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Form CMS-116 - Home - Centers for Medicare & Medicaid Services

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Form CMS-116 - Home - Centers for Medicare & Medicaid Services

clinical laboratory improvement amendments (clia) application for certification i. General information ... The CLIA application ... 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: 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 Clinical Laboratory Improvement Amendments (CLIA)

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 Correspondent:

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

CLIA APPLICATION . The Texas Department ... tHe clinical laboratory improvement amendments (clia) application ... as waived mUst apply for a clia certificate of waiver. note: laboratory directors performing non-waived testing (including ppm) must meet ...

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

Date added: August 30, 2014 - Views: 1

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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) APPLICATION ...

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION ... The CLIA application (Form CMS-116) ... Certificate of Waiver . can only perform tests categorized as waived;* •

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.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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***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 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 ...

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? - 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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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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State of California Health and Human Services Agency ...

State of California—Health and Human Services Agency ... Instructions for Applying for a California Clinical Laboratory Registration and CLIA Certificate of Waiver or PPMP If your facility is performing Waived or Provider Performed ... 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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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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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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COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH ...

Federal Register implementing theClinical Laboratory Improvement Amendments of 1988 ... applicable, the compliance fee. The appropriate certificate (certificate of waiver, certificate for provider-performed microscopy procedures, ... 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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Medical Test Site (MTS) Application - Certificate of Waiver

Clinical Laboratory Improvement Amendments of 1988 (CLIA). You do not need to apply to the Centers ... Certificate of Waiver Medical Test Site Application Checklist and Instructions Revenue Section P.O. Box 1099 Olympia, WA 98507-1099 253.395.6746

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

Date added: September 28, 2012 - Views: 7

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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 for the purpose of providing information for the diagnosis,

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

Date added: August 16, 2013 - Views: 1

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Clinical Laboratory Application 2008 - Department of Health Home

WAIVER COMPLIANCE ACCREDITATION PROVIDER PERFORMED MICROSCOPY PROCEDURES (PPMP) ... Return both CLIA and Clinical Laboratory Application to: Bureau of Laboratories P.O. Box 500 Exton, PA 19341. Title: Microsoft Word - Clinical Laboratory Application 2008.doc

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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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 performing all testing, e.g. blood glucose monitoring, a

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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RI Department of Health - Rhode Island

Application and instructions for Clinical Laboratory RI General Law Chapter 23-16.2 ... Out-of-state laboratories provide a copy of your state license and/or your CLIA certificate. ... to the Rhode Island Division of Taxation pursuant to Chapter 76 of Title 5 of the Rhode

http://www.health.ri.gov/applications/ClinicalLaboratory.pdf

Date added: June 13, 2012 - Views: 3

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CLINICAL LABORATORY APPLICATION - Enterprise Portal Information

clinical laboratory application for department use only state id # level ... clinical laboratory improvement amendments (clia) #: ... type of clia certificate requested (check one) certificate of waiver provider-preformed microscopy procedures (ppmp)

http://www.portal.state.pa.us/portal/server.pt?open=18&objID=1224557&mode=2

Date added: October 19, 2012 - Views: 4

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

Directions for the CLIA Waiver Application For Blood Glucose in the Field To get the CLIA Waiver Application, go to: ... Michigan Department of Licensing and Regulatory Affairs Bureau of Health Systems, Division of Licensing & Certification

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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State of Connecticut - CT.gov Portal

How to obtain a CLIA Waiver……………………………………………… ... CLIA Application for Certification Attachment 15A: ... Connecticut Department of Public Health has a Companion Awareness Risk Education

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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Clinical Laboratory Improvement Amendments (CLIA) Background

Clinical Laboratory Improvement Amendments (CLIA) Background Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for ... 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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Clinical Laboratories Improvement Act (CLIA) Information

CLIA Information Revised 9/2012 . ... Administration (FDA), they must obtain a CLIA Certificate of Waiver. The tests that qualify for this waiver can be found at http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/waivetbl.pdf • The application form, ...

http://www.health.state.mn.us/divs/fpc/profinfo/20120912cliawaiverinfo.pdf

Date added: December 30, 2012 - Views: 2

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Application for a Pennsylvania Clinical Laboratory Permit

Clinical Laboratory Improvement Amendments (CLIA) ID Number . TESTING LOCATIONS . Location (Name and/or address) Date(s) Bureau of Laboratories Application for a Pennsylvania Clinical Laboratory Permit To Operate Screening Sites Updated 2/22/12 Page 2 of 5

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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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 system. A fee coupon will be mailed in 2-3 weeks. Follow the instructions for payment of 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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Question Answer Federal requirement - Wisconsin Department of ...

CLIA Certificate of Waiver? Requirements include: ... Complete the CLIA application form, CMS-116, and submit it to the state agency along with a copy of the Laboratory Director’s State of Wisconsin license (see state agency contact info below).

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

Date added: February 14, 2012 - Views: 8

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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 Certificate of Waiver, or other CLIA certificate number, on your claim for Medicare reimbursement or reimbursement will be denied.

http://www.hmscweb.com/PDF_Files/Cholestech/Technical_Bulletin_LDX_-_CLIA_88.pdf

Date added: May 11, 2012 - Views: 30

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

APPLICATION TYPE CHANGE (Compliance, ... Compliance. Waiver. Accreditation PPM Proposed certified as: Compliance. Waiver. Accreditation PPM Effective ... \MSOFFICE\Word\Labs\CLIA Change Form.doc . May 14, 2012 . LIST OF TESTS PERFORMED

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

Date added: April 6, 2012 - Views: 2

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GENERAL INSTRUCTIONS FOR COMPLETING AN APPLICATION FOR ...

and attach check to the application. If you are performing only CLIA waived tests in a specialty, do not check off that specialty on Page 7. ... Certificate of Waiver Certificate for Provider Performed Microscopy Procedures Certificate of Compliance Certificate of ...

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

Date added: February 13, 2012 - Views: 6

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CLIA Update - Centers for Disease Control and Prevention

CLIA CLIA Update CLIAC March 2011 Harriet Walsh Deputy Director. Division of Laboratory Services. CLIA Topic Areas ... Waiver Non-exempt Laboratories by Application Type Number of Laboratories CLIA Year. CLIA CMS Waived Project-Complaint Scenario

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 a CLIA certificate of waiver? - Rapid Pathogen ...

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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Please complete and submit 3 forms: Application for ...

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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What is CLIA ’88 - Medical Supplies and Equipment

CLIA Certificate of Waiver. The fee for the Certificate of Waiver is $150 and is valid for two years. 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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CLIA LABORATORY CERTIFICATE CHANGE FORM - Kansas

CLIA LABORATORY CERTIFICATE CHANGE FORM ... NEW Certificate: _____ Waiver _____ PPM _____ Compliance _____Accreditation If requesting an accreditation certificate, please ... Microsoft Word - CLIA Change Form Feb 17 2014.doc Author:

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

Date added: January 16, 2013 - Views: 4

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SUMMARY OF STATE REGULATIONS AFFECTING HEALTH PROMOTION ...

CLIA WAIVER STATE REGULATORY STATE RECOGNIZED OTHER REQUIREMENTS/RESTRICTIONS ENTITY (CLIA) ADDRESS TELEPHONE. MARYLAND NO No trig or glucose testing permitted Dept. of Health BB Building, Laboratory Unit 410-402-8025

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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SECTION 12 LABORATORY SERVICES - Missouri Department of ...

Missouri MO HealthNet follows Medicare guidelines for billing of professional and ... 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.cms.hhs.gov/forms/cms116.pdf “WAIVED” HIV Special Projects Waiver Application .

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 (Clinical Laboratory Improvement Act) Re ...

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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Current CLIA Regulations (including all changes through 01/24 ...

Clinical Laboratory Improvement Amendments (CLIA) 493.39 Notification requirements for laboratories issued a certificate of waiver Subpart C--Registration Certificate, Certificate for

http://michigan.gov/documents/HCFA0301_95161_7.pdf

Date added: September 26, 2012 - Views: 13

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CLIA LABORATORY USER FEES - New Jersey

CMS Centers for Medicare and Medicaid Services CLIA LABORATORY USER FEES CLIA ID Number Fees for Certificate of Certificate Period Payment Due Date Total Payment Due

http://www.nj.gov/health/phel/documents/userfees_coupon.pdf

Date added: January 28, 2012 - Views: 6

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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. Number of Laboratories. ... Clinical Laboratory Improvement Amendments (CLIA) Equivalent Quality Control Procedures. Brochure #4. What are they, and when can I use them?

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

Date added: July 20, 2012 - Views: 8

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Role & Responsibilities of a Laboratory Director Under CLIA

PT Check UP POL Library ROLES & RESPONSIBILITIES OF A CLIA CERTIFICATE OF WAIVER LABORATORY DIRECTOR CLIA Requirements In 1988, Congress passed the Clinical Laboratory Improvement Amendments (CLIA)

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

Date added: September 26, 2012 - Views: 15

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STATE SURVEY AGENCIES (CLIA CONTACT LIST) - Amcon Labs

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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In-House CLIA Waived Point-of-Care Diagnostic Testing

In-House CLIA Waived Point-of-Care Diagnostic Testing Presented by: Ann Hinson, MT (ASCP) CHCANYS Annual Conference, October 5, 2010

http://www.chcanys.org/clientuploads/2010_pdfs/October%20Conference%20Presentations/HeartHealthIn_HouseCLIAWaivedPOC_AHinson.pdf

Date added: March 24, 2013 - Views: 8

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Rumpakis- Unraveling The Mysteries of CLIA

Understand the application process and how to obtain a CLIA waiver for their ... Unraveling The Mysteries of CLIA – John Rumpakis, OD, MBA Page 2 of 2 ... Navigating the CLIA application process successfully ...

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

Date added: August 1, 2013 - Views: 1