Inside the Lab Industry: Labs Challenged in Creating Uniform Policies for Ebola Response

The first recorded cases of the Ebola virus in the United States have been unsettling sentinel events. The health care sector has appeared unsure in its ability to contain the handful of cases that have cropped up to date. That’s particularly the case with the two Dallas nurses at Texas Health Presbyterian Hospital who were infected by the virus as the result of treating Thomas Eric Duncan, a Liberian national who contracted the disease in Africa but did not become symptomatic until he arrived in the United States. Both nurses contracted Ebola despite wearing protective gear and following protocols. Meanwhile, a Dallas Presbyterian lab employee took a pleasure cruise not long after her facility handled Ebola specimens. That has raised some questions about how prepared is the provider community—labs included—to confront the deadly virus. Staff at Texas Health Presbyterian have also alleged that some of the most basic handling protocols were not followed, such as using hand-delivered specimens rather than the pneumatic tube delivery system. “Regarding the ED tube delivery system utilized during Mr. Duncan’s initial visit, all specimens were placed into closed specimens bags and placed inside a plastic carrier that travel[ed] through a pneumatic system,” said Dallas Presbyterian in a statement that was issued on Oct. 16. “At no time did Mr. Duncan’s specimens leak or spill—either from their bag or their carrier—into the tube system.” The hospital added that the tube system was avoided completely when Duncan reappeared at the hospital after being sent home in late September. He was diagnosed with Ebola at that time. In a webinar held earlier this month by the American Association for Clinical Chemistry (AACC), Sheldon M. Campbell, M.D., an associate professor of laboratory science at Yale University, observed that avoiding pneumatic tubes while handling Ebola specimens should be standard protocol. Dallas Presbyterian appears to have paid a steep business price for having at least two of its health care workers infected, as well as the initial laxity involving its specimen handling. Its patient census dropped swiftly to 33 percent—an almost unheard-of number for a major urban facility and a stark state of affairs for a facility that accounts for about 17 percent of all revenue for its parent company, Texas Health Resources. Meanwhile, Moody’s Investors Service has announced it has put Texas Health Resources on watch, suggesting it may make an announcement about its debt rating in the near term. With the financial stability of providers treating Ebola victims potentially at risk, questions have arisen as to how labs will test for the presence of the virus, ensure their actions do not infect other employees, or even appropriately transport specimens if the need arises. CDC Revises Guidelines The federal Centers for Disease Control and Prevention (CDC), which initially appeared to suggest that the nurses who were infected had not completely followed protocol for wearing and shedding protective gear, instead revised its protective guidelines earlier this month for health care workers and handling laboratory specimens. It was recommended that front-line health care workers exposed directly to patients wear a hood-style mask that drapes to the shoulders, and special coverings on their feet. As for laboratory workers, the CDC recommended that “any person testing specimens from a patient with a suspected case of Ebola virus . . . should wear gloves, water-resistant gowns, full face shield or goggles, and masks to cover all of [the] nose and mouth.” The agency also recommended as an additional precaution the use of a certified class II biosafety cabinet or Plexiglas splash guard. “U.S. clinical laboratories can safely handle specimens from these potential Ebola patients by taking all required precautions and practices in the laboratory, specifically designed for pathogens spread in the blood,” the CDC said in its interim guidance. Nancy E. Cornish, M.D., a medical officer with the division of laboratory science and standards at the CDC, said during the AACC webinar that labs should consider elevating their biosafety levels and work at least at biosafety level 4 if the facility believes it may have to handle suspected Ebola cases. Meanwhile, transporting of suspected Ebola specimens has become far more complicated. Campbell suggested that labs in Connecticut would encounter difficulties transporting Ebola specimens for testing. Although he deferred to state health authorities when asked for more specifics, policies elsewhere suggest he’s correct. Quest Diagnostics, the nation’s largest laboratory, told at least one news outlet this month that it will not undertake blood draws or handle specimens from suspected Ebola patients. A Quest spokesperson did not respond to a request for comment. In Canada earlier this week, Air Canada refused to transport a specimen for a suspected Ebola case from Edmonton to Winnipeg, causing a delay in testing. The Emory University Hospital in Atlanta, which has treated some American relief workers who were transported back from Africa after being stricken by the disease, decided against transporting any specimens at all except to the nearby CDC, relying instead on point-of-care (POC) testing at patient isolation sites. “We believe . . . that this policy was highly effective and beneficial in alleviating any initial concerns about potential exposure among phlebotomists and laboratory personnel. Nevertheless, it created the need for us to offer a broader range of POC tests within the unit that might be required for optimal care of patients infected with Ebola,” wrote pathology department physicians and personnel in a recent issue of the journal Laboratory Medicine. The UCLA health care system, which operates two hospitals in the Los Angeles area, recently announced that all Ebola-related testing would be performed at a special mobile laboratory in order to minimize any risk of spreading the virus. The California Department of Public Health (CDPH) is in the middle of negotiating with several hospitals that would be designated to care for any Ebola patients in that state. However, there are only 13 labs nationwide that are certified to confirm Ebola cases, with California’s sole facility in Los Angeles. The lab has helped to rule out two suspected cases so far, in the Los Angeles and Sacramento areas—350 miles away from one another. At a recent media briefing, CDPH Director Ron Chapman, M.D., said that his agency had already contracted with a courier service certified by both state and federal authorities to transport suspected Ebola specimens. That company, World Courier, is a subsidiary of AmeriSource Bergen. It transported the suspected Ebola specimen in Canada that had encountered delays. Meantime, the CDC recommended in its interim guidelines that “risk assessments should be conducted by each laboratory director, biosafety officer, or other responsible person to determine the potential for sprays, splashes, or aerosol generated during laboratory procedures.” UCLA tested its mobile lab during a recent safety drill, and the Mayo Clinic is engaged in drills that involve not only laboratory staff but virtually any employee who might be involved in or would be near a specimen. “We’ve had a plan in place for the past six weeks,” said Curt Hanson, M.D., a Mayo Clinic pathologist and lab scientist, “and we’re continuing to try and improve and modify it.” Hanson noted that one of the keys to maintaining integrity of the handling process is to communicate to everyone on every level what their role is and how it should be carried out. Practices, or “dry runs,” as he calls them, have also been carried out. Those are crucial to determining if there have been any breaches in protocol. When they’re discovered, staff is educated further. “Anytime you put in an institutionwide process in an enterprise as big as a hospital, there can be complications, poor planning and communication,” Hanson said. “But the practice is crucial, and in the laboratory, it teaches us how to do things with less movement, less people, and less exposure.” Takeaway: The outbreak of the Ebola virus has put laboratories on their toes and has made contingency preparations virtually mandatory to ensure testing is performed in an appropriate and timely manner.