A University of Hawaii lab that was envisioned to ramp up Honolulu’s ability to conduct widespread COVID-19 testing has been struggling to get off the ground.

The partnership between Honolulu and UH, announced in May, was supposed to provide nearly 100,000 tests to people on Oahu. With the help of $3.9 million in CARES Act funds from the city, the John A. Burns School of Medicine was going to provide “surge capacity” of 50,000 traditional diagnostic tests by the end of the year, conduct 49,000 antibody tests, and develop new methods to test for the coronavirus, officials said at a press conference.

At the time, the city said the new lab should be operational within six weeks.

Nearly four months later, the lab has yet to conduct a single test. Delays in delivering funding and setting up the lab infrastructure mean the program hasn’t accepted any patient samples and doesn’t know when it will be able to, according to Rosie Alegado, a UH professor and community liaison for the lab. 

“On paper, the six weeks number was if we had the money today, we would be able to order the machines, do X, Y, and Z and do all of this,” she said. “But of course, there are many things out of our control.”

On Monday, Mayor Kirk Caldwell announced the results of a federal surge testing effort: the virus is not circulating widely islandwide but rather is confined to certain populations and areas. Overall, the island has a low positivity rate, the mayor said.

The next step is more targeted testing of areas experiencing high case counts, which includes the Pacific Islander and Filipino communities, Caldwell said.

While the city has 30,000 remaining tests left over from the feds, officials are still looking to the UH lab to create extra on-island capacity. The hope is that UH’s testing efforts, along with the contact tracing and isolation efforts funded by city CARES money, can help keep case counts in check as the island endeavors to open up businesses, according to Josh Stanbro, the city’s chief resilience officer who is helping to lead the city’s pandemic response.

Meanwhile, the clock is ticking. CARES Act funds need to be spent before Dec. 31, or they’ll need to be returned to the federal government.

Setting Up A New Lab Takes Time

With over 4,000 tests being conducted every day in Hawaii, according to the Department of Health, the JABSOM lab would increase Oahu’s testing capacity by 25%.

But UH has encountered numerous obstacles in trying to make this program happen, according to Alegado.

Funding was one of them. In order for the JABSOM lab to receive the first batch of funding from Honolulu, it needed the approval of the UH Board of Regents. Members approved the program at their monthly meeting on June 18. Approximately $200,000 from the Rockefeller Foundation didn’t arrive until July, Alegado said.

“We really got off and running in July,” Alegado said.

The lab also had to get testing machines and materials, which were in high demand around the world, Alegado said.

“One of the biggest hurdles is just, as usual, Hawaii is at the end of a long global supply chain,” she said.

As of last week, the JABSOM lab does have its testing machines and is calibrating them to ensure they work properly, according to Alegado. That can take a week to 10 days, she said.

The team is still working on establishing a communication system that connects community health care centers, where the patients are, to the lab. Then they have to ensure the lab can send results to patients’ doctors and the Hawaii Health Information Exchange. HHIE is a nonprofit intermediary that shares data with the Hawaii Department of Health.

The communication of health information needs to happen in a way that doesn’t jeopardize patient privacy, which is protected by federal law.

“What we’re in the process of doing now is running those test codes to see, OK, we have a result and we’re running it through HHIE. Can we make it all the way to DOH?” she said. “We have to get through all the way to DOH.”

DOH itself is decades behind technology-wise and relies on two fax machines to intake information for its contact tracing program. JABSOM will provide its results digitally, Alegado said, but they’re still working out the kinks.

“It’s just that for a new entity, you know, there’s always some troubleshooting that needs to happen,” she said.

It is unclear when exactly the program will be able to resolve all these issues and start testing, according to Alegado.

“Until we can get the data workflow finalized, I cannot give you a clear date,” she said. “I will say that on the lab side, we will be ready to go in a very short period of time.”

UH still needs to obtain a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Compliance, which will happen after the lab successfully completes an on-site inspection. However, the lab can begin patient testing before then, according to Alegado, once it completes the validation and verification of its equipment and protocols and completes competency checks of personnel.

Honolulu ‘Not Concerned Yet’

Honolulu pursued the deal with UH at a time when Caldwell was frustrated with a lack of testing at the state level, said Stanbro.

The Caldwell administration tried to take testing into its own hands by purchasing thousands of test kits from the Texas-based company Everlywell. However, the DOH objected because of concerns about the reliability of the tests, and Honolulu backed off.

“DOH, at the time, was saying we don’t need more tests,” Stanbro said. “We thought otherwise.”

The city was trying to be as aggressive as possible to expand the island’s testing capacity, Stanbro said, and a deal with UH was one way to accomplish that.

“When we first looked at it in May, it looked like a straight path to get there, and there has been a lot of curves,” he said. “We’re trying to do projects that usually take months and months of negotiating, have lawyers get involved, set up reporting parameters, and phased funding – all that we’re doing in a matter of weeks.”

Having on-island testing capacity is the difference between a one- to two-day turnaround on results versus a three- to five-day turnaround with a lab on the mainland, according to Stanbro. Acting faster can help contain the spread of the virus, he said.

“If they get their positive reading back quickly, then they can isolate and not be exposing others while waiting for a test result,” he said.

As of right now, Hawaii has enough testing capacity to meet the state’s needs, according to Edward Desmond, DOH’s State Laboratories Administrator. But that could change.

“For right now, people are comfortable with their ability to run 4,000 samples per day,” said Desmond, who conducts a monthly survey of lab capacity. “If you take answers labs give me at face value, they think we are capable of running 7,000 per day, but we couldn’t keep that up for long.”

Honolulu could have partnered with an existing lab on the island instead of standing up a new lab from scratch. But Stanbro said the city preferred to partner with an academic institution.

The cost per test is lower than it would be otherwise, he said. Plus, it’s designed to serve the public good instead of subsidizing a private company.

“Having a functioning research lab that is publicly owned, publicly operated for the value of the public is something that is far more valuable than just additional private testing capacity,” he said. 

In the long run, the lab seeks to build long-term capacity to identify, monitor and diagnose COVID-19 variations and other rare infectious diseases so that Hawaii can be on the “leading edge of pandemic preparedness,” according to the program’s goals.

In the short term, if all goes well, JABSOM aims to provide 1,000 diagnostic tests per day. But Alegado said UH’s contract with the city allows flexibility to adjust the testing goals announced at the press conference as need dictates.

Among the program’s central goals is to provide testing to “underserved, uninsured, and front-line workers who may require multiple tests for safety at their workplaces.”

The lab seeks to build long-term capacity to identify, monitor and diagnose COVID-19 variations and other rare infectious diseases so that Hawaii can be on the “leading edge of pandemic preparedness.”

That could include hotel workers, public housing residents and city employees like firefighters, Stanbro said. As of Monday, 24 firefighters have tested positive for COVID-19, according to an agency spokesman.

“It’s a cost-effective way to do routine testing on our ambulance workers, our fire department, our frontline public safety workers,” Stanbro said. 

The Pacific Islander and Filipino communities are also in need of regular testing, Alegado said.

Non-Hawaiian Pacific Islanders made up 16% of the state’s COVID-19 deaths despite representing only 4% of the population, and Filipinos represented 24% of deaths even though they are only 16% of the population, according to DOH data released last month.

So far, UH has received only the first batch of its CARES funds, approximately $1.2 million, Alegado said. Future releases are based on hitting benchmarks. In other words, the University of Hawaii has about 100 days to spend millions of dollars that the city hasn’t even released to the institution yet.

“Once lab machines are validated and data workflow is running, we can receive the next round of funding which is almost completely dedicated to covering test and processing costs,” Alegado said.

Stanbro said he’s “not concerned yet” that the clock will run out before all $3.9 million can be spent.

However, testing needs and technological advances can shift rapidly.

In October or November, if the island no longer needs the lab as originally envisioned, Stanbro said the city can pull back some of funds and allocate them elsewhere, such as rent relief. Either way, UH is expected to carry on operations of the lab after the new year, Stanbro said.

“It took longer than we would’ve liked to get it up, but once it’s up, it’ll be a permanent asset for not just Oahu but the entire state,” he said.