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Quality improvement (QI) systems are imperative to a well-run lab. They ensure that a laboratory is staying up to date with practices and that it provides high-quality care for patients. But developing a system of quality improvement is no small undertaking. No matter what system you use—Total Quality Management, Six Sigma, LEAN, or any of their competitors—building and maintaining a system of continuous improvement typically requires a cultural transformation.

To get at the heart of what that cultural transformation might look like in your institution, start with basic concepts so everyone is on the same page, says Dana Warfield, MPA, CPHQ, CPPS, DLM(ASCP), Director, Quality and Regulatory, Department of Pathology at NYU Langone Health in New York City.

According to Ms. Warfield, it’s vital to fully grasp the difference between QI, or continuous improvement (CI), and quality assurance (QA). “In QA, you’re making sure that your processes are performing as intended, so that your results will be timely and accurate and also meet benchmarks,” she says. “But the heart of QI or CI is that you’re trying to attain a new level of excellence. If the goal is to impact culture, it’s important to get as much buy-in as you can so the lab has cohesion when you gain momentum to achieve the project mission.”

For Sachin Gupta, PhD, MBA, ASCPi (MLS, MB), LSSBB, CPHQ, Scientific Director of the Center for Quality and Patient Safety at the American Society for Clinical Pathology (ASCP), an important difference is that QA is reactive and focuses on meeting regulatory requirements, while QI is forward looking continuous improvement that targets processes and systems and seeks to exceed overall quality.

Improvement requires a champion

Given the complexity of creating institution-wide improvement, senior leadership support for CI is a must, Dr. Gupta says. “If your institutional leadership and your senior staff are not committed to continuous quality improvement, you might as well just give up,” he says. “Everybody is so busy, especially since the pandemic, that no one will make time to follow through with CI without strong leadership.”

The conventional wisdom is that, in addition to the prerequisite senior leadership support, you also need a passionate, motivated champion to lead the effort to build a CI culture. But that champion might not always be who you think it is, explains Ms. Warfield. “People often think successful champions have to be a higher up, but I also consider champions who are at the bench,” she says. “I’ve found that peers are very effective influencers.”

One trait that champions and would-be champions generally share is that they’re open to new ideas, Ms. Warfield says. “By definition, change management is a huge part of CI, so it helps to involve people who are early adopters and on the forward edge of being open to change.”

Focus on the process, not the person

When problems occur in a CI environment, the ideal approach is to determine where the process is flawed, versus heaping blame on the individual team member who made the error.

Dr. Gupta suggests considering the common scenario of a mislabeled specimen arriving in the laboratory. “People might start playing the blame game as to who caused the error, but that is not productive,” he explains. “Of course, we want to educate the team member involved, but what we really need is a root-cause analysis to understand the relevant process and why that team member did not follow the process. We also need to fix that process when warranted.”

Shifting the focus from human error to the underlying process can help ensure that problems come to light more quickly, allowing for correction before serious harm occurs. “In your ‘old’ culture, people won’t report their own errors because they fear the consequences,” Dr. Gupta says. “But once you create confidence that the focus truly is on improvement and not blame, team members will start reporting their errors by themselves.”

What should you do when team members express their opposition to CI efforts? Ms. Warfield suggests letting the relevant improvement speak for itself. She speaks from experience, recalling that she was introduced early in her career to a process change that she thought was a poor idea and turned out to be a meaningful patient safety measure.

“I was adamantly against this idea and also told others that it would never work,” says Ms. Warfield, noting that her perspective soon changed: “Within just a couple of months, I loved the new process because I understood how it benefited patients.”

This experience helps Ms. Warfield empathize when colleagues resist change, even positive change. “It’s challenging to coax someone out of the state of mind I was in when I had contempt prior to investigation and decided that project wouldn’t work,” she says. “On occasion, someone will dig their heels in and it’s not always fun. It isn’t advisable to let a few oppositional voices be a barrier to overall improvements and project success. You do, however, need to hear the reasons behind the pushback. They may be important and valid points for you to consider before moving forward. Also, don’t forget to emphasize and celebrate successes!”

Addressing burnout

Dr. Gupta believes it’s important for leaders to be sensitive to team members’ state of mind when considering quality initiatives. “Every department is fighting employee burnout these days, from the lab to nursing to physicians, so we need to figure out some kind of reward system to help people adapt to quality initiatives,” he says. “Use your knowledge of your colleagues and your institution to figure out what appealing rewards might be, whether they’re tangible or intangible, expressions of appreciation, or recognition on a larger platform.”

But Dr. Gupta also believes that quality leaders should help their colleagues see CI as a tool to combat burnout. “We’re all facing workforce shortages these days, and inefficient laboratory processes make the problem worse by overwhelming our staff,” he says. “When QI improves processes in the laboratory, that takes pressure off our staff members by letting them work more efficiently, which in turn fights burnout.”

Building on success

By their nature, CI programs will never be a “set it and forget it” endeavor. “The nature of any quality management program is that it’s set up with metrics that make sense for your institution, and you review those metrics at a routine frequency, and then you get information on what needs to happen based on those metrics,” Ms. Warfield says.

Many institutions rely on the familiar Plan-Do-Check-Act (PDCA) or Plan-Do-Study-Act (PDSA) paradigms to help keep their quality programs running smoothly. “I’ll make sure that whatever we do, the real-time optimization of a process remains day after day, week after week, month after month, and even year after year,” Ms. Warfield says. “These routine, formalized check-ins help avoid the problem of suddenly realizing the process changes you made two years ago reverted at some unknown point in the past or are no longer effective.”

Since Ms. Warfield is responsible for quality for all the laboratories in the NYU Langone Health Department of Pathology, their CI process is built on metrics developed for each specific laboratory. “If I’m looking at laboratory turnaround time, a hospital might support an Emergency Department that needs to get results STAT, versus an outpatient location, where the metrics can be more forgiving,” she says. “And we also need to consider the patient population each lab serves: children versus adults, as well as the demographics of the community so that we can be sure we always use the correct reference ranges.”

One thing that all laboratories have in common is their need to always keep the patient’s needs in mind, even during the times of upheaval or crisis in the laboratory. For Dr. Gupta, helping team members focus on patient wellbeing can become a unifying force in the laboratory. “It can be easy to forget why we’re all here, especially for team members who are not patient-facing,” he says. “But we can all agree that streamlined, effective processes and CI efforts ultimately help us provide better, safer care to patients.”