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Risk management steps up labs’ QC game under IQCP

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Anne Paxton

September 2014—Industrial risk management. It may not seem all that sexy as a concept, but in the field of laboratory quality control, risk management has become about as buzzworthy as is possible. One of the key reasons: The Centers for Medicare and Medicaid Services has embraced risk management as the foundation of a new option for meeting CLIA quality control standards called IQCP, or Individualized Quality Control Plan.

A voluntary QC option under CLIA, IQCP aims to give labs greater flexibility in achieving QC compliance by customizing lab QC plans to each unique testing environment via the use of risk-management strategies. Employing electronic/integrated controls, IQCP intends to adapt to future technological advances and strengthen manufacturer-laboratory partnerships.

“Many assays appear to be okay when we run our QC,” says Alison Woodworth, PhD, director of esoteric chemistry, associate director of clinical chemistry, and assistant professor in the Department of Pathology, Microbiology, and Immunology at Vanderbilt University Medical Center. “But when we do more in-depth risk analyses, they may not be okay.”

With IQCP, “labs will have a choice now. They can use a one-size-fits-all approach of running two levels of external QC material once a day, the bare minimum under CLIA requirements, or they can do a risk-assessment evaluation to better determine how their assays are performing and how much QC they should run.”

IQCP is available for all CLIA-regulated nonwaived tests except pathology and its subspecialties, which the CMS says will be considered later. The CMS announced IQCP last fall as an exercise of its enforcement discretion under CLIA; CLIA regulations of QC remain unchanged from the last update in 2003.

Following IQCP’s official launch on Jan. 1, labs were given two years to make the transition to IQCP and to test laboratory operations under that option. After Jan. 1, 2016, the old EQC, or Equivalent Quality Control, procedures will no longer meet CLIA standards.

What does IQCP mean for laboratories in specific terms? No process maps, fishbone diagrams, or formal risk-assessment charts and protocols will be required for laboratories to develop an IQCP, the CMS promises. But laboratories will need to have sufficient data to support their decisions, and all IQCP activities must meet documentation requirements.

IQCP and its related method, the EP23 standard offered by the Clinical and Laboratory Standards Institute since 2011, may save laboratories some work, but do not necessarily represent a lowering of QC requirements, says quality control expert James Westgard, PhD. A cofounder of Westgard QC in Madison, Wis., Dr. Westgard was the first chairman of the Evaluation Protocols Area Committee in CLSI (then known as NCCLS).

Although he would prefer to see more rigorous regulation of QC, “Technically, if you look at the CMS regulations, the requirements haven’t been reduced with IQCP,” Dr. Westgard says.

For laboratories tasked with performing quality control, he says, “You have option A, you have option B, and now you have option C. Option A is guidance on doing the right QC for precision and accuracy and detecting medically important errors. Option B, if you do not want to do that [option A], is to run at least two levels of QC once a day. And now option C is this risk-based QC, and if you do it, you can probably get by with less.”

Risk management—using analytical tools to assess the risk of reporting unreliable patient results and risks that attend such results—is a major new direction within the field of laboratory quality management, Dr. Woodworth says. “Risk management didn’t start in the clinical lab. It started with manufacturing and the folks using six sigma, but now with the publication of CLSI’s EP23 and other similar documents, it is a hot topic in laboratory medicine.”

Dr. Woodworth

Dr. Woodworth

Although the CLSI EP23 guideline is a tool for implementing IQCP, the fact that it has been in place for a few years already has helped people become oriented to the concept of risk management, she adds.

Using risk assessment, Dr. Woodworth’s research focusing on HbA1c has vividly demonstrated some of the inadequacies of analytical QC programs currently in place in clinical laboratories. Looking at eight different HbA1c platforms at four academic medical centers, her team used QC materials and analytical tools to assess risk.

“What we found is that most assays out there are not that good. The bare minimum approach of two levels of QC once a day is not sufficient to evaluate the risk of reporting unreliable results for HbA1c.”

All but one platform showed that the laboratory should be running the maximum number of QC (three levels three times a day). “It caused us to take a step back and think about the performance of this particular assay,” Dr. Woodworth says (Woodworth A, et al. Clin Chem. 2014;60: 1073–1079).

That doesn’t mean every test should have the maximum rather than the minimum QC, she notes. “We calculated sigma metrics, which are an estimate of risk. They take into account the allowable total error for the assay along with the analytical performance, the precision, and the bias of the assays. The sigma is equivalent to the six sigma goal in manufacturing. In the laboratory the sigma metric helps to estimate the risk of reporting an unreliable patient result—one outside the allowable total error limits. Then we can use recommendations from national thought leaders to determine an appropriate analytical QC program based on sigma metrics—i.e. how many levels and how often QC should be run each day.”

“It’s really just a simple formula to calculate a sigma metric. Anybody who uses Excel can gather the analytical data they are already generating, imprecision can be gathered from the QC they run, and bias can be garnered from their proficiency testing results.”

Software tools by such companies as Bio-Rad, CRI, and Carepoint Solutions have been developed to help. (Randox’s Acusera 24.7 wasn’t designed to be used to develop an IQCP but can be a useful tool in carrying out an IQCP, according to a company spokesperson.) Dr. Woodworth’s laboratory now uses Bio-Rad’s Unity, which receives data from the automated instrumentation in the clinical chemistry lab and allows frequent evaluation of QC. “With Unity, I can look at shifts and trends in my analytical QC as well as generate sigma metrics and receive recommendations on amount of QC to run.”

A current limitation is that not all labs connect all instruments to the Unity program. “If you are using devices that are not interfaced, then you have to manually enter the data,” she says. For example, with Vanderbilt’s point-of-care testing and some of the endocrine lab assays, QC results are entered manually. “It can be done, but it’s more challenging.”

But Dr. Woodworth is enthusiastic about the potential contribution of IQCP to laboratory quality. “We all should be looking more closely at how each assay performs prior to determining how many QCs to run. But the only way IQCP is going to work is if people do a good job of evaluating the risk. Where it could falter is if the risk-assessment piece is not complete. All labs must understand that they need to start working on more complex statistical evaluations of the analytical piece as well as incorporate the total testing process, the preanalytical and postanalytical.”

It’s important to keep in mind, Dr. Woodworth stresses, that EQC is going away and IQCP is already available to start trying out. “Very soon, labs will not be able to use EQC. Most labs do assess risk and work constantly to refine processes, but IQCP is providing a little more structure to what we do already.”

With EP23 and IQCP, “CMS is getting out of micromanaging and dictating that there is only one way to run QC,” says James Nichols, PhD, medical director of clinical chemistry and professor in the Department of Pathology, Microbiology, and Immunology at Vanderbilt. IQCP and EP23 really evolved over the last 10 years out of concerns about the limitations under CLIA of one-size-fits-all QC, he adds.

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