Pages 1-3 and 42-44---CMS-Theranos enforcement...

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Transcript of Pages 1-3 and 42-44---CMS-Theranos enforcement...

Page 1: Pages 1-3 and 42-44---CMS-Theranos enforcement letteronline.wsj.com/public/resources/documents/cms20160412.pdf · 12/04/2016 · In addition, CMS determined that various CLIA Standard-level
Page 2: Pages 1-3 and 42-44---CMS-Theranos enforcement letteronline.wsj.com/public/resources/documents/cms20160412.pdf · 12/04/2016 · In addition, CMS determined that various CLIA Standard-level
Page 3: Pages 1-3 and 42-44---CMS-Theranos enforcement letteronline.wsj.com/public/resources/documents/cms20160412.pdf · 12/04/2016 · In addition, CMS determined that various CLIA Standard-level
Page 4: Pages 1-3 and 42-44---CMS-Theranos enforcement letteronline.wsj.com/public/resources/documents/cms20160412.pdf · 12/04/2016 · In addition, CMS determined that various CLIA Standard-level
Page 5: Pages 1-3 and 42-44---CMS-Theranos enforcement letteronline.wsj.com/public/resources/documents/cms20160412.pdf · 12/04/2016 · In addition, CMS determined that various CLIA Standard-level
Page 6: Pages 1-3 and 42-44---CMS-Theranos enforcement letteronline.wsj.com/public/resources/documents/cms20160412.pdf · 12/04/2016 · In addition, CMS determined that various CLIA Standard-level

Theranos Biz Model

Theranos Biz Model

Theranos 2567 04-25-2016

Theranos 2567 04-25-2016

1 CLIA CMS CLIA Update 2010 For CAP Annual Policy Meeting May 2010 Harriet Walsh, Deputy Director, Division of Laboratory Services, Centers for Medicare.

1 CLIA CMS CLIA Update 2010 For CAP Annual Policy Meeting May 2010 Harriet Walsh, Deputy Director, Division of Laboratory Services, Centers for Medicare.

Details of CLIA Final QC Regulatory Changes Division of Laboratory Services CMS.

Details of CLIA Final QC Regulatory Changes Division of Laboratory Services CMS.

Ask the FDA and CMS/CLIA - AABB

Ask the FDA and CMS/CLIA - AABB

DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS …dph.illinois.gov/sites/default/files/forms/cms-116-clia-application.pdfOnce the completed Form CMS-116 has been returned to the applicable

DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS …dph.illinois.gov/sites/default/files/forms/cms-116-clia-application.pdfOnce the completed Form CMS-116 has been returned to the applicable

CLIA Workgroup Report§No routine oversight/inspections by CMS §CLIA personnel standards do not apply. CLIA Certificate of Waiver (COW) (cont.) Additional Comments ... Provide state

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Jones Theranos

Jones Theranos

CMS CLIA QuickStart Guide 202-08-202020-10-1 · LABORATORY QUICK START GUIDE TO CMS CLIA CERTIFICATION . AUGUST 2020 . STEP 5: Receive Certifcate and Begin Testing • View laboratory

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CLIA-RELATED HEARING DECISIONS - CMS...2017/08/14  · CLIA certificate revoked. 42 CFR 498.40 Request for Hearing. An affected party entitled to a hearing. 2/16/1999 [CR576] BAN Laboratories

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Compliance Issues Affecting Laboratories · Compliance Issues Affecting Laboratories ... • Developed checklist for waived laboratories ... • CMS cannot revoke CLIA certificate

Compliance Issues Affecting Laboratories · Compliance Issues Affecting Laboratories ... • Developed checklist for waived laboratories ... • CMS cannot revoke CLIA certificate

CLIA-RELATED HEARING DECISIONS - CMS · 2019-09-13 · CLIA-RELATED HEARING DECISIONS. The following is a list of hearing decisions, in hearing decision date order, related to the

CLIA-RELATED HEARING DECISIONS - CMS · 2019-09-13 · CLIA-RELATED HEARING DECISIONS. The following is a list of hearing decisions, in hearing decision date order, related to the

The Future is Now: Global Application of CLSI and ISO ... · zEthiopia zRwanda zBotswana What About the United States? 42 CLIA, CLIA, CLIA … CLIA is enforced by Centers for Medicare

The Future is Now: Global Application of CLSI and ISO ... · zEthiopia zRwanda zBotswana What About the United States? 42 CLIA, CLIA, CLIA … CLIA is enforced by Centers for Medicare

CMS Manual Systemdph.illinois.gov/sites/default/files/publications/clia-cptcodeswaivedtests.pdf86803QW November 29, 2011 OraQuick HCV Rapid Antibody Test and OraQuick Visual Reference

CMS Manual Systemdph.illinois.gov/sites/default/files/publications/clia-cptcodeswaivedtests.pdf86803QW November 29, 2011 OraQuick HCV Rapid Antibody Test and OraQuick Visual Reference

CLIA Update 2014 - ftp.cdc.gov · CLIA Update 2014 . Judith Yost, M.A., M.T.(ASCP) Director . Division of Laboratory Services . CLIA. CLIA. ... • Goal – Improved compliance with

CLIA Update 2014 - ftp.cdc.gov · CLIA Update 2014 . Judith Yost, M.A., M.T.(ASCP) Director . Division of Laboratory Services . CLIA. CLIA. ... • Goal – Improved compliance with

DEPARTMENT OF HEALTH & HUMAN SERVICES · PDF fileSunil Dhawan, M.D., Director Elizabeth Holmes, Owner Ramesh Balwani, Owner Theranos, Inc. 7333 Gateway Boulevard Newark, CA 94560 CLIA

DEPARTMENT OF HEALTH & HUMAN SERVICES · PDF fileSunil Dhawan, M.D., Director Elizabeth Holmes, Owner Ramesh Balwani, Owner Theranos, Inc. 7333 Gateway Boulevard Newark, CA 94560 CLIA

Clinical Laboratory Improvement Amendments (CLIA) ID ... · - All laboratory services subject to the CLIA submitted on either a CMS 1500 claim form or HIPAA 5010 837P claim file •Requires

Clinical Laboratory Improvement Amendments (CLIA) ID ... · - All laboratory services subject to the CLIA submitted on either a CMS 1500 claim form or HIPAA 5010 837P claim file •Requires

INFORMATIONAL SUPPLEMENT (2006) - CMS › ... › CLIA › Downloads › Informational_Supplem… · CLIA law. We will continue to add inquiries to this Informational Supplement,

INFORMATIONAL SUPPLEMENT (2006) - CMS › ... › CLIA › Downloads › Informational_Supplem… · CLIA law. We will continue to add inquiries to this Informational Supplement,

Ask the FDA and CMS/CLIA - AABBaabb.org/.../2018-Ask-the-FDA-and-CLIA-Transcript.pdf · Ask the FDA and CMS/CLIA 2018 AABB Annual Meeting Boston, Massachusetts October 16, 2018

Ask the FDA and CMS/CLIA - AABBaabb.org/.../2018-Ask-the-FDA-and-CLIA-Transcript.pdf · Ask the FDA and CMS/CLIA 2018 AABB Annual Meeting Boston, Massachusetts October 16, 2018