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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Laboratory Outreach Program Flourishes at Evanston Hospital

Across the country, many hospital laboratory outreach programs continue to grow and prosper, despite a sour economy and higher rates of unemployment. That’s true in Chicago’s northern suburb of Evanston, Illinois, where the laboratory outreach program of Evanston Hospital enjoys solid rates of growth in specimen volume and revenue.

This week, Dark Daily visited Evanston Hospital and spent time with Thomas A.Victor, M.D., Ph.D., Chair of the Department of Pathology and Laboratory Medicine, and his laboratory team. Evanston Hospital is the anchor facility for Northshore University Healthsystem, which includes Glenbrook Hospital, Highland Park Hospital, and Skokie Hospital. These four hospitals total 1,043 beds. Northshore is affiliated with the University of Chicago School of Medicine.

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SWINE FLU UPDATE FOR CLINICAL LABORATORIES: Tuesday, April 28, 2009

Rapid diagnostic test rRT-PCR Swine Flu Panel cleared by FDA for emergency use

Early today, it was reported that major hospitals in Mexico have fewer numbers of new cases of suspected or confirmed A/H1N1 swine flu. That is considered a favorable trend, even as there are now 92 confirmed cases worldwide, in at least six other countries.

The Associated Press quoted Mexican Minister of Health Secretary Jose Angel Cordova, as saying that the number of new cases of confirmed or suspected swine flu at “Mexico’s largest government hospitals” had declined in the past three days, falling from 141 on Saturday to 119 on Sunday and 110 Monday.

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First Two Laboratories in U.S. Earn ISO 15189 Accreditation

It’s an important first for the laboratory medicine profession in the United States. In recent months, two clinical laboratories received formal notice of their successful accreditation with the standards of ISO 15189:Medical Laboratories.

In November 2008, Piedmont Medical Laboratory of Winchester, Virginia became the first laboratory in the United States to be officially accredited under ISO 15189. Last month, in January 2009, the laboratory at Avera McKennan Hospital and University Health Center Avera McKennan Medical Laboratory in Sioux Falls, South Dakota received its official notification of ISO 15189 accreditation.

The Dark Report was first to alert the laboratory industry to the accreditation efforts by Piedmont and Avera McKennan. (See “First U.S. Laboratories Nearing ISO:15189 Accreditation,” The Dark Report, August 18, 2008) The decision by both laboratories to pursue ISO 15189 accreditation shows how the quality management trend is establishing deeper roots among labs in this country.

ISO 15189 is designed specifically for medical laboratories. It is a quality management system to help laboratories develop a highly-disciplined approach to improving the quality of services and outcomes. It provides a road map for identifying opportunities to improve, implementing change, and then sustaining the resulting gains in quality. The process involves nine steps and typically takes two years to complete.

Both Piedmont and Avera achieved their ISO 15189 accreditation through a new program offered by the College of American Pathologists (CAP). In the United States, ISO 15189 accreditation is a voluntary step and does not replace a laboratory’s requirement to maintain its CLIA license.

One reason Piedmont Medical Laboratory invested the considerable time and resources required to achieve ISO 15189 accreditation is to build its credibility with local businesses and employers. Joseph Skrisson, President and CEO of Piedmont Medical Laboratory, points out that most businesses are very familiar with ISO accreditation. Many companies have become ISO-accredited themselves over the years. On the other hand, they generally don’t recognize the significance of accreditation through the programs of either the Joint Commission or CAP.

Leadership in quality management is a primary strategy at Avera McKennan Laboratory. Leo Serrano, Director of Laboratory Services at Avera McKennan Laboratory, observed that achieving ISO 15189 accreditation is consistent with his laboratory’s use of quality management methods such as Lean and Six Sigma. As with Piedmont, Avera McKennan believes that ISO 15189 accreditation will be recognized and respected by local employers and businesses.

Regular readers of Dark Daily now that ISO 15189:Medical Laboratories is gaining acceptance across the globe as an international standard for laboratory accreditation and reimbursement. This is particularly true in countries which have previously lacked any type of licensing or accreditation requirement. Because of the existing, rigorous federal and state licensing mandates in the United States, only a limited number of labs in this country will likely invest the resources to achieve ISO 15189 accreditation in the short term. -P. Kirk

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Huge Molecular Asteroid on Track to Smash Planet Pathology and Planet Radiology

Powerful, fast-moving trends are propelling pathology and radiology toward personalized medicine

February 11, 2009

It is no exaggeration to characterize the advances in molecular technologies as a huge “molecular asteroid” on a target path to smash Planet Pathology and Planet Radiology. That is the collective wisdom shared by experts speaking here in Philadelphia yesterday and today at the second annual Molecular Summit on In Vivo and In Vitro Integration.

This important conference, produced by The Dark Report, is the only global event which brings together innovators in the fields of molecular imaging, molecular diagnostics, and health informatics to share their progress on establishing integrated diagnostic and therapeutic services for clinicians and patients. Yesterday’s podium fireworks offered attendees impressive insights on the current level of molecular transformation underway in molecular imaging and molecular diagnostics-along with a impressive consensus on the future for these diagnostic areas.

For example, keynote speaker George Poste, DVM, Ph.D., Chief Scientist and Director of The Biodesign Institute of Arizona State University, laid out a compelling argument that personalized medicine is an unstoppable trend. Poste, a leading international expert on biomarkers, declared that multi-modality diagnostics will play an essential role in how healthcare evolves toward a pro-active healthcare system organized to serve the needs of personalized medicine.

Of particular interest to pathologists and laboratory professionals, Poste characterized the field of diagnostics as rapidly organizing around multiplex, automated, miniaturized assays, amid plenty of chaos as new science and technologies upset long-standing practices in laboratory medicine. He illustrated this chaos by noting that “there are approximately 157,000 biomarkers in the literature with some claim of validity. These biomarkers were developed mainly in academic settings and are supported mostly by anecdotal evidence.”

Throughout the day, experts at the Molecular Summit podium stressed several common themes about how molecular imaging and molecular diagnostics is transforming. These are valuable insights for the many pathologists and radiologists who work in community hospital settings and don’t often have the opportunity to participate in conferences such the Molecular Summit on In Vivo and In Vitro Integration:

* Personalized medicine is already happening. It is not an idea, but is now an active trend in the American healthcare system.
* There will be swift progress to move away from single-analyte assays (such as potassium and chloride) and single biomarker tests (such as HER2/Neu) in favor of multi-analyte assays. Microarrays with their tens of thousands of data points are just one example of how diagnostics is incorporating huge amounts of measurement points.
* Multi-modality disease assessment will become the norm. Molecular imaging, molecular diagnostics, and other relevant clinical data sets will be pulled together and assessed. Diagnosticians will then provide an integrated answer to the clinicians. This integrated answer will address diagnosis, therapeutic options, and patient monitoring.
* In anatomic pathology, technology will make it possible to extract quantitative data from specimens. The technology will reduce human variability in assessment of the specimen and will provide richer information for diagnosis, to guide therapeutic decisions, and patient monitoring.

Dark Daily will provide more insights from this Molecular Summit, which continues through the end of today. As noted above, there is strong consensus among the speakers that a transformation of diagnostic services is underway. Such a consensus among numerous experts in molecular imaging, molecular diagnostics, and health informatics is, by itself, confirmation that a major trend is unfolding.

Armed with this understanding, it explains why the metaphor of a huge molecular asteroid striking Planet Pathology and Planet Pathology is apt. Look for additional intelligence about the presentations and insights emerging from this year’s Molecular Summit!

Your Dark Daily Editor,

Robert L. Michel

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2009 Molecular Summit on In Vivo and In Vitro Integration

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/).

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