Luann Ochs, MS
Vice President, Regulatory Affairs and Clinical Operations
BD Diagnostics - TriPath

Currently, you are the Vice President of Clinical Operations at BD Diagnostics - TriPath. Can you describe a bit about the work you do in that position?
In my role at BD Diagnostics - TriPath, I oversee and provide strategic direction for the Clinical Trials and Regulatory Affairs functions for TriPath’s new cancer diagnostic tests. The Clinical Trials group determines the product’s performance, and the Regulatory Affairs group then takes the data and obtains regulatory approvals so that our products can be utilized by laboratories and physicians for assessing patient health. 

Prior to your job at BD Diagnostics - TriPath, you served as Director of US Regulatory Affairs at Roche Diagnostics. What was your role in that position?
My last position at Roche was similar to my function at TriPath, overseeing the regulatory approvals and the clinical trials. Previously at Roche, I worked in research and development, helping to develop new diabetes and point-of-care assays.

What initiated your involvement in CLSI? What has sustained your interest?
I have a long-standing desire to make a personal positive impact on the quality of health care. As a user of the CLSI standards, I came to understand that consistency is one of the keys to quality. Utilizing CLSI standards helps the diagnostics industry report performance claims consistently, thereby making information easier for laboratories to interpret. When I found out that I could actually participate in the process of creating standards, it coincided directly with my personal desire to impact quality.

You serve in leadership roles and participate on numerous document development committees for CLSI. What are the highlights of your involvement?
Launching a new document and seeing it being accepted as useful is always rewarding. CLSI activities give me an opportunity to interact with and solicit feedback from other members of the laboratory community. I also especially enjoyed facilitating the Leadership Conference in 2006.  We had an exciting topic, alternative quality control, and the energy level and participation were outstanding.

In your role as Chairholder of the Area Committee on Evaluation Protocols, what are your insights on the pressing issues that need to be addressed with consensus standards?
I see two pressing areas: 
1) Clinical laboratories in the US still need help in implementing the Clinical Laboratory Improvement Amendments (CLIA) quality guidelines released in 2003. CLSI should work closely with the Centers for Medicare & Medicaid Services (CMS) to identify those areas where the laboratories are struggling to comply, and develop standards to address them.
2)  Manufacturers face issues when different countries have their own specific requirements for validation testing. One good example is stability testing. World-wide recognized standards for testing of stability of reagents and samples are needed in order to bring consistency to the testing and the various country validation requirements. The EP area committee has a new subcommittee formed to address the evaluation of stability of in vitro diagnostic method products.

Why do you feel volunteering for CLSI is important?
Volunteering for CLSI gets people out of their isolated environment and allows them to view laboratory medicine from many different perspectives. It is a great venue for establishing working relationships with opinion leaders, and it is very personally rewarding to help establish standards that represent best practice.

How have you benefited by becoming a CLSI volunteer?
Besides meeting my personal goal of positively impacting the quality of health care, I’ve developed wonderful friendships and working relationships with people who share my same goals. In addition, I’ve gained a great appreciation for the consensus process; and I’ve learned to be a pretty good facilitator.

You participate as Chairholder of the Executive Committee for the US Technical Advisory Group (TAG) to International Organization for Standardization (ISO) Technical Committee (TC) 212, Clinical laboratory testing and in vitro diagnostic test systems. Did your work in CLSI lead to your involvement in ISO?
Definitely. I began participating in ISO when I was invited by a Roche colleague to help develop ISO 15197—In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. He was aware of my previous experience with developing standards at CLSI. I really enjoyed the brainstorming and authoring sessions with rooms full of bright, dedicated laboratory professionals. After that experience, I was hooked.

What do you see as the role CLSI plays in global standardization?
CLSI has developed a great consensus process that is unmatched in the laboratory community. It makes perfect sense for CLSI to expand its process to meet the needs of the world, not just the United States. I am very excited at the new global initiatives being pursued by CLSI.

What do you see as the key topics for global standards development in the future?
All people of the world should be able to expect to receive excellent health care. This can be accomplished through education of quality practices, including implementation of the same consistent quality standards throughout the world. Global standards that incorporate the needs and limitations of resource-limited countries are greatly needed.

You were recently appointed to serve on the CLSI Board of Directors. What led you to this leadership role in the organization?
When my General Manager, Wayne Brinster, stepped down from the Board, he suggested that I might be an appropriate addition. CLSI approached me and asked if I would be interested. Of course, I was highly honored and accepted.

What do you see as a path forward for CLSI? More specifically, do you have any particular suggestions for what you would like to see happen in the organization during your tenure on the Board of Directors or in the future?
I would like to see CLSI find innovative ways to support their work financially, so that they can make the standards universally available for very low, or no cost. The Board should find ways to remove any barriers that stand in the way of adoption of the standards by laboratories around the world.

"Volunteer Focus" is an eNews feature that highlights Clinical and Laboratory Standards Institute volunteers from different areas of the healthcare community and describes the contributions they are making to the patient-testing world through CLSI and their daily work.  To recommend a volunteer to be featured in an upcoming issue, e-mail Communications.
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