DOH press release: Hawaii Department of Health issues cease and desist order, $ 58,000 penalty to NextHealth for performing unauthorized COVID-19 testing
Posted on December 10, 2021 in Latest department news, Press room
HONOLULU – The Hawaii Department of Health (DOH) has ordered NextHealth to immediately stop performing COVID-19 testing in the state of Hawaii without a license, permit or written approval. The DOH also imposed an administrative penalty of $ 58,000.
NextHealth performed COVID-19 testing starting October 11, 2021 at the Four Seasons Resort Maui in Wailea located at 3900 Wailea Alanui Drive, Kihei, Hawai’i. About 982 patients were tested during this time.
Laboratories are regulated under federal and state laws, which ensure that providers operating in Hawai’i provide quality services that meet federal and state standards.
“Testing is critically important as we continue to navigate this pandemic. Residents must ensure that tests are carried out accurately, appropriately and safely ”, said Health Director Dr Elizabeth Char, FACEP.
After learning that NextHealth was performing COVID-19 testing in Hawai’i, the DOH contacted NextHealth regarding the operation of a clinical laboratory without proper permits. The DOH Office of Health Care Assurance (OHCA) then conducted an on-site investigation and determined that NextHealth was operating without a CLIA exemption certificate and without a Hawaii State Class I clinical laboratory license as required 42 CFR Part 493 Subpart A and 11-110.1-6 (a) Hawaii Administrative Rules (HAR) for Establishing a Clinical Laboratory as required by law.
NextHealth receives the order to:
- Cease and desist from operating a Class I clinical laboratory at the Four Seasons Resort Maui and any other clinical laboratory in the State of Hawaii;
- Pay an administrative penalty totaling $ 58,000;
- Notify in writing the DOH OHCA of all clinical laboratories operated by NextHealth in the State of Hawaii and confirm the date on which operations ceased; and
- Do not open or operate a clinical laboratory in the State of Hawaii without a valid state certificate, license, or obtaining prior written approval from the DOH OHCA.
People who have been tested through NextHealth should contact their doctor to see if they should seek testing from another provider.
Click here to read the full cease and desist order.
For more information on COVID-19 testing, visit HawaiiCOVID19.com / testing.
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Media contact:
Jacques Gonser
Communications office
E-mail: [email protected]
Telephone: (808) 733-8360
