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Clinical-lab board expands fee authority, clarifies waived tests and the committee holds one PCR/closed‑system waiver provision for review
Summary
The Board of Clinical Laboratory Practice updated fee authority and clarified exemptions for CLIA‑waived tests, but the committee voted to hold over one contested subsection (item 20) relating to PCR/molecular/closed‑system language after public comments raised contamination and workflow concerns about a specific vendor's multi‑step product.
The Board of Clinical Laboratory Practice presented amendments to expand fee authority and to clarify which waived tests and instruments may be performed without full licensure. Dr. Christy Mason told the committee that the changes modernize the board’s fee structure and update a list of FDA‑waived tests (including influenza, strep A, RSV and certain instrument platforms) so that permitted, low‑complexity tests are clear to…
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