First, the bad. Well bad is maybe too strong a word.
If you have ever read an ISO standard, you will notice that something is missing. There is no list of authors or committee members. The people who write the standard should be listed!
ISO 9001, ISO 15189
In the 90s, companies would display banners stating there were ISO 9001 certified. From the ISO website “Using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits.” But accreditation success is judged by the documentation that the organization has, to show that it is following the processes that it has developed. A company could have poor quality but if they can prove through documentation that they follow their processes, they will be accredited. The same applies to ISO 15189, the clinical laboratory version.
Krouwer JS ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry Accred. Qual. Assur., 9: 39-43 (2004)
This standard describes the required accuracy for patients with diabetes who self-monitor their glucose with glucose meters. It came out in 2003 and was updated in 2013. The 2003 version allowed 5% of the results to have any difference from reference (hence 5% unspecified). The 2013 version reduced the unspecified amount to 1%. People with diabetes do a lot of testing. To have 5% unspecified meant that once a week you could get a result that could kill you from an ISO acceptable glucose meter 2003 version). For the 2013 version this was once a month. I was invited to attend an early meeting of the 15197 committee. It was not run by endocrinologists, but rather by regulatory affairs people from industry.
Krouwer JS Wrong thinking about glucose standards. Clin Chem, 2010;56:874-875.
I spent many years contributing to CLSI in the area of evaluations. This group is dominated by regulatory affairs people and it was always difficult to finish any evaluation standard. For example, when I became chairholder of the committee, I finally published a bunch of standards which had been sitting around for 14 years!
I thought Jim Westgard’s original idea about total error made a lot of sense, so I established and chaired a standard about total error (EP21). When it was time to revise the standard, it occurred to me that the original document was about “total analytical error.” I suggested that in the revision, we include pre- and post-analytical error. There was strong opposition to this and not just by the regulatory affairs people but also by hospital clinical chemists. After a while, the CLSI management threw me out of CLSI.
Clinical Chemistry (Journal)
There have been a lot of good things in the journal Clinical Chemistry but here is one that is not so good. The journal will not accept for review a Letter to the Editor except if the Letter is about an original article. That means that about half of the content in the journal (case studies, opinions, editorials, and so on) are off limits. I asked the editor of the journal during a local AACC meeting and his response went along the lines – we vet our articles very carefully and don’t wish to burden the journal with useless blather. My Letter to Clinical Chemistry published in 2010 about the ISO glucose standard would not be considered today.
I like all sections of the AACC Artery. I look at it every day.