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You would be hard pressed to pick up a newspaper, click on a news feed or turn on the radio or television and not hear something about the panic associated with the Ebola virus. Hospitals, which initially calmly declared their readiness for managing the crisis, now appear to be in crisis mode as they implement a plan for managing it. As is often the case, a rush to get something in place often fails to consider some important points that may include the following: Ebola, like many other issues is a public health crisis and a hospital should not begin an implementation plan without considering state and local agencies who have primary responsibility for the maintenance of the public s health. Not every hospital should see itself as a site to provide care to patients with Ebola (and it is likely most organizations will never actually care for a patient with Ebola). Certainly it has been shown that specially trained facilities with all necessary equipment and designated care areas deliver better outcomes; so within a community or a region, it is not only likely, but also appropriate that a very small number of facilities will be identified as sites where care is to be provided. The survivors in the United States all have one thing in common they were rushed to two of the country s four hospitals that have been preparing for years to treat a highly infectious disease like Ebola. At the present there are only four hospitals in the US that have been identified as capable of treating rare and contagious infectious diseases. These hospitals have special isolation wings with specialized air filtration systems capable of limiting transmission of diseases like Ebola. The four hospitals are: Emory University Hospital in Atlanta Georgia, The University of Nebraska Hospital in Omaha Nebraska, St. Patrick s Hospital in Missoula, Montana and the National Institute of Health (NIH) in Bethesda, Maryland. Once the regional sites have been designated, a clear communication plan should 1

be devised alerting all individuals who might fear that they have been exposed to Ebola to seek healthcare only at those facilities. However, some patients may present at hospitals that are not one of these designated facilities unaware of why they are ill; it is imperative that front line staff (ED personnel and Ambulatory clinic staff) of all hospitals are advised of the need to quickly identify an at risk individual. Resources to assist in screening for Ebola can be found at http://www.cdc.gov/vhf/ebola/pdf/evdscreening-criteria.pdf. Communication is vital ---triage staff must be alerted to the importance of communicating to all staff who may come in contact with the at risk patient the factors which make them potentially contagious. (These include recent travel to countries in Western Africa where cases of Ebola have been reported and /or close contact with someone infected with Ebola). Even before confirmation of the Ebola virus, an affirmative response to the aforementioned screening questions should cause the providers to isolate the patient and institute all precautions pursuant to CDC recommendations. It should be noted that the guidance and recommendations from CDC are changing constantly as more is learned about the manner in which the disease is spread and thus, someone should be designated in the facility to check daily with the CDC and local agencies to make certain that all staff are aware of and following the most current protocols and policies. The most recent document developed by the CDC and released on October 20, 2014 can be found at http://www.cdc.gov/media/releases/2014/fs1020-ebola-personal-protectiveequipment.html Managing Ebola requires a specialized team effort. After meeting with local health agencies and determining the role your organization should play, you should begin your plan, but do so in a manner which is strategic and cognizant of the potential for risk. Risk managers who are enterprise risk management experts or schooled in the use of the VA Severity Assessment Code (SAC) Matrix (http://www.patientsafety.va.gov/professionals/publications/matrix.asp) should apply those same skills to determine potential for, and the severity of, risk. 2

What is Ebola Virus? According to the CDC Ebola, previously known as Ebola hemorrhagic fever, is a rare and deadly disease caused by infection with one of the Ebola virus strains. Ebola can cause disease in humans and nonhuman primates (monkeys, gorillas, and chimpanzees). Ebola viruses are found in several African countries. Ebola was first discovered in 1976 near the Ebola River in what is now the Democratic Republic of the Congo. Since then, outbreaks have appeared sporadically in Africa. The natural reservoir host of Ebola virus remains unknown. However, on the basis of evidence and the nature of similar viruses, researchers believe that the virus is animal-borne and that bats are the most likely reservoir. Four of the five virus strains occur in an animal host native to Africa. i Signs and Symptoms Symptoms of Ebola include: Fever Severe headache Muscle pain Weakness Diarrhea Vomiting Abdominal (stomach) pain Unexplained hemorrhage (bleeding or bruising) Symptoms may appear anywhere from 2 to 21 days after exposure to Ebola, but the average is 8 to 10 days. Recovery from Ebola depends on good supportive clinical care and the patient s immune response. People who recover from Ebola infection develop antibodies that last for at least 10 years. ii Transmission Because the natural reservoir host of Ebola viruses has not yet been identified, the manner in which the virus first appears in a human at the start of an outbreak is 3

unknown. However, researchers believe that the first patient becomes infected through contact with an infected animal. When an infection does occur in humans, the virus can be spread to others in several ways. Ebola is spread through direct contact (through broken skin or mucous membranes in, for example, the eyes, nose, or mouth) with any of the following: blood or body fluids (including but not limited to urine, saliva, sweat, feces, vomit, breast milk, and semen) of a person who is sick with Ebola objects (like needles and syringes) that have been contaminated with the virus infected animals Ebola is not spread through the air or by water, or in general, by food. However, in Africa, Ebola may be spread as a result of handling bushmeat (wild animals hunted for food) and contact with infected bats. There is no evidence that mosquitos or other insects can transmit Ebola virus. Only mammals (for example, humans, bats, monkeys, and apes) have shown the ability to become infected with and spread Ebola virus. Healthcare providers caring for Ebola patients and the family and friends in close contact with Ebola patients are at the highest risk of getting sick because they may come in contact with infected blood or body fluids of sick patients. During outbreaks of Ebola, the disease can spread quickly within healthcare settings (such as a clinic or hospital). Exposure to Ebola can occur in healthcare settings where hospital staff are not wearing appropriate protective equipment, including masks, gowns, and gloves and eye protection. There is also a high incidence of contamination when family members bury their loved ones after they have died from the Ebola virus. Once someone recovers from Ebola, they can no longer spread the virus. However, Ebola virus has been found in semen for up to 3 months. Abstinence from sex (including oral sex) is recommended for at least 3 months. If abstinence is not possible, condoms may help prevent the spread of disease. iii Ebola Comes to America Although Americans have known about Ebola it was long considered a disease that was not likely to spread to the US and was viewed as not only found in Africa but 4

only fatal due to the poor and under resourced health care systems in the countries impacted. Ebola came to America when two US health care workers, Dr. Kent Brantly and Nancy Writebol who were working in Liberia contracted the disease there and were air-lifted back to the US for care. The images of them being transported to US hospitals in full protective gear was frightening to many, and politicians and pundits alike argued over the wisdom of bringing Ebola to the United States. Many called for travel bans for all patients traveling from West African countries were cases are being reported. Both of these individuals survived their treatment and were released from the hospital and the concern seemed to briefly die down as the CDC and other health care experts advised us that America was safe from this dreaded disease. A few weeks later Thomas Eric Duncan arrived from Liberia via Dulles Airport into Dallas Texas. There are reports that while in Liberia he was in direct contact with a young woman who died from Ebola in his neighborhood. Although asymptomatic prior to departing from Liberia he soon began to feel ill and sought treatment at Texas Health Presbyterian Hospital. According to press reports, Mr. Duncan advised the nurse who first interviewed him that he had recently come to the US from Liberia (although he allegedly denied being in contact with anyone who was sick with Ebola) but somehow this information, though documented, was missed by the treating physician who sent him home with antibiotics. Three days later Mr. Duncan returned to the same hospital much sicker and tested positive for Ebola. He was the first person to be diagnosed with Ebola in the United States. His condition quickly worsened and despite aggressive intensive care Mr. Duncan died on April 8 th. Again, pictures of waste removal from the hospital and his apartment sent fear and concern across the state of Texas and across the entire country. On October 13 th (ten days after Mr. Duncan was admitted to the hospital) it was announced that a nurse, Nina Pham, who closely cared for Mr. Duncan when he was the sickest, had contracted the disease during the course of providing his care. Ms. Pham became the first person who contracted this deadly virus in the US. On October 15 th, Amber Vinson, became the second nurse working at Texas Health Presbyterian Hospital who tested positive for Ebola. Her situation raised even greater concern for the public when it was revealed that she had reported to the CDC that she had a fever and was not advised that she could not travel. She flew home to Ohio on a plane with 132 other passengers all of whom later were notified of her situation. Finally it was announced that an unnamed lab technician, also working at Texas Health Presbyterian Hospital who came in contact with Mr. Duncan s blood, had boarded a cruise ship and was being quarantined in her cabin, along with her husband until the cruise returned to port. She later tested negative 5

for Ebola but the fears and chaos this story created left the public even more concerned about our country s public health infrastructure and about the ability to keep health care providers and citizens safe. Now it seems that a period of irrational fear is setting in with every health care organization and provider feeling the need to become an Ebola expert and to be prepared to treat Ebola patients. Despite the current sense of panic in reality the likelihood of becoming infected with Ebola in the US is very rare. According to the website Vox.com if you do the math, a single case in the US could lead to one or two others which is exactly what has happened in the US so far with the Dallas situation. Because we have robust public health measures here, it probably won't go further than that. Compare that to West Africa, which is now dealing with upwards of 8,000 cases in a completely broken health system. That's where experts say the worry about Ebola should be placed. (http://www.vox.com/2014/10/4/6896867/hospitals-ebola-how-to-prepare, accessed 10/22/2014) So the message for hospitals and risk managers should not be: don t do anything, but rather educate yourself so that you do the right thing. Consider the risks that might make your organization or the providers or other patients in it vulnerable and develop and communicate a clear strategy grounded in facts rather than fears. 6

Developing Your Plan Like any effective risk management program the key to success is careful planning along with thoughtful and thorough execution. Using tools that are consistent with enterprise risk management, a collaborative team made up of senior operations staff, clinicians (especially ED and Infectious disease staff), supply chain staff, waste management and facilities staff, compliance staff, risk management staff, someone from the legal department, communications and public relations staff should convene to perform a risk inventory, establish priorities and take necessary action. This team should consider the potential risks that preparing for and caring for individuals with Ebola might pose and the likelihood that these are real risks for their organization. Risks to consider include (but are not limited to): Financial Risks Operational Risks Legal or Compliance Risks Patient safety risks Human capital (employee ) risks Environmental / Hazard risks Financial Risks to Consider The costs of caring for patients with a confirmed diagnosis of Ebola can be very high with the expense of Haz-Mat suits fitted with special hoods that must be donned and removed with each patient interaction and the need for most equipment used in the care of the patient to be either autoclaved or burned. It is likely that most healthcare facilities have just in time supply chain programs, which means that they may only have enough of these suits available should an immediate need arise and the ability to order what might be needed if a diagnosis is actually confirmed. The actual costs of care for these patients might also be extremely high with the need for ICU isolation, aggressive IV fluid replacement, if the condition deteriorates mechanical ventilation and dialysis. In patients without insurance this can result in huge unrecoverable debt for the hospital. Hospitals should also consider the likelihood that once a patient with Ebola is confirmed to be in their hospital, they might see patients wishing to delay admission or elective procedures out of fears that they might be vulnerable. Consistent and accurate communication with patients and their families will be necessary to avoid this potential loss of revenue. 7

Operational Risks The procurement of all necessary supplies will fall to the supply chain team at the hospital. This will be an essential function as early reports suggest that the two nurses infected at Texas Health Presbyterian Hospital did not have available to them the hoods needed to cover their necks and head. With the amount of supplies needed to care for these patients, it is likely that one individual or small team should be appointed to meet with the clinical team daily to assess what supplies might be needed for the next 24 hours to assure that they are available. Other operational risks include the ability to flag such patients in the EHR so that communication of the actual or potential risk is clear to all providers and any staff who may come in contact with the patient. It seems that this communication failure at the hospital in Texas might have contributed to the patient being discharged from the ED following his initial visit, so it is essential to design a protocol to assure that the communication of risk is complete. Legal or Compliance Risks There are many legal and compliance risks that may come into play in the care of Ebola patients. One of the most obvious is the potential conflict of supporting the local, state and federal public health mandates regarding safeguarding others from contagious diseases while still maintaining the patients right to privacy afforded under HIPAA. In addition, legal and compliance staff will have to review CDC and OSHA regulations regarding the handling and disposal of medical waste and design a process that will be in compliance with all relevant regulations. (There is further discussion of this below in the section pertaining to the handling of hazardous waste.) Patient Safety Risks Obviously, despite the many challenges these patients may present, designing systems and processes to assure that they receive the highest quality of care possible remains an imperative. The care of patients with Ebola is rapidly changing with the introduction of experimental drugs and successes recognized after giving patients diagnosed with Ebola plasma from Ebola survivors. 8

Human Capital / Employee Risks Hospitals owe their employees an environment where they can care for the sickest of patients without the risk of becoming ill or dying. Organizations need to recognize that proper training, proper provider protective equipment and support are necessary to assure that all staff knows how to identify and avoid risky situations associated with the care and treatment of patients with Ebola. Training must include all staff not just physicians and nurses and the training must be regularly repeated to ensure that information provided becomes embedded in the manner in which each employee performs their job. If employees are exposed, the organization should place them in isolation and continue to pay them for 21 days until they are deemed outside the window for becoming ill. In addition, the organization needs to affirm that it has a culture that is supportive and honest. Ebola is a frightening disease and even with the recent successes in curing those infected, staff might still be anxious about even the prospect of caring for patients diagnosed with this disease. Environmental /Hazard Risk for Hospitals to Consider Dedicated medical equipment (preferably disposable, when possible) should be used by healthcare personnel providing patient care. Proper cleaning and disposal of instruments, such as needles and syringes, is also important. If instruments are not disposable, they must be sterilized before being used again. Without adequate sterilization of the instruments, virus transmission can continue and amplify an outbreak. Disposal of Medical Waste In a recent article appearing in the LA Times iv A single Ebola patient treated in a U.S. hospital will generate eight 55-gallon barrels of medical waste each day. Protective gloves, gowns, masks and booties are donned and doffed by all who approach the patient's bedside and are then discarded. Disposable medical instruments, packaging, bed linens, cups, plates, tissues, towels, pillowcases and anything that is used to clean up after the patient must be thrown away. Even curtains, privacy screens and mattresses eventually must be treated as contaminated medical waste and disposed of. 9

Dealing with this collection of pathogen-filled debris without triggering new infections is a legal and logistical challenge for every U.S. hospital now preparing for a potential visit by the virus. Medical waste generated in the care of patients with known or suspected EVD is subject to procedures set forth by local, state and federal regulations. Basic principles for spills of blood and other potentially infectious materials are outlined in the U.S. Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen standard, 29 CFR 1910.1030. v Although the CDC recommends autoclaving (a form of sterilization) or incineration (burning) of medical waste as the best method for destroying the virus vi it recognizes that the handling of medical waste is also subject to local and state regulations. It should be noted that the burning of medical waste is effectively prohibited in California and in at least 7 other states thus limiting the options available to many hospitals. Some states are already considering the trucking of medical waste across state lines to facilities where it can be incinerated but the transport of a Class A infectious substance is viewed by many as an additional risk to the public and one which should be avoided. Obviously, at this point this issue is still being discussed and it would be wise to check back to the CDC and OSHA websites for up-dates and recommendations. There is also confusion about human waste and whether it can be flushed down the toilet. Patients in the late stages of this disease can lose up to 14 liters of bodily fluids per day and that waste has to go somewhere. The CDC has stated that it is acceptable to flush it down the toilet stating sanitary sewers may be used for the safe disposal of patient waste. Additionally, sewage handling processes (e.g., anaerobic digestion, composting, and disinfection) in the United States are designed to inactivate infectious agents. vii Some recent reports suggest that when using toilets bleach should be poured into the toilet and mixed with the waste prior to flushing but this does not seem to be required by the CDC. Readers are urged to check frequently for the latest opinions regarding the correct disposal of medical waste and to verify that CDC and OSHA recommendations are consistent with state and local policy. Insurance Issues to Consider In a recent bulletin from Advisen viii it was reported that a major insurer is warning customers it may impose restrictions on Ebola-related liability claims for businesses and organizations with employees traveling to West Africa, in what is believed to be the first such move by the insurance industry as economic ripple effects of the deadly disease spread. 10

Zurich-based ACE Ltd., a leading global property-and-casualty insurer, has begun selectively excluding Ebola from its coverage "on a case-by-case basis" for U.S. customers "that have foreign travel exposure to certain African countries," the company said in a statement to The Wall Street Journal on October 21, 2014. The possible exclusion applies only to new and renewal policies, "based on information about each company's travel to and operations in select territories," the company said. Insurance-industry participants said ACE appears to be the first major insurer to go on record flagging its concerns about the financial exposure it could face if Ebola infections spread widely outside the African countries where the problem is now concentrated. Insurance executives and brokers said the types of customers potentially affected by ACE'S move could include energy and commodities firms, media businesses, nongovernmental organizations and religious groups. Robert Hartwig, president of trade group Insurance Information Institute in New York, said he wasn't aware of any insurers putting such restrictions into place, but said "it is standard operating procedure for insurers to adjust the questions they ask when it comes to underwriting an insurance policy in the face of new risks." Insurance companies can deny coverage to customers with higher risks, charge them a higher premium or put caps on payouts for claims. Business insurers have fairly wide latitude to adjust the terms and conditions of policies they renew or sell to new customers, unlike insurers selling consumer car and home policies, which can be subject to strict regulatory oversight by state insurance departments. As with all other aspects of this disease, much is changing and it will be important for the risk manager to maintain a dialogue with the organization s broker to learn of any possible new products that might minimize the potential of financial losses or any changing in policy language upon renewal. Summary As discussed in this article the management of Ebola is a complex process and requires a multi-disciplinary effort. Hospitals and providers must recognize that as 11

a public health threat and that public health officials may be required (and may be most appropriate) to take the lead on all planning efforts. Even though the risk is remote, applying an enterprise risk management approach can assure that organizations identify and plan for all potential risks so that providers (and the public) can remain safe and afflicted patients can receive the best possible care. References i http://www.cdc.gov/vhf/ebola/about.html accessed 10/21/2014 ii http://www.cdc.gov/vhf/ebola/symptoms/index.html (accessed 10/22/2014) iii http://www.cdc.gov/vhf/ebola/transmission/index.html (accessed 10/22/2014) iv http://www.latimes.com/science/la-sci-ebola-waste-disposal-20141020- story.html (accessed 10/22/2014) v See https://www.osha.gov/sltc/bloodbornepathogens/index.html (accessed 10//22/2014) vi http://www.cdc.gov/vhf/ebola/hcp/medical-waste-management.html (accessed 10/22/2014) vii http://www.cdc.gov/vhf/ebola/hcp/environmental-infection-control-inhospitals.html (accessed 10/22/2014) viii http://fpn.advisen.com/fpnhomepagep.shtml?resource_id=226939652133347222 0&userEmail=byoungberg@luc.edu#top (accessed 10/22/2014) 12