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CLIA application (Form CMS-116)

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CLIA application (Form CMS-116)

clinical laboratory improvement amendments (clia) application for certification. ... categorized as waived must apply for a clia certificate of waiver.

http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf

Date added: June 18, 2012 - Views: 115

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Clinical Laboratory Improvement Amendments ( CLIA...

Clinical Laboratory Improvement Amendments (CLIA) How to Obtain a CLIA Certificate of Waiver When is a CLIA Certificate of Waiver Required? NOTE: Congress passed the ...

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf

Date added: July 5, 2012 - Views: 89

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CLIA Waiver Application - Food and Drug...

CLIA Waiver Application CLIA Categorization Only Previously Cleared Device HemoCue WBC System (K071652) Official ...

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/HematologyandPathologyDevicesPanel/UCM172009.pdf

Date added: February 1, 2012 - Views: 50

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State of California—Health and Human Services...

Instructions for Applying for a California Clinical Laboratory License Page 2 . Federal forms to complete: CMS 116 — CLIA application, unless already certified by CMS

http://www.cdph.ca.gov/programs/lfs/Documents/F-Lic-Application-Instructions.pdf

Date added: December 30, 2011 - Views: 23

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HOW DO I APPLY FOR CLIA CERTIFICATION? - Amcon...

HOW DO I APPLY FOR CLIA CERTIFICATION? CLIA applies even if only one or a few basic tests are performed, and even if you are not charging for testing.

http://www.amconlabs.com/faq/CLIA.Basic.Information.pdf

Date added: February 14, 2012 - Views: 17

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DIRECTIONS FOR THE CLIA WAIVER APPLICATION - Maine

DIRECTIONS FOR THE CLIA WAIVER APPLICATION FOR EMS ORGANIZATIONS Revised March 7, 2012 To get the CLIA Waiver application, you can either contact:

http://www.maine.gov/ems/documents/CLIAwaiverappinstructions.pdf

Date added: April 22, 2013 - Views: 8

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CLIA APPLICATION - Texas Department of State...

42 CFR Part §493 – Laboratory Requirements §493.35 Application for a certificate of waiver. (c) Application format and contents. The application must--(1) Be made ...

http://www.dshs.state.tx.us/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=8589958429

Date added: May 13, 2013 - Views: 14

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State of California Health and Human Services...

State of California—Health and Human Services Agency ... and CLIA Certificate of Waiver or PPMP ... LAB 155 — Application for Clinical Laboratory Registration

http://www.cdph.ca.gov/programs/lfs/Documents/F-Registration-Instructions.pdf

Date added: February 5, 2012 - Views: 24

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DEPARTMENTOF HEALTH AND HUMAN SERVICES CENTERS FOR...

clinicallaboratoryimprovement amendments of 1988 (clia) application for certification i. general information ... must apply for a clia certificate of waiver.

http://www.emsi.org/webfm_send/24

Date added: April 6, 2014 - Views: 1

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Important*** ***Before submitting your application...

Completed CLIA application in agreement with State application Copy of CLIA certificate and State Laboratory License, if applicable

http://dhmh.maryland.gov/ohcq/Labs/docs/LabsApps/md_compliance_app.pdf

Date added: June 23, 2012 - Views: 5

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CLINICAL LABORATORY IMPROVEMENT AMENDMENTS ( CLIA...

clinical laboratory improvement amendments (clia) ... the clia application ... tests categorized as waived must apply for a clia certificate of waiver.

http://www.dlp.vermont.gov/forms/clia-application

Date added: November 14, 2012 - Views: 13

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CLIA Waiver - ftp.cdc.gov

2 • Introduction of CLIA waiver in general terms • Concepts of how a test system qualifies for a CLIA waived categorization Topics

http://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/Addenda/cliac0908/Addendum%20Q.pdf

Date added: August 10, 2014 - Views: 1

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COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC...

COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH ... (certificate of waiver, ... CLIA Application

http://www.mass.gov/eohhs/docs/dph/clinical-lab/clia-application-letter.pdf

Date added: May 11, 2012 - Views: 9

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Clinical Laboratory Improvement Act ( CLIA)...

Title: Clinical Laboratory Improvement Act (CLIA) Program Information Author: Minnesota Department of Health Licensing and Certification Section

http://www.health.state.mn.us/divs/fpc/profinfo/lic/CLIAinformation.pdf

Date added: April 22, 2012 - Views: 4

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FDA’s CLIA Waiver Approval Process and Criteria

FDA’s CLIA Waiver Approval Process and Criteria Prakash Rath, Ph.D. Food and Drug Administration . Office of In Vitro Diagnostics and Radiological Health (OIR)

http://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/Addenda/cliac1114/6_RATH_CLIAC_Nov-2014.pdf

Date added: November 22, 2014 - Views: 1

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Clinical Laboratory Improvement Amendments ( CLIA...

Clinical Laboratory Improvement Amendments (CLIA) Background ... Under CLIA Application of Waiver submission, the fee charged for a two-year certificate is $150.00,

http://www.hivdent.org/_hiv_screening/2011/OQA0285_0411_CLIA_Waiver_Instructions.pdf

Date added: February 18, 2012 - Views: 7

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CERTIFICATE FEES FOR CLIA LABORATORIES - Oregon

CERTIFICATE FEES FOR CLIA LABORATORIES CLIA fees for Waived, PPMP, ... Waiver’ or ‘Certificate of Provider Performed Microscopy Procedures (PPMP)’. Non-

http://public.health.oregon.gov/LaboratoryServices/ClinicalLaboratoryRegulation/Documents/cliafees.pdf

Date added: June 10, 2012 - Views: 10

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Guidance for Clinical Laboratory Improvement...

Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM070890.pdf

Date added: July 25, 2012 - Views: 12

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CLIA Update

CLIA CLIA Update CLIAC March 2011 Harriet Walsh ... Waiver Non-exempt Laboratories by Application Type Number of Laboratories CLIA Year. CLIA CMS Waived Project-

http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0311/Addendum_E_WALSH.pdf

Date added: March 27, 2012 - Views: 29

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Certificate of Waiver Medical Test Site -...

Certificate of Waiver Medical Test ... Certificate of Waiver Medical Test Site Application ... exempt from the Clinical Laboratory Improvement Amendments of 1988 ...

http://www.doh.wa.gov/Portals/1/Documents/Pubs/505038.pdf

Date added: September 28, 2012 - Views: 11

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Clinical Laboratories Improvement Act ( CLIA)...

Clinical Laboratories Improvement Act (CLIA) ... tests that qualify for this waiver can be found at http://www.cms.hhs.gov/clia • The application form, ...

http://www.health.state.mn.us/divs/fpc/comphomecare/surveyforms/cliawaiverinfo.pdf

Date added: December 25, 2014 - Views: 1

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CLIA Waiver Determination Decision Summary

CLIA Waiver Determination Decision Summary . A. Document Number: k053110/A001 – A005 . B. Purpose for Submission: Request for CLIA Waiver . C. Measurand (Analyte):

http://www.accessdata.fda.gov/cdrh_docs/clia_waivers/K053110.pdf

Date added: December 30, 2011 - Views: 4

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To Test or Not to Test? - Centers for Disease...

test under a CLIA Certificate of Waiver. Additional materials that may be useful: The Ready? Set? Test! booklet describes recommended practices for physicians,

http://wwwn.cdc.gov/clia/Resources/WaivedTests/pdf/WavedTestingBookletWeb.pdf

Date added: August 8, 2013 - Views: 12

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Clinical Laboratory Improvement Amendments ( CLIA...

Clinical Laboratory Improvement Amendments (CLIA) Waivers Every public school that does even one lab test needs to have a CLIA waiver. If a student is independently ...

http://www.nmschoolhealthmanual.org/forms/sectionII/Clinical%20Laboratory%20Improvement%20Amendments%20for%20SHM%20(final).pdf

Date added: November 19, 2013 - Views: 11

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New Jersey Department of Health APPLICATION FOR A...

APPLICATION FOR A ... CLIA Number (8) ... Certificate of Waiver Certificate for Provider Performed Microscopy Procedures Certificate of Compliance

http://www.state.nj.us/health/forms/cl-3.pdf

Date added: April 21, 2012 - Views: 3

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As you want it to appear on CLIA Certificate)...

As you want it to appear on CLIA Certificate) Legal Name of Facility. ... APPLICATION TYPE CHANGE ... Compliance. Waiver. Accreditation PPM Proposed certified as: ...

http://dhhs.ne.gov/publichealth/Documents/CLIA_Change_Form.pdf

Date added: April 6, 2012 - Views: 2

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TEXAS DEPARTMENT OF STATE HEALTH SERVICES

CLIA APPLICATION . The Texas Department of State Health Services CLIA Program requires the following ... as waived mUst apply for a clia certificate of waiver.

https://www.inofficelab.com/v/vspfiles/files/TX%20CLIA%20Application%20Packet.pdf

Date added: July 21, 2013 - Views: 2

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STATE SURVEY AGENCIES (CLIA CONTACT LIST)

STATE SURVEY AGENCIES (CLIA CONTACT LIST) ALABAMA DEPARTMENT OF PUBLIC HEALTH Division of Health Care Facilities CLIA Program P.O. Box 303017

http://www.amconlabs.com/faq/CLIA_State_Agencies.pdf

Date added: October 22, 2011 - Views: 13

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RI Department of Health

RI Department of Health Application and instructions for Clinical Laboratory RI General Law Chapter 23-16.2 Licensee Name

http://www.health.ri.gov/applications/ClinicalLaboratory.pdf

Date added: June 13, 2012 - Views: 3

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Clinical Laboratory Improvement Amendments ( CLIA...

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION. I. GENERAL INFORMATION. ... Certificate of Waiver (Complete Sections I – VI and IX ...

http://www.idph.state.il.us/clia/pdf/CLIA_LicenseApplicationCMS-116_and_Instructions1.pdf

Date added: May 18, 2015 - Views: 1

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form...

clinical laboratory improvement amendments ... The CLIA application ... as waived mUst apply for a clia certificate of waiver.

https://www.miemss.org/home/Portals/0/Docs/CommercialAmbulance/CLIA%20Waiver%20Form.pdf

Date added: February 2, 2016 - Views: 1

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State of Connecticut

How to obtain a CLIA Waiver ... State of Connecticut Department ... AIDS & Chronic Diseases Section should be contacted to obtain an application.

http://www.ct.gov/dph/lib/dph/aids_and_chronic/prevention/pdf/prevention_protocol.pdf

Date added: February 25, 2012 - Views: 5

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CLIA Waiver Determination Decision Summary

CLIA Waiver Determination Decision Summary . A. Document Number: k992140/A002 . B. Purpose for Submission: Request for Waiver . C. Measurand (Analyte):

http://www.accessdata.fda.gov/cdrh_docs/clia_waivers/K992140.pdf

Date added: May 22, 2012 - Views: 2

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health.mo.gov

centers for medicare & medicaid services clinical laboratory improvement amendments certificate of compliance laboratory name and address missouri state public health lab

http://health.mo.gov/lab/pdf/clia_certificate.pdf

Date added: October 31, 2015 - Views: 1

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TA bulletin - clia waiver 01.10.07

obtaining a CLIA waiver Download a CLIA application at: ... You will receive your CLIA waiver number once your completed application is entered into the

http://www.dshs.state.tx.us/WorkArea/DownloadAsset.aspx?id=21742

Date added: December 25, 2014 - Views: 1

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WAIVED HIV SPECIAL PROJECTS WAIVER APPLICATION

u:\web uploads\clia\hiv-waived-test-application.rtf DEPARTMENT OF PUBLIC HEALTH CLINICAL LABORATORY PROGRAM 99 Chauncy Street, Boston, MA 02111

http://www.mass.gov/eohhs/docs/dph/clinical-lab/hiv-waived-test-application.pdf

Date added: November 8, 2012 - Views: 5

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CLIA ( Clinical Laboratory Improvement Act)...

CLIA (Clinical Laboratory Improvement Act) The TearLab Osmolarity System, as an in‐vitro laboratory device, is regulated under

http://www.tearlab.com/pdfs/regulatory/clia_united_states.pdf

Date added: August 18, 2013 - Views: 1

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This test is CLIAWaived

This test is CLIA “Waived” ThyroChek® TSH ... does not have a Certificate of Waiver, the Application for Certification (Form CMS-116), can be

http://www.cliawaived.com/web/items/pdf/PMS-120-Binsert.pdf

Date added: August 16, 2013 - Views: 1

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CLIA LABORATORY CERTIFICATE CHANGE FORM - KDHE

CLIA LABORATORY CERTIFICATE CHANGE FORM ... _____ Waiver _____ PPM _____ Compliance _____Accreditation If requesting an accreditation certificate, ...

http://www.kdheks.gov/lipo/download/CLIA_Certificate_Change_Form.pdf

Date added: January 16, 2013 - Views: 4

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CLINICAL LABORATORY EVALUATION PROGRAM - Wadsworth...

Administrator of the Clinical Laboratory Evaluation Program is responsible for maintaining the records of such information. ... CLIA STATUS AND APPLICATION TYPE .

http://www.wadsworth.org/labcert/limited/Ltd_Instr.pdf

Date added: June 16, 2012 - Views: 14

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What is a CLIA Waiver -2015 - Ohio Assisted Living...

Ohio Assisted Living Association - 2015 What is a CLIA Waiver? …Do RCFs need a CLIA Waiver? A CLIA Waiver is a certificate issued by CMS authorizing simple ...

http://ohioassistedliving.org/What%20is%20a%20CLIA%20Waiver%20-2015.pdf

Date added: December 31, 2015 - Views: 1

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CLIA No: INITIAL LIMITED SERVICE LABORATORY...

INITIAL LIMITED SERVICE LABORATORY REGISTRATION APPLICATION ... CLIA STATUS AND APPLICATION TYPE: If your laboratory already has a CLIA number, ...

http://www.wadsworth.org/labcert/limited/Ltd_Regist.pdf

Date added: December 6, 2012 - Views: 5

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APPLICATION FOR STATE OF GEORGIA CLINICAL...

YEAR CLIA # PART I. GENERAL INFORMATION Name of Laboratory: Address: City: County: State: Zip Code: ... APPLICATION FOR CLINICAL LABORATORY DIRECTOR

http://dch.georgia.gov/sites/dch.georgia.gov/files/imported/vgn/images/portal/cit_1210/62/60/157324995statelaboratoryapplicationpacket.pdf

Date added: June 24, 2013 - Views: 7

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Clinical Laboratories Programs and Services...

Clinical Laboratories Programs and Services Georgia Department of Community Health ... CLIA Regulations (Clinical Laboratory Improvement Amendments) , ...

http://dch.georgia.gov/sites/dch.georgia.gov/files/imported/vgn/images/portal/cit_1210/1/7/144864579Clinical_Laboratories_July_2012.pdf

Date added: March 27, 2013 - Views: 3

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clia non- waived tests - Association of Public...

Application at: http://www.cms.hhs.gov/clia ... of Waiver (or higher level ... CLIA - Clinical Laboratory Improvement Amendments ...

http://www.aphl.org/aphlprograms/lss/clia/Documents/CLIA_2011_Non-Waived-Tests.pdf

Date added: July 31, 2013 - Views: 19

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STATE OF WEST VIRGINIA DEPARTMENT OF HEALTH AND...

STATE OF WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN RESOURCES Bob Wise Paul L. Nusbaum ... • Meet CLIA requirements for a certificate of waiver ...

http://www.wvdhhr.org/labservices/shared/docs/clia/clia%5Fcertificate%5Fof%5Fwaiver.pdf

Date added: July 26, 2014 - Views: 1

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What is a CLIA certificate of waiver? - RPS...

CLIA FAQs What is a CLIA certificate of waiver? The CLIA certificate of waiver is a registration with the U.S. Department of Health and Human Services that allows

http://www.rpsdetectors.com/in/wp-content/uploads/2012/07/FORM-MKT-055.0-CLIA-FAQs.pdf

Date added: December 30, 2012 - Views: 2

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C&S, TUBES FOR VENIPUNCTURE AND ALL THESE ARE SENT...

clia application (waiver) rapid street, glucose meter test, we use cups to collect speciments for u/a, c&s, tubes for venipuncture and all these are sent out to lab ...

http://homecareoffice.com/images/CLIA%20APPLICATION%20(WAIVER).pdf

Date added: August 16, 2013 - Views: 1

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CLIA OWNERSHIP INFORMATION - Nebraska

STATE OF NEBRASKA – ONLY FOR LABORATORIES LOCATED IN NEBRASKA CLIA OWNERSHIP INFORMATION To complete information about a laboratory’s operation, please complete ...

http://dhhs.ne.gov/publichealth/Documents/CLIA%20Ownership%20Information.pdf

Date added: September 12, 2013 - Views: 1