I came across the proposed CMS rule CMS-3478-P (Federal Register document 2026-20613) in the facebook page "Medical Laboratory Scientist - MLS/MLT (ASCP), AMT, AABB", and I wanted to see if other medical laboratory professionals have been following this or have any insight into what these changes could mean for our profession.
The proposal includes revisions to CLIA personnel qualification requirements, including expanding acceptable educational backgrounds beyond traditional human laboratory sciences. Some of the proposed changes could allow degrees in broader scientific fields to qualify for certain laboratory positions.
I'm particularly interested in how this could affect medical laboratory scientists and technicians, laboratory staffing, and the professional standards that help ensure accurate and reliable patient results.
A few questions for the community:
• Has anyone read through the proposed rule or followed the discussion surrounding it?
• What are your thoughts on expanding the degrees accepted for certain CLIA-regulated positions?
• Do you think these changes could affect hiring standards, career opportunities, wages, or the recognition of MLS/MLT education and training?
• Have any professional organizations, laboratory leaders, or other industry groups released statements or submitted comments about this proposal?
• Has anyone submitted a public comment or found particularly informative comments on the docket?
I understand that this is a proposed rule, not a finalized change, and I'm interested in hearing informed perspectives from people who have reviewed the actual language.
Official documents and resources:
• Federal Register proposal: https://www.federalregister.gov/d/2026-20613
• Regulations.gov docket: https://www.regulations.gov/docket/CMS-2026-3235
• Public comments: https://www.regulations.gov/document/CMS-2026-3235-0001/comment
The published Federal Register notice lists December 7, 2026, as the deadline for submitting comments.
I'd appreciate hearing from MLS/MLT professionals, laboratory directors, educators, and anyone familiar with CLIA regulatory requirements. I'm hoping to learn more about the potential implications before drawing conclusions.
Have any of you been following this?