Feb 18, 2009 | Laboratory News, Laboratory Pathology
The Central Laboratory of the Centre for Infectious Disease Research in Zambia (CIDRZ) has developed a profitable business model that might offer wealthy nations a way to jumpstart similar programs worldwide, then create profit centers to help sustain them.
This business model, developed under the leadership of Executive Director Jeff Stringer, MD, and Laboratory Director Ron Brown in collaboration with the lab’s new Business Manager Henry Latner-formerly of PACLAB Network Laboratories in Washington’s Puget Sound region-creates a sustainable funding source to assist funding at 64 free AIDS clinics in urban Luska, Zambia. The clinics provide more than 140,000 HIV-infected adults and children Antiretroviral Therapy (ART) and Prevention of Mother to Child Transmission (PMTCT) services.
With funding from the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) , the Central Laboratory experienced rapid scale-up of services over the last four years, growing at an annual rate of about 250%. Today, the lab performs more than one million tests annually.
The steep growth curve caused Brown to focus on workload forecasting and continual service demand projections to ensure adequate testing resources are in the pipeline as needed to meet demand for growing services. This prudent planning resulted in operational efficiencies that created consistent excess testing capacity in key analytic areas, allowing the laboratory to market testing services to private sector clinics, faith-based and other non-government organizations in the region. Offering this service added a revenue stream for sustainable growth that reduces dependency on foreign donor support for anti-retroviral treatment programs.
Latner’s business plan called for building the for-profit laboratory service on an existing, well-established services foundation, including current courier routing and result delivery systems, and focusing on creating efficiencies and standardizing work in pre- and post-analytical areas of the lab.
CIDRZ Medical Laboratory Ltd., a separate, not-for-profit company which falls under the parent company of CIDRZ, now provides daily, full-service laboratory support to several hospitals and care clinics throughout the greater Lusaka region. Key to the success of this service are the focus on consistent, predictable, high-quality laboratory testing, with excellent customer service and a fair market price.
This business model was evaluated by a team from the Global Health Delivery program at Massachusetts Institute of Technology’s Sloan School of Management to validate current financial forecasts and potential for additional revenue streams, based on demand for private healthcare growth and market research. The analysis indicated potential for continued growth in demand for laboratory services by private care facilities in this region, and if managed well, Central Laboratory can expect a strong, sustained revenue stream to support CIDRZ care and treatment programs well into the future.
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Feb 16, 2009 | Laboratory News, Laboratory Pathology
To encourage development, diffusion, and adoption of innovations in healthcare, the Agency for Healthcare Research and Quality (AHRQ) recently launched a new online “best medical practices” information exchange. The Healthcare Innovations Exchange is a searchable database of treatment innovations that improve patient outcomes.
AHRQ is an agency of the Department of Health and Human Services. It is charged with research and development of best medical practices. The goal of this free service, which currently contains more than 200 innovations, is dissemination of information about best practices among healthcare facilities.
Users can search the database for innovative practices by one or more subject fields. These fields include disease or clinical area, patient population, stage of care, patient care process, care setting, and domain of quality. Each “best practices” case study often represents a remarkable innovation. One example is an infection surveillance system that completely eliminates vancomycin-resistant enterococcus infection in an ICU for transplant patients. Another is a system that reduces the incidence of bed sores by 5% in high-risk nursing home patients.
Too often, innovations within one healthcare facility remain unknown to the wider healthcare community. A primary goal of this AHRQ Website is to overcome that “silo” effect and make the knowledge available to a wider community. To accomplish this objective, the Innovations Exchange program provides practitioners a standardized format for submitting ideas. The format includes an outline of the medical issue addressed, a description of the innovation, journal references that support the concept, and results attained when the practice was tested. The listing also provides information on how the innovation was implemented, resources required to adopt it, and contact information for innovators and other adopters.
The Web site links to other online tools for quality improvement, such as Joint Commissions’ Laboratory Services National Patient Safety Goals and American Association for Clinical Chemistry’s Lab Tests Online.
Not surprisingly, the Innovations Exchange Web site has not been flooded by visitors, since many healthcare providers are reluctant to change, let alone be innovative. One year into this service, few innovations listed have generated similar projects. For example, a system for reducing “door-to-balloon time” for heart attack to as little as 82 minutes-well below the national 90-minute average-was posted in May, but its creators have not received a single call.
AHRQ’s Innovations Exchange Web site is one more small step in nudging healthcare providers toward a mindset of continuous improvement. As policymakers and payers turn up the heat on hospitals and physicians to deliver improved outcomes in return for pay-for-performance incentives, providers can be expected to pay more attention to fostering innovation within their organization.-P. Kirk
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Feb 13, 2009 | Laboratory News, Laboratory Pathology
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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Feb 11, 2009 | Laboratory News, Laboratory Pathology
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
Feb 6, 2009 | Laboratory News, Laboratory Pathology
If you believe the press releases, the race to be first to achieve the $1,000 full human genome sequence is narrowing down to two primary contenders. One is Complete Genomics, Inc. of Mountain View, California, and the other is Pacific Biosciences (PacBio).
Last fall, Complete Genomics, Inc. was profiled in The Dark Report. It has ambitiously declared that, by this spring, it will be ready to roll out a global commercial DNA sequencing service. The company intends to offer pharmaceutical firms and researchers genetic sequences for $5,000 each, but predicts the cost could eventually come down to as low as $100! (See “Rapid Genome Sequencing Predicted by Mid-2009, The Dark Report, October 20, 2008)
The other contender believes it can tap the immediate consumer market for genomic profiles. Pacific Biosciences, a Menlo Park, California biotechnology firm, vows to offer a personal genome profile in 15 minutes for under $1,000 by 2010. The company predicts the cost could drop to a mere few hundred dollars.
Experts have long predicted that “less than $1,000” is the price point required for advancing the use of whole human genome analysis in patient care. Currently it takes about six weeks and costs $100,000 or more to sequence the entire DNA of a single human.
Both companies are leveraging novel technology platforms to reduce time and cost of full sequencing of an individual human genome. Complete Genomics’ proprietary sequencing technology, a combination of biochemistry and nanotechnology, uses much lower volumes and concentrations of reagents than existing sequencing systems. That supports higher throughput and reduces materials costs to $1,000 per sequence.
PacBio, on the other hand, has developed innovative Single Molecule, Real-Time (SMRT) DNA technology that uses a small chip with tiny observation wells, called Zero-mode waveguides (ZMWs). The chip separates the DNA and deposits it into ZMWs, where a DNA polymerase molecule duplicates the DNA strands. The SMRT DNA machine captures the process as it occurs while reading longer fragments of DNA sequence. According to PacBio, this produces a faster, more complete read of the original DNA sequence.
Inexpensive whole human genome sequencing will trigger a rapid series of advances in genetic knowledge and new clinical services. Assuming that software systems can stay up with the billions of data points generated by a single human genome, then researchers will be able to search for how hundreds and thousands of genes may be implicated in different diseases and health conditions. In turn, that knowledge will be used to create new diagnostic tests, thus opening up a new field in laboratory medicine.
Next week, at the Molecular Summit in In Vivo and In Vitro Integration, this topic will be discussed. Experts in the molecular biomarker field, such as George Poste, DVM, Ph.D., Chief Scientist at the Biodesign Institute of Arizona State University, will be addressing personalized medicine, companion diagnostics, and the role that whole human genome sequencing will play in transforming healthcare. You can register and attend this exceptional conference by visiting this site: http://www.molecular-summit.com 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)
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