Two U.S. Labs Pursuing ISO 15189 Accreditation

Nation’s first ISO:15189 accreditations will be milestone in use of quality management systems

CEO SUMMARY: In their first public interviews, the nation’s only two laboratories to seek ISO 15189:2007 accreditation share insights about the process, along with its challenges and benefits. Both laboratories are in the final stages of implementation and expect to earn accreditation by year end. Their achievement will represent the next advance in how laboratories in the United States use quality management systems and the tools of continuous improvement.

TWO LABORATORIES IN THE UNITED STATES ARE WEEKS AWAY FROM ACHIEVING accreditation under ISO 15189:2007 Medical Laboratories. These will be the first ISO 15189 accreditations in this country.

The two labs working toward their ISO 15189 accreditation are Piedmont Medical Laboratory (PML) in Winchester, Virginia, and Avera McKennan Hospital & University Health Center in Sioux Falls, South Dakota. PML processes about one million tests per year and Avera McKennan processes almost three million tests per year.

This is a notable development for the laboratory industry in the United States. Because ISO 15189 is designed to be a comprehensive quality management sys- tem (QMS), it will provide American laboratories with valuable lessons about the benefits and costs involved to become accredited under ISO 15189:2007.

Lab leaders at both Piedmont and Avera were among the first in the nation to embrace and implement Lean and Six Sigma earlier in this decade. This fact adds interest to the decision by each of these laboratories to devote considerable time and resources to attain accreditation under ISO 15189:2007 Medical Laboratories.

It shows how the original decision to introduce quality management systems, including Lean and Six Sigma, encourages a laboratory to further advance its use of continuous improvement techniques. Additionally, both laboratories believe that ISO 15189:2007 accreditation will make them tougher competitors in the lab outreach marketplace. One reason is that, outside healthcare, many companies are ISO-accredited. They and their employees understand and recognize the value of this achievement, as do many payers.

This issue of THE DARK REPORT contains interviews with leaders of both Piedmont Medical Laboratory (pages 5-8) and the Avera McKennan laboratory (pages 9-11). In each case, it is the first time either laboratory has been willing to publicly discuss why they decided to pursue accreditation under ISO 15189:2007, as well as the benefits and challenges of the ISO 15189 accreditation process.

Lab Quality Confab Speeches

Lab directors and pathologists have the opportunity to personally meet these lab leaders and hear more about their experience with ISO 15189. Each lab is presenting at the upcoming Lab Quality Confab in Atlanta on September 24-25. Piedmont Medical Lab’s Quality Management, Compliance and Education Coordinator, Benita Haines, will do the first public presentation about her lab’s experience with ISO 15189 accreditation. By the time of Lab Quality Confab, PML will have completed the assessment step and will be awaiting confirmation that it has met all accreditation requirements. Also speaking at Lab Quality Confab is Leo Serrano, Director of Laboratory Services at Avera McKennon. He will discuss his lab’s use of Lean Six Sigma methods and automation, particularly in histology.

Growing Role For ISO 15189

THE DARK REPORT recommends that lab administrators and pathologists begin paying closer attention to ISO 15189:2007 and its growing acceptance as an international standard for laboratory accreditation and reimbursement. This international trend is likely to have consequences for laboratories in this country. Two points support this prediction.

First, around the globe, ISO 15189 is being adopted by a steadily-increasing number of countries which, up to now, have never mandated any form of medical laboratory accreditation. That number may be reaching critical mass. For example, the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) conducted the “Joint WHO-CDC International Conference on Health Laboratory Quality Systems” in Lyon, France, earlier this year, on April 9-11. Upwards of 150 delegates from 69 countries participated at this meeting and there was plenty of discussion about the fitness of ISO 15189:2007 for use as a laboratory quality system ( eqauconference/en/index.html).

Second, in the Canadian province of Ontario, mandatory laboratory accredita- tion is based upon ISO 15189:2007. It is estimated that, by year’s end, almost 200 laboratories in Ontario will have earned ISO 15189 accreditation.

Laboratory Accreditation

These two examples show that ISO 15189 is gaining international acceptance as a useful approach to laboratory accreditation. This development has not attracted much attention in the United States. That is probably because labs in this country already must comply with long-established state and federal requirements for licensure and accreditation.

ISO 15189:2007 is not likely to rapidly change this licensure/accreditation status quo. But something else may occur. It was earlier in this decade when a handful of pioneering labs began to adopt Lean and Six Sigma methods and used them to realize impressive gains in operational quality, productivity, and financial performance—often generating competitive advantage in the outreach marketplace.

So it may be that a handful of pioneering labs, led by Piedmont and Avera McKennan, choose ISO 15189:2007 accreditation as the quality management system they use: 1) to drive further improvement to their laboratory’s quality and performance; and, 2) to gain competitive market advantage at the same time.


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