What’s new in quality & regulatory expectations for laboratories? [2020]

December 9, 2020
11 a.m.–Noon CT

Cost

Free for all participants.

Overview

This presentation will provide an overview of new regulatory changes and issues that have the potential to affect laboratory operations. The speakers will also discuss potential legislation affecting the regulation of laboratory developed tests (LDTs) found in the Verifying Accurate, Leading-edge IVCT Development (VALID) Act.

Presenters

Shannon Bennett
Director - Regulatory Affairs
Department of Laboratory Medicine and Pathology
Mayo Clinic, Rochester, Minnesota

Jennifer Nosbisch
CLIA Compliance Program Manager
Integrity and Compliance Office
Mayo Clinic, Rochester, Minnesota

Learning Objectives

Upon completion of this activity, participants should be able to:

  • Review the regulatory gymnastics around COVID LDTs.
  • Describe potential new LDT regulations and oversight by the FDA.
  • Understand CLIA updates and clarifications communicated in 2020.

Intended Audience

This series is appropriate for laboratory administrators and managers, quality assurance and control staff, supervisors, and other laboratory personnel who are dedicated to continuous quality and process improvement.

Credit

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 California

Mayo Clinic Laboratories is approved as a Continuing Education Accrediting Agency for Clinical Laboratory Sciences for the State of California. This program has been approved for 1.0 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 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 intermediate.

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

Additional Resources

MCL Education

MCL Education

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