ASCLS has submitted comments in response to a wide-ranging Request for Information from the Centers for Medicare and Medicaid Services that will shape future regulations of clinical laboratories under CLIA. The voluminous document covers many topics, including breath testing, specimen preparation personnel, handling of suboptimal specimens, remote competency assessment, and cybersecurity. Subject matter expertise was…
The bipartisan Medical Laboratory Personnel Shortage Relief Act of 2025 (H.R. 5444) has been introduced by Congresswomen Deborah Ross (NC-02) and Jen Kiggans (VA-02). The bill will help establish a federal grant program to increase the capacity of the U.S. to train those with an interest in laboratory science. These grants will also help programs…
ASCLS recently joined 66 other healthcare associations and signed on to requesting that Congress reauthorize the Health Resources and Services Administration’s (HRSA) Title VII and Title VIII funding. This letter was sent to House Energy and Commerce Chair Brett Guthrie (R-KY) and Ranking Member Frank Pallone (D-NJ), as well as Senate Health, Education, Labor and…
Today, Rep. Deborah Ross (D-NC) introduced the Medical Laboratory Personnel Shortage Relief Act of 2024 (H.R.9849) in the House of Representatives. ASCLS is a strong supporter of this important legislation which would authorize up to $25 million in annual funding for MLS and MLT programs. The bill would also expand the National Health Service Corp…
September 23, 2024 – Congressional leaders unveiled a bipartisan, bicameral agreement on a three-month Continuing Resolution (CR) to fund the federal government through December 20, 2024. Included in the CR is a one-year delay in PAMA cuts and data reporting, until January 2026. The House is expected to vote on the CR as early as…
Damien Garza from ASCLS-Wisconsin shares why and how all clinical laboratory professionals should be advocating for the passage of SALSA. Labvocate for SALSA Passage What Can You Do? Visit stoplabcuts.org to contact your representative and senators. Sending them a personalized email, phone call, or letter expressing your support for H.R. 2377/S. 1000. Tell them who you…
On May 6, 2024, the Food and Drug Administration (FDA) published the final rule defining how the agency will be changing enforcement discretion on LDTs. The rule is substantially changed from the preliminary rule published late last year. The changes are directly responsive to many of the concerns raised by ASCLS and other laboratory groups, which universally told FDA…
The Centers for Medicare and Medicaid Services (CMS) has published final rules related to personnel regulations under CLIA. The proposed rules were published in 2022 and generated thousands of comments back to the agency. The entire community of medical laboratory professionals had a significant impact on the final outcome. “Because of the work of so many…
The deadline to comment on a U.S. Food & Drug Administration (FDA) proposed rule to begin regulating Laboratory Developed Tests (LDTs) is December 4. ASCLS encourages all members of our community to read the proposal and provide input. The proposed rule would amend the FDA’s regulations to make explicit that LDTs (defined by FDA as…
The House of Representatives and Senate have passed approving a continuing resolution (CR) that includes a one-year delay of implementation of the PAMA Medicare payment cuts to clinical laboratory services and data reporting, until January, 2025. The President is expected to sign it into law this week. Thank you to all who participated in some…