Catholic Health System hopes to acquire speeded-up Covid-19 tests in the coming week, after federal officials directed the manufacturer to send its test kits to New York State, not to the Catholic hospitals in Western New York, which had wanted to buy them.
Catholic Health CEO Mark Sullivan said last week that the Federal Emergency Management Agency and the Department of Homeland Security ordered Cepheid, the Sunnyvale, Calif., company that developed the tests, to ship them first to "hot spots" where the impact of Covid-19 is more severe.
"From what I understand, Cepheid was in contact with Homeland Security and FEMA and asked their advice as to where to distribute. There was a protocol that came out that they were going to distribute to the hot spots," Sullivan said.
Even with the number of confirmed cases in Western New York topping the 900 mark Friday, this region apparently was not considered enough of a hot spot.
"I immediately got on the phone with our elected officials in Washington, who reached out to FEMA and to Cepheid, and we're working through it, and I'm hopeful we'll be getting some tests soon," Sullivan said.
Rep. Brian Higgins' office contacted FEMA, which denied blocking the purchase. Higgins' staff found that last week New York State received a large order from Cepheid, but none of it was earmarked for Catholic Health.
Higgins' office said the state is designated Tier 1, the highest priority for resource allocation, by FEMA, the Centers for Disease Control and Prevention and the federal Coronavirus Task Force.
"FEMA does not have the authority to marshal equipment or forcibly interfere in a private contract in any way," FEMA told Higgins' staff. "Our procurement teams are using the same process as state and local officials, hospitals, etc., throughout the country to identify and obtain medical equipment and PPE (personal protective equipment). While we cannot speculate on the reason Cephid cannot fulfill the order, we can assure you that it was not because of any action taken by FEMA. We do recommend, however, that the Catholic Health System contact their local and state officials if they have unmet needs."
"Cepheid's been prompt in letting us know the status, but we haven't gotten any tests," Sullivan said.
Cepheid did not respond to requests for comment.
"I'm pretty confident that within a week we'll have more news and we'll have a significant amount of tests," Sullivan said.
He announced March 22 that Catholic Health was ready to buy 72,000 testing kits from the California company.
Sullivan said he's talked directly with Gov. Andrew M. Cuomo's staff about other supplies.
"The state has committed to giving us swabs," Sullivan said. "That, I believe, we're going to be all set with."
Cepheid's system also will work with a saline wash if no swabs are available, according to the company's news release announcing its new testing system.
The company's kits, approved March 21 by the U.S. Food and Drug Administration, contain genetically engineered chemicals that react with a specimen from a test swab to show within 45 minutes whether the sample contains the Covid-19 virus.
The kits work only on Cepheid's machines, but Catholic Health has one in each of its local hospitals.
With the ability to run numerous tests simultaneously and obtain fast results, Sullivan estimated at the time of his announcement that Catholic hospitals could test 800 people per day for the virus.
That would speed up the numbers of tests in the region exponentially.
The Erie County Public Health Laboratory is able to process 80 to 100 tests per day, a county Health Department spokeswoman said Friday.
Last week, Kaleida Health said it was able to do 100 to 200 tests a day on its in-house system, made by Abbott Molecular. That number hasn't changed much, said Dr. John A. Sellick Jr., hospital epidemiologist at Buffalo General Medical Center. Kaleida said its laboratories have completed over 1,300 tests to date, and are currently completing testing for Kaleida Health patients deemed critical plus healthcare workers from Kaleida Health, ECMC and Catholic Health System.
"We have Cepheid up at the VA (Medical Center), and we're getting these kits in boxes of 30. You don't know when the next one is going to show up," Sellick said.
"We're hopeful that we're going to have more testing capability relatively soon, not just at Kaleida but all over Western New York, because we have an absolute need for this," he said.