IQCP: Bridging QC and QA
It appears that there is still some confusion among
laboratory personnel in differentiating QC from QA, and that this uncertainty
has been compounded by the introduction and implementation of the
Individualized Quality Control Plan (IQCP). These are different concepts, and
it is important to understand these differences—both from the practical
standpoint of what you are trying to accomplish, as well as how you get there.
Basically, laboratory quality control is designed to detect,
reduce and correct deficiencies in a laboratory's internal analytical process
prior to the release of patient results in order to ensure the quality of the
results reported by the laboratory. Quality control is a measure of precision,
or how well the measurement system reproduces the same result over time and
under varying operating conditions. Laboratory quality control material is
usually run at the beginning of each shift, after an instrument is serviced,
when reagent lots are changed, after calibration and whenever patient results
seem inappropriate. The effectiveness of quality control is assessed on a per-test
On the other hand, quality assessment is more broadly
focused; it is an on-going program for auditing an organization’s processes and
systems. It involves setting quality goals, deciding whether or not these goals
have been achieved and implementing corrective action if these goals have not
been reached. It includes auditing the effectiveness of your policies and
procedures, encompasses all phases of testing and general administration. There
are no limits for quality assessment audits—going well beyond the more test-specific
focus of quality control.
The CLIA regulations (Subpart K) address specific quality
assessment requirements. The Code of Federal Regulations (42 CFR 493) states
that laboratories “must establish and follow written policies and procedures
for a comprehensive quality assurance program that is designed to monitor and
evaluate the ongoing and overall quality of the total testing process.” The QA
the effectiveness of the lab’s policies and procedures.
2. Identify and correct
3. Assure the accurate,
reliable and prompt reporting of test results.
4. Assure the adequacy and
competency of the staff.
But now we have the Individualized Quality Control Plan (IQCP),
which is the new alternative QC option permitted by CMS and is based on risk
assessment. As such, the process of determining the appropriate IQCPs for your
laboratory involves many of the elements of the traditional quality assessment
process to determine the most effective QC based on examining all aspects of
the laboratory operation to determine risk.
In effect, this brings the QC/QA relationship full circle,
from where the traditional (analytic phase focused) QC is a key part of QA to
where QA processes are utilized to determine the best QC to use. However, the
one constant is that QA remains process and systems focused, while QC/IQCP is
still utilized for use on a per-test basis.