Tuesday, July 22, 2014

Quality, Standardization, and MH17



We live in a complicated world; events overtake events.  Today we are learning more about the blasting of a Malaysian airplane out of the sky, killing 300 people.  It must be horrible for the families, friends and colleagues of the people killed.  

There are so many moving parts to this tragedy.  If the airline had flown a different route, If two neighbouring countries were not in dispute, if rebels weren’t committed to shooting airplanes out of the sky, if countries had not provided them with sophisticated arms capable of pinpointing targets 33,000 feet away, things might have been different.  

Many of the people on board were en route to the 20th Annual Meeting for HIV, this year in Melbourne, which got me thinking about the risks associated with work related travel.  

In the last while there have been a number of airplane mishaps including for example Malaysian Airlines 370 (the missing airplane) and a series of near misses in airports across the United States and around the world.  I understand that people make choices but I wonder how often travel related risk ever rises to a level of conscious consideration when it comes to attending meetings.  

This is not a new theme for me; I was one of the organizing committee that had planned an international conference on proficiency testing for September 21, 2001 (The meeting was postponed for a year).  I have also spent most of my career attending international conferences in microbiology and standards development.  

This is only a guestimate but there are approximately 300 organizing and technical committees associated with the International Organization for Standardization.  If on average each TC has 80 regular attenders going to ISO plenary meetings; that would represent some 24,000 annual travellers.  If in addition, each of those TC has 4 workgroups or subcommittees that meet annually with 25 people attending, this would mean an additional 30,000 annual world travelers, adding up to over 50,000 world travellers attending ISO related meetings.  

So, taking aside the costs associated with 50,000 annual travelers (well in excess of $100,000,000!) one has to wonder about whether or not it is time to re-evaluate the role and necessity of routine travel to attend standards development meetings.

So with this in mind, I argue the most common reasons that travel related on-site meetings are regularly held.

A: The most important part about meetings is that people meet. 
This is the most compelling argument for on-site meetings.  People of like mind get together.  Sometimes the creative spark occurs and new ideas are spawned.  In my experience these moments do occur, albeit rarely.  Most of the time is consumed with pretty routine discussion and social interactions among friends.  But people do meet and sometimes brilliant things do happen.

B: Meetings are more productive when you can see the folks face-to-face.
This is dubious at best and nonsense at worst.  In the standards development process, when people get together we see the whole array of behaviours, many counterproductive.  For every one person who comes prepared and has read the documents there are multiple others who have not.  The process of consensus is often over ridden by the loudest voice, or the orchestrated voice, and the silencing of the ignored voice.  All too often documents are created despite the meeting rather than because of the meeting.

C: Meetings create opportunity for all to attend and participate in one place and one time.
It is true that finding an on-line time that works for all is difficult when meetings involve people around the world.  Just finding a meeting time across Canada with 5 time zones can be a challenge.  But the reality is that in-face on-site  meetings are only meetings of the rich, and exclude people from developing countries.  Countries that are looking for benefit from standards rarely get the opportunity to attend because they are far too expensive, and their issues never get raised.  

Documents are the product of wealthy countries and deal solely with wealthy country issues.  That may not be a bad thing, but we do need to be honest about who is at the table and whose issues are addressed. 

D:  Electronic meetings are rarely effective.
This is patently not true.  Electronic document writing can be done asynchronously within specific time frames, but within each person’s own time zone.  Software exists that allows each person to comment on the same parent document with the ability to add comments and revisions but not alter the original version.  At one time this was a real challenge, but today it is commonplace and affordable world-wide.  At the end of the time frame, the team lead integrates the comments and revisions and creates the next version (keeping in mind the importance of document control).
The point that I am making is that today when it comes to the development of international standards we have choice and how we go about the process.  It is nice and social that the group gets together on a regular (annual or bi-annual basis) but is hardly necessary.  Without forcing a decision, let me argue that regular on-site meetings are expensive, exclusionary, and no more effective or efficient than electronic alternatives, and yes, maybe in a small way increase unnecessary personal risk.

It may be time to start looking to change.

Monday, July 14, 2014

Hot Stuff about Quality Control



Reflections on Quality Control

As a general rule any time you meet a group of people thinking on a specific topic and all have (A) different ideas and strategies and (B) confidence that there way is best, it means that the subject is very complex and not yet at the point for much more than general consensus.  What is interesting is that this describes today’s focus on Quality Control in the Medical Laboratory.

What is even more interesting is that whether you date this back to Shewhart, or up a couple decades to Levey and Jennings, we’re talking about a topic that dates back at least 50 years plus.  

I was recently at a miniseries of industry supported workshops on the subject in China.  While most of the speakers were not English speakers, through the hard work of our simultaneous translator, the messages were pretty clear, and it was evident that the audience was very happy and impressed.   If customer satisfaction is a measure to monitor for situations like this, the workshops were a pretty substantial success.  I was given the opportunity to present an overall perspective on the subject, and focused on the error consequences when Quality Control is done poorly or, not at all.  

Usually I don’t talk about others in MMLQR, but in this case, I will tell you that the most interesting person that I met was Dr. Richard Pang, a now retired laboratorian who combined brilliant insights with incredible wit.  

Right after my opening talk he zeroed in on the single most significant question on peoples mind; how many QC samples is the right amount to do, and is there a wrong amount.  It is of course an impossible question to answer with a specific number.  I  knew it and of course so did he.  It was a gotcha question. 

Rather than go down the path of number picking I said it was a matter of balance that each laboratory has to figure out for itself and in its own situation.  Doing too little risks the opportunity for missed error and setting the laboratory up for TEEM failure.  Doing too much risks financial ruin and never getting the work done, and still having enough gaps that failures can still occur.  

From my perspective, and I will preface this with the disclaimer that I don’t manage biochemistry laboratories for a living, there are a number of variables that have to be taken into consideration, like: volume of samples, complexity of assays, morbidity of the patients being cared for, the consequence of false positive or falsely elevated results, and the consequence of false negatives or falsely low results.  Add it personal liability, institutional reputation and liability and you have a start.  There is a guideline that talks about QC and risk and predicates decisions on severity-occurrence grids, which is correct, provided that folks understand the inherent subjectivity of the tool.  This is not an evidence based tool, rather it is a reasoned opinion rationale tool.  

One keeps an open mind and if they are smart, they avoid formulas and dogmatic argument.  It’s not “what’s right” or “what’s wrong”, its more “what works for me today”, while reserving the right to change your mind tomorrow.  

If I found one aspect of the meeting a little disappointing it was a conversation that I had on Costs of Poor Quality where the notion of trying to calculate what part of Quality Costs can be cut when the boss says “cut costs”.  Throughout my career I have seen the consequence of making compromise cuts.  If history teaches anything, it is that sometimes you have to stand firm.  Many years ago, one of those compromise cuts included cease doing gram stains on genital swab cultures.  First, they ALWAYS lead to unintended consequences. Second, they never save money, and third they always create more work and bother (ie increase stress and strain – ie TEEM).  Juran pointed out way back when that failure costs are always way bigger than prevention and appraisal and cutting prevention and appraisal always increases failure.

Cutting Quality Costs always reminds me of the movie “War Games” (an early effort by Matthew Broderick), where the supercomputer learns about thermonuclear war strategies by playing tic-tac-to.  “It is an interesting game” the computer says.  “The only way to win is to not play the game”.  

More on this later.
 

Tuesday, July 8, 2014

Education and VCOLE



I find the Economist magazine to be perhaps my single most reliable source of current knowledge.  In the June 28th 2014 lead article entitled Creative Destruction, the author speaks to the end of universities in the style to which we have become accustomed.  The combination of middle class entitlement, government support, has lead to huge classes, a disappointing dropout rate, rising cost and debt, all in all not a model of sustainability. Add to that, changing technology which has resulted in many the the traditional jobs that university graduates believed they were heading for being replaced with automation.  And add to this city crowding has obsoleted the idea that students and faculty and staff should all drive, bus, or bicycle to a bricks and mortar facility in which to  learn and teach. 

The first assault against this old way was the creation of the MOOC (Massive Open On-line Courses), which brings to the computer screen all sorts of lectures from top-notch people either at a very low cost or for free.  The problem with MOOCs however is that it is passive and solitary education, no free flow of ideas or discussion.  You look at the screen and learn.  If it works, good, if it doesn’t, too bad.
But there is another approach, which we refer to as VCOLE (Virtual Classroom On-line Education, which takes advantage of the on-line environment, but doesn’t lose the features of classroom education that are so valuable: smaller groups, discussion, debate, peer-to-peer experience.  

That is the style of our Certificate Course for Laboratory Quality Management, which is about to go into its 2015 season.  So far it has proved itself as a successful model.  

VCOLE is an ideal approach for people who are busy working but are looking for ongoing continuing education either to reinforce their knowledge or to learn new skills, which in our case is all about laboratories and quality improvement.   
It allows you to learn in your own place and on your own time, but in the virtual company of others.  You don't drive to meet them.  You meet in a common spot together. 
The course composition is broadly narrow, broad in the sense that it includes pathologists, clinical scientists, technologists, and some mature students, and broad in the sense that they come from across Canada but also from around the world.  But the group is narrow, in the sense they all are people with a lot of laboratory experience (we require at least 5 years), all have a good command of language, and all are committed to getting the most from the course.  

And importantly we get a lot of participation in dialogue and discussion, which is an essential component for adult learning in both the on-site and the virtual classroom.  On average people enter 100-150 comments over the course duration in discussion, with some much much higher.  Every group has its talkers and its listeners.  But since participation is an essential component of the final grade, one cannot be just a listener.

There is a certain consistency to the content, we talk about standards and standards development, and we talk about the tools and skills that people need for quality including risk management and quality indicators, and audits, and root cause.  But the information goes through annual review and section re-write and refreshment, and usually additional add-ons.  Two years ago we started a module on communication through word-clouds, and word-games and newsletters. 
This year we will be making a faculty change as well.  One of our very knowledgeable and experienced mentors is leaving, to be replaced by someone from a completely different career path, and for me the new person in took this course about seven years ago as a medical resident, and is now the head of a large division, so she has the strength of knowledge, experience and expertise, and the foundations of quality.  That is a pretty powerful combination for a course faculty member.

In the old days of Canada, we could have a course like this to be held in one centre, and it would serve people of one province.  Or if we were in a smaller country we could serve people from all over.  But that is not Canada and the way we need to provide new knowledge.  Today we need to think broader, but keep in mind that people (at least most people) don’t learn from sitting in their room by themselves looking at a screen.  People learn from people.  People learn through discussion and debate.  

People need VCOLE.


Wednesday, June 18, 2014

Standards People



Standards People

So we have just gone through another very successful conference and Annual General Meeting for the Canadian Standard Association (CSA).  Canada is a very large geography with a very small population, but CSA continues to demonstrate its commitment to being a national (and international) organization by ensuring that the AGM travels across the country, touching every province through its cycle.   

In my short connection with CSA AGMs I have been to 3 different provinces and with the now established plans there will be 5 different provinces over a 6 year period.  

The AGM is an interesting mix of organizational information, standards oriented presentations, and working committees, and a broad array of expert presenters, all put together to bring together a very eclectic group of folks with interest or passion for national and international standardization.  

We standards people are indeed an interesting lot, who all approach the field from our own perspectives.  There are some who are truly entrepreneurs with a commodity perspective, some seeing income generating consultant opportunities.  There are some who focus on the production of standards with a purist point of view; create good standards for the sake of making good standards, while there are others, who are passionately involved in their work sector and approach documents as a way of improving service to their own field of interest.  Then there are the regulator types who like rules creation; they are balanced by the educator types who are mostly interested in standards mostly as valuable opportunities for research and outreach through academia.  And then there are the “just curious” and the the rest who just like being there for the sake of being there and having a good time.  Motives for attendance and participation are wide and varied, but it seems to me that there is something for everyone and solid reasons for being there.  

As for me, I see my motivation as being a combination of many of the above.  I am certainly committed to healthcare and see one of my roles as a Quality leader and educator and standard developer, and am not ashamed of finding opportunities to intermittently promote my knowledge as a consultant and public speaker.   but I can honestly say that I am also at these meetings because I get to meet interesting folks and have a good time.  

This range of views attitudes is actually very important for standards development.  If we were all of one point of view, the standards that get written would likely become very narrow, and very difficult to use.  Without diversity of opinion, there is little need to seek out consensus.  

I personally do not see standards as black-or-white precision documents; you might say I have a more nuanced, shades-of-grey perspective.  In most cases, at least in my area of interest, standards need to include a significant sense of flexibility that is, within a certain range, open to interpretation.  If they are going to be available on tablets, they have to be of the electronic kind and not Mount Sinai stone.  

But I also recognize that if all standard people approached documents my way, the products would be too fluffy to be of value.  On the other side, the precision-driver-obsessive-compulsive-kill every-loop-hole folks without my counterbalance would create tomes that best belong in tombs.  

So this is my point, folks interested in being engaged in standards are always enhanced by attending conferences with people with the broad range of views.  We get the opportunity to express our point of view and at the same time experience tempering through competing ideas. 

Working on standards in isolation of diversity of opinion makes for bad standards.  

Three cheers for AGMs

To learn more about Standards Development, visit www.polqm.ca and consider joining our Certificate Course in Laboratory Quality Management.