Hospitals Grapple With Lack Of Testing Agents
For nearly two weeks, a machine meant to run COVID-19 test results has been assembled and ready to operate at George E. Weems Memorial Hospital in rural Franklin County.
But the hospital, a 25-bed facility in picturesque Apalachicola, hasn’t been able to use the instrument to get results for any COVID-19 tests the hospital or its clinics have administered to local residents.
The hospital can’t get testing agents needed to process the tests and has been told by the company that manufactured the instrument that what are known as “reagents” won’t be available for another four or five months.
Hospital CEO David Walker turned to the state health department, which also uses the type of machine manufactured by the company Cepheid, for assistance. He asked whether the state could send some testing supplies until the facility could secure its own, a request that was denied by Department of Health Secretary Scott Rivkees.
“The state does not have a stockpile of reagents,” Rivkees said during a phone call last week with health care providers across the state. Rivkees noted that the state had advised health systems to ensure they used more than one testing platform so testing agents would be less of a concern.
After Gov. Ron DeSantis last week lifted restrictions on businesses such as bars and restaurants and as flu season approaches, questions are mounting about whether results of COVID-19 tests can be processed quickly enough to notice any upturns in cases.
“The problem is, rural hospitals, we don’t have that much money,” Walker told The News Service of Florida in an interview following Rivkees’ statewide phone call last week. “We don’t have money to get multiple systems. So I wasn’t too happy with the answer.”
Walker said the county-owned hospital spent more than $59,000 on the machine. But the hospital continues to send its COVID-19 tests to outside labs, Walker said, noting that it takes about three days for the results to return, down from what was once a three-week waiting period.
“It was very important for us to get (testing capability) because we are geographically isolated, we are a rural community,” he said. “We have school starting and the flu season’s right around the corner. You really want to have all the resources you can in a small community to do these tests to get the result back in an hour.”
Walker also has turned to the Florida Hospital Association for assistance but has not got the reagents he needs.
Association interim president Crystal Stickle said in a statement that hospitals and other health care providers have faced many supply chain disruptions during the COVID-19 crisis.
“Early on, laboratory testing supplies and personal protective equipment availability were at the forefront of hospitals’ concern,” Stickle said. “While the PPE supply chain has stabilized to some degree, lack of reagents for hospitals to conduct on-site COVID-19 testing has persisted as a global manufacturing issue.”
She said that the hospital association is assessing the problems with reagent shortages and that hospitals facing an immediate need for supplies are supposed to notify their local emergency operations departments.
Yet emergency management officials say they aren’t hearing about supply shortages. Local emergency management officials in Broward, Palm Beach and Orange counties told the News Service that there have been no reports of reagent or testing-kit shortages in recent weeks.
Jaime Caldwell, chairman of the Broward County Healthcare Coalition, said his group has not heard recently from area hospitals about reagent shortages, though it did earlier in the pandemic. The coalition includes all Broward County-area hospitals and representatives from the local health department, the Florida Division of Emergency Management and the Florida Department of Agriculture and Consumer Services.
But an August survey by the American Association of Clinical Chemistry indicated that 67 percent of laboratories were having issues getting reagents and COVID-19 testing kits, the highest percentage of reported difficulties since May when the group, which represents commercial, hospital and public-health laboratories, began surveying its members.
Additionally, the August survey showed that 28 percent of the member labs said they expected to be unable in the coming weeks to process all requested COVID-19 tests within a week because of supply issues and challenges.
“Supply chain issues continue to be a problem throughout the U.S. There are several supplies needed to do SARS-CoV-2 testing like swabs, test kits, and disposables. It is difficult to predict what will be in short supply at any given time,” American Association of Clinical Chemistry President David Grenache, who is chief scientific officer of TriCore Reference Laboratories, said in a statement. “AACC (the association) has been calling for federal oversight of coronavirus testing supplies throughout the pandemic. We believe a centralized response is the only way to resolve these issues.”
While Weems Memorial is a rural facility, some larger hospital systems also face challenges.
Thanh T. Hogan, vice president of clinical operations at UF Health Jacksonville, said there have been problems with the availability of testing reagents since the beginning of the pandemic.
“We would get to within 24 or 48 hours of supply and keeping our fingers crossed that we would get additional supply before we run out. And some of our partners have called us because they are down to 24 hours of supply,” she told the News Service. “And so far it’s worked out. At the last minute, we would get the supplies we need or our colleagues would get the supplies that we need. But that’s what we are running up against.”
Hogan said the health system, at times, has had to stretch supplies.
“Sometimes we have to alternate strategy or plans. For example, we may not be able to test everyone today but we can next week. Or things like that. It’s playing with different strategies,” she said.
Because the UF Health Jacksonville system includes a nursing center, it also received rapid-response COVID-19 testing kits from the federal government. But Hogan told state regulators on last week’s call that the rapid testing kits had limited amounts of reagents. And when she contacted the manufacturer, she was told that it could be months before reagents were available because the federal government had purchased all the supplies.
“Does that mean that the facilities that did get some already will continue to get some on an ongoing basis or is that one-time shipment and we have to wait for the company to get more, which is projected to be in 2021?” Hogan asked.
Rivkees deferred the question to Agency for Health Care Administration Secretary Mary Mayhew, who acknowledged she didn’t know.
“I'm not sure that I have any additional information to offer on that,” she said.