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Question
Is the registered nurse (RN) allowed to perform a Clinical Laboratory Improvement Amendments (CLIA)-waived COVID-19 test without an order or standing order from an authorized health care practitioner?
Answer

Yes. The RN may perform a CLIA-waived COVID-19 test based on the nursing process without an order or standing order from an authorized health care practitioner if the CLIA-waived test is done for screening purposes and not diagnostic purposes. For screening tests, the RN must document whether a test result is positive or negative but may not diagnose the patient with COVID-19 or any other condition. Employers/facilities may have policies requiring an order for these tests and other requirements, such as completion of competency assessment, and quality control testing. The employer/facility must have a CLIA-waived certification:

Medical Test Sites (MTS) | Washington State Department of Health

Waived Tests | CDC

Clinical Laboratory Improvement Amendments (CLIA) | FDA

 

The employer/facility should follow established guidelines specific to the facility type:

Point of Care Testing Guidelines (wa.gov)

 

The employer/facility must follow quality control measures as required with the CLIA-waived certification and/or as required by accreditation organizations (e.g., Joint Commission):

COVID-19 - Quality Control Testing for COVID-19 Tests | Laboratory | Quality System Assessment for Nonwaived Testing Quality System Assessment (QSA) | The Joint Commission

 

Other Resources:

Waived Testing- Screening or Definitive | Laboratory | Waived Testing WT | The Joint Commission

Screening Versus Diagnostic Tests for COVID-19, What’s the Difference? (asm.org)

COVID-19 Testing: Health Care Provider Resources & Recommendations | Washington State Department of Health

Reporting COVID-19 Test Results for Point-of-Care Testing Facilities | Washington State Department of Health

RN Authority with COVID-19 CLIA-Waived Tests in School Settings | WABON

Testing in Schools Frequently Asked Questions | Washington State Department of Health

Guidance for SARS-CoV-2 Rapid Testing Performed in Point-of-Care Settings | CDC

Waived Tests | CDC

FAQ Category
Nursing Delegation
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