What’s New in Quality and Regulatory? [2024]

Oct. 15, 2024
11 a.m.–Noon CT

Cost

Free for all participants.

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. 

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

MCL Education

This post was developed by our Education and Technical Publications Team.