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MOVING TO NONWAIVED TestING
Abbott Point of Care is committed to helping support your transition from waived to nonwaived testing.
waived to moderately complex testing
waived tests are simple tests with a low risk for an incorrect result.1
NonWaived TESTS, also called Moderately Complex tests, are those tests that require a number of criteria to be met prior to the operator running the testS.1
BENEFITS OF OFFERING NONWaived PoC TESTING:
- Offer broader menu of tests in your healthcare facility.
- Minimize delays in care and reduce return visits due to unavailable or delayed lab results, which may improve patient satisfaction.2
Moderately complex testing TOolkit
Module 1: Applying for a CLIA Certificate of Compliance or Accreditation
Learn how to access, complete, and submit the CMS-116 form for a certificate of moderately complex testing to the State Agency. (Length: 11:53)
How to apply for a CLIA Certificate CLIA STATE AGENCIES CMS 116 Form Nonwaived Testing Quick Reference GuideModule 2: Lab Director and Technical Consultant Requirements
Review the CLIA definitions for Laboratory Director, Technical Consultant, the responsibilities, qualifications and how to obtain CMEs to meet the Lab Director requirements. (Length: 6:16)
Lab Director Qualifications Lab Director Responsibilities Technical Consultant Qualifications Module 3: Quality Control Options
Review the definition of quality control, what the CMS/CLIA requirements are for nonwaived testing, what an IQCP is and tips to develop a quality control plan for the laboratory. (Length: 10:56)
Introduction to IQCP Module 5: Performance Verification
Information regarding the CLIA requirements, data collection template for documentation, and directions of where to find PV protocol and value assignment sheets. (Length: 7:16)
CLIA PV Brochure PV Quick Reference Guide i-STAT PV Data Sheet Module 6: Proficiency Testing
Review the definition of Proficiency Testing, the CLIA requirements for nonwaived testing, how to enroll in a PT program and tips for performance. (Length: 7:09)
CLIA PT BROCHURE PT Testing Module 7: Testing Personnel
Review the CLIA qualifications for testing personnel and documentation of proof. This module only refers to CLIA standards. (Length: 2:38)
Module 8: Competency Assessment
Review the CLIA requirements for Competency Assessment using the six elements for documentation. Directions on where to find examples of a checklist and test questions that can be used to meet CMS/CLIA requirements. (Length: 7:20)
CLIA Competency Assessment Brochure
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The material contained on this website is for informational purposes only and not for the purpose of providing legal or regulatory advice. Use of the information provided on this website is at your own discretion. Please contact your attorney and regulatory experts to determine the best approach for your lab.
REFERENCES
1. CDC. Waived Tests. Cdc.gov. Available at: https://www.cdc.gov/clia/waived-tests.html [Accessed November 18, 2019]. 2. Crocker J, et al, Implementation of Point-of-Care Testing in an Ambulatory Practice of and Academic Medical Center, Am J Clin Pathol November 2014;142:640-646. (Actual savings can vary depending on state-specific factors.)