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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Leaders Call on Anatomic Pathologists to Develop New Skills

Pathology is changing so quickly that anatomic pathologists need to add new skills to be successful in a clinical and business environment that is now more intensely competitive, particularly in two ways. First, regional and national pathology firms are raising the bar on clinical services in many subspecialties of anatomic pathology. Second, anatomic pathologists must have a better understanding of the business and financial skills required to succeed in today’s laboratory medicine marketplace.

One group on the forefront of these developments is the American Pathology Foundation (APF). “It’s no longer sufficient for a pathologist to come in every day and simply look at slides and make accurate diagnoses of biologic processes,” explained Luke Perkocha, M.D., Assistant Clinical Professor at the University of California San Francisco and chair of the APF’s conference program committee. “Demands for higher quality clinical services, declining reimbursement, and more intense competition for specimen referrals now require every pathology group practice to have skilled leaders. These pathologist business leaders need to understand the fundamentals of business and management. Just as medicine needs physicians who take the whole patient into account, pathology practices need leaders who take the whole business into account and think on a strategic leadership level.”

To give pathologists and lab directors an opportunity to learn the skills necessary to compete effectively today, the APF is conducting the Pathology Leadership Conference on Wednesday, September 17, 2008 at the Marriott Crystal Gateway Hotel in Arlington, Virginia. Perkocha noted that the day is organized around four specific areas of emphasis, with sessions led by experienced leaders of pathology groups from different areas of the country:

  1. Marketing. In this session, George Miaoulis, Jr., Ph.D., Professor of Marketing, at the University of Maine, will speak on, “Advanced Concepts in Marketing Pathology Professional Services: It’s Not Just a ‘Lab Test’ Anymore.”
  2. Finance. Two speakers from large pathology practices will address pathology billing issues. Del Berryman, Executive Director of Brown & Associates, in Houston, Texas, will discuss, “Evaluating and Selecting an Outside Billing Company-What Matters Most.” In the same session, Bob De la Torre, Practice Administrator at Pathology Services of Arizona, in Tempe, will discuss “Insider Expertise on Billing-Do it Yourself-Benchmark your Results.”
  3. Leadership. Pathology groups need an effective plan for succession, recruiting, and retaining skilled pathologists. Eric A. Hanson, Ph.D., Executive Consultant of Development Dimensions International, in Pittsburgh, Pennsylvania, will speak about, “Leadership Succession: Are you ready? What you should be thinking about now.” He will be followed by, Tedd Taskey, Associate Vice President, Pathology, at Slone Partners, in Denver, Colorado, discussing “Recruiting and Retaining Your Next Pathologist: Avoiding Expensive Mistakes.”
  4. Strategic business planning. Pathology practice mergers, consolidations, and integration of regional services will be discussed by Jeffery B. Drummond, an attorney with the law firm of Jackson Walker LLP, in Dallas, Texas, in his session on “Pathology Practice Mergers: New Imperatives and New Models.” Caitlin Cameron, CEO, of CellNetix Pathology & Laboratories, in Seattle, Washington, will address, “Pathology Practice Mergers: Smart Thinking in the Trenches and the Development of ‘Best Practices’.”

Founded in 1959, the American Pathology Foundation was probably the nation’s first pathology organization with a specific focus on business, management, and financial resources that would allow pathologists to succeed and prosper. Thus, it often has early and valid perspectives on unfolding trends within the anatomic pathology profession.

Perkocha’s message about the need for anatomic pathologists to support leadership skills within the pathology group practice setting is consistent with Dark Daily’s observations about unfolding changes in the anatomic pathology marketplace. With genetic medicine on the horizon, Wall Street and the national lab companies believe anatomic pathology will be hugely profitable because of new molecular assays. Community hospital-based pathology groups must respond to these strategic threats if they are to remain both clinically and financially viable. One way to acquire the necessary leadership and business skills is for pathology groups to send their business-minded partners to conferences such as the APF’s Pathology Leadership Conference.

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UK Junior Doctors Ordering Lab Tests They Can’t Interpret

Findings of a recent study on laboratory test ordering confirm what is widely-known by laboratory professionals across the globe. In the United Kingdom, many junior doctors do not understand common hospital laboratory tests and are putting patients at risk as a result. This was the primary observation of UK biochemists in a recently-published study.

Dr. Trevor Grey from the Northern General Hospital in Sheffield, England surveyed 80 junior doctors, asking them how they felt about the clinical biochemistry tests they were expected to order on a daily basis. His findings were published as “Learning Needs in Clinical Biochemistry for Doctors in Foundation Years” in the January 2008 issue of The Annals of Clinical Biochemistry. The article reported that one in five (18%) of more than 80 junior doctors surveyed were happy to order a test they could not fully interpret. The article, along with an editorial piece by Dr. Danielle Freedman of the Association of Clinical Biochemistry, blamed both poor teaching and a reduction the amount of pathology and laboratory medicine taught at medical schools.

When asked about 12 common lab tests, junior doctors questioned during this survey said they were not entirely confident about interpreting the results for 10 of them. For three common types of lab tests, more than one-third of the junior doctors surveyed said they were not confident about interpreting the results. 18% of the junior doctors said they were happy to order a test which they did not fully understand how to interpret. Seven out of 10 junior doctors said they would find more teaching in biochemistry to be useful.

In Freedman’s editorial, she said the results revealed “a national problem” in the UK. She knew of situations where patients were discharged from a hospital, only to suffer a major heart attack because a key laboratory test had either not been ordered or the results had not triggered an appropriate clinical response. The UK’s General Medical Council is currently preparing to review its guidance on the content of medical education.

Across the laboratory medicine profession, there is recognition that time devoted to pathology and clinical lab testing in medical school is often not adequate to teach new physicians to be: 1) both competent and confident in ordering the right tests at the appropriate time; then 2) responding to the lab test results with the correct, recommended actions. Efforts to constantly improve patient safety will eventually evaluate and assess how young physicians are using laboratory tests. It will take a few more years for that to happen.

However, when real-time data is gathered that links errors in patient care to inappropriate ordering of lab tests and improper response to test results by young physicians-who were not properly trained during their medical education-only then is it likely that healthcare systems in the UK and other countries will take active steps to remedy this long-recognized deficiency.

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Big Pharma Ready to Crowd Into the Laboratory Testing Marketplace

Whether laboratory medicine is ready or not, Big Pharma is ready to crowd its way into the laboratory testing marketplace. The world’s largest pharmaceutical companies are recognizing that the success of their prescription drugs will increasingly depend on a clinically-useful companion diagnostic test. Since pharma companies like control over their products, Dark Daily predicts that deals between pharma companies and in vitro diagnostics (IVD) firms will soon be announced.

As this happens, laboratory medicine is likely to be influenced and transformed in ways that will be difficult for pathologists to control and influence. That’s because Big Pharma has tens of billions of dollars to invest in research, clinical trials, and development of products that support the introduction and clinical acceptance of new therapeutic drugs.

This development is directly linked to advances in genetics and molecular diagnostics. Researchers are identifying populations of patients with genetic attributes that either make them prime candidates to respond to a therapeutic drug or a lead pipe cinch to get no therapeutic benefit and even negative side affects. As this occurs for specific cancers and diseases, pharmaceutical firms are recognizing that, for their new drugs to accepted by clinicians and payers, it will need to have a companion diagnostic lab test that affirms that the patient will benefit. Of course, the most recognized example of a companion diagnostic is when the breast cancer patient is tested for the HER2neu mutation. Only if the patient is positive for HER2neu is she a candidate for the drug Herceptin.

Evidence of Big Pharma’s pending move into in vitro diagnostics comes from public statements at various scientific meetings and investor conferences. For example, last month, at the annual meeting of the Society of Clinical Oncology (SCO) in Chicago, discussion of promising new drugs in development invariably included mention of how bio-markers for companion diagnostics were part of the drug development and clinical trial process. Reporters Ron Winslow and Marilyn Chase of The Wall Street Journal covered this meeting, and wrote that research presented at SCO “highlights an important shift in cancer treatment and in attitudes of pharmaceutical and biotechnology companies toward ‘personalized medicine,’ in which treatment is tailored to an individual based on his or her genetic makeup. Companies are beginning to accept a smaller market for some medicines in return for a better chance that those who use them will have a good result.”

The key point to emphasize here is that Big Pharma has the potential to radically transform laboratory medicine as we know it today. Armed with the cash flow from $200 billion in prescription drug sales in the United States alone, Big Pharma has the clout, both financially and politically, to pursue its agenda with vigor.

Further, it should not be overlooked that imaging giants Siemens (NYSE: SI) and General Electric (NYSE:GE) are actively staking out their presence in the in vitro diagnostics sector. In the past 24 months, Siemens invested more than $14 billion to become the world’s second largest IVD manufacturer. On the pharma side, earlier this year, drug and IVD giant Roche Holdings AG (VTX:ROG.VX) invested $3 billion to acquire Ventana Medical Systems, Inc. and its $300 million in annual revenue.

Should the considerable activity of the imaging companies to enter the laboratory testing marketplace be matched by equal or greater activity from Big Pharma, then the traditional profession of laboratory medicine as we know it today is likely to undergo a far-reaching transformation. Lots of money generally implies lots of influence. If pathologists have been worried about how Siemens and GE, with their imaging revenues anchored in radiology, might change the collegial specialty of pathology, then think what can happen as Big Pharma starts pouring some of its billions into in vitro diagnostics with the goal of controlling bio-markers and pointing research into directions that serve their corporate objectives.

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