Monday, June 20, 2016

The Clash Between Laboratory Quality and Personal Study?

It seems to me to be inherently obvious that Quality is a collective group activity.  

 Quality is measured by response to customer (the public) needs.  Quality is empowered by the collective Culture of Quality, meaning the power of the total group drives Quality benefits of continual improvement and continuing education.  Quality is the product of peer groups working together to find opportunities for innovation, improvement and success.  Quality is driven by the sense of openness associated with acknowledging errors and other opportunities for improvement (OFIs). Quality is predicated on standards and guidelines which are  the product of consensus and compromise.  

I think as a general experience, the least successful approach towards making positive change for improvement is to have someone sit alone in their office and draw charts and diagrams and write strategies without the input of others.  

So I think that the people who would be attracted to working in the Quality arena would be folks that enjoy the group collective experience.  They would be the folks that enjoy working with others; discuss, maybe debate, but to come to a consensus opinion and a collective plan for going forward.  Quality people, you would think, should be people persons.

I raise this because we have put on a university based certificate course in laboratory quality management every year since 2002.  I have mentioned it before.  It has evolved into a 21-week on-line course in what we call a VCOLE format (virtual classroom on-line education) where the central essence of the course is that most of the course is in the form of small-group discussion and most of the assignments are in the form of small-group team (collective) efforts.   

We do it this way because the best way for adults to learn is to work in groups and bounce ideas back and forth.  Increasingly there is evidence that the worst way to learn is to sit in front of a computer screen by yourself and study by yourself and do your assignments by yourself.  

Apparently the duration of time that information retained (persistence)  in the discussion based model is much greater than the individual learning model.  For reference see “Effects of Small-Group Learning on Undergraduates in Science, Mathematics, Engineering, and Technology: A Meta-Analysis  (2013)[ ]
So imagine my disappointment when in our collective survey of opinions on the course (Yes, we do a lot of customer satisfaction surveying in this Quality Management course) I receive the following comment:
“The group work was challenging, and some members definitely did not do their fair share. … I certainly did not appreciate putting so much effort on an assignment, and then have someone parachute in, and ride on the coat tails, contributing very little, but still getting the same mark as everyone else.”

I have to say that that is not a comment would likely come from a consensus oriented, collective driven, people person.   It sounds more that an academic competitive person for whom sharing and participation is far less important than getting an “A”.  If I wanted to be pejorative I would refer to it as being very high-school. 
But that would be very rude of me, and probably inappropriate (Donald Trumpish?).  

Our opinion surveys are intentionally done in a manner that does not allow me to know or find out who wrote the comment might be.  So I don’t know how well or unwell this person did, other than to say that most people who take the course do very well.  As to whether this person stood first, or in the first 10 percent, or the middle or the last 10 percent, I have no idea.

But to that person let me just say the following…  I
When you find work in the Quality arena, you will find yourself working in small groups all the time.  It is the nature of Quality.  
 Some people will get really engaged and do a ton of work. (That might be you.) Others will be less interested and do less.  And some will pop in-and-out and not contribute much at all.  That is the nature of small groups.  

You had a great experience, you learned some new information, and new skills and probably did well.  Why does it matter how others scored or not scored (actually we keep a close eye on how much individual participants actually participate and their overall participation score reflects their degree of activity)

If you are uncomfortable with small group dynamics, you probably should stay far away from the quality arena.  You will be miserable every day on every project.  If you can’t cope with small group committee dynamics in a simple learning environment, it sure won’t work for you in the real world.  

Too bad.

Note:  The preceding may be interpreted by some as a betrayal of confidentiality because it contains participant comments from our course.  Please note that all the comments are submitted anonymously and cannot be traced to any individual or IP address. 

PS:  If you are interested in university based on-line education for medical laboratory quality management that is open to Canadian AND international students, please go to  Our next course starts in January 2017. 

Monday, May 30, 2016

Innovation and the Modern Medical Laboratory 2016

A number of years ago I was invited to give a presentation on Quality practices for the research laboratory.  I recommended at good practices would include (1) adherence to established standards (2) Calibrate your equipment regularly (2) strict adherence to quality control (3) ensure that graduate students are properly trained and competency assessed before performing assays (4) where feasible work with a partner laboratory or participate in existing applicable proficiency testing programs to ensure that your procedures are working properly and (5) on a regular basis arrange for some form of external assessment.  

A senior person at the presentation said that he was very successful in funding awards, and never did any of those steps.  

Is it any wonder that only about 10-30 percent of published research is reproducible (see: August 2013).

I raise this story because it relates to a recent threat on LinkedIn by the ASQ “What Do you think? Is Quality shifting to be the Driver of Innovation? .  I have previously commented that Quality is not so much the driver of Innovation, but may be making Innovation better.

Medical laboratories are largely populated by folks who are creative by nature, and always ready to try out something new.  Sometimes it resembles innovation by distraction by the shiny bauble.  But most of the time it is about a self-driven desire to tweak existing processes, as in “if I do this”, I bet I can make this assay easier, or faster, or better.  


The reality is that usually, the assay is not improved, and sometimes it is made worse.  At the very least what happens all too often is that even critical basics of accountable change do NOT occur.  There is little or no verification that the changes result in consistent values, or validation that changes don’t have unsuspected impacts due to age, gender, medications, or geography.  A few studies get done, some basic statistics are generated, and off we go.  We have another new Laboratory Developed Test (LDT) that gets presented as an abstract at a meeting, or gets published in a journal, and everyone is happy, except maybe the clinician who gets a wrong test interpretation, or the patient that gets put on a wrong treatment track.  


Stories come to mind.  The first is the tragic story of misinterpreted test results for her2 (breast tumor responsiveness to the drug Herceptin) that resulted in patient mistreatment and death and led to the hugely expensive and public Cameron Commission in Newfoundland.  


Over recent years, medical laboratories have been galloping forward creating new tests to find new information, largely based on new molecular (i.e. DNA based) assays in the disciplines of genetics, and detection of microbial pathogens of all sorts.  


New laboratory ideas are being generated on a daily basis and new procedures are being created almost as quickly, most commonly using DNA strands that are created in-house.  Laboratories often do a side-by-side comparison of the information generated by the “standard” test, and if the new assay is pretty much in line with the standard assay, then the transition is made.  And if there was not previous assay, but the test worked for other targets, and it seems to work well here, then that is good enough evidence to go forward. The result of this is more tests, more results, new knowledge, and better and faster patient information. And some of the information is very good and very helpful. 

The problem of course is that sometimes results don’t quite go as planned. 


In our Quality course we talk about Quality Partners helping laboratories advance their Quality improvement.  But we point out that the impact of the partners on laboratory performance pales in comparison to the power of an unhappy public who gets fatigued with new ideas bad outcomes and demands something with a lot more rigor.  Today it is the US Food and Drug Administration (FDA) that has made it really clear that the day of free-reign LDTs is over, at least in the US.  The sheriff is going to be laying down some new rules.  If laboratories are not going to discipline themselves, the gov’ment is going to do it for them. 

Needless to say lots of laboratories are unhappy.  Definitions are being made that may or may not work well.  Restrictions are being imposed, and delays are inevitable. 

Gee whiz.  What did they think was going to happen?  When you upset the public enough, you have little control over what happens next.  

But just to be clear, medical laboratories are not the only organizations that have fallen into the rush to innovation trap.  Think Theranos. 

Without going too far into the story (you can read it everywhere and anywhere) this was a new-tech company that figured they could revolutionize all blood sample testing; less blood, easy collection, faster results, simpler testing, better than the best sliced bread.  Going to revolutionize and take over the laboratory industry.

If only it had worked, which it turns out it did not.  And now there are enough bad outcomes to bring in the gov’ment and the lawyers.  It is going to be a very ugly summer for Theranos.


There are tons of opportunity and need for research and improvement and innovation in the medical laboratory arena. But there are some basics (PDSA and basic quality management come to mind) that would increase the odds for success.  

There is always a need for new ideas and improvement, and some basic application of Quality Management would go a long way to move the needle in the right direction.


Tuesday, April 26, 2016

When the VoC is screaming

When the VoC is screaming

Today I received an on-line satisfaction survey from a company that I use regularly.  They are a well-informed “partner” of ours, in the sense that we use their product on a regular basis, and the quality of our program is in part linked to the quality of their product.  That is exactly the type of company to which I will respond.  

These days, every time you go to a store, every time you go to a hotel, every time you travel, you get another survey request, most of which I have found best to ignore, because responding just leads to more surveys.  So I, like I am sure most of you, limit the number of satisfaction surveys that I complete.  I suspect that many of you go one step further and delete them all.

So I open up the survey and the first page has 3 straightforward single answer demographic type questions designed to get some basic information but nothing that could be construed as personal or invasive.  A good start.  The second and third pages are a little longer, but clear in intend with a request for multiple answers, if appropriate.  This is followed by another 4 pages with single questions only.  

And then we hit page 8 and all of a sudden things change.  Now we have 2 grids, each with 5 rows and 6 columns, with a complex set of instructions.  Further both grids are marked as must be completed in order to proceed.  I look to the top of the page to see how far I am into the survey to make a guesstimate on how much more time I am going to have to commit to the survey, but there is not guide provided. 

And my attitude towards this survey starts to change, in a real hurry.  I have three choices.  I can either quit not bother any longer, or I can continue on, row-by-row, or I can send a message.  

And I decide that this is message time.  So I fill in the two grids by random choice just so that I can get to the next page, of which I ultimately discover there are 5 more, all of which get the same sort of treatment.  

On the second to last page I find a text box, in which I comment, “send out crap surveys, get crap information”.  (I found the text box by ultimately getting to the last page and looking for the “Many thanks.  Please leave any additional comments here” box, which did not exist).  Then I hit the “previous” button to find an available text box.

Maybe they read my comment, probably they will not.  What is more likely is that some analyst looks at the collective compiled data, does a bunch of cross-cuts, creates a report which someone reads (or not) and the world goes on.
 The problem with this is that Quality Managed companies actually do need to be able to get information from their customers in order to find out how if they are meeting their needs and requirements.  It is a Crosbyesque as you can get.  

You can get information in a number of ways, one of which is on-line surveys.  There are a lot of other choices, but if done well and carefully, on-line surveys provide a combination of immediacy and directness and distribution that few other choices can provide.  

So if you are going to send out surveys, the least you should do if create them in a manner that optimizes the opportunity for good information and reduces the opportunity for bad information.  

In previous writings [ ] , I created a number of recommendations to increase your potential for good information, which include:

a.    Focus them to a single issue
b.    Limit the survey to only a few questions , best is to keep it to 5-6 and NEVER more than 10,
c.     Make the questions as uncomplicated as possible.

d.    Pre-test the questions to reduce (you can never avoid) ambiguity and
e.    Make sure that it can always be completed in 3 minutes or less.
f.      Never require an answer. That is a guaranteed invitation to bogus information.
g.    Decide in advance which slice of your audience you are interested in and then only focus your energy on that group. General send-outs are a total waste of time.

Now, some 5 years later, these still seem to be very useful rules to live by, although I would probably now raise the recommendation to limit the questions to 9-10 and never more than 12, provided that you don’t break the 3 minute rule.

In our programs, we continue to rely heavily on our surveys for information from clients, and course participants, and organization members. 

There is no doubt that when performed properly on-line surveys are extremely useful.  When performed improperly they are not only a waste of time and energy, they result in poor information and potential poor decision making.

Saturday, April 2, 2016

Making the Healthcare Mission Real

Making the Mission Real
In a previous post [see: ] I railed against the tragic levels of customer service in  Canadian Healthcare.  In as much as being a disgruntled healthcare customer (nobody really wants to be in a position of needing healthcare services) as a Quality person I was appalled at how far off track we have come.  

 If there was a single irritant above all the irritants experienced it was the declarative Mission Statement (however named) Embed patient-centered practices in the delivery of all care and services.”  This might have been written in some aspirational moment of hope, but in reality it was both meaningless and, at least from the perspective of this one observer, galling.  In my experience there was no evidence of any effort to support or justify such a declarative statement.
What it made me appreciate all the more is the concept that Mission Statements have to be more than a bunch of nice words, they have to be credible and achievable in a way that the customer and employees can point to an say “Yes, and good-on-ya”  

So it made me think of all those statements that sound good but are of little use.  They remind me of the Crystalian character Fernando, “It is better to look good than to feel good”.  All SHOW and no GO. 

Here are a few:
Quality is Job 1
We meet and beat all requirements and standards of excellence
We provide world-class service.
We are the world leaders in care.
Excellence in all actions all the time.
(and with apologies to Philip Crosby) “Doing it Right the First Time Every Time”

Mission statements are important.  As pointed out in ISO 9000, the organization's mission statement or policy is its “purpose for existing as expressed by top management”.  If it is not real, staff and customers have nothing to hold on to and either ignore or scoff, or as in this situation get angry.  It doesn’t make the organization better; it makes the organization worse because it provides the opportunity for cynicism.  Good words-No substance.

So here is how I see it. 
There are some organizations that need the Fernando Format.  It is not about Quality; it is about profile and promotion; high profile major manufacturers may need at least as much pizazz as punch.  That is about advertising and promotion.   But healthcare organizations do not fall in that category.  Healthcare needs to “put up.  Period.”  Healthcare needs to be good, not just look good. 

So can we agree that unachievable mission statements achieve little other than make the promotion folks feel good.  So put out the message that we want to be there and intend to work damn hard to get there.  And on that point you can hold us accountable.

Our vision is to be recognized by our community and peers in Canada and beyond as a valued contributor to healthcare delivery and  innovation and as a passionate advocate for continued quality improvement for the benefit of patients and their families. 

Too long?  Maybe, but it  delivers  real measurable aspiration. 

I am open to suggestions for improvement.