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IN PERSON

Speaking with one voice

Collaboration between the IVD industry and clinical labs is the most effective way to implement change.

Interview by Richard Park

Steven Goss, PhD, is chair of the American Association for Clinical Chemistry industry division and is a staff scientist in chemistry/ immunochemistry R&D at Dade Behring Inc. (Newark, DE). He can be reached at steven_goss@ dadebehring.com.
Five years since it became an official entity, the industry division of the American Association for Clinical Chemistry (AACC; Washington, DC) continues to carry out its mandate—to forge relationships with its clinical counterparts and to educate the public about its position in healthcare.

Developing programming that addresses the needs of the industry division membership is not an easy task, since it is composed of individuals with very diverse needs and interests. However, the broad resources and perspectives of its members are also strengths that can be tapped into in order to provide help to the clinical laboratories.

Through increased collaboration and understanding of each other’s strengths, IVD companies and clinical laboratories can work together to stake out mutually beneficial positions on difficult issues, such as reimbursement, through the use of a cohesive voice.

To learn more about how diagnostics companies and clinical labs are shaping the testing dialogue, IVD Technology editor Richard Park spoke with Steven Goss, current chair of the AACC industry division and a staff scientist in chemistry/immunochemistry R&D at Dade Behring Inc. (Newark, DE). In this interview, Goss talks about what the division is doing to solicit support and raise its public profile. He also discusses collaborations with nonindustry organizations, the role of government lobbying, and what IVD professionals can do to get more involved in promoting diagnostics.

IVD Technology: How was the industry division of AACC formed? Since becoming an official segment of AACC, how has it been received by those inside and outside the IVD industry?

Steven Goss: In 1998, the division was formed by a group of people who recognized that they needed a voice to express the concerns and needs of AACC members in an IVD setting.

The industry division was widely accepted at a very early date. However, understanding was limited of what role it would serve. Many AACC members working in industry may not have understood what the division could offer.

The good news is that the division has been growing. It has been offering many educational sessions and symposia, and these have been seeing a continual increase in attendance. The industry division is collaborating more often, both within AACC and with outside organizations.

I believe that all of these things in combination are slowly increasing awareness of the role industry plays in the quality of healthcare.

What sort of image issues was the IVD industry hoping to address by creating this division?

Rather than image, the key issue is awareness. I went to a program coordinating commission meeting last year and there was a discussion about whether the public recognizes what a clinical chemist is and what clinical chemistry is.

Even within AACC, there are still opportunities to expand awareness of the important role of the IVD industry.

On our division Web site, under our governance, there are two clear goals. The first is to identify common interests and concerns among industry members and to develop programs to address those.

The second goal is to identify and develop synergies between industry and clinical lab members. Both of these are critical steps to achieve greater awareness.

What efforts have been made by the division to raise its stature and to educate people about its role?

As a first step, the industry division just issued a survey to its members to solicit input. So far, there has been a good response, and the quality of these responses has also been good. The survey results will be reviewed at our annual membership meeting. The input we receive will be used both for developing programs to address immediate needs as well as for planning long-range goals. The survey results will also be published on the industry division’s Web site.

One of the challenges we have in this division is commonality. Membership is based on where we work, not necessarily on a shared interest. For example, I’m devoted to assay development; however, my colleagues may be interested in regulatory issues or customer support or consumables manufacturing. There’s a whole variety of interests represented. So it’s a challenge to develop programs that meet the needs of such a diverse group and to increase involvement.

What efforts are being made to increase the membership of the division?

We are highly focused on assessing the needs of our current membership, and developing programs to meet their needs.

With all of the different divisions, one common thread is working to encourage the involvement of the current members. I believe that if we do increase involvement, this will also bring in new members over time.

Recently, the division has focused on encouraging the involvement of young AACC members through a collaboration with the Society for Young Clinical Laboratorians (SYCL). In fact, I was a member of SYCL, and that was how I became involved in the executive committee for industry.

Is there any concerted effort to also recruit nonindustry people to join the division?

Many of the programs that have been developed in recent years are directed toward clinical laboratorians. We believe a range of the tools commonly used in industry can be helpful in the clinical lab.

An example of this is risk management and other safety issues. By providing educational opportunities to clinical labs, awareness of the division and the desire to learn more about it should increase. This, in turn, should increase membership.

Making Connections

What educational programs has the industry division organized and been involved in?

During the past few years, the focus of the division has been on the challenging and difficult-to-understand requirements we all face. Topics such as traceability, quality control, and risk analysis have been addressed because they have an immediate impact on the members. We’re now at a point where we need to broaden the scope of the programs we’re providing to involve the members who have been silent.

One difficulty we’ve had is that the chair position for the industry division is a one-year term, so every year a new person comes in and brings a new set of strengths and visions.

The division has put together a plan to try to provide some continuity to the different programs being developed. This is being accomplished with the longrange planning group, which was put together last year and is chaired by the past industry division chair.

How are these programs chosen?

Each year, the program planning commission assembles a list of hot topics based on input from the AACC membership as a whole. In the past, a committee has been responsible for setting up the programs according to what is currently a hot topic that would be appropriate for the division to address. However, recently we’ve been approached by other divisions, as well as organizations outside of AACC, to codevelop educational sessions. This is actually how two of the sessions were put together for this year.

These proposals are submitted to the divisions management group, where they are reviewed.

What other educational areas is the division hoping to expand into?

This will be steered in large part by the results of the current survey. However, on a personal note, I would like to see more guidance and career development information available for those entering the IVD industry.

What networking efforts has the industry division been engaged in?

Within AACC, there is a critical need to strengthen relationships, specifically between the clinical laboratorians and people in diagnostics.

I’ve been at Dade Behring for five years. I arrived after completing a clinical chemistry fellowship program and found a very different workplace in industry. I’ve been lucky to have had some good people mentor me, and it would be nice to make sure other people also have these opportunities.

When the division was established, we worked to integrate the different views of people within the industry. This has helped us focus on helping people understand what the field is, the unique challenges that it faces, and the opportunities we can create through collaborations.

As industry representatives, we believe a strong relationship with the clinical laboratory is synergistic and ultimately helps both the labs and industry increase their ability to contribute to cost-effective healthcare.

Can you provide examples of the programs that have been codeveloped?

This year, the Laboratory Information Systems and Medical Informatics division—LISMI—has put together a session called “Application of Standard Vocabularies with the Laboratory Information Systems.” The industry division is cosponsoring this event, many of our members work to provide the tests that labs use, and the results of these tests are going into their information systems. Therefore, agreement upon a standard vocabulary is necessary in this electronic age.

Another group that has approached us is the National Institute of Standards and Technology (NIST; Gaithersburg, MD). In order for NIST to create new standard reference materials to support global innovation and new technologies, they need agreement upon what these materials should be.

As for additional collaborations, the joint divisions mixer is something that started out with just a couple of divisions and has grown over the years. This year, five divisions are going to be participating in the mixer.

Has the industry division been involved in any governmental lobbying efforts?

Lobbying efforts have not been a focus of the division. It is an issue brought up in membership survey responses.

We have been approached by the 212 working groups of ISO’s Technical Committee. When ISO generates new documents, it sends them to us in draft form. We post them on the Web site and invite different members to comment directly.

I do believe the industry division would be a very strong lobbying voice, especially if it can collaborate with the clinicians.

Reaching Out to Labs

You mentioned that one of the goals of the industry division is to create synergies with labs. How have relations been between the division and the other AACC members, the vast majority of whom are laboratorians?

The relationship has been good. We’re continually expanding our understanding of member interests and needs, and exactly how we can provide unique value. The attendance at educational sessions has sent a strong signal that we are providing the right tools to benefit our colleagues in the clinical laboratory.

Do you think that, since its creation, the industry division has helped foster a better understanding by clinical labs about what IVD companies do?

Yes, I believe that it has helped, through exposure, networking, and relationship building.

On what issues are the industry division and laboratorians finding common ground for working together?

Both groups see that we share a common goal, to provide quality healthcare. As long as increasing the quality of healthcare is the common goal, there are a lot of issues that can be addressed together.

The overall cost of healthcare is increasing, and clinical laboratories are under greater pressure to achieve cost efficiencies under tight reimbursement. IVD companies can help with the development of products and services that help labs achieve these efficiencies.

As you mentioned, reimbursement is a critical and complex issue. Do you think it is also something for which the industry division could coordinate or develop education programs or workshops?

I do believe it will be a future direction for the division. The survey results we have received so far have included quite a few mentions of reimbursement rates and trying to educate everyone about the situation we’re facing.

A better understanding of what’s going on will be helpful to the membership.

Do you think there is an understanding that everyone— both the clinical labs and IVD companies— is affected by reimbursement issues?

Yes, I do. Understanding the key issues facing the clinical laboratory is integral to developing the right products and solutions. Assays and systems must not only provide quality clinical information, but also be efficient and cost-effective.

The Future for Industry

You’ve already mentioned some of the programs and activities being organized by the industry division for this year’s AACC annual meeting. What else is being planned?

This year we have the Saturday evening session that was codeveloped with the LISMI division. We also have two brown-bag sessions that are going to be held on Monday. One is focused on creatinine standardization, and the second will look at error proofing and process improvement techniques at a laboratory. We’ve posted more information about these topics, as well as details about the speakers, on our Web site.

We will also be holding what’s always been a very successful OEM lecture series on Tuesday and Wednesday mornings. This year, it consists of 24 presentations.

The NIST session will be held on Tuesday evening, just prior to our joint division mixer, and we will be holding our industry division meeting on Wednesday evening.

The industry division is also offering two awards. One is in memory of former industry division chair Lou Dunka, who passed away last year. This will be awarded for outstanding service to the industry division. We also have an abstract award. The awards committee will review the submitted abstracts and rank them based on quality and interest to the division. Each award is for $750.

I was happy to see that this year we had almost 10 times the number of applications for the abstract award. So, interest is definitely growing, and it’s very good to have a large database to select from.

What new goals is the industry division planning to pursue this year?

The two main goals are to stimulate more activity within the current membership and to better educate society about who we are and the critical role we play within the healthcare system.

Hopefully, we will be getting a lot of information about how to do this from the survey. There was one question in the survey about whether or not members would like to become more active in the division, and in what capacity. There are a lot of people who said they are interested in helping to develop educational sessions and also in serving on the board. Once we tap into this resource, I believe we’ll have a lot more input and be able to develop more comprehensive programs.

The division is increasingly collaborating with groups like NIST, and our members are playing roles in organizations and initiatives such as ISO and the National Kidney Disease Education Program. Although not all of these activities are officially sanctioned by the industry division, it would be very natural for them to transition to that state. These collaborations being put together are critical and are going to form the basis of a lot of future work that we do.

Information on the AACC’s industry division is available online at www.aacc.org/aacc/members/divisions/industry.

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