CEO SUMMARY: For three lab directors in the Midwest, a seemingly endless cycle of COVID-19 lab-supply shortages crops up almost daily. These labs might not have enough test kits one day, and be short of reagents, transport vials, or specimen collection swabs the next. To address these problems, the lab directors have cobbled together a variety of solutions, but they continue to run short of full capacity were all constraints to be removed, and one lab still operates at only about 20% of full volume.
AS THE COVID-19 PANDEMIC ENTERS ITS SIXTH MONTH, clinical laboratories seeking adequate supplies to test patients for the novel coronavirus face a significant problem of continuing shortages.
Hospital and health system laboratories and regional and community lab companies all seem to be at the end of the supply chain as in vitro diagnostics manufacturers and government agencies, such as the Federal Emergency Management Administration (FEMA), decide how to allocate supplies of reagents, test kits, specimen-collection swabs, transport media, and other equipment.
Continuing Supply Shortages
Over the past two months, The Dark Report has interviewed about a dozen clinical laboratory professionals at hospitals and health systems, including lab directors at two hospital systems who explained the problems they encounter every day without enough supplies to do routine and SARSCoV-2 testing. All three asked not be identified so that they could speak freely.
From about mid-March through mid-June, all three lab directors said their facilities had trouble getting the supplies they need to run these tests at full capacity. The lessons they learned from this experience include being persistent with all supply vendors by calling them on the phone almost daily and by seeking out new supply vendors whenever possible.
In addition, they learned to take a more drastic step—by adding new assays—that they might not pursue otherwise. One lab even went so far as to spend almost $100,000 to add a new analyzer for COVID-19 testing. In normal times, these labs might hesitate to buy, install, and validate new testing platforms because of the huge outlay required in time and capital.
But these are not normal times, and so the lab directors have learned that when supplies run short from one or more of their legacy vendors, they can switch testing to another manufacturer’s equipment and vice versa.
As the lab directors use these stopgap measures to address the supply shortages, they continue to receive inconsistent answers about why their labs’ supplies continue to run out six months after the first death due to COVID-19. A lab director at one of largest health systems east of the Mississippi said some vendors have explained the problem and others have not.
“Abbott Laboratories has been very forthright in saying that our lab’s capacity is directed by the government,” the lab director noted. “We have yet to learn which department of the government, however.”
Another vendor has been less than straightforward about the shortages. “We still have difficulty getting supplies from Cepheid,” he added. “And company representatives won’t say why those supplies to our lab are short. “I don’t know if the shortages are a result of some government action, or it is simply that our vendors keep selling more new equipment to their laboratory customers, but then continue to send only the same number of test kits and other supplies as they shipped normally.
“We keep hearing from lab vendors that we’re among the few hospitals getting the most COVID-19 test kits, and that we get even more than their other hospital clients get,” this lab director added. “That’s bad, because if we’re not getting much, those other hospitals must be getting even less.
“Even now, months into the pandemic, we are forced to limit our COVID-19 molecular tests to just 500 to 700 tests each day because our supply of nasal swabs is very limited,” he said. “Our lab’s testing capacity is more than 3,000 COVID-19 molecular tests per day.”
This lab’s SARS-CoV-2 molecular tests are the reverse-transcription polymerase chain reaction (RT-PCR) assays that require analysis of specimens collected with nasopharyngeal swabs. Those swabs have been in short supply nationwide since March.
“Toward the end of April, we were running about 500 of the RT-PCR tests, and now two months later, we can do about 600 to 700 of those tests every day,” he added. “That’s not much of an increase, mostly because we’ve had supply chain problems.”
This health system has more than 3,000 beds and during the first three months of the pandemic, the state reported some of the highest numbers of cases and deaths per 100,000 residents among all states.
“Back in February, we heard that Cepheid was planning to send us 20,000 rapid viral test kits, but we never saw any part of that,” he noted. “We worked with our U.S. Senators to get us some of those kits, but that didn’t help much.
Need for Faster TAT
“At about that time, we were told to send the tests we couldn’t run to LabCorp and Quest Diagnostics, but those labs were unable to deliver results fast enough,” he added. “Then we were told to send the tests we couldn’t run to NxGen MDx in Grand Rapids, Mich.” NxGen MDx is a private lab that specializes in next-generation sequencing which reportedly had reagents and some idle equipment.
“But sending to NxGen was a problem, because we don’t have a contract or an electronic interface with them,” the
lab director noted. “That means we had to enter all the patient data for each test manually. Typing all that information into the electronic health record for thousands of tests is a recipe for disaster.
“When you want your lab to do 3,000 or more of these tests a day, every part of the process needs to go smoothly because any bumps can lead to mistakes,” he added.
Since March, Laboratory Corporation of America and Quest Diagnostics increased their testing capacity and cut their turnaround times dramatically. Therefore, the health system has sent any COVID-19 tests it cannot run to those labs. But doing so extends the turnaround time for results and reduces revenue.
Patients Are First Priority
“We’d certainly prefer to run all of these tests ourselves for our own economic health, but our first priority is to take care of our patients,” he commented. “If we could, we’d like to use the Cepheid machines in our lab, because we can get those results in about an hour. We’d prefer that and so would our physicians, because waiting three days for a COVID- 19 test result is usually not helpful.
“At the moment we use our send-out COVID-19 testing for pre-op patients,” he reported. “That means we test those patients four or five days ahead of their surgery and tell them to quarantine themselves and not get exposed for those days before the surgery.
“That saves our in-house SARS-CoV-2 testing capacity, so that when patients come in who are symptomatic and we suspect they have the COVID-19 illness, we can swab them and tell right away if they’re positive or negative,” he added. “More SARSCoV-2 testing that produces rapid answers, such as when patients arrive for surgery, would be better for everyone.
“Testing our pre-op patients is important because published studies show that patients who are COVID-positive, and who will have major surgery, have worse outcomes than people who are COVID-negative,” he explained. “As it is, we need to use a testing algorithm, because we’re facing these shortages,” he concluded.
“An algorithm would help us to preserve our rapid COVID-19 tests for the most urgent patients and conserve the COVID-19 tests that produce results in several days for other patients.”
Six Months After First Infection, Lab Directors Ask: Why Are SARS-CoV-2 Supplies Still Short?
IN THE UNITED STATES, THE FIRST PATIENT with the novel coronavirus was diagnosed on Jan. 19 in Snohomish County, Washington, according to the New England Journal of Medicine.
Within weeks, clinical laboratories nationwide began adding SARS-CoV-2 tests but were soon stymied in their efforts to test at full capacity due to limitations in the number of nasopharyngeal swabs, reagents, test kits, and viral transport media, among other supplies. Six months after that first diagnosis, those shortages continue to plague labs today, according to clinical lab directors and experts who monitor testing nationwide.
“In our experience, the reasons for supply shortages of critical lab supplies are multifactorial,” said one lab director from a Midwest hospital who asked not to be named. “Every day, we have what seems like a supply problem—whether it’s a shortage of test kits, extraction reagents, transport media, or something else.
“There are so many pieces that could be short on any given day,” he added. “And that’s what happens: each day brings a new problem. Out of necessity, our lab has done things differently than we’ve ever done before, and we’ve done things that we didn’t want to do.”
In January, this lab director had three analyzers capable of running the reverse-transcription polymerase chain reaction test for the SARS-CoV-2 coronavirus. Since then, he’s added testing on three more machines and has ordered a fourth new analyzer.
“Right now, we have five different vendors so that we can test our patients in some capacity,” he explained. “But having all those analyzers means the lab staff needs to be nimble enough to move on demand from one machine to another.
“Because of the various supply chain issues we’ve had, we may have one or two vendors that are constrained for whatever reason,” he explained. “When that happens, we move on to another machine that has the testing capability for a certain number of COVID-19 tests.
“But then that vendor may have a problem and we’d have to move again,” he added. “It seems like the dust never settles, which has become the new normal. That’s why we now have multiple testing platforms just so we can address these supply chain issues.”