What’s new in quality & regulatory – 2021 edition


Continual Improvement Webinar

Expires: December 8, 2023

PRESENTATION RECORDING COMING SOON

Overview

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

Presenters

Jenny Nosbisch, MBA

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

Photo of Shannon Bennett

Shannon Bennett, MS, MBA, CM/QOE (ASQ)

Directory of Regulatory Affairs
Department of Laboratory Medicine and Pathology
Mayo Clinic, Rochester, Minnesota

Learning objectives

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

  • Prepare for increased Office of Inspector General (OIG) attention on medical necessity documentation
  • Outline requirements for remote review of clinical laboratory data, results, and pathology slides
  • Adapt best practices for remote and hybrid inspections to your laboratory
  • Describe potential new laboratory developed test (LDT) regulations and oversight by the FDA

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

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 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. Watch the video.

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

MCL Education (@mmledu)

MCL Education

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