What’s New in Quality and Regulatory Expectations for Clinical Laboratories? [2016]

Expires March 14, 2018


Length: 54 mins


This presentation will provide a review of regulatory and accreditation updates that occurred during 2015 that have the potential to affect laboratory operations.


After attending this forum, participants should be able to:

  • Describe the current status of the U.S. Food and Drug Administration’s (FDA’s) proposed oversight of laboratory-developed tests (LDTs)
  • Summarize the CMS regulations related to the Protecting Access to Medicare Act of 2014 (PAMA)
  • Identify laboratory services that require registration on the Molecular Diagnostic Exchange

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.

Level of Instruction



Photo of Janna GalbreathJanna Galbreath
Quality Manager
Department of Laboratory Medicine and Pathology
Mayo Clinic
Rochester, Minnesota
Janna Galbreath is the Quality Manager for the Department of Laboratory Medicine at Mayo Clinic. She began her career at Mayo in 1973, working as a laboratory technologist in Transfusion Medicine. Janna received the MT(HEW) certification in 1979, a Medical Laboratory Technician (ASCP) in 1982, an A.A.S. from Rochester Community Technical College in 1994, and a Bachelor of Science degree in business management in 2002.

Janna’s laboratory interests initially focused on the development of infectious-disease testing for blood donors and quality. During the last 25 years, Janna has developed a broad background working with both clinical laboratories and support services to facilitate development, training, implementation, and maintenance of the Quality Management System used by Mayo Clinic’s clinical laboratories. She has participated at local, national, and international events through poster presentations and papers, and she has spoken on topics to promote the advancement of quality principles and concepts in laboratory medicine.

Photo of Sheri TranSheri Tran
Operations Manager
Laboratory Compliance Office
Integrity and Compliance Office
Mayo Clinic
Rochester, Minnesota
Sheri Tran is the Operations Manager for the Laboratory Compliance Office within Mayo Clinic’s Integrity and Compliance Office. She began her career at Mayo in 1980, working in the Blood Donor Center and Hospital Transfusion Services in the Division of Transfusion Medicine. Sheri has a Bachelor of Science degree in business management and a Master of Science degree in healthcare administration. In her current role, Sheri’s primary focus is regulatory oversight of laboratory services, ranging from CMS guidelines, CLIA requirements, to FDA regulations for blood and blood products, human cells and tissues, and the FDA’s potential future oversight of laboratory-developed tests.


The following types of credit are offered for this event:

State of California
State of Florida

To obtain credit:

  1. Watch the video.
  2. Complete the posttest and evaluation that launches immediately following the video.
  3. Generate and print your certificate(s).

Note: Participants requesting P.A.C.E.® credit, in compliance with ASCLS P.A.C.E.® program requirements, must attain a score of 70% or higher on the posttest to obtain a certificate.

Mayo Medical 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. Level of instruction for this program is intermediate.

Mayo Medical Laboratories is approved as a Continuing Education Accrediting Agency for Clinical Laboratory Science for State of California and State of Florida credit. Florida Board of Clinical Laboratory Personnel has designated this program for Supervision/Administration, Quality Control/Quality Assurance, and Safety credit. The level of instruction for this program is intermediate. This program has been approved for 1.0 contact hours.


MML Education

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