News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Oprah Endorses Laboratory Tests as Life Savers for 2009

Several key laboratory tests have a prominent place on Oprah Winfrey’s “Ultimate Checklist” for a healthy life. Oprah, long a champion of personal accountability for one’s own health, kicked off the New Year with a focus on health improvement through self-help activities. It is another example of how consumers are being educated about the importance of using laboratory tests as guideposts to improve their health.

With a theme of “Best Life Week”, Oprah featured her medical expert Dr. Oz and his advice on how people can get healthy and peel years off their bodies. Laboratory tests play a prominent role in Dr. Oz’s “Ten Step Ultimate Health Checklist. Under step five, “Know Your Numbers”, Oprah urged her listeners to pay attention to five laboratory tests:

  • Cholesterol, with LDL less than 100 and HDL greater than 40
  • Blood sugar
  • Vitamin D
  • C-Reactive Protein
  • Thyroid Stimulating Hormone (TSH)

Also included in the “Know Your Numbers” step were recommendations to check waist size and monitor both blood pressure and heart rate.

Other recommendations in the “Ultimate Health Checklist” were to get a medical check-up; recruiting a health advocate; securing a copy of personal medical records; and getting diagnostic and preventive medical tests and screenings on time.

Oprah’s promotion of Dr. Oz and his recommendations for better improving personal health makes for good ratings. Lab administrators and pathologists should take that as a sign that consumers are interested in healthcare. Another sign of how important television has become as a source of health information is the selection of CNN’s Chief Medical Correspondent, Sanjay Gupta, M.D. to be Surgeon General in the new administration. Expanding media coverage of health and wellness topics plays to the strength of medical laboratories. Media coverage of health issues creates an opportunity for laboratories piggyback on this interest and market directly to consumers. – P. Kirk

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Pathology and Radiology Must Prepare for Personalized Medicine

If there is one healthcare trend that will be truly disruptive to pathologists, it is personalized medicine. The concept behind personalized medicine is simple: understand the genetic and metabolic differences unique to the individual patient. Then use this knowledge to tailor a custom program of therapy, including prescription drugs, that offers the maximum potential for success while minimizing possible side affects.

Personalized medicine is closely linked to the emerging field of companion diagnostics. In combination, these two new ideas have the potential to revolutionize how laboratory testing services are used in developed healthcare systems. For one thing, clinical laboratories and anatomic pathology groups-traditionally the “go to” source for information to drive diagnostic, prognostic, and therapeutic decisions-will have serious competitors in the world of personalized medicine and companion diagnostics.

One keen observer of the personalized medicine trend is Bruce Friedman, M.D., Professor Emeritus of Pathology at the University of Michigan Medical Center in Ann Arbor, Michigan. In his popular LabSoft news blog, he defined companion diagnostics in this manner:

Briefly stated, [companion diagnostics] is a strategy pursued by some IVD companies, Roche Diagnostics in particular, whereby the company develops a gatekeeper biomarker assay. This is a lab test that serves to qualify a patient for treatment with a particular drug. The most common example of such a test is the HER-2/neu assay that is required prior to treatment with Herceptin.

Friedman, like your Dark Daily editor, recognizes that advances in genetic science and molecular technologies are making it possible for other medical specialties to crowd into the diagnostic field. He believes that the current, commonly-used definition of companion diagnostics-as primarily measurement by use of serum biomarkers-is outdated. He thinks the definition should be widened, writing in his blog that: “I personally have begun to routinely assume that diagnostics, unless otherwise qualified, should be more broadly defined to include both the analysis of serum and tissue biomarkers as well as medical imaging procedures. I have posted a number of notes about molecular imaging, which is defined in the following way in the Wikipedia:

[Molecular imaging] differs from traditional imaging in that probes known as biomarkers are used to help image various targets or pathways, particularly. Biomarkers interact chemically with their surroundings and in turn alter the image according to the molecular changes occurring within the area of interest. This is markedly different from previous methods of imaging which primarily imaged differences in qualities such as densities or water content.”

Friedman continues, saying: “I think that we now need to broaden our definition of companion diagnostics to include both the measurement of serum/tissue biomarkers as well as medical imaging and particularly molecular imaging. Such an approach also echoes my belief, expressed in a number of previous notes, that pathology, lab medicine, and radiology are becoming much more closely aligned and should now merge into a new discipline of diagnostic medicine. This broader definition for companion diagnostics also suggests that Roche, GE, and Siemens are embarking on very similar strategy in the pursuit of personalized medicine.”

All pathologists and radiologists should track this trend, which is poised to disrupt long-standing practices in their respective medical specialties. Friedman will speak on this topic at the upcoming Molecular Summit on the Integration of In Vivo and In Vitro Diagnostics in Philadelphia on February 10-11, 2009. Location is the Sheraton Society Hill Hotel in Philadelphia, Pennsylvania. Joining Friedman is a faculty of 27 other leading national and international experts in molecular imaging, molecular diagnostics, and healthcare informatics.

Speakers from such organizations as Massachusetts General Hospital, Stanford University Medical Center, MD Anderson Medical Center, UCLA Medical Center, Siemens, and the Institute for Systems Biology will provide the latest innovations in the integration of in vivo and in vitro diagnostics. Last year’s Molecular Summit attracted 225 attendees, along with editors and reporters from 15 healthcare publications. This upcoming Molecular Summit has compelling case studies of how molecular diagnostics, when integrated with molecular imaging and other data sets, is giving clinicians powerful new insights for making diagnoses, identifying appropriate therapies, and monitoring patient progress.

Register today and guarantee your place at this important event for pathology and radiology! The full agenda and speaker line-up for Molecular Summit 2009 on February 10-11 can be viewed here (or paste this URL into your browser: http://www.molecular-summit.com/program.htm )

Early-Bird Discount Registration now available online

Visit http://www.molecular-summit.com

Download Full Program Agenda

Four Easy Ways to Register:
1. Register ONLINE
2. Call 800-560-6363. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
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Put April 28-29 on your calendar and join us for Executive War College 2009!

We’re Heading Back to New Orleans!

Get the latest and best in lab and pathology management!

Add this website to your favorites and check back often: http://www.executivewarcollege.com


Make your plans to join us for the biggest and best Executive War College ever! Last year’s event was sold out and we plan to exceed it with timely topics, powerful speakers, and the profession’s best networking.

Executive War College 2009 will take place on April 28-29, 2009. Location will be the Sheraton New Orleans. After several years away, we are heading back to New Orleans!

As the lab industry’s leading showcase of innovative laboratories and pathology groups, it’s your best opportunity to get up close and personal with some of the nation’s best-performing laboratory directors and pathologists.

We’d also like to ask your help. What topics would you like to be presented at Executive War College 2009? Share your suggestions with us by emailing rmichel@darkreport.com Besides topics, do you have speaker suggestions, including yourself? We work hard to locate some of the industry’s most interesting innovators. You may be among them, so let us know what your lab is doing!

In closing, don’t forget to mark your calendar and block April 28-29, 2009. We’d love to have you with us at the 14th Annual Executive War College!

Regards,
Robert Michel

Are Corporations Poised to Dramatically Reform U.S. Healthcare?

Rising costs of employer-sponsored health plans now threatening both sustainability of a healthy workforce and the viability of U.S companies in a global marketplace. That means the business sector may be the most likely game changer in reforming the U.S. healthcare system. So argues Modern Healthcare Editor David Burda. He contends that the business sector is poised to dictate healthcare costs. Based on defined healthcare goals, business will decide for what and how much it will pay.

Burda, who attended the National Business Coalition on Health (NBCH) conference last fall, says there is a sense of urgency among employers to act now. Otherwise the government will step in to do it. If that happens, it will stifle innovation.

The NBHC is made up of nearly 60 employer-led coalitions which share the common goal of improving the value of employer-sponsored health plans. The organization represents 10,000 employers with 34 million employees and their families. NBHC was established to implement national purchase initiatives. It wants to help employers get more value for healthcare services. In recent years, NBCH’s role has expanded as employers strive to accelerate progress towards safe, efficient, high-quality healthcare.

Employers are in the forefront of efforts to link value to quality of care. Topping their list of desired innovations is implementation of financial incentives that are linked to health improvement programs. These programs are designed to encourage employees to quit smoking, eat right, exercise, and better manage chronic medical conditions.

The strategy appears to be working, according to NBCH’s 2008 eValue8 report, which employers use to compare the quality and efficiency of health plans. Andrew Webber, NBCH President and CEO wrote that: “Given today’s dire economic climate, purchasers need to continue to encourage health plans to adopt plan designs that will enable consumers to keep themselves healthy and not incur higher, preventable healthcare costs in the future.”

The report, which represents information from 100 HMO and PPO plans, found that many health plans have reduced barriers to essential treatments: 43% of plans waive co-pays for preventive health visits; 27% waive co-pays for diabetes drugs and equipment and 33% reduce co-pays; 20 % of plans waive co-pays for drugs and equipment and 28% reduce co-pays.

While keeping people healthy is good for society, Burda notes that healthcare providers must figure out a way to make money by keeping people healthy-rather than by treating them when they’re sick. Those providers who are reluctant to change, he suggests, can expect a return to the good old days when providers got paid to take care of someone-albeit cheaply, slowly, and only after complying with complex reporting and billing rules.

NBCH’s eValue8 report offers medical laboratories and other providers a compass for designing value-added strategies that meet the evolving goals of employers-who fund lots of healthcare in this country. Clinical laboratories are well-positioned to support changes in healthcare delivery for improved accountability, better quality and lower costs. – P. Kirk

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New Patient ID Systems Use RFID Technology

Move over bar codes! RFID (radio frequency identification) may be ready as a patient identification solution for hospitals and other healthcare settings. Advocates promote RFID as a way to improve patient safety without the problems common to manual or bar code patient ID systems.

Overseas, the U.S. Navy uses an RFID-based patient ID system, called “Smart Band”, to track the status and location of wounded soldiers, prisoners, refugees, and others arriving at the Navy’s Pensacola Fleet Hospital in Iraq. Here in the United States, 473-bed Jacobi Medical Center in New York City has begun using the Smart Band system in its two acute care departments. Smart Tag is manufactured by Precision Dynamics Corporation of San Fernando, California.

RFID uses electronic chips embedded on tags to transmit radio waves. Tags can be encrypted with any type of information. Tags attached to products, assets or medical records and or embedded in security cards and wristbands allow early adopters to track medical devices, drugs, and people, according to a report on RFID technology applications from the Health Industry Business Communications Council (HIBCC), an industry-sponsored nonprofit organization dedicated to developing standards to facilitate electronic data exchange among all facets of the healthcare industry.

The technology can also be used to encrypt wristbands with information critical to patient safety and for quality assurance purposes, encrypting medical supplies and drugs with information like lot numbers and expiration dates and test samples and other laboratory items with special instructions or critical data like the temperature for monitoring sensitive products like blood. It also could improve tracking of instruments for infection control, allowing RFID-enabled trays to be followed through sterilizing departments, and high-cost medical devices like defibrillators, pacemakers and prostheses.

Unlike conventional labeling technologies, such as barcodes, RFID tags have both read and write capabilities, can be read simultaneously rather one at a time, allow invisible and resistant marking for special applications like patient wristbands, require no line of sight to read them, and permit reading orientation directly through materials like cardboard boxes and cloth.

RFID technology, however, is viewed as an enhancement-rather than a replacement-for current labeling systems, as it has disadvantages. It is expensive because it is not yet plug-and-play. Reliability is an issue in large-scale implementations. Additionally, current RFID tags cannot withstand extreme heat without special housing and their reliability can be affected by humidity, metal surfaces and other environmental conditions. Additionally, there are interoperability issues because the technology uses different RFID standards. For example, no single reader exists that can read from the multiple frequencies used in different RFID technologies.

Dark Daily expects rapid advances in RFID technology. Phlebotomists and lab staff know that use of bar codes comes with its own set of headaches. Thus, as RFID performance improves and its cost to use declines, hospitals will have a motive to incorporate RFID solutions for patient identification. Clinical laboratories will be interested in using RFID solutions to track specimens. Such an application is already in use between the gastroenterology surgery suites and the histology laboratory at the Mayo Clinic.
– P. Kirk

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