4 companies, including Kauaʻi firm, issued violations for providing illegal lab testing

Hawai‘i Department of Health Office of Health Care Assurance issued a violation and order notice against John Roehm — chief executive officer of Scottsdale, Ariz.-headquartered Ulta Lab Tests — for illegally providing direct-to-consumer laboratory testing to Hawaiʻi consumers since May 2022.

Ulta Lab Tests is affiliated with three laboratory test and healthcare sites in Hawai‘i, including one on Kauaʻi, where specimens are collected directly from a person without a request by an authorized person, as required under Hawaiʻi law.

The firm is also not a clinical laboratory certified under federal law and, as such, does not meet state requirements to establish collecting depots in the island. Ulta Lab Tests, furthermore, did not apply for nor receive Office of Health Care Assurance written approval to establish any collecting depots in Hawaiʻi.

Ulta Lab Tests is ordered to cease and desist its affiliations with the following entities acting as collecting depots:

• Lab Exodus, a mobile phlebotomy service owned and operated by Rachel Moke, located in ʻEleʻele.
• Maui Midwifery, owned and operated by Whitney A. Herrelson and Alexandria Amey, located in Wailuku, Maui.
• Mālama Regen Med Group doing business as Maui Longevity Rx, owned and operated by Emily Loren, located in Pāʻia, Maui.

A Hawai‘i Department of Health inspector — after conducting an investigation — confirmed the aforementioned entities were also illegally operating as collecting depots for Ulta Lab Tests without Office of Health Care Assurance approval.

The three above entities also each received violation and order notices to cease and desist operations as a collecting depot for Ulta Lab Tests and fined $15,000.

A collecting depot is a place separate from patient care facilities where specimens are received or taken from an person’s body for laboratory examination elsewhere.

Ulta Lab Tests, Lab Exodus, Maui Midwifery and Maui Longevity Rx have 20 days from the date they received their violation notices to submit written requests for a hearing.

A violation becomes final and enforceable after that 20-day period.

Direct-to-consumer laboratory testing is prohibited in Hawaiʻi. State law requires an “authorized person” or “designee of an authorized person and others deemed qualified by [Office of Health Care Assurance] to order, receive and interpret laboratory test results within the scope of their practice.”

Hawaiʻi Department of Health’s clinical laboratories in Hawaiʻi section regulates and licenses clinical laboratories that perform testing for the purposes of providing information for diagnosis, prevention or treatment of any disease, impairment or assessment of the health of people in Hawaiʻi.