US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1231: Ensure confidentiality of patient information throughout every phase of the total testing process under the laboratory's control

What does 1231 require?

The laboratory must ensure the confidentiality of patient information throughout all phases of the total testing process that are under its control: specimen receipt and accessioning, testing, result entry, reporting and record storage, including information held in the laboratory information system and transmitted to clients or interfaced systems.