Chunk #67 — PART II. CORE QUESTIONS — F. What is the Content of those Responsibilities? Four Issues and Who Should Address Them — Step 1: Clarifying the criteria and roster
the Clinical Laboratory Improvements Amendments of 1988 (CLIA).92 CLIA and its accompanying regulations impose a number of test quality assurance requirements when test results are being generated and returned for clinical purposes, including measures to ensure that the test result indeed belongs to the individual and has not been mixed up.93,94 Where the initial lab generating the findings is CLIA-certified or the researchers can reconfirm the results in a lab that is CLIA-certified, this is not an obstacle to return. (Note that this may require that researchers plan ahead to retain samples adequate for retesting in a CLIA-certified lab.) However, controversy surrounds the question of whether results can be returned if confirmation by a CLIA-certified lab is not available.86 The literature explores models that would allow researchers to provide or access testing in CLIA-certified labs.96 Fully clarifying best practices may require working with the Center for Medicare and Medicaid Services (CMS), the agency that administers CLIA.
