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CLSI Offers Online Workshop on
IQCP Guidance From CMS
Clinical and Laboratory Standards Institute (CLSI), has
released its first online workshop. EP23™ Online
Workshop: Risk-Based Tools to Meet IQCP Requirements
imparts the knowledge and skills necessary for the
successful implementation of CLSI document
EP23-A™—Laboratory Quality Control Based on Risk
Management; Approved Guideline.
Performing "The Right QC" The CLSI
guideline EP23-A was created through a consensus process
that included individuals representing the Centers for
Medicare & Medicaid Services (CMS), the US Food and Drug
Administration, the Centers for Disease Control and
Prevention, as well as leading industry and health care
professionals. The document enables laboratories to
perform “The Right QC” based on risk, and guides
laboratorians through the process of gathering the right
information needed, performing a risk assessment,
creating a quality control (QC) plan, and reviewing the
plan for effectiveness.
more information about EP23,
well as an online demo,
Major concepts from
the EP23 guideline have been adopted by CMS through the
Clinical Laboratory Improvement Amendments (CLIA)
interpretive guidelines and are included in a new QC
option for laboratories based on risk management. This
new option, called an individualized quality control
plan (IQCP), provides the ability to customize QC
policies and procedures based on the test system used.
As the current version of equivalent QC in the CLIA
guidance will no longer be an acceptable option for
compliance, the CLSI EP23 Online Workshop is an
invaluable tool to guide users through the process of
establishing an IQCP.
Online Workshop: Risk-Based Tools to Meet IQCP
Requirements' on December 18, 2013, January 7, 2014 and
January 22, 2014.
Click here for more.
The Biggest Mistake Doctors Make
harmful and costly. But they're often preventable.
By Laura Landro,
assistant managing editor for The Wall Street Journal
Not only are
diagnostic problems more common than other medical
mistakes—and more likely to harm patients—but they're
also the leading cause of malpractice claims, accounting
for 35% of nearly $39 billion in payouts in the U.S.
from 1986 to 2010, measured in 2011 dollars, according
to Johns Hopkins.
The good news is that
diagnostic errors are more likely to be preventable than
other medical mistakes. And now health-care providers
are turning to a number of innovative strategies to fix
the complex web of errors, biases and oversights that
stymie the quest for the right diagnosis.
Part of the solution
is automation—using computers to sift through medical
records to look for potential bad calls, or to prompt
doctors to follow up on red-flag test results. Another
component is devices and tests that help doctors
identify diseases and conditions more accurately, and
online services that give doctors suggestions when they
aren't sure what they're dealing with. Finally, there's a
push to change the very culture of medicine. Doctors are
being trained not to latch onto one diagnosis and stick
with it no matter what. Instead, they're being taught to
keep an open mind when confronted with conflicting
evidence and opinion.
"Diagnostic error is
probably the biggest patient-safety issue we face in
health care, and it is finally getting on the radar of
the patient quality and safety movement," says Mark
Graber, a longtime Veterans Administration physician and
a fellow at the nonprofit research group RTI
Uneasy Dance with POC Glucose in the ICU
By Anne Paxton,
CAP Today, October 2013
much of a good thing can be wonderful,” Mae West
famously said. And some feel our culture of excess
reflects that value. Perhaps as a reaction there has
been a surge of interest recently in the embrace of
“enough” as a worthwhile goal. But when it comes to
precise measurement of glucose values in the intensive
care unit, the often-warring needs for speed and
accuracy make the issue a critical matter of patient
care. For point-of-care glucose testing in the ICU, how
much precision is “enough”?
That’s the question
at the heart of a simmering debate in clinical
chemistry. In January, the Clinical and Laboratory
Standards Institute released new guidelines for the
appropriate uses of POC blood glucose testing in the
hospital, including performance standards for the
glucose testing devices (Point-of-Care Blood Glucose
Testing in Acute and Chronic Care Facilities; Approved
Guideline—Third Edition, POCT12-A3). The International
Organization for Standardization has also issued new
performance standards for home testing.
At the same time, the
Food and Drug Administration has expressed reservations
about use of the POC devices in treating critical care
patients, with new FDA guidelines reportedly in the
works. Particularly controversial has been the whole
area of point-of-care glucose testing in the ICU because
of one of its major uses: tight glycemic control.
“There have been
questions about the impact of tight glycemic control on
patients probably since the protocol took hold a decade
ago,” says Timothy R. Hamill, MD, vice chair of the CAP
Point-of-Care Testing Committee and director of clinical
laboratories at the University of California, San
Francisco. “Initially, the idea was that if you keep
glucose levels tightly controlled—below 100 mg/dL and
even down to the 70s—there will be fewer infections,
decreased morbidity, and lower length of stay.”
Click here for more stories
in our Article Archives...
POCT on CAP
Last updated: 12/11/2013
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