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Who's
Who in Point-of-Care Testing...
How
long have you been involved in the POCT field? In what capacity? Please
include every position and how you evolved from one to the next.
I’ve been involved in Point of Care in one way or another
for more than 15 years. My
first exposure was when I was at Instrumentation Laboratory.
IL was a leader in both Blood Gas and Coagulation testing, I was
Senior Research and development Manager there.
Following IL I joined LifeScan first as manager of QA
Development. In this
position I managed the QA individuals who participated on our new
product development teams. I
progressed to Principal Scientist, Advanced Research in Quality
Assurance and am now Principal Scientist in Professional Affairs. As I
moved from one position to the next, my exposure to activities outside
the company grew. I have
worked on several projects within NCCLS, have worked on two groups that
have developed International standards within the International
Standards Organization (ISO) and have been active in AACC activities.
Through this focus, I have had the ability to work with FDA, CDC
and NIST on projects. I
also am LifeScan’s representative to AdvaMed (The Advanced Medical
Technology Association) a trade organization for manufacturers of
Medical Devices.
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The
company for which you work for is heavily involved in POCT with blood
glucose meters. What
initiatives are being taken to expand upon this menu?
LifeScan has shown the Harmony INR meter, a device for
measuring prothrombin time in patients on anticoagulant therapy.
We are exploring opportunities that could expand this menu.
Any opportunity would have to provide a robust, high quality
product for the customer, be a strategic fit for LifeScan’s existing
businesses and provide a cost-effective alternative to current testing
methods.
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What
are some of the biggest changes you have seen in POCT during the time
you have been involved in this field?
Please answer this from a global perspective as well as from the
changes experienced within your own organization.
The first major change has been the broad expansion in menu
in a brief period of time. The
second has been the exciting advances in technology that allow analytes
such as cardiac markers to be measured at the Point of Care. The third, and most important has been the emergence of the
role of Informatics in Point of Care Testing.
The progression from data to knowledge to action is changing the
way patient treatment is being applied.
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You
were an integral part of the CIC and now the NCCLS standards body for
connectivity. What would
you like the POCT community to know about these two organizations and
what they have done for the future of POCCs?
CIC was a unique meeting of the needs of Health Care
Providers and Point of Care Testing Device manufacturers at a point in
time that was propitious for both.
For providers, this provided a forum to articulate their needs
and requirements. For
manufacturers, this provided a rare opportunity to work together for the
common good of our customers, rather than competing.
NCCLS is an organization that has been a forum for the
development of standards for the Clinical Laboratory for decades.
In this case, NCCLS allowed deviations from their normal
processes to allow the CIC specifications to be published as POCT-1, an
approved standard seven short months after the formation of the
Subcommittee on Point of Care Connectivity.
Under the able leadership of Dr. Jeffrey Dubois of Nova
Biomedical, members from the Providers, Industry, CIC, HL-7, IEEE, CAP
and FDA worked together to complete the process of writing the standard
in record time. Kudos are
due to all who participated.
As POCT-1 is implemented, the life of a Point of Care
Coordinator will be simpler, without the need to maintain multiple data
management systems and LIS interfaces.
Additionally, the consolidation of all Point of Care Testing data
into one repository will facilitate detection of trends in the data that
were not obvious when the data were stored in separate data management
systems.
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Discuss
for us where you see POCT going in the future? Include why you think this and how all of us can
contribute..
Several demographic trends are converging to provide a
bright future for Point of Care Testing.
Reimbursement policies are pushing patient care away from the
very expensive critical care units.
At the same time, the number of trained laboratory professionals
is falling behind the demand. These
trends have been a major driving force behind developing simple to use
devices that can be operated by non-laboratorians.
Technological advances have allowed smaller samples with no
sample pre-treatment to be applied directly to the devices.
Test times have dropped dramatically.
Data management and connectivity have made the Point of Care Test
result just one more value in the patient record.
With the advent of wireless communication embedded in the
devices, each device will become a little lab of it’s own.
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