1. Guidance from the CDC. 2. Acquired knowledge of the biological characteristics of enveloped viruses.

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1 Introduction October 24, 2014 As reported by the Centers for Disease Control and Prevention (CDC), the 2014 Ebola epidemic is the largest in history, affecting multiple countries in West Africa. In the United States, some cases have been reported. The CDC and partners are taking precautions to prevent the further spread of Ebola within the United States. The College of American Pathologists is working closely with the Centers for Disease Control and Prevention in reviewing information for the handling of specimens from patients who meet the case definition criteria for possible Ebola virus infection. Further, in partnership with the CDC, we have consolidated CDC recommendations to handle specimens known to contain or that possibly may contain highly infectious agents such as Ebola virus. This and other laboratoryspecific information follows and we will continue to update the information. For more information regarding Ebola, please refer to the CDC website. The CDC has set up an and telephone number to handle all laboratory-specific questions: Handling of specimens from patients who meet the case definition criteria for possible Ebola virus infection Purpose Millions of laboratory tests are performed each day in the United States. Many of these specimens contain blood-borne pathogens, such as hepatitis viruses and HIV. Universal Precautions are the safety precautions utilized by laboratory professionals to avoid contracting these infections while performing testing. Adherence to these guidelines is the best protection against the acquisition of a blood-borne pathogens, including the Ebola virus. The implementation of enhanced precautions, used by personnel testing specimens from patients who meet the definition of a person under investigation, are not feasible or warranted to enact for large volumes of routine testing performed on a daily basis for patients who are not under investigation for Ebola virus infection. Heightened precautions are recommended for the handling of specimens from a patient that meets the CDC criteria of a person under investigation for Ebola virus disease (EVD). The performance of testing should be limited to those studies that are absolutely essential for patient care. These recommendations provide guidance for laboratorians for the handling of specimens from a person that meets the case definition for possible Ebola viral infection. 1

2 Sources of Recommendations 1. Guidance from the CDC. 2. Acquired knowledge of the biological characteristics of enveloped viruses. Case Definition There are three criteria that must be met for a patient to qualify as a person under investigation for EVD. The CDC criteria are: 1. Fever of greater than 38.6 degrees Celsius or degrees Fahrenheit. 2. Symptoms, such as severe headache, muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage. 3. Epidemiologic risk factors within the past 21 days before the onset of symptoms, such as 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; or direct handling of bats or non-human primates from disease-endemic areas. NOTE: It is important to recognize that without these criteria, public health laboratories will not perform testing. It is recommended that the assessment of these criteria is made by at least two experienced physicians; if possible, one of these physicians should have subspecialty training in infectious diseases. Consolidated CDC recommendations to handle specimens known to contain or that possibly may contain highly infectious agents such as Ebola virus 1. Infection control when collecting and handling specimens OSHA bloodborne pathogens standard: All laboratorians and other health care personnel collecting or handling specimens must at least follow established standards compliant with the OSHA bloodborne pathogens standard, which includes blood and other potentially infectious materials. These standards include wearing appropriate personal protective equipment (PPE) and following all safety rules for all specimens regardless of whether they are identified as being infectious. Additional protective equipment, such as double gloves or double gowns, is acceptable. Recommendations for risk assessment to staff: Risk assessments should be conducted by each laboratory director, biosafety officer, or other responsible personnel to determine the potential for sprays, splashes, or aerosols generated from laboratory procedures. They should adjust, as needed, PPE requirements, practices, and safety equipment controls to protect the laboratorian s skin, eyes, and mucous membranes. Recommendations for specimen collection by staff: Any person collecting specimens from a patient with a case of suspected Ebola virus disease should use a PAPR or N95 respirator; a single use (disposable) fluid resistant or impermeable gown that extends to at least mid-calf or a coverall with without an integrated hood; gloves (two pairs with at minimum the outer glove having extended cuffs); full face shield, helmet or headpiece, if the PAPR option is selected; single-use (disposable) fluid-resistant boot covers that extend to at least mid-calf or single-use shoe covers; and, a single use (disposable) fluid-resistant or impermeable apron. Details are provided at 2

3 Recommendations for laboratory testing by staff: Any person testing specimens from a patient with a suspected case of Ebola virus disease should wear gloves, waterresistant gowns, full face shield or goggles, and masks to cover all of nose and mouth, and as an added precaution use a certified class II Biosafety cabinet or Plexiglass splash guard with PPE to protect skin and mucous membranes. All manufacturer-installed safety features for laboratory instruments should be used. Some laboratory procedures (eg, centrifugation) have the potential to produce aerosols or small droplets. If such procedures must be performed, physical containment devices such as sealed centrifuge rotors or centrifuge safety cups should be used, along with PPE as indicated above. For automated systems, the manufacturer-installed safety features and decontamination protocols appropriate for enveloped viruses such as HIV, influenza, or hepatitis C, should be used to ensure additional protection and safety. Specimen handling for routine laboratory testing (not for Ebola diagnosis): Routine laboratory testing includes traditional chemistry, hematology, and other laboratory testing used to support and treat patients. Precautions as described above offer appropriate protection for health care personnel performing laboratory testing on specimens from patients with suspected infection with Ebola virus. These precautions include both manufacturer installed safety features for instruments and the laboratory environment as well as PPE specified above. If resources are available, some have opted to dedicate validated and approved point of care (POC) testing instrumentation to areas in or near the isolation units for patients under investigation, so as to decrease the need for specimen transport, handling, and testing in the larger hospital chemistry and hematology laboratories of the hospital. (See additional information on POC testing below). Specimen containers that may have been contaminated during collection: Use a US Environmental Protection Agency (EPA)-registered hospital disinfectant with a label claim for a non-enveloped virus (eg, norovirus, rotavirus, adenovirus, poliovirus) to disinfect environmental surfaces. 2. Environmental cleaning and disinfection Use a US Environmental Protection Agency (EPA)-registered hospital disinfectant with a label claim for a non-enveloped virus (eg, norovirus, rotavirus, adenovirus, poliovirus) to disinfect environmental surfaces in rooms of patients with suspected or confirmed Ebola virus infection. Although there are no products with specific label claims against the Ebola virus, enveloped viruses such as Ebola are susceptible to a broad range of hospital disinfectants used to disinfect hard, non-porous surfaces. In contrast, non-enveloped viruses are more resistant to disinfectants. As a precaution, selection of a disinfectant product with a higher potency than what is normally required for an enveloped virus is being recommended at this time. EPA-registered hospital disinfectants with label claims against non-enveloped viruses (eg, norovirus, rotavirus, adenovirus, poliovirus) are broadly antiviral and capable of inactivating both enveloped and non-enveloped viruses. 3. Management of laboratory waste Waste generated during laboratory testing should be placed in leak-proof containment and discarded as regulated medical waste. To minimize contamination of the exterior of the waste bag, place this bag in a rigid waste container designed for this use. If available, steam sterilization (autoclave) or incineration as a waste 3

4 treatment process can inactivate the virus and reduces waste volume. For equipment that drains directly into the sewer system, the United States sanitary sewer system handling processes (eg, anaerobic digestion, composting, disinfection) are designed to safely inactivate infectious agents. However, check with your state's regulated medical waste program for more guidance and coordinate your waste management activities for the laboratory area with your medical waste contractor. Instrument decontamination: Contact instrument vendor and perform the recommended decontamination procedure. 4. Preferred specimens for detection of Ebola Ebola virus is detected in blood only after the onset of symptoms, usually fever. It may take up to three days after symptoms appear for the virus to reach detectable levels. Virus is generally detectable by real-time RT-PCR from 3-10 days after symptoms appear. Ideally, specimens should be taken when a symptomatic patient reports to a health care facility and is suspected of having an Ebola exposure. However, if the onset of symptoms is <3 days, a later specimen may be needed to completely rule-out Ebola virus, if the first specimen tests negative. A minimum volume of 4 milliliters of whole blood preserved with EDTA is preferred but whole blood preserved with sodium polyanethol sulfonate (SPS), citrate, or with clot activator can be submitted for Ebola testing. Specimens should be shipped at 2-8 C or frozen on cold-packs to CDC or an authorized State Public Health testing facility. Do not submit specimens to CDC in glass containers. Do not submit specimens preserved in heparin tubes. Standard labeling should be applied for each specimen. The requested test needs to be identified only on the requisition and CDC specimen submission forms. In compliance with 29 CFR , specimens should be placed in a durable, leak-proof secondary container for transport within a facility. To reduce the risk of breakage or leaks, do not use any pneumatic tube system for transporting suspected Ebola virus disease specimens. Specimens collected for Ebola virus disease testing should be packaged and shipped without attempting to open collection tubes or aliquot specimens. Specimens for shipment should be packaged following the basic triple packaging system which consists of a primary container (a sealable specimen bag) wrapped with absorbent material, secondary container (watertight, leak-proof), and an outer shipping package. 5. Use of point of care (POC) testing devices Although specimens from PUI for EVD can be safely handled in a clinical laboratory using the guidance provided above, POC instrumentation may also be utilized. However, the following points should be considered as relates to CLIA implications with regards to POC testing devices: If POC instruments are used in the critical care of isolated patients then the clinical laboratory must ensure POC instruments used have Food and Drug Administration clearance for intended use in critical care patients. 4

5 Additionally an alternative plan for specimen transport to the clinical laboratory should be in place should a POC instrument fail or critical testing be required that cannot be performed by POC. If clinical laboratories decide to add POC instruments specifically for testing PUI for EVD, they should provide training and have staff practice these procedures while wearing the appropriate PPE in advance. Changing to unfamiliar equipment or PPE without sufficient training and practice may lead to breaches in safe practices and may increase a person s risk of contaminating their clothes, mouth, or eyes. 6. Guidance for malaria testing of blood from patients under investigation for Ebola The modification of the procedure for the preparation of thick and thin smears for the assessment of malaria in patients under investigation follows: For thick smears: 1. There is no pre-hemolysis in water and no fixation. 2. The working Giemsa stain should be prepared with 2 ml of 5% Triton X-100 per 40 ml. The thick smear slides are first placed into this solution for 45 minutes. 3. The working Giemsa buffer should be prepared with 2 drops of 5% Triton X-100 per 40 ml. The stained slides should be washed as normal for 5 minutes in this buffer. For thin smears: 1. Fix thin smears for 15 to 30 minutes in 100% methanol. 2. The working Giemsa stain should be prepared with 2 drops of 5% Triton X-100 per 40 ml. The dry thin smear slides should be placed into this solution for 45 minutes. 3. The working Giemsa buffer should be prepared with 2 drops of 5% Triton X-100 per 40 ml. The stained slides should be washed as normal for 5 minutes in this buffer. The thick smears and the thin smears must be treated and stained differently so they cannot be on the same slide. For more information, see the CDC website: 7. Guidance for safe handling of human remains of Ebola patients in US hospitals and mortuaries These recommendations give guidance on the safe handling of human remains that may contain Ebola virus and are for use by personnel who perform postmortem care in US hospitals and mortuaries. In patients who die of Ebola virus infection, virus can be detected throughout the body. Ebola virus can be transmitted in postmortem care settings by laceration and puncture with contaminated instruments used during postmortem care, through direct handling of human remains without appropriate personal protective equipment, and through splashes of blood or other body fluids (eg, urine, saliva, feces) to unprotected mucosa (eg, eyes, nose, or mouth) which occur during postmortem care. 5

6 Only personnel trained in handling infected human remains, and wearing PPE, should touch, or move, any Ebola-infected remains. Handling of human remains should be kept to a minimum. Autopsies on patients who die of Ebola should be avoided. If an autopsy is necessary, the state health department and CDC should be consulted regarding additional precautions. 8. The shipping of specimens for Ebola testing The Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease in the United States has been provided (see below including link). It is important that the individuals who will be packaging and shipping the specimens for Ebola virus testing are appropriately trained. The responsible party from each laboratory should contact their State Public Health laboratory regarding where testing will be performed, if it is needed. Detailed information is provided in the link below. ( 6

7 9. Personal protective equipment for postmortem care personnel Personal protective equipment (PPE): Prior to contact with body, postmortem care personnel must wear PPE consisting of: surgical scrub suit, surgical cap, impervious gown with full sleeve coverage, eye protection (eg, face shield, goggles), facemask, shoe covers, and double surgical gloves. Additional PPE (leg coverings, apron) might be required in certain situations (e.g., copious amounts of blood, vomit, feces, or other body fluids that can contaminate the environment). Putting on, wearing, removing, and disposing of protective equipment: PPE should be in place BEFORE contact with the body, worn during the process of collection and placement in body bags, and should be removed immediately after and discarded as regulated medical waste. Use caution when removing PPE as to avoid contaminating the wearer. Hand hygiene (washing your hands thoroughly with soap and water or an alcohol based hand rub) should be performed immediately following the removal of PPE. If hands are visibly soiled, use soap and water. 10. Postmortem preparation Preparation of the body: At the site of death, the body should be wrapped in a plastic shroud. Wrapping of the body should be done in a way that prevents contamination of the outside of the shroud. Change your gown or gloves if they become heavily contaminated with blood or body fluids. Leave any intravenous lines or endotracheal tubes that may be present in place. Avoid washing or cleaning the body. After wrapping, the body should be immediately placed in a leak-proof plastic bag not less than 150 m thick and zippered closed. The bagged body should then be placed in another leak-proof plastic bag not less than 150 m thick and zippered closed before being transported to the morgue. Surface decontamination: Prior to transport to the morgue, perform surface decontamination of the corpse-containing body bags by removing visible soil on outer bag surfaces with EPA-registered disinfectants which can kill a wide range of viruses. Follow the product s label instructions. The visible soil has been removed, reapply the disinfectant to the entire bag surface and allow to air dry. Following the removal of the body, the patient room should be cleaned and disinfected. Reusable equipment should be cleaned and disinfected according to standard procedures. Individuals driving or riding in a vehicle carrying human remains: PPE is not required for individuals driving or riding in a vehicle carrying human remains, provided that drivers or riders will not be handling the remains of a suspected or confirmed case of Ebola, and the remains are safely contained and the body bag is disinfected as described above. 11. Interim guidance regarding compliance with select agent regulations for laboratories handling patient specimens that are known or suspected to contain Ebola virus Ebola virus is listed as a select agent. Biological agents that the Department of Health and Human Services (HHS) has determined to have the potential to pose a severe threat to public health and safety, such as Ebola virus, are regulated under the HHS Select Agent regulations (42 CFR Part 73). Ebola virus is also listed as a Tier 1 agent. (A subset of select agents and toxins has been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety). 7

8 Nucleic acids (genetic materials) that cannot produce infectious forms of a select agent (such as from the Ebola virus) are not regulated as a select agent If live-infectious Ebola virus is confirmed, any diagnostic or clinical specimens (eg, blood, urine, tissue, and other body fluids) that are kept would be covered by the regulations and would have to be destroyed, decontaminated, or transferred to a registered select agent facility within seven days of notification that live-infectious Ebola virus was detected. Specimens that were collected but not kept, eg, blood collected for routine patient care and then decontaminated or destroyed after testing, are not subject to the regulations. After the patient has been determined to no longer be infected with Ebola virus, specimens taken after that point are not subject to the select agent regulations. Additional links to CDC website information poster instructing proper procedure for donning PPE 8