THE TRANSITION FROM EQC TO
IQCP: WHAT IT MEANS TO PHYSICIANS
OFFICE LABORATORIES
MARIA HARDY, IMA (ASCP)
TECHNICAL WRITER, COLA RESOURCES, INC. (CRI®)
O
What IQCP Means to
Physician Office Labs
n January 1, 2014, the Centers for
Medicare and Medicaid Services
(CMS) implemented a new
alternative Quality Control (QC)
option for non-waived laboratory
testing. CLIA laboratories can now begin to
voluntarily transition away from Equivalent
Quality Control (EQC) and begin using either the
default CLIA Quality Control (QC) requirement,
or the new option called the Individualized
Quality Control Plan (IQCP). Physician Office
Laboratories (POLs) will now have to determine
if IQCP is the right choice for them.
Laboratory Directors will be tasked with
determining whether to maintain the CLIA
minimum of at least two levels of QC per day, or
to transition to the IQCP approach. The
cornerstone of IQCP is identifying, evaluating,
and controlling potential sources of error relevant
to the individual laboratory. Performing a Risk
Assessment will facilitate the development of an
IQCP, which is achieved by implementing
targeted quality control measures.
According to CMS, “There will be an IQCP
Education and Transition Period to allow
laboratories an opportunity to learn about
IQCP and implement their chosen QC policies
and procedures. The IQCP Education and
Transition Period will begin on 01/01/2014,
and conclude on 01/01/2016.”
With the transition period already
underway, labs are advised to begin now to
educate themselves about IQCP. CMS stand
ready to assist laboratories in this process; the
educational arms of laboratory accrediting
organizations also offer a variety of resources.
While IQCP may seem like yet another
regulation to follow, as an article in the
American College of Physicians’ ACP Internist
states, “While office labs do pose some
disadvantages in the form of regulations, the
rules are probably not as formidable as you
think. Federal regulations are neither
particularly expensive nor difficult to follow.”
In fact, IQCP can present distinct
advantages to POLs. Because IQCP is Quality
Control based on Risk Management, it can
help mitigate the level and frequency of risk
to patients. While a small office lab may not
have the luxury of a designated QC Officer,
this does not mean that they are not
concerned about providing accurate test
results to their patients. Indeed, it is most
likely the opposite: Most POLs opened a lab
in their practice to reduce turnaround time,
paperwork and logistical headaches for
diagnostic testing. Their Laboratory Director
has committed to ensure that the site is
compliant with all regulations, that the staff is
competent and well trained and that patient
test results are reliable and reproducible.
The New Quality Control Choices
During the IQCP Education and Transition
Period, laboratories will have three
acceptable QC options:
1. Follow the CLIA QC regulatory
requirements as written
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