Labquality Days: A Quality Adventure

Labquality Days: A Quality Adventure

Over the last while I have had the opportunity to attend a number of laboratory quality oriented conferences; Laboratory Quality Confab in San Antonio (held this year in New Orleans), Seeding Knowledge conference in Jeddah, our own POLQM Laboratory Quality Conference in Vancouver, and most recently LabQuality Days in Helsinki Finland.  Each has been a unique experience and each equally excellent with its own features. 

Of the group, LabQuality Days has had the longest run; this year was the 43^rd holding, going back to 1973, apparently without a break.  I could be wrong, but that must be the longest run for a medical laboratory quality oriented conference anywhere in the world.  

Apparently over the years there have been both lean and abundant attendances.  This year there were about 500 people split into two simultaneous sub-conferences, one held in Finnish, and the other in English.  The Helsinki Conference held the session without any difficulty.  

I can’t speak about the Finnish conference in large part because my facility in Finnish is non-existent.  (Apparently I am not alone.  I am told that the only place where Finnish is spoken is in Finland.)  But I can say that as I walked by their sessions in the main auditorium it was always full.  The international conference was held in a smaller room for about 200 people and it was always well attended as well.

The international conference had a dual theme: Pre-analytics and Point of Care; two topics with a lot of current interest, obviously with widespread appeal.  The speakers were widely distributed from Canada (me), Australia, and an array from across Europe including Norway, Denmark, Germany, Portugal, Lithuania, UK, the Netherlands, and Switzerland.  Apparently that was only a small subset of the total group distribution; in total there were folks from 26 different countries.   

I probably shouldn’t speak for others, but I leaned tons, and was really happy that I had attended.  

The meeting was started by the keynote speaker Bruce Oreck (a former American Ambassador to Finland) who talked about the state of highly disruptive change that is impacting business in general and by inference the medical laboratory.  Bruce is not the first speaker to raise the topic, but certainly was very effective.

To my mind, the person from who I learned the most was Anne Stavelin, from the EQA/PT program in Norway (NOKLUS) who was very much in the disruptive mode herself.  Norway was recognized that the primary user of Point of Care tests is NOT the hospital laboratory or emergency department, but is the family docs in the community, and also recognizes that they also have an obligation to be competent and deserve the opportunity to learn through quality assessment.  Astoundingly in a country of 5 million people, NOKLUS has almost 5 thousand clients participating in EQA associated with POCT.  For the arithmetically challenged, that means that close to one out of every 1000 people (0.1percent) living in Norway is involved in quality assessment.  The mind boggles.   

For the anatomic pathology folks Pedro Soares de Oliveira from Portugal was pretty disruptive as well as he talked about how much the preparation of glass slide samples for pathology analysis continues to be an “art “ rather than a “science” still dependent on touch and feeling rather than precision and standardization.  I wonder how one would calculate the measurement uncertainty of the impact of sample reading and interpretation and diagnosis.  Clearly the times, they are a-changing very soon

I am really happy that I have had the opportunity to be introduced to this meeting.  Better late than never.  This will not be a one-off attendance.

A warning to folks not living in northern climes; the weather is not nice, but the hospitality  and meeting  and greeting and learning opportunities abound and far out way the inconveniences of some rain, or snow and cold.

PS:  We will be continuing to host our POLQM Medical Laboratory Quality Conferences  in October in Vancouver.  I am not sure that we will hold 43 conferences under my management, but maybe with my successor?

The Laboratory Exoskeleton

One of the advantages of attending conferences is all that empty time that occurs while sitting on the airplane on the way home.  I know that many people would not see that as a plus, but this is one of the few moments in time when your mind is set into motion having absorbed all sorts of information – some new, novel and excellent, some maybe not so much.  There have been conversations, again some routine, but others very intriguing and stimulating.   And now you find yourself on the airplane, usually alone, contemplating and reviewing and contextualizing. 

That opportunity rarely comes along, except in the situation as described. 

On this occasion I was returning home after attending the Labquality Conference in Helsinki for two days, and was now spending what was feeling almost as long sitting in airports and airplanes waiting to get home.  

The conference was excellent; interesting people, interesting topics, interesting ideas.  Much more on this later.

The two themes of the conference were Pre-Analytics and Point of Care Testing.  (Personally, I think the term Pre-analytics is incorrect; the correct term would be Pre-Examination.  That being said, I agree that pre-analytics is easier to say and easier to write.)  This was not particularly surprising because these have become very hot topics in the medical laboratory arena over the last few years, with Quality folk interested in both, each in its own distinctive way.  The two topics were presented on sequential days to pretty much the same audience.  As much as they are very different topics, they felt they were  kinda-sorta related.  

So I came up with a way to formally put them together. 

During the “Pre-analytics” portion of the conference, every presenter, including myself came up with a slide that showed a version the Total Testing Cycle or the Laboratory Testing Cycle.  You know what I am talking about:  It goes from the Patient to the Pre-Pre-Examination Phase to the Pre-Examination Phase to the Examination Phase and on to the Post-Examination and Post-Post Examination phases and then back to the Patient.  I think of this as a linear horizontal pathway.  

It works, but focuses on one aspect of the laboratory activity, specifically the testing process. But it leaves out a lot of other stuff that is equally important; laboratory Quality, laboratory Safety, laboratory Communications.

So I have put together another schema,  this based on a core, a layer of activities that holds the core together and intact, and related activities that occur outside and separate from the laboratory.  I think of the layers as:

The laboratory core:  the central activity of laboratory testing.  It is the laboratory analysis activity area.  This is the testing activity that occurs within the four walls, the ceiling and the floor of the laboratory space.  

Exo-Analytic Layer:  The layer of activities that sits outside the testing core and serves as providing support and binding. The prefix "exo" means “outside but an extrinsic part”.  Think of this as the exoskeleton of laboratory activity.  This is the layer that includes Quality, Safety, Communication and Education, plus others.

The Extra-Laboratory Layer:  The layer beyond out side the Exoanalytic.  The  prefix “extra” means outside and separate, but may be related.  This would include activities that includes transport and legislation issues as well as home and residential considerations.   

These days this schema gives a way to indicate that Point of Care Testing crosses into all aspects of the laboratory with a very small component being part of laboratory testing, a larger amount being part of the exo-analytics, and an even larger part in the extra-laboratory.  

The advantage of this layered view is that it makes clear that some exo-analytic activities have important associations with laboratory testing, others have associations with the outside community, and others have both.  Each has to addressed in its own way.  

Over time I will refine the model.  Today I think it works; I will see if it continues.

Important message to self: the long sit on the airplane can be filled with moments other than Sudoku.   

Voice of the Customer (revisited)

Voice of the Customer (revisited)

I have written on the subject of customer/consumer/complainer voice many times (see for example: http://www.medicallaboratoryquality.com/2012/11/voc-voice-of-complainer.html ).  Asking for, and acting upon input from those that use your product or service is about as Deming as you can get.  Without that input there is no “S” for PDSA.  

Without feedback there is no Crosbian Quality until it is too late.  If you don’t ask, then the only way to discover that you are not meeting customers’ requirements is when they walk away.

So asking is not only important, it is critical, provided that you do it in a way that invites the responses that you want and need (see: http://www.medicallaboratoryquality.com/2011/06/satisfaction.html ).

But for every “ointment”, there is always the probability of the “fly”.  (Said another way, for every silver lining, there is always the dark cloud).   To stretch this analogy sequence one more time, what do you do when you send out your party invitations and still nobody shows?  

 
My point is that writing the perfect survey doesn’t cut it when nobody responds.

So let’s go through the possibilities.

Personal error:  You created the survey but forgot to actually send it out.  Oops – dummy!

Technical error:  You tried to create the survey but copied the link to the survey incorrectly, so that people who tried to respond could not find the survey.  Oops again – dummy dummy!!

Tactical error:  You created the survey and sent it out correctly, and yet many did not receive it.  That actually can be more common than you think.  There are some (many?) employers that do not allow surveylinks  into their email system. 

Selection error:  You picked and focused on the wrong audience.  Folks who are one time or sparsely intermittent users are rarely sufficiently interested in giving an opinion, although that may be a really important group to try and nurture; what is it about what you are trying to do that elicits indifference.  And is there something that you can do to change their attitude and interest?

This is actually a long preamble for me to express my own personal frustration.  I work in a world with a lot of folks interested in Quality.  We have that in common.  I provide a service for which they or their employers pay for them to participate.  That should make many of these folks “motivated customers”.   I know they receive the invitation to participate and I know the link works, but if I get a 50 percent opening up the survey rate, that is an exceedingly rare event.  Indeed it is rare that I ever exceed 33 percent.

Frankly I don’t get it.  We promote the survey only and with the information on why it is important.  The survey takes less than two minutes to complete.  The vast majority of information can be addressed by choice buttons, so that they don’t have to write anything.  There are multiple ways that their anonymity is protected.   Any yet not only do they not respond,  many don’t even open the survey.

Being involved in Quality usually means being interested in expressed opinion – of theirs and others.  In my experience, Quality oriented folks are rarely shy about expressing their mind, and inviting others to do the same.  And yet many, (far too many in my opinion) are comfortable in bypassing an open invitation to be involved. 

But let me be really clear.  Of the folks that do participate, we are really pleased with their opinions.  Most (YAY!! ) and pleased with what we are doing, others maybe not so much (kind of yay).  While we can’t respond directly back to the critical or positive folks (the downside of anonymity) we can be collectively transparent by sharing the results, which we do.  

Sometimes I speculate about sending out a survey to discern the characteristics of survey responders versus survey non-responders, but that would seem to be a hopeless jump down the wrong rabbit hole.  

When there appears to be no solution, does that mean give up and move on?  

Not very likely!!!

The State of North America Laboratory Quality 2015

The State of North America Laboratory Quality 2015

Earlier this week I was invited to participate in the 2015 edition of Robert Michel’s and Dark Daily’s annual Laboratory Quality Confab held in New Orleans.  I was the third speaker in a symposium on the challenges facing US laboratories.  The lead speaker was Ellen Gabler, a journalist with the Milwaukee Journal Sentinel who had written a number of articles on the questionable quality of what the Commission on Medicaid and Medicare Services (CMS) and the Clinical Laboratory Improvement Act (CLIA) refer to as unwaived tests, i.e. tests that are so easy to perform correctly they require no quality assessment, and on the state of laboratory inspection (accreditation).  [in a nutshell… big glaring problems abound with both].   

The next speaker was Elissa Passiment, the Executive Vice President for the American Society for Clinical Laboratory Science and importantly the head (former) of the Clinical Laboratory Improvement Advisory Committee (CLIAC), the body that reviews activities associated with CLIA and reports to Congress.  Elissa talked about the challenges that CLIA has posed, and continues to pose to US laboratories.  And as she put it CLIA has become a driver to the bottom rather than an inspiration to excellence (Those aren’t quite Elissa’s words, but certainly the sentiment!).

I talked about Quality Partners (a favorite subject of mine) [see: http://www.medicallaboratoryquality.com/2014/12/competition-and-quality-partner-dynamic.html ] , emphasising both their strengths and weaknesses and how laboratories need to progress through the development of Quality Progress Plans, basically a page out of the newly published crown document of organizational quality, ISO9001:2015. 

I thought the symposium went well, although my guess is that it was way over the heads of most of the audience.  While I give them all points for wanting to be at a laboratory quality conference, for 80 percent of the audience this was their first time attending.  More importantly, and without putting too much importance on show of hand displays during conference presentations,  when I asked how many worked in laboratories where they regularly performed internal audits or if they maintained an Opportunities For Improvement list, for both questions I got about a 10-15 percent response.  So their notions about quality are not really yet on the foundations of quality improvement.

Of interest to me, following my presentation, Robert Michel asked me in front of the audience with microphone in hand, how I felt about Canada being a country with provincial control over laboratory quality and would we do better if we had CLIA. 

My response was that it is a tragedy that in Canada our federal government has never engaged in a process, voluntary or mandatory to insist on an across-the-country approach to laboratory Quality, leaving a true hodgepodge mess.  But on the other hand I thank my lucky stars that we do not have to put up with the tired and obsolete mess that the US Congress has made with CLIA.  

 If there is a true and singular tragedy it is that in 1967 the US Congress create a ground breaking approach through the creation of a quality concept, but over time, with the introduction of lobby power over quality power, and political expedience over any interest in patient care, CLIA has fallen from being a force for quality to one of the exact and very opposite.  CLIA today almost guarantees Quality-by-luck rather than Quality-by-design.

Even a quick look at CLIA rules today points to the absence of quality assessment for the vast majority of tests, the absence of any semblance of clinical appropriateness requirements, test acceptability tolerances that one could drive a Mack truck through, and a series of silly regulations about who you can and cannot talk too, or how many times you can or cannot test a proficiency testing sample as if any of that is monitorable or has anything to do with Quality.  What it speaks to is how poor regulations lead to gaming rather than improvement.  

Tired, broken, lack of innovation.  Not at ringing endorsement.

Given the choice, between Canadian hodgepodge and American tired-obsolete, I think if I really needed to have a laboratory test performed today, I would have far greater confidence on the accuracy, quality, and interpretability of the test performed in a Canadian laboratory.

Today we have a new government in Canada with a 4-5 year majority mandate (in other countries we would call that a benevolent dictatorship), and perhaps a new opportunity for a new beginning.  Perhaps this is the right new time to start communicating with my federal government contacts.