IVD Technology
Magazine
IVDT Article Index
Originally Published IVD Technology July/August 2005
In Person
Partnering with the clinical laboratory AACC’s industry division views collaboration as essential for the future of IVDs.
 |
| Rick Miller is chair of the industry division of the American Association for Clinical Chemistry (Washington, DC) and is a staff scientist in Consumables Manufacturing at Dade Behring Inc. (Deerfield, IL). He can be reached at rick_miller@dadebehring.com. |
When the American Association for Clinical Chemistry (AACC; Washington, DC) approved an official industry division in 2002, it stated as one of the goals of such a group the need “to identify and develop synergies between industry and clinical laboratory members.” This charge to cultivate common interests marked a shift from the traditional view of IVD companies and laboratorians as distinct entities.
In the past three years, the industry division has pursued this goal in conjunction with its educational seminars, symposia, and programs—another main objective laid out in its bylaws. In covering topics of interest to IVD manufacturers, the division has also aimed to promote the role of the laboratorian in the future of diagnostics.
To learn more about the strides the industry division is making toward accomplishing its goals, IVD Technology editor Richard Park spoke with Rick Miller, chair of the AACC industry division and staff scientist in Consumables and Manufacturing at Dade Behring Inc. (Deerfield, IL). In this interview, Miller outlines current priorities and successes, and discusses the salient challenges for industry–clinical lab collaboration, both today and in the future.
IVD Technology: Since becoming an official AACC division in 2002, how has the industry division been received by the IVD industry? How have its interactions been with people outside of the IVD industry?
Rick Miller: We have been well received by the industry. As we have launched programs and explained the division to the IVD industry in general, a number of people have told us that we are doing good things and have joined the division as a result.
I believe that we are also starting to be recognized by those outside the industry. A number of people have given us positive feedback on the Edutraks, workshops, and other programs that we offer at the AACC annual meetings. The industry division has also run an individual program every year for the last three years on the progress of the Joint Committee for Traceability in Laboratory Medicine (JCTLM) that has been well received.
How many members are currently in the industry division? What efforts are being made by the division to increase its membership and appeal to those outside of the industry?
As of December 2004, we had approximately 395 members. Until this year, we had not done a lot of focusing on increasing our membership—that is, other than providing excellent programs and publicizing them. We are now networking with the Society for Young Clinical Laboratorians (SYCL), as well as initiating programs that will make us better known to other AACC members. We especially wish to attract the attention of young scientists since that is where the next generation of IVD manufacturing scientists may come from.
Does the industry division have a certain membership target for future years?
No. This is not something that has been discussed with the executive board or other active members. My belief is that if we do what the industry members need, they will come. Setting targets is good, but membership will be driven by the services we provide.
You noted that the division has plans to collaborate with AACC on other programs. What areas are you planning to get involved in?
We have been approached by several clinical chemists and AACC members about helping with error proofing and risk management. This is a very high priority for the clinical laboratory and has been for the last couple of years. Some of non–industry division members of AACC who have attended our Edutraks or have helped with the recent draft ISO documents on risk management recognize that the IVD industry has the technology to assist the clinical laboratory. As a result, we have been asked to help train clinical laboratorians.
Education and Outreach
Education has been made an important priority for the industry division. In developing programs, what areas do you look to focus on?
Most of the areas that we have focused on in the past and will continue to focus on are in response to the requests of our members and the interests of those people who provide the programs. In the past, these have taken the shape of AACC-meeting-specific workshops, Edutraks, and similar types of courses that look at risk analysis and management, calibrator traceability, submissions of 510(k)s, and other types of
submissions to FDA. We have also been working with the AACC representative to ISO TC212 and now distribute draft ISO standards that may be of interest
to the IVD industry when they are
sent for comment. We solicit comments from our members and forward
those received back to ISO TC212 for consideration.
Is there a specific group of members involved in forming these education programs?
No, we don’t have a formal
mechanism to review or solicit ideas
for programs. Most of the planning
and organization process is done by word of mouth. We did conduct a survey a couple of years ago, and the
response was quite low. We do solicit input from several sources, including the membership and those who volunteer information—for instance, with our
risk management program for clinical laboratories. But most of this process is still informal.
Do the Edutraks that are put together by the industry division tend to be more of a regulatory or technical nature?
We try to cover both. Because we are relatively young and have notdeveloped a highly technical infrastructure, by nature we tend to respond to the more-immediate regulatory issues.
What networking efforts has the industry division been engaged in? Do these involve AACC divisions as well as other, non-AACC organizations?
I think that prior to this year there was less of an attempt to network. For the past couple of years we have participated in a formal mixer where we meet with the molecular pathology and the pediatric and maternal/fetal divisions. This year we have also started a collaborative award with SYCL that will recognize the best abstract of interest to the industry submitted for the annual meeting.
Does the industry division have any plans to get involved in governmental lobbying efforts? What comes to mind, of course, is the medical device trade group AdvaMed (Washington, DC).
Many division members have individual relationships with non-AACC people and have used these connections to forward our cause. For example, the work that Don Powers has done with ISO TC212’s Working Group 3 is one of the reasons we developed a program with TC212 to review TC 212 standards. Don’s interest in obtaining our feedback pointed out the need to circulate them. So, yes, there is some of what you might call lobbying, but it isn’t based on a formal policy.
We have not considered a formal lobbying effort at the present time, and it has never been mentioned at membership or board meetings in the years that I have been involved with the industry division. I think that by working with ISO TC212, ISO, and CEN to reach a common agreement is a mechanism to assure the standards developed are useful and technically sound. Since many of the standards that come out of ISO TC212 and CEN 140 are what are called “normative,” and may actually support the IVD Directive, we are indirectly lobbying with government groups when we assist with those efforts. While we aren’t making a conscious effort to lobby the European Union or FDA, we are still having an impact on how the IVD industry will be judged against the IVD Directive. In some cases, too, we are having an impact on how clinical laboratories will be judged against the international standards used in Europe.
In the past, the industry division has identified the IVD Directive, traceability, labeling, and self-certification as priority issues. Are these areas still of central interest? Or are there new priorities that the division will focus on?
We still consider those important issues, and we need to continue them. Error proofing and risk management are also important. In addition, I believe that the industry has an image problem.
I think of this as a twofold issue. The problem resides not just with the image of the IVD manufacturer, but also with the image of the clinical laboratory. Many do not know what a clinical
laboratory does or its value to healthcare.
So, why would our products be considered of great value to the general public?
Organization and Integration
How have the relations been between industry division members and the rest of AACC, the vast majority of whom are laboratorians?
Last year, I probably would have
answered that question differently than I will today. I would have told you that other AACC members did not consider our division a force, or even understand it. Starting last fall, however, I have seen evidence that has changed my mind.
We have been asked to assist with a training program on error proofing and have had requests to help with other
issues specific to the clinical laboratory as well.
Is this because the other AACC members have come to realize the importance of IVD industry involvement in these issues?
To some extent, yes. Some clinical laboratorians have attended our workshops and Edutraks and have learned that our outlook has some strength attached to it. Some of our programs on traceability have created interest as the concept trickles down to the clinical laboratory outside of the United States and creates a double standard. People are starting to wonder what is going on in Europe and the rest of the world, and how can we synergize with some of these efforts.
So, I think that people are starting to appreciate those things that we have been looking at and are beginning to wonder what they can learn from our courses.
Has the creation of the industry division given the diagnostics industry a greater profile among clinical laboratorians?
It gives individuals who want information about the issues a place to go. I think we have provided some exposure for our practices and rationales, and some clinical laboratorians have said, “You know, that does make a little bit of sense. Maybe we should learn a little bit more about it.”
Examples of this are the requests we have received to discuss lean enterprise. Some laboratories have started to work on applying lean-enterprise principles and they have had wonderful results. IVD manufacturers and others have been doing this for years. So, laboratorians have come to us and said, “Can you hold some roundtables and workshops and help us figure out how to implement lean in our settings?”
Building Coalitions
As mentioned, in the past the industry division and laboratorians have found common ground on such issues as reimbursement in competitive bidding, traceability, risk management, and error proofing. A moment ago, you added lean enterprise to this list. How have you gone about moving toward a consensus?
Most of the efforts for which we have found common ground that I am aware of are relatively recent. We are still forging partnerships in those areas, so it is hard to see the full impact of these partnerships. So far the reception has been good, however, and we have striven to include other members of the healthcare community in our educational programs.
We have found common ground up to this point by recognizing the issues and working on them. And by recognizing the need for common ground. This year we hope to initiate a program that we will partner on from the beginning.
One concern that I spoke about before is our common image. We need to work together on this. It is something that has come up in division management meetings. We need to partner with AACC and other laboratorians in order to help them put a positive face on their products and on the IVD industry.
Have you found that at the various Edutrak roundtables and meetings the number of attendees from the laboratory community has increased?
Yes, it has. I don’t know that I could provide you with actual statistics but there is a general impression of this increase. For example, comparing the very first traceability Edutrak we did three years ago with the one we did last year, I would say that there were more than twice as many clinical laboratorians in the audience.
While the division has had success forming alliances with laboratorians, there are also areas of disagreement. One of these seems to be in point-of-care testing. Other potential disagreements are regarding cost containment and quality control. How has the division worked to reconcile these differences?
I am not aware of any specific industry division efforts in the area of point-of-care testing. I am also not aware of any significant efforts to date in the areas of cost containment or quality control. We, as an industry, have obviously been dealing with our own cost-containment issues and our need to provide competitively priced products as an industry, but we have not addressed any of those as industry division efforts.
I guess I would suggest that any differences in these haven’t been identified by the industry division or the board as issues to work on. Obviously, as individuals, many of us may be aware of the issues and do what we can to rectify them, but they have not been identified as an industry division effort.
What other differences with laboratorians does the industry division have to overcome?
I think the main one is that many of our clinical laboratory practitioners don’t think of us as partners. This is as much our fault as it is a false perception on their part. By carrying out some of the programs we have planned for this year and next year, we will be able to turn that around. It would be my hope that in the future, we are accepting challenges jointly and dealing with them in ways that are mutually advantageous to both industries in providing higher-quality, cost-effective healthcare. I’m taking a long-range view. I would like to see this cooperation become the norm in less than 10 years.
AACC Today and in the Future
What programs and activities does the industry division have planned for the July AACC annual meeting in Orlando?
We will be conducting workshops and Edutraks on traceability and risk management and error proofing. We are also holding a special program in conjunction with the National Institute of Standards and Technology. This will focus on the IVD Directive and the reference laboratories in North America that need to be certified to become part of the JCTLM list of reference laboratories. Most North American reference labs aren’t aware of this certification, or if they are, it is almost peripheral. We hope to have an education program and develop a strategy to help these people provide their services to the IVD industry going forward.
We are also sponsoring the OEM Lecture series again this year. This has become such a fixture of the Division, it is hard to imagine not having it. Bob Jenik has planned another good program for Orlando.
You’ve brought up the industry’s image problem a few times. It’s a topic that has been discussed in a couple of issues of IVD Technology this year, too. The problem obviously won’t be solved overnight, but from your broad experience with IVDs, how does the industry go about starting to address and solve it?
I am not sure that I know yet. It is one of the things that our board has discussed as a high priority and it will probably continue to be one for the next few years. The image problem is, as you mentioned in an editorial, that we don’t have one. I personally believe this is a concern we share with the clinical laboratory. We both provide excellent service to the healthcare community as a whole, but no one knows what it is. What little publicity I do see is negative. For example, there have been congressional hearings about a hospital in Baltimore that was providing erroneous HIV and hepatitis results for more than a year. This type of incident doesn’t help either the clinical laboratory or the IVD industry.
And this isn’t just a U.S. issue. If we want to improve the market, we need to look to other countries, too. People in Europe also have similar misconceptions. We need to partner with the clinical laboratory to improve the image for both. We won’t get better reimbursement or a reduced attempt at controlling IVD products or laboratories through legislation unless we can change this image.
In our spring newsletter, I have written a challenge to our membership to address this issue. I am requesting suggestions and ideas about how to bring together our 390-plus people who are members to deal with the issue. We will find strong ways of addressing it, but I suspect we will also need to do so through organizations such as ourselves, the European Diagnostic Manufacturing Association, AdvaMed, and AACC as a whole before things will really happen. There is no magic bullet.
The second new issue for us that we are taking on this year is risk management and error proofing. We are exploring the possibilities of partnering with representatives of the Centers for Disease Control and Prevention, AACC, the Clinical and Laboratory Standards Institute (formerly NCCLS), and CLIA to initiate an effort to train clinical laboratories in risk management and error proofing. We have also been considering how to bring forward IVD experts in these areas and make them more available to interested clinical laboratorians. The general public will have an opportunity to see IVD members and clinical laboratorians solving important problems in healthcare and demonstrating our ability to provide high-quality solutions and products. By doing this, we are letting the public know we will be coming together to serve them better.
Would you say that by strengthening the ties between the IVD industry and the clinical laboratory community, especially considering their shared interests and concerns, the two groups can improve their chances of resolving these issues?
If we can develop the networks and the ties that help us address these issues well and also let people know that we are addressing them well, we both will benefit. To my knowledge, there has not been a very large effort in this area. Certainly, when you hear about budget cuts on reimbursement for laboratory testing, the general public doesn’t know the value of the services they receive or what they are getting from the laboratories and the IVD industry. If we don’t gain the public’s respect, there will be even greater cost-containment and regulatory pressures. That would speak directly to our ability to develop new products, and our ability to be a profitable industry and provide the service we do to the healthcare community.
To learn more about AACC’s industry division, please visit its Web site at www.aacc.org/divisions/industry/default.stm.
Copyright ©2005 IVD Technology
