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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