Quality Partners - Gap Analysis versus Gap Repair

The other day I received an email from a friend with whom I have worked in past on implementing quality practices.  He wrote in part:

A lot has changed at “the laboratory” and the staff in the lab need more than just documentation.   All through the mentorships, they seem to have been playing for time and now that I am here with them daily, they have realized that they have to try hard to change their behaviours and work more towards living quality and not just trying to write, read and sign SOPs.  It is amazing, some of the things I have found within one month of stay here. You will not believe that they have been participating in EQAs for the past five years but have never ever reviewed any of their returns for UNACCEPTABLE RESULTS.

In many countries including North America and Europe and Australia and New Zealand laboratories are required to participate in an accreditation program which provides some oversight to ensure that laboratories are doing what they are supposed to do to maintain some level of quality and competence. In other countries, national accreditation is available, but not required.  Laboratories that see a quality or business advantage participate on a voluntary basis.  In other countries there is no national accreditation, but laboratories can seek an international accreditation, from my experience mainly from United States or Australia or South Africa.  Generally the experience seems to be that laboratories with resources or connections seek accreditation, while the others do not. 

The accreditation process is not perfect.  It can generate many unintended consequences, most notably the tendency to brief moments of activity surrounding an impending visit followed by long sleep.  The other is the tendency to game (cheat) at quality control and quality assessment. 

But as the letter above so clearly demonstrates the absence of accreditation and the assumption of voluntary commitment does not work either.  The letter indicates some pretty concerning messages.  The laboratory has demonstrated to itself and to the PT provider that it can perform incompetent testing.  The laboratory has demonstrated the same fact over and over for (according to my colleague) for 5 years.  And it appears that the laboratory does nothing about it. It seems that putting out incorrect results is not a problem.  It seems that failure to support patient care is acceptable practice.  

Somewhere in the education and training and knowledge of the laboratorians at the laboratory there has been a key breakdown.  The point of the exercise is not to look for errors or opportunities to improve.  The point is to do something about it.

To be fair this is not the only laboratory that misses the point and continues with a pattern of failure.  It happens every where.  And you can see how it happens.  The whole chain from top to bottom is broken.  The reality is that in many places NOBODY cares… not the Ministry of Health, not the Hospital Superintendent and not  the Clinical staff and not the Laboratory administration. 

Personally I put the greatest blame on the laboratory directors.  It is probable or at least possible that no one in the ministry or the hospital or the clinicians have any idea about right results and wrong results or about proficiency testing as a quality indicator.  They have other things on their respective plates.  But the directors should at least be sufficiently knowledgeable about laboratory work to know when their laboratory is giving out wrong results.  

Actually in my experience the one group that does do something to address the problem is the group of clinicians.  They simply stop sending specimens.  What is the point.  They know from their own experience to not trust the results anyways.

Finding solutions can be a challenge.  The PT provider most likely is aware of who is failing and who is not.  Start off with an email or a phone call and find out what is happening or perhaps if anything is happening.  And see if some assistance can be provided within the finances and scopes of the organization and the laboratory. 

If there is no interest to work toward solutions, then the only reason that the PT provider can justify continuing to provide the service is strictly for the money. 

And that is immoral. 

At least that is my opinion.