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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. GENERAL INFORMATION. ... Certificate of Waiver (Complete Sections I – VI and IX – X) Certificate for Provider Performed Microscopy Procedures (PPM)

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

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 to HHS or its designee on a form or forms

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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Maryland State Compliance Application - DHMH - ...

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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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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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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Laboratory Registration Application Instructions ...

and CLIA Certificate of Waiver or PPMP If your facility is performing Waived or Provider Performed Microscopy Procedures (PPMP) ... LAB 155 — Application for Clinical Laboratory Registration LAB 116 — Laboratory Personnel Report

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

Date added: February 5, 2012 - Views: 15

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

0938-0581 CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION I. GENERAL INFORMATION ... The CLIA application (Form CMS-116) collects information about your laboratory’s operation which is necessary

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 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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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 ...

COMMONWEALTH OF MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH Clinical Laboratory ... [CLIA] Application On February 28, 1992, the Department of Health and Human Services published regulations ... Application for Clinical Laboratory Improvement Amendments of 1998 [CLIA] Certificate - complete ...

http://www.mass.gov/eohhs/docs/dph/clinical-lab/clia-application-letter.pdf

Date added: May 11, 2012 - Views: 9

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Clinical Laboratory Application 2008 - Department of Health Home

WAIVER COMPLIANCE ACCREDITATION PROVIDER PERFORMED MICROSCOPY PROCEDURES ... American Thoracic Society (Blood Gas Only) (212) 315-8808 Pennsylvania Limited Survey ... Return both CLIA and Clinical Laboratory Application to: Bureau of Laboratories P.O. Box 500 Exton, PA 19341.

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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Medical Test Site (MTS) Application - Certificate of Waiver

Certificate of Waiver MTS Application Checklist and Instructions (continued) DOH 505-039 (April 2014) 2 of 2 Note: The lab contact will receive all information that we mail to your medical test site.

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

Date added: September 28, 2012 - Views: 7

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

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.azdhs.gov/lab/documents/license/certification/cms116.pdf

Date added: May 29, 2013 - Views: 2

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CLINICAL LABORATORY APPLICATION - Enterprise Portal Information

CERTIFICATE OF WAIVER PROVIDER-PREFORMED MICROSCOPY ... Return both CLIA and Clinical Laboratory Application to: Bureau of Laboratories P.O. Box 500 Exton, PA 19341 For overnight delivery services, our physical location is:

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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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 Laboratories Improvement Act (CLIA) Information

Administration (FDA), they must obtain a CLIA Certificate of Waiver. The ... Guidance/Legislation/CLIA/Downloads/waivetbl.pdf • The application form, called CMS -116, and instructions on how to fill out

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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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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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

http://www.hivdent.org/_hiv_screening/2011/OQA0285_0411_CLIA_Waiver_Instructions.pdf

Date added: February 18, 2012 - Views: 7

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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 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 - 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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Mississippi Medicaid CLIA Certification Information Section D ...

Mississippi Medicaid CLIA Certification Information Section D – 1 ... return with your provider application. ... If the CLIA number is not issued to the person/entity indicated above, please provide below a

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

Date added: March 12, 2012 - Views: 2

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GENERAL INSTRUCTIONS FOR COMPLETING AN APPLICATION FOR ...

New Jersey Department of Health ... Certificate of Waiver Certificate for Provider Performed Microscopy Procedures Certificate of Compliance ... (Include CLIS ID Number on check. Include photocopy of submitted check. Attach check to application.) 1. Fee for CLIA Waived Tests Only ...

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

Date added: February 13, 2012 - Views: 6

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

APPLICATION TYPE CHANGE ... Currently certified as: 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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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 CLIA ’88 - Cholestech LDX, Protime, InRatio, A1C ...

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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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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CLIA LABORATORY CERTIFICATE CHANGE FORM - Kansas

CLIA # _____ Date: _____ Laboratory Name ... _____ Waiver _____ PPM _____ Compliance _____Accreditation If requesting an accreditation certificate, please specify the accrediting agency:

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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WAIVED HIV SPECIAL PROJECTS WAIVER APPLICATION - Mass.Gov

CLIA #: Certificate Type: II. SCREENING PROGRAM INFORMATION ... “WAIVED” HIV Special Projects Waiver Application . Training Program . Copy of training program / material . Ongoing competency protocol . Training records for current testing personnel .

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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SECTION 12 LABORATORY SERVICES - Missouri Department of ...

Clinical Laboratory Improvement Act (CLIA) CLIA WAIVER PROCEDURES MO HealthNet providers possessing a “Certificate of Waiver” are allowed to perform the following procedures. Laboratories/providers with this type of certificate can bill only the

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

Date added: May 6, 2014 - Views: 2

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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 (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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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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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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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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NORTH CAROLINA STATE LABORATORY OF PUBLIC HEALTH CLIA ...

NORTH CAROLINA STATE LABORATORY OF PUBLIC HEALTH CLIA CONTRACT PROGRAM 2009 INTRODUCTION: The Clinical Laboratory Improvement Amendments (CLIA) ... NOTE: The technical consultant must review and approve the application and/or

http://slph.ncpublichealth.com/doc/2009_CLIA_Contract_Description.pdf

Date added: June 14, 2012 - Views: 5

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CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA ...

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) APPLICATION FOR CERTIFICATION I. GENERAL INFORMATION Facility Name Federal Tax Identification Number ... Certificate of Waiver (Complete Sections I - VI and VIII - X)

http://www.hmscweb.com/PDF_Files/HMSC/CLIA_Application.pdf

Date added: April 6, 2012 - Views: 10