IQCP EDUCATION: HOW THE
LEADERS OF THE LABORATORY
MUST BE LEADERS ON IQCP
Maria Hardy, IMA (ASCP)
A
Online courses, workshops, and webinars are
some of the most popular forms of learning in
a lab culture that is always pressed for time. In
considering what to focus on as a topic of
choice, two key concepts must be explored -Quality Control and Risk Management.
More than the presence of a positive and
negative reaction on a test strip, Quality Control
(QC) is the continual review and assessment of
laboratory activities. The ISO 9000 definition of
Quality Control is “part of quality management
focused on fulfilling quality requirements.” CMS
states that “QC consists of the procedures used
to detect errors that occur due to test system
failure, adverse environmental conditions and
variance in operator performance, as well as the
monitoring of the accuracy and precision of the
test performance over time.” The concept of QC
as it relates to IQCP is to consider QC concepts
as well as implementation. Concepts must be
identified in the three phases of testing -- preanalytic, analytic and post-analytic. If you are
starting to think that all of this may be “too
technical” for your testing personnel, remember
that it is the technical aspects of QC that makes
it essential to lab quality.
Most people think of Risk Management in
terms of insurance and business. In laboratory
science, Risk Management seeks out errors
with the potential to cause human harm. Risk
Management is defined in ISO 14971 and
referenced by CMS as the “systematic
application of management policies,
procedures, and practices to the tasks of
analyzing, evaluating, controlling and
monitoring risk.” Risk Management consists of
identifying, evaluating, and controlling the
s the transition period from EQC
to IQCP reaches its midpoint, the
task of compliance falls squarely
on the shoulders of the
leadership of the laboratory.
Approximately one year remains before the
new Centers for Medicare & Medicaid Services
(CMS) Individualized Quality Control Plan
(IQCP) Interpretive Guidelines become the
regulation of the land. Laboratory Directors
(LDs) and Technical Consultants (TCs) as the
leaders of the laboratory must be ready to not
only answer questions from staff but to step
up to their own responsibilities as well.
According to CMS, “The laboratory director
is responsible for deciding whether a
laboratory will seek to meet its CLIA quality
control obligations through IQCP, and if they
decide to do so, they are also responsible for
ensuring that the QCP they develop meets
the IQCP requirements.” As the LD you may
think, “I already know about Quality Control. I
sign off on all of the QC documentation.” Now
the task is to ensure that the testing
personnel are just as confident in the decision
to follow the minimum 2 levels of QC per day
of testing or making the switch to IQCP.
What do LD’s and TC’s need to know?
IQCP is Quality Control based on Risk
Management. LD’s and TC’s will be held
responsible for reviewing the information
available and ensuring testing personnel not
only understand the concepts, but receive
training and are deemed competent as well.
Education on IQCP can come in many forms.
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