I have started the process of transferring older posts, which were in my now defunct website, to this blog. It will take a little while and additionally it will take some time for the search engines to catch up.
As of the end of 2016, I stopped consulting. I still follow lab medicine topics that interest me, and will still publish both papers in journals and entries on my blog.
I ended my website KrouwerConsulting.com – it doesn’t work anymore – and I realize that some of my earlier blog entries can’t be accessed because they were on KrouwerConsulting.com (written before I started my current blog). I will fix this and transfer all of these entries to my current blog, as soon as I figure it out!
I want to thank all of my clients. Their problems kept me thinking and I enjoyed both the technical tasks and meeting people to discuss a variety of issues.
Most people have seen the video of a passenger being forcibly pulled off a United flight. After some missteps, one would think that the CEO would say the right thing. But he said the following (as seen on CBS news on 4/27).
“Our policies were placed ahead of our shared values and procedures got in the way of what we know is right.”
To people like me, who have worked in industry, “shared values” sounds like a mission or vision statement. The problem is that a mission statement is supposed to dictate policies and procedures and of course, it is management that defines policies and procedures. Hence, the quote sounds hollow.
What a company does can be considered its mission. If it conflicts with its mission statement, then the mission statement is out of whack.
In the recent hubbub about the use of PSA to screen for prostate cancer, the word overdiagnosis has appeared several times. In an online dictionary, it is defined as “the diagnosis of a disease more often than it is actually present.”
But the diagnosis of prostate cancer is pretty straightforward, with a biopsy determining whether cancerous cells are present. The diagnosis can be either correct or incorrect. But, there can be overtreatment, when low-risk prostate cancer is treated aggressively. So somehow, overtreatment has spilled over into diagnosis to produce the word overdiagnosis. That is, if a person has a biopsy confirmed prostate cancer, which is low risk and receives aggressive treatment – he has been over treated, not over diagnosed.
For almost all of my career, I’ve been working to determine performance specifications for assays, including the protocol and data analysis methods to see if performance has been met. This work has been performed mainly for companies but occasionally also for standards groups. There are some big differences.
Within a company, the specifications are very important:
If the product is released too soon, before the required performance has been met, the product may be recalled, patients may suffer harm, and overall the company may suffer financially.
If the product is released too late, the company will definitely suffer financially as “time to market” has been shown in financial models to be a key success factor in achieving profit goals.
Company specifications are built around two main factors – what performance is competitive and how can the company be sure that no patients will be harmed. In my experience this has simply led to two goals – 95% of the differences between the company assay and reference should be within limits which guarantee a competitive assay and no differences should be large enough to cause patient harm (a clinical standard).
Standards groups seem to have a different outlook. Without being overly cynical, the standards adopted are often to guarantee that no company’s assay will fail the specification. Thus, 95% of differences between the assay and reference should be within these limits. There is almost never a mention about larger errors which may cause patient harm.
Thus, it is somewhat ironic that company specifications are usually more difficult to achieve then specifications published by the standards organizations.
Looking at my blog stats, I see that a lot of people are reading the total analytical error vs. total error post. So, below are the slides from a talk that I gave at a conference in Antwerp in 2016 called The “total” in total error. The slides have been updated. Because it is a talk, the slides are not as effective as the talk.