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Clinical Laboratory Improvement Amendments (CLIA) Application ...

clinical laboratory improvement amendments (clia) application for certification. i. ... certificate of waiver

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

Date added: June 18, 2012 - Views: 47

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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: 38

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CLIA Waiver Application - Food and Drug Administration

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: 35

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CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION ...

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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State of California—Health and Human Services Agency ...

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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***Important*** ***Before submitting your application, please ...

Maryland Department of Health and Mental Hygiene Office of Health Care Quality – Laboratory Licensing Programs ... Completed CLIA application in agreement with

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

Date added: June 23, 2012 - Views: 5

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HOW DO I APPLY FOR CLIA CERTIFICATION? - lens cleaner ...

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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Laboratory Registration Application Instructions ...

Instructions for Applying for a California Clinical Laboratory Registration and CLIA Certificate of Waiver or ... LAB 155 — Application for Clinical Laboratory ...

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

Date added: February 5, 2012 - Views: 15

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DIRECTIONS FOR THE CLIA WAIVER APPLICATION - Maine.gov

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: 4

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CLIA APPLICATION - Texas Department of State Health Services ...

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: 2

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Guidance for Clinical Laboratory Improvement Amendments of ...

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: 2

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Clinical Laboratory Improvement Act (CLIA) Program Information

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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Medical Test Site (MTS) Application - Certificate of Waiver

Clinical Laboratory Improvement Amendments of 1988 (CLIA). ... Medical Test Site (MTS) Application Certificate of Waiver, CLIA Application Certificate of Waiver

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

Date added: September 28, 2012 - Views: 7

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

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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CLIA Waiver - Where to Send - HIV - Early Intervention Service

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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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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RI Department of Health - Rhode Island

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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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) Waivers

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: 2

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COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH ...

Federal Register implementing theClinical Laboratory Improvement Amendments of 1988 ... (certificate of waiver, certificate for ... 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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Application for a Pennsylvania Clinical Laboratory Permit

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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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: 3

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DEPARTMENTOF HEALTH AND HUMAN SERVICES CENTERS FOR MEDICARE ...

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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Application for a Pennsylvania Clinical Laboratory Permit

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

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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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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APPLICATION FOR STATE OF GEORGIA CLINICAL LABORATORY LICENSE

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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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: 3

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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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Role & Responsibilities of a Laboratory Director Under CLIA

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: 16

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Mississippi Medicaid CLIA Certification Information Section D ...

Section D, Page 1 of 1 Mississippi Medicaid CLIA Certification Information Section D – 1 (Page 1 of 1) General Instructions: Please complete this form.

https://msmedicaid.acs-inc.com/cliaCertificationInfo021403.pdf

Date added: March 12, 2012 - Views: 2

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CLIA Update - Centers for Disease Control and Prevention

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: 4

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Clinical Laboratory Improvement Amendments (CLIA) Background

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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State of Connecticut - CT.gov Portal

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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CLINICAL LABORATORY EVALUATION PROGRAM - Wadsworth Center ...

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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TA bulletin - clia waiver 01.10.07 - Texas Department of ...

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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CLIA Technical Bulletin - Medical Testing Equipment, Health ...

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: 30

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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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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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Considerations for Waived Testing - Centers for Disease ...

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: 1

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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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WAIVED HIV SPECIAL PROJECTS WAIVER APPLICATION - Mass.Gov

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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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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New Jersey Department of Health APPLICATION FOR A Clinical ...

CL-3 OCT 14 Page 1 of 8 Pages. New Jersey Department of Health Clinical Laboratory Improvement Services PO Box 361 Trenton, NJ 08625-0361 APPLICATION FOR A

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

Date added: April 21, 2012 - Views: 3

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Handbook for Providers of Laboratory Services Chapter L-200 ...

The Clinical Laboratory Improvement Amendments of 1988 ... The provider may obtain one of four types of CLIA certificates: A. Certificate of Waiver ... Illinois ...

http://www.hfs.illinois.gov/assets/072103lab.pdf

Date added: March 18, 2012 - Views: 8

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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/FAQ.PDF

Date added: February 14, 2012 - Views: 7

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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: 7