Tuesday, August 28, 2012

Report from Berlin: ISO TC 212

I have been in Berlin for our ISO Technical Committee 212 meeting.  This represents 19 consecutive years of direct involvement.

From my perspective it was a not-so-busy but in the long run a very successful meeting; but mostly it was a vocal meeting.  I talk a lot at meetings, usually with a “polite” assertiveness (some might say aggressiveness), but I come with an agenda and have a goal to have my issues addressed, preferably successfully.  Personally I see little value in traveling long distances to attend a meeting only to spend my time being quiet and passive and not addressing the issues that are important to me.  

A good friend, a successful senior bureaucrat, taught me his secret; set your agenda, and push hard for what you think is important.  Celebrate your successes and walk away from your failures knowing that you tried.  You won’t win them all, but you can’t win any if you don’t step up to the plate.

As a side note I have a lot of empathy for the folks who attend the meeting with English not being a fluent language.  For them, making their issues understood is unfairly very difficult, considering that these are international meetings.  I would like to think that there could be an easy and effective and equitable solution.  

The final international vote on the next iteration of ISO 15189 is underway.  It is an OK document, not a perfect document,  with the same mistakes and errors carried forward for another 5 years.  Changing words with changing content, in my opinion, is not what standards development should be about.

But with respect to the issues that I consider important, I pushed hard to promote the newest iteration ISO 15189 to respect the ISO CASCO neutrality principle when it comes to recognition of third-party organizations including both certification bodies and accreditation bodies.  This would have significant positive ripple effect for Canadian standards development.  We hopefully will get a senior level ISO opinion on our position soon.  Maybe this can get squeezed in as a last moment editorial change.

For a long time I have advocated that Measurement Uncertainty should be recognized as a useful laboratory tool, but only as one of a variety of techniques to measure variation rather than as the sole and mandated requirement.  Requiring laboratories to perform complex statistical analysis like MU for the sole purpose of satisfying an accreditation body requirement is probably one of the best examples of Poor Quality Practices and generally a total waste of time and effort.  

At this meeting I think we had a major step forward with respect to MU.  While I was not able to get everything I wanted written into the next version of the standard, the other options are going to be included within a new international MU implementation guide being developed within the technical committee.   It should carry a lot the weight, so that is a good thing.

Another important development is that for the first time, TC212 is going to be writing a document that extends beyond the traditional scope of the laboratory and diagnostics manufacturers.  The plan is to re-develop our document on the use of Point-of-Care instruments for organizations that are not directly affiliated with the medical laboratory.  Consider the use of breathalysers and drugs-of-abuse testing and full blood chemistry by police, pharmacies, and schools.  A guidance document that explains appropriate quality control and assessment will be very useful.   

More importantly this writing committee will have consumer representatives from ISO COPOLCO [see http://www.medicallaboratoryquality.com/2012/01/protecting-our-consumers.html ].  We talk about patient's interests; now we are involving their voice.  That is a big step forward.

It is important for laboratorians to remember that all organizations, even including the august and respected International Organization for Standardization are the sum total of volunteers efforts, usually well-intended and well-meaning but all  with their own competitive biases and influences and memory lapse foibles.  Consensus is not always easy to come by, and sometimes document development does not follow in a straight line.  We had a good example with a document being approved as a work project in last years’ meeting only to be rejected this year.  It makes some people wonder about why they put effort into developing documents; that is never a way to encourage participation.  I expect that the decision will be addressed yet again.

The problem is a combination of long intervals between meetings, vague minutes, not so diligent project tracking, and a general short term approach.  It may be just “human factor” at work or play, but somehow I think we should be able to do better, including myself. 
By bottom line: ISO is big and clumsy and vulnerable to human foible.  It is also the only organization that can create truly international guidance.  It is a real opportunity to work with them.  

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