One of Canada’s two national newspapers carried an interesting article today about a federal study that identified problems with transfusion medicine in Canada. See National Post: “Errors, mislabelled samples pose ‘staggering’ cost to Canada’s blood banks” [http://news.nationalpost.com/2012/08/06/errors-mislabelled-samples-pose-staggering-cost-to-canadas-blood-banks/] .
The studied identified collection errors, transport delay errors, and identification errors and others that collectively resulted in loss and destruction of units of blood, inconvenience to patients, and loss of money. It was a small study, involving about 10 percent of facilities and still found over 6000 errors.
This is not really a surprise. In our own studies, about 80 percent of reported laboratory errors occur in the pre-examination phase of sample testing, with the issues identified being the most common problems.
But it is disappointing, and should be a national embarrassment.
Our Canadian blood system was torn apart in 1996-7 as a result of pretty serious errors in judgement that resulted in a Royal Commission of Inquiry lead by Mr. Justice Horace Krever. While Krever did not address issues of collection errors, the government was sufficiently motivated to seek the creation of a quality standard on blood services practices by the Canadian Standards Association which was published as “Z902:2004(?) Blood and blood components”. Z902 was identified as a national standard. It has recently been republished under its current iteration Z902:2010.
Z902 had a Quality Management section within it, albeit not as complete or as rigorous as ISO 15189, but had sufficient clarity around issues of collection and labelling and transport and corrective action and internal audit that by now these practices should be routine practices and well established.
Today’s report suggests that that is not necessarily be the case.
My own speculation is that the problem is that in too many laboratories, the notion of Quality is still stuck in the 1980’s at the level of Quality Control within the 4 walls of the laboratory. Laboratory personnel are very strong on control charts and SOPs, but still weak on internal audits, preventive action, and active continuous improvement strategies. As much as we talk about a laboratory cycle and all the steps that occur before the sample gets to the laboratory window and all the steps that occur after, we still focus the majority of our time on technical procedures inside those secure walls that separate us from the outside world.
And that is not a good thing.
A bold statement? Perhaps. But I have a lot of evidence to support my speculation.
In our proficiency testing program we have always taken the position that all errors are errors, including transcription errors. This started when we worked in pencils and paper, and has continued on as we moved to internet based reporting forms. Every send-out we have laboratories that fill in reports using the wrong identifiers and then complain when we grade them down. But if laboratories will do tests and mix them up in proficiency testing where they know that the results are being scrutinized, then how do we know that they don’t do the same with clinical samples?
I personally keep a watch of how many misdirected, mislabelled reports I receive from clinical laboratories. I have talked about this before. Over the years it is in the 10s of thousands, with no evidence that it will ever slow down or stop.
We have made big strides on our internal Quality, but our communication with the outside world is probably as bad today as it ever was.
If this was isolated to a few laboratories, we could focus on the problematic few and move on. But this is not an isolated issue. It is widespread and systemic. It is nation-wide and international.
So am I surprised? Not at all. But I am encouraged.
Here we are in Canada, 15 years “post-Krever”. A study is performed by the Public Health Agency of Canada. It is reported by the National Post newspaper. Our public Quality Partners are doing their work, shining a very bright light on a very ugly problem.
Let’s see what happens next.