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December 2004
Some of you may have been wondering how I’m coping after the November election. I’m pleased to tell you that I’m over it and have learned my lesson. The American people have spoken and elected to stay the course, right or wrong, so I am going to change my ways. No more liberal idealism; I’m going to accept neoconservative unrealism.
After much soul searching and as an act of contrition, I have decided to embrace EQC. While I have been stubbornly opposed to EQC on scientific grounds, I now recognize that science has nothing to do with the proposed use of EQC.
I realize now that EQC is more like a faith-based initiative. Of course, that’s really not fair to say. People of real faith have moral values and ethics, among them doing the right thing, even when it’s not profitable to you. Proponents of EQC seem to be most interested in the cost of doing business, which is really all about profitability.
But let’s put that aside, since I now embrace EQC. All that is required at this point is “truth in labeling.” We only need to call EQC what it is – not Equivalent QC, but Equivocal QC.
- [adj] open to two or more interpretations; or of uncertain nature or significance; or (often) intended to mislead; “an equivocal statement”;
- [adj] open to question;
These two terms – equivalent and equivocal – are so close in letters that I can’t imagine anyone will notice the difference. All I ask is that laboratories properly disclose on their test reports and manufacturers properly label their instruments and methods with the words “In George We Trust.”
I was wrong when I said that:
- An evaluation period of 10 days was not sufficient to establish that a method is stable for 30 days. I now believe that 10 days is the same as 30 days. Time flies when you’re having fun, and it flies even faster when you're getting old!
- Immediate error detection means quicker than 7 days or 30 days. If something really bad happens, I believe someone will notice that something funny is going on, particularly the well-trained clerical staff who are performing many of the laboratory tests today.
- Control limits need to be properly set if the analysis of control materials is to detect instability or changes in method performance. Limits are limits! If the errors are really bad, the smoke alarm in the laboratory will probably go off and those bad results won’t get reported anyway.
- The quality required for a test must be defined to properly evaluate “equivalent quality testing” and determine what QC is needed. I now trust the collective judgment of government that the quality being achieved is good enough for the many patients who don’t have access to healthcare today.
- Sigma metrics would provide an objective assessment of method performance and better guidance for selection of appropriate QC procedures. I now recognize that Six Sigma is a secular philosophy grounded in business practices, and even though there are no ethical standards in business today, I now believe that manufacturers wouldn’t sell analytic systems unless they provide the quality necessary for patient care.
- CMS doesn’t know what they’re doing. I can now see that they are staying on message. I have learned that staying on message is more important than the message being true.
- Truth and quality are related values. I can now see that truth is unknowable and unimportant. That makes it inescapable that quality is unknowable and that quality control is unimportant.
It has not been easy to teach an old dog new tricks, but I am learning that:
- Hearing is not the same as listening. CMS has heard my complaints about EQC for almost 2 years now, but thankfully, they never listened to what I was saying. Now I will reform and tell them what they want to hear, that I believe in them and the political process as the best way to provide quality laboratory testing and quality healthcare.
- All QC procedures are created equal! It doesn’t matter what is done for QC as long as there is something called QC. Patients don’t know the difference, neither do the docs! As long as they don’t know that we don’t know, that knowledge is sufficient for today’s "evidence-based" medicine.
- All’s well that ends well! As long as an answer can be obtained quickly, the immediate needs of the physicians and patients will be met. Remember that customer satisfaction comes first and timeliness is much easier to evaluate than quality. As long as we emphasize timeliness in customer surveys, we can keep the customers happy.
- QC is really about quality compliance with government regulations, not about control of quality to provide the correct answers. Political correctness has no place in healthcare today. Ideological dogma is the new reality.
- The healthcare industry and manufacturers only have the best interests of the patients at heart. They would never do anything just to make money. Look at Merck and the Vioxx debacle. Those things happen because the Devil is in the details.
- The liberal media has overblown the problems about the quality of American healthcare. We know we have the best healthcare that money can buy – everyone agrees it’s only a question of having enough money to buy it.
Rather than require EQC for laboratory tests that fit the CMS/SOM options, let's just eliminate QC altogether for those testing applications. A little QC is actually worse than no QC. A little QC gives us the illusion that we are doing something about quality when we aren't. Let's just be honest and not require any QC in those testing sites that can't, don't, or won't do what's right to assure the quality of test results.
In fact, we don't need all this government regulatory overhead to tell us to do nothing. We can make a big enough mess of things ourselves without any government assistance. At the same time we eliminate QC, we can also eliminate the whole CLIA program.
Trust me on this!
Ok, I take it all back.
2004 was an exhausting year for me. As much as I traveled in 2003, I traveled even more this year. Last year I went to 8 foreign countries, this year it was 10 (Belgium, Canada, China, Denmark, Germany, Italy, Japan, Mexico, South Korea and Turkey). I lost count of how many cities in the US I visited.
With all the people around the country and around the world I have spoken to, there is a great and growing hunger for doing the right thing. With the CLIA Final Rule, this drive is stronger than ever. People in our profession are reluctant to suspend their disbelief when it comes to Equivocal QC and patient care. In the absence of great pressure or great greed, they prefer doing real QC over Equivocal QC.
For all my public appearances, the website continues to grow faster and larger in its audience. For the last 9 years, year after year, more people visit, more people download, more people read one of our books on quality. This year we broke the records again. Our free demos, chapters, and worksheets were downloaded more than 5,000 times. Over 6,000 people are now subscribed to our newsletter. And we reach over 10,000 visitors a week with the website. We are inundated by email and requests and questions (I apologize if we haven't gotten back to you yet) and this encourages us to persist.
I am thankful for those of you who have listened to me, or who have read some of the essays or the books. I hope that they help you do the right thing. Even in the face of adversity, the right thing is still the right thing to do.
There has been a lot of talk about despair and dismay in the “blue” states. While disappointed by election results, I remain unshaken in my beliefs and unwavering in my goals. But, as I have said before (here and here), I am lucky. I have the luxury of speaking freely on this website, and while I can, I am dedicated to fight for those less fortunate.
In times like these, what sustains me is my Norwegian heritage and the experience of growing up on a farm in North Dakota. Norwegians and North Dakotans know how to face a long, brutal winter and make it to the promise of spring. Farmers know that it takes a vast amount of toil just to reap the smallest harvest, and that you are often at the mercy of unpredictable and capricious events. But we are stubborn. We keep going.
As my ancestor Hagar the Horrible once told me, Being a Viking is a tough way to make a living: commuting in all kinds of lousy weather (picture his boat on a rough sea); fighting with ill-tempered customers (picture him scaling a castle wall against an avalanche of rocks, arrows, and spears); and if you're lucky enough to make a little money, there are always tax collectors (no picure needed here). Yet when I asked him if he ever thought of quitting the Viking business, he answered "Naw, it's a lot easier than farming." That's how I feel about the healthcare and the laboratory business. No matter how hard it gets, it's a lot easier than farming.
Please keep this in mind during this holiday season. Let's take some time and count our blessings, which includes family and friends and especially grandchildren. That will renew the spirit for the new year and the continuing challenges in the new world of tomorrow.
Other Essays:
