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Monday, September 4, 2017

Medical Laboratories in Challenging Times.

In many respects in today’s medical laboratory reminds me of Charles Dickens: “It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair…”
(Well maybe winter of despair is a little excessive!)

When those of us old enough to compare where we were in laboratory quality and error in the 1970s, we can certainly say that compared to then, these are indeed the “best of times”.  In many countries, Quality management programs which are based on international standards and monitored by accreditation bodies.  None of these existed prior to 1975, or indeed for much of this improvement even before  2005.  

But it far too early for us to pride ourselves with a high-five “problem solved”.  

Indeed many of the problems are not solved, they are brushed over, and the errors that do occur, harm a lot of people.  If these are not the worst of times, I think we can all say that we can and should be doing a lot better.

In my opinion across many developed countries we continue to put pressure of improvements by continuing with laboratory consolidation [see:
http://www.medicallaboratoryquality.com/2016/03/cum-minus-facerent-malum.html ] which for the sake of efficiencies we reduce contact and interaction with our prime customers resulting in poorer service, poor care, more error and more cost.  Not only is our system less effective than it could and should be it is even less efficient than before we started down this pathway.
But rather that looking down the spiraling whirlpool, we can look to  the evolution of some distinct opportunities for improvement.  The concept of patient centred care has come to the fore in both private and public sector healthcare, in large part being driven by vocal and activist patient demands.  

We see professional assistance initiatives such as antibiotic stewardship programs, helping to promote better antibiotic usage as an approach to contain emerging antibiotic resistance.

We see more organizations hiring more better trained Quality team managers and members working through the complexities of laboratory testing.  And as a large step in this direction, we see more laboratories dropping the “project approach” towards quality and better implementation of programs that introduce a better local culture of quality based on more sustained quality improvement.  Quality Management has become a focus and interest of leadership and in places has spawned leadership training.

We see innovation and initiative at improving how we can monitor and advise laboratories to allow for better attention to potential areas of needing more improvement. 

We see stronger bonds between laboratories and their quality partners, especially in developing countries resulting in real and present growth and improvement in laboratory performance.  We see sustained on-site mentoring programs which promote better education, better practice, better communications and a stronger sense of leadership and accomplishment and culture.  (From my perspective, what I am seeing is that in terms of rate of growth the focus on quality and improvement in the developing country laboratory education and training is rapidly outstripping what is happening here in Canada, and as best as I can tell in most of the developed world.  We will have to do something about that soon).

We are now living in the era of disruptor technologies that are rapidly changing how the world sees laboratory function.  In 2001, President Bush of the United States saw the crisis of HIV destroying African population.  Through the development of the President’s Emergency Program for AIDS Relief (PEPFAR) laboratories in Africa jumped from being incapable to doing anything for patients to being able to diagnose and monitor patients through doing Point of Care Testing and Viral Load testing, indeed in many situations faster than the same technologies became available here. 
Today we are going through a similar revolutionary leap in bacterial diagnosis through the use genetic examination of mass body flora (the microbiome) and the use of Matrix Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (can you blame anyone for bypassing all that science stuff and saying MALDI TOF MS !). 
Rather than continuing along the path developed by Pasteur and Koch, laboratories can now identify bacteria in minutes as opposed to days or weeks, based on analysis of mass amounts of nucleic acids and minute amounts of proteins.  These giant leaps have heralded a new era for laboratory innovation which can lead to untold advances in disease understanding and diagnosis.  It is indeed an exciting time, provided that we can protect ourselves from the past follies and flaws of laboratory developed tests.

For those interested in these and many more related topics I encourage you to attend our POLQM October Quality Conference in Vancouver BC Canada – October 1-3, 2017.  

It will be the most important days you have immersed yourself in the Quality arena – EVER!!!

Thursday, August 10, 2017

Attending Conferences and Human Behaviour

I was chatting today with one of our conference registrants about larger versus smaller conferences.  I understand their concerns. 
They were concerned because our conference will have fewer than 1000 attenders.  Big conferences offer the offer to meet LOTS of people and by corollary, small conferences do not.

Clearly the reason that there are lots of people at large conferences is because lots of people think that bigger is better.  Better to be where all the people are.  

Size Matters”.  

In the medical laboratory arena, many of the conferences of interest exceed 20,000 attendees.  They are held in the few cities that facilities to host these events.  The conference rooms are designed to hold thousands beyond thousands.  While you may hear a “world famous” person speak as a key-note, the reality is that you will see them only on a large television screen.   

More annoyingly for the lesser sessions for people and presentations of interest, the room may hold a couple hundred seats, but if a couple thousand have similar interest, the odds are you either don’t get in, or you are stuffed at the back in the standing room only.  And as for connecting in the evenings, most people will be scattered through 5 or 6 or 10 hotels.  So you will probably eating lunches and dinners with the same folks you attended with.  

And here’s a reality check.  Meeting with speakers and having an opportunity to discuss some fine points, is NOT going to happen.  The reality is that there probably will be sufficient time for 2 or 4 people to ask a question from the floor, but odds are (by sheer numbers) is that your question will NOT be one that gets addressed.
You might get a chance to buy a copy of their presentation on tape (remember those?) or one disk, or by streaming video off their conference website, but that you could have done at home, without the cost of travel and attendance.

One thing that you can definitely do in a large conference is get your poster on a poster board, along with a couple other thousand.  You might even get few people to stop and read it, but probably not.  Most of the traffic in the poster area is other people with posters, who are checking out the competition, or are people who are bored and doing the “poster wander” which means they look at the board, and maybe stop for 7 seconds with a blank stare and walk on.  Some will ask a banal or convoluted question which is best translated is “your stuff is crap and my work is so much more insightful”.  

But on the positive side you did get a citation for your abstract.

Smaller conferences are by every measure better.  

Take our upcoming Program Office for Laboratory Quality Management Conference on “Medical Laboratory Quality in Challenging Times.  [see: http://conference.polqm.ca ]

The conference is being held in Vancouver BC, but NOT in the mega conference centre.  The Paetzold Education Centre is right sized for a few hundred  attendees.  We may not have any former Presidents like Bill or Barack, but the speakers, when it comes to laboratory quality are by every measure world class and expertly share tons of interesting, relevant, and skillfully crafted information.  And you can actually meet them and talk and discuss with them.  Probably get a chance to take a selfie and maybe get an autograph or two (!).  Might even find the opportunities of common interest to later pursue.  

Rather than being part of an audience, you actually have the opportunity to be part of the discussion and debate.

And when you present your poster, there is less competition and a lot more interest, and you still get your citation.

When the smoke clears and the conference is over, you have some new friends (maybe) some new colleagues (probably) and a whole bunch of new insights and ideas (absolute certainty).

Register Today.

Monday, July 24, 2017

Eliminate the Laboratory Internal Customer

I was at a laboratory conference recently and again went through the ever-present hand-to-heart, sonorous syrup voicing “We have great respect for you, our staff, for all you do.  You are our most important internal customer”.  
To which I say “bull-pucky” !!
Before you get the wrong message, I will be clear beyond clear:  Laboratory staff is essential to laboratory operations and function and culture.  This rant is in no way intended to suggest or imply anything other than the critical role laboratory workers play.
It is the term “internal customer” that gets my ire; it is both meaningless and trite.  
The term customer is well defined as a person (or organization) that has a use or interest in our product of services.  Customers may (usually) pay a fee for use, and often (but not necessarily) have a choice of supplier.  Importantly Philip Crosby pointed out the very definition of Quality is the degree to which we meet the NEEDS (as opposed to the “wants”) of the customer.  
Put together we have a good sense of who a customer and what they should be able to expect from us. 
 In exchange for a fee we must meet their needs and expectations (within the limits of the product). If we can do that we can say that we have met the needs of Quality and perhaps earned the opportunity for a repeat customer.    
We can monitor our customers to determine their degree of satisfaction with our actions through satisfaction surveys, or received comments, or complaints monitoring, all of which gives a picture, but never is as good as monitoring repeat business. 
There are a bunch of definitions for “internal customers”; most typically “a co-worker, another department, or a distributor who depends upon us to provide products or services which in turn are utilized to create a deliverable for the external customer. 
  Examples might be the sales department, or the accounting department as a customer of manufacturing.
Interesting, and maybe relevant to some industries, but it is hardly applicable to what happens in a laboratory.   
Calling our laboratory staff our internal customer is just an incorrect and nonsense use of a wrong term.
There are certain situations where staff are justifiably very interested in the results of certain laboratory tests.  Staff should be aware when there is an increased risk of communicable disease or toxic chemicals within their vicinity.  That doesn’t mean they have a right to breach patient confidentiality, but they should be made aware of the accessibility of potential risk factors.  
So I have come up with a classification table that defines three levels of “customers” that works really well in the medical laboratory setting but does not use the term internal or external.  I strongly advocate for adoption.
Medical Laboratory Customers are individuals who directly or indirectly order or use or services including our generation of information.  These customers are either clinicians (doctors, nurse practitioners) or patients.  These customers, depending on the medical services system may nor may not pay a fee and may or may not have a choice of supplier.
Medical Laboratory Interested Parties are individuals who are not customers but have a definite interest in results.  These may include patient friends or family or community contacts, or laboratory/institution contacts (such as nurses, technicians, housekeepers, visitors etc.)  who may be at risk of certain exposures.  It may include Public Health workers whose job it is to do further follow-up.  
Medical Laboratory Stakeholders are individuals or groups who have work necessity to be aware of activities or risks within the organization and their potential impacts.  This might include (but not be limited to) institutional administration, media services, legal and liability services, union stewards.
This classification works on many levels.  It makes the point that direct users of our information and service have a special connection with us and we have a special responsibility for them.  Second it highlights that our customers can have impact on many that surround them and we have a responsibility that they too are protected from harm.  Third, it acknowledges that there are others that have a “need to know” even if they don’t need to know a lot of details.
Customers, Interested Parties, Stakeholders… and NO Internal Customers.  
How good is that!!!

Thursday, June 15, 2017

Implementing the Essentail Eight for quality success

In the last while I have had 3 sessions with different audiences, all interested (if not necessarily committed) to laboratory quality management.  As much as we have made huge progress, it seems to me that we still have a long way to go.
As a group, these laboratorians have reached the step of vocabulary recognition.  They know the terms “Quality Indicators” and “Gap Analysis” and ISO15189, but putting these into an operational context is still missing.  What stands out more than anything else is the understanding that when it comes to  Quality Management and improvement activities it is NOT a one-and-done process, and equally important, almost all are missing the driving force “if not you, who?”.  Interest without commitment does not make for quality improvement.

What laboratorians must grasp as critical understanding that if Quality is going to improve it will have to involve their own personal and ACTIVE engagement on a regular and on-going basis.

There is an appreciation that putting in Quality Indicators is a good thing to do, but what is missing is that while Quality Indicators can be a useful measurement tool to address point specific concerns, the average laboratory has dozens (if not hundreds) of point specific concerns.
There is a full array of Quality Tools that should (must) be used to get a good overall picture of how well (or unwell) the laboratory’s quality efforts are working.  I think of them as the Essential Eight, and I argue strongly that (a) every laboratorian needs to be aware of each of these techniques and (b) each laboratorian should get their hands dirty by participating in implementing each of these techniques early-on.   

And laboratories have to develop and hone their Quality routine so that their Essential Eight activity is both Early and Often.
A quick look at the Essential Eight might suggest they are  divided into 2 groups, those for which the laboratory is responsible, and the others which are effected by others.  But coming to that conclusion would be wrong.  

The laboratory  has to take an active position in rolling out Proficiency Testing (EQA), making sure that every person at one time or another is involved and the challenges are tested using the laboratory’s normal and standard procedures, and that the reported results reflect how the laboratory would normal report.  

 And if the laboratory takes on a passive role of awaiting to be contacted by an Accreditation Body to prepare for an upcoming external audit, it is almost a guaranteed outcome that the preparation will be at best superficial and transient.  Every laboratory should be actively filling the time between accreditation external audit visits by doing their own internal audits either as a full audit or as a series of mini targeted audits.  Either approach can be effective and depends upon the size of the laboratory and the degree of change and innovation that is going on in the laboratory.

And if you feel that doing your own internal audit creates a risk for personal bias, then consider inviting someone (either a consultant, or a colleague) to come in and do an audit for you.  We call that an external-internal audit.  

Of the remaining essentials, without doubt the single most important essential is the setting up of an active Opportunity for Improvement (OFI) list that is honest and open and complete.  If the laboratory is not prepared to record their errors and mistakes, there will NEVER be any recognition, NEVER be any examination, and NEVER be any corrective action.  We can say with ABSOLUTE CERTAINTY, that in the absence of an OFI list  the laboratory is doomed to repeated errors and never achieving any evidence for improvement.

Quality Control as a monitor for quality is a given.  If a laboratory is not doing quality control, then it is difficult to think of it as a laboratory, and will undoubtedly be closed down by accreditation or lawyers, whichever comes first.

I have mentioned before the importance of recognizing the importance of customer needs [see:  http://www.medicallaboratoryquality.com/2016/10/conference-report-laboratory-and.html  ].  Waiting for complaints to come in is the way we used to deal with customer service, but that was a long time ago.  Actively seeking customer input and opinion is the only way to know if your efforts to improve are being noted and serving customer needs.

Without expounding on the other activities, let me point out opportunities to improve are all over the spectrum, and if your laboratory is not looking everywhere, many problems will be missed, until it is too late.    

By using all of the power of the Essential Eight, you increase your likelihood of success.  Put another way, there is an association between implementing Quality Improvement and playing Golf.  In theory, one can play a round of golf only using a seven iron and if you are patient and lucky you might succeed.   
if you goal is to capture as many of your error opportunities  as possible you will be far more successful of you take advantage of all your 14 clubs (or in this case 8!), each in its own appropriate way and place.  

The more essential tools the we don't use, the more gaps are created,

And Quality Gaps are BAD THINGS.