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Expert Q&A: Quality, Proficiency, and CLIA Updates

Expert Q&A: Quality, Proficiency, and CLIA Updates

by Michael Schubert, PhD | Jun 20, 2024 | CLIA-lca, Compliance-lca, Essential, Lab Industry Advisor

Lighthouse Lab Services chief quality officer Anna Hill offers advice on keeping your lab compliant with the latest CLIA changes.

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Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards

Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards

by Ron Shinkman | Mar 27, 2024 | Clinical Diagnostics Insider, FDA-dtet

The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements

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Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality

Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality

by Glenn S. Demby | Jul 31, 2023 | CLIA-lca, Essential, Lab Compliance Advisor

Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.

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How to Resolve Three Common Types of Preanalytical Interference

by Michael A. Vera, BA, Joe M. El-Khoury, PhD, DABCC, FACB | Jan 26, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Special Focus-dtet

Experts share new strategies for dealing with hemolysis, icterus, and lipemia interference.

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Device Makers to FDA: Give Us More Time for ISO 13485 Harmonization

Device Makers to FDA: Give Us More Time for ISO 13485 Harmonization

by Glenn S. Demby | Apr 7, 2022 | Articles, News, Open Content

On Feb. 23, the U.S. Food and Drug Administration (FDA) issued a proposed rule to harmonize its good manufacturing practices (CGMP) regulations for medical devices with International Standardization Organization (ISO) 13485. The basic proposal is to replace the...
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