By: Interview by Richard Park

To learn more about the Industry Division and its goals, IVD Technology editor Richard Park spoke with Chandra Jain, chair, AACC Industry Division (Washington, DC). In this interview, Jain talks about who the division includes, what the division does, and how it addresses the special needs of IVD manufacturers.

 

IVD Technology: IVD Technology: You are the current chair of the Industry Division. Will that change next year? 

Chandra Jain: I am the current chair for this year. Next year, the current co-chair, Dr. Barnard Cook of Beckman Coulter, will become chair, and we will select a new co-chair. 

 

How has this division been received by those inside and outside the IVD industry? 

We have seen increasing trend in the membership since its inception that can be viewed as a very positive sign of acceptance. Another sign is the increasing attendance at the events sponsored by the Industry Division at the AACC mational meeting. Industry is also amajor employer of clinical chemists.

 

Are these events that take place only during the AACC Annual Meeting and Clinical Lab Expo? 

Yes, that’s where we see most of our members, customers, and prospective members. So that’s where our effort is focused. 

 

Outside of the AACC annual meeting and the Clinical Lab Expo, has the industry division sponsored any events during the year? 

No. We mainly focus our efforts at the AACC national meeting. Industry Division sponsors Edutrak, symposia, short courses, and the OEM Lecture Series, which are well attended by industry members as well as by clinical laboratorians. These events do attract more prospective members and bridge the gap with our customers. 

 

Are there any plans or goals to host other events besides the ones that you sponsor and put together for the annual meeting? 

I’m not sure at this time. We see the most attendance at the national meeting. In these times of budget crunch, resources are to be used wisely. Our focus is on the AACC national meeting because that’s where we can get more bang for our buck.

 

How many members are currently in the industry division, and what efforts are being made by the division to increase its membership and reach out to those outside of the industry? 

We have about 400 members. To attract more members, besides sponsoring symposia, Edutraks, et cetera, Industry Division business meetings are informative. Information on key topics is provided that enhances professional development and knowledge. One of the topics at the 2010 business meeting will be updates on CLSI standards. The times for business meetings are listed in the AACC National Meeting calendar.

 

Is your membership primarily the bigger IVD companies, medium- to small-sized companies, or a mix?
I believe it’s a mixture. AACC national-meeting exhibits have larger and smaller IVD companies. Our membership mirrors that.

 

What educational programs has the industry division organized and been involved in, and are there certain areas and topics that the division focuses on in its education programs? 

Since most IVD companies are global companies, in past years we have covered topics that affect other markets besides the U.S. market. Last year, Industry Division sponsored  a symposia called “Emerging Regulatory and Harmonization Trends for the Clinical Laboratory, a Worldwide View.” We had an interactive workshop called “The Central Role of the Sample: You Can’t Get a Good Answer Without a Good Sample.” The brown-bag topic was “Testing for Chronic Kidney Disease (CKD): Creatinine, eGFR, UAlb and More: Industry Responses to Clinical Needs.” 

At this time, most of the industry and industry members are focused on the standardization of patient results, because we want to make sure that patient results are of high quality and can be transported through time and space. So that’s one of the focus areas right now. A lot of our members are involved in working organizations such as ISO and CLSI, updating old standards and writing new standards. Our members also help in evaluating physical standards. This is again, as I said, to achieve portability of patients’ results in time and space, and that helps in the correct diagnosis and treatment. 

 

What networking efforts has the industry division been engaged in? How does the industry division network with other AACC divisions as well as with other non-AACC organizations? 

We have our own business meeting, which is more informational in nature, and we welcome any other division members or whoever is interested. Information on the program is published. We also have a combined mixer with other divisions that gives a networking opportunity for our members as well as others. 

 

How has the industry division been involved in any government lobbying efforts? 

We really don’t put forth any lobbying efforts. We leave that up to AACC headquarters. 

 

How are the relationships between the industry division members and the vast majority of the AACC members, particularly laboratorians? 

Those relationships are pretty good. I base that assessment on the attendance of the Industry Division–sponsored events. 

You said earlier that a lot of the events that the industry division puts together and sponsors are attended both by members of industry and clinical laboratorians. Do you get much attendance by laboratorians, and do they express an interest in attending events that are particularly geared toward IVD companies and acting manufacturers? 

I am not privy to the impressions of the attendees. So I really cannot comment. But I do know that the laboratorians come and they interact with IVD manufacturers because IVD companies do provide a lot of jobs for graduating clinical chemists. So I think there is a lot of networking and interaction that way. 

 

And there is a lot of information exchange related to technologies and job openings and other matters? 

Yes. That is my impression.

 

What issues are the industry division and laboratorians finding common ground for, which they can work on together? 

Common topics are quality of patient answers, process improvement (making lab processes simpler), and increasing work efficiency. We also see our members helping in the implementation of national and international initiatives. 

 

Does the industry division get involved when AACC plans its events? Do you try to focus on issues that really interest IVD industry members, such as reimbursement, healthcare reform, and regulatory matters? You mentioned traceability. You mentioned harmonization and quality. Are those the types of things that you try to focus on? 

Yes. That’s what we have been doing for the past two to three years because these issues are picking up steam and are really important. It also speaks to the quality of the results that our instruments produce in the clinical laboratory. 

 

Do you reach out to and coordinate your efforts with various other organizations, such as JCTLM, ISO, and CLSI? If so, what is the nature of such coordinated efforts with these other groups and organizations? 

Our members are actively participating in JCTLM, CLSI, and ISO, and they are involved in writing standards. So we have our presence among those groups. When the physical standards are available, Industry Division members do help in evaluating these standards so that smooth implementation can be achieved.

 

What differences in viewpoints with laboratorians does the Industry Division have to overcome, and what activities is it involved in to do so? 

There is suspicion that the IVD industry is not concerned about quality. Not so, we are bound by GMP which is as rigorous as any CAP checklist requirements for our U.S. customers. As a matter of fact, IVD manufacturers also have to comply with all the international quality regulations to stay in business.   

 

What programs and activities does the industry division have planned for this year’s AACC meeting? 

They include the following: “Creatinine, GFR, UAlb and More: Industry Responses to Clinical Needs,” an Industry Division business meeting, a joint mixer, and a short course presented by Bernard Cook of Beckman Coulter. 

 

What new goals is the industry Division planning to pursue this year and in the coming year? 

One of our goals is to promote standardized, quality patient results, which will provide portability of test results. It’s going to take a while to get everything in place. But that’s what our focus will be: to provide portability of patient results through time and space so that they can lead to the correct diagnosis and treatment. 

 

Please elaborate on what you mean, exactly, by “portability of standardized patient results,” and why has the industry division chosen this as a priority issue at the present time? 

Portability of patient results is very important. The world is really small now. So let’s say a person is being treated in California. That person happens to get sick in Europe and she gets tested. Are test results the same in California and in Europe? So portability of the patient answer means that tests are producing similar patient results anywhere in the world. But since there are different IVD manufacturers making instruments for testing the same analytes, we are trying to standardize the patient test results. so that whether an assay is done on instrument A or instrument B in California or Europe, the test results are similar. That is why the standardization and harmonization is very important. 

 

Has the industry division set up any sort of subcommittees to look into, for instance, a working group to make headway on this issue? 

We do not have any specific committee per say, but our members are involved in the standardization committees such as ISO Technical Committees, Clinical Laboratory Standards Institute (CLSI), IFCC, JCTLM. These committees either write standards or endorse physical standards produced by National Standard Institutes.

 

Has the industry division been working with various outside groups and organizations on this issue? 

Yes. As I mentioned before, we have been involved with ISO TC212 and CLSI on writing standards, such as standards to improve quality, standardized patient results, labeling, packaging, et cetera. The above mentioned organizations have members from industry, regulatory bodies, and clinical laboratories. Writing standards is a team effort.

 

What other priority issues has the Industry division identified for this year and next, and how does the division plan to address these issues? 

We will continue to sponsor relevant Edutraks, workshops, and symposia at the AACC national meeting. The IVD industry is focusing on traceability and standardization of various assays. It is a huge undertaking; so many assays needs to be standardized and harmonized.

 

How does the Industry Division go about go about deciding what issues it wants to pursue? 

We have discussion on topics that members send out before the annual business meeting. In our membership we have people who are from all areas of interest. Marketing and regulatory folks are always keeping an eye on what is needed by our customers. These members also help in setting the agenda for business meeting. 

 

So members can submit the topics they would like to be discussed in advance, and those can be put onto the agenda at the business meeting? 

Yes, exactly. I would encourage our members to be more involved in setting Industry Division goals.

 

And how do members go about doing that?

It’s generally through e-mail. Members can contact the chair or co-chair. All of our e-mail addresses are available.

 

If readers want information about the various activities and programs that the industry division has planned, where can they get that information? 

It will be published in the AACC national program calendar. It should also appear on AACC’s Web site. Now our members will have information through this article also.

 

Regarding the business meeting at the annual meeting: is it strictly for industry division members, or can nonmembers attend? 

I believe it is for members but nonmembers are always welcome.  

 

How does one become a member of the Industry Division? 

At the time of applying or renewing AACC membership, one has to check off the Industry Division box and pay the dues. It is very easy to become a member of the Industry division.