What’s New in Quality & Regulatory? (2025)
Oct. 14, 2025
11 a.m.–Noon CT
Cost
Free for all participants.
Overview
This webinar will provide an overview of recent regulatory changes impacting clinical laboratories. This will include the latest updates to Clinical Laboratory Improvement Amendments (CLIA) memos and brochures, the termination of Clinical Laboratory Improvement Advisory Committee (CLIAC) and its impact to clinical laboratories, a summary of the FDA LDT final rule regulatory journey, and a discussion of the shift to announced inspections.
Presenters
Chelsea Conn, M.A., CQA(ASQ), MLS(ASCP)CM
Director of Regulatory Affairs
Department of Laboratory Medicine and Pathology
Mayo Clinic, Rochester, Minnesota
Jennifer Nosbisch, MBA
CLIA Compliance Program Manager
Revenue Compliance Office, Integrity and Compliance Office
Mayo Clinic, Rochester, Minnesota
Learning objectives
Upon completion of this activity, participants should be able to:
- Describe the current situation with the Clinical Laboratory Improvement Advisory Committee (CLIAC) and implications to clinical laboratories.
- Determine the operational impact of recent updates to CLIA brochures and memos.
- Summarize the regulatory journey of the FDA’s LDT final rule.
- Describe the shift from unannounced to announced inspections by CAP and AABB.
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.
Credit
The following types of credit are offered for this event:
ASCLS P.A.C.E.®
Mayo Clinic Laboratories is approved as a provider of continuing education programs in the Clinical Laboratory Sciences by the ASCLS P.A.C.E.® program. This program has been approved for a maximum of 1.0 P.A.C.E.® contact hour.
State of Florida
Mayo Clinic Laboratories is approved as a Continuing Education Accrediting Agency for the Clinical Laboratory Sciences for the State of Florida. Florida Board of Clinical Laboratory Personnel has designated this program for Supervision/Administration, Quality Control/Quality Assurance, and Safety credit. This program has been approved for 1.0 contact hour.
To obtain credit
1. Register for and participate in the program.
2. Complete the evaluation that will be sent to you after the program.
3. Generate and print your certificate(s).
Level of instruction for this program is basic.
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
