UPGRADE YOUR FACILITY TO NONWAIVED TESTING AND TRANSFORM YOUR POINT-OF-CARE EXPERIENCE

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MOVING TO NONWAIVED TESTING

Abbott 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 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
 
Module 1: Applying for a CLIA Certificate of <br> 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.

Module 1: Applying for a CLIA Certificate of <br> Compliance or Accreditation
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.

Module 2: Lab Director and Technical Consultant <br> Requirements
Module 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.

Module 3: Quality Control Options
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.

Module 4: Procedure Manual
Module 4: Procedure Manual

Learn how to access the procedure manual on the Abbott Point of Care website.

Module 5: Performance Verification
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.

Module 6: Proficiency Testing
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.

Module 7: Testing Personnel
Module 7: Testing Personnel

Review the CLIA qualifications for testing personnel and documentation of proof. This module only refers to CLIA standards.

Module 8: Competency Assessment
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.

Module 1: Applying for a CLIA Certificate of Compliance or Accreditation

Module 2: Lab Director and Technical Consultant Requirements

Module 3: Quality Control Options

Module 6: Proficiency Testing

Module 8: Competency Assessment

Contact us

Need more information to transform your facility to moderately complex testing?

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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 an Academic Medical Center, Am J Clin Pathol November 2014;142:640-646. (Actual savings can vary depending on state-specific factors.)