Articles
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Ensuring Personnel Competency at All Levels
Evaluation of competency is expected for all laboratory testing personnel. This occurs at least twice in the first year that…
Implementation Deadline Approaching for Adapting to Proficiency Testing Regulations
Clinical laboratories produce test results that are crucial to providers’ decision-making in ensuring patients receive consistently high-quality care. How do laboratories ensure providers receive consistently accurate test results? Laboratories conduct proficiency testing to meet CMS quality assurance rules, including rules now being updated.
Heads Up, Laboratories! Dengue Virus, Novel Influenza, and More
On June 25, 2024, the U.S. Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) message about an increased risk of dengue virus (DENV) infections in the United States in 2024.
U.S. Agencies Monitoring Avian Influenza While Measles and Mpox Demand Attention, Too
First, birds, of course. Then cows contracted A/H5 avian influenza. And now with a human case confirmed, the Centers for Disease Control and Prevention is taking steps to help manufacturers prepare to mass produce devices for testing. And in the U.S. and elsewhere, measles and Mpox require watching, too.
CMS Publishes Final Rule Updating CLIA Regulations
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.
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.