The state Department of Health today ordered Embry Health to immediately cease and desist collecting specimens for COVID-19 tests in Hawaii.
DOH also levied a $207,000 administrative penalty, the department said in a news release.
Embry Health has been operating COVID-19 testing collection depots on the Big Island and Oahu, according to the DOH.
Embry Health’s testing sites known to DOH included Mauna Kea Beach Resort, Kahala Mall, Kaimana Beach Hotel, Patsy T. Mink Central Oahu Regional Park, Wahiawa District Park and Waipahu District Park.
Collection depots are sites that collect test specimens and send them to a laboratory for analysis.
Laboratories and collection depots are regulated under the authority of federal and state statutes, which ensure providers operating in Hawaii deliver quality services that meet federal and state standards.
“Testing is an important tool in our fight against the pandemic. It is critical that all individuals seeking testing in Hawaii can trust the results they receive,” said Health Director Dr. Elizabeth Char. “We will continue to enforce all regulations to protect Hawaii residents and we thank our government partners for their collaboration on this action.”
Individuals who received testing through Embry Health should contact their physician for guidance on whether they should seek testing through another provider, the DOH said.
After learning that Embry Health was collecting specimens for COVID-19 tests in Hawaii, DOH made repeated attempts to work with Embry Health to secure the necessary certification or approval, according to the department.
Embry Health withdrew its application for certification on October 19.
Following the withdrawal of this application, the DOH Office of Health Care Assurance conducted an investigation. The City and County of Honolulu cooperated with the investigation. The investigation determined that Embry Health was operating collection depots without clinical laboratory certification or written permission from DOH as required by law.
In addition to the cease and desist order and fine, Embry Health was ordered to notify the DOH in writing of all collection depots operated by Embry within the state and confirm the date operations ceased, and not open or operate collection depots without a valid state certificate, permit or obtaining prior written approval from DOH.