Saturday, March 23, 2013

Quality as a survivor meme

Quality as a survivor meme

In 1976 Richard Dawkins, a genetics biologist and an ultra-believer in Darwin’s Theory of Natural Selection proposed an ethereal construct, the meme. 

According to geneticists pieces of DNA produce genetic units (genes) that produce proteins that lead to characteristics that allow organisms to either succeed and prosper, or fall behind and fail.  Genes can be passed from organism to organisms or can mutate. Sometimes genes interact with other genes like switches, turning each other on or off.  Darwinists go one strp further; successful genetic codes are the ones that “program” characteristics in a person, or animal, or plant that increase their likelihood to survive or die off (survival of the fittest).  Ultra-Darwinists believe that a gene’s primary goal of survival defines the selfish gene trait.

 Memes are ideas that have all the functional (but not the physical) characteristics of genes.  Successful memes pass from person to person, sometimes mutating, sometimes remaining stable.  Selfish memes move through the greatest number of individuals thus ensuring their survival.  Less fit memes ultimately lose in the competition of ideas and fade away.  The notion that the world is round and moves around the sun is an example of a survivor meme.  That the world is flat is an unfit meme. 

I think we can all agree that the world and existence is more complicated than as described, but it does create enough of a foundation that allows for some discussion:  we, who are interested in the notion that Quality is a positive characteristic, can and should ask: are we colonized with a meme that is ultimately healthy and fit to survive, or are we infected with a meme with little chance of long term success?

The ASQ writes that the history of Quality can be traced to guilds in England in the 13th century.  Others [ see: ] date it much further back (10,000 BC).   The point being that this Quality idea, this Quality meme, has been around for a long time, and has seemed to have spread pretty effectively. 

Over the years this Quality meme has evolved in part from natural evolution (Taylorism, Shewhart, Deming, Lean, Six Sigma,), in part from environmental pressures (Industrial Revolution, Public demand for Quality) , in part from competition (Agile project management, Risk Management). And the path for the Quality Meme has not always been smooth. 

There have been competing memes, some with the power to modify meme expression (turn down) Quality expression and some that will completely turn off Quality development, In business and industry, the quarter-by-quarter analysis meme which opts for short term results tends to suppress Quality and any other activity that takes time to develop.  In single payer health care the all too regular meme that opts for all too regular across-the-board cutbacks is a perpetual attack on Quality monitoring costs.  And the all too familiar and pervasive mantra “doing-better-with-less” approach has had a similar deleterious impact.

Of more concern is the absentee meme “DKDC or Don’t know – Don’t care” which opts for doing work on the fast and cheap and with a fast exit approach. 
But the worst of all is the “Quality is futile, Quality is bad” meme.  In the last while we have seen three expressions; the least worst is the meme that points to analysis of how many of the top 50 industries did not bother with Quality processes such as Six Sigma or ISO9001:2008 and were still successful.

The more toxic expression is the one that talks about how Quality processes were introduced but the ranking of the company went down. This is an inane idea based on some view that the world we live in is strictly dichotomous: black versus white, right versus wrong.  The idea assumes that the ONLY variable that changed was the introduction of Six Sigma, as if the economic downturn never occurred, or customer preferences changed (think Nokia, or RIM or Apple).

The most vile expression of Quality-is-futile, is that Quality standards such as ISO9001 are failed documents because most organizations do not or can not maintain their certification, either due to the ineptness of Quality or because the assessment bodies are only in it for the money, and therefore they should all be avoided.  Stunningly this idea actually comes out of the mouths of committees within ISO and other tragically jealous competitors.

So where does all this go.?  Memes, like genes, come and go.  Some, like the genes responsible for making dinosaurs thrive until they become overwhelmed by competition or circumstance and die.  Memes of the flat-earth category fall into that category. 
So far the Quality meme has shown considerable staying power, slowly evolving, shifting, but at their core, remaining true to principle.  But modern anti-Quality memes are certainly around. 

So will Quality continue as a long term survivor that integrates itself through all societies?  I would like to think so. 

Only time will tell. 

Monday, March 18, 2013

Quality and Accreditation: Partnership or What?

Quality and Accreditation: Partnership or What?
Module 3 of our certificate course in Laboratory Quality Management is always of great interest to me.  It is here that we introduce the concept of Quality Partners.  This is a topic that comes up frequently in this web-journal. [ see: ]

With wanting to be unduly repetitive, there are organizations whose raison d’etre is in large part to support medical laboratories around the world,… to make them better places.  The partners include Standards Development Organizations (SDOs), Accreditation Bodies (ABs), Proficiency Testing Schemes (PTs), Education Providing Institutions (EPs), Professional Organizations (POs) and Industry Suppliers (IND).  Each of these groups is instrumental in supporting a laboratory’s efforts to learn, implement, and maintain a Quality structure. 

Each year a question arises, which tests (at least in my opinion) the understanding that laboratorians have about who does what and who is responsible for what and who has authority.

There appears to be confusion between Quality and Accreditation; are they two sides of the same coin, or are they Partners in purpose. 

Accreditation Bodies are very important to the medical laboratory.  They gather documents written under the authority of SDOs, interpret them, devise strategies on how to measure them, and then action the strategies.  They provide an external eye that informs laboratorians, and others, in their respected opinion, that the SDO developed document is being adhered to, or is not.  They provide a method that measures Quality.
And where Quality is being missed, by their measurement, they can highlight where improvements can or must be made, in order to allow for the AB to affirm compliance and competence. 

It is a process that provides an invaluable assist.

But, can Quality and competence exist outside of Accreditation?  This is very different from the philosophical conundrum of “if a tree falls in the forest, and nobody is around, does it make a sound?”.  With the tree, if there are no ear-drums around, then all the vibration from the falling tree is for naught.  No ear-drums, no sound.  But in the laboratory, even without an external visit, or a certificate, a laboratory can still faithfully adhere to all the requirements of Quality.

Laboratorians can and do acquire documents themselves, interpret them themselves, plan implementation themselves and monitor outcomes themselves.  Faithful adherence is a matter of choice and will.  This is the process in jurisdictions that do not mandate accreditation but endorse the values of Quality.

Is it a hard process? Absolutely.  Does it fail frequently? Absolutely absolutely.  But can it work?  Absolutely absolutely absolutely, sort of.  In my experience, there are all sorts of good examples to support the notion.  I have visited laboratories that where management decided that adopting ISO15189 was a good idea.  They came upon the decision on their own.  Through the use of consultants they went through the process of implementation, and worked hard to maintain what they had achieved.  Eventually they found that there was value, in going through a voluntary affirmation by hiring an AB from another country to look over what they had done, and indeed received their certificate of accreditation. 
There is much to be gained through the external process of assessment, and in terms of building a Culture of Quality, the process of external assessment can serve as a positive binding force.  But the power to decide and create and maintain is one that can, and indeed must come from within.

Let me argue that in the absence of separate, independent SDOs, the risk of biased documents becomes very high and the value of Quality becomes questionable.  In the absence of IND committed to effective efficient consistent equipment and supplies and an ongoing program of maintained assured product quality, the laboratory has no chance at all.  In the absence of EDs and POs and PTs that promote Quality through education and challenge and continuing education, the message is lost.  All these Partners assist the laboratory, some I would argue more powerfully and more permanently than others. 
So, if there is a truism here it is that the spirit and commitment to Quality can and must come from within.  Quality Partners can and do provide the essential and powerful supports and affirmation and validation. 

Without the internal spirit and commitment, Quality will always fail.

Wednesday, March 13, 2013

Drive-by Quality

Drive-by Quality

Paul B writes an interesting blog note about Quality solutions that you see in real life situations  [ see:].   

In web-parlance we have a phrase that addresses unconscious or casually uninformed activities sometimes with unintended consequence.  You can call that drive-by Quality.   Sometimes drive-by activity is a negative, such as when you download some software that ends up causing grief.  In this situation, I consider drive-by Quality more as an unintended and unexpected but often very pleasant positive.  

I was working with a group of students who were given an assignment to do a presentation.  After being given their topic, the two students got together and scoped out their topic, and developed the list of items they wanted to talk about.  Then they assembled their presentation and did a practice run and found the places it didn’t flow properly and adjusted them.  Then when they were finished,  they invited me to hear the revised practice which went very well.  

“Have you ever heard of a guy named Deming or a process called PDSA before?” I queried, only to get a very blank look in response.  I pushed a little harder.  “What you just did is a really good example of what Quality folks call Planning – Doing- Studying - and Acting.  It’s kind of the cornerstone tool of Quality Management”.  Again I got the same “that’s interesting” response, but I knew that what they were really saying was “whatever!!”

Students tend to gather into two types; those that instinctively get the concept of PDSA and those that do not.  So much so, that in my mind I am tempted to think that it is an X-chromosome linked genetic trait.  Girls are more likely to organize their way through a problem, while guys are more likely to be of the “shoot from the hip” disposition.  I suspect it had something to do with survival of the fittest 50,000 years ago.

But there are clearly more environmental factors at play as well.  Think Nature-Nurture.   There are lots of guys who figure out that being burned from rapid-fire problem solving is not a good way to go forward in many (most?) modern life challenges.  Mature learners who start getting really busy in life and no longer have the time to recover from dumb and repeated mistakes figure out the P and S are real time savers.  

I know from my own personal experience that if I was borne with the PDSA gene, it was very very recessive.  It took me a long time to realize that making the same mistake over and over and over was not a good strategy.  But even I was able to figure it out and start some Quality learning.  Fortunately both of my sons inherited a more potent version of the gene from their mother who clearly has a double dose carrying PDSA on both her X chromosomes.  

Bottom line, the concept of quality may be inherent in some people and you will see “PDSAers” all over the place.  That is a good thing.

PS:    To be clear, there are lots of girls in this world who appear to be PDSA gene deficient.  Some of them go on and learn the concept later in life, but many don’t.  Just like guys.
PPS:  To be equally clear, I don’t know if PDSA is a genetic trait of not.  This falls into the category of evidence and proof known as speculative conjecture or a “hunch”.

Sunday, March 10, 2013

Taking some of the Risk out of Risk

If you look at Quality blogs these days, including this one, you see a lot of discourse about Risk.  Risk has become, I fear, today’s Quality flavour.  It’s too bad, of course because flavours come and go, but true and valid concerns about putting patients, clinicians, laboratory staff, and the community and environment at risk in a constantly changing healthcare landscape are very real. 

Most times when you look at the blogs, the breadth and depth of the discussion is about Failure Mode Effects Analysis (FMEA), but as a colleague once told me, Risk goes a lot further than that.  The FMEA approach says that you can look at a piece of equipment or a procedure and break it down to all of its parts and sort out what can go wrong and then fix them.  That’s simple.  Solve all your problems before they exist using an FMEA strategy.  Live is solved.

Recently I have been spending a lot of time in the Risk arena, and I have come to appreciate that Risk owes a lot to both Game and Chaos theory – two mathematical systems that address decision making.  Both make the point that life is a cause and effect experience but it is loaded with uncertainty, most of which is immeasurable and unpredictable.  Often the chain of events that leads to an outcome may not be easy to trace. 

Benjamin Franklin, a lot time before Chaos theory said it poetically: 
“For the want of a nail the shoe was lost,
For the want of a shoe the horse was lost,
For the want of a horse the rider was lost,
For the want of a rider the battle was lost,
For the want of a battle the kingdom was lost,

Donald Rumsfeld said it more recently, but equally poetically, when he talked about the decisions that surround the famed weapons-of-mass-destruction:

“There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don't know. But there are also unknown unknowns. There are things we don't know we don't know.

The point is that it is impossible to calculate all risk out of life’s equations. 
For me, the real Risk challenge is referred to by Frame as “Planning for Risk”.  Regardless of what risk analysis tool is used, and regardless of what business or industry you are working with, at some point someone has some decisions to make.  Can we live with this risk, or are we better off not getting involved.  Can we use a different approach?  Can we off-load the risk to an insurance company?  Or can we provide people with an informed consent making it clear that we will only go ahead if they clearly understand the risks and are prepared to live with them one way or another?

Frame says that companies fail at this game when they don’t create the process that says this is the person whose responsibility it is to make the decisions for this level, and that is the person whose responsibility it is to make decisions that that level.  And that person is the one who makes the ultimately hard and final decisions. 

What I see especially in hospital and government politics is the opposite of “planning for risk”; junior people refusing to taking on decisions, because they fear repercussion (aka cover-your-backside) or worse, senior people creating road blocks and bottlenecks by demanding all decisions get made only inside their office. 

Competent management sets up the structure for decision making well in advance, and ensures that people understand their zone of authority.  And if circumstance changes, to let the people know that too.  Then when decision time comes, people can be forearmed, informed, and ready and comfortable to do what makes sense at that time.  If they still can’t make a decision then either they don’t understand the question, or they are the wrong person in the wrong job.

Bottom line;
Risk is about making decisions.  Risk tools are about helping to make more informed decisions.  Risk Management is about making the most benefit from informed decisions that turn out well, and reducing the downside when they don’t.

Thursday, March 7, 2013

Is ISO “Compliance” cheating?

Is ISO “Compliance” cheating?

I find myself in the middle of a moral dilemma.  On the one side I feel perfectly comfortable with what we are doing.  On the other side, I have spent a lot of time and voice and ink arguing the other side.

I operate a university based medical laboratory proficiency testing program focused on microbiology.  We have been in operation across Canada for many years.  We provide a unique service that closely mimics clinical specimens because standards including ISO15189, ISO/IEC17025, and ISO17043 and WHO all clearly recommend that proficiency testing should, to the extent possible, highly look like and act like the samples they are challenging. 

That makes infinite sense to me.  If you want to know that a laboratory can process a certain type of sample, then you have to give them something that duplicates that sample.  If they meet the requirement we can call them proficient; if they can not, then they have work to do.  If they get a PT sample that requires all sorts of manipulation and special processing, then you may be able to argue you have measured a level of technical competency, but that is something very different from proficiency. 

But I digress.   I will get back to the issue at hand.

Long before there were guidelines and standards for proficiency testing Quality, there was only  the quintessential Quality requirement: ISO9001.  That was the document that we adopted as the basis for our Quality system.  We are externally assessed against the document every year.  We have a lot of confidence in our Quality system.

In 2008 ISO CASCO decided to create a new document specifically to address competency for proficiency testing programs.  It was a collaborative effort with international accreditation bodies and when published was known as ISO17043:2010 (Conformity assessment - General Requirements for Proficiency Testing).  A number of proficiency testing programs from across the spectrum of testing laboratories were included in the writing committee.  We were a part of that process.  

When it was done 17043 was a pretty good document; its management side was not as complete as 9001, but its technical side was a vast improvement and much more appropriate than ISO/IEC17025 (Competency for testing and calibration laboratories).

Our program has looked at 17043 a number of times, and has implemented it as part of our own technical and management performance efforts.    We declare ourselves to be compliant, but to date we are not accredited. 

Our problem is strictly one of budget.  We can not afford to pay an accreditation body what they charge, especially since we know that our laboratories trust our ISO9001 certification, and don’t seem to care if we consider the new standard.  

Were we to decide to add the new accreditation, we would have to add the cost to our fees and pass the expense on to the laboratories. 

And then a new problem manifested today.

We got a request from a laboratory outside Canada, asking for samples, but also asking if we are “compliant to 17043”.  Our response was to the affirmative, but left out the part about no accreditation.  I don’t know if she knew what she was asking, if she understood that there is a difference between being accredited to a document and being compliant with the document.  At the time I didn't feel like getting into the discussion, but now I am concerned that we might be seen as being a little deceptive.  Perhaps we lead her astray.  That is never a good way to start off a new relationship.

What we gave was an honest answer, but arguably a little incomplete.  What we probably should have said is:  “Yes, we are knowledgeable of 17043 and self-declared as compliant, but as of yet not accredited.  Our Quality system is assessed in the context of our activity, which means that the assessor factors in that we provide Quality Assessment products and services.   
We invite organizations  to come and do their own site visit, and assess us for themselves.  The only provisos are that they arrange in advance for an appointment, come at their own expense and do a focused assessment."

If she calls back we will tidy up any confusion that we may have caused.
She may not care, but I will.

note: edited post release for grammatical errors - Mar 8, 2013 

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 ]

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 [ ], 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.