493.15—Laboratories performing waived tests.
(a) Requirement.
Tests for certificate of waiver must meet the descriptive criteria specified in paragraph (b) of this section.
(2)
Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
(c) Certificate of waiver tests.
A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others:
(9)
Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout.
(d) Revisions to criteria for test categorization and the list of waived tests.
HHS will determine whether a laboratory test meets the criteria listed under paragraph (b) of this section for a waived test. Revisions to the list of waived tests approved by HHS will be published in the Federal Register in a notice with opportunity for comment.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993]