State issues cease-and-desist, $207,000 fine to widely-used COVID testing provider

The state DOH has ordered Embry Health to stop conducting COVID testing in Hawaii because it does not have the proper authorizations or approvals to do so.
Published: Nov. 5, 2021 at 1:20 PM HST|Updated: Nov. 5, 2021 at 4:13 PM HST
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HONOLULU (HawaiiNewsNow) - The state Health Department has ordered Embry Health to stop conducting COVID testing in Hawaii ― including at Kahala Mall and several parks ― because it does not have the proper authorizations or approvals to do so.

The company was also fined $207,000 ― $1,000 for each day it operated in the state.

The enforcement action comes after weeks of discussions with the provider, which was conducting tests up until Friday and said it planned to fight to resume operations.

DOH, meanwhile, says there was no evidence the tests were putting anyone at risk.

The agency said people who got tested through Embry Health should contact their physician for guidance on whether they should seek testing through another provider.

The company has been reporting the results of the 4,200 tests it conducted to the state.

Embry Health has been operating COVID testing collection depots on Oahu and Hawaii Island, including at Kahala Mall, Kaimana Beach Hotel, Mauna Kea Beach Resort, the Patsy T. Mink Central Oahu Regional Park, and Wahiawa and Waipahu district parks.

The site at Kahala Mall now has a hand written sign on the door notifying people that it was closed.

The company, based in Phoenix, launched in Hawaii in September and sent specimens to an out-of-state lab. After learning Embry Health was conducting tests, the state said it made repeated attempts to work with the company to get the necessary certification or approval.

But on Oct. 19, Embry Health withdrew its application for certification.

“Quite out of the blue they sent us an email saying they wanted to withdraw their application as a collecting depot. It took us a bit by surprise,” said Keith Ridley, of the Health Department.

Raymond Embry, CEO of the company, blamed the certification issues on “extremely confusing” regulations in Hawaii. “Our organization is an organization of health care providers,” he said.

“We need to ensure that every person has access to zero cost, safe, reliable COVID-19 testing. That’s what our mission is all about and we’re going to do everything possible to get operations reopened in Hawaii as soon as possible.”

The city had invited Embry Health to operate at parks because of a high need for testing, but has since rescinded their permits.

“It is greatly disappointing Embry Health did not follow through on its end of the permit and comply with the Hawaii Department of Health regulations,” said Hiro Toiya, director of the city Department of Emergency Management.

For other testing sites on Oahu, click here.

The Health Department said both collection depots and labs are regulated by state and federal laws. The state said Embry Health can’t re-open in Hawaii until it gets the proper certifications.

“Testing is an important tool in our fight against the pandemic,” said Health Director Dr. Libby Char, in a news release. “It is critical that all individuals seeking testing in Hawaii can trust the results they receive.”

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