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Preparing clinical laboratories for future pandemics

The rapid flourishing of the Ebola outbreak in 2014 caught clinical laboratories in the United States off-guard, and exposed a general lack of preparedness to handle collection and testing of samples in patients with such a highly lethal infectious disease. While the outbreak was largely limited to West Africa, fears in the United States became heightened in September of 2014 with the first reported imported case diagnosed in Texas. Most concerning to healthcare professionals was the subsequent news that two healthcare workers involved in caring for the Texas patient contracted Ebola virus disease in mid-October.

Ebola is known to be transmitted via direct contact with body fluids, including but not limited to blood, urine, saliva, and feces. Clinical laboratory personnel routinely collect, process, and test body fluids and thus risk of exposure to Ebola was an immediate concern following news of infected healthcare workers in Texas. While clinical laboratory personnel view all specimens as potentially infectious, it was clear that Ebola virus represented a higher level of risk and concern amongst those in the healthcare community, which led to a rapid effort to implement new procedures, processes, and guidelines for handling specimens from patients with suspected or known Ebola virus disease.

Several questions quickly arose within the clinical laboratory community:

  1. Should clinical laboratories test specimens from patients with suspected or known Ebola virus disease in their main laboratory facilities, on instruments used for routine patient care, or should testing of these specimens be quarantined?
  2. What laboratory tests are necessary for adequate evaluation of patients with suspected or known Ebola virus disease?
  3. Should clinical laboratory personnel be allowed to opt out of collection, processing and/or testing of specimens potentially infected with Ebola virus due to concerns for personal safety?
  4. What level of personal protective equipment, or PPE, should be worn by clinical laboratory workers handling these specimens?
  5. How should specimens be transported for testing within the clinic/hospital or for shipment to outside testing facilities?

In the summer of 2014, the University of Minnesota Medical Center and its affiliated non-profit healthcare system, Fairview Health Services, determined that establishing a stand-alone clinical care unit and laboratory for the care of Ebola patients was a priority. With no firm consensus guidelines published on how to set up a containment laboratory from scratch, we set forth to answer the above questions in consultation with the Minnesota Department of Health (MDH) and the Centers for Disease Control and Prevention (CDC). We also referred to the first publication with details on providing quarantined laboratory testing for Ebola patients, published by providers at Emory University Hospital on their high-containment facility.

We then established our own process for a stand-alone laboratory for the care of patients with Ebola virus disease. The first step was deciding that all clinical laboratory testing on suspected or known Ebola patients would be quarantined and performed on instruments dedicated for use on Ebola patients only. Given the high level of risk and concern surrounding Ebola, we did not feel comfortable requiring all laboratory staff to work in the containment lab. Instead, we decided to seek volunteers amongst our clinical laboratory personnel to staff the facility. We were fortunate to have an adequate number of volunteers who were able to provide on-call coverage for the laboratory 24/7.

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Soldier-scientists begin closure of Ebola testing labs by Army Medicine. CC BY 2.0 via Flickr.

Out of concern for the safety of our laboratory personnel, we decided that laboratory staff would wear head-to-toe personal protective equipment (PPE) that included a hooded respirator, impermeable gown, boot covers, and double layer of gloves. We also purchased two level 2 biosafety cabinets where staff would work when handling or manipulating samples for testing, for added protection. Since our Ebola care unit was quarantined, transport of samples within our hospital was minimized and only required movement across a small hallway from the patient care room to the laboratory space. The only testing performed outside our hospital involved screening or confirmation for the presence of Ebola virus; this testing was performed by the MDH and CDC, and we followed their instructions for specimen collection and transport.

While the 2014 Ebola outbreak caused some momentary chaos for clinical laboratories in the United States who were unprepared to initially handle these specimens, the chaos of that time has borne fruit with several detailed publications and guidelines outlining how to safely and effectively perform clinical laboratory testing on patients with suspected or known Ebola or other highly infectious diseases. This includes detailed guidance from the CDC on specimen collection, transport and submission of specimens, packing and shipping of specimens, and managing and testing routine clinical specimens. These guidelines provide a robust framework that can be used if and when future pandemics arise. Additionally, our facility at the University of Minnesota Medical Center was selected to serve as one of nine regional treatment centers for Ebola or other severe, highly infectious diseases, with support funding awarded from the US Department of Health and Human Services. The clinical laboratories at these centers are currently ready and able to provide immediate quarantined testing, and thanks to the lessons learned from the Ebola outbreak, we are better prepared to handle future pandemics, should they arise.

Featured image credit: “Medic Hospital Laboratory” by DarkoStojanovic. CC0 Public Domain via Pixabay.

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