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Clinical Laboratory Improvement Amendments (CLIA) Application ...

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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: 43

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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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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://dshs.state.tx.us/hfp/pdf/CLIA-Application.doc

Date added: August 30, 2014 - Views: 1

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HOW DO I APPLY FOR CLIA CERTIFICATION? - Amcon Labs

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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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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Maryland State Compliance Application - DHMH - ...

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 Agency ...

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: 15

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

Directions for the CLIA Waiver Application For Blood Glucose in the Field ... Michigan Department of Licensing and Regulatory Affairs Bureau of Health Systems, ...

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES FORM APPROVED CENTERS ...

THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION (FORM CMS-116) INSTRUCTIONS FOR COMPLETION CLIA requires every facility that tests human specimens ...

http://www.cardinalhealth.com/content/consumerhealth/files/20090701_CLIA%20Waiver%20Application.pdf

Date added: August 16, 2013 - Views: 1

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Medical Test Site (MTS) Application - Certificate of Waiver

Certificate of Waiver Medical Test Site (MTS) Application Packet ... Clinical Laboratory Improvement Amendments of 1988 (CLIA). You do not need to apply to the Centers

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

Date added: September 28, 2012 - Views: 7

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

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: 1

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Application for a Pennsylvania Clinical Laboratory Permit

Operation of a clinical laboratory in Pennsylvania requires a federal Clinical Laboratory Improvement Amendments (CLIA) certificate in addition to a Pennsylvania permit.

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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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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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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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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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 ) 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 Frequently Asked Questions - Wisconsin Department of ...

Division of Quality Assurance CLIA – Frequently Asked Questions June 2013 responsible for the survey/inspection. 6) How do I apply for a CLIA

http://www.dhs.wisconsin.gov/rl_dsl/Labs/q&aclia.pdf

Date added: February 14, 2012 - Views: 8

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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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CLIA FAQs 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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State of Connecticut - CT.gov Portal

CT DPH Laboratory Forms ... CLIA Application for Certification ... CLIA waiver applications can be obtained by contacting John Murphy, at

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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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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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/hivstd/fieldops/TA_Bulls/clia_waiver.pdf

Date added: February 14, 2012 - Views: 9

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Karen W. Dyer, MT(ASCP) DLM Daralyn Hassan, MS, MT(ASCP)

Point-of-Care Testing ... Waiver Non-exempt Laboratories by Application Type. ... waived Tests under the Clinical Laboratory Improvement Amendments ...

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

Date added: July 20, 2012 - Views: 8

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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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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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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 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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SECTION 12 LABORATORY SERVICES

Clinical Laboratory Improvement Act (CLIA) CLIA WAIVER PROCEDURES MO HealthNet providers possessing a “Certificate of Waiver” are allowed to perform the

http://dss.mo.gov/mhd/providers/education/health/health12.pdf

Date added: May 6, 2014 - 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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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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CLINICAL LABORATORY EVALUATION PROGRAM - Wadsworth Center

This information is needed to assign and maintain your CLIA certification. Indicate your laboratory ... Once the Limited Service Laboratory Registration application ...

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

Date added: June 16, 2012 - Views: 2

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Administrative Changes to FDA’s CLIA Categorization Program

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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STATE OF MARYLAND - ADAA - Home

All Behavioral Health Treatment Programs . Page 2 . 2. The State Compliance Application and CLIA application request the name of a Laboratory Director.

http://adaa.dhmh.maryland.gov/Documents/content_documents/QualityAssurance/Compliance/LabRegsforprovidersApril2013.pdf

Date added: May 14, 2013 - Views: 2

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CLIA Waiver - Centers for Disease Control and Prevention

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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What is CLIA ’88 - Medical Supplies and Equipment

CLIA ’88 stands for Clinical Laboratory Improvement ... How to I get a CLIA Certificate of Waiver? - Download the file “CLIA Application,” found on the Unicity ...

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

Date added: February 14, 2012 - Views: 7

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CLIA - Medical Testing Equipment, Health Test Kits, Drug ...

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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To Test or Not to Test?

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: 1

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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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Rumpakis- Unraveling The Mysteries of CLIA

Unraveling The Mysteries of CLIA – John Rumpakis, OD, MBA Page 2 of 2 Management, Consulting, Audit, Appraisal, Education

http://www.coavision.org/files/CLW1-%20Unraveling%20The%20Mysteries%20of%20CLIA.pdf

Date added: August 1, 2013 - Views: 1