A network of 14 public laboratories scattered around the U.S. is geared up and ready to test for Ebola -- including the Texas state lab in Austin.
They're backed up by federal labs at the CDC and the U.S. Army Research Institute of Infectious Disease (USAMRIID), whose researchers developed the test that's being used, according to Chris Mangal, MPH, director of public health preparedness and response for the Association of Public Health Laboratories, based in Silver Spring, Md.
"The list will expand," Mangal told MedPage Today, "as the CDC looks to distribute the assay to other laboratories."
The labs are selected members of the Laboratory Response Network, which was set up to allow rapid detection of a host of chemical or biological threats, including emerging infectious diseases.
In August, the FDA issued an emergency use authorization for an Ebola test, using real-time polymerase chain reaction methods (RT-PCR), and the CDC asked several labs to gear up for testing using the assay, Mangal said.
Aside from Texas, the labs now in the network include state facilities in Nebraska, Montana, Maryland, Florida, Minnesota, New York, Michigan, Virginia, North Carolina, Pennsylvania, and Washington, as well as local labs in New York City and Los Angeles County.
The testing process begins, of course, with a patient -- someone who fits the profile of a possible Ebola victim. That profile includes fever and recent travel to West Africa, the center of the current Ebola epidemic.
But the initial symptoms are nonspecific and mimic several other diseases, including malaria, which is also endemic in the Ebola hot zone.
So the first step in the process is a consultation between the hospital, local or state health department, and the CDC to decide if the clinical picture is worrisome enough to warrant testing, Mangal said.
When Duncan was diagnosed Sept. 30, the CDC had taken part in about 100 such discussions and had suggested going forward to full testing in just 15, according to agency Director Tom Frieden, MD. In all but the Dallas case, results were negative.
Once it's decided to test a patient, the hospital collects blood, using its usual precautions associated with blood-borne pathogens, and ships samples to both the CDC and its designated reference lab.
The blood is shipped in watertight plastic tubes placed within a watertight secondary packaging, with the whole enclosed in a rigid box. Samples are often shipped using commercial couriers, but some locations might also have their own transportation facilities, Mangal said.
At the lab, "everyone knows this is on the way," Mangal said, and only designated staff members are permitted to accept the shipment and move it into the test area.
The CDC's guidance for testing suggests that laboratories can use biosafety level 2 (BSL-2) methods, but most are taking the additional precautions associated with BSL-3 facilities, Mangal said. None of the 14 labs has BSL-4 capability, although both the CDC and USAMRIID do.
Personnel carrying out the test need both training and practice, Mangal said, but the "good thing for us" is that all of the designated labs had staff with the appropriate knowledge. "These are the types of things they prepared for and were ready to respond to," she said.
The test gives a "presumptive" positive or negative verdict, which must then be confirmed by parallel testing at the CDC, Mangal said. If the results differed, she said, the CDC would likely do additional testing, but "we have not seen that."
Nurses Feel Left Out
Meanwhile, a large nurses' unions says hospitals aren't communicating effectively with registered nurses about how to prepare for a possible Ebola patient.
In a survey of members by National Nurses United, also based in Silver Spring, nearly 80% of respondents said their hospital has not yet told them what the policy is regarding admission of Ebola patients.
And 85% said hospital education on Ebola has not allowed nurses to interact and ask questions.
"Handing out a piece of paper with a link to the Centers for Disease Control, or telling nurses just to look at the CDC website -- as we have heard some hospitals are doing -- is not preparedness," said union spokeswoman Bonnie Castillo, RN.
"Hospitals can and must do better, and we should have uniform national standards and readiness," Castillo said in a statement.
Some 1,400 RNs at more than 250 hospitals in 31 states have responded to the survey, the statement said. The union has about 185,000 members, according to its website.
http://www.medpagetoday.com/InfectiousDisease/Ebola/47980
If another Thomas Eric Duncan sought medical treatment today, Dallas County guidelines might well lead a doctor to send him back home.
Duncan met three Ebola criteria when he first walked into the emergency room of Texas Heath Presbyterian Hospital Dallas last month. He had recently lived in Liberia. He had a fever. And he had symptoms consistent with Ebola: abdominal pain and headache.
But the county health department says that isn’t enough to test someone for the virus that made Duncan its first fatality in the U.S. and has killed thousands of other West Africans.
Why? Because Duncan reported no known exposure to infected people or animals. A county screening document says that such patients are considered unlikely to be infected if an alternate diagnosis exists for their symptoms and they need not be tested for the virus. Federal guidelines call for greater scrutiny of such patients.
The early symptoms of Ebola — Duncan’s symptoms — resemble those of other diseases. That can make it difficult to rule out other diagnoses. Everything boils down to a clinical judgment in what may be a frantically busy emergency room.
Why not just test anyone who meets the three criteria that Duncan met?
Its important to try to eliminate likelier diagnoses such as malaria first, Dr. Wendy Chung, Dallas County’s epidemiologist, said in an interview Friday. “You don’t want to waste resources.”
Chung, who is responsible for the county’s algorithm establishing Ebola guidelines, said she didn’t know the cost of testing.
The Texas Department of State Health Services and the federal Centers for Disease Control and Prevention perform the tests. Carrie Williams, a spokeswoman for the state agency, said in an email Friday evening that she did not have enough information to estimate their cost.
See a related video on Dallasnews.com
“The test kit itself is from the CDC at no cost,” she said, “but there are costs to us” for example, staffers’ time and the need to equip them with special protective gear.
Presbyterian says it has depended on the county’s screening document. However, that apparently wasn’t what led the institution to discharge Duncan early Sept. 26, without consulting the county health department. The hospital blames that on an ER doctor not knowing — for unexplained reasons — what a nurse knew: that the patient was newly arrived from West Africa.
After four hours in the ER that first visit, doctors decided he had sinusitis, gave him antibiotics and sent him home, according to a timeline released Friday by the U.S. House Energy and Commerce Committee.
(ежу понятно, что при синусите наблюдается так же острая боль в животе, а не только голова болит и температура)
On Sept. 28, Duncan returned to Presbyterian. This time he was in an ambulance, much sicker, having vomited uncontrollably. This time the hospital suspected Ebola and contacted the county.
But there was still no rush to test him for Ebola, said his nephew Josephus Weeks. So on Monday morning, Sept. 29, he complained to the CDC. Officials there, he said, referred him to the Texas health department.
Weeks said Chung called him that afternoon and refused his plea for expedited testing.
“I said, ‘You know he came from Liberia, and it’s infested with Ebola,’” Weeks recalled. “She said, ‘We can’t send it out [on a rush order] unless he said he had contact with an Ebola patient.’”
Chung said she notified her bosses about Duncan that afternoon. Ordinarily, she said, she would not tell them about an infectious disease case until a test confirmed it.
Chung said she shared Weeks’ concern about Ebola “and let him know that testing had already been ordered.”
Officials in Liberia and the U.S. have accused Duncan of concealing contact he had with a dying Ebola victim shortly before flying here. Weeks vehemently disputes that. Duncan’s family says he told them he was unaware he’d been exposed.
Chung said that expedited testing after Duncan returned to Presbyterian would not have changed the care he received. Presbyterian promptly isolated him, she said.
And there is no established treatment that leads to a cure for Ebola, which has killed about 50 percent of people who contracted it in Africa.
But expedited testing does enable a faster public health response — faster identification and assessment of those who may have been exposed to the virus.
It isn’t clear whether Weeks’ complaint speeded testing. He said Chung told him on Sept. 29 to expect results in three to seven days. But the Ebola confirmation came on Sept. 30.
The actions of Chung and the hospital might have seemed reasonable to many health care experts at the time. Nobody had ever developed Ebola in the United States. And no hospital or doctor was required to use government screening guidelines.
Dr. Christopher Perkins, the Dallas County health department’s medical director, stressed that the county’s guidelines are “ not the law. Each clinician has at his or her discretion to evaluate in real time what’s going on.”
A questionnaire that accompanies the screening document says doctors should isolate patients who have the symptoms and history Duncan did on his first visit to Presbyterian. Doctors are also told to consult their hospitals’ infectious disease experts and the health department.
“These two pages are connected,” Perkins said.
The questionnaire is on the page that follows the algorithm. The questionnaire appears to offer the proper procedure, conflicting with the algorithm. But if doctors were to use the algorithm to diagnose Duncan, his stated lack of known exposure might not have pointed doctors to that other page.
Dr. Daniel Varga, chief clinical officer of Presbyterian’s parent, Texas Health Resources, said the county guidelines were issued to the staff in August.
“The [Ebola algorithm] that we communicated to the staff was the county health department’s algorithm,” he said.
The hospital has since issued its own guidelines to caregivers that appeared to be consistent with CDC protocols.
Dallas County’s health department is not the only one to offer its own guidance on Ebola. For instance, the Florida Department of Health distributed a flow chart on Sept. 5 that is almost identical to the Dallas County screening tool. As in Dallas, someone in Florida with the history and symptoms of Duncan’s first visit would be classified “NOT CURRENTLY SUSPECTED – NO TESTING.”
Some hospitals have developed their own protocols. Parkland Memorial Hospital in Dallas developed its own response to Ebola, officials there said.
On Aug. 1, the CDC sent health providers an Ebola alert. Shortly thereafter, Parkland changed its intake procedures, said the hospital’s disaster medical director, Dr. Alexander Eastman.
All patients are asked at intake about travel to the Ebola-active parts of West Africa, he said. If the answer is “yes,” that patient is isolated immediately and met with staffers wearing protective gear before any additional examination or testing, he said.
That’s far above what either the county or CDC recommends. The process was developed by a committee of infectious disease experts who looked at recommendations available and came up with their own checklist, Eastman said.
More than 44,000 patients on the main hospital campus alone have faced those new Ebola-related initial questions since August, he said.
After Duncan’s diagnosis was made public, Parkland added another early question having to do with contact with someone with Ebola in Dallas.
“We are constantly tweaking it,” Eastman said.http://www.dallasnews.com/news/metro/20141017-dallas-county-protocol-could-let-ebola-carriers-slip-through-the-system.ece