WASHINGTON – As the federal government scrambles to rapidly boost the nation’s capacity to test for the coronavirus, cutting red tape and leaning on the speed and technology of the private sector, new delays are developing because of a shortage of raw materials and vital items: chemical solutions, swabs and even face masks for health-care workers.
From coast to coast, local and state officials complain that shortages of everyday supplies are disrupting efforts to sharply ramp up testing, which is key to identifying the spread of disease. The scarcity is hampering both the ability of health-care workers in hospitals to draw samples to send to laboratories and the ability of those laboratories to confirm infection.
This week, the Centers for Disease Control and Prevention attempted to address the mask shortage by recommending the use of bandannas, if necessary. “In settings where face masks are not available, [health-care providers] might use homemade masks (e.g., bandana, scarf) for care of patients with COVID-19 as a last resort,” the CDC said, referring to the disease caused by the virus. “Caution should be exercised when considering this option.”
At major hospitals in Seattle and the District of Columbia, mask shortages had already become so acute that doctors and patients were being asked to reuse the masks, not dispose of them as traditional CDC protocol requires, even after contact with infected patients.
At Rush University Medical Center in Chicago, hospital staffers have started using washable lab goggles instead of throwing away face shields for eye protection.
The federal government’s decision on Monday to let state governments regulate the production and use of coronavirus testing kits has jump-started efforts at a wide variety of research institutions and commercial laboratories.
But even as commercial laboratories pledged to boost production of testing kits, hospital officials say time it takes to get lab tests back from private firms or state labs has roughly doubled.
Meanwhile, hospitals fear that the surging number of cases will overwhelm any increase in the availability of tests and other vital supplies.
Nicole Lurie, who served during the Obama administration as assistant secretary for preparedness and response at the Department of Health and Human Services, said the bandanna option suggested by the CDC should be “a wake-up call.”
“The bottom line is, if you cannot protect health-care workers and they get sick, the whole system goes down,” she said. “The priority to maintain public health is to protect health-care workers.”
Jennifer Avegno, director of the New Orleans Health Department, said that there are not as many test kits available as she would like and that the turnaround times with the commercial labs are “significantly longer than advertised or hoped.”
“This backlog really hinders our ability” to ramp up drive-through testing as the city planned, she said.
Brian Stein, a spokesman at Rush University Medical Center, said delays in testing results mean hospitals must use protective gear for longer times without knowing whether the patients are potentially infectious.
In South Carolina, some hospitals reported they were down to as many as four days’ worth of personal protective equipment, the highest level of medical protective gear, said Laura Renwick, spokeswoman for the South Carolina State Emergency Response Team.
So the state requested materials from the Strategic National Stockpile, and the first shipment arrived Tuesday – 55 pallets’ worth of N-95 masks, face shields, masks, gowns and gloves. Shipments are expected to continue over the next three weeks, Renwick said in an email.
South Carolina Gov. Henry McMaster, a Republican, has ordered all hospitals to cease elective procedures, which has freed up 15,130 beds across the state.
In Florida, where covid-19 cases surged 45% overnight, state officials on Tuesday asked the federal government for 500,000 each of additional gowns, gloves and collection kits. Florida officials also requested 2 million N95 face masks, 100,000 16-oz. bottles of hand sanitizer and 5,000 each of additional hospital beds and ventilators.
Matthew Binnicker, director of clinical virology at the Mayo Clinic, said he had been in meetings where hospital leaders began to discuss what would happen if they ran out of swabs used to scrape the back of people’s throats and noses, a vital and unpleasant part of testing. One possibility they discussed was using a syringe to squirt some saline into people’s noses and draw it back.
He noted that each part of the process depends on an essential component remaining intact. For example, after a patient is swabbed, the swab needs to be put into special vials that contain a distinctive growth media, which is also vulnerable and went into shortage in a past outbreak.
Many laboratories have complained about shortages and back orders of reagents, chemical solutions that are key components of testing kits. The reagents are used to isolate the genetic material from the virus.
The International Reagent Resource (IRR), established by the CDC, supplies the reagents used in laboratory tests and assures their quality. But “the IRR is not keeping up with the demand,” according to one public lab official who spoke on the condition of anonymity to avoid antagonizing the CDC. “They might ask for 100 of something and they are getting 20. The supply chain is backed up. We haven’t figured out how that is getting resolved.”
Columbia University’s Irving Medical Center in New York said that a week and a half ago it received a six-month supply of the necessary reagent from New York state. In a statement, the hospital said it was now performing covid-19 clinical testing. “We have an adequate supply of all other reagents needed to meet our current testing needs,” it said.
The Dutch diagnostics company Qiagen said Tuesday it would quadruple the supply of reagents to support 6.5 million tests a month by the end of April and over 10 million tests a month by the end of June. But Josh Sharfstein, a public health expert and physician at Johns Hopkins University, said in an interview that his best speculation was the country might ultimately need to carry out hundreds of thousands of tests a day.
The American Clinical Laboratory Association, which represents commercial and hospital laboratories, said its members have performed roughly 27,000 tests to date – including 8,200 on Monday. The group said that the Food and Drug Administration’s recent approval of large, automated platforms for testing will help dramatically increase testing capacity, assuming there aren’t ongoing shortages of necessary materials and supplies required.
The group said commercial capacity to test for covid-19 is expected to exceed 280,000 tests per week by April 1.
Firms such as Roche and Thermo Fisher Scientific have been working to send new testing platforms approved by the FDA to major labs. Once those are up and running, testing capacity should greatly increase. But that change won’t happen overnight.
“There’s a process of validation. It’s not like flipping a light switch,” Julie Khani, ACLA’s president, said in an email.
In addition, there are ongoing worries about the supply chain required for such large-scale testing – a chain that includes chemicals needed to process tests, personal protective gear, testing swabs and shipment of specimens.
“Any one link in the chain of supply and demand could suddenly cause a bottleneck,” Khani said.
In many places across the country, the potential for shortages has led officials to limit who gets access to the limited number of tests for the virus.
On Tuesday, for instance, Minnesota’s Department of Health announced that “due to a national shortage of COVID-19 laboratory testing materials, the state is forced to make adjustments to its testing criteria to focus on the highest priority specimens, including hospitalized patients.” It said that health-care workers and those in long-term care and assisted living facilities would also be given “high priority.”
Utah health officials are also telling patients to refrain from getting tested unless they are displaying obvious symptoms of covid-19.
“Unfortunately, we are faced with infrastructure and logistical challenges that prevent us from being able to test everybody,” Utah’s state epidemiologist, Angela Dunn, told reporters Tuesday. She said that officials instead are trying to reserve tests for the most at-risk populations. “There’s not a win in that situation. It’s just what we have to do,” she said.
From coast to coast, communities are wrestling with similar problems.
“The testing situation is a frustration for all of us. . . . That is our tool for understanding disease location and transmission,” Jennifer Vines, the lead health officer for Oregon’s Multnomah County, which is home to Portland, told reporters Tuesday. “I just want to be very clear that there is no withholding of supplies or testing capability. We are doing the best we can. . . . I can assure you that a lot of people are looking high and low for a solution to the testing supply question.”
Vines said the county has a two-week supply of protective gear for medical workers. She also said officials might be forced to do less testing in the short term, prioritizing only the highest-risk cases, to preserve supplies and protect health workers.
Rhode Island’s Department of Health said the governor had been “on the phone with the federal government – endlessly, continually” trying to push for more supplies to enable the state to ramp up testing.
Abbott, a diagnostics and device company, received authorization from the FDA for a coronavirus test Wednesday and announced that it would ship 150,000 tests immediately, ultimately ramping up to 1 million tests per week. Those tests can run on more than 175 instruments already deployed at U.S. laboratories.
Another major company, Thermo Fisher, has said it has enough reagents for the 1.5 million test kits that it is distributing. It plans to ramp to 5 million per week in April, but spokesman Ron O’Brien said that the scarcity of raw materials – such as reagents – and instruments could limit testing capacity.