Hawai‘i Department of Health issues cease & desist, $207,000 penalty to Embry Health for conducting unauthorized COVID-19 testingPosted on Nov 5, 2021 in COVID-19, Newsroom
HONOLULU – The Hawai‘i Department of Health (DOH) today ordered Embry Health to immediately cease and desist collecting specimens for COVID-19 tests in the State of Hawai‘i without a license, permit or written approval. DOH also levied a $207,000 administrative penalty.
Embry Health has been operating COVID-19 testing collection depots on O‘ahu and Hawai‘i Island. Embry Health testing sites known to DOH include Kahala Mall, Kaimana Beach Hotel, Mauna Kea Beach Resort, Patsy T. Mink Central O‘ahu 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 Hawai‘i 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 Hawai‘i can trust the results they receive,” said Health Director Dr. Elizabeth Char, FACEP. “We will continue to enforce all regulations to protect Hawai‘i residents and we thank our government partners for their collaboration on this action.”
After learning that Embry Health was collecting specimens for COVID-19 tests in Hawai‘i, DOH made repeated attempts to work with Embry Health to secure the necessary certification or approval. Embry Health withdrew its application for certification on October 19.
Following the withdrawal of this application, the DOH Office of Health Care Assurance (OHCA) 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.
Embry Health is ordered to immediately:
- Cease and desist operating all collection depots within the State of Hawai‘i;
- Pay an administrative penalty totaling $207,000;
- Notify DOH OHCA in writing of all collection depots operated by Embry Health within the State of Hawai‘i and confirm the date operations ceased; and
- Not open or operate collection depots in the State of Hawai‘i without a valid state certificate, permit or obtaining prior written approval from DOH OHCA.
Individuals who received testing through Embry Health should contact their physician for guidance on whether they should seek testing through another provider.
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