The AACC industry division helps members manage market shifts, adapt to global guidelines, and build positive relationships with laboratorians.
Jack Levine is 2008 chair of the American Association for Clinical Chemistry industry division and is a senior clinical consultant at Siemens Healthcare Diagnostics (Tarrytown, NY). Siemens Healthcare Diagnostics is a diagnostic solutions company specializing in performance-driven products and services that assist in personalized healthcare and disease management. He can be reached at jacob.levine
Six years since its inception, the American Association for Clinical Chemistry (AACC; Washington, DC) industry division continues to find common ground between industry manufacturers and clinical chemists and address the interests and concerns shared by both. Gathering feedback and encouraging laboratorians to take advantage of the industry division's role in facilitating change has spurred the collaboration of clinical chemists from every industry setting. In an attempt to expand the division's role and influence on the national stage, the IVD industry hopes to tackle the shared concerns of all division members regarding efficiency, productivity, and compliance.
To learn more about the goals and priorities of the AACC industry division, IVD Technology editor Richard Park spoke with Jack Levine, current chair of the AACC industry division and senior clinical consultant at Siemens Healthcare Diagnostics (Tarrytown, NY). In this interview, Levine discusses upcoming sessions for the 2008 annual meeting, adapting IVD products to international requirements, and the call for more training and educational programs. He also talks about the importance of internal and external networking opportunities, increasing international membership while continuing to meet the needs of national industry professionals, and the benefits of laboratorians and IVD manufacturers working together to weather market changes.
IVD Technology: How has the industry division been received by those in the IVD industry and those outside the IVD industry since becoming an official AACC division?
Jack Levine: Many are beginning to recognize that the IVD industry is becoming a major employer for clinical chemists. It is also a niche where clinical chemists can find positions and focus on creative work. I think those outside the IVD industry also recognize that the division is an important player in advocating the concerns of clinical chemists in the IVD industry.
How has the industry division at AACC made itself available for potential clinical chemists to find employment in the IVD industry?
The industry division's objective is a different. Our objective is to provide useful information to its' member clinical chemists that could benefit their career development. One of the issues currently plaguing the clinical chemistry profession is the decreasing number of training programs and job opportunities. Industry can provide future job opportunities for people who go through post-doc programs or other advanced training as clinical chemists. A lot of those opportunities are going to be in the IVD industry, including commercial reference laboratories, rather than in the traditional hospital environment.
A similar phenomenon has occurred in nursing and education where a number of programs have been discontinued because they weren't seen as generating revenue. We are not replacing ourselves. Because the industry division largely consists of professionals working in an industrial setting, the group has an opportunity to influence the practice of clinical chemistry. We have to train our members to understand and meet new professional standards and requirements.
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?
The industry division will have an update at the industry division's business meeting at the AACC annual meeting for its membership that will provide information on key topics that could affect the way members interact within their work environment. One of the topics that will be addressed pertains to the Clinical and Laboratory Standards Institute (CLSI) evaluation protocols. The update will supplement CLSI's activities by informing members of changes in the evaluation protocols utilized by industry. Clinical chemists conducting evaluation studies and developing protocols for validation of product claims will have the opportunity to incorporate the latest guidelines from CLSI into their work.
Another topic that will be covered is the new German RiliBAK regulations that will be implemented in Germany in 2010. These new regulations will have an impact on the German IVD marketplace similar to the implementation of the CLIA'88 regulations in the United States in the 1980s. The RiliBAK group has defined specific performance standards for IVD methods used by clinical laboratories in Germany. Companies marketing on a worldwide basis need to be aware of these new guidelines in the German market before they are implemented in 2010. Our goal is to make sure that IVD professionals attending the industry division business meeting are aware of RiliBAK's initiatives and its potential effects. It will be an important factor in terms of U.S.–based companies' ability to be competitive in a global market and export technology overseas.
The industry division is there to help clinical chemists understand that by attending the session, they can gather useful information to take back to their respective companies. The agenda will also include discussions regarding the new standardization approach for hemoglobin A1c that the International
Federation of Clinical Chemistry and Laboratory Medicine is currently proposing, as well as the efforts of the National Kidney Disease educational program in harmonizing creatinine results. Such discussions will supplement other activities by various groups at the annual meeting.
The information session at the division's annual business meeting is called “Emerging regulatory trends for the clinical laboratory, domestic and international.” It will be held on July 30 from 12:30 to 2:00 pm at the Renaissance Hotel, Washington, DC, in meeting room 16.
Keeping Members Informed
Does the industry division have any short-term or long-term plans to expand the division's involvement in the planning of education programs throughout the year?
Yes. The industry division is cosponsoring a symposium with the AACC and the laboratory information division scheduled for Saturday, July 26, from 5:30 to 8:00 pm. The symposium topic will be the “Language of information technology and laboratory medicine.” The meeting will provide an opportunity to update members on industry news as quickly as possible. This is a way the industry division can more or less encourage activities and influence how the AACC tackles educational programs throughout the year. The industry division also plans to become involved in creating symposium topics for the 2009 annual meeting. If the information session at the division's annual business session is well received it will give the industry division the momentum to recommend this session for a 2009 symposium topic.
Does the industry division have any plans to continue or expand the cosponsorship of education programs and workshops at other AACC-related events?
Not at this time. It's an interesting idea, but at this point, the industry division needs to focus its goals on the national meeting. The AACC already has strong meetings and groups, which are well established and well attended.
What networking efforts has the industry division engaged in? How does the industry division network with other AACC divisions as well as other non-AACC organizations?
The primary networking opportunity lies in how the AACC brings the various divisions together. A number of teleconferences are held between the division heads each year, and the annual meeting will feature a leadership meeting. The AACC's goal is to bring the chairman, chairman-elect, and other members of the core group in the divisions together to network throughout the year.
I admit that the AACC industry division is a little unusual in that chairmen only serve a one-year term of office. Several of the other AACC division chairmen have two-year terms. In reality, it probably takes a chairman a year to learn the necessary ins and outs of the division. However, time pressures factor into the position as well. It would be helpful to revisit the issue in the future. In the meantime, there are projects the chairman can implement in terms of vision management programs. Ultimately, if members want the chairman to serve a two-year term, they will have to vote on the issue. It may be a topic that can be addressed on a future divisional ballot.
How has the industry division been involved in governmental lobbying efforts?
I don't see governmental lobbying as the industry division's role at the moment. Lobbying is something that the AACC undertakes as an umbrella organization at a higher level. Realistically speaking, it makes more sense to have the AACC act as the lobbyist for the needs of all clinical chemists. In my opinion, there are people involved in government affairs within the AACC organization who can be much more effective in lobbying than any single division.
How have the relations between the industry division members and the vast majority of AACC members, particularly laboratorians, developed since the division's inception?
I've been a member of the AACC for more than 40 years, and I think the relationships between the industry division members and the majority of AACC members have become more collegial over time. Many of the
hospital-based members recognize the importance of IVD manufacturers and their impact on the daily life of clinical chemists. A collegial environment encourages laboratorians and industry-based clinical chemists to communicate effectively to improve product outcomes. The IVD industry needs feedback from laboratory-based practitioners of clinical chemistry to implement product improvements and plan new methods and systems.
An added advantage of such positive relationships is the ability to facilitate and promote consensus guidelines. In the United States, IVD products marketed for the clinical laboratory have to meet FDA approval. Many CLSI guidelines have been accepted by FDA as baselines for method and product validation. Clinical chemists who participate in the development of CLSI guidelines can have an impact on FDA's clearance of new IVD methods and systems. The industry division encourages its members to get involved in CLSI activities along with other clinical chemists from government and user environments. The AACC doesn't write guidelines directly, but AACC members can participate in developing guidelines.
On what issues are the industry division and laboratorians finding common ground that they can work on together?
One of the aspects that I enjoy about the annual meeting is learning about what's going to come down the pike in five or ten years, not necessarily what's going to be available next year. We get a chance to look at automation and new laboratory test development that may produce significant industry changes in the future; division members can analyze the requirements for clinical laboratories given the basic research currently underway. Industry division members can focus on how that research, when converted into a product, can be used on a routine basis.
Are these opportunities where the industry division could get involved in terms of working with their colleagues in the laboratory community? What would be the best way to approach the development of those technologies?
That will be something the next chairman of the industry division will have to grapple with. An important consideration for the future is how IVD manufacturers and laboratorians handle change. Change can be as simple as clinical laboratorians changing their expectation of lab test performance to how and where the tests are actually performed. The industry division membership has the advantage of experiencing change more rapidly than many of those working in academic or hospital settings.
Adapting for the Future
Is there a plan to expand the industry division's role and objectives to create an opportunity for the IVD industry and clinical lab industry to meet and exchange ideas that deal with industry issues and affect IVD companies in general?
A clinical chemist working in the industry has many of the same concerns as a clinical chemist working in a hospital laboratory. At the annual meetings, the industry division membership gets a chance to learn about laboratorians' concerns in detail. Then, as clinical chemists return to their various industrial settings, they can determine if they're working in the same direction as their fellow laboratorians. It's an interactive learning experience. By attending these meetings, the industry division members get to hear issues and concerns that require the most attention in the lab and then adapt their products to meet those needs.
The IVD industry often acts on the premise: What do you need in your laboratory to make your job more effective? A manufacturer must produce cost-effective improvements to succeed in this tough marketplace because if the laboratory is not efficient and cost-effective, it won't succeed either. These are common concerns shared by laboratorians and IVD manufacturers regarding efficiency, productivity, and turnaround time.
What sorts of efforts are being made by the industry division to broaden its membership from a global perspective, in terms of attracting members and interests from overseas?
The AACC recognizes that the organization has a very large international membership. Their journal goes out all over the world and clinicians travel from halfway around the globe to attend the annual meeting. To some extent, the AACC is also trying to make sure that the core membership, who reside largely in the United States, understand their impact outside the United States Since most companies are exporting their products now, it's important that diagnostic manufacturers understand the market from a global perspective and use the AACC annual meeting as a platform.
What priority issues has the industry division identified for this year and the coming year? How does the division plan to address such issues?
One of the priority issues for the industry division is to gain more visibility so that we may act as a spokesperson for the industry members of the AACC. The division values their input and wants members to feel that if they come up with a good idea, we can follow through on it.
What efforts are being made to increase the industry division's visibility?
There are plans to sponsor at least one symposium at the AACC 2009 annual meeting. Due to the number of topics proposed for major symposia at the annual meetings, I've set a goal of submitting proposals for three symposia. If the division sponsors at least one symposium in 2009, it's going to open doors for more opportunities and encourage members to be more creative in their sponsorship of topics discussed at future annual meetings.
Hopefully, the industry newsletter will help facilitate these opportunities. One area the division needs to improve is the newsletter. With the AACC enhancing their infrastructure, any AACC member should have the ability to access the individual division newsletters on the Web site. The industry division welcomes anyone who wants to participate. The more assistance and insight the division receives from its members, the more effective we can be.
What new goals is the industry division planning to pursue this year and in the coming year?
The industry division's main goal is to influence the annual meeting topics so more industry interests will be included on the program in future meetings. We believe those areas represent, either directly or indirectly, the interests of the average laboratory participant at the meeting. We want to make sure the topics cover issues and concerns industry members will find interesting and useful, much in the same way a clinical chemist working in a hospital setting might.
Information on the AACC's industry division is available online at www.aacc.org/members/divisions/industry.