Tuesday, November 15, 2016

RCA and Gnosis

Recently I was in a conversation with a standards development person, and an interesting (and new to me) turn of phrase was used.  ISO9001:2015 was called an “agnostic” standard by which my colleague meant that it would be generally applicable to every business or organization regardless of sector.   To me, agnostic has a very different meaning, a “don’t know, don’t care” attitude towards religion.

At first I thought that referring to a standard as agnostic was borrowing from religious terminology rather pedantic, but upon reflection I realized that referring to a standard as agnostic is a high compliment. In its purist form agnostic is derived from early Greek; “a” meaning “without” and “gnosis” meaning “esoteric knowledge” or “dogma”.  I can’t think of a better way to refer to a standard describing it as being “without dogma”. 

The Quality movement has tried to the extent possible to be agnostic and even scientific.  There is effort to stay away from devolving into its own belief system or esoterica or dogma.  In many instances it has been successful; in other places, to my mind, not so much. 

The other day I was reading in ASQ’s November issue of Quality Progress, and came around to an article by Matthew Barsalou entitled “A Better Way” in which he means a better approach to performing Root Cause Analysis  (RCA).  With no disrespect for Mr. Barsalou intended, in my mind, I find it difficult to put the words “Better Way” and “Root Cause Analysis” in the same sentence.  

I cannot think of anything more the opposite of “agnostic” than the concept of root cause analysis (RCA).  To my mind RCA is the very poster child of dogma in Quality. 
In the medical laboratory, it is an absolute that the investigation of nonconformities requires a Root Cause Analysis.  Accreditation bodies spend all sorts of time expecting laboratories to have RCAs for every proficiency testing error, every audit deficiency, and every complaint.  That is a requirement in ISO15189:2012 (medical laboratories – requirements for quality and competence) and also in ISO17043:2010 (Conformity assessment -- General requirements for proficiency testing).   

While I don’t have my copy of ISO/IEC ISO/IEC 17025:2005 (General requirements for the competence of testing and calibration laboratories) close at hand, I am almost certain it is in there as well. 

To their credit, the crafters (ISO TC176) of ISO9001:2015 (and its previous iterations) did not use that phrase; instead it simply says to “review, analyze, and determine the cause, and the determine if similar nonconformities exist or could exist”.  (Personally I would prefer a small but critical variation – “determine the possible or probable cause…).

RCA assumes that if you know that a bad thing has happened, a knowledgeable person can trace back to the point of origin which indicates the root of the evil outcome.  It’s like Stephen Hawking’s tracing back to the origins of time.  RCA is totally dependent on the assumption of traceable knowledge. Putting that level of faith in RCA flies directly in the face of important concepts like, Mathematical Chaos Theory, Knightian Risk, and Risk Management and the whole science of uncertainty.  

Chaos Theory is the mathematical model that informs that every cause leads to an effect, and every effect has a cause.  Causes and effects are non-linear, in that small cause may have big effect, or not.  Once causes occur the ripples that result can be altered, buffered, changed before the effect manifests, and the greater the time interval between the cause and effect, the more likely alterations occur.  And finally the “effect” you see may not be the significant effect. 

 That does not mean that we can just shrug our shoulders and soldier on.   We can and should do a look back and see if there is a possible or probable error that could account for our problem.  Sometimes it comes down to maybe a slip or a distraction, or perhaps an error in the procedure.  More often than not, it is little more than a supposition, unless there has been two or three events (boo hiss!) when at least you can look for common factors.  You can try to layer in another piece of swiss cheese (think James Reason).   

And then monitor to see if the problem stops happening.

So let me argue, that the time has come that we can follow the lead of the crafters in TC176 and get rid of the phrase “Root Cause”.  We can look and we can investigate and sometimes we will find a possible or probable cause.  

Just so long as we don’t make the transition from investigation to blame.  

Quality is about a lot of things, but laying blame is not one of them.

But maybe that’s just my own Dogma.

Note: a critical spelling error was found, and amended.  My apologies to any who might have been offended.

Thursday, November 3, 2016

The Road to Perfect EQA?

WARNING:  As I write this entry, I am wearing my Proficiency Testing hat.  Folks interested in laboratory quality, but not in proficiency testing may find this really boring.  If PT/EQA is NOT your thing, that is OK; please leave NOW.  

The annual meeting for the European Organization for External Quality Assessment for Laboratory Medicine (EQALM) was an excellent get together for EQA providers.   Gradually EQALM is becoming not only the gathering point for European international EQA providers, but intercontinental as well.  

LABQUALITY [http://www.labquality.fi/eqa-eqas/?x2520204=3249645 ] has already written a nice summary on the meeting.  

The theme of this year’s meeting symposium was The Road to Perfect EQA.  That is a pretty good way to celebrate 20 years as a EQA provider group.  The presenters tackled 4 topics (a) Commutability (b) Traceability and (c) Accuracy and (d) the challenge to Homogeneity when internal reagents cause mischief.  All were interesting and important EQA topics, especially if you are focused on producing challenges for Chemistry laboratories.  (Note: that does not include me).  

If I had an issue about what was presented, it was small but important (at least in my mind).  The term commutable is not a particularly good word for EQA because it has a number of meanings.  It can mean “capable of used for commuting” or can mean “capable of being exchanged” or lastly “capable of being converted”.  In the context of EQA, I am pretty sure he was not think about commutability in the context of transportation.  I think the presenter was intending that EQA samples should be sufficiently similar to clinical samples, that they can be used as an exchangeable material in the sense that there are no matrix effects.  EQA samples should act like regular samples.  I can live with that, but in chemistry the term can also mean being converted or degraded to end-products, so you might say you want the sample to be commutable, but you don’t want it to be commutable.  I think the term is probably not the best choice.  

In our clinical microbiology program we try to take the sense of being exchangeable with clinical samples a little further.  We make the sample to contain both host and microbial components, combine pathogenic flora with background flora, and we try to the extent possible to make our samples look like and act like clinical samples; the point being that being exchangeable just for the machine and not for the laboratory workers does not go far enough.

But I have a much bigger issue with what I see as a major weakness in the symposium.  It is about what was not presented.  It was far too technical focused and did not include that the REAL Road to Perfect EQA program is the one that leads laboratories to want to use and learn from EQA.  

In my now near 35 years of PT/EQA with observations around the world in developed and developing countries, I have seen almost every variation to EQA experience.  Most laboratories still see PT/EQA only as something that Accreditation requires, or something they just have to do.  They either never investigate errors, or given the opportunity never even look at results.  When they have a problem they get picky beyond picky on interpretation of instructions or provided clinical information rather than acknowledge that they did not process the sample as required and expected.  And sometimes (fortunately not very often these days) some laboratories use deceptive methods to cheat an answer rather than risk the challenge.

We even have members from our own committee who feel compelled to argue against the challenge when they participated in every part of the selection and preparation process.  We have seen laboratories threaten regulatory action because they felt the challenge was too hard/ too easy/ too costly/ too too…

The Perfect PT/EQA program wouldn’t have any of those responses.  Instead there would be a deluge of letters “Thank you for helping us find our system error” or “Many thanks for that interesting challenge.  We have incorporated a number of changes to take that into consideration”, and especially “Many thanks for those educational and informative critiques.  We can’t get along without them”.
OK, maybe I’m a little over the top, but EQA is an important exercise for all laboratories in all fields; water, food, medical, construction, electrical.  In some areas, detecting errors actually saves lives.  

Having laboratories miss the point of the exercise does no one a service, certainly not to laboratory who chooses to ignore or deflect opportunities to improve, and most certainly not the customer who in our case represents patients, clinicians and the community.  It is a program of purpose.

So, let me propose to my PT/EQA and in particular EQALM colleagues, “good-on-ya’” for a symposium well done and focusing interest on an important side of what we do.  But maybe at the next major anniversary (the 25th, or 40th, hopefully we don’t have to wait for the 50th!) we can have The Road to Perfect EQA – Part B where education and customer focus also get discussed.

October 1-3, 2017
POLQM Fall Conference  on Medical Laboratory Quality