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
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It may be a small number of 15189-accredited medical laboratories, but these are prominent lab organizations and their ranks are growing

One by one, a small number of innovative clinical laboratory organizations are taking steps to earn accreditation to either ISO 15189 or CAP 15189. This is a quiet trend and one that has yet to attract widespread notice across the world of medical laboratory and pathology testing.

It is a trend that touches clinical lab organizations of all sizes. For example, many lab executives may be surprised to learn that multibillion-dollar Laboratory Corporation of America (NYSE: LH) has five different clinical laboratory locations that have earned accreditation to CAP 15189.

ISO 15189 Is a Significant Trend for Clinical Lab Industry

What makes this nascent trend significant for the entire clinical laboratory industry is that ISO 15189 is the gateway to the effective use of the quality management system (QMS) that is an integral part of all ISO standards. These standards range from the basic ISO 9001 to ISO 15189–Medical Laboratories and ISO 17025–Competence of Testing and Calibration Laboratories.

Dr Zarbo LQC 2011

Richard Zarbo, MD, Senior Vice President & Chair, Pathology & Laboratory Medicine Henry Ford Health System was one of the key note speakers at Lab Quality Confab 2011.

QMS is the “secret in the ISO accreditation sauce.” That is because the quality management system, once properly implemented by a clinical laboratory or pathology group, provides the foundation for ongoing improvement across every functional area of the organization. All employees in a medical lab accredited to ISO 15189 typically get training in the QMS.

Therefore, the QMS becomes the shared framework for identifying the source of systemic errors and recognizing how to better meet the expectations and needs of the lab’s customers.

More significantly, in labs that are accredited to ISO or CAP 15189, the QMS engages all organizational activities. That brings management, sales, marketing, finance, courier/logistics, and information technology activities into the mix, along with the actual testing of patient specimens. It means that every department within the organization is using the QMS to solve problems, reduce or eliminate the source of systemic errors, as well as recognize and pursue opportunities to deliver more value to customers.

Traditional Medical Laboratory Management

By contrast—and this contrast is significant—a clinical laboratory organized and managed in the traditional way tends to focus much of its attention and improvement efforts on the analytical phase. Traditional methods of managing a medical laboratory generally fail to engage the entire staff—from front line to executive suite—in the relentless pursuit of continuous improvement and Six Sigma quality.

Readers of Dark Daily may be interested to learn that the largest gathering of clinical labs accredited to ISO 15189 or CAP 15189 will take place on November 6-7, 2012, at the Sixth Annual Lab Quality Confab, to be held at the Hyatt Regency Hotel in San Antonio, Texas. Speaking about their lab’s experience with 15189 will be:

  • How ISO 15189 Accreditation Can Benefit Your Lab: An Assessor’s Candid View;Valerie Ng, M.D., Ph.D., Chair, Laboratory Medicine & Pathology, Alameda County Medical Center, Oakland, California
  • LabCorp’s Lessons Learned in Accrediting Five Labs to the QMS of 15189;Kathy McCloy, Quality Assurance Director, Laboratory Corporation of America, Franklin, Tennessee.
  • Understanding the Obvious and Subtle Benefits of ISO 15189 Accreditation;Marvin Lessig, M.D., Nationwide Laboratory Services, Fort Lauderdale, Florida.

This is a unique opportunity for any clinical lab manager who is interested in learning more about ISO 15189. Not only will these speakers be accessible for personal conversations, but representatives involved in 15189 accreditation programs from both the College of American Pathologists (CAP) and the American Association of Laboratory Accreditation (A2LA) will be exhibiting at Lab Quality Confab. This makes it easy to get all the information you need at one time and one place.

Learn Innovative Ways to Use Lean and Six Sigma in Your Lab

In addition to this detailed and extensive look into QMS and ISO 15189, Lab Quality Confab will feature more than 40 presentations and 50 speakers. It is a comprehensive range of information, knowledge, and case studies about how clinical labs are using Lean, Six Sigma, and rapid process improvement methods to great advantage.

A special learning opportunity is being offered for the first time. Six Sigma Yellow Belt Certification will be conducted by Maureen Harte MT (ASCP), Six Sigma Master Black Belt. The 12-hour training and certification class will provide the required education about Six Sigma tools and methods, illustrated by examples from clinical laboratories and pathology groups. This is Yellow Belt training by a clinical lab professional, designed for clinical lab professionals.

Poster sessions of Lean and Six Sigma projects will take place, and national awards and prizes totaling $3,000 will be awarded. To see topics, speakers, and all the events at Lab Quality Confab, visit To register for Lab Quality Confab, visit

Your laboratory organization should be among the 270 participants expected from as many as 10 different countries at this year’s Lab Quality Confab. Interested lab managers and pathologists are encouraged to register today to guarantee their place at the Sixth Annual Lab Quality Confab.

Related Information:

Four Easy Ways to Register:

1. Register ONLINE

2. Call 707-829-9484. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.

3. Fax this complete registration form to 707-829-9483

4. Mail the one page form with payment to:

21806 Briarcliff Dr
Spicewood, TX 78669


Related Information:

Clinical Laboratory Innovators in Lean Six Sigma to Gather in San Antonio November 6-7, 2012

ISO 15189 Proves to Be a “Hot Topic” for Clinical Pathology Laboratories at 2011 Lab Quality Confab

Genzyme Laboratory Recognized for Quality

Ontario’s Mandatory Accreditation to ISO:15189:2003, Quality Management Program—Laboratory Services, Ontario Laboratory Accreditation

ISO 15189:2007 Medical laboratories—Particular requirements for quality and competence