannot be overemphasized. This included how to “don and doff” impermeable fluid-resistant body suits, proper use of PAPRs, coordination of the disposal of waste, and the handling and transport of lab samples. EHSO also helped prepare and support the team psychologically, challenging them with spills and other incidents to practice remaining calm in the face of potential unexpected occurrences. Team engagement demonstrated the importance of melding the philosophies of clinical treatment/practice and biocontainment/biosafety. Feedback from frontline physicians, nurses, and hospital staff highlighted the contributions of EHSO to the effort and the value of the EHSO biodefense education and training expertise.

Waste Management

Waste management for EVD is a significant hurdle. EVD results in copious amounts of vomit and diarrhea with up to 10 liters of fluid lost by patients each day. Up to 40 large “bags” per day of regulated medical waste were generated by our first two patients. A large-capacity autoclave was mobilized, with postautoclaved waste stored in 32-gallon leak-proof rubber waste containers in the SCDU until removal and incineration. All waste in toilets was disinfected with an EPA-registered disinfectant before flushing. Importantly, no traces of Ebola RNA on "high-touch surfaces" such as beds and bathrooms were detected during active care or after patient discharge prior to terminal decontamination with vaporized hydrogen peroxide.

Communications

Guiding principles for communications included consistent messaging and protecting patient privacy while educating the public. Internal communications with a focus on transparency and education, within the bounds of confidentiality of medical information and protecting our patients’ privacy, were vital. These included meetings with EUH hospital leadership and staff to address concerns, frequent emails and other communications with all faculty and staff at EHC and Emory, making sure instructions/checklists were in place, and facilitating the dissemination of protocols. To avoid unauthorized access to electronic medical records, a chart-warning flag was implemented. Confidentiality of medical information regulations were repeatedly stressed to all medical staff, residents, and fellows.

In external communications and interface with the media, the Emory communications teams tirelessly addressed media logistics, developed web and social media material, worked closely with governmental and nongovernmental external groups, developed talking points, and prepared the hospital and SCDU teams for communications venues. To maximize our preparedness and to address national concerns, press conferences and media interviews were conducted, and an EVD Questions and Answers document was developed and posted. The story exploded in broadcast print and social media. Over 84,000 media stories have been written linking Emory and Ebola. Emory communications created an Emory Healthcare Ebola Preparedness Protocols website (www.emoryhealthcare.org/ebolaprep) [11] to make our clinical and biosafety protocols and other information widely available to the public. To date, 20,267 registrants have downloaded these educational materials.

Addressing a Surge of Cases of Possible Ebola

The admissions heightened Ebola and other bio-threat concerns both locally and nationally. Questions about potential EVD patients began to occur immediately in our health care system and throughout the US. We developed and disseminated flow diagrams, algorithms, and SOPs [11] for evaluating patients in emergency rooms and other health care provider settings where EVD was a consideration. CDC guidelines as they became available and current EVD articles were also disseminated. Our teams engaged local, regional, state, and national health care groups, and guidance was provided to questions about travelers from the region coming to Emory, to airlines flying to West Africa, and to multinational corporations based in West Africa. Travelers’ diarrhea with fever and malaria are the problems most commonly encountered by travellers to West Africa. However, yellow fever along with Lassa fever, endemic in West Africa as well, can cause similar symptoms to those of Ebola. Typhoid and less frequently diseases such as dengue and other viral syndromes can cause such signs/symptoms, though not usually as severe. The intersection of the seasonal influenza epidemic with returning CDC workers from West Africa further amplified the evaluations of febrile episodes. Timely initial screening—with establishment of contact and droplet precautions early while the risk assessment, including an extensive travel history and the evaluation of exposure risk and symptoms, was continued—was emphasized. Policies and procedures for the continuing care of our discharged patients were also developed [11].

Disseminating Knowledge: Education and Training

As noted, a highly trained group of faculty, nurses, biosafety support, and other providers staff the EUH SCDU. While no trainees (e.g., fellows, residents, or students) served on the direct care team, trainees benefitted from the experience of the unit and clinical experience with EVD through conferences and other education venues (e.g., Public Health Grand Rounds and ID seminars). An EVD “Micro Vignette” and other educational materials were developed for resident and fellow education. Further, ID and other specialty fellows have been integrated into the management planning for EVD patients, educated on the broader policies and procedures of the unit, are involved with the development of protocols for the management of Ebola patients who present to the Emergency Department (ED) or other clinical settings, and are educated about the collective experiences in treating the patients. In addition, a Massive Open Online Course (MOOC) “Ebola at Emory: Patients to Populations” has been launched [14], an EBOLA Academic Learning Community was established, and other efforts to educate and support graduate and undergraduate student activities were undertaken. Emory faculty and staff also actively participate in national education and training efforts, including multiple presentations at national meetings, engagement in training forums sponsored by the CDC and the US Department of Health and Human Services (HHS), writing publications and communications, and conducting press conferences. Fifty-five US hospitals, including many in academic medical centers, have now been designated as Ebola treatment centers.

Generating New Knowledge

Work was initiated to better understand EVD pathogenesis and therapeutic options [7–11,15–19], including optimal patient management, fluid and electrolyte replacement, and dialysis [7–8]; evaluation of concomitant infections (e.g., malaria or Lassa fever); levels of EVD viremia, monitoring viral RNA in body sites [19] and environmental samples; tracking EVD specific immune responses [17]; evaluation of available investigational drugs and their safety, risks, and benefits; options for immune therapy (monoclonal antibodies [mAbs], convalescent sera) and available supplies; available investigational vaccines [2,18], best practices in clinical operational management; and postexposure prophylaxis. In addition, the generation of new knowledge about EVD biosafety, infection control, and waste management has resulted from this event. These activities have now expanded as a broader institutional effort that includes new drug discovery for EVD, generation of human Ebola mAbs, expanded study of EVD glycobiology, focus on biomarkers as correlates of clinical EVD outcome, work on the ecology and the emergence of EVD and other tropical-associated zoonoses, clinical trials of Ebola vaccine, and modeling the spread and control of EVD in West Africa. This work required close coordination with and the support of the Emory Institutional Review Board (IRB), collaboration with the FDA, establishment of emergency investigational new drugs (INDs), and work with drug and biologic manufacturers and with multiple other governmental agencies. These and other EVD research and scholarly projects generated by the decision continue at Emory.

The event also led to broad faculty engagement across all parts of the institution through the creation of an Emory Ebola Task Force and Ebola Faculty and Community Discussion Forum [20]. The Task Force includes leaders from across the campus and is directed at facilitating cross-cutting institutional initiatives such as EVD research, education and training activities, input into public policy issues around EVD, development of an institutional travel policy to West Africa, establishing procedures for trainee involvement in Ebola care, and the support of the humanitarian, research and control efforts in West Africa.