Wednesday, July 24, 2013

Laboratory Quality: words or rhetoric?

Laboratory Quality: words or rhetoric?

This month the Infectious Diseases Society of America published a new article (A Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2013 Recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)) in the journal Clinical Infectious Diseases. It is an impressive document and for those interested in laboratory medicine, and clinical microbiology and laboratory diagnosis to assist infectious diseases, it is an impressive document.  It is about 100 pages long and includes 250 references, so it would be fair to call it comprehensive. 
It was an impressive task to compile all this information and put it together in a single comprehensive manuscript.  The authors should be congratulated. 
Unfortunately, despite all these positives and kudos, it not only misses the bull’s eye, in my opinion it by-and-large misses the whole target. 
The shame of the matter, is that the authors are all very well know and well respected microbiologists in the clinical laboratory community; and they know what the target is, or at least should be.  They say right up front “Physicians need confidence that the results provided by the microbiology laboratory are accurate, significant, and clinically relevant. Anything less is below the community standard of care.” And they are bang-on.  I agree entirely. 
So what is their plan to ensure that laboratory results meet those criteria; their answer is that “all microbiology specimens be properly selected, collected, and transported to optimize analysis and interpretation.”  The problem is that this is just far enough off to be misleading and misguided. 
Don’t get me wrong, I think that collection and transport of clinical samples is important, indeed very important.  And if you want a document to help with clinical sample collection and transport, you can consider this manuscript, or better, look at the Canadian Standards Association document “Z316.7-12 - Primary sample collection facilities and medical laboratories - Patient safety and quality of care - Requirements for collecting, transporting, and storing samples”, which I think is eminently readable and applicable. 
Where we diverge from the value of the IDSA article, is that even if the sample is collected and transported properly, that does not ensure that it will be processed properly or accurately, or that the results reported in the clinical report will be significant or  clinically relevant.
While it is true that many, indeed most REPORTED laboratory errors are derived from the pre-examination phase and it is also true that testing accuracy and significance are affected by specimen quality, it is also true that testing, interpretation are influenced largely by laboratorian practice and competency as is the ability to generate a clinically relevant report.  We know that from data generated from our proficiency testing program over the last 10 years. 
In the table below, you can see performance of advanced laboratories (Blue), intermediate (Red), small (Silver) and very small (Green).  

Creating a manuscript that says all the problems are caused by improper collection and transport is an easy out.  “It’s not my problem, it’s not my fault.  Those guys who collected the sample did it wrong.”  “And if they don’t understand my report structure or my report content or my report jargon, that’s their fault too. “  “The problem isn’t me.  I know what I’m doing.  It’s all those other guys (i.e. you!) who are the problem.” “Trust me, trust me.” 
It speaks to the mindset of the authors when the word “Accreditation” is found in a 100 page (about 10,000 word) document only once, and this is in a footnote.  The word “proficiency” is similarly found only once, and not in the context of proficiency testing.  And the word “competency” is not found at all, nor is the phrase “quality management”. 
If clinicians are going to have the confidence that laboratory results are accurate, clinically relevant, and significant we need to be able to document in a public fashion that we laboratorians take these issues seriously and that we undertake the necessary steps to ensure through qualified external assessment that our leadership and sample management and competence and knowledge and proficiency are active and intact.   

PS: The October in Vancouver Conference for Medical Laboratory Quality is coming along nicely.  Hotel space is filling up well.  I suspect we will have more registrations than rooms at the convention rate.

Sunday, July 14, 2013

The Customer you do not have.

The Customer you do not have.

This is an interesting time for me in the Quality arena.  In addition to focusing on my programs and activities including CMPT our proficiency testing program and our POLQM course and conference I continue to be very engaged in standards development in particular with ISO and the Canadian Standards Association (CSA).  The more that I do, the more I find that all these activities interact and evolve together.   Recently that interaction and evolution has become very active in the collective areas of requirements and satisfaction and risk and innovation.  

ISO 9001 has started towards its new iteration for :2015(?) which will see some key changes with respect to the significance of products and services, and variations with respect to quality management principles, but it seems to me it will still address the business customer from the sense of meeting needs, ensuring satisfaction, monitoring complaints, and investigating error. All of these are important because businesses survive on repeat customers who have to be satisfied customers.  I understand this and it makes sense to me.  It is all consistent with the 4 absolutes as iterated by Phillip Crosby way back when.

The same message is carried in the two laboratory oriented documents ISO/IEC 17025:2005 (!) for testing and calibration laboratories and ISO 15189 for medical laboratories.  These two documents address satisfaction and customer needs although not to the same degree or sophistication as ISO9001.  ISO 15189 really only addresses the needs of one of its customer groups (the test ordering, report receiving, report interpreting clinicians) but is not as thorough when it comes to the other critical customer – the patients.
But the point that I want to make is that all these documents are viewing their customers from a singular point of view, the customer that they have now.  While the customer they have now is important, the reality is the businesses cannot survive for the long run if they only consider the customers they have now.  They also have to think about the new customer that they want.  The new customer that they want is the source of growth and opportunity.  The new customer they want is the inspiration for innovation and for positive risk. 
[Most risk documents define risk in the sense of negative risk through uncertainty, making decisions in the absence of thorough information which may result in the bad things happening.  Positive risk is the recognition that decisions can result in good things happening.  More on this later.]
My experience is that innovation is not a domain in which most laboratorians are particularly focused, in large part because the needs and pressures are innovative change are muted.  Hospital laboratories especially in Canada have a locked-in community of users and a locked-in budget. Attracting out-patient activity is not within their mandate, and in some provinces is contrary to budget realities.  Changes occur but within a very limited dynamic having more to do with staying connected with the current commercial technical wave.  
There are exceptions, for example Dick Zarbo, pathologist at Henry Ford Health in Michigan has made tremendous transformation in the delivery of pathology services.  Dick spoke at our last Quality Conference.  In October we will be having a presentation by Judy Isaac Renton, on how public health laboratories under pressure of growing necessity redesign the massive flow of information that gets generated with public health crises like influenza outbreaks.    Increasing public demand and pressure for public health information creates new and novel solutions.  NOTE: You can hear more about this presentation at our Quality Conference in Vancouver in October 16-18, 2013 [see: ]

In CMPT meeting customer needs is critical because laboratories don’t have to use our program; in Canada they have choice.  Meeting customer needs has kept our program viable and going for now 30 years.  But that is not enough because over the last decade governments and health authorities have shrunk the number of laboratories through consolidation making our group smaller and impacting on revenues.  In order to continue we have had to be innovative, shrink expenses, grow products and services, and importantly grow our laboratory base.  We have been hugely successful and developing new and better products and services.  We have to develop relationships with the new customers that we want to attract.

That is especially true for our course and our conference.  Course participants generally only take the course once. Even if they were the most satisfied group of course participants in the world, there would be very few that would take the course year over year.  We need the participants to be an ambassador group that will spread the word and encourage their friends and colleagues to see the value in taking the course.  And we need to develop new and better strategies for creating interest.  It is all part of academic innovation.  New participants, new approaches, new activities;  all to attract the customers that we want, but do not have yet.

The focus of laboratory Quality is changing and those at the forefront need to be aware and be prepared to lead.

Thursday, July 11, 2013

Quality and Social Networking

Quality and Social Networking
Paul Borawski asks an interesting question about the use of Social Networking by Quality Managers [see: ] 
I have to tell you that every time I hear the term “social network” I think of West Side Story and the song Gee Officer Krupke  that includes the line:  “Hey, I got a social disease…”  I don’t know if Stephen Sondheim appreciated that he was writing for the ages, but I think he pretty much nailed it with the line “It’s not I'm antisocial, I'm only anti-work”. 
Social networking, in all its manifestations is more about anti-Quality and about pro-Quality.  It’s about wasting time, and letting your ego get ahead of the thinking part of your brain.  It has more to do with addiction and self pleasure (dare I say the “M” word?) than about constructive activity. 
Is there anything really productive about Facebook or Linked-in?  Not very much.  Lots of pictures, lots of writing, lots of trivia and fun, and lots of minutes and hours consumed.  No wonder so many companies and organizations block access.
But the social network programs are part of our world now and some of it, used sparingly, can actually verge to the edge of being productive. 
Take Twitter for example.  Whatawastatime.  Pretty much a total self amusement for narcissists who think that folks should care about what they ate for dinner.  But in certain situations Twitter can be a powerful notice provider when there is a crisis.  For the Quality team, 140 characters is pretty much all you need to let folks know to look in the manual for a notice of document change, or to check the office white board for a procedure notice.  Yes, you can do that all by sending a group email but it is easier to send with Twitter and a lot easier to receive, provided that reading Tweets is reserved for when you are NOT doing critical activities. 
And how about Blogs? Again, pretty marginal.  For some, 700 words is about what they need to put together a cohesive cogent argument.  Blogs can be a structure to substitute for self-published manuscripts.  Readers need to be really careful and really selective because of the absence of a professional or peer reviewer of editor, but occasionally the information can be, if not useful, at least interesting.  For me, I have always been a diary writer; I think better when my hands are busy.  So for me, my blog is as much personal as it is public.  But I do understand that some folks see blogs as strong manifestation of self-absorption. 
As a provider of education courses, I personally find You Tube as a powerful tool for sharing video information with course participants, and there are tons of really good examples on You Tube of video procedures.   In the “olden days” creating video meant going to a studio and paying a whole wack of money to put together a series of teaching clips.  Today you can do the same thing for free and in less time, making it possible to provide regular video updates.  If there is a downside to the  ease of use is the temptation to generate clips that are too casual.  Take the time to create work with polish. 
Where will we be as time goes by?  Who knows.  Over the short term probably we will see more of the same.  But with the internet the one thing that is certain is that there will be change and innovation and new ways to while away the time.
PS:  Our Vancouver conference on Medical Laboratory Quality is shaping up really well.  Vancouver is a great place to be in October.  I look forward to meeting your there.  For more information, visit  [ ]

Saturday, July 6, 2013

Meeting Student Needs in Academia

Meeting Student Needs in Academia

If Quality is important to you, then it doesn’t matter what is the field of interest.  The principle of meeting customer needs has be a central determinant of success.  That is why we take the participant evaluations from our UBC Certificate Course in Laboratory Quality Management seriously.  

At the end of each teaching module and again at the end of the course we have a survey completed.  It is not a mandatory requirement but we make several urgings as reminders along the way.  Generally we get a response rate between 50 and 75 percent.  We could make responses mandatory and we could make answering all questions mandatory, but all we would do is increase the likelihood of deceptive answers.  (I have mentioned this before.  All the on-line survey programs offer the ability to make answering mandatory.  Just because you can doesn’t mean you should.  If you want more reliable satisfaction surveys, look at entry:  )
Anyways, back to the issue at hand.  From my perspective, I think we had a good year.  All people who started and completed the course ended up with a successful certification.  The range on performance was between 96 and 73 percent with a median performance of 88.  

There was a small group who started the course, but stopped after a few weeks.  This is not an uncommon event with continuing education for volunteer adult learners.  There are always good reasons; workload, illness, family circumstance, other priorities.  To be honest, I can’t  be too hard on folks that drop out.  Last year I started a second level conversational French course but dropped out after I missed 4 weeks due to work related travel; an example of poor forward planning.
On the positive side, there was support for our overall course in almost all aspects, from meeting all our objectives, to faculty meeting participant needs, to overall rating, and the absence of bias.  

There were some opportunities for improvement as well.  Most of the books and standards that we provide are viewed as valuable for the course and the sort of books that will remain is their personal libraries for ongoing use.  Others were seen as less helpful.

There are others that find problems with the quizzes and assignments and final examination, either because of load of work or the style of questions.  That is a bigger problem because it we want to have a course that we can provide on a certification basis, we need to be able to have an evaluation system.  Maybe it is an issue of volume.

The bigger problem is that every year there are some students (always a definite minority) who complain about our small group virtual-classroom experience.  I think it is very important and learning theory promotes small group discussion as valuable tool for learning.  The problem is that some folks choose to not participate and that can interfere with the learning experience for the others.  Some folks really get upset when their group falls apart because they have too many non-participants. 
The problem for me as the program organizer is that both groups are right and the faculty has to work this through.  We can’t force people to participate in small groups.  These are adult learners who know what they want to learn, and how they want to learn it.  Even if we think that small groups are a good thing, some folks love the classroom experience, and others don’t.  It’s not about good and bad or right and wrong; it is personal preference, and imposing our interpretation of pedagogy is clearly not meeting some customers’ needs.  It is self-defeating to try to be hard line about this; don’t work with your small group then you don’t get your certification?  Not a good or constructive plan.  It’s back to the topic of making things mandatory.
I think when we have our faculty meeting later this month we will need to figure out changes that we can balance the needs of folks who are comfortable with group participation and the needs of those who are not. 

This year we have one of the participants from the course giving a presentation at the POLQM Quality Management in Laboratory Quality Management conference in October 16-18 in Vancouver [see:  ] .  The subject will be on the value of Quality Management education as a part of medical laboratory training.   I am tempted to expand this to a bigger session with a number of speakers and follow up with a panel discussion.  

Looking forward to seeing some of you at the conference.  If you do get a chance to attend, find me an tell me you are a blog reader.  Cup of coffee - on me.