Clinical Laboratory Improvement Amendments
United States federal regulatory standards
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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.