ADLM Calls on HHS to reinstate CLIAC
The ADLM has urged HHS to reinstate the CLIAC, warning that its elimination endangers test quality and patient care.
Category: Compliance
Compliance
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Compliance
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Labs Express Concern about Testing Access if FDA Regulates LDTs
Nearly 85% of respondents to an ARUP Labs survey on the impact of the FDA's proposed rule to regulate LDTs believe it will hurt their labs.
Compliance
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AACC Urges Cutting VALID Act to Preserve Patient Access to LDTs
The AACC is urging clinical lab professionals to write to their legislators to keep the VALID Act out of a Fiscal Year 2023 budget agreement.
Fast Facts: Your Guide to the VALID Act
The bipartisan VALID Act would implement a risk-based review system for all diagnostic tests, including LDTs, under the FDA.
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Do Laboratory-Developed Tests Have a Future?
As the bipartisan VALID Act moves closer to a vote, the potential regulation could impact the future of laboratory-developed tests (LDTs).
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CAP Files Amicus Brief in Support of No Surprises Act Lawsuit
The College of American Pathologists warns the No Surprises Act will further drive more physicians out of their patients’ health plan networks.
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Accelerator Facility Launched for Clinical Lab Tests
To help diagnostics start-ups from around the world more rapidly enter the U.S. market, 20/20 GeneSystems is giving access to a CLIA laboratory.
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FDA Response to COVID Gives Insights for Regulatory Future of LDTs
Certain temporary deviations in FDA policy in response to the COVID-19 pandemic may offer a blueprint for regulatory oversight of LDTs.
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FDA Warns of Potential for False Positives with Roche Cobas SARS-CoV-2 and Influenza Test
Roche Molecular Systems’ cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test is for use on the cobas Liat System. The false positive results may be related to two issues observed by Roche.
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Helmer i.C3 Download Functionality Supports Clinical Laboratory Compliance
The i.C3 monitors the temperature inside a laboratory refrigerator or freezer and activates alarms if the temperature rises or falls outside of the acceptable range.
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COLA Launches Toolkit for Waived Laboratories
COLA’s Waived Testing Toolkit provides guidance and tools to help staff achieve and maintain waived testing excellence, including guidance on covid-19 reporting.
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FDA Issues New Policy for Evaluating the Impact of Viral Mutations on Covid-19 Tests
The new guidances for medical product developers, specifically covering vaccines, diagnostics, and therapeutic products, address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes covid-19.
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MedTrainer Introduces LabComply to Simplify Lab Compliance
LabComply manages laboratory safety, administrative and engineering controls, training, documentation, and reporting as part of MedTrainer’s all-in-one healthcare compliance solution.
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FDA Issues Alert to Clinical Laboratory Staff Regarding SARS-CoV-2 Viral Mutation
The FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests.
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Webinar: Solving Confusion with Regulations, QC Design, and Troubleshooting for SARS CoV-2 Assays
The webinar, sponsored by Technopath, will cover quality control regulations, setting the proper QC strategy/design, and troubleshooting SARs CoV-2 and other semi-qualitative tests in the laboratory.
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FDA Updates Serology Templates for Covid-19 Test Developers
The two new templates offer recommendations on what to include in emergency use authorization requests for serology tests.
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From the Commissioner: FDA’s Ongoing Commitment to Transparency for Covid-19 EUAs
I want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise or revoke EUAs for drugs and biological products, including vaccines.
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FDA Updates FAQs on Testing for Covid-19
The changes make it easier to navigate to questions by topic.
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