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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Regional Laboratory Networks Sprouting in the United Kingdom

BIRMINGHAM, ENGLAND – Here in the United Kingdom, regional laboratory networks are finally catching on. The number of “pathology networks,” as they are called here, has increased in recent years. As was true of Canada in the late 1980s and the United States and Australia during the 1990s, clinical lab leaders in the United Kingdom are finding regional laboratory networks to be effective business models to achieve tight integration of lab services, realize significant cost savings, and eliminate excess lab testing capacity in regional markets.

These achievements were confirmed by presentations delivered yesterday in Birmingham, England, at the sixth annual Frontiers in Laboratory Medicine (FiLM) conference yesterday. Produced jointly by the Association of Clinical Biochemistry and The Dark Report. Your editor, Robert Michel, is here and participating in all the sessions. Four regional laboratory networks presented their accomplishments yesterday.

In the northwest of England, the Greater Manchester Pathology Network, formed in 2005, is composed of laboratories from 16 hospitals and serves a population of 2.5 million people. In his presentation, co-presenters Neil Jenkinson, Ph.D., Network Director, and Keith Hyde, Ph.D., Deputy Director of Laboratory Medicine, reported how participating pathology laboratories (as clinical laboratories are called in this country) are progressively developing integrated lab testing services. One key objective is to develop a common laboratory informatics capability that allows the 16 hospital laboratories to more effectively serve primary care clinics in the region.

Local to the Birmingham area, Coventry and Warwickshire Pathology Services was created in May 2007, by two acute care trusts that had always been wary of each other, According to Neil Anderson, Ph.D., Director, this pathology network has 412 employees and provides lab testing services to a population of 950,000. Steps toward integration and consolidation of lab testing services centered around three areas of lab testing:

  • Blood sciences (Chemistry, Hematology, Transfusion medicine and Immunology)
  • Microbiology (Microbiology, Virology, and Laboratory Infection Control)
  • Cellular Pathology (Histopathology, Cytology and Mortuary services).

Anderson explained that, within two years, the pathology network had delivered £1.9 million (U.S.$2.8 million) in savings to its two parent trusts. As well, steps had been taken to install a common laboratory information system (LIS), and flexibility in staffing was contributing to improved levels of service to clinicians.

Two overseas regional laboratory networks were at FiLM to share their successes learned. In Australia, Sullivan Nicolaides Pathology Laboratories, a division of Sonic Healthcare, LTD, operates a regional laboratory network in Northeastern Australia that serves a population of 3 million people. With a central laboratory in Brisbane, it has 21 other laboratories located across a service area of millions of square miles in the states of Northern Territory, Queensland, and New South Wales. Executive Manager Tony Badrick, Ph.D., observed that, with an operating history of several decades, this regional laboratory network’s current objective is to quality management systems to advance the performance of operations. Sullivan Nicolaides is certified under ISO 9001 and ISO 15189. It is working on its ISO 14000 certification.

The fourth regional laboratory network presented at FiLM Tuesday was Calgary Laboratory Services in Calgary, Alberta, Canada. This case study was presented by Fred Swaine, M.D., Chief Operating Officer. This regional laboratory network was created back in the mid-1990s, when the government of Alberta mandated an immediate reduction of 35% in funding for laboratory services. Swaine described how this regional laboratory network is in the midst of its third cycle of lab consolidation and integration since 1996. It serves 1.2 million people and is currently comprised of one central laboratory, with rapid response labs in four hospitals.

Swaine noted that one notable accomplishment of the early network organization was to install a single laboratory information system (LIS). That has made it easier for Calgary Laboratory Services to collect, store, and provide access to laboratory data across its entire service region.

Dark Daily notes that these four examples of regional laboratory networks demonstrate how this trend has established strong roots. For almost two decades, operational regional lab networks in Australia, Canada, and the United States have proved to be effective providers in their respective service areas. It is expected that the number of pathology networks will continue to expand.

Related Information:

Top Ten Lab Industry Stories for 2008 Announced by The Dark Report

It’s no surprise that topping The Dark Report’s list of Top Ten Most Important Stories of 2008 for the laboratory industry is the successful repeal of the Medicare Part B Laboratory Services Competitive Bidding Demonstration Project. Across the nation, labs feared the consequences were federal health officials to have implemented the flawed scheme that was scheduled to commence in the San Diego-Carlsbad-San Marcos SMA (statistical metropolitan area) by July 1, 2008.

Our list of the Top Ten Most Important Lab Industry Stories of 2008 leads off the latest issue of The Dark Report, published last week and arriving at client’s locations here and abroad. This annual listing is closely-watched because it provides a clear assessment of major trends unfolding in laboratory medicine.

Editor-In-Chief Robert Michel, after explaining why repeal of Medicare Competitive Bidding was the single most important development during 2008, characterized the balance of 2008 as otherwise a quiet and relatively uneventful year. He wrote “No other story on the Top Ten list approaches the magnitude of importance and implications of Medicare competitive bidding repeal. However, that is a good thing because it means that, over the course of 2008, there were few events that represented disruptive or unwelcome change to the majority of laboratories and pathology group practices.”

In fact, Editor Michel picked the huge increase in the volume of Vitamin D testing as the second most important lab industry story for 2008. “This phenomenon is directly related to widespread media stories about: 1) the alarming increase in the number of people with Vitamin D deficiency; and, 2) the negative health consequences for individuals who are deficient in Vitamin D,” noted Michel in The Dark Report. “Attention to Vitamin D deficiency during the past two years shows how speedily a new clinical guideline can become accepted, particularly when it is something that is easy for consumers to understand.”

Top story number ten was described as “2008-Not a Year for Big Lab Deals as Relative Calm Rules Lab Market.” Michel observed that no major or disruptive laboratory acquisitions took place during the year. He noted how this was unusual for a trend that reaches back to the mid-1980s. However, it remains true that Wall Street is keenly interested in molecular diagnostics. That was reflected in the willingness of Roche Holdings (NYSE: RHHBY) to pay the premium price of $3.4 billion last April to acquire then $290 million Ventana Medical Systems. (See Dark Daily, “Roche Purchases Ventana by Offering Higher Price”, February 22, 2007).

Subscribers and readers of Dark Daily are invited to send in their picks for the most important medical laboratory stories for 2008, along with their reasons why the story is significant. We will publish the best of these submissions. E-mail to: rmichel@darkreport.com.

Related Information:

2008’s Top Ten Lab Stories Lacked Disruptive Impact

Invivo and In Vitro Integration Unfolding at UCLA Laboratories

California is often a national leader for innovations in managed care contracting, as well as new approaches for delivering healthcare. So when your Dark Daily editor visited the laboratory at the UCLA Medical Center this week, he was quite curious about the ways in which clinical laboratory testing and anatomic pathology services are being used at this respected national academic center.

For one thing, UCLA has recently moved into a brand new hospital building. The Ronald Reagan Medical Center is a 525 bed facility (all single patient rooms) and is designed to be state-of-the-art. The UCLA Medical Center is also a world-class institution. It is proudly flying banners throughout the campus which recognize its selection by U.S. News and World Report as the nation’s number 3 best hospital. (Are you interested in which hospitals are ranked 1 and 2? We provide a list of U.S. News & World Report’s Top Ten Best Hospitals at the end of this e-briefing.)

Exciting things are unfolding at the Department of Pathology and Laboratory Medicine. In a briefing session with Scott W. Binder, M.D., Senior Vice Chair, Pathology Clinical Services and Chief, Dermatopathology, your Dark Daily editor learned about a collaborative effort with the Department of Radiology and the Department of Molecular and Medical Pharmacology to develop integrated patient care pathways in several different types of cancers. The particular focus is on lung cancer, melanoma, and breast cancer. The goal is to develop an integrated report which incorporates the radiology components with the pathology report. Molecular assays will be used so that the report emphasizes information about prognostic genes and the most appropriate therapeutic options for the patient. This is an effort to integrate in vivo and in vitro diagnostics to advance patient care.

Over in the clinical laboratory, there were several interesting things that are unique to the UCLA Medical Center. At the 10-story Ronald Reagan Medical Center building, there is a new core laboratory. However, competition for space within the facility meant that the clinical laboratory did not get all the square footage it required to centralize all laboratory testing activities across the campus into one site. Consequently, there are at least four different locations where significant laboratory testing activity takes place.

For example, a medical building next to the new hospital holds a large patient drawing center (serving an average of 500 patients per day). This space also has the accessioning center for routine specimens, along with a fully automated pre-analytical line supplied by Beckman Coulter that includes specimen sorting, de-capping, centerfuging, aliquotting, and re-capping. Prepped specimens are then sent next door to the new core laboratory in the Reagan Medical Center for testing. At the core laboratory, different academic experts supported their “best of breed” choices for analyzers. Thus, the automated line is by Beckman Coulter, while Roche and Olympus supplied chemistry and immunoassay analyzers. PT/PTT testing is done on a system by Siemens (Dade Bering), and hematology is performed on a Sysmex automated line. The clinical laboratory performs tests for inpatients, outpatients, and outreach patients.

Dark Daily summarizes this day of site visits and learning with two observations. First, UCLA’s Department of Pathology and Laboratory Medicine is proactively crossing traditional medical specialty silos to support collaboration with a goal to advancing personalized medicine. For that reason, expect to see some interesting research breakthroughs, particularly in the areas of molecular and genetic testing, from the UCLA pathology department.

Second, the competition for limited resources in healthcare was visible at the new Ronald Reagan Medical Center. Even in a new, state-of-the-art facility, demand for space by all the clinical services was so intense that the clinical laboratory had to settle for a space allotment that made it impossible for them to consolidate all major laboratory testing facilities into a single location.

Related Information:

U.S. Hospitals Honor Roll

Top Ten Hospitals as Ranked by U.S. World & News Report in 2008:

1. Johns Hopkins Hospital, Baltimore
30 points in 15 specialties

2. Mayo Clinic, Rochester, Minn.
28 points in 15 specialties

3. Ronald Reagan UCLA Medical Center, Los Angeles
25 points in 14 specialties

4. Cleveland Clinic
25 points in 13 specialties

5. Massachusetts General Hospital, Boston
24 points in 12 specialties

6. New York-Presbyterian Univ. Hosp. of Columbia and Cornell
22 points in 12 specialties

7. University of California, San Francisco Medical Center
21 points in 11 specialties

8. Brigham and Women’s Hospital, Boston
18 points in 11 specialties

9. Duke University Medical Center, Durham, N.C.
18 points in 11 specialties

10. Hospital of the University of Pennsylvania, Philadelphia
18 points in 10 specialties

New Use for Existing Lab Technology Wins UK Technology Award

Here’s another example of taking existing laboratory technology and applying it in a new way. A scientist at Queen’s University Belfast in the United Kingdom is using an existing technology to create what he describes as “intelligent molecules,” capable of identifying tags in human cells that could signal the presence of organisms common in an epidemic. They also could be use to track infections in a population and identify patients who would be vulnerable to certain infections.

This new application of existing technology earned A. Prasanna de Silva, Ph.D., Professor and Chair of Organic Chemistry at Queen’s University, the 2008 Royal Society of Chemistry’s Sensors Award, sponsored by GE Healthcare. The award is given biannually for chemical input into the design of novel sensors or novel applications of existing sensors.

The technology incorporates fluorescent “catch and tell” sensors that emit light signals when they catch chemicals in the blood. It is familiar technology to most laboratories, as it is incorporated into in blood diagnostic cassettes sold worldwide. Hospitals, ambulances, veterinarians, and others use this fluorescent sensor technology to monitor blood for levels of common salt components such as sodium, potassium, and calcium.

The worldwide market for this type of blood diagnostic cassettes totals $50 million. Roche Diagnostics Inc. uses the fluorescent sensor technology in the chemistry module of the OPTI point-of-care blood analyzer, a module that has produced worldwide sales of $39 million.

Using an extension of the same design, de Silva has developed molecules that act as ‘logic gates,’ which are similar to the mechanisms in computers. De Silva and colleagues at Queen’s University are using these molecular logic gates as identification tags for objects the size of biological cells.

The new application could be used in a variety of clinical and other settings, de Silva said. “One such use could be as an ID tag for cells in an epidemic, such as a bird-flu outbreak,” he explained. “From a population, our sensor molecules could help track infection and highlight vulnerable people. Another one is a ‘lab-on-a-molecule’ system which combines several lab tests with a rudimentary diagnosis without human intervention.”

This example demonstrates how advances in science, combined with the ongoing ability to continually shrink the size of diagnostic analyzers, will package long-established and familiar diagnostic technologies in new ways. It is a reminder that, outside today’s clinical laboratory, large numbers of research projects and biotech companies are rapidly developing new assays. It is one reason why laboratory medicine is almost overwhelmed by the daily and weekly stream of press releases and product launches for new biomarkers and new laboratory tests.

Related Information:
New ‘Catch-And-Tell’ Molecules Designed By Queen’s Chemist

New ‘Catch-and-tell’ Molecules Send Out Light Signals When They Catch Chemicals In Blood

One Barrier to EMR Adoption May be “Close to Retirement” Doctors

As the nation’s healthcare system pursues the goal of a universal electronic medical record (EMR) and a paperless, all-electronic environment, one barrier to adoption may be the large number of physicians nearing retirement. That’s the opinion of a neurosurgeon in his recent testimony before a congressional committee.

Physicians within five years of retirement may not get a return on their investment, Philip Tally, M.D., a neurosurgeon in Bradenton, Florida, told a hearing on “Cost and Confidentiality: The Unforeseen Challenges of Electronic Health Records in Small Specialty Practices,” on July 31 before the House Committee on Small Business.

Just 4% of physicians have an extensive, fully functional EMR and only 13% have a basic system, Tally told the committee, citing an article, “Electronic Health Records in Ambulatory Care-A National Survey of Physicians,” in the July 3, 2008, issue of the New England Journal of Medicine. The committee hearing was on the unforeseen challenges faced by small specialty medical practices when installing an EMR system.

“If you’re not thinking about practicing more than five years, don’t bother because the transition and the cost and the time to make it proficient for you in a small practice is probably not worth it-with one exception and that would only be if you intend to sell your practice someday,” Tally told Modern Healthcare magazine. When selling a practice, the physician who buys the practice is likely to want the EMR, he added.

The American Medical Association’s Physician Characteristics and Distribution in the U.S., 2008 edition, shows how physician demographics are weighted toward approaching retirement. There are 921,900 physicians in this country, of which 343,200 (37.2%) are over age 54. Approximately 166,000 physicians are aged 55 to 64 and 177,200 are aged 65 and older.

Interestingly, Tally was speaking from experience. His three-physician practice of neurosurgeons installed an EMR in 1992, making the group just the fifth in the nation and the first neurosurgery group to do so. At the time, the practice spent $50,000 for the EMR and about $5,000 annually to maintain the system. Tally, who chairs the Florida Medical Association’s IT committee, the congressional hearing that his group spent about 1,000 hours to configure the system after it was installed. His medical office staff found the process challenging, as the staff turnover rate climbed to 30%. Tally did observe that the EMR system, once implemented, significantly increased productivity.

Accurately measuring the return on investment (ROI) that accrues to a physician group from implementing an EMR is complicated by many factors. These include: 1) savings from eliminating the need to maintain and store paper charts; 2) savings in time for physicians to see patients under the new EMR system versus the time it took under the old system; and, 3) savings from electronic data entry of laboratory tests results in the EMR. Perhaps most difficult to measure is physician and patient satisfaction with the new EMR system versus the old.

Tally has an overlooked perspective on why physician age is likely to be an impediment to EMR adoption. He points out that more than one in three physicians in this country are within a decade or less from retirement-and are thus likely to find the transition to an electronic medical records system to be both uneconomical and unwelcome. It may turn out that more financial incentives from federal and state government sources, along with private payer incentives, will be required to encourage smaller physician groups to implement an EMR system. Clinical laboratories will need to take these factors into consideration as they develop effective strategies for supporting to move to a fully-digital patient health record by their office-based physician clients.

Physicians in America (In round numbers)

Younger than age 35     141,500
35 to 44                        213,300
45 to 54                        223,900
55 to 64                        166,000
65 and older                 177,200
Total                             921,900

Source: American Medical Association’s Physician Characteristics and Distribution in the U.S., 2008 edition
Related Information:
Dr. Tally’s prepared remarks for the House Small Business Committee:

Committee Examines Costs and Challenges of Electronic Health Records to Small Medical Practices

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