Labs should get ready now for a new quality control (QC) model from regulators that is slated to launch next year, according to officials at the Centers for Medicare and Medicaid Services (CMS). Called the Individualized Quality Control Plan (IQCP), this optional program will allow labs to customize QC based on risk management principles, and in certain cases may allow them to run fewer external liquid controls as long as they follow an instrument manufacturer's instructions. Ann Snyder, MT(ASCP), a medical technologist with the CMS Division of Laboratory Services, introduced the new program at the 2013 AACC Annual Meeting during a short course on hot topics in point-of-care testing.
As clinical laboratory instruments have become more sophisticated, regulators have struggled to find a way to account for innovations in internal, electronic QC systems that manufacturers employ in new instruments. CMS first allowed labs to use what the agency termed equivalent QC in 2003, a controversial provision where labs could reduce the frequency of their external QC runs—down from the CLIA default standard of two levels per day to as infrequently as once per month—after a 10-day trial.
Now CMS is ready to roll out a more refined alternative, this time based on the new EP-23 guideline from the Clinical and Laboratory Standards Institute (CLSI). The IQCP protocol borrows risk management principles from the CLSI guideline, but is not identical to it, Snyder noted.
Snyder emphasized the holistic approach of IQCP. It requires labs to carefully review all phases of the testing process and perform a thorough risk assessment, the results of which may not necessarily lead to fewer external QC runs. "This plan can be customized based on patient population, environment, test system, personnel, and test uses. It's for your unique laboratory. You'll look at the entire testing process," she said. "It also allows you to adapt to future technology, as manufacturers continually improve their instruments."
The essence of IQCP, according to Snyder, is balancing manufacturers' instructions for an instrument while still meeting regulatory requirements. "At a minimum, labs must follow manufacturers' instructions. The whole reason we're doing IQCP in the first place is that we have manufacturers who have developed processes for external QC that are less stringent than the QC regulation requirement of two levels per day," Snyder explained.
IQCP will be voluntary—labs can still abide by the default two levels per day originally required by CLIA. However, if labs wish to reduce external QC runs based on a manufacturer's instructions, they must use IQCP. "I want to be very careful to say to you, that if, for example, the manufacturer says the QC frequency is once a week, and you want to employ that QC frequency of once a week, you have to use IQCP," Snyder said. "If you run QC at a frequency that is below what CLIA normally requires, you must use IQCP."
Labs can't begin using IQCP until January 1, 2014. However, an updated section of the CLIA Interpretive Guidelines that lays out the program is now available on the CMS CLIA website, along with other educational material.