Tuesday, December 28, 2010

Resolutions 2011

I used to think that New Year’s resolutions were pretty much a waste of time. Most people that I know still do. I vow to be good; I resolve to quit eating; I resolve to quit smoking:   I resolve to get more exercise.  I resolve to stop being sarcastic. Yeah, yeah, and ...yeah.

But over the 5 or 6 years, the concept of resolutions started to make a little more sense. New Year's Resolutions are just a variation on the theme of setting Objectives and Goal.
I mentioned before that CMPT`s quality system has been certified to ISO9001: (2000 - 2008) since 2002. Every year in October we set quality and programmatic goals and objectives and then monitor to ensure that we meet our goals.  When we started we did this so that we would continue to get certified, but after a while we saw the value in the exercise, and did it for us... to keep CMPT on path and on track.  And it seems to actually be effective.

So it started to make sense that if we can do this positively and painlessly for a proficiency testing program, we should be able to do the same thing for the Program Office for Laboratory Quality Management, and for my teaching commitments, and also for the medical laboratory at which I worked as a medical director for Quality. And again, the experience reinforced itself by actually being productive. 

Go figure.  Those guys like Deming and Crosby actually knew what they were talking about.

And now that MMLQR goes though its first New Year,  it is time to start setting some objectives for it too.  Actually MMLQR has only been running for 6 months, but this is sort of like setting or re-setting an organization's fiscal or operational calendar.

Just to make sure we are on the same page, I use the term Objective to mean a large scale outcome that may take a number of steps to reach, and I use the term Goal to identify the individual steps.  To be credible the objectives should be achievable and the goals should be measurable.

So here are my goals and objectives for MMLQR for calendar year 2011

Objective 1:

MMLQR will be recognized as an active and credible and readable website to promote diversity of opinion and discussion for the full range of issues that surround quality management of medical laboratories.

Goal 1
To meet the measure of "recognized" I will promote MMLQR to support current readership and to encourage a broader audience.

Goal 2
To meet the measure of ``active``, I will generate at least one new entry each week.

Goal 3
To meet the measure of ``credible`` I will actively seek review and comment by others with long term interest in medical laboratory Qualitology.  This might be in the form of another shot at an electronic survey, or in the form of an external-internal audit.

Goal 4
To meet the measure of ``readable`` I will reduce the number of spelling and editing errors per entry.  (This one will be tough because I am terrible at proof-reading).

Goal 5
To meet the measure of ``diversity of opinion and discussion" I will invite and publish comments and commentary of differing opinion (as long as words like "jerk" and "pinhead" are not included) . 

Goal 6
To meet the measure of "full range of issues that surround quality management"  I will expand the topics covered including more commentary on politics and quality partners, as I see it.

So that is a good start with an achievable objective and a series of measurable goals.  MMLQR is a young start-up which has met reached a certain level of fragile stability (similar to how they describe the Canadian economy).  Going to the next step will take the discipline of setting some objectives and goals and PDSA.  We will see how I do by the end on the year.

See you in 2011.


Sunday, December 26, 2010

Predictions in Qualitology - 2011

As the year slowly creeps to a close and the next year gallops forward, I start to wonder what 2011 will look like for medical laboratory quality.

1: Flavor of the decade?
It is unlikely that Quality is going off the agenda in the next while in health care.  Across Canada the media has decided to keep an eye on the laboratories, waiting for the bad thing to happen.  We are unlikely to disappoint. 
This will put increasing pressure on provincial governments and maybe (but unlikely) Ottawa. 
Organizations like the Royal College will have a hard time turning away.

The validity of Crosby will ring true in health: the costs of non-conformance, in NOT doing it right the first time, are too high.  I don't know if we will ever actually achieve zero tolerance for error, but 2011  will be a pressure point.

2: Jobs, Jobs, Jobs
As the world comes out of recession and folks again have money to spend, the jobs will return.  This will be true in both the private and the public sector.  Near the top of the list will be the positions postponed or sacrificed along the way.  People over machines.  Buying bigger and better analyzers is unlikely to be seen as the best way forward.  But institutions will still be cautious and a major priority will be effective use of money and more effective monitoring. 
And that will mean more interest for more quality team positions.
Add to this, increasing political pressures (as mentioned above) and there will be even more Quality positions.  Think of 2011 and 2012 as the equivalent of what SARS did for Infection Control.

3: Knowledge is King.
In Canada, we had our Royal College meeting and the importance of shared knowledge in Quality was seen as priority number ONE.  In the US the audience for quality is growing, as is the number of laboratories seeking supplemental accreditation.  The number of folks coming to our training programs is increasing from around the world.  So the message is clear in healthcare that more folks need more information, and we will see the sharers of the that knowledge in more demand.
Again as mentioned above, the wave of new positions will require a wave of new educational opportunities.
Universities and Colleges will become more actively engaged in Quality.

4: Conferences - maybe
Organizations are increasingly leery of  conferences as good vehicles for continuing education.  Airfares, hotels, meals are very expensive.  So how does this fit with Knowledge is King".

First the number of on-line courses and conferences and confabs will increase using a wider array of communication tools that will promote connectivity.  Video conferencing, collective conversation,creative use of networking software will be an increasing part of the on-line education experience.
Second, when conferences are held, they will attracting an audience will be tougher as folks get more selective.
The conferences that survive will be fewer but better.

Successful conferences will be the ones in the right place, and the right time, with the right information, and the right contacts. For example, Vancouver in June at the POLQM Quality Weekend Workshop (visit www.POLQMWeekendWorkshop.ca )

So I'm looking forward towards an exciting year coming up with lots to keep us all busy.
See you next year!


Thursday, December 23, 2010

Message to self

Let me start by saying that I do a lot of surveys. To date my account has 82 surveys completed and an additional 3 currently active.  I survey students regularly during courses, and annually we do at least one customer satisfaction survey for CMPT.  I have done surveys for the International Organization for Standardization (ISO) and for International Laboratory Accreditation Cooperation (ILAC).  Over the years I have become adept at creating surveys that address the issues that I want addressed.

Last week's survey was my first experiment of linking a survey to a discussion website like MMLQR.  I would not call it a totally successful experiment. 

When I look at the reported results, first I noted that we are attracting a variety of laboratory Quality professionals from Canada and internationally.  There are some positive trends.  Based on a 6-point Likert scale, this site was ranked either as Excellent or Good by near everyone with regard to variety of topics, relevance, clarity, accessibility, and refreshment.  There were no "poor" or "unacceptable" responses.  The same was true for the Overall assessment.

So this is all good, Yes?
Well it provides documentation that supports impressions based on the progressively increasing readership, and it confirms that the people that I am interested in engaging in conversation aer finding the site.  But based upon the number of tracked page views, it looks like less than 4 percent of people connecting to MMLQR have responded to the survey.

With the information that I can garner, I don't know how many people opened the survey but chose to anwer no questions, but I assume that that is a very small number

So there is a problem, but a generalisable problem.  Almost all the surveys I have done in the past have been to a closed or faily closed population, where I could go back to the group and try again and again.  This is a survey to an open population.  In that regard it is similar to attempting to do a satisfaction survey of people exiting a laboratory patient service centre, or of physicians that use laboratory services.  
In all these situations, one can generate a denominator of how many potential responses there could have been.  The challenge is how does one increase the numerator without generating bias, both positive and negative.

In the laboratory setting, one might try creating focus groups as definable groups, but one has to create incentives to garner participation.  This is potentially expensive and would only be applicable if one risked confidentiality breaches.  One could combine focus groups with electronic surveying, but still one would have to have identifiers to work with.
In this setting, I have no access to identifiers, and no obvious inducements that might entice a response.

So it is back to the drawing board with some questions to be asked, like who do I want to attract to the survey, and how can I entice them to participate, and what is a sufficient cluster, and what kinds of questions will capture the information that I want.  And maybe to affirm why I want to generate the information.

It's kind of like my own PDSA

If I come up with some answers I will try again.
In the meantime if you are in the 4%, many thanks for participating.

In the meantime, I am going to take a few days off and come up with my predictions and resolutions for a happy and Quality 2011.

For those of you who celebrate the day, Merry Christmas.


Sunday, December 19, 2010

Preparing our next generation of leaders

I am preparing a number of new presentations for our Resident and Graduate Student Quality Seminar Series and took the opportunity to re-read Deming’s Out of the Crisis, written in 1982 to expand on the 14 Principles.  In chapter 2 Principles for Transformation of Western Management he writes “Support of top management is not sufficient.  It is not enough that top management commit themselves for life to quality and productivity.  They must know what is is that they have committed to – that is, what they must do.  The obligations can not be delegated.  Support is not enough; action is required.

This is a core message that I am going to convey.  

Medical laboratories provide a broad variety of services including creation and provision of a menu of diagnostic tests, creation of a method for ordering tests (I hate that term: more on this later) and then providing a process for collection and transport.  The samples get accessioned and tested and results get generated and reported.   

Along the way some quality processes take place, including quality control and proficiency testing and sometimes accreditation.  Some projects, like the application of “Lean”, or a Lean variant of time and motion get initiated and sometimes actually competed. But we all know that problems still continue.  Over the last very few years we have seen pathologists misinterpreting and misreporting findings, faulty HIV testing, faulty tissue diagnostic tests, and pathologists with a pathological ineptness in writing reports.  We also have well documented sample contaminations in chemistry and microbiology.
In some laboratories we are starting to do more.  Quality management is starting to manifest some continual improvement processes (which is good) and even some error investigation (which is better).

So far I have told you nothing that you don’t know and that you have not heard before. 

But here’s what our residents need to know and understand.  That when push comes to shove all the above mentioned errors have a single primary root cause and it has little to do with technologist training or standard operating procedures, or competency assessment.  Our primary root cause of laboratory error is the consistent and persisted absence of personal active engagement by our medical laboratory directors in Management Review and change.  
 Quality is not about hiring a Quality Head, however named, and then delegating authority.  Management Review is not about being handed a bunch of manuals and annually signing them off, or about asking the Quality Guy how we are doing.

Our next generation of medical laboratory directors need to know that quality management is as much a part of their job as is reading pathology slides or signing our reports or dealing with human resources and budgets.  And it is not about number of slides read per hour worked or number of INRs ordered per week.  And it barely is about some artificial and artefactual measure of turnaround.   

They need to know there is a quality expectation, a quality vision.  Keeping laboratory staff focused on what matters is a critical function of the laboratory director . They need to know that satisfaction is not about making complaints go away, but is about comprehensive communication with hospital staff and patients.   

They need to know that quality is a science of planning, execution, measurement and response.  And they need to it is their job to make these things happen.

So it should be an interesting seminar series.

PS: I have a plan to see if we can monitor our impact on three scales: immediate, intermediate and at five years.  

PPS:   We have made some important changes to the Quality Weekend Workshop.  Dr. Denise Dudzinski is a bioethicist who recently published an article in NEJM on Disclosure Dilemma – Large-Scale Adverse Events.  I am looking forward to her presentation.

PPPS: I would really appreciate it if you can go back to the previous entry and fill in the survey.

Thursday, December 16, 2010

Quality Tools for a Quality Website

The Quality Tool Box is loaded with goodies, like Quality Indicators, Analysis through Pareto Charting or Sigma Calculations, Planning with Gantt Charts, time and motion studies (is that Lean or Taylorism?), and surveying for customer opinion.  Over time, the qualitologist uses all these  tools to monitor and improve the quality of process.

Today I am interested in your thoughts.

We have done 62 entries to MMLQR.  Some brilliant, some maybe not so much.  The point of the exercise has been to develop some themes like Cost and Performance and Quality Partners.

So as I go forward I am interested in knowing if I am striking a chord with readers.  It is time for an opinion survey.

The enclosed survey should take no more than 4 minutes to complete.  It will be available for about 2 weeks.
Your participation is much appreciated.

Create your free online surveys with SurveyMonkey, the world's leading questionnaire tool.

Tuesday, December 14, 2010

Big enough to fail?


Question 1: How many laboratories in Canada (or indeed anywhere) have been closed down because they did not get a perfect score on their proficiency testing challenges? Answer: None.  Never.  Notta. Zip. Zero.
Question 2: How many laboratories have been allowed to remain open, but lost their ability to bill their provincial medical services program for services rendered because they did not get a perfect score on their proficiency testing challenges.  Answer: see above.
Question 3: How many laboratories in Canada “game” their proficiency challenges by holding the sample back until the right technologist is available, or do repeat testing, or do extended testing, or send the sample to a referral laboratory.  More than one, disturbingly a lot more than one. 
Not to belabor the issue, but what is the point of the exercise?  Are we really that insecure about our professional competence that we have to “cheat” when there is nothing on the table, nothing to gain.  No gold stars, no extra cookies, no scholarship, nothing.

What we do lose is the opportunity to check that our standard operating procedures are getting us to the right answer.  What we do lose is the opportunity to do a competency check on our operating systems.  What we do lose is all the extra time, effort, energy and money is doing the extra testing, and scheduling. Consider that  finding a single weakness through PT can save you poor quality costs equaling your laboratory's total PT costs for a whole year, or more.

There are solutions or work-arounds that can be put into place, but they are either expensive or inconvenient, or create increased, and from my perspective unacceptable risk.  
We have been toying with the possible linking proficiency testing turnaround times to clinical sample turnaround times.  If a sample should pass through the clinical laboratory in less than 24 hours, then that becomes the upper limit for the P.T. challenge.  If it should take five days, then the PT turnaround limit is five days.  It would not be particularly difficult to do, for programs with on-line entry of results.  For paper or fax entry it may be a little more difficult.   It would result in more paper work on both ends and that would result in some inconvenience and added cost.

Another solution would be to create a link between the P.T.  provider and the laboratory information systems, so that reports would be automatically generated and sent tot he provider.  This would take some initial set-up time and save time on the laboratory side, but would, in most P.T. programs, cause increased time requirements to transfer results to the data base for analysis  with an inevitable increase in cost.  Additionally, it is stunning how unstandardized our reports are.  But that is a topic for another time.

Or we could disguise the samples completely and have them submitted as clinical samples.  But that would cause all sorts of challenges with getting site specific requisitions from each laboratory and creating patient names with appropriate identification numbers.  And then we would have to sort through the problems created with billings.  (A number of years ago when I was a resident, a microbiologist in the hospital created a  throat swab with C. diphtheriae.  It was a brilliant idea except that the result got reported to public health and much chaos ensued).

Or we could just get rid of proficiency testing, but most laboratories would lose an essential quality assessment tool and a major source of continuing education.
There is, I think, a more reasonable solution.  Laboratory management including the quality manager decide that as of this day we do things differently.  No more overwork, no more processing by the QC technologist.  Routine processing only.  It's worth a try.


The POLQM Weekend Workshop is coming together well.  For those interested in doing a poster or podium presentation, register early and send your abstract to ubcpolqm@gmail.com

Saturday, December 11, 2010

The Science of Qualitology

I like the ASQ’s Quality Management Journal because it publishes articles in a science and experimental structure that I understand and expect to see in a journal.  The article that I was looking at was analyzing factors associated with Quality in hospital settings. (seeR.E Carter, S.C. Lonial, and P.S. Raju.  2010.  Impact of Quality Management on Hospital Performance: An Empirical Investigation.  QMJ.  17(4): 8-24).

The study design was based on a survey sent to hospital executives in 175 organizations in mid-US (Kentucky, Ohio, Tennessee, Minnesota, and Mississippi)). The surveys were sent to Hospital CEOs who were in turn supposed to pass them on to senior folks like the VP administration, Quality manager, Support services manager, Director of nursing.  This was very ambitious.

The conclusions they came to were what I would expect; when it comes to quality size and stress matter.  The more uncertainty in the institution, the larger the institution, the less likely they were to have “measurable” evidence of Quality. 
The “measure” of Quality in this study looked at 5 markers for financial performance, 4 markers of market/service development and 4 markers of quality outcomes.  That, in my opinion was a set unlikely to give a clear picture of hospital quality.

And that brings me to my point. 
What are the objective measures that one can monitor as an indicator for success or failure for introduction of Quality activities in medical laboratories?
Not success in accreditation or proficiency testing scores. They are too readily manipulated  (see   M.A. Noble.  2007.  Does External Evaluation of Laboratories Improve Patient Safety?    Clinical Chemistry and Laboratory Medicine.  Clin Chem Lab Med.  45(6):753-756). 
Not numbers of reported incidents or OFI’s.  They are too open to flexible interpretation.  OFI reports, if anything are like unemployment rates.  A downward movement in rates may mean more people are being employed, or it may mean that fewer people are bothering to look.  And a rise may mean more people are unemployed, or it may mean more people are hopeful and are again more actively looking.  In the same way  a rise in the OFI’s rate may mean more problems are being identified and reported meaning poorer Quality, or it may mean more engagement leading to more reporting meaning better Quality.
How about client or staff satisfaction?  Maybe, but again, very manipulatable and too vague.
And in Canada, financial stability or instability are completely inappropriate since 99 percent (or more) of resources come from the government purse.

So we have a dilemma.  For good studies we need measurable and interpretable and  monitorable outcomes on both a micro- and macro-  basis. We do this on a micro- scale all the time (call that Quality Indicators).  But to move from interesting to convincing and compelling, we will need to define our macro- outcomes as well. 

For Quality to create a lasting imprint in medical laboratories, we are going to have to speak the language of laboratory personnel, pathologists and technologists.  We will need the language of science and experimentation. outcome and conclusion. 

Any and all ideas are most certainly welcome.

PS: Absence of strong interpretable measures makes grant funding difficult, maybe impossible.  I have learned this the hard way. 

Tuesday, December 7, 2010

Implementing ISO 15189:2007

For folks interested in medical laboratory quality, it is not necessary to explain the number 15189.  In the area of medical laboratory quality it is probably the most significant harmonizing document ever created.  ISO 15189:2007 entitled "Medical laboratories - particular requirements for quality and competence" sets out a clear and comprehensive set of quality requirements for medical laboratories.  Initially published in 2003 and is in place both for laboratory and accreditation body usage in over 70 countries.  It is being used on every continent, with the possible exception of Antarctica. 
Unfortunately, ISO 15189 shares many characteristics with other documents created by the International Organization for Standardization, and lots of other standards development bodies; it can be a challenge to understand and interpret, even in English, because, as they say, the devil is in the details, and understanding the details may require a certain subtlety and appreciation for nuance. 

Enter the implementation guides.

There are a variety of implementation guides to assist with understanding this document.  Some are in the form of courses, both on-line and in-person.  Others are in the form of text books.  One of the first published was created by the Canadian Standards Association (CSA) and was known as ISO15189:2003 Essentials.  Written by members of the Canadian delegation that were actively involved in the creation of the standard, it was a small but extremely well received book, purchased and used around the world.  It suffered from some editing issues, but the content was reviewed and supported by folks in the US, UK, and Australia.
Well, time went by and in 2007, the standard was republished, with some minor text changes.  With passage of time and increasing usage of the standard, a lot of the content was open for revised interpretation and guidance and implementation advice. 

So now, the 2nd edition is available through the Canadian Standards Association.  The full title is:  The ISO 15189:2007 essentials - A practical handbook for implementing the ISO 15189:2007 Standard for medical laboratories. 
Again written and supported by the Canadian delegation to ISO TC 212 Working Group 1, it still contains the content of the standard, interpretation and guidance and tips on implementing the requirements.  The guides and tips are designed for use in laboratories with a range of size and complexity.  It will be helpful and useful for medical laboratories in many countries

Most or all of the editing issues that needed addressing in the first edition have been much improved. The book contains both table of contents, and an index, and contains all the annexes. 
So the book is worth a read.  It is a good book and I will be using it as part of the UBC Certificate Course in Laboratory Quality Management (see www.POLQM.ca).

It is available through the Canadian Standards Association web-site (www.ShopCSA.ca) at a fair and reasonable cost.  

One of the themes that I have raised before is that in many countries, medical laboratory accreditation is NOT a requirement, and in some places where it is a requirement,  there are allowable options for accreditation to requirements other than ISO15189:2007.  But in many countries, medical laboratorians recognize the value of implementing this standard on a voluntary basis because of its superior quality management and its international application. 
Some who go through voluntary implementation go further by applying for voluntary accreditation. 
Both these steps provide great value to the laboratory that makes the commitment because ISO quality implementation and accreditation can be the basis of international recognition, business opportunity and all the benefits that accrue: higher satisfaction, lower costs, improved patient safety.  
I declare my personal connection with the book.  I was the co-author of the first edition and the principle author of the new edition.   It was written under a fixed contract though the University of British Columbia.  Neither I, nor the UBC Program Office for Laboratory Quality Management, or the university receives payment in the form of royalties for present or future sales.  


PS: A third iteration of 15189:XXXX is underway and may be available in 2013.  

Sunday, December 5, 2010

I Love This Bar

Some of you are probably not followers of country music, and don’t know Toby Keith or his song “I love this bar”.  Part of the lyrics go “I love this bar.   It's my kind of place just walkin' through the front door puts a big smile on my face.  It ain't too far, come as you are.  I love this bar.” 
The song and sentiment is not about drinking, or about the location.  It is about the people. 

I raise this because in the last while I have had the time to ponder on being a medical qualitologist, I have come to the same conclusion.  I really enjoy the community of qualitology.

Over the last while we have been working on a number of projects.  UBC Certificate Course is starting to fill up, and our project with the I-TECH at the University of Washington is taking shape.  And our seminar series of Quality Management for Residents in Laboratory Medicine is shaping up as well, as is the planning and progress for our CACMID/AMMI Symposium in April and the Quality Weekend Workshop in June.  Plus, plus, plus. 
It’s good that we are busy, but what makes it all the more enjoyable is that each of these projects connects us with more folks interested in the same things that we are interested in.  
Folks in qualitology have a number of common characteristics.  They tend to be very positive, and hopeful, and interested in making what they do relevant to better workplace management.  And they see the direct link to better patient care. 

Each of these projects will end up creating supportive dialogue and improved information that will make laboratories better and safer and more effective.  And while I am looking forward to all of them, the seminar series for residents is top-of-mind.  Residency training is part of the continuum of progressive narrowing of focus that starts in high school and progresses through undergraduate college, graduate studies, medical school and specialty training.  I understand it, I am a product of it.  But what is really clear is that being finely tuned in the science base of pathology does not prepare folks for how to run an effective laboratory.  Our seminar series reverses that narrowing focus and says, “Hey folks…time to broaden out your attention.  Quality is not an innate topic, and if you expect to be an effective manager of people and information, you need to know this stuff too.  It’s call Management Responsibility and Management Review.
The series will include 10 presentations:
         Hour 1: Why Quality and Why Now
         Hour 2: History of Quality Management
         Hour 3: Quality Requirements
         Hour 4: Quality Standards
         Hour 5: Applying Laboratory Quality (1)
         Hour 6: Applying Laboratory Quality (2)
         Hour 7: Quality Partners
         Hour 8: Working with Quality Partners
         Hour 9: Costs of Poor Quality
         Hour 10 :The role of the physician laboratorian

If you are interested we will post the presentations as we go through January at www.POLQM.ca


PS: The POLQM Weekend Workshop in June is shaping up to be really exciting.
Visit www.POLQMWeekendWorkshop.ca for updates as they come.