Ensure Your Laboratory is Prepared for CLIA Regulation Changes in 2024
In our continued efforts to assist you with ongoing strategies to maintain a comprehensive compliance program for your laboratory, it is DTPM’s goal to deliver relevant regulatory changes that may impact your laboratory.
On July 11, 2022, CMS published its Final Rule – Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing -Analytes and Acceptable Performance Final Rule (CMS-3355-F). This rule revised previous proficiency testing regulations that had over time become obsolete and burdensome to the laboratory industry. The effective date of the revision is two years from the publication date posted in the Federal Register [July 11, 2024].
To review these requirements, we are providing you with the following links, one from CMS and the other from the Federal Register. The Federal Register link provides further explanation of the CLIA document.
https://www.cms.gov/files/document/qso-22-21-clia.pdf
Please note the effective date below and ensure your compliancy by that date:
“Effective Date of Final Rule: The effective date of the revisions to proficiency testing (§§ 493.2 and 493.801 through 493.959) will be delayed until two years after the publication of the final rule in the Federal Register. The effective date of these requirements will be July 11, 2024. The delayed effective date reflects the timeframe that we believe PT programs will need to produce or acquire PT samples to meet the revised regulations and incorporate any updates to PT reporting requirements. In addition, laboratories will need time to enroll in PT to meet the new requirements after the samples are available from the PT programs.
The regulations related to laboratories performing tests of moderate complexity and high complexity testing that are subject to PT enrollment and also perform waived testing (§§ 493.20 Page 6 of 6 and 493.25) will be effective 30 days [August 10, 2022] after the publication date of the final rule.”
Our goal is to deliver up-to-date compliance information that is relevant to your day-to-day operations and to help prepare you to meet the compliance demands when the industry changes.
DTPM’s CLIA Services are Available for Your Laboratory
It is our extreme pleasure to serve you as well as help you navigate your laboratory’s compliance through these revisions.
Please contact us if you have any questions
Call us at 256-979-1536 or request a call from our team and someone will reach out to you.
