What’s New in Quality and Regulatory? [2024]
Originally presented: October 15, 2024
Overview
This webinar will provide an overview of recent operational updates to the Clinical Laboratory Improvement Amendments (CLIA) and administrative process changes in the Centers for Medicare & Medicaid Services (CMS). The presenters will review new proficiency testing rules, which haven’t been updated in many years. Finally, expect a recap of activities and news surrounding the FDA’s new regulations for laboratory-developed tests (LDTs).
Presenters
Shannon Bennett, M.S.
Director, Regulatory Affairs
Quality Management Services
Department of Laboratory Medicine and Pathology
Mayo Clinic
Rochester, Minnesota
Jennifer Nosbisch, M.B.A.
CLIA Compliance Program Manager
Integrity and Compliance Office
Mayo Clinic
Rochester, Minnesota
Learning objectives
Upon completion of this activity, participants should be able to:
- Evaluate current operations to determine if impacted by recent CMS/CLIA operational updates.
- Paraphrase updates to CLIA regulations impacting CLIA fees, histocompatability, personnel, and alternative sanctions.
- Identify new proficiency testing (PT) regulations.
- Assess potential compliance gaps for FDA LDT regulations.
Intended audience
This webinar is appropriate for laboratory leaders, healthcare providers, and other laboratory personnel who are interested in innovations and the future direction of lab medicine.
Faculty disclosure
Course director(s), planning committee, faculty, and all others who are in a position to control the content of this educational activity are required to disclose all relevant financial relationships with any commercial interest related to the subject matter of the educational activity. Safeguards against commercial bias have been put in place. Faculty members also will disclose any off-label and/or investigational use of pharmaceuticals or instruments discussed in their presentations. Disclosure of this information will be published in course materials so those participants in the activity may formulate their own judgments regarding the presentations.
Questions
Contact us: mcleducation@mayo.edu
