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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Hospitals, Physicians, and Clinical Pathology Laboratories Scramble to Prepare for Use of Form 5010 Beginning January 1, 2012

Some medical laboratory organizations risk coming up short on the deadline for implementation of 5010 standards

Less than eight weeks remain before the January 1, 2012, deadline for implementation of Form 5010. Every sector of the healthcare system—from government and private payers to hospitals, physicians, pathologists, and clinical laboratories—is involved in this important healthcare reform.

Many providers and payers are scrambling to meet the Health Insurance Portability and Accountability Act (HIPAA) version 5010 compliance deadline. This is the latest version of standards for the conversion of electronic health records (EHRs).

The Centers for Medicare and Medicaid Services (CMS) continues to maintain a hard line position regarding the deadline, according to an article in Modern Healthcare. “There is no wiggle room,” Denise Buenning, Director of the Administrative Simplification Group in CMS’ Office of E-Health Standards and Services, stated. “We’re holding fast to the date.”

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Electronic Health Record (EHR) Systems Are Here: Is Your Clinical Laboratory and Pathology Group Ready?

Modern Healthcare’s list of Top Ten Hospital EHR Vendors Has Insights for Lab Managers

Published data indicates that about 90% of the nation’s hospitals have implemented an electronic health record (EHR) system. This remarkable statistic has direct implications for clinical laboratories and anatomic pathology groups, since typically 70% or more of a patient’s permanent health record is comprised of laboratory test data.

However, the 90% EHR adoption rate among the nation’s hospitals masks a more provocative truth: only a limited number of hospitals and health systems have implemented an EHR system that is fully integrated and presents a complete patient health record in real time. Thus, many hospitals are using EHR systems that fall far short of allowing clinicians to work exclusively with a complete paperless health record.

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World Congress of Pathology in Sydney Recognizes Globalization of Pathology

Pathology is on a path to globalization and evidence of this ongoing trend will be seen on March 13-15, 2009 at the XXV World Congress of Pathology and Laboratory Medicine in Sydney, Australia. For starters, several thousand pathologists from nations around the world will gather to hear 120 different sessions and visit an international hall of exhibitors. That’s an impressive demonstration of how laboratory medicine is crossing borders.

But what Dark Daily subscribers and readers may consider a fascinating sign of pathology globalization at the World Congress of Pathology is this year’s addition of a special extended session titled “Laboratory Medicine’s Transformational Role in the Genomic Age.” The goal is to predict the path of pathology as genetic knowledge unlocks new diagnostic capabilities, which give pathologists new tools to diagnose disease and identify the most promising therapies for patients. Batting first in this line-up is your intrepid Dark Daily Editor. Here’s the international panel for this session:

Why Pathology Testing Is Soon to Cross New Clinical Boundaries

Mr. Robert Michel, Editor, The Dark Report and Dark Daily, Spicewood, Texas, USA

Translation of Genetic Information into Healthcare Use

Dr. Michael Watson, Executive Director of the American College of Medical Genetics and Adjunct Professor of Pediatrics, Washington University, St. Louis, Missouri, USA

Genetics Practice and Research in a Small Country: Lessons from Iceland

Dr. Jón J Jónsson, Chair of the Division of Biochemistry, Clinical Biochemistry and Medical Genetics, Landspitali-University Hospital, Reykjavik, Iceland

In Vitro-In Vivo Diagnostic Frontiers

Dr. Don Rucker, Vice President and Chief Medical Officer of Siemens Medical Solutions USA, Malvern, Pennsylvania USA

The Future of Pathology

Dr Jared Schwartz, President, College of American Pathologists, Director of Pathology and Laboratory Medicine at Presbyterian Healthcare, Charlotte, North Carolina, USA

This year’s World Congress of Pathology is organized by the Royal College of Pathologists of Australasia (RCPA). The Aussie hosts remind us that-despite globalization- all healthcare is local by offering a series of presentations on the types of forensic pathology cases frequently in Australia, titled: “Recreational Deaths”

Ultra-light Plane Crashes

Dr. Jo Duflu

Scuba Diving Fatalities

Dr. Chris Lawrence

Australian Outback Deaths: Snakes, Sun, and Crocodiles

Dr. Kevin Lee

Certainly those topics are a reminder that some Australians enjoy activities that come with risk. The World Congress of Pathology, with its 120 sessions, will have something for everyone. The full agenda and registration information can be accessed by visiting the RCPA Web site http://www.rcpa.edu.au/Continuing/PathologyUpdate.htm (Or paste this URL in your browser: http://www.rcpa.edu.au/Continuing/PathologyUpdate.htm).

The day before the World Congress of Pathology Convenes, a special full-day seminar on the business and management of pathology laboratories will take place, co-produced by the Australasian Association of Clinical Biochemists (AACB) and the RCPA. On March Titled: “The Pathology Workforce Crisis: International Situation & Solutions.” Robert Michel, your Dark Daily Editor, will be the opening speaker. Full details for this program can be accessed at the AACB (Or paste this URL in your browser: http://www.aacb.asn.au/).

Related Information:

Siemens Health CEO Erich Reinhardt Discusses Integration of Imaging and Lab Testing

On Wednesday of last week, Prof. Dr. Erich R. Reinhardt, President and CEO of Siemens Medical Solutions (NYSE: SI), traveled from Germany to the United States to deliver an address on how Siemens expects to integrate in vivo (imaging) diagnostics, in vitro diagnostics (IVD), and informatics to create new value streams in healthcare. This is a topic of high interest within the laboratory community, ever since Siemens spent billions to buy a major presence in the lab testing marketplace last year with its acquisitions of DPC and Bayer Diagnostics.

Reinhardt was at the headquarters of Siemens Medical Solutions Diagnostics in Tarrytown, New York, to speak to a group of healthcare journalists from Europe and the United States. After Reinhardt’s address, Siemens Medical Solutions Diagnostics CEO, Tony Bihl gave a presentation that was followed by a panel of three outside experts, including Dark Daily Editor Robert L. Michel, Richard G. Friedberg, M.D., Ph.D., Chairman of Pathology at Bay State Medical Center in Springfield, Massachusetts, and Paul R. Billings, M.D., Ph.D., Vice President and Senior Geneticist, Strategic Planning at Laboratory Corporation of America.

Reinhardt’s message was clear and consistent with earlier pronouncements on this topic by senior Siemens executives. “New technologies in both imaging and in vitro diagnostics provide useful clinical knowledge for physicians,” he said. “This allows clinicians to diagnose disease earlier and with more precision. At the same time, these technologies generate increasing quantities of data. That creates the opportunity to use information technology in several ways to further increase value and enhance work flow.”

One application of information technology is to better analyze the primary data generated by an imaging procedure or a molecular laboratory test. “Smart software can analyze the ever-growing quantities of raw data and increase the sensitivity and precision of the clinical diagnosis,” explained Reinhardt. “The second, and equally valuable, contribution of information technology is to streamline clinical and operational processes in the healthcare continuum.”

Two products form the cornerstone of Siemens’ informatics strategy: Soarian and syngo. Reinhardt discussed how these software systems can be used by hospitals and healthcare providers to manage clinical work flow and operational workflow. Reinhardt noted that there are 50 such Sorian “integrated work flow solutions” in active use at 18 locations worldwide. He specifically mentioned Chester County Hospital of West Chester, Pennsylvania, which was so effective using this approach to redesign work flow that it won the “2006 North American Global Excellence Business Process Management (BPM) and Workflow Award” from the Workflow And Reengineering International Association (WARIA). One laboratory-related success at Chester Hospital was improvements in infection control that lead to a reduction in cost per case of $7,000.

One major insight from the presentations by Reinhardt and Bihl is that Siemens does not, at least in the short term, predict that some type of spectacular breakthrough or market-shaking innovation will result from its efforts to integrate imaging, in vitro diagnostics, and informatics. Rather, Siemens Medical Solutions is taking deliberate steps to integrate these three different technology areas to achieve two primary objectives. First, to improve clinical outcomes by enhancing the knowledge and clinical efficiency that these technologies deliver to physicians. Second, to contribute to efficiencies in operational work flow.

However, there could be a wild card to this effort. Siemens is the first major player in imaging to acquire and operate a major IVD manufacturing business. As Siemens’ researchers, engineers, and scientists involved in imaging and IVD manufacturing now start to meet regularly and look for specific opportunities to combine and integrate molecular technologies in imaging and laboratory testing, there is a strong possibility that these teams will find new and useful molecular markers that can be utilized by in vivo and in vitro procedures in complementary ways.

Dark Daily will be tracking these developments. Currently Siemens has a head start in the IVD manufacturing business over its major competitor. But when General Electric (NYSE: GE) becomes the owner of Abbott Diagnostics later this year, that will certainly intensify competition between these two healthcare corporations.

Related Information
The Chester County Hospital Wins Prestigious Business Process Management and Workflow Award

2006 Winners Announced for Excellence in BPM & Workflow Global Awards

Prof. Dr. Erich Reinhardt

Newt Gingrich and Siemens Medical CEO Erich Reinhardt Share Insight on the Future of Healthcare; Results of Opinion Leader Survey Will Be Revealed

Integrating In Vitro and In Vivo Diagnostics

 Across the laboratory industry, there is keen curiosity about how imaging giants Siemens and General Electric plan to integrate in vitro diagnostics with in vivo diagnostics. Executives from both companies have not been detailed in their public statements about how integration of these two medical disciplines is likely to occur. But recently the opportunity presented itself for me to learn more about this subject.

Last week, I was privileged to co-chair a laboratory management meeting conducted by Siemens Medical Solutions Diagnostics in William Shakespeare’s home town of Stratford-upon-Avon, England. This was the third annual Process Management Meeting Siemens has produced for its laboratory customers in the United Kingdom. My co-chair was David Ricketts, Laboratory Manager at North Middlesex University Hospital in London, England.

One session at this meeting was targeted specifically at the topic of integrating in vitro and in vivo diagnostics. In a point/counterpoint discussion, Ricketts challenged Nico Arnold, the newly-appointed Head of Europe for Siemens Medical Solutions Diagnostics, to lay out the company’s strategy and give everyone in the meeting a better understanding of how Siemens’ intends to proceed to achieve integration of these two diagnostic disciplines.

Nico Arnold’s message was simple and clear. “Going forward, laboratory customers of Siemens will see a continued commitment to both the latest in lab test technology and a high level of value-added service,” he stated. “With its recent acquisitions, Siemens has become the world’s largest player in immunoassays and is one of the top three largest in vitro diagnostics (IVD) manufacturers globally. Siemens fully intends to be at the forefront of laboratory medicine, just as it is a leader in radiology and imaging.”

Arnold then emphasized that integration of laboratory medicine and radiology services can only be successful so long as Siemens maintains state-of-the-art technology. It will be the intersection of these evolving technologies that will create opportunities to integrate the two disciplines, thus delivering increased value to physicians. With its laboratory customers in the United Kingdom (UK), Siemens Medical Solutions Diagnostics was consistent in its message that integration will be an ongoing, but evolutionary, strategy within the company.

Lab managers and pathologists in the United States will also be interested in several other developments revealed at Siemens’ process management meeting. Just as in this country, UK laboratory leaders are taking active steps to improve operational performance, streamline workflow, and use quality management principles to raise quality and service even while reducing cost and eliminating waste.

For example, the laboratory of John Radcliffe Hospital in Oxford, England (associated with Oxford University School of Medicine) has reduced average test turnaround times using process re-engineering and new instrumentation arrangements. Richard Taylor, BSc, Ph.D., FRCPath, a Consultant Clinical Scientist at the laboratory, described the management initiatives which achieved those outcomes.

Lean, Six Sigma, benchmarking, and best practices were also discussed in detail and in multiple presentations. Like in the United States, laboratory administrators in the United Kingdom are willing to use a variety of new management approaches and methods.

One interesting statistic illustrates the scale of the challenge in the United Kingdom. During his presentation on using Lean principles to improve laboratory workflow and quality, Tony Currell, CSci, FIBMS, the Clinical Biochemistry Service Manager at St. Helens and Knowsley NHS Acute Trust in Merseyside, England, showed a slide that tracked the number of medical technologists in the United Kingdom. Since 1990, that number, about 20,000, has remained virtually unchanged for 17 years. Yet, over that same period, there has been a steady increase in both the number of lab tests on the menu and the volume of laboratory specimens tested. These facts demonstrate how the laboratory profession has managed to sustain laboratory services by using automation, new technology, and quality management methods to squeeze every bit of productivity out of laboratory resources.

Your travelling Dark Daily Editor,
Robert L. Michel

P.S. For those of you keenly interested in how laboratory medicine and radiology is destined become an integrated service, there will be an opportunity to get insights into Siemens’ plans and strategies at the upcoming Executive War College in Miami on May 10-11, 2007. Dave Hickey, Vice President of Strategic Marketing and Planning, Siemens Medical Solutions Diagnostics, Tarrytown, New York, will speak on “Full Service Diagnostics: The Coming Convergence of Imaging, Informatics, and In Vitro Diagnostics (IVD). You can access the full details using the links below. Take action today and join us in Miami.

Early-Bird Discount Registration now available online
Visit http://www.executivewarcollege.com
Download Full Program Agenda

You can:
1. Register ONLINE right now; or,
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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