OHCA ISSUES NOVOS TO FOUR COMPANIES FOR PROVIDING ILLEGAL DIRECT-TO-CONSUMER LAB TESTING

HONOLULU — The Hawai‘i Department of Health (DOH) Office of Health Care Assurance (OHCA) has issued a Notice of Violation and Order (NOVO) against John Roehm, CEO of Ulta Lab Tests, LLC, a company headquartered in Scottsdale, Ariz., for violating state law by illegally providing direct-to-consumer laboratory testing to Hawaiʻi consumers since May 2022.

Ulta Lab Tests, LLC, is affiliated with three laboratory test and healthcare sites in Hawai‘i where specimens are collected directly from an individual without a request made by an authorized person, as required under Hawaiʻi Administrative Rules (HAR) §11-110.1-2. Ulta Lab Tests, LLC, is not a clinical laboratory certified under federal law and as such, does not meet HAR requirements to establish collecting depots in the state. Additionally, Ulta Lab Tests, LLC did not apply for nor receive written approval from OHCA to establish any collecting depots in Hawaiʻi. The NOVO orders Ulta Lab Tests, LLC, to cease and desist its affiliations with the following entities acting as collecting depots:

1. Lab Exodus LLC, a mobile phlebotomy service, owned and operated by Rachel Moke, located in ʻEleʻele, Hawaiʻi.
2. Maui Midwifery LLC, owned and operated by Whitney A. Herrelson and Alexandria Amey, located in Wailuku, Hawaiʻi.
3. Malama Regen Med Group LLC dba Maui Longevity Rx, owned and operated by Emily Loren, N.D., located in Paia, Hawaiʻi.

After conducting an investigation, a DOH inspector confirmed that the aforementioned entities were also illegally operating as collecting depots for Ulta Lab Tests, LLC, without approval from OHCA. The three entities were also individually issued NOVOs to cease and desist operations as a collecting depot for Ulta Lab Tests, LLC, and fined $15,000. 

Direct-to-consumer laboratory testing is prohibited in the state of Hawaiʻi as the law requires an “authorized person” or “designee of an authorized person and others deemed qualified by (OHCA) to order, receive and interpret laboratory test results within the scope of their practice.” (HAR §11-110.1-2) A collecting depot is defined as a place separate from patient care facilities and where specimens are received or taken from the body of an individual for laboratory examination elsewhere.

Ulta Lab Tests, LLC, Lab Exodus LLC, Maui Midwifery LLC and Maui Longevity Rx, have 20 days from the date of receipt of the NOVO to submit a written request for a hearing, or the NOVO will become final and enforceable after the 20-day period.

The DOH Clinical Laboratories in Hawaii (CLIA) section regulates and licenses clinical laboratories in the state of Hawaiʻi that perform testing for the purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of, the health of human beings.

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