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Sunday, March 3, 2013

Making your Quality Partner Your Enemy


Making your Quality Partner Your Enemy

Frequently over the years of Making Medical Lab Quality Relevant  I have recounted the story of going to a meeting where a laboratory director described how seriously he took his responsibility to ensure Quality in his laboratory.  “It is an awesome task that I take with sole responsibility”.  I responded by reminding him that while he has a lot of authority in his laboratory there are others working around him that are partners in the sense that their sole task is to  make Quality accessible and relevant and achievable.  These Quality Partners include the Standards Development Organizations, the Accreditation Bodies, the Proficiency Testing Schemes, the Educators, Professional Organizations, and the Materials Supplier Organizations, and above all the Public Voice that demands Quality and at some times forces Action.   


The reality is that these organizations (except for the Public) exist to ensure that laboratory directors have the tools to make their laboratories better.  They create the framework, the assessment, and the knowledge and the consistent quality of materials to allow Quality to thrive. 

By and large the Public does not know about the groups, nor particularly care.  The Public knows what it wants and expects and assumes exists.  But when the Public finds that its trust has been breached, best of luck, it is too late.  Change will happen, but perhaps not in the way that the providers might want.

So it always surprises (and disappoints)  me when laboratory workers from the top to the bottom, look at their Partners as the Enemy.

As a PT provider I hear it all the time.  “You guys are always trying to trick us.”  “Your samples aren’t anything like our samples”.  “You don’t work in real laboratories”.  And above all, “It wasn’t us, it was your sample that was wrong”.    The reality is that all of that is nonsense and invariably, when laboratories are amiss, there is all too frequently a system problem lurking in the background.    By taking an adversarial position, it all too often is a Quality Improvement Opportunity gone amiss.

Part of this stems, I believe, from the competitive nature of laboratory directors.  We don’t like to be told we have problems.  Part of it is the complexity of so many moving parts in an active laboratory, and part of it is the frustration of so many variables, especially in the pre-examination phase seemingly out of our control. 

But, and this is the purpose of my writing here, when the Public apparently works in what appears to be direct cross purpose, it can truly poison rather than foster any
collegial relationship.  And poisoning is never a good thing. 

I have been following along the dreadful story of what appears to be an honest miscommunication  that occurred at a US university level medical laboratory when it reported that a PT sample was referred on to another laboratory.  The story has been followed closely since June 2012 and reported faithfully by the Dark Report.  [see http://darkdaily.com/despite-passage-of-new-law-on-clia-enforcement-ohio-state-university-settles-with-cms-agrees-to-pay-268000-and-names-new-clinical-laboratory-medical-director-22013#axzz2MXpeGMtV ]

Without going into detail, because you can read the story much better in Dark Daily, the laboratory reported that as per their normal practice for clinical samples of a similar nature, a PT sample was referred on to a reference laboratory.  The regulator body, presumably deciding this was done with cheating in mind, threatened with horrific sanctions.  Fortunately congress recognized the unfairness involved and intervened with legislation (Taking Essential Steps for Testing (TEST) Act of 2012)  to address the problem.  All was made well, but the regulatory body still fined the laboratory over $250,000. 

What a tragedy.  Nobody wins with this.  Everybody (including the regulator) loses.  It puts a burden of the laboratory, a burden of the PT program, and makes the regulator look petty.  It does not build a collegial relationship; it does the opposite.   And having seen the unintended consequences of hurried legislation, nobody knows if any of this will hamper of improve the delivery of PT service. 

In my own situation, in Canada dealing with a similarly petty regulator [http://www.medicallaboratoryquality.com/2013/02/calculating-risk_27.html ], my last response basically said that from my perception, they were acting less as a friend and more as an enemy, to which they responded they were reserving their right to be a regulator. 

And I thought we were supposed to be working together with the goal to help the public interest.

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