If
you missed this timely and
informative topic
please
download the audio and slides or just slides by
clicking the
appropriate link below.
Summary - "CLIA and Point-of-Care
Testing:
-
Included current CLIA laboratory enrollment data
with a focus on the applicable CLIA requirements
for point-of-care testing.
-
Identify the CLIA requirements for POCT and
differentiate between the CLIA requirements for
the waived and moderate complexity testing.
-
Demonstrated how the growth of waived facilities
has exploded over time, why and what types of
issues CMS is finding when conducting its
educational visits to these laboratories.
-
Covered the CMS’ plans for the future with regard
to oversight of entities that do not have any
regulatory standards or surveys currently.
-
Provided plenty of opportunity for dialogue and
questions.
Objectives - After viewing this
webinar, you will be able to:
-
Have an overview of the Clinical Laboratories
Improvement Amendments (CLIA) program. This
overview includes CLIA test complexity, the
types of CLIA certificates, and the options for
laboratory oversight. Following the webinar, the
participant will know the relationship between
the CLIA test complexity and the types of CLIA
certificates.
-
Differentiate between the CLIA personnel
requirements for waived versus moderate
complexity testing.
-
Understand CMS’ position on POCT, the problems
identified in waived laboratories through the
CMS Certificate of Waiver Project, and CMS’
plans to address the exponential growth in
laboratories with no routine oversight.
Vendor Sponsors: Alere; Eurotrol;
Medical Automation Systems |
Karen Dyer, MT(ASCP) DLM is a
registered Medical Technologist with certification
in Laboratory Management. She received an AA degree
from Essex Community College in Medical Laboratory
Technology and a BA degree from the University of
Maryland Baltimore County in Health Science and
Policy. She is an analyst with the CLIA program at
CMS, working primarily with interpretation of
regulations, evaluations of survey consistency
between Accrediting Organizations and CLIA, policy
development, electronic health records and data
collection and analysis. Prior to joining the CLIA
program at CMS, she was employed by the Johns
Hopkins Hospital Medical Laboratories, as an
Affiliate Laboratory Supervisor and, most recently,
Point of Care Testing Coordinator. |
Daralyn Hassan, MS, MT(ASCP)
received a B.S. in medical Technology from Michigan
State University, and a M.S. in Health Science from
Towson State University. Daralyn has been with the
CLIA program since 2000, where she helps to provide
oversight to clinical laboratories, and surveyor
training. Prior to coming to the federal service,
she was a laboratory surveyor for the State of
Maryland, and was promoted to a Health Facilities
Survey coordinator. She has 16 years of clinical
laboratory experience.
|