Monday, August 18, 2014

The sine wave of Quality change

Bill Troy raises an interesting discussion on the future of Quality on ASQ’s blog “A view from the Q”.  Will Quality change arise by Revolution (leaps and bounds) or Evolution (inch by inch).  It is an important question as the world’s premier Quality organization plans and prepares for the steps forward into the next era of Quality advancement.

Discussion on the progress of Quality reminds me of a discussion with my mentor almost 40 years ago.  We were talking about the creation, rise, and fall of new antibiotics.  As new drugs come along they go through a certain predictable path; first they are the newest and hottest silver bullet, better than sliced bread.  With the first few treatment failures or complications, they almost immediately reverse direction and are viewed as terrible and trash, even worse than poison.  But over time we learn to recognize that these agents are neither perfect nor poison, and fall into their own individual niche within the armamentarium of treatment agents.  He called it the sine wave of medical progress. 

In my experience this is a commentary not only relevant to chemotherapy, but applies generally.   We have seen Six Sigma touted both high and low in our own Quality Progress, but it continues on as a valuable tool in the Quality Tool Box.  We have seen ISO 9001 declared as “broken”, yet it too remains as a valuable standard for implementing Quality.  And in 2010 writers in the Wall Street Journal wrote “What do weight-loss plans and process-improvement programs such as Six Sigma and "lean manufacturing" have in common?  They typically start off well, generating excitement and great progress, but all too often fail to have a lasting impact as participants gradually lose motivation and fall back into old habits.”  But Lean is not dead, and many see great value.

Attitudes come and go as people jump on and off the bandwagon of what’s hot and what’s not.  But the Quality movement continues on because society sees inherent value in confidence and competence and understands the true importance and security and safety that the Quality process brings.  

Change will come because nothing remains static.  Some will result as old guard folks retire and are replaced by newer, younger voices that  emerge.  Some will come as we attempt to fine-tune the subtleties within our standards.  Some will lurch onto the scene with new technologies.  

But let me argue that ultimately change will not be driven just from within the professional community because the real driver of change comes from public demand on one issue or another.   

Want to know the future of Quality? Keep your ear close to the ground and listen to what your customers, your workers, and the public are talking and maybe even complaining about.  

Quality change evokes better solutions.


Saturday, August 16, 2014

Managing Ebola Risk

The world these days is struggling with another infectious disease outbreak.  This time it is Ebola Fever.  As of today there are over 1000 victims to a terrible and miserable death, for which there appears to be little that can be done, at least in its current home of West Africa.  It is a major health problem, which cannot be diminished even when one takes into consideration the total population of west Africa being near 200 million.  (1000 cases represents 5 cases per million population).
The challenge to the more developed countries that the outbreak poses are many and varied, but the one that came to front of mind over the last few days in Canada, is how should Canadians health programs prepare for the possibility of a case arriving at a local hospital emergency department.  

This is a fair question to ask.  Canada is a country that sends diplomats and missionaries and aid workers around the world, some actively in West Africa.  And while there may not be a lot of tourists, there is a lot of business that goes on between the Canadian and Nigerian oil businesses.  It is not impossible that a Canadian worker could be exposed in their line of duty and then get on an airplane, and later manifest illness back in Toronto, or Montreal or Vancouver or Winnipeg. 
Regardless of how you look at the factors, the reality with respect to severity and occurrence is that the likelihood of occurrence is greater than one, and the severity of outcome would likely be considerable.  Regardless of how the S/O grid is plotted, the level of risk is going to be considered as High or Serious.  Some forward planning is clearly appropriate.

The challenge is what kind of risk strategy should be implemented; and that appears to not be a simple question.  It depends on your starting point.  If we start from the perspective of a business person who had recently visited Abuja on oil business who feels unwell, the probability of having a true case is not zero, but probably very very  low, but if we start from a doctor working with Doctors Without Borders (MSF) in the epidemic zone, the probability is higher.  

Further if one takes as the baseline the infection control and care delivery in a Canadian facility as opposed to West Africa, it would be fair to say that the risk of transmission in Canada is much much lower, but not zero.  (As an anecdote, we once had a case of human rabies in a Canadian hospital where one healthcare worker shot spinal fluid in his eye, and another cut her hand on a microscope glass slide, so incredible things can always happen!).

But does the level of risk in Canada require setting up bunker mentality barriers of hazmat suits and hypervigilance, or can one depend upon our same level of cautions as we would use for influenza or rabies suffice?  It is an interesting and important question.

The reality is that health care workers are humans and humans make mistakes.  Many struggle with even basic precautions, but putting in complex procedures are rarely sustainable.  The higher the degree of complexity, and the greater the level of stress, then the more likely errors is made.  Recent readings of Sydney Dekker make that pretty clear.  There are no perfect systems.  The other reality is that hyper isolation creates less than perfect care for some patients, especially the elderly.  Creating poor care for the “greater good” does not meet even the most basic oath of care: Primum non nocere” or "first, do no harm."

To my mind, the crafters of Risk Management standards and S/O grids have a solution.  High Risk or Serious Risk does not always necessitate extreme actions.  What it does require is engagement of the highest level of decision making.  In other words when the measures don’t contain the risk, the organization can say that the persons with the widest access to knowledge and information were engaged and the decisions had the highest degree of authority.  The buck stops at the top.

That puts a lot of pressure on the folks at the top, but that is why they are there.  In today’s world they have to take into consideration, not only the issues of risk and containment, they also need to consider the plague of 24 hour television news, public anxiety and hysteria, the politics of opposing voices, of workers refusing to work, and the general distrust of authority.  And who can forget the lawyers just waiting to pounce.   Sometimes, the loudest voice, not the best voice wins.

The reality is that this outbreak will come and go, just as did SARS, and Swine Flu.  But there will always be another.  And at some point we need to figure out how to implement risk management solutions that are truly fit for purpose.

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.