State regulators say the companies collected specimens without authorized provider orders, violating Hawaii law.
The Hawaii Department of Health Office of Health Care Assurance has issued notices of violation and orders to four companies for illegally providing direct-to-consumer laboratory testing services in the state.
Ulta Lab Tests LLC, headquartered in Scottsdale, Arizona, received a notice of violation for operating illegal direct-to-consumer laboratory testing services for Hawaii consumers since May 2022. The company’s CEO John Roehm was named in the order.
Three Hawaii-based entities acting as collection sites for Ulta Lab Tests also received individual notices and $15,000 fines: Lab Exodus LLC, a mobile phlebotomy service in Eleele; Maui Midwifery LLC in Wailuku; and Malama Regen Med Group LLC, doing business as Maui Longevity Rx, in Paia.
The violations stem from the companies collecting specimens directly from individuals without requests from authorized persons, as required under Hawaii Administrative Rules Section 11-110.1-2. Direct-to-consumer laboratory testing is prohibited in Hawaii, where state 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.”
Regulatory Violations Identified
Ulta Lab Tests is not a clinical laboratory certified under federal law and as such, does not meet Hawaii Administrative Rules requirements to establish collecting depots in the state, according to a release from the Hawaii Department of Health. The company also did not apply for or receive written approval from the Office of Health Care Assurance to establish any collection sites in Hawaii.
The three affiliated entities were operating as collection sites without proper approval. A collection site is defined as a place separate from patient care facilities where specimens are received or taken from individuals for laboratory examination elsewhere.
All four companies have 20 days from receipt of their notices to submit written requests for hearings, or the orders will become final and enforceable.
State Laboratory Oversight
The Department of Health Clinical Laboratories in Hawaii section regulates and licenses clinical laboratories in the state that perform testing to provide information for diagnosing, preventing, or treating diseases or assessing human health.
The enforcement action highlights ongoing regulatory challenges as direct-to-consumer testing services expand nationally while individual states maintain varying restrictions on such services.
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