The Road to Perfect EQA?

WARNING:  As I write this entry, I am wearing my Proficiency Testing hat.  Folks interested in laboratory quality, but not in proficiency testing may find this really boring.  If PT/EQA is NOT your thing, that is OK; please leave NOW.  

The annual meeting for the European Organization for External Quality Assessment for Laboratory Medicine (EQALM) was an excellent get together for EQA providers.   Gradually EQALM is becoming not only the gathering point for European international EQA providers, but intercontinental as well.  

LABQUALITY [http://www.labquality.fi/eqa-eqas/?x2520204=3249645 ] has already written a nice summary on the meeting.  

The theme of this year’s meeting symposium was The Road to Perfect EQA.  That is a pretty good way to celebrate 20 years as a EQA provider group.  The presenters tackled 4 topics (a) Commutability (b) Traceability and (c) Accuracy and (d) the challenge to Homogeneity when internal reagents cause mischief.  All were interesting and important EQA topics, especially if you are focused on producing challenges for Chemistry laboratories.  (Note: that does not include me).  

If I had an issue about what was presented, it was small but important (at least in my mind).  The term commutable is not a particularly good word for EQA because it has a number of meanings.  It can mean “capable of used for commuting” or can mean “capable of being exchanged” or lastly “capable of being converted”.  In the context of EQA, I am pretty sure he was not think about commutability in the context of transportation.  I think the presenter was intending that EQA samples should be sufficiently similar to clinical samples, that they can be used as an exchangeable material in the sense that there are no matrix effects.  EQA samples should act like regular samples.  I can live with that, but in chemistry the term can also mean being converted or degraded to end-products, so you might say you want the sample to be commutable, but you don’t want it to be commutable.  I think the term is probably not the best choice.  

In our clinical microbiology program we try to take the sense of being exchangeable with clinical samples a little further.  We make the sample to contain both host and microbial components, combine pathogenic flora with background flora, and we try to the extent possible to make our samples look like and act like clinical samples; the point being that being exchangeable just for the machine and not for the laboratory workers does not go far enough.

But I have a much bigger issue with what I see as a major weakness in the symposium.  It is about what was not presented.  It was far too technical focused and did not include that the REAL Road to Perfect EQA program is the one that leads laboratories to want to use and learn from EQA.  

In my now near 35 years of PT/EQA with observations around the world in developed and developing countries, I have seen almost every variation to EQA experience.  Most laboratories still see PT/EQA only as something that Accreditation requires, or something they just have to do.  They either never investigate errors, or given the opportunity never even look at results.  When they have a problem they get picky beyond picky on interpretation of instructions or provided clinical information rather than acknowledge that they did not process the sample as required and expected.  And sometimes (fortunately not very often these days) some laboratories use deceptive methods to cheat an answer rather than risk the challenge.

We even have members from our own committee who feel compelled to argue against the challenge when they participated in every part of the selection and preparation process.  We have seen laboratories threaten regulatory action because they felt the challenge was too hard/ too easy/ too costly/ too too…

The Perfect PT/EQA program wouldn’t have any of those responses.  Instead there would be a deluge of letters “Thank you for helping us find our system error” or “Many thanks for that interesting challenge.  We have incorporated a number of changes to take that into consideration”, and especially “Many thanks for those educational and informative critiques.  We can’t get along without them”.

OK, maybe I’m a little over the top, but EQA is an important exercise for all laboratories in all fields; water, food, medical, construction, electrical.  In some areas, detecting errors actually saves lives.  

Having laboratories miss the point of the exercise does no one a service, certainly not to laboratory who chooses to ignore or deflect opportunities to improve, and most certainly not the customer who in our case represents patients, clinicians and the community.  It is a program of purpose.

So, let me propose to my PT/EQA and in particular EQALM colleagues, “good-on-ya’” for a symposium well done and focusing interest on an important side of what we do.  But maybe at the next major anniversary (the 25^th, or 40^th, hopefully we don’t have to wait for the 50^th!) we can have The Road to Perfect EQA – Part B where education and customer focus also get discussed.

SAVE THE DATE:  
October 1-3, 2017
POLQM Fall Conference  on Medical Laboratory Quality

Conference Report: The laboratory and customer satisfaction

Program Office for Laboratory Quality Management (POLQM)
hosted a successful conference/workshop on
Customer Satisfaction and the Medical Laboratory.

Business and industry are very much aware of the importance of listening to and responding their customers’ needs and requirements.  It is not only good business practice and consistent alignment with international standardization (ISO9001:2015 Quality Management requirements, it makes powerful business sense.  You can call this customer-focus or customer-centric. but business understands that nothing will kill off a business faster than having a large herd of unhappy people who prefer to go elsewhere for their goods and services needs.  

Healthcare in general, and Medical laboratories in particular are now slowly getting aligned with the same mindset.  In some countries, the final argument is too compelling to ignore.  The unhappy customer is apt to “sue you into the stone age”.  

 That may not apply so much in Canada, but at least in Canada we can drag the industry forward through mandatory accreditation.  (I really don't like using accreditation as a club, but sometimes you have to make folks understand that this is something they have to do.)  

For medical laboratories in Canada, the accreditation requirement (ISO15189:2012 medical laboratories – requirements for quality and competence), has become pretty much a national requirement and an effective approach to introduce process change on customer needs.

 

On October 5, 2016 we (the UBC Program Office for Laboratory Quality Management or POLQM) hosted a one-day conference/workshop on listening to laboratory customers in the medical laboratory. Topics covered included defining who are our customers, capturing their opinions (including complaints, concerns, comments and compliments) and monitoring satisfaction as a Quality Indicator,  Speakers included experts from the American Society for Quality, private sector laboratories, public sector health authorities, accreditation bodies, and quality educators, and the new BC Agency for Pathology and Laboratory Medicine.  The participants were all from Canada from Victoria to Toronto and as far north as the Yukon Territories, and from a wide variety of programs and facilities.  

From my (clearly biased and vested) opinion the day went very well.  Most attenders were Quality Managers or Quality Leads or folks in senior positions.  While it was clear that folks came were there to support their per-existing mindset.  As best as I could tell there were no skeptics in the crowd, but perhaps if they were there they were too intimidated to speak up (That can sometimes happen).  

There were some great ideas raised; some stood out.  

• There are lots of ways to address focusing on the customer.   Maybe some are better than others, but don’t over plan.  Pick one and get going.
  
•   Laboratories have a way of thinking they know what their customers want, but all too often don’t get around asking their opinion.  Get the customers involved.
  
•    Laboratorians think their work is all about accuracy and precision.  Those are important but so is customer experience.  Many complaints result from  rudeness and indifference.

I talked about on-line surveys, and that if you are going to do them, make sure you do them right; short, simple, if possible on a continuous basis.  Don’t intrude on your customer’s time, effort, and patience, and generosity.  

No conference/workshop goes off perfectly.  One of our speakers decided to back out 4 days before the event (Whata Jerk!!).  One person was annoyed because the lunch did not accommodate vegetarians well (she was probably right; lots of sandwiches, but only about 10 percent were vegetarian.  Our mistake).  But on the whole, people found the day worthwhile and well spent.  There were a few who said the meeting was too short, but none that said it was too long.  I interpret that as a positive!

In our own on-line survey (about 35% of participants responding) they rated their program satisfaction high (mean 85% and median 90%).  

For those with interest in the topic, there is a follow-up webinar on October 27^th, and presentations are available at www.POLQM.ca

 

Safe the Date: 
POLQM
next Fall Conference on
Laboratory Quality Management
Vancouver BC Canada
 October 1-3, 2017!

When is a standard NOT a standard?

There are a bunch of words that get thrown around a lot in the Quality community; words like “continual” or “continuing” or “improvement”  or “risk”.  But I would argue that the most significant word in the Quality arena is the word “Standard”.

In the Quality arena “Standards” is a powerful word.  It describes a document that indicates either “the right and thoughtful thing to do” or “the only and absolute thing to do”.   

A standard has a higher value than “guidance” which is something you can take or leave.  The general public understands this; David Letterman used to say “Traffic signals in New York are just rough guidelines” or there was the pirate in the movie Pirates of the Caribbean who said “the code of the brethren is more what you'd call guidelines than actual rules”.  Think of standards as similar to, but more righteous than regulations or laws and certainly more dignified than “rules”, which can be arbitrary, and more real than guidelines, which all too often are not much more than a punchline.

The word “standard” must be viewed as special and be safeguarded from abuse.

Standards deserve that special prominence because there are specifics about how standards must be properly designed and properly constructed.   Simply put, a standard is a respected document of requirement, not because of its content but more so because how those words were selected for proper use.  

The ultimate source of standards is the International Organization for Standardization (ISO) which points to a process of both objectivity and consensus.  ISO as the premier standards development body has established the importance of standards development objectivity.  ISO does not decide what standards it is going to write.  Instead member bodies have to make a solid proposal which is circulated through member committees to get approved.  

ISO committees that are given approval to develop the standard are made of individuals from a variety of jurisdictions, each with their own vested opinions.  To get through this process a document has to achieve agreement from at least two thirds of committee members with less than 25 percent of votes cast to the negative.  That is called committee consensus.  

But that alone does not assure the path to publication.  After committee consensus, the document has to be circulated broadly throughout the world to interested parties to get a broad sense of opinion.  All issues and differences raised through this process have to be addressed.  Only after the process has been repeated several times, to ensure as broad an agreement as possible,  a document can be published and referred to as a “standard”.  

And importantly, in order to ensure that any error that slip by are addressed and to ensure that the standard remains relevant to the times, it must be revisited every 5 years.

If a document does not succeed in going through this arduous process, often the result of differing opinions, it can still be published, but the term “standard” cannot be used.  The meaning of the term “standard” is, as it must be, protected from abuse or trivialization. 

There are solid reasons for this arduous process.  First off, when a small group of people decides to get together and write something, there is always a great risk for bias and for exclusion.  Not asking for broad opinion almost guarantees that none will be found.  The product generated, whatever its intent and purpose, is tainted because of the lack of broad consideration.  

Tainted standards are not the product solely of small organizations who strive a little too hard.  They all too often finds itself in the products of large “august” national bodies, who should know better.  They result because of the innate arrogance of august bodies.  “We must be right because we are so damn important”.

This last while, I have been dealing with one such organization with a disturbing track record.  An organization that makes up rules without working through objectivity or wide consensus, but who stills calls its products "standards".  An organization who wraps itself in a cocoon of self-import of its own making, either oblivious or indifferent to the flaws in their own “standards”.   I can’t go into specific detail here for obvious reason, but the battle ground is now set.

So let me just end (for now) with the following thought, if an organization is not prepared to put its work through a process of objectivity and the scrutiny of consensus through transparency, then it is just a bunch of guys and women hanging out making up its own rules.  Hardly august, and hardly dignified; more about pretense and self-serving rules than actually writing standards.

Just another herd of Pirates.