Quality that drives folks crazy

The other day I was part of a meeting reviewing a document intended to standardize Quality Standards.  The point was that was being put forward was that all Quality standards should use the same words and use them to mean the same thing.  That way regardless which quality standard you use you will immediately understand the document and be able to implement the requirement.  That makes sense.

But as the document continued, the devil in the details started to appear. 

Is the word “document” a verb or a noun, or can it be both?  Is “documented” an acceptable adjective?  The same applies to the word “record”.  And what about the words “goals”, “objectives”, “aim”, and “target”; are they the same of different? Is the term “goals and objectives” meaningful or redundant. 

The terms “continuous” and “continual” are raised as well.  Is the correct term “continuous improvement” or “continual improvement”?  Apparently the word “continuous” means “ongoing without interruption”, while “continual” means “ongoing but at regular intervals”.  Both of these terms need to be differentiated from “continued” because that term means “ongoing but after having stopped”.  And should we refer to “continuous education” or “continual education” or “continuing education”?  Apparently the term “continuing” can mean one or the other.   So perhaps the correct term for improvement is “continuing improvement”.  And where might “continuity” fit in?

In my own technical committee, we have struggled with a truly pointless convention.  When a “sample” is being collected from a patient (or is that a customer or a client) then we can that this is an action (procedure) in the “pre-examination phase”.  And if someone wants to refer to this as collecting a “specimen” as part of the pre-analytic phase” then they are wrong.    This is truly the stuff that some Qualitologists and Standardization people love, but which really drives most people crazy.
This is the stuff that gives quality a bad name as being deeply involved in minutiae rather on issues that are really important to organizations.  And I agree with that too. 

There are lots of drawbacks with this sort of discussion.  First and foremost, there must be hundreds of words that would need to be examined and discussed, and thousands of people who would be affected (should we call them “stakeholders” or “interested parties” or “affected parties”).  It would take years to work through with the likelihood of some sense of “consensus” or “agreement” or “general agreement” being very limited.  And even if we could come to some “common understanding” in English, would the subtleties translate into French or Spanish or Mandarin or Russian?  And third, it drives the "big-picture" advocates crazy, and even more importantly away from trying to improve Quality.

My solution to all this is to reduce the number of jargon words in what we try to convey.  And further to the point, reduce the number of words period.  Pictures are good.  More importantly, we should quit worrying about the trivial issues. 

Quality is about big principles of making sure people understand what they are supposed to do, thinking about a project before jumping in, checking what went right and learning from what went wrong.  Whether you used a red pen, or a blue pen, or white-out is a side issue. 

As this standards year soon comes full circle (World Standards Day is October 14^th) we should resolve that next year our goal (objective) for Quality should be to keep it simple and effective.

Quality means never having to say you are sorry ... TWICE

Jim writes a very contributory comment about Quality.  It is consistent with the Crosby view of Quality (Do it Right the First Time). 

Quality is the doc ordering the right test and the lab drawing the right specimen on the right patient.  The test result is right (correctly reflects what is going on in the patient) and is sent to the right person. And the price/cost is right (we're spending taxpayers money). 

It is completely consistent with the Four Absolutes that the definition of Quality is conformance to requirements, and that the system of Quality is prevention.  The performance standard for Quality is zero defects and the measurement of Quality is the price of non-conformance.

My problem is that this is all about the ideal, and not the real world.  Slips happen and mistakes happen.  They don’t happen all the time or even at regular or predictable intervals. They annoyingly occur like atrial fibrillation, irregularly irregular.

 And as our laboratories have become more consolidated and more complex and with more highly sensitive and intricate equipment, they happen faster and in ways that many never get detected until it is far too late.  Remediating early errors is often an easy fix.  Detecting and fixing downstream errors is ALWAYS a pain.
Every day the nonconformities happen; and they never seem to stop.  Fortunately, the vast majority of nonconformances are minor and don’t affect patient care or management or result in poor outcomes.

That is not to say we should be untroubled about error, but I think that Crosby was excessive in defining Quality by the ideal.  Deming was about 20 years older than Crosby but was still very active in the 70’s which was Crosby’s heydays.  Demining wrote extensively on hazards of slogans and the anxiety they raised. He was very unimpressed by the notion of Doing it Right the First Time.

I think Deming was closer with his sense of Continual Improvement.  It is not only about putting out fires, but catching them early before they get out of control and sorting out why they happened and fixing that.  When I look at reports of patient error, if you knock out the repeat problems the total number of errors drops ... dramatically.  

So I am going to argue the following:

Since errors happen often silently and beyond your control, the effective measure of Quality is the prevention of and the rapid detection of errors in order to avoid or at least reduce customer inconvenience and harm.

Quality is never making the same mistake twice.

Tangible Quality in Action

Manky Badger asks for some tangibles that will illustrate the notion of “Quality” in action. 

These tangibles are derived from knowledge, study and experience dating back through the past 70-80 years and adopted by many business sectors.  They exist today in a variety of sources, most commonly from the International Organization for Standardization. 
Whether a laboratory adopts them because they have to (mandatory accreditation or regulation) or because they see opportunity and advantage (voluntary adoption or voluntary accreditation) depends on the situation and circumstance. 
Some laboratories do both.
Many organizations in manufacturing and service sectors have demonstrated the tangible advantages to implementing Quality practices. 

Most locales that have created requirements for mandatory accreditation adapt these same tenets into their own language, regulation or legislation

An active Laboratory Quality program includes:

Management should manage:

Laboratory Management should show leadership in the laboratory by establishing policies that are important to laboratory testing, and then ensure that everyone in the laboratory knows what they are and why they are set as policy. 
Laboratory Management should then ensure that laboratory decisions are consistent with those policies.

Laboratory suitability:

Laboratories should be fit for working in.  They should be safe and secure and have enough resources to perform the tests that they laboratory is required to perform.

In-laboratory communications:

To reduce confusion that leads to error testing, ensure that your laboratory staff know to whom they report and who reports to them. 

Ensure that laboratory users know who is responsible for laboratory decisions.

Documents:

Laboratory documents should be written in a way that can be understood. 
When there are documents that are written as different versions, people working in the laboratory  should be able to know which is the most current and active version.  
When documents are stored, they should be stored safely and in an appropriate way so that they can be retrieved when needed.

Training and competency of laboratory staff:

Employees should know what tasks they have been hired to fulfill.  They should be trained to perform those tasks and their training confirmed.  They should be checked on some sort of regular basis to ensure they have continued competency doing those tasks, especially if they have been away, or ill, or the task has changed over time.

Laboratory personnel should have access to the information and resources they need to perform their tests and tasks both efficiently and effectively.  This means there should be some form of written instructions.

Equipment, materials and reagents should be  as well as equipment and reagents should be in a condition that assures they are working properly.   

Employees should have regular access to continuing education to ensure that their knowledge and skills meet current needs. 

Employees should be aware that working in a medical laboratory creates obligations with respect to error prevention, timely testing, error reporting, and patient confidentiality. 

Error Prevention:

Laboratories have an obligation to reduce the risk of error through the programs mentioned above and also monitoring for systemic error through active programs of quality control, quality assessment, and quality indicators.  Signals of problems are investigated to determine if errors have potentially been caused, and if so ensure they are addressed.

Pre-examination error:

The laboratory should have policies and procedures that prevent poor quality samples (wrong patient, wrong test request, wrong conditions, wrong timing) from being tested in order to reduce the risk of producing results that are clinically misleading.

Post-examination error:

The laboratory should ensure that the right person gets the right report on the right sample from the right patient in a clinically relevant time.

Addressing error:

Laboratories are complex environments and to some extent some error is inevitable.  That being said, laboratorians have an obligation to monitor for error, to detected it early, to remediate it rapidly, to investigation why the error occurred and to the extent possible correct the possible causes, reducing the risk of similar errors. 

Customer satisfaction:

Laboratorians should accept all complaints as cause for investigation and action.  Where problems have lead to the complaints these should be addressed and corrected.

If a laboratory is able to say with confidence that they are working within a system that enacts these tenets, then they are doing the things that will reduce the risk of producing error, increase the possibility of detecting error, and when error is found fix it and learn from it, thereby reducing the risk of repeating the same problem again

If they are in place, we call that having a Quality program. 

To get more tangible, Manky Badger may want to consider a course such as the UBC Certificate Course in Laboratory Quality Management (www.polqm.ca)

Embracing Quality

I was putting in time sitting on the airplane, reading their airline magazine and came across an interesting note ascribed to an hotelier Jaume Tapies.  “People only embrace what they help to create.  It’s important to share projects with those who are invested in them. “   This caught my eye for a number of reasons in part because I was just returning from a successful quality assessment project and second because I know that successful hoteliers understand the importance of customer satisfaction as part of the quality process.

The notion of people embracing what they create is a really important concept as we build laboratory quality systems.  Many laboratories create quality teams who create documents and quality system trees either on-paper or on-line that are consistent with one organization or another, without ever engaging the people who are going to be expected to use the system.  Then they spend their time “communicating the system” by talking at the staff or worse emailing the staff about how user friendly the system is.  “This is how to read our new SOP.  I know it seems long and looks complicated, but it has everything you will ever need.  Trust me.  Trust me.”

This is rarely a path to embracing and engaging in the quality system.

How often do you hear comments in your organization like “Oh that’s quality.  Talk to Pat.  She’s the quality person”, or “Talk to Shirley.  I know where the Quality stuff is, but I never actually use it”.  Even worse, “this stuff is a joke.  I do it because I have to, but what a waste .  I could be doing real things, important things”.

Laboratory quality teams need to keep a few concepts in mind.  Quality is based on a very few guiding principles.  How they get manifested is up to the organization.  The quality system does not exist to meet the expectations of qualitologists or ISO or accreditation bodies; it exists to help the staff prevent errors from occurring and when they do, to catch them early, and fix them and learn from them and move on.  Quality systems that capture the guiding principles and at the same time fit the needs of the staff are good systems; and more to the point, quality systems that don’t fit the needs of the people who are supposed to use it are bad systems. 

There is another concept to keep in mind.  Embracing quality is different than being engaged in quality.  Being engaged is doing the steps you have to do.  Embracing is understanding the concepts behind doing the steps you have to do.  For lots of situations if you can get folks engaged that is pretty good.  There are all sorts of ways to get staff engaged.  You can give them pizza prizes, you can give them little gold stars.  You can remind them about filling in the forms when they forget.

Getting folks engaged can be a lot of work, but will get things done. 
Getting folks engaged is a success.

But getting the message shared and having folks understand why it’s important and how it makes their lives easier and improves the outcome of their effort is always better.  Getting folks to embrace quality is an accomplishment.

So I am interested in receiving comments from folks who have ideas about the things that we can do to get laboratory staff to embrace quality.  Twitter length (140 characters) is good but not essential.

Quality Weekend Workshop - the day after

So this weekend we had our POLQM Quality Weekend Workshop and while I may be accused of being a little biased, I have to say that it was terrific.  I am sorry that many people that I would have liked to have attend the meeting were not able to be there.   On the other hand we got the chance to connect with some old friends that I did not expect to see. 

Too bad because we had brought together some of the most significant quality gurus from around the world, including Jane Carter from Keyna, Richard Zarbo and Michael Astion and Robert Martin and Luci Berte from the US, Dr. Elisabeth Dequeker from Belgium, and George Cembrowski and David Seccombe from Canada.  David Hardwick, a visionary laboratorian with international expertise in Planning and Research in Pathology and Laboratory Medicine gave an incredible presentation on the Medical Laboratory, Past, Present, and Future... the core message being continuation of the 250 year  steady state increase in knowledge and information at 2% compounded year over year. 

Denise Dudzinski gave a thought provoking presentation on ethical issues that surround disclosure of laboratory error  to physicians and patients.  Where is the balance point between the right to know and unncessary anxiety?  This was one presentation that will have me thinking for the next year.


What was so exciting to me about this meeting was the focus on Quality Partners, something that readers of MMLQR are very much aware, but a concept emerging from shadows to prominence in the medical laboratory world.  Between Bio-Rad, BD, CSA, and DAP and a number of proficiency testing providers, a huge light was shed. 

The second theme was the growing opportunity for quality positions in medical laboratories in Canada, and around the world.  Clearly the clinical healthcare community has awoken its interest and awareness in quality.  Quality teams, Quality managers, and Quality lead positions are becoming a MAJOR growth point. As the total number of positions in laboratories gradually decreases, the positions in Quality are highly likely to remain stable or increase. 

Jane Carter gave a brilliant presentation on the Quality activities that she is involved with in Kenya, and throughout eastern and southern Africa.    She and some of her staff were able to come to Canada on support from AMREF Canada, an international office of the African Medical Research Foundation.  (More on this later).


There was a lot of discussion about making the meeting a regular event on the annual calendar, and I have had some significant discussions with two potential partners.  We would have to think about it for a while. 

From a Quality perspective, we have had a lot of success which are seen in the responses to the satisfaction comment sheets.  On a scale of 1 (poor) to 5(very positive) the meeting rates somewhere near 4.8, which high marks for speakers, and theme, presentations, staff and catering.  The registration fee was down a bit (about 4.2) but on review it would be difficult to do too much about that.  The biggest complaint was that the lecture room air conditioner was too strong.   

On the opportunity for improvement side, the biggest issue that I have to work through is in marketing.  Despite what I thought was a wide distribution of notices, we were not very successful at attracting the size of audience that I wanted.  Some suggestions have been made (such as having the meeting on Father's Day weekend).  We will have to do some significant Study (as in PDSA) before we do the next one. 

Bottom line is that the meeting was a pretty positive experience, and we have a lot of reason to be pleased. 

We have a file of presentation precis which will be available at www.polqm.ca

M

PS
I have been asked to create the opportunity for email notification for posts to MMLQR.  You can register for that in the new box on the top right (FOLLOW BY EMAIL).  If you want to give this a try, this feed is fully confidential, and is not designed or intended for any activity other than email notification of posts. 

Monitoring Satisfaction through Noble's Rules

In the laboratory business we have always thought it was all about the science and not about the business.

But we were wrong.
ISO as well as WHO and CLSI (and before them, Deming and Crosby) all acknowledge the importance of “Customer satisfaction”.

It is not so much that the customer is always right, but that the customer should always have a voice and should be heard. There is an expectation to have some form of customer input on a regular basis, perhaps as often as once a year.

The reason that the standards development bodies have included this as a requirement and the basis for policy is because it doesn’t matter if you are an academic providing a course, or a laboratory providing documented information, or a manufacturer providing umbrellas, or a proficiency testing provider, or an equipment and reagents supplier, if your customers are not happy, then bad things start to happen.

In the private product or service sector that probably means customers stop coming. And that becomes the business killer.
 
In the public sector laboratory, the customer may not have a choice of which laboratory they have to use, but that won’t stop complaints, reputation slurs, increased threat of litigation. (Incidentally, this applies to accreditation bodies as well.)
Sooner or later you risk becoming the interest of the public and the media.  
Or even worse, think about the embarrassment and humiliation of a public inquiry.

All of those are major career killers.

So what to do. In the business world, the godsend solution for customer satisfaction has become the on-line survey. It is so easy to create an on-line survey and send it out to all your important customers. So easy, in fact, that it has become too easy. 
Anyone foolish enough to give your email address to a hotel or car-rental or restaurant gets inundated with surveys. We have become a world of survey send-outers and survey send-inners, and most of it is a waste of time.

Most surveys are poorly designed; are way too long, too complex, and far too diffusely focused. If a survey takes more than 2 -3 minutes to complete, you can guarantee that either it will not be completed, or will be completed with junk information. 

Also, you have to remember that responders  always have their own bias one way or another,and probably have interpreted the questions in ways that you never dreamed of. Creating most surveys has become high risk of being counter productive for addressing customer satisfaction. As they say “Fast, easy, slick and wrong”.

If you still feel compelled to resort to surveys, spent some time at setting them up so that you might get some information that you can consider. (We call that PDSA) . 

After years of learning the hard way, I figured out a set of simple rules  that anyone interested in developing a Satisfaction Survey can follow.  I arrogantly coined them as Noble's Rules for Successful Satisfaction Surveys.  

They don't guarantee success, but not keeping them in mind will pretty much guarantee failure.

(1) Focus them to a single issue.
The more you try to pack into a survey, the worse it gets.  Pick a topic and get out.


(2) Ask the question that needs to be asked, even if you may not like the answer.  
It’s very easy to create surveys that will always give you positive feedback by simply avoiding any potentially controversial or challenging issues, but how can you study or learn what people think if you don’t open up the discussion.

(3) limit the survey to only a few questions , best is to keep it to 5-6 and NEVER more than 10, and make them as uncomplicated as possible . 
Get in, ask a few questions, and get out.  Don't give them a chance to get bored.

(4) make sure that it can always be completed in 3 minutes or less. Boredom is a guarantee for incomplete surveys loaded with random nonsense answers.  It would be better if they didn't send the response in, because the nonsense becomes pollution and the pollution leads to terrible interpretation. 

(5) Pre-test the questions to reduce (you can never avoid) ambiguity. 
Make your questions VERY simple.  Confusing questions get confusing answers.

(6) Avoid requiring an answer. That is the other  guaranteed invitation to bogus information. 
Making people answer questions, makes people angry.  Sometimes you can't avoid them, but keep them to an absolute minimum.

(7) Pick your audience and stick with it.  
General send-outs are a total waste of time.

(8) Where you can, avoid satisfaction surveys. 
More effective solutions for monitoring satisfaction is looking at objective measures.  For example, count how many complaints come in and how many are resolved within a specific time. 
Set up a system to catalogue every complaint, something that most laboratories never do. All those telephone and hall-way gripes are complaints and they need to be included. 

You may not think they were important, but the person who mentioned them did.

Education Opportunities in Quality (2 new and valuable finds)

I am putting together my thoughts about what’s new in Education opportunities in laboratory quality and I came across a new book “Quality Assurance in the Pathology Laboratory: Forensic, Technical, and Ethical Aspects” edited by MJ Bogusz and published a few months ago by CRC Press.  Let me say at this time that (a) it is an excellent book and (b) I am going to offer an unsolicited critique on Saturday, and (c ) I suspect that it will be a book that we soon will find on most of our bookshelves.  But more on this later.

Thinking only about Canada laboratory education has always been an orphan subject.  Every once in a while, over the last 40 years there would be some discussion on the subject but it was rarely done in anything other than an uninstructed fashion.  Until 2003.

In Canada, the publication of ISO 15189 in 2003 generated a lot of interest, perhaps more as a curiosity, but almost right from the beginning organizations recognized a new niche for educational opportunities.  Organizations such as the Michener Institute in Toronto started to provide educational courses, primarily for folks living in or around Toronto.  We saw opportunity for a broader audience by providing our on-line UBC Certificate Course in Laboratory Quality Management which has become both popular and well received.  Both of these courses were primarily designed to provide basic but key information to provide working laboratorians with the knowledge to take on roles for the newly created positions called Quality Managers.  
That niche has become supplemented with a variety of shorter term on-line webinars from CLSI and American Society for Quality and the Ontario Laboratory Accreditation (OLA) program.  
To date we are not seeing that niche becoming saturated.  there are many folks still seeking that information, now not only within Canada but abroad.  What began as a program focused on technologists has become popular with administrators, laboratory pathologists and laboratory pathology residents.  

But the next dimension has already begun.  We started to receive requests to provide opportunities from more extensive study and opportunities to become engaged in research.  Folks around the world are beginning to recognize that Quality in the laboratory is not just a flavor of the day, but is indeed the new discipline we have been talking about.  And a focus for attention and study and career.  This is very exciting.  Today we are finding a smattering of Masters level programs directly addressing laboratory quality in the US and soon ours in Canada, along with some others that may provide information on Quality as part of a MBA or a Masters in Health Administration or Masters in Public Health or in Leadership.

This week I was introduced to what I think is something that Europeans do so well.. a Masters program in Quality in Laboratory Quality provided by a consortium of SIX universities from Portugal, Spain (2), Norway, Poland, and China (!)  It functions interestingly as a on-site (as opposed to on-line) program with a requirement for study, and research and a thesis.
It seems to cover a broad spectrum of knowledge; indeed on paper it looks almost identical to the subject matter that we are proposing for our program.  From discussion I understand that it has been running for 2-3 years with about 30 students a year, which would put very intensive demands on teaching faculty and research facilities.
As I mentioned, I had not heard anything about this course until a few days ago.  I suspect that I am not alone.

For folks thinking that this might be an interesting focus of study today, I recommend you to check out http://cursos.ualg.pt/emqal/

For those that are still thinking about it, but not ready to commit just yet,I am looking forward to our program starting in 2012.

More on Quality Assurance in the Pathology Laboratory in a few days   .

SWOT

Recently I have been taking a close look at quality standards including ISO9001:2008, ISO15189:2007, and ISO17025:2005.  All of them have a lot in common.  First off, regardless of the decision for certification or accreditation, they are all mostly very useful reference sources for people who organize and operate laboratories.  Implementing quality management is a good thing to do.  Second, all of them recognize the importance of management setting the quality agenda based up information gathered through management review.  And third, all of them are future oriented documents that focus on ensuring the laboratory will be better tomorrow than it is today.  All that goes under the headings of planning, or prevention, or continual improvement.

Along the way, I noticed while all the documents make these points, there is one thing that they all seem to ignore or exclude, they are all weak on providing suggestions or recommendations for actually implementing business quality programs in an active laboratory.
So in that vacuum, I offer up my recommendation for inclusion of an organized look at the organizations Strengths, Weaknesses, Opportunities, and Threats as a powerful planning and improvement program.  Done correctly, SWOT analysis is an extremely useful planning and monitoring tool for laboratory management to apply on a regular basis.  

In CMPT I have taken to doing a formal SWOT every 2 years.  That way I get a chance to see if I am actually making progress or just satisfying immediate concerns.

SWOTs have a lot in common with ROOT Cause analysis.  You can do them both in 5 minutes if you want to.  In both instances you get out what you put in.  A five minute job satisfies the piece of paper and gets a tick on the assessment form.  A more formal open discussion will take a lot longer, but the outcome should be worth it.

There are probably hundreds of ways to work through a SWAO Analysis.  I try to keep it focused on the areas that matter most to me and my operation.  I try to focus on 9 topics: Management, Personnel, Facilities and environment, Quality System, Products and Services and Clients and Satisfaction, Awareness, Competition and Collaborations, and Finances.
For each of those areas I first think about what we have and how it can make us stronger, and if our current action is making us weaker.  Are there new opportunities to make things better, and if I don’t act on those or make the changes that I need, what can cause  jeopardy.  
Once I have created my list, I look at what tasks I have created and then put them in a priority order, recognizing that over 2 years I can work or 5 or 6.  

For  me and my program, the process has worked fairly well.  It has created an organized  structure for me to identify the things that we are working on now which include (a) capitalizing on non-EQA projects to create more diversity and a stronger financial platform, (b) increasing the analytes we provide (c ) aggressively finding a new location and (d) increasing the energy we put into ISO9001:2008 and (e) putting a temporary hold on implementing tje new standard - 17043:2010.  Maybe I would have identified these issues anyways, but the stucture helped make them more obvious.

And then to ensure that I actually do something, I make the whole thing public through my annual meeting and annual report, and put it on the agenda for year-over-year discussion.  I can dodge and weave, but in the process of open forum, I cannot hide.

The process has been 98 percent excellent as a forward driving device, but not 100.  I still have the same weakness and threat that I identified now 5 years ago.  I have no succession plan in place for me, and every year that looms as a greater issue.  More on that another day.

But to bring me back to  where the comment started.  All the quality documents talk about planning and review but do not identify this as a useful, indeed valuable, indeed indispensable tool.  Lots of time wasted space for other tools of dubious value (like uncertainty of measurement), but none for how to make my planning process more effective.

I need to do something about that.