Embry Health fined, ordered to stop testing for COVID-19 testing in Hawaii

The state Department of Health on Friday ordered Embry Health to stop conducting COVID-19 testing and fined the company $207,000 for operating specimen collection sites without clinical laboratory certification or written permission from state regulators.

The company, based in Phoenix, has been operating sites on Oahu and Hawaii island, including at Kahala Mall, the Kaimana Beach Hotel, Mauna Kea Beach Resort, Patsy T. Mink Central Oahu Regional Park, Wahiawa District Park and Waipahu District Park. The testing locations have been collecting specimens and sending them to a mainland lab, which has reported about 4,200 results to DOH since September.

Keith Ridley, chief of the DOH Office of Health Care Assurance, said that when his department realized the company did not have the necessary certification or approval, it began working with Embry officials to bring it into compliance. However, Ridley said, the company abruptly withdrew its application Oct. 19.

“It did appear as if they were very anxious to be compliant, and we had been exchanging documents; we had lots of emails and phone calls with them; and then, quite out of the blue, they sent us an email saying they wanted to withdraw their application as a collecting depot,” Ridley said. “So it took us a bit by surprise.”

Ridley said the approval process for a collection depot involves making sure specimens are handled properly from the time they are collected to the time they are sent off to a lab.

“While we are unaware that anyone has been harmed, and while we are certainly hoping that they did employ quality assurance procedures throughout their process, because we are unable to finalize that process with them, we can’t be assured of that,” he said.

The $207,000 fine covers the 207 days that Embry was operating without permission at all of its known locations.

Raymond Embry, chief executive officer for Embry Health, told the Honolulu Star-Advertiser that his company has ceased operations at all of its locations but plans to resume testing as soon as possible and is looking to expand even further into the Hawaii market by offering COVID-19 and flu vaccinations, telehealth services and wellness visits.

“We are here for the long term,” Embry said. “We are not a fly-by-night operation.”

Embry said his company had made the determination that it was not a collecting depot and therefore withdrew its application with DOH. He said Embry Health was instead a health care entity that provides a variety of services, which in Hawaii includes having a nurse follow up with COVID-19-positive patients to help coordinate care.

“The most important thing here is that this trusted entity scaled up rapidly in response to the delta pandemic, you know the delta wave that was spreading, as well as the ask of the City and County of Honolulu to increase access to testing,” Embry said.

But DOH said its administrative rules make clear that Embry’s operations in Hawaii fall under the department’s administrative rules governing collecting depots. Those rules define depots as “a place separate from patient care facilities and where specimens are received or taken from the body of an individual for laboratory examination elsewhere.”

“This would define Embry Health’s COVID-19 testing sites,” DOH said.

Hiro Toiya, director of Honolulu’s Department of Emergency Management, said the company also was ordered to stop all COVID-19 testing on city property.

“The city permitted Embry Health to conduct COVID-19 testing at city parks at a time when testing was in great need, however this was not a city program or operation,” Toiya said in a statement. “It is greatly disappointing Embry Health did not follow through on its end of the permit and comply with the Hawai‘i Department of Health regulations.”

This isn’t the first time Embry Health has run afoul of government regulators. Earlier this year the Arizona Department of Health Serv­ices barred the company from ordering any more COVID-19 vaccines after it found Embry Health may have administered as many as 370 expired vaccine doses, the Arizona Republic reported in June.

Meanwhile, Hawaii’s COVID-19 cases remain stable following a sharp decline that began in early September. The seven-day daily average of new reported cases stood at 98 Friday, the first time it dropped below 100 since July.

Hospitalizations also have dropped to manageable levels, with DOH’s Hawaii COVID-19 Data dashboard showing 67 patients with the virus in Hawaii hospitals as of Friday, with 14 of them in intensive care units, comprising 4% of the state’s ICU capacity, and 11 on ventilators.

DOH also reported Friday there were 12 new corona­virus-related deaths and 124 new confirmed and probable infections statewide, bringing the state’s totals since the start of the pandemic to 944 fatalities and 84,814 cases.

Nine of the latest deaths were on Oahu, two were on Hawaii island and one was on Kauai.

The new cases included 67 on Oahu, 22 on Hawaii island, 11 on Maui, 10 on Kauai, one on Molokai and 13 Hawaii residents diagnosed outside the state.

DOH said there were 1,589 active COVID-19 cases, down 15 from the previous tally. Oahu had 853 active cases; Hawaii island, 361; Maui, 176; Kauai, 193; Lanai, two; and Molokai, four.

The latest Hawaii COVID- 19 vaccine summary shows 2,227,397 vaccine doses administered through state and federal distribution programs as of Thursday, up 10,660 from a day earlier. Health officials say that 71.6% of the state’s population is now fully vaccinated, and 82.1% has received at least one dose.