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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? ... application for the laboratory sites within the same physical location or street address.

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

Date added: July 18, 2012 - Views: 33

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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 ...

Completed CLIA application in agreement with State application Copy of CLIA certificate and State Laboratory License, if applicable Copy of Director’s Maryland (Board of Physicians) license to practice medicine Copy of most recent survey, which includes cited

http://dhmh.maryland.gov/ohcq/Labs/docs/LabsApps/md_compliance_app.pdf

Date added: June 23, 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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CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION ...

THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION ... The CLIA application ... Certificate of Waiver . can only perform tests categorized as waived;* • Certificate for Provider Performed Microscopy Procedures

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 ...

If you are applying for a CLIA Certificate of Waiver or Certificate for Provider Performed Microscopy Procedures (PPMP), ... LAB 144B — Application for Additional Clinical Laboratory Testing Sites, ONLY if qualified for

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

Date added: December 30, 2011 - Views: 14

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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 ...

and CLIA Certificate of Waiver or PPMP If your facility is performing Waived or Provider Performed Microscopy Procedures (PPMP) ... CMS 116 — CLIA application, unless already certified by CMS State LAB forms can be downloaded from:

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

Date added: February 5, 2012 - Views: 15

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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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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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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 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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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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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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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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RI Department of Health

Application and instructions for Clinical Laboratory RI General Law Chapter 23-16.2 ... Federal CLIA Provider Number Federal CLIA Provider Number: _____ State of Rhode Island and Providence Plantations Department of Health Page 3 of 6 ...

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 ...

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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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 Laboratories Improvement Act (CLIA) Information

Administration (FDA), they must obtain a CLIA Certificate of Waiver. The tests that qualify for this waiver can be found at ... • The completed application form should be mailed or faxed to: CLIA Program MN Department of Health . 1645 Energy Park Drive, Suite 300 .

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

Date added: December 30, 2012 - Views: 2

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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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Clinical Laboratory Improvement Amendments (CLIA) Background

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA) APPLICATION FOR CERTIFICATION I. GENERAL INFORMATION Initial Application Survey ... 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 LABORATORY APPLICATION - Enterprise Portal Information

before submitting the application, ... clinical laboratory improvement amendments (clia) #: (if previously assigned otherwise for dept use only): ... type of clia certificate requested (check one) certificate of waiver provider-preformed microscopy procedures ...

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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TA bulletin - clia waiver 01.10.07 - Texas Department of ...

obtaining a CLIA waiver Download a CLIA application at: http://www.cms.hhs.gov/cmsforms/downloads/cms116.pdf Agencies applying for waivers complete sections I thru VI and VIII thru X, following 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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Application for a Pennsylvania Clinical Laboratory Permit

Application for a Pennsylvania Clinical Laboratory Permit To Operate Screening Sites ... Only CLIA- -waived instruments/test kits may be used to conduct testing at screening sites. The tests typically approved for use at screening sites are listed.

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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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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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: http://www.cms.gov/cmsforms/downloads/cms116.pdf

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

Attachment 14C: CLIA Application for Certification Attachment 15A:Instructions for HIV Counselors – Adult HIV Confidential Case ... CLIA waiver applications can be obtained by contacting John Murphy, at the State Department of Public Health.

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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What is a CLIA certificate of waiver? - rpsdetectors.com

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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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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CLIA Update - Centers for Disease Control and Prevention

CLIA collaborating with OCR and CDC on the best way to address patient access to laboratory test reports ... 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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FAQs for Laboratories Licensure - Maryland DHMH

A. “CLIA” stands for the Clinical Laboratory Improvement Amendments Act of 1988. ... A waiver is a level of certification that is issued by the federal government. ... application process then comes to a halt with the expiration of the provisional permit. Q.

http://www.dhmh.maryland.gov/ohcq/Labs/docs/Laboratories%20-%20License%20FAQ.pdf

Date added: December 10, 2012 - 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 (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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CLIA LABORATORY CERTIFICATE CHANGE FORM - Kansas

CLIA LABORATORY CERTIFICATE CHANGE FORM CLIA # _____ Date: _____ Laboratory ... NEW Certificate: _____ Waiver _____ PPM _____ Compliance _____Accreditation If requesting an accreditation certificate, please ...

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

Date added: January 16, 2013 - Views: 4

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

CLIA NUMBER. DATE. Laboratory Name ... APPLICATION TYPE CHANGE (Compliance, PPM and Accreditation ... Waiver. Accreditation PPM Proposed certified as: Compliance. Waiver. Accreditation PPM Effective Date for the above application type change: ...

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

Date added: April 6, 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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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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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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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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SUMMARY OF STATE REGULATIONS AFFECTING HEALTH PROMOTION ...

summary of state regulations affecting health promotion testing/hp market clia waiver state regulatory state recognized other requirements/restrictions entity(clia ) address telephone

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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Rumpakis- Unraveling The Mysteries of CLIA

Amendments (CLIA). 2. Understand the application process and how to obtain a CLIA waiver for their practice. 3. Understand the clinical tests that have a CLIA waiver and are applicable to an ophthalmic based ...

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

Date added: August 1, 2013 - Views: 1

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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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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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Clinical Laboratories Improvement Act (CLIA) Information

Administration (FDA), they must obtain a CLIA Certificate of Waiver. The 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 the form can be found at:

http://www.health.state.mn.us/divs/fpc/profinfo/20120918hccliawaiver.pdf

Date added: September 30, 2013 - Views: 1

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

Waiver Non-exempt Laboratories by Application Type. Number of Laboratories. CLIA. Year. ... 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