The Risk – Quality – Innovation Dynamic

The Risk – Quality – Innovation Dynamic

Paul writes this month in response to an ASQ survey of teens  interested in pursuing studies in Science, Technology, Engineering and Mathematics (STEM) which indicated that “nearly half of students are afraid or uncomfortable about failing”; an interesting and maybe even concerning finding.  To put this into some context, some survey detail was provided.  Survey participation was by email invitation to American youth for a week, just after New Years 2013.  The teen response group with the afore mentioned concern about failure was comprised of some 500 kids between the ages of 12 to 17 years.

See: [ http://www.asq.org/media-room/press-releases/2013/20130131-stem-careers-survey.html ]

Count me as suspicious. 

My first concern is that most 12 year olds would be in or around grade 6, most have either not started, or just started going through puberty.  Many would still call them children.  Seventeen year olds, on the other hand, are either high school juniors or seniors some (but certainly not all!) of whom are well on with developing a perspective of a world beyond themselves.  It is hard to believe that those two groups would have anything in common, especially any notion or sense of academic failure.  Second, in my experience, many (most?) teens despite angst about acne and popularity and Facebook still see themselves as pretty much invincible. 

So while I haven’t had the opportunity to look at the study design thoroughly, let me just say that I would be uncomfortable making very many generalizable comments from a small population sample size.  Said another way, recognizing the ISO definition of risk as the effect of uncertainty or lack of information on an activity or outcome, accepting the study’s headline as truth would be pretty risky business. 

Having said all there is another question asked and that is about how well or unwell Quality folks deal with failure in their own situation. 

Over the last while I have been writing on this theme from different directions (see: [ Invention and Innovation and “new knowledge” ] and [Even committedQualitologists can make mistakes ].

It strikes me that the Qualitologists fit into a special place in enterprises; on the one side we can create the conditions to reduce failure that results from the problems associated with insufficient information and excessive error.  And on the other side we can help optimise the conditions that allow for innovation to flourish.  Use of Quality tools and expertise can help determine what our customers want and need and what will work for them (think Satisfaction).  Also by promoting a culture that embraces Quality and PDSA and Continual Improvement can help promote the processes that lead to opportunity (think Improvement through Innovation).

All this got me thinking about Paul’s January A View from the Q “How Do You Define Quality?”. 

So let me provide another definition for Quality: 

Quality is the field of knowledge and action that provides the dynamic interface to reduce the hazards of Risk and optimize the opportunities for Innovation.

Does that fit with your job description?

Exciting Changes in POLQM

I regularly mention our certificate course in laboratory quality management, not only because I teach it, but because over the years it has been one of the most successful contributors to laboratory Quality Management in Canada and in many places around the world.  Over the years I suspect there is only one other course that has certified more Quality Managers of a general nature, but none more successful than ours which focuses on medical laboratories.  
It is clear that it is very valuable in the minds of the participants that take the course.  [see http://www.medicallaboratoryquality.com/2012/07/polqm-through-mirror-forward.html ]

I think the key to our success is that the core of the course remains essentially the same.  The course remains as a small group virtual classroom course with heavy emphasis on peer and faculty interaction, but at the same time there are substantial changes every year.  We have broadened the scope of the course, added new faculty, added in more challenges in the form of discussion and assignments, and introduced better technology, including video clips and YouTube.  All the change means that the faculty can not address each year as the same-old.  They have to keep it fresh.


If there has been one area that I have taken personal pleasure in, it has been the participation of pathologists and resident students.  While the numbers are still small, it means that the awareness and engagement of top management in the medical laboratory is happening, and the participation of residents in the course means that the concepts of Quality are going to be present going forward. What a change that will be!!


For the January 2013 course we will be extending the course for an additional week to focus some time on Quality tools that go beyond Quality Indicators.  These will be education oriented tools that enhance local training, and help foster a Culture of Quality.  


Last year we were able to strike an arrangement through Standards Council of Canada to provide participants with free access to a collection of 5 international standards that can have significant impact on the Quality processes for their clinical laboratories anywhere in the world.  This year that program will be expanded to up to 10 standards.  That benefit alone is worth approximately $1300.  It is an extremely generous program by Standards Council of Canada.  


We are working with several other standards development bodies to have some similar arrangements.  


Registration starts in September 2012   


We are looking to increase the course size up to 40 participants this year, but will not go any higher because it could impact on the degree of peer and faculty interaction that occurs.  
We regularly make changes but only those that will enhance education but only if they are consistent with continual Quality Improvement.

Managing Management Review.

CMPT is in it annual report season which means it is time for my doing my annual Management Review.  Over the years I have learned to enjoy the process.  

In many respects it is like eating olives or drinking coffee; the first time you to do one it is not particularly pleasant, but over time they all become an “acquired taste” and they actually become better than “not bad”. 

I recognize that my career path is probably a little different from others because I spend a lot of time in and around some of the intricacies of Quality, and so I regularly look at the management review requirements in a variety of documents including ISO 9001:2008 (Quality Systems), ISO 17025:2005 (Calibration and Testing Laboratories), ISO 15189:2007 (Medical Laboratories) and ISO 17043:2010 (Proficiency Testing Providers).

All of them have a lot in common. 

All of them in one way or another speak to reviewing existing policies and procedures, the results of audits and assessments (both internal and external), customer feedback, comments and complaints, and the processes of finding non-conformities or opportunities for improvement and ensuring that the appropriate corrective  and preventive actions have been undertaken. 

There are a few differences too.  15189 addresses a few additional issues, such as monitoring turnaround time (boo-hiss. Whatawasta time!) and reviewing an evaluation of suppliers (This is a good idea that should exist in all the other review requirements.) and the review of quality indicators for monitoring the laboratory’s contribution to patient care.  I personally think this is a good idea, but an example of really poor writing.  I think this is about readability and relevancy of reports, and maybe about test menus.  But neither of these are issues one would or could follow with an indicator.   

9001 offers some additional elements as well that contribute greatly to quality, including in the laboratory.  And laboratorians would be well advised to supplement their assessment with some or all of these because they help keep the quality system on track and current.   There is an expectation to review the organizational structure.  Laboratorians have learned all too well about the impacts of organizational change, including both the positive and the negative aspects.  You want your workers to follow the policies and procedures set for your laboratory.  They likely will be unaware of organizational changes that have a direct effect on those policies and procedures.  If you don’t make the required adjustments, don’t be too surprised when problems result.  This year in my review there were six policies that needed updating to adjust for changes that have occurred over the last year.

And let me take this one step further.  As the change management folks are fond of saying, the only constant in the medical laboratory is change.  Programs and patient care issues come and go on an irregularly irregular basis.  One day there is a haemodialysis program, the next day it is gone.  One day there is a leukemia ward, and then it is moved to another facility.   A new patient care initiative is dropped in.  Suddenly there is a new and urgent demand for three new tests.  If management does not keep these issues in mind, then meaningful strategic planning is impossible.  At least the annual management review process creates the opportunity to bring these issues to front-of-mind and to make some stabs at learning from what happened last year, and planning for next year. 

So management review is not only a nice thing to do, it provides management with the tools to make good forward thinking plans and decisions.  

Remember when management review in the medical laboratory only meant making sure that the standard operating procedures had a current date and signature. 

Pass the olives please.

Quality Education: what's it good for?

We are putting together a Master’s in Laboratory Quality Management which we expect will be available both in an on-line option and an on-site option.  The on-line will primarily be for folks who are working and intend to continue to work.  The on-site will be for folks who want to take some time away and spend some time doing primary research in medical laboratory quality.  I will continue to write on the subject as the program becomes ready for prime-time.

In the process of putting the proposal together, we did a survey of the folks who participated in the UBC Certificate Course.  Rather than invite and re-invite folks to respond to the survey we made the decision to take the responders from the first pass.  Both approaches can be equally useful, as long as you take methodology  into consideration as you interpret the results.

So after 5 days we gathered about 25 percent of course attenders.  The distribution of folks from across British Columbia and across Canada, and from outside Canada were essentially the same as the total group.  In addition the responders  equally included participants from the early years, the middle years, and the recent years, and few from the current group.   As we did not put any pressure on this group we can interpret this as a reasonably representative group.

Of interest to us was that about 90% belief there is a market for people with a Master’s degree today, and that the same percentage see that the market will be much stronger over the next 5-10 years.  That is what I believe too.

One finding that interested me, and disappointed me at the same time, was that only about 65% of responders currently are holding positions involved directly  in Quality.  We didn’t ask how many had held quality positions but had changed jobs, in large part because that was not the primary point of the survey  But what was interesting was that folks who had taken the course but were not actively engaged in Quality positions still believed there are opportunities out there, and that the market will continue to get stronger.

Which all got me to thinking; there are all sorts of positions for people interested in and trained in Quality.  The most obvious position is as part of a quality team or a part of laboratory  management.  But there are lots of other places as well.  There are positions with all the quality partners, like the proficiency testing group and the accreditation bodies.  There are positions within public or civil service, especially within the Ministries (or Departments) of Health and the health authorities, where knowledge of laboratory quality is important.  There are positions with service and equipment and reagent suppliers who need to be aware of validation, verification, stability, and measurement uncertainty.  And there are consultant positions, especially as we in Canada move more and more towards official inquiries for laboratory error.  And importantly there are increasing opportunities within education with the schools of technology, as well as the medical schools.

Bottom line appears to be that Quality in health and in particular the medical laboratory is a growth opportunity; today and tomorrow, and from the folks who responded to our survey, for the next 5-10 years plus.

Resident Quality Seminars as Adult Education

A few weeks ago I wrote (See “Communicating Quality and the Principles of Adult Education - January 30th 2011) that adults learn what they want, and  how they want and accept the knowledge if it makes sense and is consistent with what we already know.  The educator needed to be seen to be organized and pragmatic and relevant and interesting.  If adults are motivated they learn better.  

So with this in mind, can I make any objective comments about my own teaching capabilities?

I got back the results from my Resident Seminar Series.  
 
Background 
To summarize, I put on a seminar series for anatomic and general pathology residents.  The series begins the week after New Years and my sessions start at 08:00 AM.  A draw to the academic half day program is that they get a free breakfast when they attend.  
Before I start the seminar series  I create an anonymous on-line survey that includes a series of 10 questions on quality facts, along with some demographic information.  I then present 7 hours of seminars over 4 sessions and give 1 hour to a guest presenter, and after that asked the group to respond to a second on-line survey which asked the same questions as before and added some additional comments on the series based on a 7 point Likert ranked scale with a maximum value of 6.0

Attendance
The pre-seminar survey had 25 responders.  
On average there were 29-31 attenders to the seminar series.  Nearly everyone attended all 4 sessions.
The post-seminar survey had 14 responders.

Findings
So my first point.  Adult learners do what they want and respond to surveys if there is something on the table.  After the series we were able to get 14 responders (despite repeated requests).  Not getting a better response rate in the post-survey was annoying, but it is what is is.  

My second point:  There was improvement in the responses to all the fact based questions.  There was significant improvement (yates corrected p<0.05) in 2 questions.

My third point:  The responders found the information relevant to their career (5.5/6.0)  informative (5.36/6.0), relevant to their residency (5.29/6/0), and relevant to preparation for examinations (5.07/6.0)  The weakest response was when the group found the information interesting (5.0/6.0).  

Interpretation.  
Overall I can this a success.  Not an overwhelming success, but a success none the less.  

What was encouraging was that after the series, one resident  approached the hospital quality manager to get engaged in a project, and one resident approached me on a similar topic.

The increase in knowledge performance was ojectively positive and in part significantly so.  And there is a powerful opinion and recognition that knowing something about quality is important in a laboratory career.

Discussion and Conclusion
The objective measures point to the seminar series as a measurable success with opportunities for improvement.

Teaching my on;line course is the ideal adult education situation.  The participants seek us out because they want the information.  There is money on the table.  They feel free to participate actively.
With residents, they are present because they feel required to be there, even if they don’t care.  At worst they still get a free breakfast.  There is no money on the table.  They feel free to drop out if they are not being entertained.   

Note to myself:  
Look forward to doing the seminar series again, maybe next year, more likely in 2 years.  
Make some changes to beef up interest.  
And importantly don’t take the weak response rate too personally.  If they really thought the series stunk they probably would have taken full advantage to let me know.  

PS:
The information will be presented more completely and formally during the POLQM Quality Weekend Workshop in June.  There will be an education breakout session.

Measuring ISO Objectives

In the world of standards development there are folks that participate at every level, from institutional, to regional, to provincial to national to international.  At each level the documents developed become more generalizable, more applicable in a greater cross-section of environments.  That doesn’t necessarily make them better, but it does create a closer connection to international truth.  

At the top of the pyramid is the International Organization for Standardization.  
The ISO has been the crown of the standards development structure since 1946 (or 1926, depending on when you start counting).  It has as one of its mandates to create voluntary consensus standards that once applied assist the World Trade Organization promote international trade in the absence of non-tariff barriers.   I have been a volunteer Canadian representative on ISO technical committees since 1995 and am currently a member of ISO TC 212 (the committee responsible for 15189) and ISO TC 176 (the committee responsible for 9001).  Over the years I have seen both the positives and challenges of developing high level documents.  

Which brings me to the recent publication of the official ISO magazine known as ISO Focus+. This is a great magazine that I suspect most of you have never seen or heard of, much less read.  It is available at www.ISO.org, or is available through your national standards body.  In Canada that is the Standards Council of Canada (SCC); in the US it is the American National Standards Institute (ANSI).  The January 2011 issue is all about the ISO Strategic Plan for 2011-2015.  Within it are the defined strategic objectives that ISO has set for itself over the next 4 years.  

If you are interested in Quality, you need to read this magazine.  

ISO has defined the following objectives.

1: ISO deliverables meet customer needs
2: Promote innovation and provide solutions to address global challenges
3: Enhance capacity and participation of developing countries in international standardization.
4: Reach out to and engage with stakeholders.
5: Foster partnerships that increase the value of international standards
6: Improve ISO processes
7: Improve understanding of the general public, stakeholders and customers of value of voluntary international standards.

But for those of us that have set objectives for our own organizations in the past, we recognize that objectives need to meet a number of tests:
A: Are they appropriate? Are they consistent with the organization’s Quality Policy?
B: Are they measurable?  Can you by the end of the time period objectively document if you met the objective?
C: Are they achievable?  Does the organization have the resources and capabilities required to meet the objectives in the time frame that has been defined?

So how, in my opinion, do the new objectives measure up, and what will ISO need to do to meet the objectives successfully.

Objective	Quality Policy	Measurable	Achievable	CHANGE MANAGEMENT
Meet customer needs	YES	YES	YES	Process improvement
Promote innovation	YES	YES	YES	Process improvement
Developing Countries	YES	YES	NO	Communication
Engage stakeholders	YES	YES	YES	Communication
Foster partnerships	YES	YES	YES	Communication
Improve processes	YES	YES	YES	Process Improvement
Improve understanding	YES	YES	YES	Communication

Most of the work that ISO needs to do focuses on improved communication.  ISO certainly needs to do that.  The organization has become elite and presumes far  too often that the world will come banging on their door  Congratulations on recognizing that is not how it works any more.  

The other changes will come from acknowledging tat ISO has some internal work to do to tidy up its own processes.  Where there are rules, ISO needs to make sure that (A) they make sense, (B) the communicate them and (C ) they are applied consistently.

About the “NO”.  ISO can ask developing countries to be involved, but small countries don’t have the resources to attend and participate meetings. Fixing that is by-and-large outside the power of ISO.

So congratulations to the ISO.  This is a big step forward.

We will watch to see if this is "just words" or a "call to action".

m

Small World - Big World

In the last while I have become a little absorbed in the Communication of Quality as much as the Process of Quality.  Today I am extending that perspective.  .
Last week I was contacted by a colleague and was introduced to two on-line gold mines.

Pat Letendre is a transfusion laboratory professional and the coordinator of the TraQ website (http://www.traqprogram.ca/index.asp) of the BC  Provincial Blood Coordinating Office (PBCO) that was introduced as a program of the province of British Columbia and the Provincial Health Services Authority when Health Canada introduced national standards for transfusion medicine.  TraQ is an absolute gold mine of Transfusion Management information in the main, but importantly has a lot of useful Quality Management information.   The site has contains a ton of information on standards and guidelines and Continuing Education and a huge number of valuable links (including one to the UBC Certificate Course of Laboratory Quality Management). 

The site makes it clear that the information is provided as guideline and reference only, and is intended for transfusion laboratory professionals.

The other gold mine, actually the mother-load, is “Musings on Transfusion Medicine” (http://traq.blogspot.com/).  written as a personal blog of opinion by Pat Letendre.  Musings is a both fresh and mature blog, of considerable long standing.  Indeed Musings has been an active site  since 2004. 

Wikipedia says that journal or blogs sites have been making a presence since around 1997 and were seen as sufficiently mainstream by 2004.   That may be a true comment (we can’t trust everything we read in Wikipedia), but my guess is that Musings which started in 2004 had to be one of the first blogs dedicated to laboratory medicine, and by virtue of the fact that it has been on-line and live ever since must make it one of the most longstanding, which makes it a tremendous resource. 

What is fascinating about the on-line world is how difficult it is to get connected to all the material that you would like.  I have been running searches using a variety of search engines for a long time looking  for laboratory oriented sites.  I had not previously encountered either TraQ or Musings until Pat pointed me to them.  Considering that one of them  is based maybe 100 yards from my office, it points to the challenges of on-line communication.

Once I started looking more actively for laboratory focused blogs, I found lots where there was one or two entries, maybe three or four.    The number of sites that have years of activity are few and far between. 
I suspect that many laboratorians try it for a while and then either get board, or run out of ideas.  Or worse, what seemed like a good idea started to resemble work.  
My plan is to keep MMLQR as an active journal.  

Memos to self:
1: There must be a ton of sites of interest to clinical laboratory professionals.  The challenge is finding them.  If you have a list of sites with an interest for laboratory medicine, I would appreciate hearing about them.

2: Maintaining a web-log journal can be an enjoyable marathon if you don't cramp out in the first 100 yards.

3: Laboratory Quality is a topic with strong marathon potential.  
 

m

PS: Beware of on-line traps.  12manage.com comes to mind.

PPS:  We are starting to get registrants for our Quality Weekend Workshop.  If you have not seen the site recently you have not seen all our speaker bios and pics.  Also the agenda for the meeting is up.
Continuing education credits have been applied for from organizations for pathologists and technologists.

Human Factors and Safety and Quality (?)

In 1986 Briggs Phillips published a small, probably near forgotten, but important study in laboratory safety (see in Laboratory Safety: Principles and Practices.  ASM Press 1986).  The author was able to identify two groups of people: one group of 33 who had experienced at least one laboratory accident in the last 2 years, and another group of 33 who had been accident free during the same 2 years.   The two groups were matched by job classification.    

The two groups were interviewed and surveyed for additional information.   

While not matched for the following characteristics, all including age, years of education, years on the job, weight, height and gender and marriage status were identical.  In addition, wearing glasses, medication use, showed no differences.  Also of interest, accidents outside the laboratory, and driving records were also equal.  

The factors that had significant differences were (A) smoking  (B) the number of accidents and injuries and infections acquired in the 2 years prior to the current 2 years (C) personal attitude towards safety (D) opinions of the safety awareness of their supervisors and co-workers, and (E) importance of training and communication versus personal experience.  In all these, the accident involved were more likely smokers (remember this was 25 years ago), had a long history of accidents,  believed that technique was more important than attitude, but thought that personal experience was more important than training.   

The accident free group were significantly more critical of the supervisors and significantly more critical of their co-workers safety consciousness, and believed that safety attitude and awareness were more important than having techniques and equipment.  

[If you are safety aware you will avoid getting into the high risk behaviour of rushing or allowing distraction.  If you are not safety aware, you are more likely to assume that equipment will allow you to go faster and increase risk.]

The message of the study points to importance of attitude and awareness in the avoidance of having a laboratory accident or injury.  

So why am I bringing up 25 year old studies?  Two reasons.

First, a recent study in ASQ’s Quality Management Journal V18, N:1, 2011 on factors associated with continuous  improvement in patient safety  by E. Naveh et al came to a similar finding of the relative importance of opinions on attitude and priority.

Secondly, and more importantly, what made the first study possible was that records were maintained on who had been involved in a laboratory accident or injury.  In many laboratories today, we have virtually no records of Quality accidents, and where we do have records,  the names of the people are commonly deleted.  So in many (most?) laboratories if we wanted to study the human characteristics associated with increased error, it would be impossible because we have no place to even begin.

Deming wisely called to “Drive out Fear” and I agree with that.  He also said that most error was systemic, and I agree with that too.  But Quality in the medical laboratory is a new field, and it is important that we study why errors occur.  Confidentiality is important, and so if avoidance of a sense of retribution.  But let’s not “throw the baby out with the bathwater”.  Continuous improvement requires having data to study.

That’s why they call it PDSA.

Communicating Quality and the Principles of Adult Education

In recent while, I have been engaged in the active promotion of  medical laboratory quality in a variety of forums, including writing this web-log, providing an on-line course, hosting single-site lunch time education,  hosting the resident seminar series, and organizing and participating in workshops and conferences.  All of them have provided me with the opportunity to consolidate my own philosophy towards Quality.  

There is a lot of differences between all these activities; some have been held in Canada and others are international, some are one-off events while others short-term multiple events, and others yet are long multiple events, some of them are at no-charge to the participants while others are at substantial cost. Some of the participants want to be participating while others they are there because they feel compelled for one reason or another.  It would be easy to say that the only thing they have in common is a common topic, but there is something of far greater commonality; all the participants are adults.

Teaching adults is a special event because adults learn in their own special way.  There is tons written on adult learning.   For a quick summary you can visit Principles of Adult Learning at the University of Hawaii site.  

There are lots of reasons that people attend courses.  For learning, the most successful reasons are when they believe there is something in it for them; it is a topic of interest or there is an opportunity for career advancement.  Sometimes it is less about knowledge, and more about the social aspects; is a way to meet and connect with others, or is better than just being bored.  These folks may not be focused on learning, but they might connect.  Sometimes folks attend solely because they have to; it is a requirement and attendance is being taken.  This never turns out well.

Adults are autonomous and self-directed, and learn on top of their accumulated knowledge and life experiences, which means we learn what we want and how we want and accept the knowledge if it makes sense and is consistent with what we already know.  And we learn if we see the purpose to the information and especially it is meets our own goals.  And we are practical and pragmatic learners; if the information is not organized and timely then we turn-off. 

Adults tend to learn best if motivated, especially if we can link the information to what we do as a matter of competence or promotion, or job enrichment.  (Some say we learn better if there is money on the line.)  

For the educator, this means that the successful ones make the information relevant to what people do, is consistent with what they already know and link the knowledge to competence and enrichment.  Keep the information organized and timely and interesting.  For me, I have been involved as an adult educator for over 30 years.  When I think back to what I was like when I started, I can say with confidence that I am a lot better today than I was back then.  And one of these days I may actually get it right.  

One of the most successful educators I know has a formula.  He has 3 points to make (4 points a maximum).  He makes his points and reinforces them with stories and humor.  When he has delivered his points and told his stories, he stops.  I’m pretty good at the selecting 3-4 points and the telling stories.  I am pretty weak at the humor, and tend talk until I run out of time, rather that knowing when to stop.

Memo to self:  with widely divergent groups, some folks are there because they want to be there; others are not.  Remember the motivation; point of why knowing about Quality is an important   component of competency and enrichment, and can have an impact on promotion.  Be organized and know when to stop talking.  After than, the rest is largely out of your control, so don't worry about it.

m

PS: I am accumulating the post seminar series data now.  Will share the results soon.

PPS:  Big changes at www.POLQMWeekendWorkshop.ca  Lots of NEW information.