THE TRANSITION FROM EQC TO IQCP...
part of the testing procedure or as a
separate manual.
Completely voluntary. Like the other CLIA
QC requirements, IQCP is intended for nonwaived testing; however, you may perform a
risk assessment and develop an individualized
plan for ANY test in your POL, including
waived tests. Whereas IQCP is voluntary labs
may use it for all, some, or none of the test
systems in their laboratory. Indeed,
laboratories can continue to run the CLIA
“default” QC – two levels of external control
each day of patient testing – instead of
implementing Individualized QC Plans.
The manufacturer’s QC recommendation will
remain the minimum acceptable QC protocol,
but it may be necessary to develop an IQCP if
you chose to follow this protocol. If the
manufacturer’s QC recommendations for the
test are less than the default CLIA requirement
of two levels per day (for instance, the
manufacturer’s instructions say to run controls
with each lot number change), your lab may:
• Perform the default requirement of two
levels per day AND run controls with each
lot number change (to satisfy the
manufacturer’s requirement); OR
• Develop an IQCP for the test to show that
all relevant errors will be detected