Putting Six Sigma methodology to use can help laboratories in establishing better quality management systems. Specifically, Six Sigma can help clinical lab managers better evaluate the analytical quality of lab results as well as the equipment and products used to produce them.

Employing the Six Sigma metric – 3.4 defects per million opportunities – can help labs better determine if “bias, imprecision, or both” have contributed to lower Sigma metrics for equipment currently used in a lab.

That’s the argument made by Laura Smy, an assistant professor of pathology at the Medical College of Wisconsin in Milwaukee and co-director of clinical chemistry/toxicology and point-of-care section director at Wisconsin Diagnostic Laboratories. She wrote about the use of Six Sigma in managing the quality of laboratories in a recent article on the website of the American Association for Clinical Chemistry (AACC).

AACC is a global organization of scientific and medical professionals dedicated to clinical laboratory science and methods of applying it to healthcare.

Underutilized Methodology

In her article, Sym writes that “one incredibly useful, but in my view underutilized, aspect of Six Sigma involves calculating the Sigma metric.” She referred to the Six Sigma metric that tests variance and errors in a process. The goal in Six Sigma is to reduce the number of errors to 3.4 per every one million actions taken.

Sym notes that quality control has long been a part of lab management and shows dedication to producing high quality results. Her argument is that Six Sigma can help develop more precise quality control standards.

Sym writes that the Six Sigma metric can apply to assessing the value of an assay or analyzer in use by the lab. An assay or analyzer is used to measure the presence, amount or functional activity of whatever the test is targeting, such as finding the presence of cholesterol in the bloodstream.

The most difficult part of using the Six Sigma metric is to determine what data to use. Sym offers a detailed look at the different options. Because bias is different at different concentrations, she also suggests laboratorians might select average bias to represent an average Sigma.

She further argues that having this information allows for evaluation of associated processes, reducing bias and imprecision in lab results.

Six Sigma Has Made Its Way Into Lab Work Before

Sym is far from alone in finding a way to use Six Sigma or Lean to make lab work more efficient. Most involve improving processes involved with how labs manage specimens and backlogs.

For example, a clinical laboratory in Utah already has achieved the Six Sigma metric in its lab, pertaining to lost or damaged specimens. It took decades for the Associated Regional and University Pathologists (ARUP) Laboratories of Salt Lake City to achieve this goal. It’s an amazing accomplishment considering the lab handles 55,000 tests per day.

The Illinois state police is employing tactics of Lean and Six Sigma to work through its backlog of 21,000 forensic tests, one of the worst backlogs in the nation. They are using the methodology’s concepts to eliminate unneeded steps and make people more accountable.

And in Oklahoma, the Tulsa Police Department forensics lab put Lean principles into place to cut its number of backlogged cases in half.