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

June 1, 2009

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.