Which act provides exemption from CLIA requirements in certain states?

Which act provides exemption from CLIA requirements in certain states?

• A. The Public Health Service Act
• B. The Affordable Care Act
• C. The Privacy Act
• D. The Social Security Act

Answer: (A)

Exemption from CLIA in certain states comes from recognizing that some state regulatory programs for laboratories meet or exceed CLIA standards. The Public Health Service Act provides the framework for CMS to approve these state programs as equivalent to CLIA. When a state’s program is approved, laboratories within that state can operate under that state oversight and are not subject to federal CLIA requirements in the same way. The other acts—focusing on health care financing and access, privacy of personal information, or social insurance—do not address CLIA regulatory exemptions.

Exemption from CLIA in certain states comes from recognizing that some state regulatory programs for laboratories meet or exceed CLIA standards. The Public Health Service Act provides the framework for CMS to approve these state programs as equivalent to CLIA. When a state’s program is approved, laboratories within that state can operate under that state oversight and are not subject to federal CLIA requirements in the same way. The other acts—focusing on health care financing and access, privacy of personal information, or social insurance—do not address CLIA regulatory exemptions.