Dealing with complaints in the medical laboratory

There is a lot to like about Quality in the laboratory setting.  Like a lot of the laboratory process, it has some elements strongly grounded in evidence.  PDSA cycle as expressed by Deming and practiced widely is a written in stone as a proven, effective, indeed definitional approach to Quality Improvement.    
 
There is other stuff, a level down in which the concept may not be as definitive, but the probability of an established linkage is high or very high.  Working with Quality Partners is an example.  Working the partners is a powerful idea, and likely contributes to improved Quality and improve laboratory care, but this not established.


This entry is about the a concept one step lower;  Organizational Jidoka.

Jidoka is a part of Lean which automatically raises one of two probable reactions; some will automatically buy in, and others will reject almost out of hand.  But hold on.  
Jidoka has two parts, one derived from Poke Yoke, which means error-proofing.  To the extent possible, error prevention and error detection should be built into the hardware to either make it impossible to put a part in backwards, or to signal as soon as the bad thing is either about to happen, or more typically as soon as it is detected.  That is the easy part.  The second part is that the person responsible for that part of the manufacturing process is also charged with the responsibility to sort out what went wrong and fix it immediately, or to stop the system and go get help.

Recently I was reading in the Quality Digest an article by Norman Bodek and Jeremy Green (Zenjidoka, Solving Toyota's Quality Problems: A simple tool for a complex problem - Quality Insider 02/14/20) who suggest that Toyota would have been well served if every employee been given jidoka authority and responsibility to pull the red cord and stop everything.  The argument goes, that had everything been stopped when the first accelerator accident was reported,  than most of the others  would not have happened and Toyota would not have incurred all the costs associated with accidents, injuries and litigation.

This sounds like an interesting  idea, and I suspect it is probably both effective and efficient in the manufacturing setting.  But outside of the manufacturing line, this sounds like a truly scary, maybe even a dangerous concept.

With medical laboratory, it is not uncommon for automated analyzers to falter.  Usually this will trigger an alarm, just as with the manufacturing station, and at that point usually the technologist has the authority to halt function until the problem is solved.  The biggest problem in the examination phase is not when the alarm goes off; it is when the problem occurs, but the alarm does not go off.  We see this all the time with splashes, carryover, and all sorts of problems that cause screwy results.  Often equipment errors are transient and situational and don’t get detected until the clinician calls back and says the results make no sense.  In other words, most complaints are received way downstream from the causative examination phase event.

Another example can be seen when the error occurs in the pre-examination phase when the person entering accessioning information is aware of a typographical problem, they stop, correct the information and go on.  Jidoka works here too. 

But what would happen if you gave people in client services  who receive complaints the same authority.  Client complaints occur after-the-fact and most are diffuse in nature.  Many of them result, not from an analytic error, but from misinterpretation or misunderstanding.  Most resolve early and easily.  Some need a process corrective action, but only a very very few need something definitive done now.   
But the person receiving the call is not in a position to make that judgement.  If they were given the responsibility  to make  stop-action decisions it would be a lose-lose almost every time.  The first loss would be the production process would be constantly halted, and the second loss would be the impact on the person making the decision.  Everyone would be unhappy all the time.  

If there is a bigger point here it is that all too often, organizations in general, and medical laboratories in specific have no constructive approach to gathering and addressing complaints in a  rapid fashion.  Most get a phone call solution without any documentation, or collation, or evaluation or Management Review.  In our business this is our traditional standard practice but it doesn’t make it appropriate. 
If complaints were fed forward to an authorized and responsible person in a timely fashion, who could make a thoughtful and focused review the lose-lose becomes a win-win.  If someone is going to be called to account, it should be management.

So there is a message here, but it is not to adopt the concept of Jidoka as an approach to complaint resolution, just because it might be a useful component of Lean strategy in another sector.  In the medical laboratory we should not be looking to  solve problems by assigning a line-person to do management’s work.  We  solve problems by making change and requiring  management to make management decisions.