Nearly 5 years ago, the U.S. Centers for Medicaid and Medicare Services (CMS) introduced a new option for laboratory quality control (QC) called the Individualized Quality Control Plan (IQCP). Laboratories could create an IQCP as an alternative to performing two levels of external QC per day of patient testing (default QC), as long as their risk assessment supported a longer QC interval and it complied with manufacturers’ instructions.

The catch? Equivalent quality control (EQC), an option that had been available since 2004, was being eliminated. EQC allowed labs to run external QC on a weekly or monthly basis for tests with built-in QC features, as long as the schedule met minimum manufacturers’ recommendations.

Under the new rules, which took effect in January 2016 after a 2-year educational period, labs needed to write an IQCP for every test that had been operating with EQC or perform default QC. Laboratory managers, particularly those in charge of point-of-care testing (POCT), were faced with the daunting task of conducting risk assessments and writing IQCPs for dozens or even hundreds of tests.

“Initially it was like, ‘Oh my goodness, this is a lot of work for point-of-care testing,’” said Deborah A. Perry, MD, medical director at Methodist Hospital in Omaha, Nebraska, and chair of the College of American Pathologists’ (CAP) Point-of-Care Testing Committee during the IQCP roll-out. “It was a lot of work. I know a lot of hospitals struggled with that initially. But I think … now that we’re doing it and now that we’ve got it in place, it’s like, ‘Yeah, this works. Yeah, we can do this.’”

After the Learning Curve

At TriCore Reference Laboratories in Albuquerque, New Mexico, it took months of meetings across multiple departments to create IQCPs for the organization’s 10 hospitals, core laboratory, and reference laboratory, said Kathleen David, MT (ASCP), point-of-care testing manager. Now that the IQCPs are in place, though, they have become a routine part of the laboratory’s quality assurance program and don’t require much additional work.

Plus, writing the IQCPs provided an unexpected benefit, she noted. It allowed the laboratory to identify risks systematically in the preanalytical and postanalytical testing phases, rather than focus narrowly on the analytical phase. “We found out that it really wasn’t about QC,” David said. For most tests, the IQCP simply validated that EQC was appropriate.

“Most of what we found in our risk assessments was that it was the preanalytical, and a little bit less often the postanalytical, but almost never the analytical piece,” David explained. “The risks, the issues that we found, were more about operator training, preanalytical specimen collection—just a lot of things that had nothing to do with whether or not you run QC every day.”

Adil I. Khan, MSc, PhD, director of point-of-care testing and clinical chemistry at Temple University and Episcopal Hospitals in Philadelphia, said his institution also found that IQCPs did not uncover any new risks in the analytical phase of testing. “Although IQCP is quite a good thing, it hasn’t really changed a lot of our practices,” Khan said. “We still follow the minimum manufacturer recommendations, but the way in which it has helped is that it has put together a framework. It has made it more scientific—why we do the QC or why we have these various conventions. It put a rationale behind the quality assurance and the QC procedures that we do for these moderately complex tests.”

Khan said it took about a month for his organization to write IQCPs for a small number of tests in the catheterization laboratory, operating room, and heart failure unit. The laboratory had already made its own risk-based decisions regarding external QC, Khan added. But the IQCP “put a rationale in writing, supported by documentation,” he said.

Perry, who helped develop CAP’s IQCP guidelines and educational materials, also spent several months working on IQCPs back home at Methodist. She and her colleagues created IQCPs for POCT, microbiology, and some rapid molecular tests, such as Cepheid’s GeneXpert.

One benefit of the process was that it required participation from the POCT operators, she said, which helped those users feel engaged in QC, rather than simply following rules dictated by the laboratory. “You have to get the end users involved,” Perry said. “That is a good opportunity for laboratorians and nursing personnel or medical assistants—whoever is performing the test—to directly interact.”

While the learning curve was steep for laboratories when IQCPs were new, there are now plenty of resources available to anyone who needs to write a new IQCP, including templates from vendors and accrediting organizations, Perry said. Also, most laboratories now have at least a few IQCPs already written that can serve as starting points for new IQCPs. “Use your resources,” Perry commented. “You don’t have to reinvent the wheel every time. You can modify the wheel that’s already in place.”

Going forward, laboratorians should remember to consider IQCPs when evaluating new tests, Perry emphasized. If two kits are available for a test and only one is CLIA-waived, remember that the non-waived test may now require the additional work of writing and maintaining an IQCP.

The Future of Quality

So far IQCPs have been adopted mostly by POCT and microbiology departments. Yet the risk-assessment approach to QC could be a sign of things to come for other laboratory divisions. “I think there is going to be a change in the way laboratories approach quality control, and it’s going to be within the patient risk paradigm,” said Curtis Parvin, PhD, who recently retired as manager of advanced statistical research in the Quality Systems Division of Bio-Rad.

Parvin and his colleagues have developed computer algorithms to generate risk-based QC strategies for laboratories. Under their approach, there is no simple rule—such as two levels of external QC daily—that applies to every test. Rather, the type and frequency of QC recommended for each test differs based on characteristics of the test, how it is performed, how quickly the results are acted upon, and the severity of patient harm if the results are wrong.

“It’s broadening our thinking about what we need to do in the laboratory in our quality control, to consider patient risk implications, not just instrument performance implications,” Parvin said. “For so long when it comes to quality control, we’ve treated the instrument as if it’s our patient. We’re in a world now where we need to treat the patient as the patient.”

Some advocates of this new QC approach were worried when CMS introduced IQCPs, fearing they would be a shortcut that allowed laboratorians to check a box rather than create a thoughtful, patient-centered QC plan, Parvin said. But he believes IQCPs can be a valuable tool when laboratories take them seriously.

“I choose to be optimistic that the majority of laboratories want to do good quality control,” Parvin said. “They want to minimize patient risk. They believe that their role in patient care is providing useful patient results that enhance care and minimize risk. … Those kinds of thought processes, I think, will really help advance the state of the art of quality control, if we can just get people thinking beyond the instrument.”

Julie Kirkwood is a freelance journalist who lives in Rochester, New York. +EMAIL: julkirkwood@gmail.com