Monday, February 27, 2012

Don't Stretch for Quality

In our course today the term “Stretch Goal” came up for conversation. For the athletes this has nothing to do with Pilates or Yoga or muscle relaxation.  It is a term that describes having business goals that may or may not be necessary but require resources and abilities beyond current capabilities, but cannot be done  in incremental steps. A common expression is that one can’t take two steps to hurdle a fire pit.

The reality is that stretch goals sometimes are the only way to go when, for example, an organization sees itself collapsing due to a harsh economic environment or a massive competitive onslaught.  A rapid and major overall may be only way to survive.

But it is a truly lousy way to try to implement or coordinate Quality. 
In the medical laboratory unfortunately we see “Stretch Quality” all too often.  The director gets a letter saying “Dear Doctor.  This is to let you know that our accreditation team will be visiting you in 4 weeks.  Yours sincerely…”  The director looks around and sees that NOTHING has been done in the Quality area for years and tries to implement a massive fix-up.  Often it succeeds, only because the inspector group was sufficiently disinterested or ill-informed that they don’t actually bother to look around.  So the laboratory dodges a bullet and says, “Good thing that’s over.  Wake me up before the next inspection”. 

Incremental Quality is better.  A mini internal audit here and another one there and another one next month, and after a while you have a lot done.  We just did our third audit today and when we go into our external review in March we will have documented review of over 250 requirements.  Combined the mini audits took about 4 hours total.  We have reviewed our Strategic Quality Plan and developed 2 new policies and 4 revisions since our last inspection; and two customer audits.  And none of it was panic or painful.  Even with our small but very busy operation we can find the time to get this stuff done. 

I am not suggesting that we have it all together, in fact our assessment overall was 94.7% compliance which means we had missed a bunch of things that need to be fixed.  But this incremental approach meant that we caught the problems before they became institutional or blew up in our face.  So that is a good thing. 

And speaking about good things…

We have set the final agenda for our Quality Seminar to be held in Vancouver on Wednesday May 2nd at the Sheraton Wall Hotel in conjunction with the conjoint meeting of the Association for Medical Microbiology and Infectious Diseases – Canada and the Canadian Association for Clinical Microbiology and Infectious Diseases (how can one country have two organizations with nearly the same name and serving the same constituency!; long story!!). 

We will be talking about:

·       New national standard created through the Canadian Standards Association for procurement, handling and transport of samples for the medical laboratory.
·       Microbiology application annex for the new Canadian standard.
·       Monitoring Laboratory Error using a provincial on-line reporting system.
·       Direct-to-Patient reporting of laboratory test results
·        Challenges to Patient Confidentiality in the Medical Laboratory.

The meeting is only a half day (costs $100 Canadian for attendance, copy of the files, and coffee break), but for those interested in microbiology the AMMI-CACMID meeting is always brilliant.  You can find out more about the meeting at or

May is a great time of the year to be in the Canadian South-West and Vancouver is one of the best destinations in North America at that time of the year.  Amazing scenery, golf, skiing, boating, and the widest variety of incredible restaurants. 
Come join us!

In case you cannot, I plan to have the Quality Seminar on YouTube.


Friday, February 24, 2012

Teaching Laboratory Quality

I was flipping through my February edition of American Journal of Clinical Pathology and came upon an editorial article written by  Michael Laposata about the article written by Ronald Weiss et al in a recent previous edition (November 2011) about a “consensus curriculum” for laboratory management training for pathology residents.  Both articles are worth the time to read.

A few things about the Weiss article.  First, the title of the document as a consensus curriculum is not really accurate.  What the article provides is a series of responses to a number of questions asked to residency training directors.  The information was used as a basis for the creation of a curriculum, not presented in the manuscript.  What it does present is some sort of moment-in-time snapshot of what the training directors were doing at the time of the survey (2009).  Basically (as pointed out in the editorial) they were providing some sort of didactic program 1 hour a month throughout the 4 year residency on topics that include: Quality Assurance, accreditation and regulation, test validation, risk, and some cost issues like accounting and purchasing.    The number one tool was being involved in either a real or mock accreditation.  Some of the residents had a period of a month or so as a “Junior Laboratory Director”.

I think it would be fair to say that the editorial presented this month was not particularly impressed, based upon the combination of the results of the survey and his own considerable experiences.  From my own experiences, I get his point. 

It is really tough to create a sustained, effective, measureable program to train medical laboratory residents in the skills they will need to be effective leaders and managers for laboratory Quality, at least in today.  From my experience, most laboratory physicians have at best a rudimentary foundation of Quality, and are scarcely in a position to be effective educators or mentors.  For many (maybe most), Quality begins and ends with writing SOPs and doing a quick preparation for accreditation.  Throw in a side-by-side evaluation as part of test-validation, and that is about it.  They are hardly in a position to convey topics like understanding the foundations or application of standardization, or approaching continual monitoring for error and improvement, or developing Quality policies and objectives, or working with Quality Partners.  Quality Indicators include turn-around-time and temperature charts, and little else.  Their laboratory is first, foremost, and only a technical operational center. 

Having personally been involved in resident training from a variety of aspects, I understand the problem.  The reality is that Quality Management is related to, but very different from the traditional disciplines within laboratory medicine, and all adult learners tend to be attracted to the topics that interest them, and tend away from the topics that don’t.  Trying to teach Medical Microbiology to a person interested in Clinical Chemistry is a challenge and try to teach either of those to a person interested only in tissue pathology is even worse.  Talking about laboratory safety or laboratory quality to a person focused elsewhere is a lot like being a dental patient or going to a classical music concert if your tastes run more to medal and rock.  While there are some folks interested, most are not and requiring them to be there is deadly.

What I have been doing is creating a knowledge core that looks at the quality in a historical and academic perspective and trace the links between poor quality and laboratory error.  We talk about defining core beliefs into a Quality Policy and how that policy can become a driver of action.  We talk about Quality Partners and try to stress the point that proficiency testing and accreditation are tools that let you learn what you are doing well, and importantly what you are not doing well, so that you can develop a plan to improve.  We talk about using Quality Indicators (including monitoring complaints) and Internal Audits to your advantage.  And then we stop.  Four sessions (maybe 6 hours) and out.

For those that are focused elsewhere, they have some core knowledge which they can use or not use as they go forward.  For those for whom Quality is an interesting topic we provide our extended 20-week on-line course in Quality Management (Each year we get 2 -3).  And for those with advanced interest, there will be advanced opportunities at the Masters and PhD level for those that are sufficiently interested that they seek academic and research fulfillment.

To address Michael Laposata’s question of “what skill set are we trying to impart?” the answer is to discover their level of interest and how they as adult learners can optimise to their personal advantage.

Thursday, February 16, 2012

World Standards Cooperation Academic Day.

It is amazing how the calendar fills up.  In an era when budgets are tight and travel is still beleaguered with extreme security, there is always another international opportunity for Quality connections.  Today I was introduced to World Standards Cooperation (WSC) Academic Day (WSCAD) which will be held in Bali Indonesia in May 2012.  In many respects this should probably be a “must do” on my calendar. 

World Standard Cooperation Day is different from World Standards Day.  The latter, has occurred each year since 1970.  It is said that October 14th was selected for WSD because it commemorates the meeting held in London in 1946 at which it was decided to develop and organization committed to international standards.  That may well be true, but I suspect that the selection of that day was not totally by accident since it also happens to be W. Edwards Deming’s birthday (October 14, 1900).  In Canada we will be having an event in Ottawa near October 14th (this year the 14th falls on a Sunday).  Traditionally WSD has a poster competition.  While it has not been announced yet for 2012, I have been thinking about possible entries already. 

World Standard Cooperation was added to WSD in 2001.  It was developed as a joint effort between the International Electrotechnical Commission (IEC), the International Organization for Standardization (ISO) and the International Telecommunication Union (ITU), in order to strengthen and advance the voluntary consensus-based international standards systems.  It is an annual event marked with conferences and workshops.  We are looking to hold an event in 2013. 

WSC is not tied to a specific day or to a specific topic, other than the generic topic of standards promotion.  For example, in 2012 I am aware of at least 2 events, one being on application of standardization in the auto industry.  The other event is the subject of this posting.

World Standards Cooperation Academic Day (WSCAD) was started in 2010 at which time it was an Academic Week hosted in Geneva in July.  Last year it was held as an Academic Day in Hangzhou China in June and this year will be held in Bali Indonesia in May.  The purpose of WSCAD is to “promote and foster dialogue and cooperation between academic institutions and the international standards community”.  This is a brilliant idea with huge potential.  It is such a good idea that if it didn’t already exist I would invent it myself, and in a way I have with the development of the UBC Program Office for Laboratory Quality Management and our Continuing Professional Development (CPD) approved Certificate Course in Laboratory Quality Management, and our upcoming Masters in Laboratory Quality Management, and our Quality Weekend Workshops.

International Standardization is a perfect fit with academia.  It is a topic that I am strongly committed to.  In 2009 I gave a presentation at an ASQ conference in Vancouver entitled “Medical Laboratory Quality: a valuable university based endeavour” making the point that Quality has elements of research, education and outreach or service which meets all the needs of a successful academic program.   My personal experience was that over 27 years we had generated sustained growth, activity, funding, education, service, research and development, and collaborations.  Despite that my observation at that time was that, at least in Canada, universities were quite resistant to the validity of Quality as a topic-of-interest, in part because it was new, and it was trapped in a chicken-and-egg dynamic.  There was no tangible research funding for Quality issues because there was little interest, and there was little interest because there was not tangible funding. 

That has changed and in the last week we have been pre-occupied with completing grants submissions which if successful will provide support to the POLQM. 

Now we find out that over the last 3 years there has been an international movement to support and promote exactly what we have been doing here in our little silo, disconnected and independent of most other universities (University of Leuven in Belgium taken as one exception.)  Hooray!!

I may not be able to attend this year (one of my sons has his graduation ceremony on the same day) but I will likely find someone to attend in our stead.  This is too big a deal for us to miss.

Monday, February 6, 2012

Certainty about Uncertainty

I have written about this before.  But as of today there is a BIG difference.

There was an interesting dialogue that occurred in our ISO working group in the crafting of the standard ISO15189 on Quality and Competence in the Medical Laboratory.  Supposing a doctor did a blood test and then repeated it a month later and got a result that was 1 or 2 percent different from the first value and called the laboratory and ask if that difference, in the opinion of the laboratorian was a “real” difference.  The idea was that the laboratorian would respond by saying that we have done an uncertainty measurement (UM) and we think there is a 50% possibility that the numbers have the same value.  Armed with that information the doctor would make a clinical decision. 

Well that is a nice idea, but of course is nonsense.  That is not what would happen, and anyone having the slightest understanding of the clinical dynamic would understand that.  What would happen would be that the doc would probably hang up with a dazed glaze, mutter something about pin-heads and then get another test done and look at a 3-point curve for a trend.   

And this is all about to get a lot worse because now some patients have the ability to receive a results directly (direct –to-patient DTP or direct-to-consumer DTC) would be totally mystified and who knows what will happen. Without diminishing the knowledge and understanding of the general public,  UM is not a concept that the folks will understand or appreciate.  One can all but guarantee as series of bad decisions and bad outcomes.

Some of us have been arguing and roiling about this for years.  What some folks have lost along the way was that the notion of uncertainty, while an interesting concept was designed and intended for physicists working quantitative measures to distinguish between detection of ultrafine differences and noise.  As much as certain statisticians have thought they could intervene in the arena of medical laboratory interpretation, it was a nice but nonsense concept, at best, and a genuinely stupid one at worst.

There are so many variables that go into laboratory testing that can not be taken into account by a simple formula: diet, time-of-day, collection vials, temperature, transportation issues, waiting times, subtle equipment variations.  All can have some type of impact.  And worst among the worst is when the first sample is sent to one laboratory and the second goes to another.  All this is far beyond simple direct formulaic mathematical models where you punch in a couple of numbers and a computer spits out an answer.

So why do I raise this again.  Isn’t this just a matter of difference of opinion?  Just because I think it is stupid doesn’t mean it is stupid.  Right?

Well last week the ISO Committee on Reference Materials (ISO REMCO) the committee structure that is responsible for UM circulated the following:
The present GUM is focused mainly on the situation of a physical quantity which “…can be characterized by an essentially unique value”. This has probably inhibited the wide use of the GUM in some scientific disciplines, such as chemistry and biology, in which a definition of the measurand according to the requirements of the present GUM can be impossible."  (note the italics and bold and red color are mine!)

Yes!  In your face! I was right and those @#$%^&*s were wrong!

So now there is a plan to try and fix it.  The REMCO committee will try to put something together maybe by 2014. 

In all due respect, this goes back to one of the concepts that I think is really critical to the standards development process.  Standards should be written by folks that are engaged in the field.  They should not be written by folks with solely a good idea about what they think other people should be doing.   Kind of like the US constitution “for the people – by the people”.  

But before standards become the rules they need to be veted or authorized by people with a vested interest to protect the public… the watchdogs, so to speak.  Legislatures, regulators, accreditation bodies, professional colleges need to be able to speak to the benefits and detriments of the documents to ensure that the writers had the best interests of the public in mind.  That is what we call collaboration and partnership.  Each partner doing what they do best to come together with a better product: improvement through synergy.

I have to say that I am feeling really encouraged because the system working as it should.  A piece of nonsense has been recognized for what it is, and now some knowledgeable folks are going to try and fix it.  Maybe they will be successful, maybe they won’t.  Either way works for me. 

So now the question will be what do the folks responsible for oversight of medical laboratories do now?  Do they concede that this is an issue that needs fixing and back off until a better solution is found, or do they just continue on?

And the ISO REMCO folks need keep in mind that all of us are simple folks. Developing a nuanced sophisticated solution that only hypergeek mathematicians understand is of little value for the laboratorian, the clinician and especially the patient.   

Friday, February 3, 2012

New Knowledge and MLQ.

If there is a core essence to research in academia it is the production of “new knowledge”, an idea that is by design both tangible and sufficiently vague.  Pieced together from a variety of sources, knowledge is about the appreciation of concepts and relationships that link the objects within a body or area of interest.  Knowledge may be derived from information or data, but it extends beyond both.  Knowledge extends beyond facts.  It embraces integration and understanding.

Research is the method by which new knowledge is created.  Research and knowledge build from foundations created by previous research and established knowledge, resulting in new concepts, new ideas, and new relationships resulting in  (ergo) new knowledge. 

Knowledge production in its traditional concept has been characterized as having its place in academia, focused primarily within specific disciplines.  It is said to be autonomous, that is it should be able to stand alone, but at the same time is dependent upon “peer review” for its quality control.  A more modern approach, described as Mode 2 new production of knowledge (NPK) turns most of that on its head and recognizes the knowledge production is much broader in its reach and embrace and capture. Mode 2 NPK speaks much more to the issues of ethics, and society and transdisciplinary impact.  Importantly it goes beyond traditional peer review as the sole criteria of quality and looks to broader political and economic and social and cultural impacts.  This is not so much a deterioration from “good science” but a recognition that “good science” need not be exclusively tied to the beliefs and practices of tradition and peers.

I bring this to mind because at the moment I am pushing very hard to raise the concept in my institution about the value, importance, and indeed criticality that Quality adds to laboratory medicine.  We need to recognize Medical Laboratory Quality (MLQ) as a discipline worthy of research and development of new knowledge.  At the same time I am preparing to be a part of an examination committee for a candidate’s thesis defence of her work being submitted for a PhD which addresses some extremely important concepts in laboratory quality.  I suspect that once the work is finalized and published and widely distributed, her work has the potential to result in new societal ideas and change for the better.

Given the caution that my institution is showing in moving forward on a proposal to recognize the importance and opportunities in new knowledge production, it would be easy to interpret this with frustration.  Perhaps.  But this is revolutionary change that I am proposing. 

MLQ as a focus of academic pursuit is the essence of Mode 2 NPK.  It crosses the traditional boundaries within and outside the pathology laboratory.  It goes beyond traditional medical practice.  It addresses economy, society and cultural issues.  Its peer group includes medical leaders and government and business and (perhaps especially) consumer and patient advocates.  This is not intended to denigrate traditional study that leads to improved concepts and novel diagnostics.  It is about recognizing that it is time to broaden our scope.

MLQ is a new and innovative (indeed foreign) to traditional medical academic faculties.  Quality has routinely been the responsibility of (interpret that as “relegated to”) the administrative managers.  It is not the stuff that folks with MDs and PhDs would want to tinker; it is not real science.  That is not to say that there are not leaders in the world of medical laboratory quality and its first cousin, patient safety (Dick Zarbo comes to mind), but while the discipline is growing and its advocates increasing, it has been a slow process.  The peer community is small, which may be one of the reasons that I get the opportunities that I do. 

So at this point I can not yet identify the university and department that has taken the progressive step to embrace MLQ nor can I identify the candidate.  That will come.  But I can and do hand to both kudos for taking an important indeed transformative step forward.