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 11, 2009 | Coding, Billing, and Collections, Laboratory Pathology
Pathologists and lab directors concerned about training staff to implement the new ICD-10 code sets can relax-but only just a bit! The federal Department of Health & Human Services (DHHS) has pushed back the compliance deadline for implementing the International Classification of Diseases, 10th Revision (ICD-10) code sets. The new implementation deadline of October 1, 2013; replaces the existing deadline of October 1, 2011.
As it announced this extension in implementation of ICD-10 on January 15, HHS also set a date of January 1, 2012, for implementing the so-called X12 standard, Version 5010, for certain electronic health care transactions. Version 5010 is an important prerequisite to adopting ICD-10 and includes updated standards for claims, remittance advice, eligibility inquiries, referral authorization, and other administrative transactions. Version 5010 accommodates the ICD-10 code sets, which are not supported by Version 4010/4010A1, the current X12 standard, HHS said.
These two implementation dates give labs additional time to prepare and train for using the new codes. Labs will find the implementation of ICD-10 to be a costly process, in part because ICD-10 uses 155,000 seven-digit codes, compared with the existing 17,000 codes in ICD0-9. Bloomberg news reported on January 14 that the new codes will be a “nightmare” for healthcare providers.
In a report last year, Nachimson Advisors, LLC, estimated that every provider will incur conversion costs in at least six ways. Organizations representing physicians and laboratories, including the American Medical Association and the American Clinical Laboratory Association (ACLA) commissioned the report, which projected the ICD-10 implementation costs for small, medium, and large physician groups.
The Nachimson Report calculated that the typical small group of three physicians would incur costs of $83,290 to comply with ICD-10. A typical medium-sized group of 10 physicians would spend $285,195, and a typical large physician practice of 100 providers would spend $2.7 million. (See “ICD-10 Conversion Costs Underestimated by HHS,” The Dark Report, Oct. 20, 2008.) These costs include expenses for:
1) education;
2) process analysis;
3) changes to superbills;
4) information technology;
5) documentation; and,
6) cash flow disruption
Conversion costs will be even higher for labs. That’s because labs must fund extensive changes in their information systems. Labs will also need to train not only staff, but also referring physicians. One large national lab estimated that it will spend $40 million to convert to ICD-10.
Armed with the knowledge about these high costs to implement ICD-10 and train referring physicians on the new codes, physician groups and ACLA have lobbied Congress to order HHS to delay implementation. HHS received more than 3,000 comments on the ICD-10 proposal, said Kerry Weems, acting administrator of the federal Centers for Medicare & Medicaid Services (CMS).
“A number of commenters asked for a delay in the compliance dates for both ICD-10 and Version 5010, citing implementation costs, the need to train health care personnel, and to assure ample time for testing between trading partners,” noted Weems. “HHS recognized these concerns and the final rules delay the implementation dates between the proposed and final rules by 21 months for the 5010 standards, and by 24 months for the ICD-10 codes.”
Medical laboratories and pathology group practices should already have a strategy in lace for handling the transition to ICD-10 codes. This two-year extension may be welcome today, but the United States is a full two decades behind the rest of the world in its use of ICD-10 codes. So further delays in ICD-10 implementation beyond 2013 should not be expected.
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Feb 9, 2009 | Laboratory Pathology, Management & Operations
UniPath of Denver, Colorado sells its Technical Laboratories
February 9, 2009
Having shopped itself to a number of interested buyers in recent years, pathology supergroup UniPath, LLC, in Denver, Colorado, has sold its histology laboratory operations to American Pathology Partners (APP) , of Brentwood, Tennessee. It keeps full ownership of its pathology professional corporation, which has an agreement to provide services to APP.
This acquisition has several interesting and innovative aspects. These are analyzed in detail in the current issue of The Dark Report. (See “Denver’s UniPath Sells Its Histology Labs to APP”, The Dark Report, February 2, 2009) Probably the most significant fact is that American Pathology Partners now has a platform lab that enables it to immediately begin seeking new business. That may mean that local pathology groups in the Rocky Mountain states and further west will have a new pathology player in the marketplace.
“This partnership advances APP’s vision of joining with the country’s top pathologists, aligning incentives, and working together to improve the delivery of exceptional care,” said CEO Bob Yeager of APP. “APP will market UniPath’s services to small pathology groups of two, three, or more physicians on the west coast and on the east coast as well. APP has financial support from New Enterprise Associates, a venture capital firm in Chevy Chase, Maryland.
UniPath, LLC, has been a successful, aggressive pathology competitor within the Rocky Mountain Region. The company has a 40,000 square foot central laboratory in Denver, on-site labs in 11 hospitals in Colorado, and expertise in all pathology subspecialties. Among its 120 employees are 21 Board-certified pathologists, 19 of whom are partners in the professional corporation. The other two are on a partnership track. UniPath executives told Dark Daily that, in 2008, UniPath analyzed 173,000 patient cases generating 363,000 specimens, about two thirds of which originate from physicians’ offices and one third come from hospital procedures.
Under the terms of the new business arrangement, APP now owns and manages UniPath’s central laboratory in Denver, along with its 120 employees, and the on-site laboratories in 11 hospitals in Colorado. UniPath gets funding to support expansion, investment in technology and lab equipment, and sales support. As noted earlier, UniPath’s physicians continue to own and manage the professional corporation.
“As president of the professional corporation, what I found attractive about APP was they wanted to keep the professional corporation (PC) absolutely intact,” said Karim Sirgi, M.D., President of UniPath.in his interview with The Dark Report. “They allowed the PC to keep its independence with regard to decision making, staffing, and how to apply national and regional standards on the quality of care UniPath provides to referring physicians.”
Until its sale to American Pathology Partners, UniPath’s growth has come from: a) mergers and acquisitions of pathology groups in the Denver area; and, b) by investing in a regional and national marketing and sales program, funded by the partner-pathologists. UniPath’s pathologists believe their new business agreement with APP will help fuel growth in and beyond the Rocky Mountain market.
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