National Standard Academic Challenge

Canadian Standards Association (CSA) has always been an international leader organization in the arena of Quality.  Created in 1919 it was focused on ensuring the quality of bridge construction for the railroad.  As mentioned here before, early (Z299) documents from the CSA were used as the seed documents for the creation of ISO 9000.  CSA has active in the environmental industry, nuclear industry and the nanotechnology industry.  So it should not be a surprise to anyone that they would be always be so very well positioned to take the step forward in innovation and engagement.

Look across the standards world and you will see a lot of grey hair.  Granted that interest in standards development is a pre-occupation that people grow into; first you need to be engaged in an occupation or profession or field of activity long enough to know that there are such things as good practices and not-so-good practices, and the source of good practices can usually be found through reading and understanding consensus based standards.  In my experience that usually takes 5 to 10 years (maybe more – maybe less) to reach that level of insight.  But the experience is also that once in the standards enthusiasts get energized, eventually they become the standards fogies.  I would guess the mean age in the standard arena is well above 60, which means for every person age 50 there is one at age 70, and for every person age 40 there are two near 74.   As one person said, in a lot of committees it is not necessary to set 6 or 8 year term limits on chairs because lots of us won’t make it anyways.

So the answer is to start younger.  

There are all sorts of younger people who would be appropriate to engage in standards awareness and standards development.  Standards awareness should be a component of every training program in electrical, mechanical, healthcare trades and professions.  Every student should be able to know the difference between an effective standard and an ineffective one.  Every student should know which organization in their region or country is engaged in consensus based objective relevant standards.  Every student should understand how standards are the basis for consistent quality practice.  And in time once they have got their hands and head dirty in their field of interest, those folks who want to, should have the opportunity to get engaged in creation of the next generation of documents.  These are the kids who will become our next group of standards developers and quality creators.

So the CSA started with a new pilot “National Academic Challenge” this year associated with its Annual General Meeting with some young undergraduates from an Ontario university.  The presentations were appropriately enthusiastic and well done.  The subjected were perhaps young and naïve, but that’s OK. The pilot was a great success and good for the students and good for a first shot by the organization.  The students loved it and the members loved it.  The exercise was clearly a winner and well worth repeating.  

It pointed out that as a way to recruit some young blood into CSA, this model has some legs.  The yield to CSA will likely be stronger when the challenge involves participants with a little more age and experience, and a more of a focus on a career choice, but that will evolve over time.

On another level it shows that Canada is well positioned to move forward on the world stage through hosting a World Standards Cooperation Academic Day.  We have the organizations, the academics and students at a wide variety of levels.  

There is every reason for Canada to play on the world stage.

More to come. 

Assessing and improving quality in molecular genetic testing laboratories in Europe

Over the last few weeks I have referred to a person about to complete their PhD in medical laboratory Quality.  To my knowledge Sarah is the first person to have done this.  Congratulations, and here's to her being the start to a new trend.  


I have invited Sarah to prepare an entry for Making Medical Lab Quality Relevant.  I am pleased that she has contributed the following.  With that I am pleased to introduce Dr. Sarah Berwouts.


Only recently I defended my PhD dissertation and it was a pleasure to have Dr Michael Noble in the jury. I also feel honoured to get the opportunity to write a guest post on his entertaining blog. My research project mainly focussed on quality in Europe, so having input from Dr Noble on the Canadian situation was interesting and provided some food for thought. 


An intriguing discussion we had was about the difference between accreditation and certification. In Europe we believe that laboratory accreditation according standards such as ISO 17025 and ISO 15189 is the most efficient way to assure the quality in your laboratory. Certification, according to the ISO 9001 standard, is believed to imply a significant lower level of quality assurance, and not to assess, in general, the technical competence of the laboratory. Although I did not directly measure the difference in quality between accreditation and certification, I gathered information on the degree of implementation of certain quality aspects in both accredited and certified laboratories. These aspects involved, among others, having standard operating procedures, having a quality manual, and performing internal audits. I requested European molecular genetic testing laboratories to indicate the degree of implementation (fully implemented=score 3, advanced=score 2, just started=score 1 or not implemented=score 0) for these quality aspects and this degree of implementation was recalculated as a percentage. In the end, I got an overview of the implementation of the surveyed aspects in about 300 different laboratories. 


As I requested also the accreditation or certification status of the laboratories, I was able to compare the degree of implementation of quality aspects in both groups. Standard operating procedures were implemented very well in both groups (100% vs 99%). However, the availability of a quality manual in the laboratory, was implemented significantly less in the certified laboratories (96% vs 78%). A similar observation was true for performing internal audits (97% vs 68%).


These results supported the European view of certification being less stringent than accreditation. Nevertheless, it is surprising that a relatively high number of certified laboratories do not have a quality manual as this is a certification requirement. 


One could argue that there is a bias in the data, as the accreditation/certification status was collected through self-reporting and laboratories might have overestimated their accreditation/certification status. However, I validated the answers to the survey question ‘Is your laboratory accredited?’ and ‘Is your laboratory certified?’ by checking databases of accreditation and certification bodies. It is however possible that the person who filled out the survey was not aware of what is implemented in the laboratory and that this was more often the case in certified laboratories than in accredited laboratories. Or might it be possible that certification bodies certify laboratories even if they do not conform fully to the ISO 9001 standard?


I understood from Dr Noble that in Canada the situation is slightly different: certification and accreditation are closer to each other, and certification has been appreciated as a valuable tool to assure good quality in the laboratory. All depends of course also on the competence of the accreditation and certification bodies themselves. In Europe, recent efforts by the European co-operation for Accreditation (EA) lead to improved harmonisation among accreditation bodies: there can only be one accreditation body per country now, accredited according ISO 17011. Other European organisations and projects such as the European Society of Human Genetics and EuroGentest actively encourage and promote laboratory accreditation, more than certification. 
Although there might be slight differences in organisation of quality assurance in both Canada and Europe, we all aim for the release of correct and accurate test results and continued efforts are needed to assess and improve the quality in laboratories all over the world.


Sarah Berwouts (sarah.berwouts@med.kuleuven.be)

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.