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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: 58

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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: 45

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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: 43

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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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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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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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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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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: 15

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HOW DO I APPLY FOR CLIA CERTIFICATION?

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: 14

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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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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: 1

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CLIA Waiver Application—Where to Send - HIV EIS

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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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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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: 7

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Medical Test Site (MTS) Application - Certificate...

Certificate of Waiver Medical Test Site Application ... 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: 7

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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 ... Check Initial Application Leave CLIA Number blank Name of your organization

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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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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CLIA Waiver - Where to Send - HIV EIS

CLIA Waiver Application – Where to Send Where to send your CLIA Waiver application CLIA Program DHR – Office of Regulatory Services

http://www.hiveis.com/Forms/CLIAWaiver-WheretoSend.pdf

Date added: February 14, 2012 - Views: 4

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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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Application for a Pennsylvania Clinical...

TYPE OF CLIA CERTIFICATE APPLIED FOR – Attach CLIA Application for Certification (Form CMS-116) Waiver

http://www.portal.state.pa.us/portal/server.pt?open=18&objID=1240140&mode=2

Date added: March 3, 2013 - Views: 1

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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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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. ... CERTIFICATE OF WAIVER. Mailing Address: This address is optional and may be .

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

Date added: May 29, 2013 - Views: 2

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CERTIFICATE FEES FOR CLIA LABORATORIES - Oregon

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: 8

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

Page 1 of 2 FREQUENTLY ASKED QUESTIONS 1) How do I apply for CLIA certificate? https://www.cms.gov/CLIA/03_Interpretive_Guidelines_for_Laboratories.asp#TopOfP

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

Date added: May 5, 2013 - Views: 1

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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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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: 6

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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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( CLIA ) Certificate of Waiver (PDF) - HIVdent!

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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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 Certificate of Waiver Program Update

CLIA Certificate of Waiver Program Update Judy Yost, M.A., MT (ASCP) Director Division of Laboratory Services Centers for Medicare &Medicaid Services

http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0204/Addendum%20C_Yost_Certificate%20of%20Waiver_February%202004.pdf

Date added: February 14, 2012 - Views: 2

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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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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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Considerations for Waived Testing - Centers for...

use and those tests approved for waiver under the Clinical Laboratory Improvement Amendments . of 1988 ... CLIA CW Application: ... FDA’s CLIA Waived Test List:

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

Date added: August 8, 2013 - Views: 6

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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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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: 17

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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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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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New Jersey Department of Health APPLICATION FOR A...

New Jersey Department of Health ... Certificate of Waiver Certificate for Provider Performed ... Attach check to application.) 1. Fee for CLIA Waived ...

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

Date added: April 21, 2012 - Views: 3

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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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WAIVED HIV SPECIAL PROJECTS WAIVER APPLICATION

Waived HIV Special Projects Waiver - Required Documentation . CLIA application - completed and signed [if facility does not already have a certificate] website:

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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What is CLIA ’ 88 - Medical Supplies and Equipment

How to I get a CLIA Certificate of Waiver? - Download the file “CLIA Application,” found on the Unicity Start Up Kit web page and print it out.

http://www.medical-supplies-and-equipment.com/PRODUCT_GRAPHICS/PDF/CLIA_FAQ.PDF

Date added: June 7, 2012 - Views: 7

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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.

http://dhss.alaska.gov/dph/Labs/Documents/cms116.pdf

Date added: March 25, 2014 - Views: 1

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What is CLIA Waived Testing? - HCI Client

What is CLIA Waived Testing? ... The CLIA Certificate of Waiver must be renewed every two ... The state agency will process the application and send an invoice for

http://hciclient.com/pdfs/Waived_Testing_HCI_JA.pdf

Date added: May 9, 2013 - Views: 10

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CLINICAL LABORATORY EVALUATION PROGRAM

The New York State Department of Health’s Clinical Laboratory Evaluation Program has been authorized under Section 579 ... CLIA STATUS AND APPLICATION TYPE .

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

Date added: June 16, 2012 - Views: 2

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Karen W. Dyer, MT(ASCP) DLM Daralyn ... - Point of...

Waiver Non-exempt Laboratories by Application Type. ... others performing patient testing under a CLIA Waiver Certificate ... Clinical Laboratory Improvement Amendments

http://www.pointofcare.net/alabama/CLIAandWaivedTesting071311.pdf

Date added: July 20, 2012 - Views: 10