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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Two Labs in Friendly Race to Win First ISO 15189 Accreditation in U.S.

It’s a sprint to the finish line in the friendly race to be first laboratory in the United States to earn accreditation under ISO 15189:2007 Medical Laboratories. The two contestants are Piedmont Medical Laboratory (PML) of Winchester, Virginia, and Avera Health Laboratories of Sioux Falls, South Dakota.

Within the next six to eight weeks, both laboratories expect to complete all steps in the accreditation process. Each will eagerly await word that, based on the final assessment by outside auditors, all requirements have been meet and ISO 15189:2007 accreditation is granted.

This achievement will be a milestone event for the clinical laboratory industry. It marks the arrival of quality management systems (QMS) in laboratory management. This changes the status quo because quality management systems, like ISO:15189:2007 Medical Laboratories, are a comprehensive approach to managing all activities in the laboratory organization.

Until recently, both laboratories have chosen to keep their pursuit of ISO 15189:2007 accreditation out of the public eye. That is why this important story has gone unnoticed by the greater laboratory public and unreported in The Dark Report. But that is no longer the situation.

At the upcoming Lab Quality Confab on September 24-25 in Atlanta, both Piedmont Medical Laboratory and Avera Health Laboratories will be present and will make presentations on their quality journey. This is the first opportunity for lab directors and pathologists to directly the reasons behind this strategic decision and the lessons learned during the ISO 15189:2007 accreditation process.

To further help lab manager and pathologists understand the ramifications of this milestone, this week’s issue of The Dark Report published interviews with the laboratory leaders of Piedmont Medical Laboratory and Avera Health Laboratories. Among major motivations to spend the money and resources to achieve ISO 15189 accreditation was the competitive advantage each lab would realize, both with providers in the community as well as managed care plans.

In their Dark Report interview, both PML’s CEO, Joseph Skrisson, and Benita Haines, PML’s Quality Management, Compliance and Education Coordinator, stressed that ISO 15189 accreditation was triggering ongoing benefits to the laboratory, both internally in operations, quality and productivity, and externally, with regional payers and the community at large.

Leo Serrano, Director of Laboratory Services for Avera Health Laboratories, similarly stressed how ISO 15189 accreditation would help boost the competitive position of his laboratory in its service region. In fact, because of Avera’s commitment to quality, Avera’s senior administrators were immediately supportive when the ISO 15189 strategy was first proposed.

The arrival of quality management systems, including ISO 15189, will be discussed in several important sessions at Lab Quality Confab in Atlanta at the Hilton Hotel on September 24-25. Laboratory managers, pathologists, and others wanting to understand the ramifications of this new development in laboratory medicine should make plans to attend the second annual L ab Quality Confab on Quality Management in Diagnostic Medicine.

More than 50 sessions and topics will be presented, covering the full range of laboratory and pathology operations, ranging from specimen collection and courier logistics to using Lean with automation in the high-volume core laboratory. Poster sessions will take place, and national awards and prizes totaling $6,000 will be awarded. To see topics, speakers, and all the events at Lab Quality Confab, visit

To register for Lab Quality Confab, visit

Finally, Dark Daily observes that it has taken only five years, since 2003, for the laboratory industry go from the first examples of Lean and Six Sigma in hospital laboratory operations to the first examples of ISO 15189:2007 accreditation by a hospital laboratory and an independent laboratory. These developments demonstrate how the art and science of clinical laboratory management continues to be influenced by the principles of quality management.

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