Tools, Technologies and Training for Healthcare Laboratories

CLIA

Quality versus the “No Lab Left Behind” Program

September 2004

On September 30th, Dr. Westgard received the 2004 Leadership Award for Lifetime Achievement from the Washington G2 Lab Institute. You can read his thanks and remarks upon receiving this honor here.

[Remarks at the acceptance of the 2004 Laboratory Public Service National Leadership Award for Lifetime Achievement, presented at Washington G2 Lab Institute 2004, September 30, 2004, Arlington, Virginia]

From the G2 Reports.com website:

"Inaugurated in 1983, the annual Lab Institute is the foremost independent national forum for in-depth, balanced presentations and informed viewpoints on major policy issues affecting the delivery of quality diagnostic testing and related healthcare services. Equally important, it is a unique platform for networking among lab, pathology, and hospital interests nationwide.

"This award recognizes important accomplishments relative to diverse laboratory industry/professional endeavors in one or more of the following areas: professional advancement, basic or applied research, business creativity and innovations, education/training programs, public policy, lifetime achievement, or performance of a special service, task, or project benefiting the laboratory community."

Dr. Westgard's remarks:

It is a great honor to receive an award that recognizes one’s lifetime work. But no one’s work is really all their own. I have many people to thank, especially two who are here today – my boss at work and good friend, Teri Darcy, and my boss at home and best friend, Joan Westgard.

Few people have the luxury of focusing their entire career on a single issue, like quality in laboratory testing. I indeed am one of those fortunate few. This was made possible by the University of Wisconsin, one of the great land grant Universities in this country, a government institution that has made the American dream a reality for people like me.

Garrison Keiller tells the story best in his recent book “HomeGrown Democrat.” He speaks of the University of Minnesota, another land grant University, with great reverence because of the opportunities it provided. His story of growing up in a Midwestern Scandinavian community is the story of many of Midwesterners, myself included.

I consider myself to be a “Minnesotan.” While I grew up in North Dakota and have spent most of my adult life in Wisconsin, when people ask me where I’m from, I always say, “on average, Minnesota.” That answer may cause you to distrust my statistical skills, but it does represent the truth. I am truly one of the citizens of that little Minnesota town called Lake Wobegon where the “women are strong, the men are good looking, and all the children are above average.”

People sometime wonder how all the children can be above average, and I tell them it’s a government program called public education. Unfortunately, public education today is under attack. While there is a new program called “No child left behind,” that program has been misdirected by an emphasis on inspection, i.e., testing and grading rather that process improvement. It is a principle of quality management that you can’t inspect quality into a process. Measurement by itself does not provide improvement. However, if you test selectively, if states lower the standards for competency, then everyone can appear be above average. That’s what’s happening throughout the country right now.

I find it equally disturbing to see the government now introducing a “No lab left behind” program, whose purpose is to improve the grades for healthcare laboratories. Given that 5 to 10% of laboratories still show serious deficiencies in QC and QA, we now have a new program called “Equivalent QC” that will reduce these deficiencies by reducing QC. If labs won’t run 2 controls per day, then maybe they’ll run 2 per week or 2 per month. By lowering the standards and doing less QC, more labs will be in compliance and, by this illogic, will somehow provide better quality testing. Someone somewhere must believe in magic because there certainly isn’t any scientific basis or rational for this approach!

The problem is that compliance is NOT the same as quality. Compliance is about avoiding penalties and staying out of jail; quality is about satisfying the needs of patients for medically reliable test results. Quality is about patient care and patient safety!

And quality is still an issue, as revealed by the Maryland General Hospital incident this past year. However, the government, as well as many of our professional and accreditation organizations, consider MGH to fall into the category of a “few bad apples.” The bad apple theory has been widely asserted as the explanation for other serious problems, such as the Abu Ghraib prison scandal. The commonality should be very disturbing to everyone, and particularly to people with experience in quality management. It is fundamental to quality management to recognize that problems are due to management deficiencies, not the behavior of individual workers. When management assigns the lowest skilled workers and provides only minimal on-the-job training, and then things to wrong, management is responsible for what went wrong. The reason is that only management itself could have prevented the problems from occurring by proper planning and implementation of processes and procedures.

The difficulty in dealing with quality is that it is a complex value, much like truth. It’s not enough to tell a little bit of the truth. Laboratory tests must tell the truth, the whole truth, and nothing but the truth. The “nothing but the truth” part requires assuring the absence of complicating factors that might otherwise destroy the validity of the test results, such as the method being out-of-control. Less QC will not improve the quality of laboratory tests! Equivalent QC will only result in better grades for compliance.

There is a need for new leadership in this country if truth and quality are to once again become public values. It must start at the top of our government and spread through all our business and professional organizations to all the individual healthcare workers. When truth and quality are truly valued, healthcare will become focused on excellence, not just compliance.

Organizations, such as Washington G2, are in a good position to influence that future. All of you here today represent leaders in the healthcare industry. You must put truth and quality high on your agendas and make sure your organizations adhere to these values.

Thank you again for this high honor!

 


 

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.