Thursday, April 28, 2011

Personal Recognition and the CSA

The other day I received a letter from the Canadian Standards Association that I am being recognized with a 2011 Award of Merit in recognition for “visionary leadership, renowned expertise and dedication to the development and advancement of medical laboratory standards”.  I will receive the award in June at the CSA Annual Meeting in Victoria BC.  

I am not prone to personal aggrandizement, but I must say that I am really pleased by this award.  In my world, receiving a CSA Award of Merit is equivalent to receiving an Oscar or Genie.  (For those not from Canada, a Genie is a Canadian Cinema Award statue).  In the world of standards development, Canada and the Canadian Standards Association is a world leader within a very small group of leaders; ISO (obviously), CSA (Canada), DIN (Germany), BSI (UK) and maybe NATA (Australia).  So to be a recipient of a CSA award is a big deal.

Similar to other organizations the Canadian Standards Association was developed to solve the problem of incompatible technical resources that manifested during WW1.  By 1918 the organization was recognized by the young Canadian federal government as the Canadian Engineering Standards Association (CESA) with documents on the railway, bridges, and electricity, all the essential issues of the developing era of the 1920’s.  The Canadian Electrical Code was the milestone document in 1927.  
Over the years, CSA (so named in the early 1950’s) has been on the  leading edge of  every modern development, timber, steel, nuclear power, public health and occupational health, and now environmental health.   

It would be impossible to estimate how many children would have been crippled or worse had it not been for CSA focus on sports (hockey, bicycles)  helmets.  But it likely is in the millions. 

Many qualitologists (including me) are aware that one of the two seed documents that lead to ISO9000 was developed by the US military and  later modified for civilian use by BSI.  Far fewer (again, including me) know that the other document was from CSA’s Z299 series for quality assurance for the nuclear industry.

As Canadians we all know about the CSA mark on our toasters, and radios, and helmets, but I suspect  most are unaware of the major mark on international health that CSA has played in the design of health care facilities, delivery of anaesthesia and dental care,  and diabetic care, sterilization and blood transfusion and transplantation.  Hospitals around the world have benefited from CSA published standards of care.  

My personal connection with CSA began in 1996 when it rescued our fledgling Canadian Advisory Committee that was engaged with the formulation of ISO15189.  We had been raising our own resources, traveling at our own expence, and depending upon the good graces of our employers.  Had CSA not come along, we would not have been able to stay engaged in the development of that standard.  I don’t know what the document would have looked like in our absence, but I can say with absolute confidence, that it would not have been as good as it is now.  
More importantly the quality revolution that has now taken hold in medical laboratories now sweeping across Canada never would have developed the traction to get the conversation started.

So I am really pleased to have had a long standing link with CSA, and am grateful beyond grateful for the recognition.   It means a lot to me.
I have a lot of time for the Canadian Standards Association.

And so should you.

Sunday, April 24, 2011

The Measure of Quality

I have found myself in a number of common theme conversations recently about the measure of Quality as it applies in the medical laboratory. When I think about the measure of Quality, I see this as different from the definition of Quality. I am very comfortable with the definition offered by the International Organization for Standardization, which is fulfillment of requirements.

Folks who create Quality Mission and Goal statements for meeting and exceeding requirements, don’t get it. Meeting expectations is a very laudable and difficult goal. Trying to exceed is a combination of bravado, or empty rhetoric and misguided ambition.

If the client wants their product or service on Tuesday at 09:00 AM, then having it ready on Monday may exceed, but is also apt to be as inconvenient as having it delayed until Wednesday. Tuesday means Tuesday. In the medical laboratory we do this all the time. Having test results available when the clinician is not available to use them (the patient has already left the physician’s office, or the office s closed, it is the middle of the night) creates a lot of undue pressure, and is costly of time, effort, energy, and money and and often results in increased reporting errors because the results may not be properly screened.

But to get back to the point. Having a Quality program is a measurable process, and relying on customer satisfaction, while important, is not enough. Crosby talked and taught that total costs of poor quality (CPQ) as the measure, and he was right, but having set up a CPQ in the past, I know that it is a challenge that few laboratory quality managers have the where-with-all to implement tomorrow.

So how about measuring numbers of errors this year versus the number from last year. I like that as a simple countable measure. It would certainly fit with using “Do it Right the First Time” as a laudable goal. The only problem is that we can do all the right things, and have increasing success with DIRFT, and still not see an appreciable drop in the number of recorded incidents. And that doesn’t mean we were unsuccessful. Medical laboratory error is common, and to a large extent unavoidable. Bad things happen with annoying regularity and even worse with annoying and unpredictable irregularity. Slips, distractions, delayed transport, wrong names, crossover contamination and inaccurate dilutions both by “bullet-proof” analyzers. So the absence of error may not prove a useful measure.

So if you can’t really stop them, then at least you can do something about them. There is timeliness of response. The true measure of medical laboratory quality is having systems in place to catch problems quickly, fix the information before bad things start to compound. Acknowledge and advise. Learn and commit to avoid the conditions that set up the error the last time, so that it can be, at least to the extent reasonable, be avoided the next time.

Bad things happen, and they happen all the time. Quality laboratories respond quickly, openly and aggressively.

Poor Quality laboratories don’t.

And that is something that we can all measure.


May 1 is the end of the registration early bird period for the POLQM Weekend Workshop.  Those planning on registring should do it NOW to save money.

Wednesday, April 20, 2011

Oops, My mistake!!

We had our recertification audit for ISO9001:2008 last week, and for the first time since 2004 have been found wanting. Darn. For the first time we have been cited for a non-conformance. When asked to see our internal audit record, we were unable to provide one.

That is not to say we have not done a lot of the checking. We routinely check and update our Quality Manual, and update and revise our SOPs as required. We have updated our job descriptions as required. We checked our Document Control Log and Records. We have our Management Review of incidents and opportunities for improvement, and have monitored customer satisfaction through survey and complaints. But we did not complete an internal audit document to demonstrate that this was all done.

Some years we have asked an external Quality consultant to do an audit for us (an external-internal audit), but we did not get around to that, because we figured we could do it ourselves. We were wrong.

You might think that I consider this a waste of time. After-all we had done all the critical stuff; we just didn’t get around to writing it down.

 You would be wrong. We take our certification seriously. The assessor was right. We were wrong.

Having been involved in the assessment process for 8 years, we should have known better. We did get busy with a number of issues, some of them regular events, if not planned, at least they were not unanticipated. We also had a number of exceptional issues that needed addressing. None of them were issues that would could have controlled though implementation of preventive action. That is not said as excuse, but as explanation.

CMPT has benefited from its active Quality Management program. As we have become more organized, have taken on more projects, and been more effective and efficient in working through them. We have more programs, we have extended our teaching programs and our research and development. We have gained control over our finances.

From my perspective, we have strongly benefited from adopting ISO 9001:2008 as the basis of our Quality Management system, and further benefited by taking our commitment the extra step forward by working with a qualified and competent Certification Body to do regular assessments, and recognize our quality system.

Our problem is one that in that effectiveness and efficiency follow a normal curve pattern, or more likely a normal curve with negative skew, which means that effectiveness and efficiency fall off faster than they develop, which means that challenges don’t just creap in; the pace is more of a gallop.

Small organizations need to be very careful because becoming more effective and efficient can result in improved balance sheet,but may not be sufficient to generate enough revenue to hire additional hands-on personnel, so that at a certain point they need to back off on expansion of activities, even though they may feel they can keep going.
In our situation, our neglecting to complete our paper work may be an indicator that we have reached that point.

 So, now we have two things to do. First we need to do a audit now to detect how many other gaps we had created, and second we may have to do an assessment of what we are doing and what are our options.
  All this happens at an interesting time. I have been at a meeting recently where all one hears about how valuable a service Accreditation Bodies provide, and how poor a service Certification Bodies provide (They are just in it more the money). Accreditation Bodies do provide a valuable Quality Partner service, but over the last while I have seen a number of accredited laboratories doing a terrible job; and at the same time we have been assisted by a certification review that found a critical deficiency.

 So the rhetoric is not consistent with reality.

At least not with my reality.

Sunday, April 17, 2011

The Power of Voluntary Quality

If there is a single discussion point around which I am totally in self-conflict, it is the arena of voluntary efforts for quality versus mandated efforts.  As a libertarian by personal inclination, I am resistant to government mandated initiatives for Quality.  I see the consequences of mandated Quality all the time.  Mandated Quality becomes resented Quality.  
If we are not seen to do something, then someone can impose themselves.  It may mean imposed accreditation or imposed proficiency testing where the point of both exercises is not about improvement and all about getting it done an passed so that “they” will leave us alone until the next time.  Given a choice between using either or both as a learning exercise, or a something that just has to be complete with a good mark, it is strongly advised to “game for success” rather than risk intervention.  
On the other hand, as a Canadian, I see what happens in the absence of mandated Quality.  It is not by accident that our most public of Quality embarrassments (see the Cameron Commission) occurred in a part of the country that has never believed in required Quality in healthcare.     In Canada the experience unfortunately is that if you don’t mandate it, it does not get done.

That is a pretty gross overstatement, of course, but it gives me the opportunity to turn this towards an even bigger problem, not seen in Canada (more on this later) but in the US; the single greatest onslaught against voluntary Quality in the last 25 years.  As part of the new fiscal responsibility, the US white house and congress is starting a dismantling of the Baldridge Performance Excellence Program.  

The Baldridge program, first developed in 1987 under the Reagan administration created this program, with a mission to “enhance the competitiveness of U.S. businesses” It has served as a voluntary program with an national award for improvement and excellence and leadership for role models and best practices. In 1999 it was expanded to cover healthcare and education organizations, and more recently in 2005 to cover nonprofit and government organizations.  Even if it is not available in countries other than the US, it is a program that we should all hold in the highest regard because it recognizes and rewards those of us interested in Quality and Excellence, not because we have to, but because we want to.  
So why am I writing about this.  Today I read that this program which has a total budget of about 10 million dollars is slated for an over  20 percent reduction (2.2 million).
Now I strongly support tighter controls on federal governments everywhere.  One only has to look at what is happening in Greece, Ireland, Spain and Portugal to see what can go wrong.  And watching the US promote stimulus through setting the world back on the road to massive  inflation is frightening.  

What I find short sighted here (in addition to the obvious) is that organizations interested in Baldridge are not only the leaders in Quality and Excellence, but they are probably the leaders in Costs of Poor Quality containment.   If the reduction in funding results in fewer applicants, and this results in lower CPQ savings, this will be the worst $2M congress has ever saved.
What needs to happen is that the Baldridge becomes a public-private partnership with private funding but with an award that continues to carry the power and influence of national recognition.  
Message to the folks, never trust Quality to the hands of politicians.  

As a Canadian I have to wonder why no federal or provincial government has ever thought it reasonable to initiate a Canadian award for Quality and Excelllence.  Since we are in the middle of an election, maybe this is a good time to find out.

I was just at a meeting held by the International Laboratory Accreditation Cooperation (ILAC) because they have a committee with interests in proficiency testing and laboratory quality services for developing countries.  Not much to write about from the meeting, but I can show you a picture of a famous statue in the town.  
Question: Name the statue and name the town.

The attendance for our POLQM Quality Weekend Workshop is rolling in.  The early bird registration ends May 1.  If the meeting is of interest, it is time to register now and save $125.


Tuesday, April 12, 2011

One size does not fit all.

When I am doing project and lecture preparation, I tend to go back to basics; more times than not that means Deming and Crosby, two men with a common goal, but different approaches.  One place where they differ 180 degrees is in the area of error reduction and prevention.  Crosby promoted the principle that setting a goal of zero tolerance for error was the most effective way to prevent costs and consequence.  Do it RIGHT the first time (DIRFT).    Deming thought this was not only nonsense, but indeed dangerous and destructive nonsense, that would be used as a stick to punish and blame workers when things went wrong. 
 Forty years after the two were busy establishing the fundamentals of business Quality, the truth still lies somewhere in between.  

But as I was preparing for a presentation, I came across an now interesting 2007 article entitled ``Trying to Do It Right the First Time Isn't Always Best``.  Hooray for Google (see .  The author, a Quality consultant Rick Brenner, is rather dismissive of the concept of DIRFT (``These slogans might make some sense in the operational context, where tasks are very repeatable.``) , and then makes the points that an important aspect of project management and learning in general is to have the opportunity to do it wrong the first time and that risk taking is about giving permission to allow doing things wrong at first, if the consequence is that you might by accident or intent find a  better solution.

Well I can see where he is coming from.  In the research and development setting, we are looking for new insights, new knowledge, and novel approaches.  That is why we call it ``search and re-search``.  But as much as the medical laboratory is about new information, it is about correct information.  The right information from the right patient sent to the right clinician at the right time.  Everytime.  While  Brenner describes this as being merely operational, but it is pretty narrow-minded when describing this as repeatable as a simple repeatable task. 
 Clearly while being a consultant in one very narrow field, he has little interest or experience or expertise in the broader laboratory world.  
And can we agree that might not be the strategy of choice when building nuclear reactors!

From my perspective, in the medical laboratory, establishing DIRFT is not so much an imperative, but more a target and  attainable  goal, and the only way that we can move towards error reduction and reduced clinical consequence.

I recognize that in the busy laboratory there are many distractions that contribute to slips, but if information is delayed or faulty, the clinician and patient are not  interested in our problems.  They want what they want and they want it when they want it.   Period.

In 1986 Briggs Phillips published in an article entitled "Human Factors in Microbiological Laboratory Accidents" in Laboratory Safety: Practices and Principles.  Laboratory accidents, injuries and infections do not occur randomly;  most happen around a small group of people with repeat problems.  By case-control comparison to accident-free peers, accident involved people were less aware of work environment risks, Less aware of work behaviour risks, and were more prone to working quickly, especially before lunch and breaks and days end.  Accident involved people were more likely to take risks.

There is reason to suspect that similar issues are at play when it comes to Quality slips.  Most slips and errors occur in the laboratory in a similar fashion, a small group of workers represent the largest group of repeaters slippers.  I am not aware of any study that has looked at behaviors of this group, but it would not surprise me if we found a pattern similar to one described above.   Wouldn’t it be great if that type of information was available!

When we don’t don’t have an policy or a mechanism to deal with the repeaters, then we are only apt to find ourselves in the same place over and over again.  That doesn’t mean trashing the person.  Maybe  some investigation into causation and responses to distractions is in order, or some  re-training assistance may be  required.  

Regardless, at some point management needs to have a solution, and it seems to me that having accepted a DIRFT policy and principle to aim towareds is not a bad place to start.  

Sunday, April 10, 2011

Eucational Potpurri

My university provides two types of Master’s degrees, a traditional academic style, and another a more focused Professional Master’s degree intended to prepare candidates for a specific advanced position.  Examples of the Professional Masters include the Executive MBA, The Masters in Health Administration, the Masters in Public Health, and the Masters in Rehabilitation Medicine (for occupational therapists and physiotherapists).  What all these courses have in common for the most part is that they are supported by the Faculty  of Graduate Studies, and approved by the University Senate.  They are all 18-24 months with an expectation of advanced courses, and some aspect of a  designed research project.  
I raise this because we have reached a new level of interest in laboratory quality management which has spawned the activities that will lead to a new Master’s degree in Laboratory Quality Management.  I wrote about this before (see February 20th).  

The structure of the program is starting to take shape: the course will take  between 18-24 months to complete, depending on the complexity of the research component.  The fixed components will include advanced courses  in the history of Quality, the interpretation and implementation of internationally accepted quality standards ( including but not limited to ISO documents), relevant statistics for Quality Control which will also include topics such as measurment uncertainty and six sigma analysis.  
There will also be required practicum time of working with a quality partner program, and working within a quality communication program, and a research project or thesis which will advance the level of new information and knowledge in laboratory quality.

At the present time we are struggling around the best delivery format.  For many adult learners, postponing their career to take on a new academic program is unrealistic, and so a program that is completely, or at least largely on-line makes infinite sense.  At the same time, we are also aware that for some funding agencies, they can only support education that takes place in a fixed location for a fixed time.  For them an experience in Vancouver is essential.  And the question to us is to sort out which format to go with, or perhaps to try to accomodate both.  I am interested in hearing from people with an opinion or a stake on the subject,  and have been soliciting comment in a variety of meetings and conferences.  

I anticipate that I have a few months left to make an almost final decision, recognizing that in the area of education, almost all decisions at one point or another are re-visitable.

We anticipate the MLQM will be ready to go September 2012.

Now I know and understand that a Master’s program is not for everyone and that in Canada few employer’s today would recognize the degree as an essential.  But that is today, and the view of an MLQM may be very different in 2013-14.

In the meantime we know our Certificate Course in Laboratory Quality Managment (CCLQM) continues to provide a solid educational grounding for many interested in  a shift in their laboratory career focus.  Their goal is to move towards being a laboratory Quality Manager.  We will continue to offer CCLQM and each year evaluate in it to looks for the opportunities for improvement.  More on this later.

The next session of CCLQM will run January 2012.

We have posted the presentations for our Communicating Quality Seminar at

Folks interested in our POLQM Weekend Workshop need to know that the early bird date for early registration is looming close.  Those interested in attending can same a lot of money now.

Thursday, April 7, 2011

Communicating Quality - the conference

So we had our Communicating Quality Seminar today, and I have to say (patting myself on my own back), it   was a brilliant conference.  The audience was a little small, but the conference to which it was attached was the annual meeting for  Microbiology laboratorians
There were some non-microbiology types, one in particular was my friend Luc, a Quality guy and MMLQR reader who I first met  through the Certification Course a couple years ago 

But back to the conference.  There were four speakers each speaking on a different aspect of communicating Quality throughout an organization.  One (me) presented  an overview.  The next (Robert Michel)  was on creating an mixed media  megacenter of Quality information, a combination of paper and electronics and conference, all linked skillfully to a common message.  Julie Coffey talked about an educational package that she has developed for ISO15189, again an excellent talk on an excellent topic.  And finally Sara Garcha talked on the topic of looking at an an organization’s  culture structure using the well published culture assessment tool, and discussed how organizations can use that information to adopt change that would be condusive to Quality.  
The presentations were well received, and some generated a fair amount of question and conversation.

Each of the presentations was excellent and all the information was valuable.  For me, the personal highlights were  Robert Michel’s recounting the time that he spent attending W. Edwards Deming’s 4-day seminar in 1991 and Sara’s discussion of changing organizational culture.  Julie’s presentation of the work she has done on de-coding 15189 was impressive.  I reinforced that Quality costs can be measured on  TEEM scales (TIME - EFFORT - ENERGY - MONEY).  Of all the approaches to keep the Quality conversation going in the laboratory, there are many effective techniques that score low on all scales, meaning they take little time to generate, are easy to implement, and cost little or nothing to put on. 

Normally I try to do some form of informal survey following a seminar to get a sense of satisfaction.  Generating numerical data is always interesting, even when the numbers are very soft.  This time I did not, in part because I will send out sn electronic survey in a few days.  At this point I have some “key” indicators, the kind that lecturers use.  Nobody walked out.  Nobody fell asleep.  Nobody developed competing cross-talk, and there were some questions and comments following the presentations.  4-5 came up afterwards and congratulated us on a successful  afternoon.  So, those are positive indicators.  

All in all, a success.

I got a number of personal insights.  First and foremost, the idea of a discussion on a very narrow topic of how to talk about Quality in the laboratory was a good idea.  As a meeting organizer, one does a dis-service to shy away from sophisticated topics.

I have permission from all the speakers to post their presentations at  They should be there by Friday. 

 Four happy speakers,  post presentation.

For an additional look, visit

Sunday, April 3, 2011

Communicating Quality - one more time.

I have mentioned the Montreal Conference a few times.  Since it occurs on Wednesday this week, writing about it today is not to encourage more folks to attend.  That ship has gone.  We anticipate an audience which will be about 70 percent of what we had hoped for, but well over our break-even point. Since the point of this conference was not about generating revenue, I am satisfied with what we have.

Our objective was to get the message out about improving Quality communication in Canada.  Between the people who come, and the coverage that we will generate between 3 web-log (blog) sites and offerings of the powerpoint files, and the academic presentations that get generated, we will get our messsage out.

I will provide a conference summary article and make the powerpoint presentations available for sharing after Wednesday April 5 at    While ISO9001 and ISO15189 speak to communication, I perceive these requirements under the classification of “necessary, but not sufficient”.  In the Canadian Standards Association’s book 15189 Essentials: an implementation guide we speak in more detail about how to implement a quality communication program (you can order the book through through the on-line bookstore.  
Developing  an effective quality communication program in the medical laboratory has to look at developing both an in-house information program plus bringing in materials from outside.  Laboratorians have a lot of choice; we can make this as expensive or as cheap as we want, and realize that the depth of the quality communication system does not necessarily have a linear relationship with cost.  Expensive is not necessarily better.  

What is an  interesting consideration is  that as an early adopter, laboratories develop a third arm and major opportunity.  Gaining experience leads to sharing the message, and sharing the message creates opportunity for revenue generation, which can be put back into the quality program to reduce it as a cost centre, and moves towards being revenue neutral, or even better.  Even in a socialist single-payer health care system, generating revenues to promote quality for bringing in speakers or for sending people away is a good thing.  We cover this in a variety of ways at the conference.

What the quality program needs is time.  In my presentation I suggest components that would add up to 30-40 hours a month, which pretty much reinforces the imperative of creating Quality Manager and Quality Team positions.  To make it clear, I don’t expect every laboratory around the world to put in a communication program that consumes 25 percent or more of a person’s full time, but in every laboratory sharing information with staff on some regular schedule improves knowledge and engagement.  Even in laboratories in developing countries, this improves the focus of care and reduces poor care.

I know and understand this leads to the obvious question of whether improved communication results in improved quality and secondly, will improved quality result in reduced cost and improved laboratory services.    Fortunately there is a lot of published material that supports positive responses to both.

If you are planning to go to the meeting at Le Westin Hotel in Montreal, come on over and let me know that you are a MMLQR reader.  If we have a moment to chat, the coffee is on me.

Friday, April 1, 2011

Following up

A follow up on the BMLSc lecture mentioned in the previous journal entry.    As mentioned this is a group of students primarily from a science stream with some (?) interest in medical laboratory sciences.  Two of them had prior knowledge and experience in the clinical laboratory.  When I asked them about where they saw their career in the next 5 years, most could not say, but 6 or 7 thought they might be involved in clinical laboratories at some level.  So that was interesting.  

Of greater interest to me was that when the presentation was over, one student came over with a lot of questions about Culture of Quality and where that fit in as part of the laboratory.  She was not one of the two with prior laboratory experience.   If students are interested in concepts like laboratory culture. then it seems there is room for a positive outlook for the laboratories of tomorrow.

For anyone interested, my presentation is downloadable from

In a previous entry I critiqued a presentation of Jidoka, which is described as empowering line-workers and co-workers and supervisors with the ability to form immediate ad-hoc committees to resolve quality problems that appear in the assembly process of automobile manufacturing.  In error I described the extension of that processes to are beyond the manufacturing component also as Jidoka.  The correct terminology is defined as Zenjidoka (or Total Jidoka).  My apologies.
The authors in a follow-up article, describe Zenjidoka as “when an employee hears directly or indirectly about a customer problem, [even in they are thousands of miles away from corporate headquarters]  that employee is empowered to use his knowledge, skills, and judgment to immediately take action, even if that action means going against company policy or procedure.”
Assuming this is an accurate description of the intent of Zenjidoka, I cannot imagine a process more fraught with risk, with the possible exception of allowing folks to play with a loaded firearm.  In a complex organization, indeed in many simple organizations, the likelihood that an employee working at an off-site location would have immediate access to information to resolve complaints, using means that can include contravening policy would have to be categorized as an extremely high risk procedure.  

If ever there is an opportunity to increase costs of poor quality through compounding error through false calls and inappropriate action.  So while I apologize for messing up the terminology, I remain sceptical of the intent.  Count me as a continuation in the “not a fan” category.

There is a message here.  There is nothing inappropriate  with taking the time for a second thought at a new concept and rejecting it the second time, just as it was rejected the first.  It is OK to tell folks that ideas can be bold and new and wrong all at the same time.  Not every new idea is a pearl.