Understanding CLIA: Ensuring Quality Laboratory Testing in Oregon
Describing the Clinical Laboratory Improvement Amendments (CLIA) program in Oregon, focusing on sustainable compliance for quality laboratory testing. Explains the purpose of CLIA, types of certifications, and requirements for laboratories. Highlights the role of the Oregon State Agency in administering CLIA regulations and ensuring accurate patient testing.
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OSPHL Laboratory Compliance Program 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 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. OHA/OSPHL/Lab Compliance Section 2
Who 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. OHA/OSPHL/Lab Compliance Section 3
What 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 493.2 Applies 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. OHA/OSPHL/Lab Compliance Section 4
What 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) OHA/OSPHL/Lab Compliance Section 5
Types 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. OHA/OSPHL/Lab Compliance Section 6
CLIA 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 complexity It 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 OHA/OSPHL/Lab Compliance Section 7
What 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 questions 503-693-4125 OHA/OSPHL/Lab Compliance Section 8
To 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 OHA/OSPHL/Lab Compliance Section 9
After 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. OHA/OSPHL/Lab Compliance Section 10
Authorized 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. OHA/OSPHL/Lab Compliance Section 11
Resource 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.p df CDC Site for Certificate of Waiver Labs https://www.cdc.gov/clia/waived-tests.html Authorized Provider information https://www.oregon.gov/oha/PH/LABORATORYSERVICES/CLINICALL ABORATORYREGULATION/Documents/order.pdf OHA/OSPHL/Lab Compliance Section 12
Resource Material, cont. Laboratory Compliance website: www.healthoregon.org/ll Laboratory Compliance contact information: lc.info@dhsoha.state.or.us Phone: 503-693-4125 Fax: 503-693-5602 7202 NE Evergreen Pkwy Suite 100 Hillsboro, OR 97124 OHA/OSPHL/Lab Compliance Section 13
