said Health Director Dr. Elizabeth Char, FACEP.After learning that NextHealth was performing COVID-19 tests in Hawai‘i, DOH contacted NextHealth regarding operating a clinical laboratory without proper permits.
The DOH Office of Health Care Assurance (OHCA) then conducted an onsite investigation and determined that NextHealth was operating without a CLIA Certificate of Waiver and a State of Hawaii Clinical Laboratory Class I Permit as required under 42 C.F.R.
Part 493 Subpart A and 11-110.1-6(a) Hawaii Administrative Rules (HAR) for the establishment of a clinical laboratory as required by law.NextHealth is ordered to immediately:Individuals who received testing through NextHealth should contact their physician for guidance on whether they.