What’s Your Lab Doing about IQCP?
Why do we run quality control in the laboratory? The simple, obvious answer is to ensure that the entire test system working together is able to produce reliable results. The rub lies in the concept of reliability. So we run QC based on manufacturer’s directives. But how does the manufacturer come up with its recommendations for a kit, set of reagents or an analyzer?
Then we also run some QC based on regulatory requirements (accrediting agency, CLIA, best practices, state) or based on our organization’s policy. The mandate is to go with the most stringent requirement in each case, but all with the notion of ensuring that the results we produce are reliable.
So if we run quality control for an entire chemistry profile on analyzer ABC once per shift, how sure are we that every patient result generated for the next eight hours is reliable? Some of our confidence comes from studies done on that instrument, using those reagents. We know that statistically, even with the best instrumentation, we cannot absolutely guarantee 100% accuracy 100% of the time.
Over the years several advancements have been made that have helped to increase our confidence that our results are accurate, precise and reflect medically significant values. Technology has become more robust, with more internal checks and balances, reagents have increased sensitivity and specificity. The analytical measurement ranges (AMR) of most tests have increased; as has precision. Once again these factors help to make us more confident that time after time the result we receive is pretty close to the real thing.
It is because of all this progress that CLIA is introducing new QC standards using a protocol called the Individualized Quality Control Plan (IQCP). Why do we have to blindly follow the old 2 levels of controls with every run or every 8 hours if the state of the art is such that our systems have been proven over time to produce reliable results? Available as a voluntary option under CLIA, IQCP is designed to give labs greater flexibility in customizing their own QC program based on their particular environment.
The rub is that you cannot simply decide to move to IQCP, a system some might see as less demanding and less expensive. Your lab must do a risk assessment evaluation to study what QC regimen you can “get away with” under CMS regulations.
IQCP was launched in January of this year and labs that choose that option have been given 2 years to make the transition to IQCP and verify how their lab is operating under that option. IQCP applies to all non-waived testing, except Pathology. Labs will need to provide sufficient data to show a credible analysis/assessment was done.
Has your lab been contemplating IQCP? What have they done so far? How do you personally feel about IQCP?