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CLIA Application for Certification (form CMS-116)

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CLIA Application for Certification (form CMS-116)

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

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

Date added: June 18, 2012 - Views: 121

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Clinical Laboratory Improvement Amendments (CLIA)...

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: 92

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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: 50

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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/facilities/pdf/CLIA-Application.doc

Date added: October 20, 2015 - 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: 13

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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: 8

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COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC...

COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH ... (certificate of waiver, ... 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 Waiver - ftp.cdc.gov

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

http://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/Addenda/cliac0908/Addendum%20Q.pdf

Date added: August 10, 2014 - Views: 1

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Application for CLIA Certificate of Waiver.pdf -...

clinicallaboratoryimprovement amendments of 1988 (clia) application for certification i. general information ... must apply for a clia certificate of waiver.

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

Date added: April 6, 2014 - Views: 1

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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: 24

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Clinical Laboratory Improvement Act (CLIA) Program...

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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State of California Health and Human Services...

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: 28

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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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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: 9

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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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New Jersey Department of Health APPLICATION FOR A...

APPLICATION FOR A ... CLIA Number (8) ... Certificate of Waiver Certificate for Provider Performed Microscopy Procedures Certificate of Compliance

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

Date added: April 21, 2012 - Views: 3

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***Important*** ***Before submitting your ...

Completed CLIA application in agreement with 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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TEXAS DEPARTMENT OF STATE HEALTH SERVICES

CLIA APPLICATION . The Texas Department of State Health Services CLIA Program requires the following ... 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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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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CERTIFICATE FEES FOR CLIA LABORATORIES - Oregon

CERTIFICATE FEES FOR CLIA LABORATORIES CLIA fees for Waived, PPMP, ... Waiver’ or ‘Certificate of Provider Performed Microscopy Procedures (PPMP)’. Non-

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

Date added: June 10, 2012 - Views: 10

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Certificate of Waiver Medical Test Site -...

Certificate of Waiver Medical Test ... Certificate of Waiver Medical Test Site Application ... exempt from the Clinical Laboratory Improvement Amendments of 1988 ...

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

Date added: September 28, 2012 - Views: 11

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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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APPLICATION FOR STATE OF GEORGIA CLINICAL...

YEAR CLIA # PART I. GENERAL INFORMATION Name of Laboratory: Address: City: County: State: Zip Code: ... APPLICATION FOR CLINICAL LABORATORY DIRECTOR

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: 14

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Clinical Laboratory Improvement Amendments (CLIA) ...

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION. I. GENERAL INFORMATION. ... Certificate of Waiver (Complete Sections I – VI and IX ...

http://www.idph.state.il.us/clia/pdf/CLIA_LicenseApplicationCMS-116_and_Instructions1.pdf

Date added: May 18, 2015 - Views: 1

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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.

https://www.miemss.org/home/Portals/0/Docs/CommercialAmbulance/CLIA%20Waiver%20Form.pdf

Date added: February 2, 2016 - Views: 1

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CLIA Update

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: 30

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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 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: 11

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To Test or Not to Test? - Centers for Disease...

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: 12

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CLIA Requirements updated 2-29-08 with edits

Updated 2/29/08 Page 6 CLIA Requirements for the “Children’s Lead Screening Program of Idaho (Clinical Laboratory Improvement Amendments) In order to perform ...

http://healthandwelfare.idaho.gov/LinkClick.aspx?fileticket=mgMiTDEAT5A%3d&tabid=692&mid=3906

Date added: March 7, 2016 - Views: 1

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What is a CLIA certificate of waiver? - RPS...

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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health.mo.gov

centers for medicare & medicaid services clinical laboratory improvement amendments certificate of compliance laboratory name and address missouri state public health lab

http://health.mo.gov/lab/pdf/clia_certificate.pdf

Date added: October 31, 2015 - Views: 1

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WAIVED HIV SPECIAL PROJECTS WAIVER APPLICATION

u:\web uploads\clia\hiv-waived-test-application.rtf DEPARTMENT OF PUBLIC HEALTH CLINICAL LABORATORY PROGRAM 99 Chauncy Street, Boston, MA 02111

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 Waived Tests and CPT Codes

Test Name/Specific Test System Manufacturer Approved CPT Code(s) Adenovirus ... CLIA Waived Inc Rapid STREP A Test Sa Scientific Inc 87880QW

http://www.doh.wa.gov/portals/1/Documents/Pubs/681018.pdf

Date added: September 28, 2012 - Views: 79

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Overview IHCP Provider CLIA Certificate...

IHCP Provider CLIA Certificate Maintenance Form indianamedicaid.com Overview. HPE Provider Enrollment Unit IHCP Provider CLIA Certificate Maintenance

http://provider.indianamedicaid.com/media/63743/ihcp%20clia%20certification%20maintenance%20form.pdf

Date added: May 6, 2012 - Views: 1

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As you want it to appear on CLIA Certificate)...

As you want it to appear on CLIA Certificate) Legal Name of Facility. ... APPLICATION TYPE CHANGE ... Compliance. Waiver. Accreditation PPM Proposed certified as: ...

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

Date added: April 6, 2012 - Views: 2

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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 Technical Bulletin - hmscweb.com

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: 40

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

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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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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This test is CLIAWaived

This test is CLIA “Waived” ThyroChek® TSH ... does not have a Certificate of Waiver, the Application for Certification (Form CMS-116), can be

http://www.cliawaived.com/web/items/pdf/PMS-120-Binsert.pdf

Date added: August 16, 2013 - Views: 1

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PART 493—LABORATORY REQUIREMENTS

Subpart B—Certificate of Waiver 493.35 Application for a certificate of waiv- ... gent than CLIA requirements and the State licensure program has been ap-

http://www.gpo.gov/fdsys/pkg/CFR-2012-title42-vol5/pdf/CFR-2012-title42-vol5-part493.pdf

Date added: August 29, 2013 - Views: 1

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CMS-116 Clinical Laboratory Improvement...

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION ... CMS-116 Clinical Laboratory Improvement Amendements ...

https://www.colorado.gov/pacific/sites/default/files/CMS116%20Application%20with%20ATVR%20revised.pdf

Date added: April 11, 2016 - Views: 1

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CLIA LABORATORY CERTIFICATE CHANGE FORM - KDHE

CLIA LABORATORY CERTIFICATE CHANGE FORM ... _____ Waiver _____ PPM _____ Compliance _____Accreditation If requesting an accreditation certificate, ...

http://www.kdheks.gov/lipo/download/CLIA_Certificate_Change_Form.pdf

Date added: January 16, 2013 - Views: 4

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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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USC Mobile CLIA Waived Testing Policy and...

USC Mobile CLIA Waived Testing Policy and Procedures 1 updated 9/24/2013 . The USC School of Pharmacy is committed to providing the highest quality patient care

http://www.uscassp.org/wp-content/uploads/2014/03/CLIA-Waived-Lab-PP-Updated-9-24-2013.pdf

Date added: April 24, 2014 - Views: 15

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Point of Care and CLIA Waived Devices - AdvaMed

plus CLIA waiver (if not for OTC use) POC •Many categorized as moderate •PT testing and CLIA requirements ... Point of Care and CLIA Waived Devices Keywords:

http://advamed.org/res.download/172

Date added: June 3, 2013 - Views: 1

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Please complete and submit 3 forms: Application...

Please complete and submit 3 forms: Application for Certification (CLIA 116), the Health Screen Testing Permit Application and the Director Qualification

http://public.health.oregon.gov/LaboratoryServices/ClinicalLaboratoryRegulation/Documents/h-ltr.pdf

Date added: July 14, 2013 - Views: 3

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CLIA Required Personnel Qualifications - Joint...

CLIA Required Personnel Qualifications Stacy Olea, FACHE, MT(ASCP) Field Director . Surveyor Management and Development . ... CLIA The Joint Commission Created Date:

http://www.jointcommission.org/assets/1/18/CLIA_required_personnel_qualifications.pdf

Date added: March 7, 2013 - Views: 10