Thursday, January 26, 2023

Meeting Customer Threshold Needs in the Laboratory Proficiency Testing Cycle


This presentation is part 5 of a series highlighting 
Proficiency Testing as a Laboratory Quality Partner.

This series is put together by Dr. Michael A Noble BA MD FRCP the material founder and now retired chair of CMPT – Canadian (formerly Clinical) Microbiology Proficiency Testing Program.  It is based on his national and international experience and expertise in Proficiency Testing (PT/EQA).  Dr Noble continues on the advisory committee of CMPT and collaborates with other EQA programs including Oneworld Accuracy


Proficiency Testing (PT/EQA) is a Quality Partner, a program for laboratory Quality Assessment investigation and a foundational research base for learning about laboratory quality and laboratory error.  It is also a business with employees and customers and maybe even investors. 

The thing about businesses is that when they are organized correctly, they have a fair chance to succeed.  When they are organized poorly, especially about customer service, their chances of succeeding become much more limited, even if they feel protected as a required service. 

The reality is that when authorities and agencies receive enough complaints about poorly working programs, they can demand change, and programs can be dropped or replaced. 

Customer needs and satisfaction has been well studied in many businesses.  Noriaki Kano, an educator at the Tokyo University of Science was a consultant in quality management, and a pioneer in the arena of the customer satisfaction model.  Kano developed what is known as the Kano model, a structure that describes meeting customer needs in three stages, (a) threshold (or must-be), (b) linear (or progressive), and (c) customer delight.  For a more  information, you may want to visit:

Without going into detail, I offer my interpretation based on years of satisfaction surveys and our very short list of complaints of how laboratory customers view proficiency testing programs and in particular what represents not meeting the needs and what approaches customer delight. (See below). 

Customer satisfaction is critically important in today’s post pandemic era, when businesses are struggling to hold on.  If a business is unable to meet the basic needs of threshold satisfaction, customers are apt to move on to another solution.

In PT/EQA basic threshold satisfaction means getting test samples to the laboratory on-time, intact, and providing challenges that the laboratories consider both relevant and fair.  If you tell the laboratory their samples will be arrive on Tuesday, they should arrive on Tuesday, and laboratories should get exactly what they ordered.  And they also expect and their samples should be intact, and not broken or leaking.   No surprises and no inconveniences.   

Break that commitment more than once, and your organization has lost face and reputation and maybe a customer.

That is why Production and  Distribution (Team 3) is so important.  If the samples are liquid, you need to ensure that the vials you use are sealed and leak-proof.  Packaging in most jurisdictions must meet specific regulations including absorbent material and sealed inner packaging to contain any leaks.  And packaging has to remain secure even if exposed to moisture or if dropped, and may have to be marked with visible warnings if they are deemed as being potentially dangerous. 

This is especially true if the contents could be classified as "dangerous goods".

Laboratories also expect the package to include specific instructions about handling and testing the samples and demand safety information in case there is a problem. Even if it seems that they don't read either of them, leaving them out is done at your peril.

Shippers have to be arranged well in advance and their waybill lists need to be completed accurately.  And when the shipper tells you they will be there at 2PM in order to ensure your shipment will get shipped on-time, you better have everything prepared and ready to go well before 2PM.  And never get the shipping address wrong.

If there are special instructions about where the package should be delivered and who is to be notified, that information must be available and apparent, or the package will get lost. 

If these tasks seem basic, they indeed are, but if they are ignored, the risk of reputational and maybe even liability damage rises, and there is no one to blame, except yourself.   

What may not seem apparent, these steps require close attention to detail.  Putting these tasks in the hands of workers that don’t have that level of knowledge and focus and discipline puts your organization at risk.  There  probably are people in your team that skills of exacting nature and abilities.  This is their place to shine.  It is called matching tasks with talents, an important step in Employee Engagement.

Bluntly put, if your organization can’t get this right, you probably are in the wrong business. 

In the next offering we will talk about achieving better and best customer satisfaction in PT/EQA.





Monday, November 21, 2022

 World Antimicrobial Resistance Awareness Week 2022

Twenty-five years ago I gave a presentation on Canada Health Care and Laboratory Quality Management and reminded the audience there are NO clinical isolates of Methicillin Resistant Staphylococcus aureus (MRSA) or Vancomycin Resistant Enterococcus (VRE)… until a sample is collected and tested and isolates are recovered, tested and results reported by a clinical laboratory.

Today, as the number of antimicrobial agents has continued to grow, so too has the depth and range of bacteria, fungi, parasites, and even viruses with increasing antimicrobial resistance concerns, affecting not only in human patients, but in farm animals and pets and the environment in the wild.

More of the world community is aware and engaged, but what was true then is still true today, the cornerstone for detection and awareness is based on the skills and talents of an informed and engaged and diligent laboratory staff, surrounded by a committed team of Laboratory Quality Partners that provide better guidelines and information a wider array of testing methods, and valuable education and performance monitoring and assessment and accreditation.   

Better laboratories through stronger Quality Partnerships.  


Monday, November 14, 2022

Keeping Proficiency Testing Relevant (Team 2)


Understanding the Laboratory Proficiency Testing Cycle
(External Quality Assessment – EQA)

This presentation is part 4 of a series highlighting 
Proficiency Testing as a Laboratory Quality Partner.

This series is put together by Dr. Michael A Noble BA MD FRCP the material founder and now retired chair of CMPT – Canadian (formerly Clinical) Microbiology Proficiency Testing Program.  It is based on his national and international experience and expertise in Proficiency Testing (PT/EQA).  Dr Noble continues on the advisory committee of CMPT and collaborates with other EQA programs including Oneworld Accuracy


In the previous missive ( I introduced my version of the PT/EQA cycle and the Teams that work through the cycle, talked about the importance of starting and closing every cycle and event with Quality.  It is hard for PT/EQA providers to promote laboratory quality if they are not prepared to run their own Quality-Committed-Program (QCP). 

For this reason it made sense to designate the Quality Team as Team 1.  But let it be clear this is first in sequence, in the creation of an effective PT/EQA program ALL the teams are of equal and first priority.  A failure in any step along the way results in a failure for all.

This entry is on Team 2: the Organizer, the Planner, the Research and Development and Production team, which I think is the most fun.  Team 2 is all about planning and introducing new and changing challenges that are of high quality and relevant to what is happening today... and tomorrow!

Medical laboratories change all the time.  New analytes get introduced as do new equipment and reagents.  When Sunderman was looking at laboratories he created challenges for Glucose, Calcium, Salt, Urea, Protein and Hemoglobin.  Today the battery of tests is in the hundreds.   To ensure that laboratories are performing all these tests correctly PT/EQA has be change and adopt all the time.

Consider for the moment just one analyte that has consumed medical laboratories, everywhere in the world… looking for laboratory diagnostic evidence for carriage or infection with COVID 19.  In the last 3 years there have been billions of tests performed, with millions near every month. I suspect that no other laboratory test has exploded onto the world stage in as short a time ever before.

As the demand for test results rapidly increased, the number of laboratories testing for COVID around the world rapidly expanded, with many of the laboratories having little prior experience.  Laboratories performing assays at super-human capacity, all over-stretched and exhausted.  The chance that all the tests results were correct and accurate was zero. 

What was so interesting was how rapidly people at large just accepted getting their COVID test done and assumed that is was always right.  The number of positive tests was reported on a daily basis through television and internet.  Companies and institutions and governments predicated all sorts of decisions based on the results they received. With little or no consideration about accuracy or relevance. 

For those interested, here is a short presentation on what happens when tests get introduced too quickly, before sufficient training can be implemented.

Fortunately many countries appreciated that quality assessment of performance was essential if anything constructive  was going to come from the testing.  The PT/EQA providers need to generate new ways to measure testing performance.  They needed to get access of COVID RNA or COVID spike protein, and other materials.  They needed to figure out how much material was needed for each sample, dilutions, how long the material would be stable, whether the samples should be pure or were essential additives required.  Would the samples travel, how long would the last, and many more questions.  And they needed to do that all in a very short time in order to reduce the impact of poor performance.  Research and Development in PT/EQA was the cornerstone of protecting laboratories, patients, families, friends, and the community.  

Putting that together requires a team of laboratory folk; the ones who see and envision the challenge, those who plan the strategy to keep relevant and move forward, the scientists who work through the R&D details, and the ones to take the products of R&D and create it into a program challenge production.  That is the group that I call Team 2. 


Personally I love being part of that team; without it the PT/EQA program loses its relevance and  performance falls apart;  and worse, without relevant monitoring of performance, the whole of the laboratory exercise goes will slip back to what Sunderman was railing against 80 years ago. 

More on Team 3 next.