What’s New in Quality & Regulatory Expectations? [2019]

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December 11, 2019
11 a.m.–Noon CT

Cost

Free for all participants.

Overview

This presentation will provide an overview of new regulatory changes and issues having the potential to affect laboratory operations. A case study will be discussed to share a positive quality practice.

Presenter

Photo of Shannon BennettShannon Bennett
Quality Manager
Department of Laboratory Medicine and Pathology
Mayo Clinic
Rochester, Minnesota

Photo of Jennifer NosbischJennifer 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 10 most common CLIA deficiencies.
  • Review updates to CLIA interpretive guidelines.
  • Discuss recent FDA actions with pharmacogenetics testing.
  • Discuss potential FDA oversight of lab-developed tests.

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.®
State of California
State of Florida

Level of instruction for this program is intermediate.

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).

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.

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

MCL Education

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