CLSI eNews - 11 April 2005 (Plain Text Version)Return to Graphical Version | Search back issues | Print all articles In this issue: Contention, Community Mark 'QC for the Future' WorkshopGovernment, Industry and the Professions Converge in Baltimore's Inner Harbor for a First-Time Summit on one of the Medical World's Most Controversial Issues “The Best Laid Plans…” “From the Trenches” All equally fitting titles, Valerie Ng, PhD, MD says, for the presentation she gave to a standing-room-only crowd in the Baltimore Ballroom of the Renaissance Harborplace Hotel in Baltimore, as part of the Quality Control for the Future Workshop on 18 March 2005. The more subdued, diplomatic title she went with was “Laboratory Issues – POCT/POL Concerns.” But, in her good-natured, humorous presentation, Dr. Ng, Director of Clinical Laboratories at San Francisco General Hospital, did not hide the frustration inherent to the quality control issue in the current POCT environment. Ng’s comments drew the strongest responses of the day from the crowd, from laughter to applause to the occasional cheer – and, in the open discussion that she oversaw later in the day, a reciprocating measure of dissent. Kim Gregory, MT(ASCP) NCA, says, “Dr. Ng is a pathologist who is truly in tune with the day-to-day intricacies of POC testing.” As POCT Specialist at the Boston Medical Center Department of Laboratory Medicine, Gregory perceives a major disconnect between the laboratory and the clinic. “There aren't very many pathologists who can tell these day-to-day stories. Pathologists as a general rule tend to remain in the lab -- they're engaged in medical science, quantification, rendering clinical opinions..." On the other hand, Gregory says, “many physicians are out of touch with what we do. For doctors and nurses, quality control is often seen as a nuisance. They’re clinicians. They see patients – they don’t see how being so caught up in quality control can really help patients. It’s about finding a happy medium.” Which is where CLSI comes in. The Quality Control for the Future Workshop was the first event of its kind, drawing directly upon the Clinical and Laboratory Standards Institute’s (CLSI) principle of triangulated balance between government, industry and the professions, to both facilitate and temper the presentation and exchange of ideas. Says CLSI President Elect Bob Habig, PhD, VP Regulatory Affairs at Abbott Laboratories, “My biggest pleasure about planning and executing the workshop was that it allowed the flourishing of CLSI’s core competence, which is consensus building. It allowed us to get pretty disparate points of view together for a day without anybody bringing in a gun.” Luann Ochs, MS, Chair of AdvaMed’s CLIA (Clinical Laboratory Improvement Amendments) working group, expresses industry concerns surrounding equivalent quality control. “The frustration in industry is that we believe we have good scientific evidence to run good quality control, but there seems to be no mechanism under which that can be recognized by the agencies.” Ochs, also the Chairholder of CLSI’s Area Committee on Evaluation Protocols, led the CLSI Standards Development Proposal session for Option 4, which she calls “an industry response” to CLIA regulations. “When CMS (the Centers for Medicare & Medicaid Services) issued their new quality control guidelines in 2003, industry was really concerned about the way they had incorporated equivalent quality control (EQC) with the three options they had offered. And therefore the (AdvaMed) CLIA working group decided we needed to take action and call CMS, FDA, and CDC together and discuss the three options they had together, and then we came up with Option 4.” Option 4, Ochs says, is a “how-to document.” “The principles of risk management are something that people in industry use every day. But we haven’t necessarily applied those to quality control. So the document we want to write is a how-to document for applying risk management to quality control.” Sheila Woodcock, ART, MBA, Principal Consultant of QSE Consulting, who has been to every Leadership Conference since 1996, explains that this year’s Leadership Conference was designed in a “different format” with the inclusion of the QC Workshop. “We are separating the educational component from the meetings themselves, whereas before the two were intertwined.” To Woodcock, the quality control issue was an appropriate opportunity to introduce this new format of focusing distinctly upon a particular issue that concerns the CLSI constituency, and devoting time to addressing it: “The whole field of quality control is changing.” Donna Meyer, PhD, Past President of CLSI and System Director of Community Health for CHRISTUS Health, says that quality control is a timely concern. “There’s a lot more automation in laboratory equipment, and the design is different, the world has changed, our expectations of quality have changed – we’re still doing a lot of our quality systems the way we were doing them 15, 20 years ago. We’ve got to get with the times.” Harry Hannon, PhD, Chief of the Clinical Biochemistry Branch at Centers for Disease Control and Prevention, agrees. “We’re still dealing with single-analyte quality control systems, and staying too much in the traditional box; we’re not trying to think outside the traditional box and systems that we’ve been dealing with over time for clinical assays.” From her perspective as a CLSI leader, Meyer says that although concern over the future of QC is timely, it is hardly new – and CLSI members saw it as an opportunity for this first open forum of its kind. “In the last few years, we in CLSI were searching for the appropriate issue to address. And this was one of the issues that we were aware was coming around the bend. “Industry has been discussing this for the last couple of years. I heard it at an ISO meeting in Australia (in 2003) being discussed by industry people. Industry feels that they’d re-engineered equipment and that we haven’t adjusted quality systems to address the re-engineered equipment.” CLSI, Meyer says, created an opportunity for there to be a meeting of the minds rather than more frustration within each sector. “The unique value of the CLSI meeting is that you get industry and government and the professions in one room discussing the issue.” The benefit of the dialog alone was not lost on AdvaMed Associate VP, Technical and Regulatory Affairs, Carolyn Jones, JD, MPH, who says that she was “gratified” to hear members of the professional sector say training approaches for laboratory personnel are in need of change. “That’s something that’s concerned industry folks for a long time, because, as technology has moved away from… going into the back room and mixing the chemicals for the chemistry analyzer, to more black box (technology), the training of the laboratorian does need to change. And that’s where we get stuck: to what? more of an engineer? more skill? Is more of a background (needed) than what we’ve been used to providing? So it was very gratifying to see the laboratory community and the manufacturers on the same page for once. The meeting was an opportunity to show that we’re definitely not at odds with each other; we have the same problems, and we’re looking for technology approaches to address these concerns.” Cepheid VP, Regulatory & Clinical Affairs, Russel Enns, PhD, applauded the willingness of CMS to reflect on the need for improvement in its own regulations: “CMS sees the need created by the fact that, when they finalized CLIA, it did not, and could not, figure in advancements in technology that have been made since. The EQC workshop was a way to begin to repair this disjunction.” In turn, Enns says, “Industry is in favor of trying to be flexible and make changes.” According to Meyer, the timing of the conference aligned with a rising demand across the healthcare field for dialogue, and the conference “brought in lots of people that aren’t our typical internal constituency. This conference was an opportunity for people from all different backgrounds to come together, to discuss the issue, and to put a new focus on how we plan the future.” Enns says that it was no coincidence that there was a much stronger attendance at this year’s workshop than he’d seen in ten years of CLSI/NCCLS events.
“I guess you could see from the forum that nobody is particularly overjoyed with the approach that CMS has taken with quality control,” Jones says. However, Jones emphasizes that the workshop “wasn’t an opportunity to criticize CMS or CDC or any of the others that put it together. “The ultimate goal was to raise issues about, ‘Okay, we have this QC model, and it sort of freezes us in time – it doesn’t even do a good job there.’ I think Judy (Yost, MA, MT, Director, CMS Division of Laboratory Services) did an excellent job in saying, ‘We did the best we could with what we had, and now we’re coming back to you in industry and laboratory to tell us what you need.’” So the audience told, in a highly charged forum where comments quickly flashed between anecdotes and experience about the day-to-day workplace, as well as complex details about the intricacies of the tests themselves. As Jones attests, “I don’t think anybody was shy, and that’s very good.” From a POCT perspective, Ng sees the frustration as rising from inherent differences between the professional cultures that converge at the point of care. In her presentation, she commented, to wild applause, “I think I’m going to need to go back and get an anthropology degree, because that’s what I’m going to need in order to deal with all of these different cultures!” She later elaborates, “I believe (laboratorians) are self-selected to be laboratorians, because they believe in evidence, they believe in scientific methods, they recognize (that) there are true analytical ways to measure things. When you deal with nonlaboratorians , in particular… nurses (are) self-selected for nursing because they’re caring people. They’ll do whatever they can for the patient, and they see the test device as something that gives them a number, and that the number is reliable. Regardless of how you do a test, that number is truth.” For physicians, Ng says, it’s an issue of autonomy, which threatens the traditional iconic image of the doctor. “Talk about ‘wild west,’ you know? Physicians have been pretty much allowed to do whatever they wanted . Now you’re removing something that used to be totally under their own control. Now you’re placing some regulations on that. And some physicians don’t like that. I think you’re also removing from them – and this is when CLIA '88 was very sensitive – something that they considered a basic part of the practice.” After about a decade of work in the POCT environment, Ng says she still receives “calls from physicians who are asking me, “Why do I need to do these Web-based image recognition things that I do every day as part of my practice?’ And when I comment that the regulations are out there to make sure that you’re interpreting these things correctly, they just say, ‘But I’ve been doing it all my career.’ My standard line now is, ‘You know, I’ve been a practicing clinical pathologist now for 17 years. And I am challenged four times a year with five to 15 images each time, and I am graded. And I am considered the expert, so I don’t see why you’re different than me.’” “With the newer-generation physicians, who have typically trained for the past five or ten years, medicine is moving more towards a team-oriented approach. So, the current group of physicians is more accepting of that argument. It’s when (they’ve) been in practice for a long, long time (that) now you’re impinging on their authority.” While debate stirs within the professions, another angle of the issue is the disconnect created by dissatisfaction among the professions with the products, and the belief in industry that the workers using them simply aren’t being trained properly. “I think both sides are right,” Lucia Berte, MA, MT(ASCP), SBB, a Colorado-based independent quality systems consultant, says. “The government is absolutely right on in that the training that takes place of employees in the laboratory work processes and procedures is not all that it could be. If it were improved, we might get better quality control performance. On the other hand, the laboratories are also right in that they’re sitting there in a huge conference like that, and we’re hearing the government saying it’s okay to do alternative QC, and then we hear that a QC statistical process control world-renowned expert like (James) Westgard say, ‘Wait a minute, wait a minute, wait a minute -- what we’re doing now isn’t as good as it could or should be, before we even think about cutting back on quality control.’” However, Hannon says, “I think the manufacturers are giving us what we asked for. These instruments and software are complex and designed to help the analyst. But with this help, we would like to have some way to verify that the perspectives and information that they give us and the monitoring elements that they claim are working are indeed functioning. If everything you’re doing is what the manufacturer tells you to do, you have no independent verification – other than your participation in proficiency testing programs and other external quality control systems.” State-to-state differences in the interpretation of CLIA regulations is another issue that affects all three sectors. Says Mary Lou Gantzer, PhD, VP Clinical and Scientific Affairs at Dade Behring, “There is still a lot of discussion and grayness in that whole area with some state inspectors having different interpretations of the regulation than others do.” “In industry, your focus is providing the best solution for the customer that you can. When you think (you’ve done) that, and then they run into an issue with an inspector, what they’re going to do is call you, and say, ‘This is what you gave me, and this is what the inspector said.’” While CLIA is a specifically United States regulation, Canadian Society for Medical Laboratory Science Executive Director Kurt Davis ECSMLS, CAE, explains the global interest in the QC for the Future forum. “If you look at the package inserts in many of your (laboratory testing) products, there are six or seven languages today. It’s really become a global industry. “As far as the actual testing of quality assurance materials, it’s expensive,” Davis says. “So people are looking for ways to economize both the reagent costs as well as the technical costs. There’s a balance between government regulation and appropriate standards of practice, and also embracing innovative quality technologies. And James Westgard questioned, were we doing enough? So we should look at that side of the equation, because there are people out there who believe we should be doing more quality control rather than less.”
Gantzer describes how the buzz that generated workshop attendance carried over to create stronger interest and involvement in CLSI activities: “I can tell you I did have people there (from Dade Behring) who have not been involved in CLSI activities at all, and as a result of the QC Workshop, they called me and they said, ‘You know, this is stuff we really should be involved in. How do we get involved?’ So there were people who saw the value, saw that it applies to the things that they’ve been involved in, and they said, ‘I want to start getting involved.’ I think it kind of helped us to build that pool.” According to Yost, the event was a success: “The goals of the meeting were met in that we were able to identify concerns and ideas for QC for the future. I have gotten very positive feedback from members of all the representative sectors. The speakers all did an outstanding job and fulfilled their roles beyond expectations. Since they are all nationally recognized, they were true stars.” Furthermore, Yost notes, “Option 4 was very well received.” Ensuring the engagement of attendees in the Option 4 development process from the ground up, Ochs led a breakout session concerned solely with “getting people to provide me with feedback (about) what needed to go into the document; what kind of things we needed to consider; what would be the criteria for equivalent quality control.” Following the session, CLSI staff members were approached with more than 25 business cards from attendees wanting to take their involvement further. So what is the future of QC? According to Hannon, “We’re going to be somewhat left to the mercy of the manufacturer, because they’re going to build into the system all these complex control mechanisms. And you see it now – more and more instruments that do more and more of the work for the laboratorians without the laboratorians having to think about what’s going on. You’re to the point where you’re accepting the manufacturer’s programming in good faith, that everything is working and the process will give you a high-quality result; where historically, we’ve always questioned and challenged these “magical” systems. The instruments give us answers, but we wanted to prove it does that with quality, or prove it doesn’t. Now we may be at the point where this is beyond the bench chemists’ capabilities. These assay systems may come somewhat locked down, and you’re going to have to figure out ways to challenge the manufacturers’ systems to assure that you’re indeed getting what they claim to deliver.” Summing up the workshop, Berte states, “All sides are willing to keep talking, which is important.” In the meantime, she says, there was a feeling that “maybe we should keep doing what we were doing under the old CLIA requirements until things are more clear.” What was made “very clear,” Berte says, particularly by the government sector present at the workshop, is that “whereas it’s hard to change laws, through CLSI mechanisms, we might have an opportunity to craft guidance and recommendations that CMS could then put forward to the laboratory community to give them some better direction.” One of the values of CLSI, Gantzer says, is that, in bringing together the sectors of government, industry and professions, manufacturers are able to call upon the government contacts made through work in CLSI to help them understand emerging issues and regulatory parameters, so that they can serve customers better and avoid future problems. “You wouldn’t know the right people to call if you weren’t working with them on activities like CLSI activities,” she says. Davis: “It’s an issue which people are struggling with, there’s no question, and I think they were looking for solutions. I don’t think there were any people who came away with as many questions as they did answers, but at least they were better educated on some of the questions to ask now.” “I think there was better understanding,” Habig says, “at the end of the conference than when the conference started. I’m not so sure that many people had actually shifted their positions, but it’s possible to reach a consensus with full understanding that you don’t completely agree.” So, how will the debate proceed from here? Ng’s guess is that, among clinical laboratorians, it ultimately won’t.: “I actually think (the EQC debate) for clinical laboratorians is going to die. That’s just my personal opinion, but… at the practical level, the bottom line is that doing (the required sample testing and retesting) is such a nightmare for any clinical operation, not only in a storage capacity, but the impact on individual patients; it’s just not workable.” Others see the issue as just heating up. In order to keep the debate alive, Meyer advocates the development of working groups that are both geographically and professionally diverse to address the issue; she also predicts increased involvement of CLSI in the QC issue: “I think it’s got to be the start of an extensive dialogue over the next few years. This isn’t an easy one to solve overnight. We need to get working groups that really represent a good cross-section and have them develop ideas that can be brought back, to have a really substantial meeting next year. We can’t wait for the program next year. We’ve got to have lots of meetings along the way this year, so we make a year’s worth of progress, and then bring back more advanced ideas next year.” As for Yost, plans are in the works for CMS “to convene a meeting organized by CLSI and sponsored by AACC, ASCLS, AdvaMed, CMS, FDA, CDC, CAP, JCAHO, and COLA to determine a plan for ‘QC for the Future,’” she announced during her presentation. She later commented on the positive outgrowths ultimately made possible by the misunderstandings and conflicts over EQC. “I think that there may be additional options for QC for labs that could be explored using the Clinical Laboratory Improvement Advisory Committee (CLIAC), sponsored by CDC to conduct studies on QC options based on data from all constituencies.” Yost also suggests that the lack of knowledge among clinical laboratorians of the risk management concepts used by manufacturers “offers another educational opportunity for CLSI to pursue – to provide a workshop or seminar on these principles and how they can transcend into the lab from industry.” Jones left with the feeling that the QC workshop represented a landmark event not just for CLSI, but for the medical field as a whole. “It was unique in that we hit on an issue that affects everybody in pretty much the same way. In the past, you had some meetings that focused on issues that maybe affected the laboratory community, but they were of little interest to the industry constituents. But this time around, the issues hit home for almost everyone. They had an impact on all groups.” For Enns, the issue goes beyond CLIA and the national debate over US regulations, and extends into an international process of healthcare improvement. “This isn’t just a US issue; it’s a global process of deciding together how to build a better mousetrap.”
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