Mayo Clinic and Mayo Medical Laboratories staff will be blogging all week from the 2015 American Association of Clinical Chemistry Annual Meeting in Atlanta. Follow this blog to stay up to date about the latest from #AACC2015.
July 30 at 3:22 p.m.
See You in Philly!
That's a wrap from Atlanta. We are packing up the booth and heading back to Rochester. We really had fun this year and can't wait to see you all again in Philadelphia, Pa. in 2016. We had way more content than we could write up and post this week, but will be publishing many more blog posts in the coming weeks. Check back on this blog to check it out or follow us on Twitter, Facebook for notifications about our continued AACC coverage.
Safe travels and thank you for everything you do for patients around the world!
July 30 at 3:22 p.m.
Congratulations to Our Posters Presenters
This year, more than 25 poster sessions where delivered by Mayo Clinic physicians, scientists, and allied health staff. The posters represented a wide variety of disciplines.
Here are a few of the highlights:
- Dr. John Mills received a National Academy of Clinical Biochemistry (NACB) 2015 Distinguished Abstract Award and a NACB Distinguished Abstract Ribbon for, "Combining Nanobody Immunoenrichment and MALDI-TOF Mass Spectrometry to Detect and Isotype Monoclonal Immunoglobulins."
- Lucas Ouverson received a NACB Distinguished Abstract Ribbon for his poster, "Application of Assay Appropriate Statistical Analysis Dramatically Improves Turn Around Time."
- Dr. Brooke Katzman and her co-authors received the AACC Division Award for Excellence in Research (Nutrition) for their poster, "Evaluation of Test Ordering Patterns for Serum Vitamin B12 and Folate."
July 30 at 8:30 a.m.
Brown Bag Sessions
By John Mills, Ph.D.
AACC offers a variety of Brown Bag Sessions each year at its annual conference. These sessions provide participants an opportunity to interact with colleagues from around the world and discuss topics of interest. The format is a round table discussion with education being the primary focus. Below is a summary of topics that were led by Mayo Clinic colleagues this year, demonstrating our long standing goal of education, particularly in the context of laboratory medicine.
- “A New Look Over Complement Testing in the Clinical Laboratory” – Dr. Maria Willrich
- “The Do’s and Don’ts of Body Fluid Validation” – Dr. Darci Block
- “Responding to Laboratory Errors: Handling Quality Control Failures, Manufacturer’s Recalls and Other Large-Scale Testing Failure to Ensure Patient Safety” – Dr. Nikola Baumann
- “Generational Differences: Engaging Lab Staff of All Ages” – Dr. Christine Snozek
- “Monitoring and Diagnosing Monoclonal Gammopathies” – Dr. John Mills
- “Laboratory Evaluation of Disorders of Calcium Homeostasis – Appropriate Clinical Utilization of Vitamin D Metabolic Profiling” – Dr. Hemamalini Ketha
- “The Test Life Cycle: EP19-A (Draft) a Framework for Utilizing CLSI Guidelines to Evaluate Clinical Laboratory Measurement Procedures” –Paula Ladwig
The sessions are a great avenue for those attending the conference to meet new people and share your knowledge and passion for a particular area.
July 29 at 5:30 p.m.
An Introduction to Next-Generation Sequencing
In front of a full room, four leading voices in the field of next-generation sequencing (NGS) provided AACC attendees an introduction to NGS and then took them deep into the details related to the emerging laboratory approach.
Dr. Linnea Baudhuin, Co-Director of the Mayo Clinic’s Next-Generation Sequencing Core Laboratory, moderated and co-presented the workshop. Panelists included:
- Dr. Jon Logan Black, Mayo Clinic
- Christina Lockwood, University of Washington
- Eric Duncavage, University of Washington
While the hour and half presentation went into great detail, this blog post will highlight the basics of next-generation sequencing.
Next-generation sequencing builds on Sanger sequencing, which has been widely used since 1975 and was used to sequence the human genome for the first time.
While the most popular name for the testing approach is next-generation sequencing, it is also referred to as:
- Massively parallel sequencing
- High-throughput sequencing
- Second-generation sequencing
- Third-generation sequencing
- Single molecule sequencing
A range of possibilities
While the applications of next generation sequencing appear to be limitless, the most common approaches mainly focus on whole-exome sequencing and targeted sequencing to look at certain genes or genomic regions. The major applications for next generation sequencing include somatic, inherited disorders, non-invasive prenatal testing, and microbe identification.
Theoretically, next-generation sequencing has several benefits, such as:
- Enables much more comprehensive testing approaches.
- Allows laboratories to generate higher “hit” rates for diagnostic and/or actionable mutations.
- Drives clinical trial data generation and future discoveries.
- Template preparation for either DNA or RNA
- Massively parallel sequencing using clonal amplification and imaging or other detection methods
- Data analysis, including genome assemble, align with comparison sequence, and interpretation
- All next-generation sequencing tests are laboratory-developed tests, inviting a high level of review, validation, verification, and regulations.
- Interpretation is very challenging, due to the massive amount of data generated along with insufficient clinical databases to reference.
- Turnaround time is not as rapid as the industry would like it, with some tests taking up to three months.
- Not universally accepted by payers.
- Sequencing files are big, in most cases several terabytes, and data analysis is slow due to computation limitations.
July 29 at 2:18 p.m.
Fellows Make Us All Proud
On Monday, the annual Student Poster Contest was held and four Mayo Clinic fellow received awards. Please help us in congratulating:
- Drs. Waddah Katrangi and John Mills: Both participated in the Student Oral Abstract presentation contest, that selects the best four abstracts among all students. They ranked 3rd and 2nd place, respectively.
- Drs. Brooke Katzman and Hema Ketha: Both participated in the Student Poster Contest. There were 84 abstract presenters, all from students. Dr. Ketha got first place.
July 28 at 6:32 p.m.
The State of Test Utilization
In one of the several Tuesday afternoon sessions, a Mayo Clinic in Florida colleague, Dr. Jonathan Hoyne, moderated the session and co-presented, “Laboratory Test Utilization: Leading the Charge Towards Lab Stewardship.” Two additional speakers joined him: Robert Benirschke, of Peoria Tazewell Pathology Group, and Kevin Foley, of Kaiser Permanente.
The three presenters covered the what, why, and how of test utilization, providing attendees a deep background on the subject and tangible direction on how to tackle utilization within health care organizations of all sizes.
“Everyone knows that health care spending is out of control, especially when compared to the rest of the world,” says Dr. Hoyne. “That is bad enough, but it has been getting worse. Our rate of increase over the last several years has been increasing single digits each year. As it all complies, it equals a looming healthcare crisis.”
To articulate the various factors, Dr. Hoyne detailed some key statistics. The clinical laboratory and its activities contribute to:
- 4% of total health care spending
- ~10% of total spending for private insurers
- 25% of high-intensity encounters
- 60% of medical decisions
Additionally, the laboratory costs are increasing by 15-25 percent annually, primarily driven by molecular assays and one third of laboratory orders are considered wasteful. Finally, testing approaches vary widely within the industry.
“There are huge differences between how institutions, systems, regions, and countries deal more with history and facility-specific practices than medicine,” says Dr. Hoyne. “Honestly, it has more to do with how we have always done it than clinical outcomes.”
There are two primary forms of utilization issues, under utilization and over utilization, each with unique drivers.
- Underutilization is primarily driven by not applying practice guidelines, not properly leveraging screening tests, and a lack of focus on preventative medicine.
- Overutilization is primarily driven by standing orders, care sets, no communication between a patient’s multiple physicians, and taking a shotgun approach to testing.
Dr. Hoyne finished his presentation by outlining many of the root causes of test utilization issues in health care. These root causes were:
- Health care architecture: Increased utilization and fee-for-service payment models
- Industry: Launching of emerging tests prior to evidence base being established
- Government: Increased regulations and insurance coverage
- Epidemiology: Increased screening, chronic diseases rising, and aging population
- Patient: More informed, Google, and patient equate satisfaction and utilization
- Bundled tests
- Laboratory: Bundled tests, confusing nomenclature (vitamin d and genetic testing), rapidly growing test menus, increased complexity, and skyrocketing costs
- Physicians: Increased specialization, unaware of costs, defensive when presented with feedback, desire to be thorough, convenience of shotgun approach, and inexperienced, young physicians
- Information technology: The default answer to system changes is usually no and the proliferation of bundling of tests and utilization of computerized physician order entry
The ultimate challenge, according to Dr. Hoyne, is for clinical laboratories to perform appropriate test requests while simultaneously minimizing the risk of financial losses to the institutions they serve. But, laboratories need dedicated resources to tackle utilization.
“One of the most striking issues is a lack of resources to take on overutilization,” says Dr. Hoyne. “Even though the literature shows it is very effective, very few laboratories are investing in this area and dedicating the right resources to get the job done. This needs to be a priority for laboratories, especially as we move to value-based medicine.”
July 28 at 2:22 p.m.
Some Nice Tweets Today!
July 28 at 1:35 p.m.
Promoting the Laboratory as a Clinical Consultant
Over the noon hour, two of the leading advocates for the importance of clinical consultation addressed a small gathering of laboratorians in an Industry Workshop. Dr. Anthony Killeen of the University of Minnesota and Dr. Michael Astion delivered impassionate cases for why the laboratory must be a proactive, valued advocate within the clinical practices they serve.
Dr. Killeen kicked off the workshop with an overview of how laboratory can become a stronger clinical consultant and play a more central role in the day-to-day clinical decision making opportunities. According to Dr. Killeen, the forums and avenues that work the best for creating valuable and effective clinical consultation experiences include:
- Visibility and expertise
- Mobility and mortality conferences
- Morning reports
- Utilization Committees
- Diagnosis management teams
- Laboratory formulary and send-out review
- Hospital quality committee
- Hospital rounds and clinics
The workshop then shifted to a real-world application of a laboratory taking an extremely active role in a clinical practice. That example came from Seattle Children’s Hospital and its laboratory director, Dr. Michael Astion. Along with a team of pathologists, genetic counselors, and laboratorians, Dr. Astion launched the Pediatric Laboratory Utilization Guidance Services (PLUGS) to tackle utilization and improve patient care.
The initiative focused on three areas of patient harm related to laboratory testing. According to Dr. Astion, the three causes of harm are ordering the wrong test, not retrieving test results, and misinterpreting test results. To directly combat these areas of harm, laboratories must implement utilization management initiatives.
“Utilization management is making it very easy to do the right thing and extremely hard to do the wrong thing,” says Dr. Astion, who also warned that it is not always easy to implement utilization management. Dr. Astion advised that, “Laboratorians need to have some backbone to do utilization management. The laboratorian has to be an advocate and educator to their clinical colleagues.”
Areas to focus on include:
- Obsolete tests
- Not useful tests
- Test not ready for prime time
- Tests that are always positive
- Lack of utilization management practices in genetic testing and elsewhere
- High dollar inducements for reference laboratory testing
Finally, Dr. Astion emphasized the role of conversation and interaction with clinical colleagues. At Seattle Children’s clinicians “get a visitor” from the laboratory to discuss test ordering for tests that are more than $700, include multiple genes, performed by an unapproved laboratory, captured on a banned test list, and several others. Through this approach, Seattle Children’s was able to modify 32% of the tests in one year, saving the institution $597,663 in testing costs.
July 28 at 10:33 a.m.
News Release: Diadexus and Mayo Clinic Join Forces on PLAC Activity Test to Improve Patient Care for Cardiovascular Diseases
Diadexus LogoDiadexus, Inc. (OTCQB: DDXS), a diagnostics company developing and commercializing products that aid in the prediction of cardiac disease risk, and Mayo Clinic recently signed an agreement to collaborate in the areas of education, research, and innovation on the PLAC® Test for Lp‑PLA2 Activity. The test, which has been cleared by the U.S. Food and Drug Administration, is used to help identify risk for coronary heart disease in patients with no history of cardiovascular events.
As part of the agreement, Mayo Clinic’s Department of Laboratory Medicine and Pathology will participate in the Diadexus Laboratory Partnership Program, where Diadexus will provide educational support during the proper integration and use of Lp‑PLA2 Activity testing in the clinical practice. Once fully integrated, the test will be available to patients and providers worldwide through Mayo Clinic’s reference laboratory Mayo Medical Laboratories, which offers advanced laboratory testing and pathology services to more than 5,000 health care organizations.
July 27 at 3:24 p.m. EDT
Notebook: Monday at AACC
The first full day on the ground at AACC was inspiring and a great way to kick off our week in Atlanta. We started finding our groove at the conference and trying to get acclimated to the cavernous Georgia World Congress Center.
Our friends throughout Mayo Clinic started this year’s meeting strong with a number of sessions. Here are some of the highlights:
- Dr. Allan Jaffe joined panelists Alan Maisel (San Diego VA Healthcare) and Max Wicha to discuss the current state of Biomarkers in Breast Cancer. The session provided attendees an overview of the current breast cancer biomarkers, insight on the clinical importance of these biomarkers, and a glimpse into the future of biomarkers in the care of patients.
- Paula Ladwig, a Development Technologist at Mayo Clinic, offered attendees some perspective on tangible aspects of quality-focused best practices when developing and launching a new clinical assay.
Here is a brief list of Tuesday’s sessions that we are looking forward to attending:
- 7-9 a.m. – Industry Workshop: Dr. Nikola Baumann will participate in “QC Frequency: An Objective Solution Using Risk-Based Principles."
- 8-10 a.m. – The plenary session “Art, Assassination and America: How Transparency Disrupts an Industry and Changes a Nation” has a title intriguing enough to drive attendance. The presentation looks to be a wonderful and insightful look at the American healthcare system.
- 10:30 a.m.-noon – Next generation sequencing (NGS) is arguably the hottest technology in the laboratory industry. Maurizio Ferrari and Steven Wong will present on the current state of NGS and what the future is likely to hold.
- 10:30 a.m.-noon – Industry icon Rodney Forsman will provide his unique perspective on “Managing Laboratory Finances as Payment Models Change.” This presentation will be a very important presentation for laboratory leaders as we prepare for Healthcare 2.0 and the inevitable shift to value-based, outcome-driven payments.
- Noon-1 p.m. – A long-time friend of ours, Dr. Mike Astion from Seattle Children’s Hospital, will be leading the industry workshop, “Continuing the Conversation: Consulting in a Clinical Setting.” Knowing Mike, it will be colorful, fun, and definitely insightful.
- 2:30-5 p.m. – Mayo Clinic laboratory director Dr. Melissa Snyder is one of four speakers who will discuss, “Clinical and Laboratory Aspects of Monoclonal Antibody Therapeutics."
- 2:30-5 p.m. – Our colleague Dr. Jon Hoyne revisits his long-standing interest in utilization management in the laboratory and its ability to positively improve utilization throughout a healthcare organization. Dr. Hoyne will moderate the session, “Laboratory Test Utilization: Leading the Change Towards Lab Stewardship.”
- 2:30-5 p.m. – Mayo Clinic Endocrine Laboratory Director Dr. Ravinder Singh is one of four presenters who will deliver, “Urine Free Cortisol: Pros and Cons.”
Any other sessions you can’t wait for? Let us know at @MayoClinicLabs.
July 27 at 12:38 p.m. EDT
Welcome to Atlanta!
After some travel delays, we are finally on the ground in Atlanta. We are extremely excited to be here at the American Association of Clinical Chemistry Annual Meeting. While we are here, we will be sharing the sights, sounds, and the fun of this year’s meeting. We will catch up with old friends and meet some new ones.
Follow our blog all week. We will feature some guest posts from our Mayo Clinic colleagues and bring you some perspectives from speakers from around the world.
Have something to add to our blog, send us a message on Twitter @MayoClinicLabs.
Enjoy the meeting and try to have some fun!