The Laboratory Exoskeleton

One of the advantages of attending conferences is all that empty time that occurs while sitting on the airplane on the way home.  I know that many people would not see that as a plus, but this is one of the few moments in time when your mind is set into motion having absorbed all sorts of information – some new, novel and excellent, some maybe not so much.  There have been conversations, again some routine, but others very intriguing and stimulating.   And now you find yourself on the airplane, usually alone, contemplating and reviewing and contextualizing. 

That opportunity rarely comes along, except in the situation as described. 

On this occasion I was returning home after attending the Labquality Conference in Helsinki for two days, and was now spending what was feeling almost as long sitting in airports and airplanes waiting to get home.  

The conference was excellent; interesting people, interesting topics, interesting ideas.  Much more on this later.

The two themes of the conference were Pre-Analytics and Point of Care Testing.  (Personally, I think the term Pre-analytics is incorrect; the correct term would be Pre-Examination.  That being said, I agree that pre-analytics is easier to say and easier to write.)  This was not particularly surprising because these have become very hot topics in the medical laboratory arena over the last few years, with Quality folk interested in both, each in its own distinctive way.  The two topics were presented on sequential days to pretty much the same audience.  As much as they are very different topics, they felt they were  kinda-sorta related.  

So I came up with a way to formally put them together. 

During the “Pre-analytics” portion of the conference, every presenter, including myself came up with a slide that showed a version the Total Testing Cycle or the Laboratory Testing Cycle.  You know what I am talking about:  It goes from the Patient to the Pre-Pre-Examination Phase to the Pre-Examination Phase to the Examination Phase and on to the Post-Examination and Post-Post Examination phases and then back to the Patient.  I think of this as a linear horizontal pathway.  

It works, but focuses on one aspect of the laboratory activity, specifically the testing process. But it leaves out a lot of other stuff that is equally important; laboratory Quality, laboratory Safety, laboratory Communications.

So I have put together another schema,  this based on a core, a layer of activities that holds the core together and intact, and related activities that occur outside and separate from the laboratory.  I think of the layers as:

The laboratory core:  the central activity of laboratory testing.  It is the laboratory analysis activity area.  This is the testing activity that occurs within the four walls, the ceiling and the floor of the laboratory space.  

Exo-Analytic Layer:  The layer of activities that sits outside the testing core and serves as providing support and binding. The prefix "exo" means “outside but an extrinsic part”.  Think of this as the exoskeleton of laboratory activity.  This is the layer that includes Quality, Safety, Communication and Education, plus others.

The Extra-Laboratory Layer:  The layer beyond out side the Exoanalytic.  The  prefix “extra” means outside and separate, but may be related.  This would include activities that includes transport and legislation issues as well as home and residential considerations.   

These days this schema gives a way to indicate that Point of Care Testing crosses into all aspects of the laboratory with a very small component being part of laboratory testing, a larger amount being part of the exo-analytics, and an even larger part in the extra-laboratory.  

The advantage of this layered view is that it makes clear that some exo-analytic activities have important associations with laboratory testing, others have associations with the outside community, and others have both.  Each has to addressed in its own way.  

Over time I will refine the model.  Today I think it works; I will see if it continues.

Important message to self: the long sit on the airplane can be filled with moments other than Sudoku.   

PT Bonus Opportunities: would your laboratory benefit?

PT Bonus Opportunities: would your laboratory benefit?

Frequently we talk about the benefits of Proficiency Testing as a method for the detection of systemic error in laboratory testing, especially as part of the examination phase.  Once you accept that Proficiency Testing challenges have been thoroughly quality controlled and are highly reliable, then it becomes, as my old calculus professor used to say, intuitively obvious that the greatest probable cause of deviation between a clinical laboratory’s result and the PT program’s result is some form of problem within the clinical laboratory.  It likely is a slip or distraction by someone in the laboratory’s testing chain, but it may reflect a larger systemic error that is otherwise is being not recognized or is under-appreciated.  Discarding deviations in PT performance can be lost opportunities for improvement.

But recently we had two interesting results come to light that reinforce that systemic error in the testing pathway detectable with proficiency testing materials can come from all sorts of places. 

As per our normal routine, our PT coordinator was checking the laboratories that had not yet sent in their results 48 hours before the due date, and found one such laboratory and contacted them.  [As an aside we can provide that extra level of service because we are a small program.  Large programs with thousands of participants could never provide that extra assistance.]

The laboratory checked their records and came back on the phone and said that the problem was on our end, because the laboratory had never received our samples in the first place.  We were the problem.  So a check was made through the courier service and what was found was that the samples had been delivered on time as committed, and that the delivery way-bill had been signed off within the laboratory.  A call-back was made and sure enough, the box was sitting in the refrigerator where they had been placed, un-opened.

The story has two messages.  First, if this happened with our package, this could have been a one-off by someone who simply forgot (call that a human slip) or perhaps this happens more commonly than the laboratory is aware (call that a system error).  Second, our system informs the laboratory on the day the package goes out.  If there is going to be a problem it would be captured within 48 (max 72) hours.  If someone had called us and checked, the box would have been found immediately.  That this didn’t happen either means that a distraction resulted in the call not being made, or that the laboratory has an inventory-control problem which needs checking. 

Either way the point is that even without being tested, this PT shipment has resulted in detection of two problems (is it OK to call them errors?) that the laboratory now has the opportunity to check-out.  Either they were a chain of simple human foible, or they were a manifestation of failures in the delivery handling and monitoring procedures. 

A second story is similar, but starts not from us contacting the laboratory, but the laboratory contacting us with an apology for a 5 day delay in submitting results.  Apparently, there usually was a Quality technologist whose job it was to submit  PT challenges reports, but that person had recently retired and no one had yet been appointed and so the job was “slipping through the cracks”. 

We understand that people do retire; that is called “business as usual”.  But if the PT reports are not being submitted, are there other tasks that are not getting done.  If quality control testing is being delayed, and reagent defects are not being identified, then how many hours are going to be lost having to remediate erroneous test reports?  Or worse, what if quality control testing isn’t being done at all?

My point is that PT samples are more than just a material to challenge the examination phase of laboratory testing.  They are known and traceable and regularly received materials that can be used to monitor every aspect of the laboratory cycle.  Usually everything works as it should, and sometimes it does not.  It is when things do not go well that these “safe” opportunities arise for checking for system error. 

Opportunity accepted or opportunity ignored?