Giving Back and Paying Forward - 2023

In the sciences, Quality is NOT about Elegance or Specialness or Brilliant Ideas. Quality, especially in laboratories, is defined by the specifics of meeting requirements and performance. Quality provides the cornerstone for confidence through error awareness and prevention for precision, accuracy, and reproducibility, and relevance. 

The Quality Tools are essential in medical laboratory research and performance.  People's lives may depend on laboratory information.  Done well, laboratory research promotes new knowledge, new understandings, new vision.  Done poorly, it wastes time, wastes money, wastes resources, and creates harm.

I would like to think that understanding the importance of Quality is innate, but that would be expecting too much, but it most certainly is a skill that can be learned and passed on from one-to-another. 

Our university department is quietly worked at promoting laboratory quality improvement through the creation and management of 3 separate laboratory quality assessment (PT/EQA) programs, one in microbiology, one in clinical chemistry and one in tumor marker testing, all of them active in across Canada and international. We created an intense program for assisting countries already with EQA programs how to upgrade their offerings to link their programs with the expectations cited in ISO15189 (ISO15189 does NOT specify the requirements of EQA, but it does point out what medical laboratories should be expecting and looking for in EQA programs). And most recently we have been working with another program to help developing countries develop more EQA tools for their local laboratories, thus freeing themselves of the foreign programs with large costs and little relevance. 

This was not the career that I envisioned when I started my laboratory training in 1975, but I personally feel much pride in carving out was has turned out to be a very successful path for myself and for laboratory quality. I am thankful for having had the opportunity to work in a truly inspiring field,  and am proud of what I have been able to do to influence and (hopefully) inspire hundreds of students. 

So now I am starting on a new path of giving back and of paying forward. Over the last year we have developed the Michael A Noble and Family Award in Laboratory Quality which is founded on a sustained endowment to our department to highlight and reward Quality focused projects and presentations of graduate students and medical residents and course takers in our department. Last night we presented our first award to a student who has been looking at factors that can impact the survival of donor platelets, necessary for people with bleeding due to severely low platelet counts (thrombocytopenia). 

By highlighting projects and presentations that lead to new understanding and knowledge and insights in Laboratory Quality and Improvement we can help lead to further advances in Pathology and Laboratory Medicine. More importantly (in my opinion) through this recognition, we can spawn lifelong commitments to addressing and highlighting and embracing laboratory quality as an essential component of laboratory discovery. 

We look forward next year's Pathology Day 2024.

Quality upside down and backwards

Warning:  This entry is deeply in the weeds.  If you are not a ISO-wonk or Qualitologist, this will drive you crazy.  For a quick read, jump down to the last two paragraphs.

The International Organization for Standardization (ISO) is a crafter of standards, but NOT creator of original thought.  Ideas exist, usually from other international organizations, but taken to their origins, from true original thinkers.  For example ISO/IEC 17025 first came to life as ILAC Guide 25, a document created so that international accreditors could have a single source against which to assess laboratories.  Similarly ISO9000 was derived from a combination of a British Standards Institute document and a UC Military Standard and another from the Canadian Standards Association, but ultimately they were derived from the teachings of Deming and Juran and Crosby.

The concepts of Plan-Do-Study-Act, Risk, Document Control, Corrective Actions all long proceeded their appearance in documents published by ISO.  Think of ISO as the iterator or popularizer or disseminators of ideas rather that a creator.

In my laboratory when we actively decided that this stuff called TQM or Quality was something that we should look at, we learned  about it through books (read Ray Bartlett’s classic Microbiology Laboratories: Quality, Cost and Clinical Relevance) and guidelines many from the organization then known as NCCLS (now CLSI). 

We had looked at the recommendations and guidelines on how to write an SOP or how to set up document control.   The nice part was that the books and guidelines that I learned from were written as books and guidelines whose primary task was to teach.  And importantly there was no pressure.  

I could take the information as given or fiddle with it or ignore it.  My laboratory, my choice.   

Today it doesn’t work like that.  Today laboratories generally don’t start from scratch.  They start from the perspective of what is written in ISO standards or from the expectations of an accreditation body.  And that is tough because ISO standards are not, were not and never will be designed as tools from which to learn.  They are designed as documents for rules setting. 

So here is my problem.  

For the last 17-18 years we have taken the view that the way developing laboratories need to learn about implementing Quality is NOT to start from the perspective of basic components, but rather to start from obeying the dicta of ISO.  And so far that idea is not working particularly well.  And further when we assess their progress we do it against an accreditation level standard.  

Recently I was in conversation with a person very involved in monitoring progress of laboratories in a developing country and was told that the laboratories were not doing particularly well by their measurements as assessors.  I knew what the problem was; it’s was not that they had no written SOPs, it was that their SOPs did not meet the requirements of ISO.  So what!!!

These laboratories are just learning about quality management and importantly, there were no small laboratories from developing or evolving countries that participated in any part of the ISO process.  They had no opportunity to object and make the point that the standard as written was not designed or intended for them.  This is really a round hole-square peg situation.  

We should be promoting them to learn and discover Quality in the same way as we did; start from having a purpose and finding a solution.  Allow them to play around with different versions of document management, or risk, or SOP production.  Allow them to discover and appreciate value and then refine.

 We should NOT be using ISO standards to promote quality in these laboratories.  

And ANY person who answers a question by saying “we do it this way because that is what is said in ISO15189” should be thanked for their service and shown the door.    

The Quality Tree Reenvisioned.

A teaching exercise (and more)

So I was going through my regular update and revision exercise for my presentation files.  I find it I don’t do this regularly, they can get very stale, and I get bored talking and teaching about Quality.  I suspect that I am not alone.

Anyways the target audience this time is medical laboratory physician trainees.  I don’t think I am giving away any secrets when I say that this is always a tough audience.  Most of this group have a singular attitude about quality which is unfortunately “What????  DKDC!!!”  or, for those uninitiated, “Don’t Know and Don’t Care”.  

It is usually, almost always the case that Quality issues are never front-of-mind until they are in positions of responsibility and confronted with a problem, usually an unhappy doc or patient of staff member who has become entangled with an laboratory error, and find themselves trying to dig themselves out of a mess.  (It’s the same with safety)

Fortunately we are able to get enough face-time that they may have some idea about where to start.

So one of the concepts that I have worked with over the years is the Quality Tree.  Don’t think of Quality as a pyramid with Policy being at the tip-top and its effect trickling down; rather, invert that pyramid and put Policy at the bottom, as the foundation, with its impact shoring up the rest of the process.  From there it was an easy step to creating an analogy as a Quality Tree with the roots that give support and nourishment as Policy.

But recently as a result of our working on and achieving the recent certification of our laboratory’s quality system to ISO9001:2015 (YAY !!!), I realized that this was a good step in the right direction, but was still incomplete.

Organizational Quality does NOT start at the level of Policy making; it starts with asking the most basic of questions,” (1) who are we and (2) what are we doing, and (3) what do we want to be when we grow up?”  

Quality starts with Top Management envisioning the organization’s Mission and Vision and setting the organization’s Goals and Objectives. 

Once those are in place, then all the rest can and will logically and consistently  follow.  

For the purpose of this re-positioning of activities, I set up a set of definitions, that work and make sense.  Mission and Vision are general statements about who we are, what we are doing, and what we want to become.   

Goals and Objectives follow on from the Mission and Vision, and are very specific and focused on what we expect  to be doing now, and in the near and intermediate future.   

Mission and Vision and Goal and Objectives  are the real drivers of our Policies and our Quality System.  This is what really nourishes Quality.

Once those are in place we can create policies and processes that are consistent with our plan, and procedures that follow.  The fruits of our labour are not only our products and services, but our Quality message as well.  And we can then point to our need to disseminate that message, through a clear and distinct error-free and consistent documentation pathway.  

And Top Management is the gardener whose task it is to care for and nourish the Quality Tree and ensure that it remains healthy and vital and strong.  

I know this is sounding pretty “in the weed’ish” but in my mind it all becomes clear through my new Quality Tree picture.  

Quality is like every other subject that has both academic and practical applications.  I don’t think these applications can be easily separated.  If thinking people don’t understand the foundations, then applying the practical rules is done only by rote, and all too often gets screwed up.  And equally important, if the academic purists don’t appreciate that Quality is not theoretical, it has to be applicable in a way that makes sense.

So for me, the picture works.

If, upon consideration, it also works for you, use it. I put it out here in the spirit of open access.  

Or maybe I have too much time on my hands.

Our 2017 October Quality Conference is coming together nicely

Sunday October 1 – Tuesday October 3, 2017

All our subjects are in place

All our speakers are in place

Our venue is contracted 

http://conference.polqm.ca 

More news to come.

Teaching Quality – Part 3: Practical Suggestions

In the previous parts of this series I have addressed that education theorists have long ago determined that adult learners are different.  When it comes to learning, the adage “adults are just big children” does not apply.  Andragogy is the theory (science?) of mentoring adults is not the same as pedagogy (mentoring children).   The challenge and message to us is that if we want to mentor our adult co-workers about Quality Management in the workplace then we are well advised to use the mentoring and teaching skills that work best for adults.  

The problem is that most of us (a) are busy learning ourselves about quality (b) have never sought out training as teacher/mentors and (c) don’t know, indeed have probably never heard words like andragogy or pedagogy.  The best we have to go on is our past experience as learners, which was unfortunately mostly during the time of our own childhood and adolescence which usually means standing in front of the group, usually with a PowerPoint file and drone on, point after point, for 40 minutes and then ask if anyone has any questions.   And then wonder why most wander out, no questions asked, and usually no information absorbed.

Adults like to learn what they want, when they want, and are very specific in their expectations.  Adults highly value their own experiences and usually like to share them, and importantly prefer learning by asking their own questions rather than by being pumped by others.  And if it isn’t working they move on.

We also have another problem; many of us work in organizations like to talk about continuing education, but rarely like to support it with time or money or resources or even top management engagement.  

So many of us step up to the plate with two strikes against us before we even get started; we don’t really know what we are supposed to do, and tend not to have the money or resources that we think we need.  

So with that sort of an ugly start, let me share some ideas that will allow you to mentor Quality more effectively.  That way when you do get some money, you can save it up for a bigger ticket item, like supporting a special speaker, or sending someone to a Quality conference, or perhaps subsidizing a person taking a course.  Some of these come from Roberta Silfen’s book Teaching the Adult Learner; others are mine from my own experience.

First off, avoid the turn-offs.  Forget the sign-in sheet.  The notion of mandatory training is a crock.  Mandatory education is something that kids get.  And keeping “numbers of people taught” as a metric is a fool’s joke.  The point is not how many bodies were there, it was how many brains you stimulated.  If you really want to know how successful you were, try have a BRIEF post session satisfaction questionnaire.  

 
And if you are putting on successful mentoring sessions, the audience will either coalesce into a small core of the focused and  interested, or will grow.  

Try an “open mike” session by giving people the opportunity to share their experiences on Quality.  A person stands up and tells a Quality story, and then the audience can ask a few questions about it.  In an hour you can get maybe 4 or 5 speakers.  You get a chance to understand what your colleagues think about Quality.  The Quality Manager can introduce the session and perhaps do a summary at the end and maybe start the questions off, but otherwise keep quiet.  This is not your time to speak; it is your time to listen. 

Try an interview session.  Set up two chairs at the front of the room.  You invite perhaps the laboratory director to participate, and have a Quality interview.  What does Quality mean to them?  Did they learn Quality through courses, or was it something that they learned to experience and osmosis?  The point is not to pin them to the wall, or show off how smart you are or to throw in the gotcha question; the point is to give them the change to engage with the staff on why Quality is important for your laboratory.  Staff might even get a chance to engage in some of the questions as well.

Try the journal club approach, where the Quality Manager finds a Quality oriented article or book (article is better) and share it with the group in advance.  You might want to consider, for example, taking one or two blog entries or a current newspaper article, both of which might be ideal because they tend to be short.  Someone presents the article and then gives their opinion which might range from “pearls” to “pin-cushion”, and then open the article to discussion where folks can relate to their own experience.

Try a lecture, but do it in an adult fashion.  If you have 50 minutes for a session, don’t lecture for any more than 25.  Appoint someone as the question person who can start off with two or three questions, and then open up to others.  

The bottom line is always the same.  Put out the information towards adult mentoring and learning strengths.  Don’t hog the time.  It is not about you.  It is about exposing your adult staff to new ideas.  Keep things moving, and allow your audience to get engaged, and participate and share.

So, what do you think?