November 2008: Volume 34, Number 11
Risk Management for Clinical Labs
As CLIA Turns 20, A New QC Paradigm Lies Ahead for Labs
By Bill Malone
When the first stories about misread Pap smears broke in the fall of 1987, a painful and uncomfortable chapter began for clinical labs that provoked Congress to press for closer government oversight of laboratory quality. Yet the rush by Congress to amend the 1967 law that governed labs and the eventual publishing of the final CLIA rule in 1992 did not close the book on quality issues. As technology in labs has pressed forward in the 20 years since then, it has left in its wake a wider spectrum of possibilities and pitfalls that require a new approach to quality control (QC). Add to this the continuing strain to meet the twin goals of quality and efficiency, and many laboratorians wonder whether CMS’s controversial 2004 equivalent QC (EQC) program will keep this balance from snapping again as it did in 1987. Now, stakeholders from government, industry, and clinical labs want to usher in a new chapter in quality management for labs by rolling out a risk management model based on ISO principles, hoping to bring manufacturers and labs closer together in a more comprehensive approach to assuring quality.
According to Judith Yost, MA, MT (ASCP), director of CMS’s division of laboratory services, CMS never anticipated that large, independent labs or hospital labs would adopt EQC to any great degree. However, Yost says she expects that the new risk management model that’s being distilled for labs in the Clinical and Laboratory Standards Institute (CLSI) EP (Evaluation Protocol) 22 and EP23 guidelines will allow each one of the approximately 36,000 labs subject to biennial surveys to develop a QC plan that suits its individual needs. “Risk management is a very practical, logical approach. I think in that way it should be very well received, because people will be able to understand it and see how they fit into it, rather than just some blanket requirement that has no logic,” Yost said. “The guidelines basically will enable a laboratory to utilize the enhanced information provided by the device manufacturer to customize its QC program based on the type of testing that it performs, its patient population, the whole testing environment—even how the test results are used.”
CMS plans to take the key concepts of the final CLSI guidelines and incorporate them into the Interpretive Guidelines, part of the State Operations Manual (SOM) to which labs refer to stay in compliance and surveyors use to assess compliance. But just how risk management will complement or replace CMS’s current EQC standards remains to be seen. Yost said it’s too early to say whether her agency will keep current EQC in place once the risk assessment model is fully rolled out—which may not happen until 2010. But even though the details of the guidelines are still being hammered out by the CLSI subcommittees, risk management looks to be an inevitable paradigm shift for labs that both champions and critics of the model are saying laboratorians need to understand.
CLIA’s 20 Year History
A Glance Back
Large CLIA Timeline
When President Ronald Reagan signed CLIA into law on October 31, 1988, it marked a confluence of events outside and inside labs that would change the landscape of testing for decades to come. Before CLIA ’88, labs worked under a bewildering patchwork of regulations. Essentially there was one standard for Medicare laboratories, and another for labs that did interstate testing, such as independent clinical labs, explained Vince Stine, PhD, AACC’s director of government affairs. “In addition, a number of states also had separate laboratory standards. This created a lot of confusion and consternation, within the laboratory sector,” Stine said. In addition, physician office labs performed testing outside of any oversight at all.
Then in November of 1987, the Washington, D.C. affiliate of NBC aired a story about misread Pap smears that created a public outcry over the problem. Within a few weeks, a handful of congressional committees announced hearings on lab testing. “What happened during the hearings is that, although the Pap smears issue was what got everyone’s attention, the laboratory community took the opportunity to broaden the debate,” said Stine. “The laboratory groups came in and started talking about the quality of physician office labs and other issues, which gave lawmakers a basis for enacting much more sweeping legislation.”
One of those changes that found its way into the new legislation was the complexity model, mainly advocated by ASCLS. Out of this came the concept of high-complexity, moderate-complexity, and waived tests. Remarkably, this relatively speedy expansion of government oversight of clinical labs took place during a political atmosphere marked by a movement to shrink government and reduce regulation. “This was in an anti-regulatory environment, but here you are expanding federal oversight from about 15,000 labs to upwards approximately to 200,000 labs,” said Stine. It took 7 years before CLIA ’88 was fully effective, with provisions like proficiency testing fully phased in. At this same juncture, some in Congress began a push to exempt physician office labs from the regulation, but the lab community pushed back and defeated the legislation, maintaining the integrity of the original CLIA law, which focused on testing, rather than testing the site.
Equivalent to What?
When CMS crafted the EQC guidelines for laboratories, the idea was based on the belief that lab devices, especially for point-of-care testing, had advanced to the point that in some cases it was no longer necessary to do two levels of external QC every day, explained Yost. However, some laboratorians have found it difficult to come to terms with EQC’s 10-, 30-, and 60-day evaluation periods for an instrument that then allow the lab to reduce external QC to a monthly or weekly basis, still performing the internal QC for the test system daily.
One of the most outspoken critics of the EQC guidelines has been James Westgard, PhD, FACB, emeritus professor in the department of pathology and laboratory medicine at the University of Wisconsin Medical School and president of Westgard QC, Inc. “So what are equivalent QC procedures? Equivalent in performance? Equivalent in detecting medically important errors? Equivalent in assuring the necessary desired quality is achieved?” asked Westgard at a September 4 AACC audioconference called “New Directions in Laboratory QC: EQC, Alternate QC and Risk Assessment.” “No, it’s none of the above. It’s just a name. It has nothing to do with any practical meaning in terms of what we think of equivalents. It’s just a name,” he said.
Yost stands by CMS’s reasoning behind EQC. “We felt that the technology and even the point-of-care experts would acknowledge that many of those devices are very accurate and reliable, and so doing two levels of external QC every day of testing was probably superfluous,” she explained. According to Yost, many labs have implemented EQC successfully with no other quality problems identified during inspections. She also commented that with unit-use devices, doing QC on one cartridge doesn’t really tell you much about the performance of the rest of the cartridges, anyway. “You’re just using up a cartridge, whereas internal controls can tell you a whole lot more about the test system,” she said. Moreover, CMS requires that all other systems and processes in the laboratory—quality assessment (QA), personnel competency, and proficiency testing (PT) performance—be working well before a lab can consider reducing QC. “CLIA was always intended to be baseline standards,” Yost explained. “And we certainly don’t discourage anybody from doing more than what CLIA requires. We realize that there are cases in which laboratorians think that we’re too hard, while others say we don’t go far enough.” Yost noted that CMS heard the concerns about EQC and worked with its sister HHS agencies and CLSI to convene the “QC for the Future” meeting in 2005. It was this meeting that generated the idea for the two CLSI documents. She said CMS hopes to encourage the accrediting organizations that also survey non-waived laboratories under CLIA to adopt the EP protocols.
A New Vocabulary for the Lab
While it’s unlikely that the debate over the current EQC program will fizzle out any time soon, those working on CLSI’s guidelines EP22, Presentation of Manufacturer’s Risk Mitigation Information for Users of In Vitro Diagnostic Devices, and EP23, Laboratory Quality Control Based on Risk Management, predict that risk management will appeal to laboratorians’ desire for a logical, scientific approach to quality management (See Box below). “It’s a new vocabulary to talk about quality,” said James H. Nichols, PhD, DABCC, FACB, associate professor of pathology at Tufts University School of Medicine and director of clinical chemistry at Baystate Health in Springfield, Mass. “If you look at the evolution of quality management, continuous quality improvement became total quality management. Then the Joint Commission and CAP started talking about the entire testing process, and now we’re talking about risk assessment, hazard analysis, and risk mitigation—these are becoming the new terms.” Nichols is chair of the subcommittee developing CLSI’s EP23 guideline that aims to help labs develop a laboratory-specific QC plan using risk assessment metrics. The companion CLSI guideline also under development, EP22, will provide a framework for manufacturers to spell out what might go wrong with their device and what a lab can do to prevent these problems, using risk assessment to structure their efforts.