Saturday, March 12, 2011

The Quality Partner Dance

I have been thinking about Quality Partners recently.  We are discussing them in this month’s module of the Certificate Course and I am working on a new document for the Canadian Standards Association and I am preparing for an ILAC meeting of the Proficiency Testing Consultative Group.  And we are working on a new microbiology media in CMPT.  At his moment I must be one of the most engaged Quality Partner types in the whole Quality Partner arena.
The laboratory quality system is totally dependent upon the Quality Partners, but recently I have been thinking about some of the conflict issues that can arise from being too engaged.  

One example that ILAC is concerned with is when an accreditation body owns an operates a proficiency testing program which it mandates as the sole acceptable PT program in order to qualify for accreditation.  I think this is a fairly easy issue to sort through.  It is a double financial dip with a hostage component.  A laboratory has no chance for accreditation unless it pays the organization on the one hand for inspection and on the other hand for PT services.   Many accreditation bodies have thought their way through the process and have either divested themselves of their PT program or have built a firewall between the two.  Most, but not all have opened up their programs to accept PT data from other programs.

I have to say that I am not sure that oversight organizations do anyone or any laboratory a favour when they try to retro-fit new ethical rules into long established situations because they can lead to unintended convolutions in long established programs.  But as an independent university based proficiency testing program I appreciate that I can provide an excellent program that laboratories appreciate in a variety of jurisdictions.  

But there is a conflict of interest that does concern me, and I have to regularly examine my own situation to make sure that I don’t cross the line.  When ISO 15189 was first conceived it was designed and intended to be a document written by laboratorians to help set a Quality pathway for medical laboratories.  The committee included accreditation bodies, proficiency testing bodies, government bodies, professional organizations, equipment suppliers, and private consultants who during a previous life were laboratorians, but the bulk of the committee was active laboratorians.
Gradually the committee started to change.  Today the number of active laboratorians is approaching near zero, and the committee’s largest constituencies are either government bodies or accreditation bodies.  
And that to me is a problem in evolution which will ultimately need to be addressed.  There is something fundamentally wrong with a group of vested interest groups creating a standard and then either charging for their service to help laboratories or charging to accredit to the standard they created, or writing legislation in the absense of input from the affected party.  This starts to leave the concept of Quality Partnership and starts to smack of Quality Collusion.

Having said this, I don’t have an easy solution.  Organizations like the International Organization for Standardization can set rules about language, scope, intent, but can not dictate to countries who they will include or not include as delegates that they send to technical committees.   Technical committees do not have the authority to add it its own advisors.  
This is very different from committees within the Canadian Standards Association that committees  have a balance between users and interested parties and oversight bodies and (super importantly) a representative of the public .  If a committee is unbalanced, it is required to fix the problem before going ahead with new documents.  

So the message to self is, look at documents as the product of people and what they bring to the table.  Be ever diligent for bias, and be selective.  And really important, if you are going to have to live with a new document, get engaged early. 

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