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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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 http://www.labqualityconfab.com.

To register for Lab Quality Confab, visit http://www.labqualityconfab.com/register.htm.

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.

Related Information:

Four Easy Ways to Register:
1. Register ONLINE
2. Call 800-560-6363. 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 512-264-0969
4. Mail the one page form with payment to:

THE DARK REPORT
21806 Briarcliff Dr.
Spicewood, TX 78669

World’s Largest Gathering of Lab & Hospital Lean Six Sigma Black Belts Coming to United States

No, it’s not karate that will be the topic of this Black Belt gathering! Early this fall, the world’s largest gathering of Black Belts, Green Belts, and Yellow Belts working in laboratories and hospitals will assemble in Atlanta, Georgia. They will gather to share best practices and innovations in the use of Lean, Six Sigma, and Rapid Process Improvement methods in clinical laboratories, hospitals/health systems, pathology groups, and in vitro diagnostics (IVD) manufacturers.

Speakers involved in Lean Six Sigma programs in laboratories and hospitals from the United States, Canada, Australia, New Zealand, the United Kingdom, and Sweden will deliver presentations to a crowd expected to swell past 300. All of this global activity is powerful evidence that healthcare is embracing quality management methods, including Lean, Six Sigma, Rapid Process Improvement, and ISO:15180.

In fact, last year, The Dark Report assessed the extent of Lean and Six Sigma programs in laboratories and hospitals/health systems across the United States and concluded that, as a trend, use of quality management systems was now in a phase of general adoption. It was in 2003 that the first three major hospital laboratories in this country boldly experimented with Lean by radically restructuring their high-volume core laboratories. Use of Lean techniques like small batch and single piece work flow allowed DSI Laboratories (Fort Myers, Florida), West Tennessee Healthcare Laboratories (Jackson, Tennessee), and Fairview Health Laboratories (Minneapolis, Minnesota) to achieve remarkable gains. In projects lasted around 12 to 15 weeks, and each lab reported 50% reductions in average lab test turnaround times, along with labor productivity increases exceeding 40%.

In 2003, it was just these three pioneering laboratories. By 2007, several hundred hospital laboratories had active Lean and Six Sigma quality programs. Pathology groups, inspired by what they see happening in clinical laboratories and the hospitals they serve, are also initiating Lean and Six Sigma projects. It took just four years for this trend to gather credibility, acceptance and momentum. 2007 was the year that the Lean Six Sigma trend moved from the early-adopter stage into general acceptance.

Laboratory managers, pathologists, and others wanting to learn more about quality management will find the second annual Lab Quality Confab on Quality Management in Diagnostic Medicine to be a comprehensive resource. Lab Quality Confab will take place on September 24-25, 2008 at the Hilton Hotel in Atlanta, Georgia. 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 http://www.labqualityconfab.com.
To register for Lab Quality Confab, visit http://www.labqualityconfab.com/register.htm.

Lab directors and pathologists wanting to continuously improve their laboratory operations and workflow will find Lab Quality Confab to be a comprehensive, one-stop resource concerning Lean, Six Sigma, Rapid Process Improvement, and ISO:15189. At one time and in one place, the nation’s leading labs and hospitals will share their case studies and exchange innovations. Your laboratory should not pass up this exceptional opportunity to get lots of knowledge, build a network, and meet all the consultants and experts who can help your lab build a top-performing Lean Six Sigma program.

Related Information:

Four Easy Ways to Register:
1. Register ONLINE
2. Call 800-560-6363. 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 512-264-0969
4. Mail the one page form with payment to:

THE DARK REPORT
21806 Briarcliff Dr.
Spicewood, TX 78669

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