Clinical Laboratory Improvement Amendment CLIA State Agency for Oregon January 27 2022 Jeremy Bliss AS2 Lab Compliance Oregon Health Authority Objective Describing CLIA and Certificate of Waiver ID: 929498
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OSPHLLaboratory Compliance Program
Clinical Laboratory Improvement Amendment (CLIA)
State Agency for Oregon
January 27, 2022
Jeremy Bliss, AS2
Lab Compliance
Oregon Health Authority
Slide2Objective:
Describing CLIA and Certificate of Waiver
Ultimate goal is to assure all laboratories achieve and maintain sustainable laboratory compliance to ensure quality laboratory testing.Who we are, when to call and where to contact Laboratory Compliance Section for laboratory questions and concerns.
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Slide3Who is Laboratory Compliance
Our office is the State Agency (SA) for CLIA in Oregon
Contracted by Centers for Medicare & Medicaid Service (CMS) to administer CLIA in Oregon.
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Slide4What is CLIA?
Clinical Laboratory Improvement Amendments (CLIA) formalized by Congress in 1988. It is called CLIA ‘88.
CLIA is federal regulation that oversees lab testing on human specimens for
the purpose of treatment, diagnosis or assessment of health to ensure accurate, reliable and timely patient testing. 42 CFR 493.2Applies to all entities providing clinical lab testing for a patient, including simple tests such as blood glucose, when performed by facility staff for the patient.
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Slide5What Is A Lab?
If an entity performs even a single clinical lab test where a test result may be read it is considered a lab for the purpose of CLIA regulation. (42 CFR 493.2, Definitions)
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Slide6Types of CLIA Certification
Certificate of Waiver (Simplest testing)
Certificate of Provider Performed Microscopy (Requires Qualification)
Certificate of Compliance (Requires Qualification)Certificate of Accreditation (Requires Qualification)
Food and Drug Administration (FDA) determines complexity of testing and complexity determines type of certificate required to perform the test.
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Slide7CLIA Certificate of Waiver
Cost is $180.00 for a two-year certificate
No qualification of Laboratory Director or testing personnel
May only perform tests authorized for/rated as waived complexityIt is incumbent on holder of the CLIA certificate to ensure they comply with all regulations and are only performing testing appropriate to the certificate.Waived from routine onsite survey and waived from personnel qualification. Not waived from CLIA regulation
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Slide8What Testing is Under Certificate of Waiver?
Fully Authorized by Food and Drug Administration
Complexity rating = Waived
Food and Drug Administration (FDA) Emergency Use Authorization (EUA)Authorized Setting = W
Manufacturers include this in the package insert or instructions for use.Call us if you have questions503-693-4125
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Slide9To Apply for a CLIA Certificate of Waiver
Complete sections I-VI, IX and X of CMS-116 application.
Application should be signed and dated by Lab Director named on page 1 of application.
Application should be emailed, faxed or mailed to Lab Compliance for review and processing.Application may be found here:www.healthoregon.org/ll
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Slide10After Submission of Application
Please ensure we have good contact information for applicant in case we need to communicate with you.
Once application is processed the fee for certificate must be paid.
Payment is made directly to federal program-not State of Oregon.After being paid for the certificate will be printed and mailed to the certificate holder.
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Slide11Authorized Provider
Oregon law requires an order for a clinical lab test to be performed in most circumstances. ORS 438.430 (1)
Authorized provider is defined by individual licensing in State of Oregon
MD, DO, PA, NP, etc.Pharmacists may also order for COVID testing only.Authorized Provider does not need to perform the test just order the test to be performed.Performing personnel must be trained to do so and follow package insert instructions.
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Slide12Resource Material
CMS material for CLIA
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/cliabrochure.pdf
https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdfCDC Site for Certificate of Waiver Labs
https://www.cdc.gov/clia/waived-tests.htmlAuthorized Provider informationhttps://www.oregon.gov/oha/PH/LABORATORYSERVICES/CLINICALLABORATORYREGULATION/Documents/order.pdf
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Slide13Resource Material, cont.
Laboratory Compliance website:
www.healthoregon.org/ll
Laboratory Compliance contact information:lc.info@dhsoha.state.or.usPhone: 503-693-4125Fax: 503-693-5602
7202 NE Evergreen PkwySuite 100Hillsboro, OR 97124
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