--- title: CMS IQCP Clarification for EUA Tests description: COLA Inc. has extended its partnership with the CDC through the Laboratory Communicators’ Network (LCN) in the Division of Laboratory Systems (DLS) to provide additional updates and resources to our laboratories and affiliates. image: https://blog.cola.org/hubfs/LOCS_600.jpg --- ISO 9001:2015 - [Careers](http://www.cola.org/careers/) - [A Great Place to Work](http://www.cola.org/careers/a-great-place-to-work/) - [Current Openings](http://www.cola.org/careers/current-openings/) - [Press Room](http://www.cola.org/press-room/) - Member Login - [COLAcentral](https://www.colacentral.com) - [Board of Directors](http://board.cola.org/) - visit related COLA sites - [GiveBack365](http://www.GiveBack365.org) - [Lab Testing Matters](http://www.LabTestingMatters.org) - [MyConsultantCentral](http://www.myconsultantcentral.com/) - 1-800-981-9883 ![ColaUpdatedLogoStackedWhiteBackground-1](https://blog.cola.org/hs-fs/hubfs/ColaUpdatedLogoStackedWhiteBackground-1.png?width=306&height=111&name=ColaUpdatedLogoStackedWhiteBackground-1.png)   ![ColaUpdatedLogoStackedWhiteBackground-1](https://blog.cola.org/hs-fs/hubfs/ColaUpdatedLogoStackedWhiteBackground-1.png?width=210&height=76&name=ColaUpdatedLogoStackedWhiteBackground-1.png)   ISO 9001:2015 - 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[Tweet](https://twitter.com/share) ***COLA is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. Below is a link to the most recent message about CMS Individualized Quality Control Plan (IQCP) clarification for EUA tests.*** [CMS IQCP Clarification for EUA Tests](https://www.cdc.gov/csels/dls/locs/2020/cms_iqcp_clarification_for_eua_tests.html) The U.S. Centers for Medicare & Medicaid Services (CMS) has issued a statement in response to the recent confusion regarding quality control for tests with FDA emergency use authorization (EUA). See below for the statement from CMS: “The manufacturer’s instructions for all tests that have authorization for use as EUA must be followed, to include quality control (QC). Surveyors will ensure that the laboratory is following the EUA Instructions for Use (IFU) as well as its own established policies, specifically its QC procedures. QC for EUAs must be followed, and no deviations to the QC requirements in the EUA are permitted; Individualized Quality Control Plan (IQCP) is not applicable to EUAs.  Please note: The laboratory director may determine, based on risk assessment, that additional QC needs to be implemented above what is required in the EUA IFU. Please also note: States and Accreditation Organizations (AOs) may have more stringent requirements.” [Click here to read more.](https://www.cdc.gov/csels/dls/locs/2020/cms_iqcp_clarification_for_eua_tests.html)   - [FDA Updates COVID-19 Test Policy and FAQs](https://blog.cola.org/cdc-updates/fda-updates-covid-19-test-policy-and-faqs) October 10, 2022 - [CDC Issues Select Agent Gram for Monkeypox Virus](https://blog.cola.org/cdc-updates/cdc-issues-select-agent-gram-for-monkeypox-virus) October 10, 2022 - [HHS Declaration of Public Health Emergency for Monkeypox Diagnostics and New FDA Guidance](https://blog.cola.org/cdc-updates/hhs-declaration-of-public-health-emergency-for-monkeypox-diagnostics-and-new-fda-guidance) October 10, 2022 - [Variant Influenza Virus Infections](https://blog.cola.org/cdc-updates/variant-influenza-virus-infections) September 06, 2022 - [Best Practices for Suspected Monkeypox Lesion Specimen Collection](https://blog.cola.org/cdc-updates/best-practices-for-suspected-monkeypox-lesion-specimen-collection) September 05, 2022 - [FDA Updates COVID-19 Test Policy and FAQs](https://blog.cola.org/cdc-updates/fda-updates-covid-19-test-policy-and-faqs) October 10, 2022 - [CDC Issues Select Agent Gram for Monkeypox Virus](https://blog.cola.org/cdc-updates/cdc-issues-select-agent-gram-for-monkeypox-virus) October 10, 2022 - [HHS Declaration of Public Health Emergency for Monkeypox Diagnostics and New FDA Guidance](https://blog.cola.org/cdc-updates/hhs-declaration-of-public-health-emergency-for-monkeypox-diagnostics-and-new-fda-guidance) October 10, 2022 - [Variant Influenza Virus Infections](https://blog.cola.org/cdc-updates/variant-influenza-virus-infections) September 06, 2022 - [Best Practices for Suspected Monkeypox Lesion Specimen Collection](https://blog.cola.org/cdc-updates/best-practices-for-suspected-monkeypox-lesion-specimen-collection) September 05, 2022 Advertisement ### Posts by Tag - [CDC LOCS (4)](https://blog.cola.org/cdc-updates/tag/cdc-locs) Search Blog: [Careers](http://www.cola.org/careers/) | [Press Room](http://www.cola.org/press-room/) ![ColaUpdatedLogoStackedWhiteBackground-1](https://blog.cola.org/hs-fs/hubfs/ColaUpdatedLogoStackedWhiteBackground-1.png?width=175&height=64&name=ColaUpdatedLogoStackedWhiteBackground-1.png) 9881 Broken Land Pkwy Suite 200 | Columbia, MD 21046-3016 Phone (800) 981-9883 | Fax (410) 381-8611 | Email [info@cola.org](mailto:info@cola.org) [Privacy Policy](http://www.cola.org/privacy-policy/) | [Terms Of Service](http://www.cola.org/terms-of-service/) | [Interested In Advertising?](https://education.cola.org/cola-adnetwork) - follow us: - - - - Visit: [Near Patient Testing Matters](http://www.nearpatienttestingmatters.org/) [Lab Testing Matters](http://www.labtestingmatters.org/) [My Consultant Central](http://www.myconsultantcentral.com/) Member Login: [COLAcentral](https://www.colacentral.com) [Board of Directors](http://board.cola.org/) site development by [![](https://blog.cola.org/hubfs/COLA-Jun2017/images/NL_bug.png)](http://www.nextlogik.com) © 2004 - 2017 COLA All Rights Reserved ![](https://dc.ads.linkedin.com/collect/?pid=169932&fmt=gif)