What’s New in Quality and Regulatory? [2023]

Video length: 60 minutes

Overview

This “Continual Improvement” webinar will provide an overview of the most common CLIA deficiencies in 2022 and ideas for avoiding noncompliance. The presenters will also review new CMS rules for remote review that were published at the end of the COVID-19 public health emergency and provide an update on efforts to reform the Protecting Access to Medicare Act (PAMA) provisions that are used to calculate laboratory reimbursement. The ongoing saga of FDA regulation of laboratory-developed tests continues, with FDA signaling the agency may rescind its enforcement discretion and treat LDTs as medical devices. The presenters will discuss what that could potentially mean to clinical laboratories.

Presenter

Shannon Bennett, M.S.

Director, Regulatory Affairs
Department of Laboratory Medicine and Pathology Quality Management Services 
Mayo Clinic
Rochester, Minnesota

Jennifer Nosbisch, MBA

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

Learning objectives

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

  • Identify the top CLIA deficiencies in 2022.
  • Adapt remote review requirements to your practice.
  • Advocate for laboratory reimbursement reform.
  • Examine potential implications of LDT regulation as medical devices.

Intended audience

This webinar 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 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. Watch the video.

2. Complete the post-test and evaluation that launches immediately following the video.

3. Generate and print your certificate(s).


Level of instruction for this program is basic.


Credit expires: 9/13/25

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.