By SOO RIN KIM, OLIVIA RUBIN and ALI DUKAKIS, ABC News
(NEW YORK) — As coronavirus cases surge in much of the country, issues with testing availability and access have once again arisen in nearly every aspect of the testing supply chain, local officials and hospital leaders in several states told ABC News — a troubling echo of the shortages that plagued the nation’s initial response to the virus months ago.
Testing issues have manifested differently in different parts of the country, from states in the midst of a renewed battle against COVID-19 and those who still fear one might be coming, officials said.
In California and Nebraska, some testing sites were forced to close down because of a shortage in testing kits, chemical reagents, and other supplies. Arizona and South Carolina reported slower turnaround times for test results from labs due to lack of capacity. In New York, private labs now take up to a week to return test results. In Oregon, supply shortages with certain testing machines are slowing the volume of tests that can be done in at least nine hospitals, and one has stopped testing all together, according to a state health department report.
State, local and hospital officials at 13 states said they are experiencing some sort of issue with testing, and in all instances, the shortages and delays contribute to effectively limiting the number of Americans with access to coronavirus testing, which experts have long said is a first key step to stemming the spread of the virus.
“The cornerstone of our response to COVID-19 has always been about testing capacity,” said Dr. John Brownstein, chief innovation officer for the Boston Children’s Hospital and a professor of epidemiology at the Harvard Medical School.”
“Our lack of initial testing prevented early intervention,” added Brownstein, an ABC News contributor. “Our inability to ramp up testing prevented us from mitigating the impact on morbidity and mortality. And now our lack of test availability and timely diagnosis five months into the pandemic will directly contribute prolonging this first wave.”
Nearly 65,000 new cases of the virus were reported across the country on Thursday, a new record, and while the U.S. has dramatically ramped up its testing capacity since the beginning of the pandemic nearly five months ago, it may not be enough to keep up with the new pace of the virus.
According to a new report from Democratic staff of the Senate Health, Education, Labor and Pensions committee, coronavirus testing labs said supply chain issues in testing are a current challenge. One company called the existing issues “a giant Jenga running in front of a freight train.”
And the challenge may only become greater looking toward the fall as the strain could be exasperated by the coming flu season, according to labs cited in the report.
Asked for comment on the obstacles states are reporting with testing, a spokesperson for Health and Human Services told ABC News Thursday, “HHS and FEMA [Federal Emergency Management Agency] send states COVID-19 testing supplies, namely, swabs and transport media — to each state and territory based on what the state or territory has requested each month.”
Spokespeople for HHS and FEMA said those supplies are then distributed to localities at the direction of the state. The FEMA spokesperson added the agency is committed to supporting states and urged them to coordinate closely with the federal government.
“FEMA remains committed to providing maximum support and critically needed testing supplies in a timely manner to our state and local partners in response to the coronavirus (COVID-19),” the FEMA spokesperson wrote. “We encourage state, local, tribal and territorial governments to coordinate closely with FEMA Regional Offices to determine the type and level of federal support needed.”
In South Carolina, a soaring positivity rate; in California, a reversal on universal testing
As of Wednesday, more than 30 states reported a test positivity rate — the number of total tests that come back positive — over 5%, a threshold recommended by the World Health Organization.
The positivity rate is a key indicator that experts from Johns Hopkins University say provides insights into “whether a community is conducting enough testing to find cases.” According to the experts, “If a community’s positivity is high, it suggests that that community may largely be testing the sickest patients and possibly missing milder or asymptomatic cases.”
Currently, the national positivity rate is a whopping 9%, according to an internal Federal Emergency Management Agency memo from Wednesday obtained by ABC News. South Carolina on Wednesday reported a test positivity rate of 20%, and Arizona’s number has been around 30% in recent days. By contrast, in New York, which suffered the worst of the outbreak early on, about 1% of tests currently come back positive.
“We haven’t been able to surge the testing supplies as much as nature has been able to surge cases,” Dr. Helmut Albretch, chair of Department of Internal Medicine Prisma Health Midlands in South Carolina, told ABC News. “The more cases you have the more you have to test — we don’t have that surge capability with testing.”
Albretch emphasized testing needs to be “massively” ramped up to help flatten the curve, adding the test turnaround time from both commercial and public labs has gone up. It usually takes about a week to get a test result back in the state, which is “just not usable,” Albretch said, as it makes containing infections incredibly difficult.
The resurgence of the coronavirus in some areas, and the renewed strain on testing, is starkly illustrated in California, which previously reported a steady positivity rate and where local leaders were confident enough in the states’ testing capability that they urged those without symptoms to be tested.
Now the state has reimposed lockdowns in 19 counties with record numbers of cases, and Gov. Gavin Newsom last week urged hospitals and testing labs to prioritize testing for those most at risk for spreading the virus to others, including those already showing symptoms and vulnerable populations like nursing homes.
“As more states begin to scale their testing capabilities, new constraints are materializing within the supply chain,” California’s Health and Human Services Secretary, Dr. Mark Ghaly, wrote in a statement, referring to the rising demand for testing across the country. “Simultaneously, laboratories are becoming overwhelmed with high numbers of specimens, slowing down processing timelines.”
Testing turnaround time for some commercial labs in California has gone from three to five days, to five to seven days, or even longer, San Diego County’s health agency spokesperson Tim McClain said. In Sacramento, five community sites are reportedly closing due to supply shortages. And in Los Angeles, where the city was providing free testing to all residents regardless of symptoms, the city and the county are now moving to prioritize testing to symptomatic patients again, local officials said.
In Louisiana, shortages have officials considering reimposing restrictions on testing not seen since earlier in the pandemic — when it was limited to those with symptoms or at high risk. In an interview with ABC News, Dr. Alex Billouix, the state’s assistant secretary of Health, said the state has been expanding testing capacity more rapidly than the supply chain’s ability to expand production.
He floated the possibility, like California, of limiting testing availability to symptomatic patients if the shortage in supplies continues, though he said the state is not there yet.
“And the worst-case scenario is having to limit testing to only individuals who are hospitalized because it makes an impact on PPE [personal protective equipment] utilization and potentially treatment with things like [the antiviral medication] remdesivir. We are not there yet and we hope to not get there,” Billouix said.
In Arizona, where nearly one in every three tests performed is returning positive, the state’s health department spokesperson, Chris Minnick, said there’s been “quite a bit of a high demand for testing” and the turnaround time has been “slightly slower” but the state currently isn’t facing a major supply shortage issue.
But Phoenix Mayor Kate Gallego said her city is facing a “huge testing shortage,” saying people are waiting in line for as long as 12 hours to get tested.
She said the state requested assistance from the federal government, but a lack of medical staff and testing materials has been a challenge.
U.S. Assistant Secretary for Health Adm. Brett Giroir said during a White House Coronavirus Task Force briefing on Wednesday that the federal government will help add high volume test sites in west Phoenix.
Jo Lynn Garing, a spokesperson for a leading high-volume test manufacturing company Roche Diagnostics, said the company is aware the “demand for diagnostic tests and the instruments [to] conduct them has continued to outstrip supply since the beginning of the pandemic.”
Garing said the company not only has been expanding its production capacity but also continues to be “very intentional” on its allocation and distribution of supplies, “prioritizing labs with the broadest geographic reach and highest patient impact.” Garing said the current priority areas are the same areas seeing surges, including Florida, Arizona, Texas and California.
Darcy Russ, a spokesperson for Abbott, another leading test manufacturing company that provides both rapid point-of-care tests as well as larger capacity lab tests, said the company has a “consistent supply of reagents,” touting the company’s supply of nearly 4.7 million of its rapid tests known as ID NOW, the majority of which has been allocated to outbreak hotspots with the focus on front line healthcare workers and first responders. The company has also shipped nearly four million of its high-volume molecular lab tests across the U.S., Russ said.
In states seeing relatively little to no resurgence, testing issues remain
Officials say shortages are not contained to states where outbreaks are currently raging. Other states that seem to have gotten a relative handle on the virus are worrying about their ability to prepare for the worst as national resources are funneled into hotspots.
In New York, where cases mostly remain flat and just above 1% of tests are returning positive, private labs, which process the majority of tests conducted in the state, now take up to a week to return results due to an increased demand from the rest of the country after the federal government asks those labs to prioritize high-risk states, according to state officials. Some hospital labs in New Jersey, too, reported they are starting to see a testing chemical shortage, a state health department official said.
New York had served as the deadly epicenter of the pandemic in the U.S. early in the outbreak but then saw a drop in cases for weeks. But the downward trend has diminished in recent days, worrying local officials.
In Oregon, Charles Boyle, the press secretary for Gov. Kate Brown, on Tuesday told ABC News he is “concerned” that surges in the south and west will begin to hinder testing capabilities there, and spoke out against what he said was “lack of equal support” from the federal government in ensuring that all states have the ability to properly test.
“We also continue to be frustrated that Oregon has received a small fraction of testing equipment and supplies from the federal government compared to other states,” Boyle said. “While we understand that states like Florida and Arizona with greater numbers of infections and hospitalizations than Oregon are taking priority, from the beginning of this pandemic we have essentially been punished for working proactively to contain Oregon’s COVID-19 outbreaks.”
Last month, Gov. Brown, a Democrat, who has previously criticized the Trump’s administration’s lack of support, urged the federal government to fill her entire request for supplies so the state can continue testing nursing homes and long-term care residents, one of the most at-risk populations for the coronavirus.
What the state has received, Brown wrote in a letter to Health and Human Services Secretary Alex Azar, is “not adequate and will slow down our plan to implement our universal long-term care testing program. Meanwhile, other states are receiving dramatically more testing transport media and swabs.”
A FEMA spokesperson told ABC News the agency has provided Oregon with 206,000 swabs and 185,550 media as of Thursday.
In Omaha, Nebraska, a county-supported testing site primarily serving a highly impacted Hispanic population — which is already hard hit by the virus — closed shop earlier this week because of a supply shortage, in an example of how the testing shortage may be disproportionately affecting vulnerable or underserved populations. Cases have not been rising steeply in Nebraska, but testing has been going down, and a higher percentage of tests are returning positive.
“There are all sorts of different links in the chain that can break down,” said Dr. Anne O’Keefe, a senior epidemiologist at Douglas County Health Department.
O’Keefe told ABC News that despite the high needs in the area, there has been a supply chain blockage because test manufacturing companies are prioritizing states with a bigger case surge.
Michigan, where cases are going up at a slower rate than the harder-hit states and the positivity rate has remained steady under 3%, echoed the concerns.
Michigan Department of Health and Human Services spokesperson Lynn Sutfin told ABC News FEMA supplies “have not met the overwhelming demand” the state is “still working through supply shortages,” which have limited the number of tests that can be run per day and have caused some laboratories or medical providers to restrict the types of individuals eligible for testing.
FEMA has provided Michigan with nearly 1.1 million swabs and 846,407 media as of Thursday, the agency’s spokesperson said.
In June, Dr. Anthony Fauci, the nation’s top infectious disease official, appeared to justify the fears of the lesser hit states, as COVID-19 does not respect interstate borders.
“If we don’t extinguish the outbreak, sooner or later, even ones that are doing well are going to be vulnerable to the spread,” Fauci said. “So we need to take that into account because we are all in it together, and the only way we’re going to end it is by ending it together.”
Copyright © 2020, ABC Audio. All rights reserved.