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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 users.
The board reported it solicited public comment and considered feedback. Several members of the committee questioned a vendor product with a multi‑step molecular (PCR) workflow that the board said did not present the same containment and simplified workflow characteristics typical of CLIA‑waived tests. Dr. Mason described demonstrations and said the board had concerns about contamination risk and the number of manual steps in that vendor’s methodology; she said those concerns informed the board’s decision to limit some PCR‑type instruments on the waived list.
After discussion, Senator Meerdahl moved to hold only item 20 (the contested waived‑test subsection) over for further review and documentation from the board; Senator Rohrs seconded. The committee adopted the motion by roll call. The chair stated that all other amendments in the board’s package would go into effect, and that subsection 20 would be revisited at the committee’s next meeting (the board expects to present supporting documentation and responses to public comments).
What’s next: The board will provide the written comment records and any additional information requested by committee members about the contested PCR/closed‑system item; item 20 remains held over until the next Administrative Rules Committee meeting.
