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What’s New in Quality and Regulatory Expectations for Laboratories? [2022]


Continual Improvement

December 14, 2022
11 a.m.–Noon CDT

Cost

Free for all participants.

Overview

This “Continual Improvement” webinar will provide an overview of new or changed regulations for 2022, and other regulatory issues that have the potential to affect clinical laboratories. The latter half of the year has been very busy for laboratory-related regulations and legislation, including the potential VALID Act and its impact to laboratory developed tests (LDTs), the SALSA Act which seeks to address reimbursement issues with the Protecting Access to Medicare Act (PAMA), and the potential end of the COVID-19 public health emergency. 

Presenter

Shannon Bennett, M.S.

Director, Regulatory Affairs 
Department of Laboratory Medicine Quality Management Services
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:

  • Review the implications of the VALID Act to clinical laboratories
  • Describe problems with PAMA and how the SALSA Act could fix them
  • Evaluate implications of the COVID PHE ending

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 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 Supervisor/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 (@mmledu)

MCL Education

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