News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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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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Charles Roussel Selected as New Executive VP for College of American Pathologists

Major changes may soon be unfolding at the College of American Pathologists (CAP), based in Northfield, Illinois. On October 30, CAP announced that Charles Roussel would be its new Executive Vice President. In this role, Roussel is responsible for daily operations at CAP and he reports directly to CAP’s Board of Governors. But that’s just the starting point for this story.

Roussel is an organizational change agent. He has actively consulted with corporations in such industries as electronics, high tech products, and telecommunications. That means Roussel is likely to bring a decidedly non-healthcare perspective, as well as a pro-active mindset, to the strategic direction of the College of American Pathologists.

Roussel comes to CAP from The Atlantic Philanthropies, a $300 million non-profit organization. Earlier, he served for many years at Accenture, a major consulting firm. While at Accenture, Roussel led the Global Thought Leadership Program and was a partner with the Accenture Strategy Competency. Accenture described Roussel’s expertise as including “channel management, organizational design, strategic change management, mergers, acquisitions and alliances.”

These skills are sorely needed at the College. Over the past two decades, CAP found itself challenged on multiple fronts as the pace of change in healthcare accelerated. For example, since the adoption of DRGs by Medicare in the early 1980s, the College has struggled to craft an effective strategy to protect and enhance reimbursement for clinical pathology professional services. That area of pathology services and income continues to be attacked, particularly by private payers and hospital/health system administrators.

In recent years, this same pressure on clinical pathology professional service reimbursement has expanded into anatomic pathology (AP) professional services. Since 2003, the AP marketplace has seen the emergence of anatomic pathology condominium laboratory complexes (AP condo labs or “pod” labs), as well as numerous TC/PC schemes that permit specialist physicians to capture for themselves revenue from AP services provided to their patients. During this same period, competition for pathology specimens intensified as both the two blood brothers-and a growing host of regional and national pathology lab companies-sent sales reps into communities across the country to divert specimen referrals away from community hospital-based pathology groups.

However, the greatest challenge for the College of American Pathologists is not in countering the multiplying threats to the integrity and financial stability of the pathology profession as a medical specialty. The greater challenge is in crafting a strategy to favorably position pathology in the fast-approaching age of genetic medicine. Genetic testing represents the single greatest opportunity for pathology specialty in the past four decades. Here is where Roussel’s talents, experience, and insights may serve the members of the College best. Anticipating the future and positioning this organization to be the right resource for that future will require special leadership skills.

Finally, it must be noted that, among all the medical specialties, pathologists have a reputation for being extremely cautious when evaluating new business options. They are frequently reluctant to change the status quo in most areas of their private practice setting, whether it be expanding the test menu or making investments in their own medical practice. This reluctance to change means that, during the past 20 years, CAP’s membership has chewed up and spit out more than a few accomplished change agents. That includes a number of visionary pathologist-leaders who were unable to gain sufficient traction with their peers.

Thus, from the start of his tenure, it should be recognized that new Executive Vice President Charles Roussel faces what might be aptly characterized as a “Sisyphean” task. His success will come as much from his ability to persuade CAP’s member pathologists to embrace and execute daring new organizational strategies as it will come from the unique and market-appropriate strategies he may develop.

It is notable that the College of American Pathologists went outside healthcare to tap someone with Roussel’s qualifications. This step could turn out to be a positive gamebreaker for the pathology profession by helping it craft an essential role in the coming age of genetic medicine and integrated healthcare.

Related Information:
College of American Pathologists Selects Charles Roussel as Its New Executive Vice President