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Ebola HCA Continental Division Response October 13, 2014 Prepare to Detect Prepare to Protect Prepare to Respond Information Sources • Centers for Disease Control and Prevention • University of Nebraska Biocontainment Patient Care Unit • University of Texas Medical Branch-Galveston National Laboratory Biosafety Level 4 • HCA: Clinical Services Group • World Health Organization Presenters • Gary Winfield MD – Division Chief Medical Officer • Lindy Garvin RN, CPHRM – Division Vice President of Quality and Patient Safety • David Markenson, MD – CMO Sky Ridge Medical Center • Steve Quach MD – CMO PSL Medical Center • Paul Hancock MD – CMO Swedish Medical Center • Dianne McCallister MD – CMO The Medical Center of Aurora Agenda • • • • • • Introduction Ebola History and Overview Prepare to Detect Prepare to Protect Prepare to Respond Division Response and Communication Ebola History and Overview David Markenson, MD Chief Medical Officer Sky Ridge Medical Center Overview • Ebola hemorrhagic fever or EVD – Viral Hemorrhagic Fever – Rare and deadly disease – Caused by infection with one of the Ebola virus strains. • Named after the Ebola River in the Democratic Republic of the Congo (formerly Zaire) • First outbreak (Zaire 1976) – 318 human cases – 88% mortality – Disease spread by close personal contact in hospital setting • Five types – Zaire, Sudan, Tai Forrest, Bundibugyo and Reston Viral Hemorrhagic Fevers • Cases in the United States are extremely rare – Have occurred multiple times – Yearly there are possible cases as well as actual • Dengue probably most common – Recently have visited endemic areas – Potential occupational exposure Viral Hemorrhagic Fevers (cont.) • Vascular Damage and hemorrhage • Fatality < 10% (Dengue) to 90% (Ebola) • Five families of viruses – Arenaviruses (Lasa, Junin Virus) – Bunyaviruses (Nariovirus, Hanta Virus) – Flaviviruses (Dengue, Yellow Fever) – Filoviruses (Marburg & Ebola) – Paramyxoviruses (Hendra, Nipah but also Measles and Mumps) Ebola Past Outbreak – Key Points • Predominantly Africa • Many index cases are people who ate bush meat • Only one sub-type (reston) had possible airborne transmission – Only transmitted to non-human primates – Evidence for airborne is weak – Not common species of Ebola • Spread has been due to healthcare sites, burial rituals and close family contact with ill patient's – Most cases found no PPE Overview-Current Outbreak • West Africa – Guinea, Liberia, Sierra Leone, Nigeria and Senegal – 8397 cases (probable, suspected and confirmed) with 4032 deaths • Democratic Republic of Congo – 71 cases with 43 deaths – The index case was a pregnant woman who butchered a bush animal. – She became ill with symptoms of EVD, reported to a private clinic in Isaka Village, and died on August 11, 2014. – Local customs and rituals associated with death meant that several healthcare workers were exposed to Ebola virus. • United States – 2 confirmed and 1 death • Spain – 1 confirmed Transmission • • Contagiousness – Not during early stages – As the illness progresses, bodily fluids represent an extreme biohazard Methods of Transmission – Direct contact • Blood , secretions , organs – – – • • Unsterilized needles Burial ceremonies Infected animal Airborne transmission – Only circumstantial evidence is in non-human primates Highest risk has been – Healthcare providers in Africa – Family and friends in close contact – Burial Rituals Transmission • Because the natural reservoir is unknown, the manner in which the virus first appears in a human is unknown – Researchers believe that the first patient becomes infected through contact with an infected animal • Not spread through the air or by water, or in general, by food. – May be spread by handling bushmeat and contact with infected bats – There is no evidence that mosquitos or other insects can transmit Ebola • Only mammals (for example, humans, bats, monkeys, and apes) have shown the ability to become infected with and spread Ebola virus. • If someone recovers from Ebola, can no longer spread virus. – Ebola virus has been found in semen for up to 3 months. People who recover from Ebola are advised to abstain from sex or use condoms for 3 months. Pathogenesis Symptoms • Symptoms may appear from 2 to 21 after exposure – Average is 8 to 10 days. • Initial Signs – Fever (at least 102°F) – Weakness & exhaustion – Pain • Severe headache • Muscles & joints • Abdominal pain – Sore throat – Nausea – Dizziness Symptoms (cont.) Progressed Symptoms • Vomiting • Diarrhea • Extensive bleeding – Red eyes • hemorrhage of sclerotic arterioles – From mouth, nose, eyes, rectum & mucosa membranes • Maculopapular rash – Spreads over the body (often hemorrhagic) • Other secondary symptoms – Hypotension , Hypovolemia , Tachycardia – Organ damage – Internal and external bleeding Clinical Course (cont.) Recovery • 10 to 12 days after the onset – sustained fever may break, with improvement and eventual recovery of the patient. • 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 Death • 1-2 weeks after onset – Death often preceded by hemorrhagic diathesis, shock, multi-organ system failure Diagnosis • Diagnosing Ebola in an person who has been infected for only a few days is difficult – Early symptoms, such as fever, are nonspecific to Ebola infection – Same symptoms often seen in patients with more commonly occurring diseases • Malaria • Typhoid fever • Dengue – Not common but more so than Ebola CDC Case Definition • Person Under Investigation – Clinical Criteria - fever of greater than 38.6 degrees Celsius, and additional symptoms such as severe headache, muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage – Epidemiologic Criteria (21 days before the onset of symptoms) – • Contact with blood or other body fluids or human remains of a patient known to have or suspected to have EVD • Residence in—or travel to—an area where EVD transmission is active • Direct handling of bats or primates from disease-endemic areas • Probable Case – PUI with High or Low Risk Exposures • Confirmed Case – Laboratory confirmation CDC Case Definition (cont.) • High Risk Exposure – Percutaneous (e.g., needle stick) or mucous membrane exposure to blood or body fluids of EVD patient – Direct skin contact with, or exposure to blood or body fluids of, an EVD patient without PPE – Processing blood or body fluids of a confirmed EVD patient without PPE or standard biosafety precautions – Direct contact with a dead body without appropriate PPE in a country where an EVD outbreak is occurring CDC Case Definition (cont.) • Low risk exposure – Household contact with an EVD patient – Close contact with EVD patients in health care facilities or community settings • 3 feet of an EVD patient or within the patient’s room or care area for a prolonged period of time while not wearing PPE • Direct brief contact (e.g., shaking hands) with an EVD patient while not wearing PPE – Brief interactions, such as walking by a person or moving through a hospital, do not constitute close contact • No known exposure – Having been in a country in which an EVD outbreak occurred within the past 21 days and having had no high or low risk exposures Diagnostic Testing Timeline of Infection Within a few days after symptoms begin Diagnostic tests available •Antigen-capture enzyme-linked immunosorbent assay (ELISA) testing •IgM ELISA •Polymerase chain reaction (PCR) •Virus isolation Later in disease course or after recovery •IgM and IgG antibodies Retrospectively in deceased patients •Immunohistochemistry testing •PCR •Virus isolation Preparedness for Ebola Virus Steve Quach MD CMO, PSL Medical Center Sources • Centers for Disease Control and Prevention • University of Nebraska Biocontainment Patient Care Unit • University of Texas Medical Branch-Galveston National Laboratory Biosafety Level 4 • HCA: Clinical Services Group • World Health Organization Real World Experience Assumptions • Facilities will only have 1 potential Ebola patient at a time – With more than 1 patient the plan would be altered • Emergency Department is at highest risk to receive a patient with Ebola • Ebola is transmitted through contact with infectious droplets and contact with body fluids • Donning and doffing of PPE presents the highest risk of exposure to healthcare workers • Facilities will restrict the number of healthcare workers that come in contact with patient – Physicians and nurses will perform all patient care and daily cleaning of patient room Key Personnel • Emergency Department – Physicians and Nurses • Intensive Care Unit (Adult & Peds) – Physicians and Nurses • Infectious Disease Physicians – Adult and Pediatric Specialists • Respiratory Therapy – Adult and Pediatric Therapists • Security – First point- of-contact screening – Traffic control • Radiology – Portable equipment, dedicated to a single patient • Environmental Services – Waste removal • Laboratory – Laboratory assistant to transport specimens to Colorado Department of Public Health – Medical Technologists • Infection Prevention – Coordination between our facility, the health department, and the CDC Preemptive Conversations With all key personnel: • Are they willing to commit to care for a patient that may have Ebola? • Address all fears • Educate on all processes • Keep lines of communication open Infectious Disease Screening • Screening of patients at all points of access. • Emergency Department Screening 100% of patients. – Security completes screening form • If positive, Security contacts ED staff – Patient is masked – Asked to wait in wheelchair for ED staff • If negative, form is given to patient or visitor Arrival by EMS • If EMS notifies Emergency Department about possible or probable Ebola patient: – Staff will meet ambulance wearing PPE in ambulance bay • PPE based on report from EMS – Patient will be masked and covered with clean sheet to enter facility – EMS will be directed to decontamination shower and provided scrubs as needed Family Members and Visitors • Family and visitors accompanying patient will be placed in private room – Will be asked to perform hand hygiene – If clothing is contaminated will be asked to shower • Will be provided clothing or paper scrubs – Family members and visitors will be asked to remain in the private room until released by the Colorado Department of Public Health If, at any time, a patient is deemed high risk for Ebola Virus, initiate Level II Isolation immediately. Patient’s Infectious Disease Screen positive for travel history, exposure, and/or symptoms Put Patient in Level I isolation (contact & airborne) If physician has high clinical suspicion, initiate Level II Isolation Page Infection Prevention through PBX Provide Infection Prevention to Call CDPHE CDPHE to determine index of suspicion and initiate testing R/O Ebola Infection Prevention to initiate Level II Isolation Not Ebola Infection Prevention to notify ED To Notify House Supervisor AOC Physician Leadership Notify: Receiving Unit Lab Radiology EVS FANS RT Other Related Departments Evaluate need to Incident Command Notify Dr. Quach and CMO and ID Dr Terra Notify Facility Physician Travel history, exposures, onset date, symptoms, and any pertinent clinical information Levels of Isolation • Level 1 ( Possible Ebola): – Airborne and Contact Isolation – Gown, gloves, N95 • Level 2 (Probable Ebola): – – – – – – Impermeable gown 3 layers of gloves N95 or PAPR hood Face shield Surgical hood Boot covers Personal Protective Equipment • • • • Surgical hood Impervious gown Duct or Chem tape 3 layers of gloves – 1st: exam gloves – 2nd: Long cuffed nitrile surgical gloves – 3rd: exam gloves • N95 or PAPR hood • Face shield • Boot/leg covers Additional Equipment • Hospital laundered scrubs • Crocs- hospital issued • Doffing pad • Dedicated or disposable equipment – – – – – Stethoscopes Blood pressure cuff Radiology equipment Centrifuge Medical equipment can be cleaned but must be dedicated until discharge or no longer needed – Disposable food tray and utensils Donning PPE Impermeable Gown 1. 2. 3. 4. 5. 6. 7. 8. 9. Perform hand hygiene Put on washable footwear (Crocs) Put on leg/boot covers Put on head protection Put on gown Perform hand hygiene Put on N95 respirator Put on face shield Gloves – Three layers! Doffing PPE: Impermeable Gown 1. Remove 3rd layer of gloves in patient room 2. Remove duct or Chem tape and 2nd layer of gloves 3. Remove gown 4. Remove leg/boot covers 5. Remove 1st layer of gloves 6. Perform hand hygiene 7. Put on clean pair of gloves 8. Remove face shield 9. Remove N95 respirator 10.Wipe top and bottom of shoes with bleach PPE: Gloves Donning – 1st layer of gloves: standard patient care gloves, bring cuffs of gown over gloves – 2nd layer of gloves: nitrile long-cuff gloves secured to gown with Chem or duct tape – 3rd layer of gloves: standard patient care gloves donned after entering patient room. Doffing – Grasp outside of glove with opposite gloved hand; peel off – Hold removed glove in gloved hand – Slide fingers of ungloved hand under remaining glove at wrist – Peel glove off over first glove – Discard gloves in waste container PPE: Face Shield Donning • Place over face and eyes and adjust to fit Doffing – Grab rear strap and pull it over the head forward, gently allowing face shield to fall forward – Dispose face shield in waste container PPE: N95 respirator Donning Doffing • Secure ties or elastic bands at middle of head and neck • Fit flexible band to nose bridge • Fit snug to face and below chin • Fit-check respirator • Front of respirator is contaminated — DO NOT TOUCH! • Grasp bottom, then top ties or elastics and remove • Discard in waste container Reminders: PPE Removal • Remove the 3rd (external) pair of gloves while in patient room. Wipe down second pair of gloves with bleach wipe prior to exiting patient room. • Remove PPE on doffing pad in anteroom or directly outside patient room. • Perform hand hygiene after removing PPE and if hands become contaminated between steps Transportation • Moving patients must be coordinated through Infection Prevention and the managers of both the sending and receiving units • Transport of patient will be performed by 2 separate teams Transportation- Team 1 • Team 1: Physician/Staff in the patient room – Prepare the patient – Staff must wear all required PPE – Put the patient in a surgical mask and drape with a clean sheet – Disinfect the bed rails and equipment with 10% bleach wipes – Transfer the patient to Team 2 Transportation- Team 2 • Team 2: ICU Staff members and security – Staff members involved in transport must wear all required PPE – Additional team member will accompany transport to push elevator buttons and open doors. Staff member will wear PPE but remain “clean” – Security will be utilized for traffic control during transport – Determine route of transport to limit exposure to public Location of Care • All patients will be cared for in ICU setting – Ideal location equipped with: • Negative pressure room • Sink outside door to patient room • Anterooms no longer required or needed for negative air pressure rooms due to more efficient design. – Location isolated from other patients if possible – Locations may vary within hospitals. • Facilities should designate rooms and equipment for these patients. Patient Care • Supportive care • Common complications include: – Sepsis – Coagulopathy – Secondary infections – Multi-organ failure Ebola Treatment • IRB will need to be prepared for immediate approval – Emergency investigational new drug application at • http://www.fda.gov/Drugs/DevelopmentApprovalProcess/H owDrugsareDevelopedandApproved/ApprovalApplications/I nvestigationalNewDrugINDApplication/ucm090039.htm – Mapp Biopharmaceutical and contact information at • http://www.mappbio.com/ – ZMapp information at • http://www.mappbio.com/zmapinfo.pdf – Chimerix brincidofovir information at • http://ir.chimerix.com/releasedetail.cfm?releaseid=874647 Laboratory • The utilization of available point-of-care testing is required to decrease potential lab exposure • The following tests can be performed on the iStat: – Arterial, venous, or capillary blood gases (pH, pCO2, PO2,HCO3,TCO2, BE, O2 sat) – Glucose – Sodium – Potassium – Hematocrit/calculated hemoglobin – Ionized calcium – Bun/creatinine – PT /INR – ACT activated clotting time – Lactate – Troponin Lab Specimen Handling Options • Specimens can be centrifuged in laboratory – Care must be taken when opening centrifuge after spin • Centrifuge can be placed in negative airflow room near patient Specimen Transport • Clearly label specimen at the bedside with a sharpie • All specimens requiring centrifugation will be spun prior to transport • Outside of specimen will be disinfected with 10% bleach wipe and then placed in a clean plastic biohazard bag • Biohazard bag will be placed in an impervious plastic container • All specimens will be walked and hand delivered to the Chemistry lab for receiving and processing Lab Specimen Handling • All technologists processing the sample will wear: – – – – Triple gloves Fluid resistant gowns Full face shields or goggles N-95 Mask to cover the nose and mouth • Special care should be taken when removing lids of blood tubes to assure safe handling – Utilize BioSafety cabinet – Remove blood caps with gauze to contain any potential spray and remove behind a shield Ebola Testing • All Ebola testing will be coordinated by Infection Prevention through the Colorado Department of Public Health – Testing can ONLY occur through this process • Specimen requirements: – Minimum of 4mL of whole blood in EDTA (purple) plastic tube is preferred but can be submitted in sodium polyanethol sulfonate (SPS) (light yellow), citrate (blue), or with clot activator (red with or without gel) – Specimens cannot be submitted in glass or heparinized tubes (light green or dark green) Daily Room Cleaning • Only use 10% bleach wipes – Keep all surfaces wet for 4 minutes (contact time!) • • • • Clean all horizontal surfaces Clean all high touch areas Put any soiled linens in hazardous waste bins EVS will not do routine cleanings Initial Discharge Cleaning • Only use 10% bleach wipes – Keep all surfaces wet for 4 minutes (contact time!) • Clean all surfaces • Put all linens in hazardous waste bins • Put all disposable items in hazardous waste bins Discharge Cleaning for EVS • Only enter after approval by Infection Prevention – Room will sit unoccupied for 24 hours – All PPE will be worn for cleaning • Only use 10% bleach wipes – Keep all surfaces wet for 4 minutes (contact time!) • Remove the privacy curtain and discard • Perform standard discharge terminal clean – Consider use of UV or Steriplex if facility standard Waste • Waste is an ongoing and unresolved issue • Class A waste is infectious/biohazardous waste as defined by the Department of Transportation • All waste goes into Class A biohazardous bins delivered by EVS. – If not available, waste should be collected in impervious containers and secured Sharps • Sharps should be disposed of in a “normal” sharps container • Contact EVS management for removal – EVS will treat as Class A waste • Place container in red bag • Dispose of in Class A container Waste Removal • Contact EVS management to have container delivered and waste removed – All waste will be handled as Category A waste and treated as follows: • Place soft waste or sealed sharps containers into a primary medical waste bag (1.5ml – ASTM tested; can be provided by Stericycle). • Apply bleach or other virocidal disinfectant into the primary bag to sufficiently cover the surface of materials contained within the bag; securely tie the bag. • Treat the exterior surface of the primary container with bleach or other virocidal disinfectant. • Place the primary bag into a secondary bag and securely tie the outer bag. • Treat the exterior surface of the secondary bag with bleach or other virocidal disinfectant. • The double bagged waste should then be place into special Category A packaging provided by Stericycle with the liner tied securely and container closed per the packaging instructions provided. • Store the Category A waste containers separate from other regulated medical waste and in a secure area preferably isolated and with limited access. Disposal of Fluids • All body fluids must be disinfected • After disinfection, all fluids can be flushed into the sewer system • Contact EVS management to obtain the disinfectant Drills • Practice taking patient through process from ED to ICU – Will be able to identify additional issues or processes that need to be addressed – Will increase the comfort level of staff If you have: • Fever (greater than 38.6°C or 101.5°F) • Muscle pain • Diarrhea • Unexplained bleeding or bruising Attention Patients • Severe headache • Vomiting • Stomach pain AND You have traveled to any of the following areas in the past 3 weeks Democratic Republic of the Congo (DRC) South Sudan Uganda South Africa Liberia Senegal Gabon Ivory Coast Republic of the Congo (ROC) Guinea Sierra Leone Nigeria Please put on a mask and notify Emergency Department Personnel Immediately Employee Health Guidance Paul Hancock MD CMO Swedish Medical Center Employees who have travelled to West African or Central African countries • Should be screened by phone by an Infection Prevention nurse prior to returning to work. • Employees who are deemed to be at low risk for Ebola exposure should: • self-monitor for fever and other signs of illness and • report to Employee Health for a temperature check and brief review of systems at the beginning of every shift until the 21-day incubation period has passed. (Nursing Supervisor during off-hours) • Employees who are considered high-risk based on travel to areas of Ebola breakouts or contact with Ebola patients should not return to work until the 21 day incubation period has passed. • Discussion: pay for employees who are asked not to work because of their high-risk status Employees to provide care for Ebola patients • Consider developing a list of staff who are willing to participate in the care of an Ebola patient • Exclude employees who are pregnant or who are on immunosuppressive therapy for autoimmune disease or other conditions Accessing The HealthONE Division Ebola Website HealthONE Division Ebola Website www.healthonecares.com Concerns or questions can be directed to [email protected] Questions?