Clinical Laboratory Improvement Amendments

United States federal regulatory standards

Follow Clinical Laboratory Improvement Amendments on Notably News to receive short updates to your email — rarely!

2023 Global laboratory-developed testing (LDT) market valued at US$ 3518.7 million, with projections for significant growth in personalized medicine and diagnostics.
2022 A lawsuit in Michigan found that the state's Newborn Screening program's long-term storage and sales of blood spots to third parties violated state statutes.
2022 The Institute for Justice filed a class-action lawsuit in New Jersey challenging the retention of Newborn Screening cards used in warrantless law enforcement investigations without consent.
December 2022 TJC announced they would no longer recognize COLA for lab accreditation, giving hospitals and facilities until December 31, 2024 to transition accreditation.
December 2016 The 21st Century Cures Act was enacted, allowing researchers to waive informed consent requirements for clinical testing that poses minimal risk and includes appropriate safeguards.
2014 A2LA (American Association for Laboratory Accreditation) was recognized as a CLIA accreditation organization.

This contents of the box above is based on material from the Wikipedia articles Laboratory developed test & Clinical Laboratory Improvement Amendments, which are released under the Creative Commons Attribution-ShareAlike 4.0 International License.

See Also