Centers for Medicare & Medicaid Services (CMS) has published final rule CMS-3326-F to update Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. Topics include the CLIA fee and alternative sanctions, along with histocompatibility and personnel requirements.
Clinical Labs
CMS Changing CLIA Proficiency Testing Regulations
Staff and administrators of some clinical laboratories will have rules changes to keep up with in the months ahead as Clinical Laboratory Improvement Amendments (CLIA) proficiency testing regulations take effect.
Changes to Know for Clinical Laboratories
COVID-19 tests and cholera testing remain current topics. The U.S. Food and Drug Administration has issued a bulletin about a COVID-19 test recall and has approved four more at-home antigen tests.
COVID-19 Tests Recalled and Others Approved; Cholera Review Urged
COVID-19 tests and cholera testing remain current topics. The U.S. Food and Drug Administration has issued a bulletin about a COVID-19 test recall and has approved four more at-home antigen tests.
FDA and CDC Provide Updates for Monkeypox, COVID-19, and Ebola Testing
Federal agencies offer guidance on collecting, transporting, and shipping specimens for Ebola testing and ensuring authorized, valid, and ever-advancing tests for monkeypox and COVID-19 are available for use.
Specimen Collection, Shelf-Life Extensions, and More
From best practices for collecting suspected monkeypox specimens to dealing with possible false negatives on COVID-19 testing, the CDC and the FDA provide updates and advice. Review the topics below and share the information with your networks.
Preparing for the End of the COVID-19 PHE
On July 15, Xavier Becerra, Secretary of Health and Human Services, extended the COVID-19 public health emergency declaration for another 90 days. One month later, on August 18, the Centers for Medicare & Medicaid Services (CMS) published a blog titled, “Creating a Roadmap for the End of the COVID-19 Public Health Emergency.”
The Monkeypox PHE
Two years ago, “PHE” probably wasn’t one of the health care acronyms that everyone immediately understood. COVID changed that and monkeypox has reinforced the learning with the declaration made by the Secretary of Health and Human Services on August 4, 2022.



