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

Hosted by Robert Michel

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

Hosted by Robert Michel
Sign In

Growing interest in Quality Management Systems (QMS) surfaces at Lab Quality Confab

DATELINE: ATLANTA, GA—From nine countries around the world, several hundred clinical laboratory and pathology quality experts gathered in Atlanta this week for the third annual Lab Quality Confab. Dominating the sessions are impressive success stories from laboratories using Lean, Six Sigma, and similar quality management approaches.

Today is the last day of this high-energy gathering. At least two valuable insights emerged from the collective comments of more than 40 speakers—all of who spoke about different ways that their clinical labs, pathology groups, and hospitals are using Lean, Six Sigma, ISO, and the like to advance the quality of care and the service performance of their organizations.

First, uniformly, laboratories and pathology groups find it relatively easy to achieve significant improvement in multiple performance attributes with their Lean projects. Whether the laboratory is doing a “Lean Light” approach—like simply scheduling rapid kaizen events at certain intervals, or in the midst of a full implementation of the Lean mindset throughout the entire organization—impressive gains result. This is true of test turnaround time, with improvements typically in the range of 50%. It is the same with staff productivity, reduction in errors, and elimination of unnecessary costs, which can all generate 30% or 40% improvement following implementation of the Lean project.

Lab Quality Confab 2009 talks ISO9001 and ISO15189

Second, a surprising development was the frequency with which speakers mentioned the importance of transitioning their clinical laboratory and pathology group toward implementation of a quality management system (QMS). The most prominent quality management systems discussed at Lab Quality Confab were ISO 15189 Medical Laboratories.  The nation’s first laboratory to earn accreditation under ISO 15189 was Piedmont Medical Laboratory (PML) of Winchester, Virginia. Joseph Skrisson, CEO of PML told the Lab Quality Confab audience that this quality management system “was an essential strategy for us to differentiate our laboratory in our regional market. ISO 15189 provides our staff with the form, structure, and on-going evaluation requirements that enables us to sustain continuous improvement that is directly linked to meeting the expectations of our patients, physicians, and payers.

“A QMS like ISO 15189 has the rigor and discipline that reinforces use of Lean and Six Sigma techniques,” explained Skrisson. “It takes substantial effort to achieve this accreditation. However, the direct return on investment is swift and significant. More importantly, it gives our laboratory staff the foundation to sustain improvements and support innovation that distinguishes our laboratory with the patients and physicians we serve every day.”

The value of a quality management system was reinforced by Patrick Horine, Executive Vice President, Accreditation, DNV Healthcare, Inc. , Cincinnati, Ohio. Last year, the Centers for Medicare and Medicaid Services approved his company as the first new accrediting body for the Medicare program in 40 years. One distinctive feature of DNV’s hospital accreditation service is that it offers hospitals a way to achieve Medicare accreditation while simultaneously earning certification as compliant with ISO 9001.

Horine told Lab Quality Confab attendees that this dual feature accreditation service filled an unmet need. “In the United States, there are a number of hospitals and health systems which understand the value of a quality management system,” he noted. “The ISO 9001 certification gives them a way to implement a QMS in a way that is consistent with Medicare’s accreditation requirements.

“Keep in mind that the reason why a quality management system unlocks different performance outcomes in an organization is because it does not establish an objective,” continued Horine. “Rather, it defines the frame around an activity. It then encourages the organization to measure and evaluate its compliance and performance and use those measures to stimulate ongoing and continuous improvement.” Horine is describing the dynamic way that adoption of a quality management system helps a hospital or clinical laboratory implement and maintain an environment of continuous improvement.

Dark Daily observes that the wide interest in ISO 15189 and ISO 9001 at this year’s Lab Quality Confab is a new phenomenon not seen at Lab Quality Confab in either 2007 or 2008. It is an early sign that quality management systems are finding favor and acceptance by forward-looking clinical labs and pathology groups, not just in the United States, but in a number of other countries around the world.

From Atlanta, your Dark Daily Editor,

Robert Michel

e-mail your opinion or comments to

Related Information:

Lab Quality Confab 2009 speakers and sessions

Quality Management Systems

First Two Laboratories in U.S. Earn ISO 15189 Accreditation

CMS Approves Norwegian Company for Hospital Accreditation in the U.S.