Monday, December 10, 2018

In-Country Proficiency Testing (EQA)

For those of you who live in the United States or Canada or Europe this will likely be a curiosity rather than the big deal that it actually is.  The North American history of Proficiency Testing started in the 1960-1980s when countries recognized the importance of externally monitoring the quality of medical laboratory test results.  We have in place very sophisticated systems.

The reality was, and still is, that in the vast majority of situations, laboratory test errors go undetected and a wrong result is reported to a physician or patient with frightening frequency. Even doing conventional quality control can’t control this.  The reason they go undetected is because when we go down, humans have enough internal mechanisms that we usually get better on our own regardless of what caused the problem.  Even if we have a diagnostic test that is ordered and performed with the best of intentions but is of wrong value, and is followed up with a medication that we don’t need, we usually have enough internal resources to tolerate all sorts of wrong impressions and inappropriate “medications” that we receive.  There are MANY people walking around with all sorts of missed or incorrect diagnoses. 
But every once in a while, a BAD thing happens, and a person either doesn’t get better, or gets worse and sometimes dies. By then it is too late, and all hell is likely to break loose.

So, our predecessors figured out that by requiring laboratories to test samples where they don’t know the actual result, but an external body does, we may catch more of these errors.  If the laboratory returns the correct accurate result, we inform them they are “proficient” or “competent”.  If they get it wrong, we don’t call them “incompetent” but harsh words hurt, but we say they have “opportunities for improvement”.  

The organizations that send out these quality check samples to laboratories are known either as Proficiency Testing bodies, or more frequently in most places around the world. External Quality Assessment bodies (or EQA).  

Now 30-50 years later, most wealthy countries have developed their own EQA bodies, that focus primarily on the quality concerns of their own countries.  Poorer countries have often struggled to get similar programs up on their own, and end up buying samples from the wealthy countries, which in the majority of situations has been a real failure approach.    

The samples that are sent all too often are inappropriate for the laboratories that receive them and importantly they don’t survive the travel, unless they have been freeze dried for the convenience of the sender (but not for the receiver!).  And more importantly, they were rarely designed with poor countries’ needs in mind.  They are designed for the complex sophisticated laboratories in the countries that created them.

We have struggled with this as a challenge for near 20 years with some success, but also a lot of failure (about 50:50).   We would invite countries to send staff to our EQA laboratory in Vancouver and would teach them a series of simple to learn, easy to implement methods that we developed so they could create their own stable samples at home.  

The methods are usually bullet proof even in climes with elevated temperature, but they depended up the country having some infrastructure to make the program happen.  And sometimes that infrastructure was not there.

So in a new collaborative program with another EQA provider, we are trying a new strategy.  Rather than have people come to us, we are going to them, working in their laboratories working with their staff, and ensuring at some essential parts of the necessary infrastructure, like the informatics system is in place.  So the samples can be made and be distributed in-country, and the information resulting can be simply entered into a computer hooked up to a sophisticated data base and the results can be sent to the key people.

Importantly, this way the country picks the challenges that it wants to send, with the microbiological test challenges it wants to use, rather than depending on samples from companies with a different approach.

So, this week we just did our first in-country training for in-country microbiology EQA in a county in West Africa.  The training program went even better than we anticipated, and plans are being put in place for the infrastructure and follow-up. 
Guaranteed success?  No… but so far things look really good and promising.  We will know a lot more in a few months from now.  But if it works the country will have taken control of the quality of its own laboratories, will have saved mountains of money by not buy samples from other countries, and will have the quality challenges that it needs, not what it receives.

Fingers crossed.

Thursday, November 1, 2018

Customer Service - The Paradigm Shift in Laboratory Quality

Customer Service - The Paradigm Shift in Laboratory Quality
In the 18th Century, Immanuel Kant writing in Critique of Pure Reason (1787) described the change in approach to scientific study as a “revolution of the way of thinking”.  In the 20th century, Thomas Kuhn in his book The Structure of Scientific Revolutions (1962) advanced the phraseology to “paradigm shift”.  By whichever phrase we want to call it, today we are going through an new phase in thought and practice in Laboratory Quality, especially as it refers to customers and service, that is truly a significant shift.

Recently I hosted a conference in Vancouver on the topic of Quality Improvement, Knowing your Customers.  One of our speakers, Colleen Taylor, in a most creative way talked about the dual understanding of the word Patient.  In healthcare we use Patient to refer to one of our customer groups, the person who is the end-user of our products or services.  Equally “patient” describes our all-too-common approach to the end-user: “ You are tired of waiting?  Well we are all very important and very busy, and you just have to be PATIENT.  So just go sit there and we will get to you when we get to you.  Just sit there and be quiet, and you better be darn grateful when we get around to providing you with our time and services.”  

The rest of the world has figured out that that is no longer a winning strategy.  Increasingly customers have figured out there is always choice.  Hospitality, and retail, and banking and schools have figured it out; making an unhappy customer leads to an unhappy customer and a bunch of unhappy friends, and one day you look around and there are fewer and fewer people coming in your door.   And all of a sudden, your business is in trouble.  

Think it can’t happen to medical laboratories?  Point-of-Care Testing did not start in a vacuum.  Pharmacy based testing didn’t just happen.  Theranos, may have turned out to be a failure, but the reality was that Silicon Valley was responding to a perceived need, and there is every reason to believe that the next change will be far 
more successful.  

So at our conference we learned some truly important lessons. 

Hospitality industry can track millions of customer experiences, and can maintain complaints at a level of 3 per 10,000 (sigma 6.17).  They track and correct because they understand that every complaint that goes through the door unresolved gets increasingly expensive.

Tracking customer satisfaction in healthcare facilities can be done competently and comprehensively on a same day basis, and indeed on a same hour basis. 

Healthcare executive administrations are looking for service excellence solutions

International Organization for Standardization (ISO) is developing new standards and tools in service excellence under a new technical committee (ISO TC312 Excellence in Service).  

Some laboratories are developing some novel approaches for improving customer experiences

The approaches of “the customer is always right” and “the customer always comes first” are being replaced by “Your Customer have to come second because your staff have to come first.  Staff who are acknowledged and appreciated for their skills will take care of your customers needs in ways that are in both the short and long term successful”.   

We can shift staff attitudes and culture using thoughtful analysis using techniques like Organizational Culture Assessment Instrument (OCAI) and staff management skills and techniques.  

Small changes can have big impacts. Small changes regularly have huge impact.  

Starting now is ALWAYS better than starting later.

To be clear, other aspects of laboratory quality can not be forgotten about.  Areas like error awareness, error reduction, opportunities for improvement through audit and prevention and correction, continuing education, continual improvement throughout the pre- peri- post- and examination phases will not go away.  But their impact and success will be much enhanced through the dynamic of staff and customer satisfaction. 

For those interested in seeing some of the materials from our conference/workshop you can visit 

Tuesday, September 4, 2018

Standards Do Not Create Quality.

So I am putting on new course and it gave me the opportunity to shake and shape my thoughts around Quality; to clear the cobwebs.  What I re-discovered was that standards don't create Quality and nor does accreditation or certification.  It is the reverse that is true.  Quality is derived from Principles, some decades and centuries and millennia old that are the real foundation.  

So what are these core Quality Principles and could I put them together in a sufficiently coherent  structure that I could convey them to students?

Here is what I came up with.

Before you can implement a Quality Program,
first you must understand The Quality Principles

While in this course we are focused on issues related to laboratory quality management, it is important to understand that Quality is universal, and independent of sectors and industries.  Quality is driven by underlying principles that put value on error free products and performance and put value on customer and staff needs. 

Quality Principles in one form or another have existed for decades and centuries.  Early evidence of principles the creation of Egyptian Pyramids (3500 BC)  and creation of Greek ships (2500 BC) creation of Roman Coliseum (1000 BC)

Quality Principles are seen in works of Eli Whitney (Interchangeable parts; 1800), Frederick Winslow Taylor (Time and Motion Studies;1890), Henry Ford (Variation control; 1910),  Walter Shewhart (Quality Control; 1920), W. Edwards Deming (Organizational Management;1940), Piggly Wiggly (Just in Time Inventory Management; 1950) , Taiichi Ohno (Waste Reduction;1970), Phillip Crosby (Error and Quality; 1980)

Quality is the underlying theme of key standards and of accreditation, but it is important to remember that standards and certification and accreditation are the products of Quality Principles, and not their source 

Most groups who understood and adopted Quality as a strategy have gone on to succeed; man who decided to take a different path have failed.  

These Quality Principles include:
a.     Know your Structure
b.     Efficient (time and money)
c.     Organized (work to a plan)
d.     Be Faithful to the Purpose
e.     Prevent and Reduce Error
f.       Prevent and Reduce Waste
g.     Take Risk into Account
h.     Open to Learning and Growing
i.       Create Change and Measure Change
j.       Focus on all your staff
k.     Focus of all your Customers

Know your structure. 
Every organization has a structure.  Someone is the “boss”.  Someone answers directly to the boss, and others report to them.  In a healthy organization, everyone knows to whom  they report and who reports to them.  The chain is essential for clarity and  for avoiding cross purpose.

Efficient (time and money)
Respecting time and money means that work gets done on time and within the limits of resources.  Being efficient allows you to be more productive and more effective.

Organized (work to a plan)
Effective work stems from a plan and stays true to the plan through the hills and valleys If change is required, that too should work to and from the plan

Be Faithful to the Purpose
Creation stems from a vision and a purpose.  Deviating from the vision and purpose risks meandering and loss.  Quality activity is fit-for-purpose.

Prevent and Reduce Error
We cannot stop all error, but we can learn from it in a way to prevent it from recurring.  Other errors may occur, but repeated error is opportunity lost.

Prevent and Reduce Waste
We cannot stop all waste, but we can learn from it in a way to prevent it from recurring.  Waste is can be an abuse of resources and cause damage to our plan.

Take Risk into Account
Pushing limits leads can lead to growth and change and progress.  Extending beyond  limits risks collapse and failure.  

Open to Learning and Growing
If an organization is providing opportunities for all to learn and grow, then the organization risks stagnation.

Create Change and Measure Change
Change is good, but only if it is measured.  If you don’t know how you got to here, then you can’t know what you will be leaving.

Focus on all your staff
Your staff are your business.  Without them you will fail.  Know and understand and respect your staff.

Focus of all your Customers
Without customers, your business will fail.  Know and understand and respect your customers.