Slide 1 Slide 2 Slide 3 Few Hazardous Materials Spawn the Level Of

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The 2014 Ebola Crisis A Wake Up Call For U.S. Hospitals

Presented By: Mark A. Wehner, ARM, CHMM and Brenda S. Halminiak, P.G., CHMM 1

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Slide 3 Few hazardous materials spawn the level of trepidation that Ebola does.

3 Slide 4 It is a hazardous material that few CHMMs will ever encounter in their careers, yet it is one that tens of thousands of healthcare workers with little or no previous hazmat training must be prepared to deal with on a daily basis.

Slide 5 For most Americans, the 2014 epidemic was just another 3rd world disaster on the evening news

Slide 6 But in early October just as the epidemic was peaking in Sierra Leone

6 Slide 7 Things suddenly changed…

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Slide 11 This is the story of how the diagnosis of a single patient ignited one of the most intensive hazmat training programs in U.S. history as over 4,000 hospitals across the U.S. frantically prepared for the possibility of an Ebola patient walking through their doors at any moment.

11 The story is told through the eyes of an 11-hospital network in Texas that in only a few months, created an entire Ebola program from scratch and trained over 1,000 staff members in Level 1 & 2 PPE protocols.

This is also the story of the continuing threat in this country and abroad from Ebola and other High Consequence Infectious Diseases.

Slide 12 Hello, My name is Mark Wehner and I’m the Regional Hazmat Safety Officer

Mark Wehner, ARM, CHMM with Medxcel for the Texas Region. Regional Hazmat Safety Officer – Texas [email protected] I’ve managed hazmat for nearly 30 Brenda Halminiak, PG, CHMM Regional Hazmat Safety Officer – Wisconsin [email protected] years and helped develop the Ebola program for our hospital network during the 2014 epidemic.

12 My colleague is Brenda Halminiak, who is the Regional Hazmat Safety Officer for Wisconsin. Prior to working in healthcare, Brenda worked for the Wisconsin Department of Natural Resources.

Slide 13 Medxcel is the largest sole provider of Who is Medxcel? healthcare facilities services in the U.S., practicing an integrated model to Largest sole provider of healthcare facilities services in the U.S., using an integrated model to best serve our clients best serve large healthcare systems. SERVICES Medxcel provides facility operations;

• Emergency Management & • Capital Planning • Energy Efficiency Safety • Master Planning • Waste & Chemical environment of care, emergency • Compliance Consulting • Design & Construction Management • Life Safety Standards • Education & • Environment of Care • Construction Project Communication management and safety; planning, • Facility Maintenance & Management • Water Conservation Services • Energy Consumption • Grounds design and construction; and energy services to the hospitals it serves. 13

Slide 14 Medxcel is a wholly owned subsidiary

Large Health System Perspective of Ascension Health, one of the

Clinical Stats 161 Hospitals leading non-profit healthcare systems Number of Births >84k ED Visits >3.1M Outpatient Visits >23M 2,600 Surgical Visits – Outpatient >400k Sites of Care in the country. Medxcel provides Equivalent Discharges >1.6M

21 States and the More than design, building maintenance and 22k District of Columbia Available Beds operation, safety and emergency

34k Affiliated 156k Associates management services for over 2600 Physicians sites of care in 21 states.

Slide 15 The 2014/15 outbreak in Africa was

2014 Ebola Outbreak the largest and most lethal Ebola epidemic. Ground zero is believed to Largest, most severe Ebola outbreak in history March, 2014: first case reported in Guinea, followed by cases in Sierra Leone and Liberia be some children who found a bat in May 2014: Funeral of ‘traditional healer’ may have led to 365 infected people the jungle and brought it back to their August 2014: WHO declares outbreak “international health concern” village. In May, the epidemic got a September 2014: U.S. sends 3,000 military personnel to set up 17 treatment centers jump start when 365 people became September 30, 2014: 6,574 infected – 3,091 deaths October 12, 2014: 8,997 infected – 4,493 deaths infected at the funeral of a traditional December 29, 2014: >20,000 infected – 7,900 deaths healer. By August, the epidemic was 15 declared an “international health concern” by the World Health Organization and in September, the U.S. sent 3,000 military personnel to build treatment centers in affected areas.

Slide 16 Ultimately the 2014/15 outbreak

2014 Ebola Outbreak infected 28,637 people, killing 11,315. Ultimately over 28,637 people were infected with the Hardest hit was Sierra Leone with Ebola virus in the 2014/15 outbreak. 11,315 of those infected died (including 1 in the U.S. Liberia close behind. and 6 in Mali). So how did Ebola get to the United States during the 2014 outbreak? Let’s take a look at the chain of events – and missed opportunities – that led to 16 Ebola arriving in the U.S.

Slide 17 Thomas Eric Duncan is considered Thomas Eric Duncan – Patient Zero in the “Patient Zero,” the person who U.S. 9-15-14: reportedly took his landlord’s brought Ebola to the U.S. during the daughter to and from the hospital in Monrovia (she later died) 2014 outbreak. Mr. Duncan had been 9-20-14: arrives in Dallas from Monrovia living in Monrovia and reportedly took (asymptomatic) his landlord’s daughter to and from 9-25-14, approx. 10:30 pm: presents at Texas Health Presbyterian Hospital (THPH) ER with the hospital in Monrovia on 100.1 F fever (spiked to 103 before dropping to 101.2) Abdominal pain September 15, 2014. This woman later Dizziness Nausea died from Ebola. 17 Headache On September 20, 2014, Mr. Duncan arrived in Dallas. At that time, he was asymptomatic.

On September 25, Mr. Duncan presented at the Texas Health Presbyterian Hospital Emergency Room at approximately 10:30 pm with symptoms of fever, abdominal pain, dizziness, nausea, and headache.

Slide 18 During the early morning of

Timeline (cont.) September 26, Mr. Duncan was

9-26-14, early morning: discharged with prescription of discharged with a prescription for antibiotics for “sinusitis and abdominal pain” *** travel history not communicated to physician *** antibiotics for “sinusitis and 9-28-14: rushed by ambulance back to THPH abdominal pain.” Although a nurse did Diarrhea, abdominal pain, nausea, vomiting ***now considered Ebola risk; CDC is notified*** make a note that Mr. Duncan had

9-29-14: Nurse Nina Pham treats recently arrived from Africa, that Duncan for first time; reportedly doesn’t wear any PPE that first time information never made it to the attending physician. the physician 18 accessed the electronic health record, or EHR, where travel history would have been listed, but there’s no way to know what information the doctor actually looked at in the EHR.

On September 28, Mr. Duncan was rushed by ambulance back to Texas Health. He was experiencing diarrhea, abdominal pain, nausea and vomiting. Finally, based on his travel history and symptoms, he was considered an Ebola risk and the CDC was notified.

On September 29, Nurse Nina Pham treated Mr. Duncan and reportedly did not wear any PPE on her first encounter.

Slide 19 On September 30, the CDC confirmed

Timeline (cont.) that Mr. Duncan had Ebola, and on

9-30-14: CDC confirms that Duncan has Ebola October 8, 2014, Thomas Eric Duncan 10-8-14: Thomas Eric Duncan dies died. It’s estimated that as many as *** As many as 100 people may have come into contact with Duncan himself or with someone who came into 100 people may have come into contact with Duncan *** contact with Mr. Duncan himself or 10-10-14: Nurse Amber Joy Vinson, who cared for with someone who came into contact Duncan, travels from Dallas to Cleveland via airplane; with Mr. Duncan. asymptomatic, cleared by CDC to fly 19 On October 10, Nurse Amber Joy Vinson, who had cared for Mr. Duncan, traveled from Dallas to Cleveland via airplane. At that time, she was asymptomatic and the CDC had cleared her to fly.

Slide 20 On October 10, the same day that

Timeline (cont.) Nurse Vinson flew from Dallas to

10-10-14: Nurse Pham shows symptoms, placed in Cleveland, Nurse Pham began showing isolation at THPH; Ebola confirmed on 10-12-14 symptoms of Ebola. She was placed in 10-13-14: Nurse Vinson returns to Dallas via airplane, despite having fever of 99 F isolation at Texas Health and was 10-14-14: Nurse Vinson placed in isolation at THPH; Ebola confirmed on 10-15-14 confirmed to have Ebola on October 10-15-14: Nurse Vinson transferred to Atlanta’s Emory University Hospital, 1 of 4 biocontainment units in the U.S. 12. 10-16-14: Nurse Pham transferred to National Institutes of Health in Bethesda, Maryland *** Both nurses eventually recover.*** On October 13, despite having a fever 20 of 99 degrees, Nurse Vinson returned to Dallas via airplane.

On October 14, Nurse Vinson was placed in isolation at Texas Health, and on October 15, it was confirmed that Nurse Vinson also had Ebola.

On October 15, Nurse Vinson was transferred to Atlanta’s Emory University Hospital, which had one of only four biocontainment units in the United States at the time.

On October 16, Nurse Pam was transferred to the National Institutes of Health in Bethesda, Maryland, to another of the biocontainment units.

Both Nurse Vinson and Nurse Pham eventually recovered.

This timeline clearly shows that in 2014, U.S. hospitals weren’t prepared to deal with Ebola, and that much work was needed to prevent more people from contracting Ebola in the United States. Now here’s everything you wanted to know about Ebola Virus Disease, and some things you probably didn’t.

Slide 21 Let’s start with some important

Definitions definitions. The first is “Category A Category A infectious substance: an infectious substance infectious substance.” A Category A that, through exposure, is capable of causing permanent disability, or life-threatening or fatal disease infectious substance is an infectious Examples: substance that, through exposure, is Dengue virus (cultures only) Ebola virus capable of causing permanent Hepatitis B virus (cultures only) Marburg virus disability or life-threatening or fatal West Nile virus (cultures only) Yellow fever virus (cultures only) disease.

21 Examples of Category A infectious substances include Dengue, Ebola, Hepatitis B, Marburg, West Nile, and Yellow Fever viruses. Some of these viruses, including Dengue, Hepatitis B, West Nile, and Yellow fever, are only Category A when cultured (concentrated). This is significant when dealing with transportation and disposal of contaminated items, which we’ll talk about later in the presentation.

Slide 22 Remember! All Category A infectious

Remember! substances ARE ALSO hazardous materials as defined by DOT and All Category A Infectious Substances are also hazardous materials (DOT) and hazardous hazardous substances as defined by substances (OSHA) OSHA.

DOT defines a hazardous material as any item or chemical which, when being transported or moved in 22 commerce, is a risk to public safety or the environment.

OSHA defines a hazardous substance as any biological agent and other disease-causing agent which after release into the environment and upon exposure, ingestion, inhalation, or assimilation into any person...will or may reasonably be anticipated to cause death, disease, behavioral abnormalities, cancer, genetic mutation, physiological malfunctions...or physiological deformations in such persons or their offspring.

Clearly, the Ebola virus is a hazardous material and a hazardous substance.

Slide 23 Let’s look at another important Definitions definition, and that’s high High Consequence Infectious Disease (HCID) Potential to cause high mortality rate among otherwise healthy consequence infectious disease, or people Some types of direct clinical specimens pose generalized risks to HCID. lab personnel Risk of secondary spread within health care settings or unknown mode of transmission No routine vaccines exist Difficult to recognize and detect quickly An HCID has the potential to cause Examples: Ebola Virus Disease high mortality among otherwise Marburg Hemorrhagic Fever Lassa Fever healthy people. Some types of direct Crimean-Congo Hemorrhagic Fever Monkey pox clinical specimens pose generalized 23 risks to lab personnel. With HCIDs, there is a risk of secondary spread within health care settings, or there is an unknown mode of transmission. No routine vaccines exist for HCIDs, and they’re difficult to recognize and detect quickly.

Examples of High Consequence Infectious Disease include Ebola Virus Disease, Marburg Hemorrhagic Fever, Lassa Fever, Crimean-Congo Hemorrhagic Fever, and Monkey Pox.

Slide 24 So what are the origins of Ebola?

Origin of Ebola Ebola was first identified in 1976 in Zaire, now known as the Democratic First identified in 1976 in Zaire (now Democratic Republic of the Congo or DRC) & Sudan (now Republic of the Congo or DRC, and in South Sudan) Name derived from Ebola River in Zaire Sudan, now known as South Sudan. Five strains: Zaire ebolavirus Sudan ebolavirus The name for the virus is derived from Tai Forest ebolavirus Bundibugyo ebolavirus the Ebola River in Zaire. Reston ebolavirus (only affects monkeys) 24 There are five known strains of Ebola: Zaire, Sudan, Tai Forest, Bundibugyo, and Reston. Reston ebolavirus only affects monkeys.

Slide 25 This map shows the location of past Past Outbreaks outbreaks in Africa. The larger the circle, the more people were infected. The red circles denote the Zaire ebolavirus, while the other three colors are for the Sudan, Tai, and Bundibugyo viruses. Reston ebolavirus outbreaks are not represented on this map. 25

Slide 26 This table provides a summary of the

Country Town Cases Deaths Species Year Dem. Rep. of Congo, Uganda multiple ongoing ongoing Zaire ebolavirus 2018-2019 known Ebola outbreaks since 1976, Dem. Rep. of Congo Bikoro 54 33 Zaire ebolavirus 2018

Dem. Rep. of Congo Likati 8 4 Zaire ebolavirus 2017 multiple, Équateur Dem. Rep. of Congo 66 49 Zaire ebolavirus 2014 including the most recent, ongoing province Multiple countries multiple 28652 11325 Zaire ebolavirus 2014-2016 Uganda Luwero District 6* 3* Sudan ebolavirus 2012 Dem. Rep. of Congo Isiro Health Zone 36* 13* Bundibugyo ebolavirus 2012 outbreak. During these outbreaks, Uganda Kibaale District 11* 4* Sudan ebolavirus 2012 Uganda Luwero District 1 1 Sudan ebolavirus 2011 Dem. Rep. of Congo Luebo 32 15 Zaire ebolavirus 2008

Uganda Bundibugyo 149 37 Bundibugyo ebolavirus 2007 anywhere from just a few to tens of

Dem. Rep. of Congo Luebo 264 187 Zaire ebolavirus 2007 South Sudan Yambio 17 7 Sudan ebolavirus 2004 Republic of Congo Mbomo 35 29 Zaire ebolavirus 2003 thousands of people were infected. Republic of Congo Mbomo 143 128 Zaire ebolavirus 2002 Republic of Congo Not specified 57 43 Zaire ebolavirus 2001 Gabon Libreville 65 53 Zaire ebolavirus 2001 Uganda Gulu 425 224 Sudan ebolavirus 2000 South Africa Johannesburg 2 1 Zaire ebolavirus 1996 You can see that the 2014-2016 Gabon Booue 60 45 Zaire ebolavirus 1996 Gabon Mayibout 37 21 Zaire ebolavirus 1996 Dem. Rep. of Congo Kikwit 315 250 Zaire ebolavirus 1995 outbreak was by far the largest and Côte d’Ivoire (Ivory Coast) Tai Forest 1 0 Taï Forest ebolavirus 1994 Gabon Mekouka 52 31 Zaire ebolavirus 1994 South Sudan Nzara 34 22 Sudan ebolavirus 1979 Dem. Rep. of Congo Tandala 1 1 Zaire ebolavirus 1977 most widespread outbreak ever. By South Sudan Nzara 284 151 Sudan ebolavirus 1976 26 Dem. Rep. of Congo Yambuku 318 280 Zaire ebolavirus 1976 shear numbers alone, the Zaire ebolavirus has infected more people than all the other strains combined.

Despite Africa having multiple Ebola outbreaks dating back over 40 years, there were still many people in Africa in 2014 that thought Ebola was just a government hoax. This widespread ignorance combined with traditional burial rituals that involve direct contact with body fluid from the deceased, were largely why the 2014 to 2016 epidemic was as bad as it was.

Slide 27 This map shows how the Ebola virus

Spread of 2014 outbreak spread from January 1, 2014, to December 30, 2015.

Slide 28 Let’s talk for a minute about how

Transmission of Ebola Ebola is transmitted. Ebola is a Ebola is a filovirus filovirus, which is a filamentous RNA Reservoir: fruit bats most virus of a genus which causes severe likely hemorrhagic fevers in humans and primates, and includes the Ebola and Marburg viruses. Once a person is Human consumption of bushmeat linked to animal-to- infected with the Ebola virus, the virus human transmission of prevents infected cells from triggering diseases including Ebola 28 the immune system, thereby making it difficult or impossible for the body to fight the virus.

It’s believed that fruit bats are the reservoir – or host – for Ebola virus, but human consumption of bushmeat has also been linked to animal-to- human transmission of some diseases, including Ebola. Humans can be infected with Ebola through close contact with blood, organs, or bodily fluids of infected animals. After this initial transmission from an animal to a human, further transmission is human-to-human.

And if you’re wondering what “bushmeat” is, it simply means the meat from non-domesticated wild animals, reptiles, amphibians or birds. Bushmeat is usually dried out and sold in open air markets.

Slide 29 Ebola is transmitted from person to

Human-to-human transmission person by direct contact through

Direct contact through broken skin or mucous membranes with broken skin or mucous membranes Blood or body fluids of person who is sick with or died from Ebola with blood or body fluids of a person Objects contaminated with body fluids (blood, feces, vomit) Incubation period of 2 to 21 days who is sick with or died from Ebola, or Health care workers in Africa are 21 to 32 times more likely to become infected through contact with objects Burial ceremonies that involve direct contact with body of deceased can result in transmission contaminated with body fluids such as ***Cannot spread Ebola until symptoms develop*** ***Virus only transmitted through direct contact with body fluids*** blood, feces or vomit. On dry surfaces like doorknobs and countertops, the 29 virus can survive for several hours. In body fluids like blood, the virus can survive up to several days at room temperature. Proper disinfection is obviously critical for rooms where Ebola patients have been cared for.

Ebola has an incubation period of two to twenty-one days from initial exposure, which is why people were quarantined for 21 days during the 2014-2016 outbreak.

Health care workers are at risk of contracting Ebola if appropriate infection control precautions are not practiced. The World Health Organization stated that African healthcare workers during the 2014 outbreak were 21 to 32 times more likely to become infected than the general public. In fact, from 2014 to 2016, 881 health care workers were infected with the Ebola virus and 513 of those infected died.

Traditional burial ceremonies that involve direct contact with the body of a deceased person can result in transmission of Ebola, which was part of the reason for the massive outbreak in 2014-2016 in Africa.

It’s very important to understand that a person cannot spread Ebola until he or she has developed symptoms, and the virus can only be transmitted through direct contact with body fluids of an infected person.

As I was doing research for this presentation, I thought about similarities to the early years of the HIV epidemic. People didn’t fully understand how HIV was transmitted. They were afraid that it could be contracted simply by touching a person who had the disease…just as many still fear Ebola, here in the U.S. and in Africa.

Slide 30 This picture shows some of the

Symptoms of Ebola symptoms of Ebola, which can include headache, fever, muscle aches, diarrhea, stomach pain and vomiting, skin rash, sore throat, and difficulty swallowing.

It’s easy to see that people suffering from Ebola can exhibit symptoms common to many other ailments, which is why it made accurate – and quick - diagnosis of Ebola extremely difficult in 2014. Recent advances in laboratory procedures have shortened the diagnosis confirmation for Ebola. What once took 24-hours can now be run in 4-6 hours.

Slide 31 The symptoms of Ebola are similar to

Diagnosis other infectious diseases like malaria, dysentery, typhoid fever and Symptoms are similar to other infectious diseases like malaria, dysentery, typhoid fever meningitis, diseases which are and meningitis common in areas where Ebola Laboratory diagnostic methods are needed to confirm Ebola virus typically occurs. Samples are extreme biohazard risk Laboratory diagnostic methods are needed to confirm that a person is 31 infected with the Ebola virus, but the samples needed to make this determination pose an extreme biohazard risk to everyone who handles them, so extreme caution must be exercised when dealing with samples from a person potentially infected with Ebola.

Slide 32 Treatment of Ebola consists of

Treatment providing supportive care including oral rehydration or IV fluids, and Supportive care – oral rehydration or IV fluids Treatment of specific symptoms treatment of specific symptoms. An Experimental vaccine used in 2015 with experimental vaccine used in 2015 promising results; vaccine being used in the ongoing outbreak showed promising results, and that Drug trial currently underway in the DRC vaccine is being used in the ongoing outbreak. A drug trial is also currently underway in the Democratic Republic 32 of the Congo.

Slide 33 Medical complications and mental Post-recovery health issues have been reported in Medical complications & mental health issues have survivors of Ebola. Ebola virus is also been reported Tiredness known to persist in immune-privileged Muscle aches Eye and vision problems sites in some people. These immune- Stomach pain Ebola virus may persist in testicles, inside of the privileged sites include the testicles, eye, and central nervous system the inside of the eye, and the central May also persist in Placenta, amniotic fluid and fetus (if woman is infected nervous system. while pregnant) Breast milk (if infected while breastfeeding) 33 The virus may also persist in the placenta, amniotic fluid and fetus of women who are infected while pregnant, and in breast milk in women who are infected while breastfeeding.

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34 Slide 35 Mortality rates from Ebola vary from

Mortality Rates 25% to 90%, and the average fatality rate is about 50%. Death usually Rates vary from 25% to 90%; average fatality rate is about 50% occurs from six to sixteen days after Death usually occurs 6 to 16 days after symptoms appear symptoms first appear.

Mortality in Africa is generally higher due to a scarcity of medical facilities, the practice of traditional burial 35 ceremonies that involve direct contact with the body of the deceased, and a general fear and distrust of medical personnel.

Slide 36 In late 2014, as the Ebola outbreak was peaking in Africa, infected travelers started showing up in Asia, Europe and the U.S.

And when Thomas Duncan was diagnosed with Ebola in Dallas, Texas on September 28th, everything got real. Few hospitals outside Africa had 36 seriously considered the implications of an Ebola patient presenting at their hospital. Most people and even many clinicians did not know much about Ebola, and they were scared. Some nurses actually quit their job rather than risk having to care for an Ebola patient. But the majority of healthcare professionals did what they always do, they rolled up their sleeves and got to work.

Slide 37 Many U.S. hospitals were left to their

Ebola Personal Protective Equipment own devices to develop and implement an Ebola Operations Plan. PPE Focus Since 9/11 was on Chemical Chemical suits, PAPRs w/chemical hoods used They soon realized that there was no Existing PPE Not conducive to patient care Biological contamination can’t be measured in real consistent voice to guide them on how time like many chemicals or radiation to properly manage such a deadly Use Level 1 and 2 to differentiate from chemical PPE levels (A/B/C/D) disease. Many hospitals fell back on the only thing they knew at the time, chemical PPE. 37 Almost overnight, there was a run on all types of protective suits and gear. Many hospitals could not get orders filled while others hoarded what they could get.

Slide 38 Many hospitals had been working to

Ebola Personal Protective Equipment develop chemical and biological decon

No Definitive Criteria for HCID Biological PPE capabilities since 9/11 but they quickly Hospitals and CDC playing catch-up found out, bulky chemical suits are not Chemical suits not practical in patient care setting Biological contamination can’t be measured in real time very conducive to patient care for days like many chemicals or radiation can Use Level 1 and 2 to distinguish HCID PPE/protocols on end. from Level A/B/C/D PPE Protocols constantly changing during crisis (‘building the plane while flying it’) While it shares much in common with University of Nebraska and Emery University widely used sources for PPE and protocols Level C PPE, this type of biological PPE 38 does have distinct differences in the way it is used. When preventing exposure to most chemicals, the hazard is reduced with each decon or doffing step. With a deadly virus like Ebola however, even the smallest amount left behind can multiply to deadly levels if it enters the body.

To avoid confusion with chemical decon PPE protocols, biological PPE for HCIDs in healthcare is typically referred to as Level 1 and Level 2.

Hospitals reached out for authoritative sources to guide them but few were available at that time. Two heavily- relied on resources at the time were the University of Nebraska Medical Center and Emery University, whose websites included detailed recommendations for biological PPE suitable for Ebola.

Slide 39 Level 1 Ebola PPE is intended for use

Personal Protective Equipment with patients and prospective patients who are not exhibiting any advanced Level 1 Intended for PUIs and patients w/early symptoms symptoms such as vomiting or Does not provide adequate protection from liquids Faster to don and doff diarrhea as it does not provide Typical PPE for ‘Awareness Level’ training adequate protection from liquids. Level 2 Intended for patients with advanced symptoms (diarrhea, vomit, blood loss) Lengthy donning and doffing protocol requiring a Level 2 is essentially a Level C chemical “Safety Buddy” and written checklist PPE with a much more elaborate 39 doffing protocol. We have since found lighter weight, liquid resistant suits for Level 2 work that are superior to the thick, stiff ones we used in 2014.

Slide 40 Level 1 PPE includes:

Level 1 PPE Tyvek suit • a lightweight Tyvek suit with hood w/hood and feet and feet, N-95 particulate Disposable face respirator shield • a disposable face shield, Surgical gown Double gloves • a fit-tested, N-95 particulate (nitrile) – first pair taped to suit respirator, • surgical boot covers Prior to donning PPE, associate Surgical boot removes personal • and two pair of nitrile gloves. covers – taped to clothing and jewelry suit and dons hospital scrubs 40 One adaptation that we made at the time, was to don a surgical gown over the Tyvek suit, the idea being that the front of the suit and hands would likely be the most contaminated areas. We wanted to reduce the likelihood of cross-contamination during decon and doffing process and the contaminated gown would easily be removed and discarded prior to exiting the patient room for PPE doffing.

We also reversed the way most hospitals were double-gloving. Because hospitals were falling back on their chemical decon training, they usually taped their outer glove to the suit. Because hands are the most contaminated part of the PPE, we wanted staff to be able to remove that contamination as often as necessary to keep from spreading it around the room. We used a slightly heavier long- cuff glove inside and taped it to the suit, then we used a lighter weight outer glove that could easily be changed out as needed.

Level 1 PPE is suitable only for patients who are not exhibiting any advanced Ebola symptoms such as vomiting and diarrhea. Other than frequent hand sanitizing, there is no decon prior to or during the doffing process for Level 1.

Slide 41 Level 2 is for the wet work.

Powered Air Level 2 PPE Purifying Respirator (PAPR) w/HEPA Level 2 PPE used a Filters and Butyl Tychem BR Rubber Hood chemical • heavier chemical-resistant Tychem resistant suit Extended-cuff, Surgical gown heavy mil nitrile BR-type suit, (not shown) worn gloves taped to over Tychem suit suit, underneath lighter mil nitrile • rubber boots, worn under the suit gloves Rubber boots worn under suit. and taped to the legs, Suit taped to Prior to donning boots PPE, associate removes personal • a powered air purifying respirator clothing and jewelry and dons hospital with HEPA cartridges, scrubs 41 • and the same double-gloving setup as Level 1.

Level 2 is sometimes worn with the surgical gown for the same cross- contamination reasons as Level 1.

Slide 42 The University of Nebraska Medical University of Nebraska Medical Center Center, which is still widely held as a “High Level” PPE Vs 2014 Level 1 PPE leading authority on the subject, having successfully treated 4 Ebola patients, including Amber Vincent from Texas Health Presbyterian in Dallas, offers numerous PPE donning and doffing educational tools.

Our Level 1 UNMC High PPE (2014) Level PPE 42 PPE for what we call Level 1 really hasn’t changed much since 2014. Despite it actually providing a lower level of protection than their “PAPR Level”, UNMC now calls Level 1 “High Level” PPE, which frankly, I find a bit confusing. There are two significant differences between UNMC’s High Level PPE and our 2014 Level 1 PPE.

First, UNMC does not use a Tyvek-type suit. Their High Level PPE uses only a surgical gown and surgical boot covers. The other difference is that UNMC now uses three layers of gloves. The inner and outer layers are regular patient care gloves while the middle layer is a long-cuff nitrile glove taped to the surgical gown. Both UNMC and the CDC have now adopted the same gloving philosophy that we did back in 2014 of not taping the outer gloves so that they can be changed frequently in the patient room.

The CDC differs slightly in that they do not tape either pair of gloves and despite also suggesting frequent outer glove changes, recommends the long cuff gloves be on the outside. In our experience, we have found that it is difficult to remove the heavier, outer long cuff glove without disturbing the inner glove if it is not taped, thus significantly increasing the chance of cross contamination.

Slide 43 Level 2, or what UNMC calls “PAPR University of Nebraska Medical Center Level” has changed more over the “PAPR Level” PPE vs 2014 Level 2 PPE years than Level 1 has. First, while still employing chemical suits, hospitals have learned from their 2014 experiences and now opt for a lighter weight, more flexible polylaminated suit. Hospitals with enough funding have also upgraded their PAPRs to one 43 with more of a biological hood. Some have even gone to what one equipment supplier calls a “CAPR”, which has the blower motor in the headpiece.

UNMC uses the same triple-gloving arrangement as they do in their “High Level”, or Level 1 PPE.

Here is a picture of our 2014 Level 2 PPE again. You can see the differences in suit weight and PAPR hood material. We still use the heavy rubber boots for Level 2 whereas UNMC opts for just surgical boot covers.

Slide 44 Hospitals learned some valuable lessons from Texas Health Presbyterian’s experience, one of which was to document every step in the patient care process, especially around PPE. Each Entrant is assigned an individual Safety Buddy, who observes, coaches and documents each step of the donning and doffing 44 process. The Safety Buddy then signs and records the time each operation is complete. In this way, if a clinician later became infected, we would be able to go back and hopefully identify how and why. But the most important purpose the checklist served was to walk them through the procedure, step by step, to ensure nothing was missed.

Slide 45 Intubating a patient is difficult under

Patient Care in Level 2 the best of conditions.

Now try it in full PPE, with limited visibility and dexterity…Oh, yeah, and on a patient that has been diagnosed with one of the most deadly infectious diseases on the planet.

45 All Level 2 training included hands-on practice with training manikins to give Entrants a feel for what they would be up against.

Slide 46 And yes…..they even practiced the ‘not so fun’ stuff. Patient Care in Level 2

Slide 47 Healthcare PPE requires innovation at times. Protecting Medical Equipment Here’s how you protect an expensive stethoscope while working in Level 2 PPE.

By the way, you also have to be able to insert and remove the 47 earpieces…which are inside the suit…with hands…that are outside the suit.

Slide 48 Category-A waste requires additional safety protocols above and beyond Packaging those practiced for standard Regulated Category-A Waste Medical Waste. Those handling the waste must don Level 1 or 2 PPE, whichever is appropriate for the nature of the waste. The waste is double-bagged and the outer surface of each bag is decontaminated with 48 bleach. Bags are closed using a ‘gooseneck’ method, just as with asbestos waste before being placed in rigid containers. Before transport off site, Category-A waste must be in DOT approved packaging.

We utilize the same patient-care clinicians, who are already trained in Level 1 and 2 PPE protocols, to package Category-A waste. That way Environmental Services staff do not have to deal with something outside of their training and comfort zone. Once properly packaged, a trained hazmat professional like Brenda or myself would oversee transportation and disposal of the waste.

Slide 49 To transport Category-A materials or

Category A Infectious Waste Disposal waste, you must have current and certified training in the shipment of Must be trained and certified to ship Category-A infectious substances (cultures, waste, etc.) 6.2 hazardous materials. Like DOT Training must be repeated every 3 years Hazmat Awareness training, 6.2 Category-A waste required specialized packaging training must be repeated every three Shipping Category-A waste requires a “Special years. In Texas, the Health Permit” from the DOT (issued on a case-by-case basis) Department offers this training at least once a year to Laboratory personnel 49 free of charge.

Shipping lab samples is one thing, but shipping Ebola-contaminated medical waste is a different story. Treating Ebola patients generates tremendous amounts of infectious waste. When Ebola surfaced in the U.S., it was soon discovered that the limited availability and high cost of drums suitable for shipping 6.2 infectious substances made shipping large amounts of Category A waste impractical.

So in 2014, the DOT issued a Special Permit to Stericycle, the largest medical waste disposal company in the U.S., allowing them more flexibility in packaging and enabling them to ship to and from anywhere in the U.S.

Slide 50 Since that time, the DOT has extended this Special Permit status to six additional waste companies.

Slide 51 Once a determination had been made

Level 1 Training on PPE and donning/doffing protocols established, a large scale training program began. In less than 4 months, over 1,000 clinical staff were trained in proper donning and doffing of Level 1 PPE.

Slide 52 Several hundred were additionally trained in the more advanced Level 2 protocols.

It’s important to remember that these were not hazmat professionals like you and me. These were clinicians, most of which had no prior hazmat experience at all. 52 Unfortunately these folks are not going to be smiling for long.

Slide 53 Fairly early in our training and

Patient Under Investigation (PUI) preparations phase, we were notified that EMS was bringing us a Patient A ‘PUI’ is an Ebola Patient Until Proved Otherwise Hospital notified that EMS was bringing us a PUI Under Investigation, or what’s known Staff were alerted and the room readied In route to hospital, ambulance A/C fails as a “PUI”. The woman had recently Paramedics are in full PPE One Paramedic collapses in patient room from heat arrived from an affected area of Africa exhaustion and began exhibiting early symptoms Staff follow strict HCID precautions for several days until patient is finally diagnosed with malaria. of Ebola. Trained hospital staff were called in and the designated Ebola 53 patient room was readied.

While on the way to the hospital with the patient, the ambulance’s air conditioning broke down. The Paramedics, who were in full PPE soon began to overheat. Remember folks, we’re talking Texas here where 90 degree October temperatures are not uncommon.

Just as EMS got to the patient room, one of the Paramedics collapsed from heat exhaustion. Luckily he was OK and did not get contaminated in the process.

After several days, the patient was finally diagnosed with malaria, a disease common to Africa with symptoms similar to early Ebola. The thing to remember here is for those 2 or 3 days, attending staff had to treat this patient just like she was contagious for Ebola because as far as they knew, she was. It was a very stressful time. When it was over, everyone breathed a sigh of relief and then started considering what we could do better the next time?

Slide 54 Hospitals and health agencies had to ask some tough questions. Treat an Financial Impacts of Ebola Ebola patient…but at what cost.

Texas Health Presbyterian reportedly lost over $8 million dollars in revenue and saw their emergency room visits drop by 50% following their experience with Ebola. 54 Our 11-hospital network spent over $1 million dollars of unbudgeted money in a few short months on training, PPE and equipment.

When asked by the State which hospital they would designate to receive Ebola PUIs, the question some CEOs asked themselves was, ‘Which hospital am I willing to lose in the aftermath?’.

Slide 55 One thing we quickly learned through

Laboratory Operations and HCIDs our first PUI was that running routine lab samples was anything but routine. In fact, our own Lab flat out refused to allow potential Ebola samples to be run through their million-dollar equipment due to the possibility of contamination. This was simply a logical decision because this 55 centralized equipment provides laboratory results for the entire 11- hospital network. The loss of even one machine could impact hundreds of patients. In this instance, we were able to have the blood samples run at the State lab.

To avoid this problem in the future, the Lab purchased two Piccolo portable analyzers that can be used right in the patient room. All clinical staff on the Special Response Team are trained on the Piccolo’s operation so that Lab staff do not have to enter the patient room to run tests.

Slide 56 In order to minimize the chance of hospital contamination, we worked with EMS to designate a separate entrance for receiving Patients Under Investigation.

56 *EMS ICU Entrance VI

Slide 57 It detailed where the ambulance would park and wait until the designated room was ready to receive the patient.

The route through the hospital was then cleared and blocked off before the patient was brought in.

*Detailed EMS ICU Entrance View 57

Slide 58 A critical component of any infectious

Ebola Screening disease management is an organized screening process. The Texas Department of State Health Services, and myriad of other state agencies across the country began screening people arriving from affected areas of Africa. The PUIs that we received had all been tracked by the State since 58 arriving in the country and case workers were contacting them regularly asking about any symptoms during the 21-day incubation period.

Slide 59 Hospitals began a similar process, screening all prospective patients Ebola Viral Disease (EVD) coming into their hospitals and clinics. Screening Tool Viral epidemics are dynamic in nature and any effective screening process must constantly be updated.

Slide 60 This is an example of the CDC’s 2014 screening template they developed for hospitals to use.

Slide 61 Our hospital network now maintains a Special Response Team, or SRT, consisting of doctors and nurses from various disciplines. The SRT can be activated through emergency messaging and can deploy to any hospital location expecting a PUI within 2-hours.

Slide 62 The group trains several times a year with local EMS at the hospital network’s current designated HCID receiving location. Membership on the team is all voluntary.

Slide 63 The hospital network maintains two identically-stocked High Consequence Infectious Disease carts, affectionately known as “Thing 1” and “Thing 2”. These carts can rapidly be deployed to any of our hospitals simultaneously as the SRT is called to respond.

Slide 64 This presentation is timely since there’s an ongoing outbreak right now in Africa. On August 1, 2018, the Democratic Republic of the Congo declared a new outbreak of Ebola. th As of August 12 , 2019, there have been 2,837 confirmed or probable cases of Ebola, and 1,898 confirmed or probable deaths as a result of Ebola. Screening activities and preparedness activities are underway in surrounding countries to prevent the spread of Ebola. Lessons learned following the 2014-2016 Ebola outbreak are being applied to the current outbreak, likely resulting in the smaller numbers of people being infected during this outbreak.

Slide 65 While Ebola and other High Consequence Infectious Diseases pose a real threat to the world population, advances are being made in the treatment and prevention of these diseases. The Ebola vaccine being used in the current outbreak shows promise, but even if or when Ebola is conquered, another lethal virus will likely be waiting to emerge. The CDC’s Division of High- Consequence Pathogens and Pathology continues to investigate, monitor, and control “sickness, disability and death caused by highly lethal viral, bacterial, prion, and related infections and diseases of unknown origin.” (https://www.cdc.gov/ncezid/dhcpp/i ndex.html)

Slide 66 This slide deck includes Mark and my contact information as well as references used in preparation of this material.