THCB

CDC Laboratory Guidance on Ebola

Tom Frieden optimizedFor more than four decades, Ebola virus had only been diagnosed in central or eastern Africa.

Then late this past March, the first cases of Ebola began appearing in a surprising part of the continent. The Ministry of Health in Guinea notified WHO of a rapidly evolving outbreak of Ebola virus disease. The outbreak in Guinea was the first sign the virus had made the jump across the continent.

Ebola then spread quickly to Sierra Leone and Liberia, and then to Nigeria.

As the world learned of the cases, CDC began receiving questions from American hospital labs. They were looking for guidance on how to handle testing for patients who had recently returned to the U.S. from West Africa with potential Ebola symptoms.

If U.S. hospitals were to run laboratory tests on these patients, how could they be sure their staff could safely handle materials that might contain this dangerous virus? Did they need the kind of personal protective equipment they saw CDC scientists using when they were testing for Ebola?

In order to ensure the safety of laboratory staff and other health care personnel collecting or handling specimens, we recommend they follow established OSHA bloodborne pathogens standards .

During specimen collection, we recommend using personal protective equipment such as full face shield or goggles, masks to cover all of nose and mouth, gloves, and fluid resistant or impermeable gowns. And we note that additional personal protective gear might be required in certain situations.

During laboratory testing, we recommend using personal protective equipment such as full face shield or goggles, masks to cover all of nose and mouth, gloves, fluid resistant or impermeable gowns AND use of a certified class II Biosafety cabinet or Plexiglas splash guard, as well as manufacturer-installed safety features for instruments.

If hospitals follow OSHA standards and lab personnel use appropriate personal protective equipment and adhered to engineered standards, they will not need additional safety measures.

Just a note that the additional personal protective gear and special equipment used by CDC lab workers in our BSL4 labs are because of the additional testing and experiments we must do to further investigate the virus. Those experiments include virus isolation in cell culture, small animal studies to determine pathogenicity, and production of reagents for use by CDC and labs around the world.

We advised hospitals that if they had reason to believe one of their patients might be infected with Ebola — because of recent travel to West Africa and appearance of symptoms — they needed to talk to their state and/or local health department and to us at CDC to determine the need for lab testing. If lab testing was needed, CDC provided appropriate shipping guidelines.

We found no Ebola virus in any of the specimens received and tested at CDC as of mid-August.

Lab-related inquiries to CDC have continued to increase.

To respond, CDC issued “Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Patients with Suspected Infection with Ebola Virus Disease,” with specific guidelines for collecting and transporting specimens.

The test for Ebola is not simple. It’s a real-time assay commonly called RT-PCR, or Reverse Transcription-Polymerase Chain Reaction. While we get the results quickly, contamination and false positives are possible if we’re not scrupulously careful at every step of the process.

Here in the United States, CDC is working with the Department of Defense to expand the number of laboratories able to test for Ebola by using the nation’s Laboratory Response Network, made up primarily of local and state health departments.  We anticipate the first labs being able to test for Ebola outside of CDC in the coming days.

And in Africa, we’re working with international partners, WHO, the Department of Defense, and the National Institutes of Health to scale up laboratory testing there.

Laboratory testing is a critical element in our fight to contain the outbreak of Ebola in West Africa and protect people in Africa and around the world.

We’ve developed this poster with the information you need if you or your colleagues have a patient who should be tested for Ebola. CDC staff stands ready to answer questions and concerns 24/7 at 770-488-7100.

Testing Collection Transport

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15 replies »

  1. If you advise in this blog post restriction of testing to closed systems (third paragraph), why do I not see this in any of the guidelines posted on the CDC website?

    Your points in your fourth paragraph are well taken, that risk assessments need to be done. This has been reflected on the CDC website, but not to the detail you describe here. With increasing use of open and random access systems, and open room designs, why are not these details reflected on the CDC website?

  2. In the Ebola guidance for healthcare workers and specifically for Specimen Handling for Routine Laboratory Testing of persons under investigation (PUI) for Ebola disease (http://www.cdc.gov/vhf/ebola/hcp /safe-specimen-management.html), CDC reminds all laboratory personnel to consider all blood and body fluids as potentially infectious. The guidance further informs laboratory personnel that strict adherence to the OSHA bloodborne pathogen regulations and Standard Precautions protects laboratory workers from bloodborne pathogens, including Ebola. In this guidance, emphasis is placed on the OSHA regulation’s requirement for performance of site-specific risk assessments. These assessments should consider the path of the sample throughout the laboratory, including all work processes and procedures, to identify potential exposure risks and to mitigate the risks by implementing engineering controls, administrative controls (including work practices), and appropriate PPE to protect laboratory personnel. Implementation of these recommendations requires that there is designated staff that is trained, competent, and confident in performing risk assessments within their laboratories.

    Many hospitals feel that the preferred method of clinical laboratory testing is to restrict testing to point of care instruments, using dedicated testing staff that is trained and familiar with the instruments and techniques, safety practices, and PPE. However, it is necessary to refer to the Intended Use statement located in the manufacturer’s package insert to make sure the instrument does not exclude testing on critically ill patients. It is the responsibility of the laboratory director to assure that the point of care instruments provide reliable results to support the care of critically ill patients. Alternately, testing can safely be done in the main clinical laboratory if a risk assessment has been performed of all laboratory work processes and procedures, along with steps taken to mitigate the risks.

    We have had many questions about whether it is safe to test using open instrumentation (you have to decap the tube with sample before loading onto the instrument). We advise, if at all possible, to restrict testing to closed systems, but still, we emphasize the need for risk assessment to assure the potential for exposure is identified and mitigated with appropriate PPE, work practices, and engineering controls.

    If open test systems are used, we caution laboratorians that decapping of the tubes should be done under a Class II Biosafety Cabinet or behind a fixed plexiglass shield while wearing a full face shield and mask. The specimen should be placed in a rigid container with lid to move to the site of the instrument for testing. Again, we strongly emphasize the need for an assessment to identify risks of these processes and procedures, including the potential for aerosolization, splashing, or spraying from the pipetting or other modules on the instrument, and implement practices, PPE, and engineering controls to mitigate the risk. Keep in mind that clinical laboratories often have open room designs, and risk may extend to workers that may not be directly involved with testing a particular sample, requiring broader use of PPE.

    Centrifugation can pose a risk of aerosolization. If centrifugation is necessary for testing, we recommend that it be restricted to use of a centrifuge that has sealed rotors; otherwise allow the sample to sit until components are separated.

    For decontamination of laboratory instruments and equipment, the decontamination protocols appropriate for enveloped viruses such as HIV, influenza, or hepatitis C, is also effective against Ebola. Follow the manufacturer’s instructions provided in the operator’s manual for cleaning the instrument and check to see what the manufacturer recommends when taking the equipment out of commission or getting it ready for repairs. CDC and manufacturers are aware of the challenges laboratorians and their institutions face when these instructions are not provided in the manuals. Because some protocols may be specific to the equipment, they are discussing how best to respond to these concerns.

    For links to additional guidance, see:

    http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-collection-submission-patients-suspected-infection-ebola.html

    http://www.cdc.gov/ncezid/dhcpp/vspb/specimens.html

    http://www.cdc.gov/vhf/ebola/hcp/select-agent-regulations.html

    http://www.cdc.gov/vhf/ebola/hcp/safe-specimen-management.html

    http://www.cdc.gov/vhf/ebola/hcp/infection-prevention-and-control-recommendations.html

    http://www.cdc.gov/vhf/ebola/hcp/procedures-for-ppe.html

  3. Our laboratory would like the answer to Tianna’s question about decontaminating lab equipment as well. We are unable to get answers from many of the manufacturers. Additionally, CDC says to use the manufacturer’s safety equipment. What if the Chemistry instrumentation isn’t a closed tube system. In other words, you either let automation decap the tube or you do it and in either case have to remove an uncapped tube when testing is complete. Is this safe??

  4. What is the answer to Tianna’s question about lab equipment contamination after running an ebola sample?

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  6. One question that we have come across in laboratory preparedness meetings is ‘is our lab equipment contaminated after running normal blood tests on a suspected patient?’. While the direction from the CDChandouts seems to be ‘go by manufacturer guidelines’, I think most manufacturers didn’t anticipate Ebola. If we were to get a suspected case in the hospital, do any of our automated blood testing machines require special decontamination or can suspected samples run along side other patient samples.

  7. While I’m in West Africa, I’ve asked CDC’s Emergency Operations Center to respond, Dr. Z.

    CDC encourages all U.S. health care providers to ask patients about their travel histories to determine if they have traveled to West Africa within the last three weeks.

    All should know the signs and symptoms of Ebola – fever (greater than 38.6°C or 101.5°F) and additional symptoms, such as severe headache, muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage – and know what to do if they have a patient with Ebola symptoms which is to first, properly isolate the patient and then, follow infection control precautions to prevent the spread of Ebola. Avoid contact with blood and body fluids of infected people.

    If you have a suspected case of Ebola and have questions, you can call 770-488-7100, a phone line that is staffed 24/7.

    Additional resources can be found here:
    · Information for healthcare workers: http://www.cdc.gov/vhf/ebola/hcp/index.html
    · Specimen Collection, Transport, Testing, and Submission guidance: http://www.cdc.gov/vhf/ebola/pdf/ebola-lab-guidance.pdf
    · Case Definition: http://www.cdc.gov/vhf/ebola/hcp/case-definition.html

  8. John, While I’m in West Africa, I’ve asked CDC’s Emergency Operations Center to respond. We have more than 60 disease detectives and other highly trained experts battling Ebola on the ground in West Africa, successfully deploying in less than two weeks the surge of help it promised within 30 days. CDC’s Emergency Operations Center is also at its highest level of alert, Level 1. The focus of the CDC effort is on stopping the outbreak. This means finding every person who is sick with Ebola and tracing their contacts.

    This response in Africa involves many healthcare personnel and community health workers. While in West Africa, CDC experts are training and coordinating these workers, collecting the outbreak information they gather, and analyzing these data to make the best use of available resources to break the chain of Ebola transmission. CDC laboratory technicians are helping to set up labs and train lab workers to conduct Ebola testing. Other CDC staff are working to educate people living in these countries on how to avoid Ebola infection and on the value of seeking help early if they develop symptoms of disease that could be Ebola. Still other CDC public health professionals are working with airport and border personnel in the West African countries to keep sick people in Ebola-affected areas from traveling.

    CDC has been:

    · enhancing surveillance and laboratory testing capacity in states to detect cases
    · developing guidance and tools for health departments to conduct public health investigations
    · providing recommendations for healthcare infection control and other measures to prevent disease spread
    · providing guidance for flight crews, emergency medical units at airports, and Customs and Border Patrol officers about reporting ill travelers to CDC
    · disseminating up-to-date information to the general public, international travelers, and public health partners

    This response to the Ebola outbreak has been rapid and large and we have only had three Level 1 responses since 2002, including the Ebola outbreak. However, CDC routinely responds to outbreaks. CDC works with state and local health departments and other public health organizations to save lives and safeguard communities from public health threats.

  9. As of today, no confirmed Ebola cases have been reported in the United States. We’ve received many calls from health departments and hospitals about suspected Ebola cases in travelers from the affected countries. These calls have been triaged, with some samples being sent to CDC for testing. Samples are being tested as they are received.
    All samples sent to CDC, including those of the patient in California, have been negative.

  10. Congratulations to the CDC.

    Yep, this is how a central organization ought to be: effective both within and across the borders.

    Here are some simultaneous equations.

    Please solve for CDC

    WHO + CDC = CDC

    WHO – CDC = – CDC

  11. Seems odd to say so, but this Ebola outbreak may on balance be a good thing. On the one hand, it is not nearly as concerning a pathogen as it could be if it were airborne or animal borne, if it had a longer incubation period, if it were contagious during incubation, if you could be a carrier and not know it, and if it killed a lower percentage of those infect. Any of those would allow it to spread much further and more rapidly — and each of these are characteristics of other pathogens we have experienced in recent years, such as West Nile, SARS, and HIV. It is sad and frightening that a thousand have died so far, but those numbers are tiny compared to the hundreds of thousands who die around the world from the annual permutation of influenza.

    On the other hand, the threat of true global pandemics is very real. The CDC, working with the WHO, is really the global front line defense, and they do great work. The fright from the Ebola outbreak may help to fix in the public’s mind (and in Congress’ mind) the importance of that work, and the importance of expanding and deepening it, if we are to avoid the deaths of millions in the future.

  12. So, on a purely tactical level….

    It’s the middle of my day – I’m running around like crazy- and I walk into an exam room and there’s a potential patient with Ebola talking to me.

    * What questions do I ask?
    * What symptoms do Iook for?
    * Am I supposed to collect the material or have them walk to the lab and potentially expose others en route?
    * Do I call Infectious Disease?
    * Is the CDC hotline available 24-7 if someone is seen in the ER or while on a different time zone than Eastern standard?

    For all the email updates, lunch conferences and public health bulletins I get, I have not received anything from my hospital, academies, or any local/state/federal organizations about an overall brief primer and step by step series of actions if needed.

    This would be very helpful.

  13. @Rockville is referring to a case in California which I think is being looked into that got some play on CNN.

    There has been a lot of talk in the media about ways in which this year’s Ebola outbreak has highlighted our vulnerability to this kind of threat. More cautious observers are pointing out the successes.

    We had a first: patients suffering from a feared and highly contagious disease transfered to the United States at the height of an outbreak and treated successfully: a bold step that a lot of people questioned.

    We had international cooperation, with CDC sending personell into the affected areas of West Africa. And we had a potential breakthrough from the U.S. biotech industry that looks as though it may offer hope to victims, although its not clear exactly what that means yet

    Given that people are still dying in West Africa, it’s a bit early to be celebrating: but what successes do you see? Have we set a precedent for the way public health authorities should respond to these kinds of threats in the future?

  14. Can you tell us anything about the condition of the Kaiser Permanente patient in South Sacramento?

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