Lab tests performed in a health care facility are most likely required to have certification under which regulation?

Lab tests performed in a healthcare facility are most likely required to have certification under the Clinical Laboratory Improvement Amendments (CLIA). This regulation specifically governs laboratory testing and ensures that laboratories meet certain quality standards in order to provide accurate and reliable test results. CLIA establishes requirements for laboratory personnel, quality control, and proficiency testing, among other aspects, which are essential for patient safety and effective healthcare delivery.

While HIPAA focuses on the privacy and security of patient information and CMS addresses healthcare quality and reimbursement, neither specifically pertains to laboratory certification. HCFA (now part of CMS) was involved in healthcare quality but does not directly address laboratory testing standards as CLIA does. Therefore, the requirement for lab tests to have certification clearly aligns with the standards set forth by CLIA.