State health officials have shut the door on an online lab testing company’s local operations, ordering it to sever ties with three Hawaiʻi collection sites and hitting the businesses with fines for allegedly selling illegal direct-to-consumer lab services. According to the Hawaiʻi Department of Health’s Office of Health Care Assurance, a Kauaʻi mobile phlebotomy service and two Maui businesses acted as collecting depots that took specimens from customers without the state-authorized medical orders that Hawaiʻi law requires.
Investigators say Scottsdale-based Ulta Lab Tests has been offering these consumer-facing services in the islands since May 2022 without the federal CLIA certification or state approvals needed to run collecting depots. As reported by Kauai Now, state inspectors confirmed that specimens were being collected directly from individuals with no request from an authorized medical professional, which put the operation squarely on the wrong side of Hawaiʻi’s clinical lab rules.
DOH issues Notices Of Violation And Order
According to a Hawai‘i Department of Health news release, the agency issued a Notice of Violation and Order against John Roehm, CEO of Ulta Lab Tests LLC, directing the company to “cease and desist” any affiliation with the three identified collecting depots.
The department states that Ulta Lab Tests is not a clinical laboratory certified under federal law. Each of the three collecting depots was assessed a $15,000 administrative penalty. The companies have 20 days from the date they receive the NOVO to request a hearing in writing. If they do not, the order becomes final and enforceable.
Health officials also underscored that state rules require lab tests to be ordered, received and interpreted by an authorized person or an OHCA-approved designee, not purchased and interpreted directly by consumers.
Which sites were flagged
The enforcement action names three businesses that allegedly served as unauthorized collecting depots: Lab Exodus LLC, a mobile phlebotomy service based in ʻEleʻele on Kauaʻi; Maui Midwifery LLC in Wailuku; and Mālama Regen Med Group LLC, doing business as Maui Longevity Rx in Pāʻia.
According to Kauai Now, the listed operators are Rachel Moke for Lab Exodus, Whitney A. Herrelson and Alexandria Amey for Maui Midwifery, and Emily Loren, N.D., for Maui Longevity Rx.
Why direct-to-consumer testing is restricted
Hawaiʻi requires that clinical laboratories hold federal CLIA certification and, depending on the testing involved, a state permit or license. Collecting depots that take specimens and send them to other labs must also secure written approval from the Office of Health Care Assurance before operating, as outlined by the Hawai‘i Department of Health CLIA program. Those rules are designed to ensure that tests are ordered and interpreted by qualified clinicians and that laboratory services meet quality and safety standards, rather than leaving patients on their own to guess at lab results.
What happens next
The NOVOs give Ulta Lab Tests and the three local collecting depots a short window to contest the findings. If they do not file a written request for an administrative hearing within 20 days of receiving the orders, the violations and fines become final and enforceable. For island residents who used or considered using these services, the Department of Health is steering people back toward the traditional route: work with authorized health care providers to order and interpret any laboratory testing.
