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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: 45

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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 - U S 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

We’re sorry, the page you’re looking for could not be found. To find the page you need, you may want to: Go to the DSHS homepage. Use the Topics A-Z ...

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

Date added: August 30, 2014 - Views: 1

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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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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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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 ...

and CLIA Certificate of Waiver or PPMP ... CMS 116 — CLIA application, ... Submit California Clinical Laboratory Registration fee and all required documents to ...

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

Date added: February 5, 2012 - Views: 15

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Download Download 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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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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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 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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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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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 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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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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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) 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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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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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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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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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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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 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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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/in/wp-content/uploads/2012/07/FORM-MKT-055.0-CLIA-FAQs.pdf

Date added: December 30, 2012 - Views: 2

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Administrative Changes to FDA’s CLIA Categorization Program

CLIA Categorization Program . Prakash Rath, Ph.D. Food and Drug Administration . ... CLIA Waiver By Application Changes . Overview of What has or is changing

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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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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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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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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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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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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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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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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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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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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How to get a CLIA Waiver for your Medical Device: One and a ...

chances for a successful CLIA Waiver application. Learning Objectives: Upon completing this course participants will know how to:

http://www.researchandmarkets.com/reports/3044234/how-to-get-a-clia-waiver-for-your-medical-device.pdf

Date added: December 25, 2014 - Views: 1

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved CENTERS ...

The CLIA application (Form CMS-116) collects information about your laboratory’s operation which is ... as waived mUst apply for a clia certificate of waiver.

http://www.innovationspracticestartup.com/docs/CLIA%20-%20CMS%20116.pdf

Date added: May 16, 2014 - Views: 1

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As you want it to appear on CLIA Certificate) Legal Name of ...

NEBRASKA CLIA CHANGE FORM ... APPLICATION TYPE CHANGE ... Waiver. Accreditation PPM Proposed certified as: Compliance. Waiver.

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

Date added: April 6, 2012 - Views: 2

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

Date added: December 22, 2014 - Views: 1

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Clinical Laboratories Improvement Act (CLIA) Information for ...

tests that qualify for this waiver can be found at http://www.cms.hhs.gov/clia • The application form, called CMS -116, and instructions on how to fill out

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

Date added: December 25, 2014 - Views: 1

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

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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SUMMARY OF STATE REGULATIONS AFFECTING HEALTH PROMOTION ...

CLIA WAIVER STATE REGULATORY ... WASHINGTON YES Apply directly to the state for CLIA application. Office of Lab Quality 1610 NE 150th St. K17-9 206-361-2802

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

Date added: April 19, 2012 - Views: 4

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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 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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CLIA - Missouri Department of Social 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