Sunday, February 27, 2011

Oldies but Goodies

About 11 years ago, as we were struggling with Y2K (remember?) there was a burning discussion about information storage, retention, and retrieval.  The tech world was moving too fast.  Information that was stored on 5 and a half inch floppies was no long accessible because computers no longer had had the right disk drive.  And the same was likely soon to be true for 3 and a half inch drives. 

 Many say the trend continues today.  CD’s and DVD’s are likely to disappear soon as well.  So what will we do.  Maybe it will be flash drives or cloud memory, at least for a while.  But if history repeats, these will be transient technologies as well.

When push comes to shove, the one answer for important information storage is now and will always be... the book.  Yes, paper forever.  

So why do I bring this up?
I was reading in the February 2011 edition of ASQ’s Quality Progress about how resistance to change is as alive today as it was many years ago.  (see  We are Different by Mike Carnell.  QP Feb 2011.  The author talked about an antique book Mary Walton’s The Deming Management Methodwhich he recalled reading in the early ‘80s and how it demonstrated how Deming battled with resistance to change in those days as much as we do today.  The article went on to discuss Deming’s “seven deadly diseases” and fourteen obstacles to the adoption of a quality culture.

First off, I enjoyed the article because I regularly struggle with folks who demonstrate their reluctance and resistance to change with the same pat concern “I know that might work for them, but you have to realize that we are different”.  “  Second, Carnell is referring to this ancient text , but we continue to use it as a core text in our UBC Certificate Course for Laboratory Quality Management   It is still published by Perigee (now a part of Penquin Putnam, New York) and is available through Amazon.
I don’t know ihow many copies they sell these days other than the ones that we buy for our course, but I would argue that it should be a compulsory book for every quality manager office.  Yesterday, Today, and maybe forever.   There are some things that are almost assuredly true.  This is a book that will never be electronic.  If you want it you probably will have to have it in that ancient of ancient formats... ink upon paper.  

But before I drift off into some sad rendition of how things were so much better in the old days, the point of this entry is that progress was not better back then, and further more, we are still struggling with the same challenges.  Experience indicates that despite 30 years of published discourse this is a lesson we have never yet  learned.  Tasks may be specific.  Quality principles are generalizable.   Quality is a central part of patient care, immunohistochemistry, building cars, and delivering pizza.  Establish policy, monitor for deviation, learn for the experience and continually improve.  Adopt and go forward.  Resist and continue along the path of repeated error.

For the laboratory in transition, reluctance to change is probably a hard wired genetic human trait.  Resistance to change is counterproductive.  

Incidentally, without getting too political, Deming undoubtedly was a visionary.  Not only did he see the problems of his day.  He was able to look forward to 2011.  In 1982 Deming wrote in “Out of Crisis.  (MIT Press, Cambridge, London):about the diseases and obstacles to  transformational change in American management.  In the automobile industry, the cost of employee health care was greater than the cost of steel per automobile.  Even Deming, who was in no way a pro-management type guy, knew this was unsustainable.  
Flash forward to today, to the challenges of General Motors and the financial burdens facing states like Wisconsin.  Who knows where the financial health of the US would be today if sometime over the last 30 years, someone would have recognized that benefit packages needed to be managed for the sustainable long term.  

If you listen real carefully, you can almost hear Deming calling out  “I told you so!!”

Wednesday, February 23, 2011

Preparing for ISO inspection

It is commonly said that when your quality management system is in place it doesn’t matter when the assessment visit occurs because you are always ready.  I’ve been at this game for a long time and I have to say that to date we have never achieved that level of perfection.  Indeed I suspect that this is one of those statements that if you are feeling generous you call hyperbole or overstatement.  If you are in a sour mood words like B*** S*** come to mind. Today I am somewhere in the benign middle and focus on it as a statement of aspiration.

What having a good quality system in place does do is reduce both the stress and the time frame for visit preparedness.  

I have mentioned before that our proficiency testing program (Clinical Microbiology Proficiency Testing program or CMPT) is annually assessed against ISO9001:2008 Quality Systems.  This is a Certification process, not an accreditation process (ISO17043:2010 is the accreditation option), although in my experience it is difficult to distinguish between the two in a real life exercise.  But I digress.  This is a big deal issue in the Quality arena, and will come back to again at some time.

Our site visit will be in April and I am putting the finishing touches on my Management Review cycle.  Today I was reviewing our Opportunities For Improvement program.  CMPT is a small program and so we can combine our non-conforming events record with our OFI program.  The NCE record is a small group of one-off events, either clerical or technical.  It would be easy in a pre-Quality era to write them off as “not a big deal”.  But for a proficiency testing program they are all indeed potentially a very big deal.  When we make a slip, a laboratory or maybe a group of laboratories can have an event that can impact on their quality process.  If we don’t take that seriously, then how can we expect laboratories to take us and quality assessment and indeed maybe even  quality management seriously.  Not to be too over the top, medical laboratories have a long history and tradition of not taking quality management too seriously.  

Perhaps my taking our Management Review more seriously is one small way that we can impact and improve medical laboratory care, at least in our little corner of the world.  

In a related note as part of our spring time customer survey we queried laboratorian believe about accreditation and quality partners.  Very early results, 95% of respondents believe that strongly or generally believe that accreditation bodies should in themselves undergo an oversight evaluation (accreditation, certification).  100% believe the same about proficiency testing providers and equipment/reagent suppliers.   About 90% believe that CMPT’s voluntary participation in oversight increases their confidence in our program and increases our value.
The survey will run for a few more weeks, and the values will undoubtedly tighten.

More on this later.

I have not talked about our POLQM Quality Weekend Workshop recently.  Today we putting the final touches on an additional breakout session.  We will be announcing it next week.  We have started to receive paid registrations, and more inquiries.  I am looking forward to a good crowd.

Sunday, February 20, 2011

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.

Wednesday, February 16, 2011

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.  
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

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.

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).  

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.  

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

Sunday, February 13, 2011

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, 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.

Quality Policy
Meet customer needs
Process improvement
Promote innovation
Process improvement
Developing Countries
Engage stakeholders
Foster partnerships
Improve processes
Process Improvement
Improve understanding

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".


Wednesday, February 9, 2011

Ranting on a Rant.

A recent article in Quality Digest Daily ( posed the question “Internal Quality Audits – Valuable or False Security?”  The question was written within The QA Pharm, an anonymous blog focused mainly on issues in the Pharma industry.  

An interesting question, with an even more interesting answer.  QA Pharm contends that internal audits are not helpful because they tend to be done by auditors who have been working too long and who are too politically aware and avoid sensitive concerns, and senior management doesn’t support them anyways.  And they never get to the root cause because company culture gets in the way.  

In a way I am not too surprised by the rant.  My experience with folks who have transitioned from pharma to health care is that the pharma culture is hyper reactive to the point of absolute risk aversion, which tends to either paralyze or drive folks in the opposite direction.   People who care for pharma quality tend to get extremely passionate.  The rest get bashed to indifference.
Pharma does have certain problems.  Most drug release decisions are made through a series of graduated studies, on pharmaceutical effect, and then controlled safety studies, and then “larger” population studies, and then after-the-fact post-market analysis.  In their world even 6 sigma (3 defects per million) can be enough to sink the ship.  But they are not unique.  It only takes one airplane to fall out of the sky or one bridge to fall down to create industry chaos.  

In contrast the health care may be a little more tolerant, maybe too tolerant.

My biggest problem with QA Pharm is not on his opinions with respect to the frustrations of practicing qualitology in the pharmaceutical industry.  It is more with the folks who read the rant, and interpret the opinion as generalizable.  

Health care laboratories are just at the beginning part of the quality process and the introduction of internal quality audits is just being introduced in a significant way.  That is not only true in Vancouver, but it is my personal experience that this is the case across Canada, across the United States, and in many countries worldwide.  This is not the time for health care laboratorians to be thinking that internal quality audits are a waste of time, or too political. 
Internal quality audits can and should be an important component of technologist training, quality manager training, pathologist training.  They can and must (shall) be a component of quality monitoring infrastructure, and the foundation of quality research and outreach.

So QA Pharm can have his(?) point of view, and that is fine, if it is intended to apply only to the pharma industry.  That internal audits are a WOT, is not my point of view and it has no place in health care laboratories.


PS:  Some of you may be in the receiving group for a POLQM Weekend Workshop blast out. next week.

PPS:  Some of you might consider sending the link to to friends and colleagues who might be interested.  All a part of being within an interest network.  Twitter works well as well.