From the guest editor

QM: 40 years of rules & regs, training & education

My career has been closely aligned with the lifetime of MLO. I count it as an achievement that we both have survived so long! Much has changed during these years, but the principles and values that should guide a lab to provide quality services have stayed the same. You may know about me because of "Westgard Rules," but I have also worked broadly in quality management. Like MLO, I try to keep abreast and, hopefully, ahead of changes, so I can help others understand what to do and how. My training and education have been in-service as a clinical lab chemist, then more formal education as a medical-school professor and teacher in clinical lab science (CLS). Trained by med techs in the lab, I continue to try to pay back the profession by contributing to CLS education and ongoing training of lab scientists. As an emeritus professor, my effort is now developing training materials and online courses through the Westgard Web.

Despite advancements in quality initiatives — QC, QA, total quality management, continuous quality improvement, Six Sigma, process re-engineering, LEAN, quality indicators, risk management, CLIA regs, CLSI standards, and ISO guidelines — quality’s heart and soul still remains management commitment and organizational culture. That is why Deming’s philosophy was so powerful in creating an interest in quality in the 1980s and 1990s when, unfortunately, that philosophy collided head-on with the CLIA regulations, which established minimum requirements rather than requiring excellence. The end result has been "compliance management," where doing the minimum to get by is considered to be good business management.

Achieving quality is everyone’s job, but management’s job is to make a commitment to quality, and to provide leadership to create a culture and related values that will involve everyone in the efforts to manage and improve quality in the lab. These words were written by me with Marian R. Hunt, BS, MT(ASCP) in 1974 for Laboratory Medicine; they remain true today! Only management can fix a problem with quality, because only managers have the power to change processes and procedures by which work gets done. Deming pointed out problems with quality are imperfections of poorly designed or implemented processes, not people. Today, we often believe we can get quality off the shelf by buying complete analytic systems. Physicians believe they can buy quality lab tests anywhere and need only consider price. But quality in healthcare and in lab services is not yet a commodity available at the lowest price. We know cost is driving most management decisions.

Management commitment to quality is required for achieving excellent services. As Ms. Hunt and I wrote years ago, "Given this, the analysts in the lab can share the responsibility for achieving quality … If management encourages quality work, well qualified and conscientious people generally will provide quality, in spite of obstacles that may confront them … Achievement requires that the lab change and respond to problems that cause poor quality … An in-service training program provides an excellent mechanism for upgrading performance and can become the means by which quality is achieved."

We have many tools for managing and improving quality, but we still need people to apply those tools to solve problems in the lab. People are the critical component if we are to improve the quality of services, but we face serious shortages now and in the near future. Our people are our key to quality, and we must provide the education, training, and leadership that allows them to make quality happen.