IN PERSON
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Paul A. D’Orazio, PhD, is chair of the industry division of the American Association for Clinical Chemistry (Washington, DC) and is director of sensor development at Instrumentation Laboratory (Lexington, MA). He can be reached at pdorazio@ilww.com.
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After a few years, an organization sometimes needs to take a step back, reassess what it is doing, and determine where it is going. Some organizations realize that in order to move forward, certain changes need to be implemented.
Such are some of the challenges that the industry division of the American Association for Clinical Chemistry (AACC; Washington, DC) is dealing with. For example, the division has been actively involved in putting together programs on regulatory issues, but not nearly enough on developing technologies. The industry division realizes that while it has established a solid base, it needs to do more in order to become a leader in the IVD industry. (To learn more about AACC’s industry division, please visit its Web site at www.aacc.orgdivisions/industry/default.stm.)
To find out more about the latest developments, IVD Technology editor Richard Park spoke with Paul D’Orazio, chair of the AACC industry division and director of sensor development at Instrumentation Laboratory (Lexington, MA). In this interview, D’Orazio discusses what the industry division has done so far and presents his views on what the division should do to become a more-effective organization.
IVD Technology: How has the industry division been received by IVD manufacturers?
Paul D’Orazio: In general, we’ve been received well by members of the IVD industry. We’ve been better received in some segments of the industry than others, only because we’ve developed programs that have been fairly narrow and have appealed only to certain segments of the industry. We have to expand our interests now and develop programs that will appeal to a broader audience within the IVD industry. But people understand what we do and what our goals and missions are.
Which specific segments of the IVD industry has the industry division been well received by?
Our educational programs have been fairly narrowly focused on areas like risk management. We haven’t done a whole lot with technology, so we’ve appealed more to the regulators within the industry and those involved in patient safety. For those involved in developing technology, we probably wouldn’t have as much appeal right now, but we need to grow that.
What are the goals and missions of the industry division?
We have to develop a long-range plan. Our interests have moved around a bit, depending on who’s chair at a certain time and what that person’s interests are. And we turn over our executive committee every year. So every year, we have new people onboard, and those people have interests and they try to get their programs off the ground. But then we have a loss of continuity when new people come onboard. We need to develop a long-range plan with some clear priorities on what we want to achieve, and then stick to that until we come to some tangible end.
How many members are currently in the industry division? What efforts are being made by the division to increase its membership and reach out to those outside of the IVD industry?
Our membership has been bouncing around between 350 and 400 for the past five years. Considering that approximately 20% of the AACC membership works in the IVD industry, that’s low, and we’re actually one of the smallest AACC divisions. We need to make the AACC membership more aware that we’re here because I’m sure some members don’t even know we exist. We need to market ourselves and do a better job advertising our educational programs. That is something that we identified as a priority for this year.
What strategies or approaches should be taken to make people more aware of the industry division and what the division does?
We need to develop programs that are of broader interest to the IVD industry. They’ve been important up to now but fairly narrow. As far as getting better recognition outside of the IVD industry, that is one area that has improved quite a bit. I’ll get into that more when we talk about our specific educational programs, especially in trying to educate laboratorians about the risk management tools that people in industry use all the time and how they can benefit from those tools in their own jobs.
Education, Networking, and Lobbying
What educational programs has the industry division organized and been involved in?
We’ve been very active in the area of risk management and patient safety. As a matter of fact, one of our members recently organized a workshop at the Clinical and Laboratory Standards Institute (CLSI; Wayne, PA) leadership conference on how to use risk management tools for improving patient safety, and it was very well received. This is an area where tools like these that are used in the IVD industry all the time can be extended to the clinical laboratory. We can develop guidelines and even modify the tools a bit for the laboratorians to use in their daily work. This has been an area where some of our members have been very active, and it’s been largely successful.
Other areas where we’ve been active is how to apply sigma metrics in the clinical laboratory. Again, here we’re taking some tools that are used in the IVD industry for improving the quality of products, and adapting them for use in clinical laboratories. Everyone’s goal and mission should be improved patient care. We’re taking these tools that the industry uses and trying to adapt them and educate the labor-atorians about how they can benefit from them as well.
Are there going to be any efforts to increase programs on technology issues that could potentially draw in more interest to the industry division?
It would be huge as far as drawing more interest into the industry division, and I’m particularly interested in this because I’m a technology developer. I recently represented the industry division at a workshop that NIH sponsored. The goal of this workshop was trying to find ways where we can take all of these technologies that are being developed in academic laboratories and move them into point-of-care testing faster, with the goal of improving healthcare accessibility especially to underserved segments of the population.
Academic centers are developing all of these technologies, and the end-users have these unmet needs. In the middle, the IVD industry is supposedly going to take these technologies, engineer them into products, and move them into the point-of-care testing sites. This NIH workshop in April was really the kickoff point for that, trying to find ways to improve healthcare accessibility by moving these new technologies into the point-of-care faster. The IVD industry that I represented in that workshop plays a very important part in that, so we’ll see how that turns out. It’s going to be a long effort because there are many issues to deal with, not just how to package the technologies for point-of-care but also other issues such as regulatory, reinbursement, etc.
What networking and cooperative efforts has the industry division been engaged in with other organizations, such as other AACC divisions and other non-AACC organizations such as AdvaMed, CLSI, etc.?
Our members are very active in CLSI committees and subcommittees in many different specialties. In particular are the two committees that have recently been formed to address quality control for the future. I’m participating on that, as are other members of the industry division.
Regarding our involvement with other AACC divisions, that’s also something that we’re trying to expand. We’ve always had a liaison to the laboratory information systems and medical informatics division. In particular, they have taken on what is a huge task of coming up with a common standardized terminology for laboratory testing to be integrated into patients’ electronic health records. So we’re working with that division to try to see how we can help.
We’re also working with the National Kidney Disease Education Program (NKDEP; Bethesda, MD). They have a joint effort going with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC; Milan, Italy), with the goal of standardizing serum creatinine measurements to improve estimates of glomerular filtration rates. This is something that’s very close to the hearts of many industry division members, and we recently reviewed some correspondence that the NKDEP wanted to send out to providers of proficiency testing programs.
Basically what they’re asking is for all the IVD manufacturers to standardize the creatinine measurements on their analyzers to the IDMS reference method in order to harmonize and improve the precision of the field methods. This will involve implementing certain changes to the way calibration traceability is done for some commercial methods. We have just gotten involved with them on this, and it is going to be one area that we’re going to be very active in this year because this is a hot area right now.
How does the industry division get involved in lobbying efforts and government affairs?
It has been limited until now. But it’s going to increase because of the CLIA ’88 guidelines that are overseen by CMS. They’ve come under scrutiny a lot lately because they’re outdated, especially regarding new technologies and point-of-care testing. A lot of these guidelines don’t apply anymore. It’s going to be very interesting to see how that plays out. The industry division will have to get involved there because it’s going to directly affect us. We have a lot of interest in seeing how the guidelines may shape up in the coming years and may change to adapt themselves to new technologies that are coming down the road, especially for point-of-care testing.
Do you envision the industry division taking an advisory or consulting role, or providing any expertise or comments for this process?
We’ll be playing an advisory role in that because a lot of our members have very strong backgrounds in regulatory affairs. That’s an area that’s going to be a priority for me for the rest of the year. Not only from my role as chair of the industry division but also in my job at Instrumentation Laboratory because this is an area where we see a need for change.
How has the industry division addressed key issues, e.g., the IVD Directive, traceability, labeling, self-certification?
My predecessor, Rick Miller, is very active in the ISO TC212 working groups. It’s been a priority not only for him but also for the industry division for a couple of years, and he and other members have served on the working groups. The industry division is always asked to comment on new documents that come out of the ISO TC212 working groups, and they’re actually posted on our Web site for review by the membership. We don’t have any organized effort right now to respond to those, but individual members have been giving their feedback. So that continues, and while it’s probably not as high a priority anymore for our division, it’s still one that we’re working with. This is another example of how our focus has been fairly narrow up to now, and we need to broaden our interests if we’re going to gain greater appeal within the IVD industry.
Working with the Lab Community
On what issues are the industry division and laboratorians finding common ground?
Basically how to improve patient care. As I said before, the industry division and its members have a lot of tools in their arsenals that we use when developing products, and we’re bound by the regulations to use risk management tools. We’re now reaching out to the laboratorians through education programs that we’ve taken on in the past couple of years and showing them how they can benefit, and ultimately how the patients can benefit, from learning to use these tools in their everyday work. That’s one place where we’ve found common ground.
Another place where we’ve found common ground is in quality control, which is related to the previous issue. I talked about how quality control of IVD tests has been evolving, and is going to have to continue to evolve to adapt to new technologies. The industry division is very closely involved in two new subcommittees which CLSI has started to address IVD manufacturers’ recommended quality control programs. There’s one document that’s going to come out that’s already in draft form. This is going to be something that the industry division would have to look at very carefully once it goes out for public comment. This document tells manufacturers what testing they have to do, and what they have to disclose to the end-users if they’re going to recommend new quality control schemes for their devices outside of the present CLIA ’88 regulations.
Another subcommittee has been formed from the laboratorian side to complement this document. That subcommittee will address what the laboratorians are going to have to do and what they will be required to do. It’s not a requirement but rather a guideline on how they will take the IVD manufacturers’ recommended quality control programs and implement them into their everyday work.
So there are two very important guidelines that are coming out, and they complement each other, because one is a manufacturers’ guideline and the other one is a laboratorians’ guideline. But they both have the same basic goal, which is how to adapt quality control to make sure we’re meeting the ultimate need of reducing risk to patients. This is something for which the industry division has great interest, and it’s a place where we’re finding common ground with the laboratorians.
How has the industry division worked on areas of conflict and differences with laboratorians, such as point-of-care testing?
I suppose the conflict that you speak of is one where the laboratorians felt that these point-of-care devices were being forced upon them when they weren’t ready to deal with them yet. I don’t sense that there is a real conflict right now. Maybe there was in the past, back in the infancy of point-of-care testing, but it’s becoming a mature field right now. The laboratorians are seeing and sensing the benefit of point-of-care testing. The IVD industry is giving them the tools they need to bring testing closer to the patient. But what’s been lacking so far, and this again is where the industry and the laboratory can work together, is showing how point-of-care testing is going to lead to improved patient outcomes.
To that end, some of our members have worked on a National Academy of Clinical Biochemistry laboratory medicine practice guideline for point-of-care testing. We looked at point-of-care testing from an evidence-based medicine point of view, reviewed the literature, and made recommendations either for or against point-of-care testing for specific applications with the ultimate goal of improved patient outcomes. The result of that work was that there’s not enough evidence in many cases to say that point-of-care testing will improve patient outcomes.
Everybody has a sense that point-of-care will improve patient outcomes because of improved test turnaround times, but without the hard evidence, we can’t quantitate that yet. That’s what’s lacking, and that’s where the IVD industry can help laboratorians. This is an area of mutual benefit. If the industry can help the laboratories show that point-of-care testing improves patient outcomes, it’s a win-win situation, because we sell more instruments, and the laboratories are improving patient care. Maybe there was conflict in the past, but now it’s more of a cooperation.
AACC Annual Meeting and the Future
What programs and activities does the industry division have planned for this year’s AACC annual meeting?
We’ve got some sessions planned, such as our OEM lecture series that we do every year. It’s a way for small companies to showcase their technologies, and that’s been very successful every year. We’ve got two brown bag sessions, which used to be called roundtables. One is on the IVD manufacturers’ quality control recommendation document being developed by CLSI. The other one is an extension of Rick Miller’s CLSI workshop on risk management for the laboratory. We then have a symposium on the codevelopment of biomarkers and drugs that’s going to be presented by Carolyn Jones of AdvaMed. In addition, we have a short course on business opportunities for clinical labs in pharmaceutical discovery. I’d also like to invite anyone who’s interested to our industry division membership meeting. If anyone wants to find out what the division’s all about and some of the things we do, I’d encourage people to come to that.
What new goals is the industry division planning to pursue, and what priorities will the division focus on in the future?
As I said, we need a long-range plan. The IVD industry has a bad reputation of only planning from quarter to quarter. But as a division, we want to look further out and really say what are we going to be working on for the next several years. I’d like to get the whole executive team onboard, and this effort is being led by our past chair Rick Miller. He’s forming this long-range plan and committee, and outlining for ourselves what we want to do for the next five years. With the whole management team onboard, I’m hoping for improved continuity from year to year. Now it’s time to set some new priorities, and expand our interest and try to reach out to have a broader appeal to the IVD industry. That’s my primary goal for the year.
We also have this issue that was brought up in one of your editorials about the image of the IVD industry. People don’t know who we are or what we do, and changing that to me is a mammoth task. I don’t think we have the resources to take on something like that. But we’ve also told AACC that we’ll help any way we can. A lot of our members are working for companies that have a lot of resources, and if we bring those to bear and work with an organization like AACC, we might just be able to improve this image. It’s not going to happen overnight, and it may take some money and some resources. But I think it’s another important goal because people just don’t know what we do.
What long-range goals or objectives would you like to see included in this long-range plan?
My personal goal would be to find out how the industry division can work on developing technologies. This goes back to what I said before, about how we can help develop emerging technologies and get them from the academic labs into the hands of the end-users faster and in a safe and cost-effective way. This is something that’s huge, and the industry division can help. That’s one place where I’m going to make an effort, and I’d like to see it become part of our long-range plan for sure.
You mentioned the challenge of changing the public image of the industry and what an enormous challenge that doing so would be. Do you think this would take a structured, coordinated effort not just by the industry division but also by other groups such as AACC as a whole, CLSI, and AdvaMed?
What it’s going to take is money, to be quite frank with you. Look at glucose meters, for example. The general public or diabetics at least know all about them. Not only because their physician prescribes it to them but also because they’re advertised on TV. When indi-viduals go to their physicians, they say they want the same glucose meter that B. B. King uses because they’ve seen it on TV. But can you imagine what kind of budget somebody’s going to need to advertise on TV? So if we want to reach out to the public, it’s going to take something like that.
