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.

Monday, March 28, 2016

Cum Minus Facerent Malum

Cum Minus Facerent Malum

It was not our plan, but my wife and I had quite the adventure this weekend.  We set out for a relaxing urban adventure but in the blink of an eye the adventure turned to rushed visits to two Emergency Departments and some emergency surgery.  A few days have passed, but it has given us the opportunity to reflect on what went well and what did not.

First off we do understand that we live in a busy big city and this was a vacation weekend, but taking all that into consideration, this still would not be considered a totally happy experience. 

A little background first.

In Canada, our healthcare story has been quite a ride.  At the beginnings of Canada the crafters of the country’s confederation saw health care as a matter best left to the province.  It was not that big a deal or interest for a national government to get engaged with.  All that changed almost 50 years ago (to the day) in 1966 when the federal government decided that if healthcare was going to be seen as equal sea-to-sea-to-sea, the feds would need to get engaged, and made an absolute commitment to contribute 50 percent of provincial costs.  Public attitudes were mixed, but the politicians of the day knew better and so the path was set.  It was written in stone. 
It took about 10 years to figure out that this was costing a bomb and government of the day decided to erase the stone and renege on payments. The stone was re-written with a new written in stone commitment called the Canada Health Act.   

Ever since the creation of the new Act, the Canadian system has been progressively gutted, less and less federal funds, and the closure of mental health hospitals, and consolidation of health facilities, and continuous reductions of staff.  It has been an experimental Leaning of healthcare on a national scale, without any Keizen.  (If only they had implemented a Poke Yoke – error prevention – program).

All of which brings me to this weekend.  We were sent to one gutted emergency department to find overly busy, swamped folks trying to cope.  The emergency doc, did what he could do and then we were put into a taxi to go to the the other
ER because they were the only ones who had an appropriate surgeon working that day.  

It felt like we were living an episode of M.A.S. H. 

At the other place the mess was infinitely bigger with stressed out staff absent of any vestige of interest or care. After being shuttled around we ended up sitting with a herd of patients in an open corridor without any interest or care or food or medication or even water.  (When I told the staff my wife was in a lot of pain, the nurse on staff to me to get out of her staff room).  This in an institution that proudly pronounces its mission statement “Embed patient-centered practices in the delivery of all care and services.”

After too many hours in the back hall we were finally seen by the appropriate surgeons and had the definitive measures completed. 

So when the smoke cleared, if you use life versus death as the outcome measure, our adventure was a roaring healthcare success; but by any other measure, not so much.  

The number of Opportunities For Improvements were far too many to enumerate, with the exception of the one where the first ER informed the second ER that we were coming but got the name totally wrong, so that when we arrived, no one knew who we were or what was going on.  Of the ones that I will not mention here, two were serious breaches.  Not many, perhaps, but those were the ones that I observed in one afternoon on one day, and I wasn't seeking them out.  

So as much as this sound like a personal grumble, that was not the point.  It is to make the point that for the last 50 years politicians and consultants have made step after step, to get healthcare under control and they have failed miserably.  All the major Leaning initiatives have been failures.  The care has not got better, it has got worse. 

As a Quality oriented healthcare person, this gives me serious pause.  What we are seeing is a lot of Doing and Checking and Acting but either with NO Plan or worse a TOXIC Plan. Deming would be shaking his head.

Nobody can be proud of this mess.