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Clinical Laboratory Improvement Amendments ( CLIA...

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Clinical Laboratory Improvement Amendments ( CLIA...

clinical laboratory improvement amendments (clia) application for certification department of health and human services centers for medicare & medicaid services

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

Date added: June 18, 2012 - Views: 65

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How to Obtain a CLIA Certificate of Waiver

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: 50

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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: 44

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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: 5

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DEPARTMENTOF HEALTH AND HUMAN SERVICES CENTERS FOR...

THE CLINICALLABORATORYIMPROVEMENT AMENDMENTS (CLIA) APPLICATION (FORM CMS­116) INSTRUCTIONS FOR COMPLETION CLIA requires every facility that tests human ...

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

Date added: April 6, 2014 - Views: 1

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CLINICAL LABORATORY IMPROVEMENT AMENDMENTS ( CLIA...

clinical laboratory improvement amendments ... 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: 5

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Download Maryland State Compliance Application...

Maryland Department of Health and Mental Hygiene ... 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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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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Laboratory Registration Application Instructions...

and CLIA Certificate of Waiver or PPMP ... LAB 155 — Application for Clinical Laboratory Registration LAB 116 — Laboratory Personnel Report

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

Date added: February 5, 2012 - Views: 16

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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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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: 12

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CLIA Waiver Application—Where to Send - HIV

CLIA Waiver Application—Where to Send This information is for laboratories operating in the state of Georgia only. If you are operating a lab in ...

http://www.hiveis.com/Forms/CLIAWaiverApplicationWheretoSend.pdf

Date added: March 20, 2012 - Views: 2

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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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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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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: September 23, 2013 - Views: 8

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Clinical Laboratory Improvement Amendments ( CLIA...

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS ... The CLIA application ... CERTIFICATE OF WAIVER. Mailing Address:

http://www.azdhs.gov/lab/documents/license/certification/cms116.pdf

Date added: May 29, 2013 - Views: 2

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CLIA Waiver Application—Where to Send - HIV

CLIA Waiver Application—Where to Send Mail Applications for CLIA Certificates to: DCH/HFRD Diagnostic Services Unit 2 Peachtree St., NW.

http://www.hiveis.com/Forms/CLIAWaiverAppWheretoSendNEW.pdf

Date added: February 15, 2012 - Views: 5

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APPLICATION FOR STATE OF GEORGIA CLINICAL...

application for state of georgia clinical laboratory license clinical laboratory licensure law, 1970 lab license # year clia # part i. general information

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: 1

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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: 10

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To get the CLIA Waiver Application, go to: Check...

Directions for the CLIA Waiver Application For Blood Glucose in the Field To get the CLIA Waiver Application, go to: http://www.cms.gov/cmsforms/downloads/cms116.pdf

http://ww4.mgh.org/mqtems/SiteAssets/SitePages/Forms%20and%20Resources/Directions%20for%20the%20CLIA%20Waiver%20Application.pdf

Date added: August 16, 2013 - Views: 2

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Certificate of Waiver Medical Test Site (MTS) ...

Certificate of Waiver Medical Test Site (MTS) Application Packet Contents: ... exempt from the Clinical Laboratory Improvement Amendments of 1988 (CLIA). You do

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

Date added: September 28, 2012 - Views: 9

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FREQUENTLY ASKED QUESTIONS 1) How do I apply for ...

health.clia@state.mn.us or mail to CLIA, 1645 Energy Park Drive, Suite 300, St. Paul, MN 55108. New certificates are issued for facility name or director changes.

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

Date added: May 5, 2013 - Views: 2

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CERTIFICATE FEES FOR CLIA LABORATORIES

2 FEES FOR CLIA CERTIFICATE OF ACCREDITATION This page for laboratories accredited by AABB, AOA, ASHI, CAP, COLA, JCAHO. The following is the fee schedule for all ...

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

Date added: June 10, 2012 - Views: 10

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Application for a Pennsylvania Clinical...

Application for a Pennsylvania Clinical Laboratory Permit ... location laboratories an individual is permitted to direct under Pennsylvania or CLIA regulations.

http://www.portal.state.pa.us/portal/server.pt?open=18&objID=1225341&mode=2

Date added: February 2, 2013 - Views: 3

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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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Download Clinical Laboratory Application...

CERTIFICATE OF WAIVER PROVIDER-PREFORMED MICROSCOPY ... Return both CLIA and Clinical Laboratory Application to: Bureau of Laboratories P.O. Box 500

http://www.portal.state.pa.us/portal/server.pt?open=18&objID=1224557&mode=2

Date added: October 19, 2012 - Views: 13

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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 Montgomery, AL 36130-3017

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

Date added: October 22, 2011 - Views: 10

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COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC...

COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH ... [CLIA] Application ... Application for Clinical Laboratory Improvement Amendments of 1998 ...

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

Date added: May 11, 2012 - Views: 9

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Role & Responsibilities of a Laboratory Director...

Director of Laboratory with CLIA Certificate of Waiver While CLIA does not specify requirements for directors of ... the person signing the CW application

http://www.cap.org/apps/docs/pt_checkup/pol_library/laboratory_directors_responsibilities.pdf

Date added: September 26, 2012 - Views: 18

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CLIA Update - Centers for Disease Control and...

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: 8

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What is a CLIA certificate of waiver?

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/en/wp-content/uploads/2012/07/FORM-MKT-055.0-CLIA-FAQs.pdf

Date added: September 5, 2013 - Views: 2

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TA bulletin - clia waiver 01.10.07 - Texas...

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/hivstd/fieldops/TA_Bulls/clia_waiver.pdf

Date added: February 14, 2012 - Views: 9

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Clinical Laboratory Application 2008

WAIVER COMPLIANCE ACCREDITATION ... Return both CLIA and Clinical Laboratory Application to: Bureau of Laboratories P.O. Box 500 Exton, PA 19341. Title:

http://www.dsf.health.state.pa.us/health/lib/health/labs/clinical_laboratory_application_2009.pdf

Date added: February 6, 2012 - Views: 11

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FAQs for Laboratories Licensure - Maryland DHMH

FAQs for Laboratories Licensure Q. What do the letters “CLIA” stand for? A. “CLIA” stands for the Clinical Laboratory Improvement Amendments Act of 1988.

http://www.dhmh.maryland.gov/ohcq/Labs/docs/Laboratories%20-%20License%20FAQ.pdf

Date added: December 10, 2012 - Views: 18

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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM...

0938-0581 clinical laboratory improvement amendments of 1988 (clia) application for certification i. general information

http://cardinalhealth.com/content/consumerhealth/files/20090701_clia%20waiver%20application.pdf

Date added: April 7, 2015 - Views: 1

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Health Care Licensing Application CLINICAL...

Renewal application for Non-Waived Laboratory ... Include a CLIA application for addition of specialties or change in certificate type.

http://ahca.myflorida.com/MCHQ/HQALicensureForms/ClinicalLab_Non-Waived/Lab_renewal_application_59A-7.pdf

Date added: April 27, 2014 - Views: 1

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CLIA No: INITIAL LIMITED SERVICE ... - Wadsworth...

CLIA STATUS AND APPLICATION TYPE: If your laboratory already has a CLIA number, please indicate here: _____ Type of Limited Service Laboratory ...

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

Date added: December 6, 2012 - Views: 5

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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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CLIA

your state and ask for a CLIA application, form HCFA-116. Cholestech Technical Service can give you the address and phone ... your CLIA Certificate of Waiver will

http://www.hmscweb.com/PDF_Files/Cholestech/Technical_Bulletin_LDX_-_CLIA_88.pdf

Date added: May 11, 2012 - Views: 31

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CLINICAL LABORATORY EVALUATION PROGRAM

CLIA STATUS AND APPLICATION TYPE . CLIA Number: If you have already obtained a CLIA certification number, please indicate the number in the area provided. If

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

Date added: June 16, 2012 - Views: 2

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STATE OF COLORADO

Our Mission is to Design and Deliver Quality Human Services that Improve the Safety and Independence of the People of Colorado. Barbara . TO: Program Approved Service ...

http://www.colorado.gov/cs/Satellite?blobcol=urldata&blobheadername1=Content-Disposition&blobheadername2=Content-Type&blobheadervalue1=inline%3B+filename%3D%22Communication+Brief%3A+Clinical+Laboratory+Improvement+Amendments+%28CLIA%29.pdf%22&blobheadervalue2=application%2Fpdf&blobkey=id&blobtable=MungoBlobs&blobwhere=1251808649464&ssbinary=true

Date added: March 17, 2014 - Views: 1

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State of Connecticut

How to obtain a CLIA Waiver ... CLIA Application for Certification ... The Connecticut Department of Public ...

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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TEXAS DEPARTMENT OF STATE HEALTH SERVICES

CLIA APPLICATION . The Texas Department ... tHe clinical laboratory improvement amendments (clia) application ... 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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CLIA Waiver

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

http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0908/Addendum%20Q.pdf

Date added: February 14, 2012 - Views: 7

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Administrative Changes to FDA’s CLIA...

CLIA Waiver by Application . Manually . CWxxxxxx Kxxxxxx . CLIA Waiver By Application Changes . Overview of What has or is changing • Administrative Tracking Mechanisms

http://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/Addenda/cliac0314/04_Rath_Admin%20Changes%20to%20FDA%27s%20CLIA%20Program.pdf

Date added: November 22, 2014 - Views: 1

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INSTRUCTIONS FOR COMPLETING APPLICATION FOR

INSTRUCTIONS FOR COMPLETING APPLICATION FOR ... G. Clinical Laboratory Improvement Act ... (CLIA) certificate or waiver?

http://www.kdheks.gov/bhfr/download/hospital_application.pdf

Date added: September 29, 2012 - Views: 2

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CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF...

clinical laboratory improvement amendments of 1988 (clia) application for certification ... categorized as waived must apply for a clia certificate of waiver.

http://www.hmscweb.com/PDF_Files/HMSC/CLIA_Application.pdf

Date added: April 6, 2012 - Views: 10

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RI Clincial Laboratory Application - RI Department...

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