$207,000 Penalty Issued to Embry Health for COVID-19 Testing Without Approvals

The Hawai‘i Department of Health today levied a $207,000 administrative penalty against Embry Health and ordered the company to immediately cease and desist collecting specimens for COVID-19 tests in the State of Hawai‘i. The DOH says the company is operating without a license, permit or written approval.

According to the DOH, Embry Health has been operating COVID-19 testing collection depots on O‘ahu and Hawai‘i Island. 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 reports it made “repeated attempts” to work with the company to secure the necessary certification or approval. Embry Health withdrew its application for certification on Oct. 19.

Following the withdrawal of this application, the DOH Office of Health Care Assurance conducted an investigation, with cooperation from the City and County of Honolulu.

“The investigation determined that Embry Health was operating collection depots without clinical laboratory certification or written permission from DOH as required by law,” according to the DOH.

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.