Sunday, August 5, 2012

Obama - Entrepreneurs and Quality

I have been reflecting on a political story that developed last week in the United States.  It has become fodder for all sides of the election debate.  In a recent speech President Obama made comments that some have interpreted as saying that entrepreneurs do not build their own businesses because someone else created the roads, and infrastructure that made the business possible.  Now I am not entering into the discussion or the debate.  I am sure that all the parties can get along without my help or interference.

But the essence of the comment rang with a certain resonance because in our view we take the position that laboratory directors and administrators can take comfort from the array of Quality Partners that provide active Quality supports and infrastructure that make implementing laboratory Quality Management systems possible.  Quality Partners make laboratories better.

In our course ( we recognize the following as laboratory Quality Partners:

  • Standards Development Organizations that develop the standards and guidelines that form the foundation of Quality process.
  • Inspection Bodies (Accreditation and Certification Bodies) that ensure that laboratories competently interpret and implement standards and guidelines.
  • Proficiency Testing Providers that provide Quality based challenges to ensure testing and interpretation competence and provide and early warning system for systemic error.
  • Professional Organizations that motivate towards continuing education and continual improvement.
  • Educators that provide the knowledge foundations and continuing education  infrastructure for all laboratory personnel
  • Equipment and Reagent manufacturers and suppliers who provide traceable materials and equipment capable of reproducible accuracy, and 
  • An active Public, as represented by the media, the legislators and the litigators that shine a bright light on actions that need attention and repair.  

Now I know and understand that the system does not always work as well and it could or should.  There are standards and guidelines created that contain anachronisms and errors, and there are accreditation bodies that make up their own rules and interpretations, and there are proficiency testing bodies who put their own costs and interests over the provision of challenges that look and act like true samples, and there are media folks more interested in the drama and tension of a spectacular story than they are on accuracy and relevancy, but by-and-large and for the most part the system works pretty well when we let it.  

Recently I was chatting with a colleague about the role of accreditation and certification and proficiency in laboratory quality and in particular if there are some approaches better than others.  As we reflected on the experiences in North America we came to consensus that all  systems have stories of problematic laboratories that met the letter of accreditation and proficiency testing but not the spirit, until they were caught out in a disaster situation, but clearly the worst outcomes come to light in the laboratories  that don’t have and never had any form of regular external Quality  assessment of any kind.

In too many laboratories we still have directors and that don’t have the slightest interest in implementing Quality systems and participating in laboratory error reduction plans.  For this group the bottom line is to keep the results flowing and do it on the cheap with minimal staff and with as little supervision as possible.  Accreditation and proficiency are nuisance activities that are best dealt with by gaming and obfuscation.
But over the last years that group has continued to shrink, and we see more and more laboratory directors that understand that patient safety and staff engagement and bottom line costs are all made better through design and management of a laboratory Quality system in all its parts. 
This has not come spontaneously, out of the ether, so to speak.  It has come from increasing literature and attention and education and awareness, all thanks in large part to the increasing visibility and activist nature of all the Quality Partner groups. 

So do entrepreneurs build their own businesses? I don’t know.  

But I know and understand deeply that better laboratories are the result of a team effort.

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