CEO SUMMARY: Here’s a new lab product launch with a surprise twist. Upon earning FDA clearance for its new HIV Ag/Ab Combo Assay this spring, Abbott Diagnostics selected a hospital laboratory in Sioux Falls, South Dakota, to be the nation’s first clinical lab to offer the assay. The honor was recognition of the Avera McKennan lab’s accomplishments in achieving an industry-leading rate of lab test quality. Television news coverage of the test launch generated a five-fold increase in HIV tests.
WHY WOULD A HOSPITAL LAB in South Dakota be selected by a major IVD company to be first in the United States to offer its state-of-the-art fourth generation HIV assay? The answer is quality, in the form of Lean, Six Sigma, and ISO 15189 accreditation.
Beating out some of the nation’s most prominent hospital and health system laboratories for this distinctive honor was the Avera McKennan Hospital & University Health Center Laboratory of Sioux Falls, South Dakota. Abbott Diagnostics selected it to be the first clinical lab in the United States to offer patients the ARCHITECT HIV Ag/Ab Combo Assay. This assay was cleared for market by the FDA earlier this year.
What put Avera McKennan at the top of Abbott’s list were two things. First was the Avera McKennan lab’s dedication to quality and to continuous process improvement. The second was the fact that the wider public, both in the lab industry and among consumers, recognizes the higher level of quality represented by use of Lean methods and the Avera lab’s accreditation to ISO 15189.
“Avera McKennan had established a quality standard that few labs have achieved,” stated David Wells, Health Systems Manager at Abbott Diagnostics. “The Avera McKennan laboratory is highly regarded in the lab industry and we pushed hard for their selection.”
Although Avera McKennan’s selection as the nation’s first laboratory to offer this latest-generation combo HIV assay came as a surprise to the lab’s management team, the reasons for Abbott’s decision were actually confirmation of this laboratory’s strategy to be a national leader in use of quality management methods and the ISO QMS (quality management system).
Committed to Quality
“I asked them why they picked us,” recalled Leo Serrano, Laboratory Director at Avera McKennan. “And they said, ‘Let’s face it, you’re committed to quality. You were the first hospital lab in the country to get CAP ISO 15189 accreditation, and you’ve maintained it.’
“Abbott recognized that our laboratory organization has a laser-sharp focus on continuous quality improvement,” continued Serrano. “It is why they picked us. To be the first laboratory to offer this new HIV combo assay to patients is quite an honor.”
“Our laboratory staff and the administration of our hospital consider this honor to be a major distinction,” added Serrano. “It is a sign that in vitro diagnostics (IVD) companies recognize the quality and the commitment we give to our patients here at Avera McKennan, and that’s very rewarding.”
There have been several direct benefits to the laboratory as a result of Abbott’s decision. “Being selected raised the awareness of our quality and our prestige with the medical staff and the patients in the community,” he noted. “This happened in some unpredictable ways.
“For example, the news that our laboratory was selected to be first in the nation to launch this new HIV combo assay was picked up and covered by local TV news teams and newspapers in the area,” he recalled. “This news coverage emphasized that our laboratory at Avera McKennan was a national leader in quality and continuous improvement. Every laboratory wants this type of public recognition of its ability to deliver quality lab testing services.
Test Volume Skyrocketed
“In the first five days after that news coverage, our HIV testing volume skyrocketed!” he continued. “It increased fivefold. People want to have the best lab testing that’s available. Once the public knew our laboratory had this test, it became a very big deal. That generated an enormous increase in the number of tests we’ve run.”
THE DARK REPORT observes that it is a relevant sign of the times when a hospital laboratory in South Dakota is selected by a major IVD company to be the first site in the country to introduce an important new assay into clinical practice. It shows how a laboratory’s adoption of quality management methods contributes to improved analytical quality.
Equally interesting, however, is the fact that television news coverage generated a five-fold increase in HIV testing at Avera McKennan. It demonstrates that “people are listening” and ready to visit a laboratory provider they perceive offers them a superior quality of lab testing services.
Improving Analytical Step with Quality Management
USE OF QUALITY MANAGEMENT METHODS at the laboratory of Avera McKennan Hospital has contributed to significant improvements in the quality of laboratory testing performed there.
“We’ve been proponents of Lean and Six Sigma for a long time,” stated Leo Serrano, Laboratory Director at Avera McKennan. “This lab was an early adopter of Lean Six Sigma back in 2004 and we are very proud of what we’ve accomplished. Because we measure everything, we have data that documents our progress.
“For example, we’ve used these quality management methods to make steady progress in reducing lab errors,” he continued. “Our definition of a laboratory testing error is any time that a verified laboratory result has to be changed significantly, for whatever reason, whether it’s operator or instrument.
“If, upon re-testing or upon request for re-evaluation, the lab result is significantly different, then we consider that a testing error,” noted Serrano. “Currently, we’ve cut laboratory errors as defined above to 5.4 to 5.5 Sigma.
“This represents an average rate of 50 to 80 defects [lab errors] per million opportunities, which we consider to be a significant result of our quality efforts,” he explained. “In the United States, particularly in labs which have yet to adopt Lean and Six Sigma methods, the lab test error rate falls somewhere between 3 and 4 Sigma. That indicates a rate of between 66,807 and 6,210 defects [lab errors] per million opportunities.”