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Tests/Methods Exempt from Licensure

Exemptions from Licensure

Section 43-48-03 of the North Dakota Century code lists individuals which are exempt from the clinical laboratory licensure law.

There are however, specific clinical laboratory tests and methods which may be performed by unlicensed individuals supervised by an individual licensed by the NDBCLP.  Sections 96-02-10-01 and 96-02-10-01.1 list these specific tests and methods.

Request Exemption of Test/Method

To request an exemption of a test/method from N.D.C.C. 43-48-03, you must submit a Request for Exemption of Test/Method from Current Licensure form and include an explanation of the instrumentation for the test and also must include package inserts.

The Board uses three criteria in determining if a test should be exempt:
(1) Methodology/Instrumentation must be included in List of Tests Waived by FDA. If the test is not on this list, it will not be approved for exemption.
(2) Exemption should improve patient care as well as provide additional staffing options.
(3) Exemption should have a positive outcome on patient consequences. please complete and submit the

All requests for exempt tests/methods must be received by the Board office no later than June 1 of every year in order for them to be considered for addition to the Administrative Rules at the Board's October meeting. If the FDA pulls approval on any of the exempt tests/methods, it is the responsibility of the lab that is using this test/method to follow the FDA requirements for further testing.

Exemption of Test/Method from Current Licensure (print form)

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