How Happy are your customers and how much do you care (Part 1)

Recently I have had the opportunity to start looking at laboratory Quality in a whole new light.   

Medical laboratories have only recently been introduced to the concept that they are businesses that have customers and that these customers have certain rights and expectations.   Quality oriented laboratories need to take customer satisfaction in mind because unhappy customers can make complaints that at a minimum can disrupt smooth administration, or they can create terrible publicity and public awareness, or the can sue.  In many parts of the world, they can drive business away and the laboratory can starve for work (and revenue).  

Unfortunately this is still all very new in the laboratory arena, and only the barest of minimums of activity are yet in place.  Few laboratories are much beyond the complaints form, and for those that are few are doing anything to really capture clinician or patient sentiment.  But to be fair, progress is slowly being made.

In many businesses, meeting satisfaction needs is only a minimum; more importantly they need to find the way to connect satisfaction to both business and revenue growth (welcome back, spend more, and bring a friend!).  This is being referred to as Service Excellence or “Customer Delight”.  (As an aside the term customer delight has been around more that 30 years, but in most English speaking countries it still sits very uncomfortably on the tongue.)

In the early 1980s Noriaki Kano, an academic in quality management and customer satisfaction wrote a lot about satisfaction.  Although his target audience was neither healthcare or medical laboratories, as I read about his model of satisfaction (referred to appropriately as the Kano Model) I can see how much of it directly is referable to the medical laboratory and quality improvement.

Kano wrote of 4 identifiers or attributes of product and service development in the context of customer satisfaction (A) Basic or Threshold (B) Performance or Linear, (C) Attraction or Delighters(!) and (D) Indifferent.

Basic satisfaction occurs when the customer gets used to having the product when they want it, then then get really annoyed when it is not available.   An example of this might be providing staff in the Emergency Department a simple point of care test to detect an infection, but then saying it will not be available for use on Wednesdays or the weekend.   

Performance of linear satisfaction is said to be positive when the service is performed and negative when the service is withdrawn.  A good example of this would be when an laboratory announces that in order to make the life of elder or very young patients easier, they offer to go to the patient’s home for sample collection rather than making them go the clinic, but then not providing the service when the driver or the collector goes on vacation for three weeks or if they decide they won’t collect the sample because maybe the patient has the flu.

Attraction or Delighter satisfaction occurs when the customer is REALLY pleased when the new service or product is available and enjoys its presence, but is not dissatisfied when it is not.  It is seen as something of special value.   It’s like when you go to the laboratory and get seen by a phlebotomist who is not only efficient and effective, but is also happy and congenial and helps take away the anxiety of visiting the laboratory.  Or perhaps when you receive a laboratory report there is an informative note that helps put the result into better perspective.  What Kano pointed out is that once an attraction/delighter action is first put into place, it is seen as something novel and keen, but overtime, everyone just assumes that it should be the norm, and gradually it shifts from being an attraction/delighter satisfaction attribute and becomes a basic one, that people expect all the time, and get really annoyed when it is no longer there.   

Finally there is what Kano called Indifferent Quality which describes quality efforts that the customer knows nothing about and is unaware if they are present of absent and have no tangible impact on satisfaction.   This with regret accounts for maybe 99% of the things that we do under the banner of Quality Management and Quality Improvement.  (We know, but nobody else is aware).

If (and that is a BIG if) documents like ISO15189 or other standards/guidelines start pushing for more innovation in laboratory customer service and more clients start demanding a higher level of attention and care, these concept are going to become very real and very familiar in your neighbourhood laboratory.

More to come,

Quality upside down and backwards

Warning:  This entry is deeply in the weeds.  If you are not a ISO-wonk or Qualitologist, this will drive you crazy.  For a quick read, jump down to the last two paragraphs.

The International Organization for Standardization (ISO) is a crafter of standards, but NOT creator of original thought.  Ideas exist, usually from other international organizations, but taken to their origins, from true original thinkers.  For example ISO/IEC 17025 first came to life as ILAC Guide 25, a document created so that international accreditors could have a single source against which to assess laboratories.  Similarly ISO9000 was derived from a combination of a British Standards Institute document and a UC Military Standard and another from the Canadian Standards Association, but ultimately they were derived from the teachings of Deming and Juran and Crosby.

The concepts of Plan-Do-Study-Act, Risk, Document Control, Corrective Actions all long proceeded their appearance in documents published by ISO.  Think of ISO as the iterator or popularizer or disseminators of ideas rather that a creator.

In my laboratory when we actively decided that this stuff called TQM or Quality was something that we should look at, we learned  about it through books (read Ray Bartlett’s classic Microbiology Laboratories: Quality, Cost and Clinical Relevance) and guidelines many from the organization then known as NCCLS (now CLSI). 

We had looked at the recommendations and guidelines on how to write an SOP or how to set up document control.   The nice part was that the books and guidelines that I learned from were written as books and guidelines whose primary task was to teach.  And importantly there was no pressure.  

I could take the information as given or fiddle with it or ignore it.  My laboratory, my choice.   

Today it doesn’t work like that.  Today laboratories generally don’t start from scratch.  They start from the perspective of what is written in ISO standards or from the expectations of an accreditation body.  And that is tough because ISO standards are not, were not and never will be designed as tools from which to learn.  They are designed as documents for rules setting. 

So here is my problem.  

For the last 17-18 years we have taken the view that the way developing laboratories need to learn about implementing Quality is NOT to start from the perspective of basic components, but rather to start from obeying the dicta of ISO.  And so far that idea is not working particularly well.  And further when we assess their progress we do it against an accreditation level standard.  

Recently I was in conversation with a person very involved in monitoring progress of laboratories in a developing country and was told that the laboratories were not doing particularly well by their measurements as assessors.  I knew what the problem was; it’s was not that they had no written SOPs, it was that their SOPs did not meet the requirements of ISO.  So what!!!

These laboratories are just learning about quality management and importantly, there were no small laboratories from developing or evolving countries that participated in any part of the ISO process.  They had no opportunity to object and make the point that the standard as written was not designed or intended for them.  This is really a round hole-square peg situation.  

We should be promoting them to learn and discover Quality in the same way as we did; start from having a purpose and finding a solution.  Allow them to play around with different versions of document management, or risk, or SOP production.  Allow them to discover and appreciate value and then refine.

 We should NOT be using ISO standards to promote quality in these laboratories.  

And ANY person who answers a question by saying “we do it this way because that is what is said in ISO15189” should be thanked for their service and shown the door.    

Fit for Process versus Fit for Purpose

Recently I have had the chance to work with a number of laboratories around the world that are relatively early on in their march to Quality Progress (by this I don’t mean subscribing to the ASQ magazine, but actually trying to making progress implementing Quality Management in their laboratories).  What I have seen is a lot of implementing new procedures which will be hopefully in time active and appropriate. But so far maybe not so much. 

What I see a lot of is laboratories deciding they want to get accredited tomorrow or they are told by their overseers that they have to implement a quality system NOW.  So they buy a book, or hire a consultant and they start by looking at the documents that they have to create: Organizational Chart, Quality Manual, Mission and Vision statements, Standard Operating Procedure forms, Document Control List, Corrective Action Form, Quality Indicator Forms, plus, plus.  

So the documents get created “by the book”, and get set up for use “by the book”.  I call this Fit-for-Process; documents that can be shown to an assessor so that they can get a checkmark in the appropriate box.  

What I also see with these documents is a ton of documentation that that looks pretty, but seems to exist solely for the purpose of being seen.  They are not designed so they can be used to actually make the quality process work better.  They become documents of busy work.  What they are NOT are documents Fit-for-Purpose.

They remind me of Billy Crystal’s character Fernando who would follow up his catch phrase in some generically hip pseudo-Spanish accent, “you look MARVELLOUS” followed by “It is better to look good than to feel good (and you know what I mean)”.  

The problem of course is that the documents get created in response to the question, “what do we need?” rather than “why do we need?”

What happens is inevitable; documents get created to record everything on every topic on every occasion.  And then fatigue sets in and they get filled in not with everything or on every occasion, but with less stuff and less often. And not far down the road, they just stop, and the complaints start; “this Quality stuff is a waste of time, and we are so busy and we don’t have the time to waste!”  

The problem was not that Quality takes too much time, it is that implementation was done in a hurry, to Fit-the-Process, to get that checkmark, to get that accreditation done and out of the way.  The purpose, if there was any, was solely about getting the certificate NOW.  

The reality is the Quality takes time, and grows with insight and with organizational culture.  And if it takes a year or so, then let that happen.  

Quality Management systems create a framework for planning and assessing risk and reducing the number of repeated errors.  When implemented Fit-for-Purpose, the process saves time rather than consumes time.  When implemented Fit-for-Purpose, the process reduces stress rather than driving the Qualitists crazy filling in the pretty documents with the excessive information.  When implemented Fit-for-Purpose, your next steps are refinements, not overhauls or do-overs.

So as you charge forward towards getting your stars or your certificate, let me ask you the obvious…”what’s your hurry?”

Upon reflection, when it comes to building your Quality system, Crosby was spot-on.  Do it Right the First Time (DIRFT).

Quality Progress Taking Hold in African Countries

I was looking at some earlier files and presentations, going back to 2004-2005.  The subject from this retrospective “look-back” was my involvement in laboratory quality in African countries.  My introduction was through a senior partner group participating in the US President’s Emergency Program for AIDS Relief (PEPFAR) program set up by George W. Bush.  To the credit of the people responsible, they were able to see that establishing a program of monitoring for AIDS diagnostics was going to require the establishment of Africa based laboratories capable of Quality and Competent practices.  

Back then there was lots of evidence that this was going to be a major barrier.  Laboratories were working with at best rudimentary equipment, usually with out-dated reagents.  Samples all too frequently were being delivered to the laboratory not in typical sample container tubes, but more likely in repurposed medication vials.  Additives like heparin were being added by hand and pipette with little sense of precision.  In microbiology, critical samples such as blood cultures were a travesty,  with reliability closer to 30-40%; huge false positive results from contamination and false negative results from faulty media and terrible technology.  

When I think back to those days, my amazement of what is happening today is triple underlined and reinforced in gold.  

This week we are finishing off a 21-week on-line course that was put on for 15 Quality Assurance Officers.  This group has the same level of knowledge and sophistication about laboratory quality as peers almost anywhere in the world, and truly better than most.  Our discussions about things Quality, like internal audit, quality indicators, document control, quality control, inventory management, Lean, 5S, Six-Sigma, SIPOC would parallel or surpass many laboratories in much wealthier laboratories.   

So how did the laboratories get from then to now?  With a lot of work both from without and within.

Importantly governments from around the world, and US in particular, have spent a ton of tax-payer supported money, supporting laboratories, equipment, PEPFAR partners, mentors, and education.

  

But all that and a another dollar and a half would still not buy a Starbucks coffee were it not for a massive effort from the Africa Society for Laboratory Medicine (ASLM).  It was ASLM who with the support of World Health AFRO who introduced two programs; Strengthening Laboratory Management Toward Accreditation (SLMTA) and Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA).  SLMTA is an education program to promote education and knowledge about laboratory quality and SLIPTA is a graduated check-list that allows laboratories work at their own pace towards preparation for international accreditation. 

SLMTA and SLIPTA were introduced and implemented into some 1000-plus laboratories in near 50 different countries.

I know these programs were effective in moving the progress towards success because we had introduced earlier progenitor programs under the PEPFAR banner.  SLMTA and SLIPTA differed from what we did because they were Africa created, Africa taught and mentored, and Africa monitored.  

[To be honest, I am not sure that I see international accreditation as an important goal for many laboratories anywhere in the world, much less in Africa.  Most laboratories don’t do enough international work that then need to achieve accreditation to keep them in the international flow.  I do see the international documents a worthy goal, and a standard that states, provinces and countries everywhere can and should adopt in lieu of home-brew accreditations. 

But while that is a side digression, let me just say the next step to African laboratory quality is going to have to require African countries stepping up to the plate and demanding laboratories meet certain accreditation expectations for the sake of patient safety.]

To be fair and honest, many (most) laboratories in Africa that I have seen would not be able to function providing services in most developed countries, but that is NOT the fault of the laboratories.  The single biggest problem is that equipment and reagent distributors do not serve the laboratory community in Africa in the same way as they do in Europe or North America.  Part of this is money, and part is passivity, but the reality is that African population is around 1.2 billion people, and there is every reason they should be able to expect and demand better service.

But getting back to my original commentary.  Over the last 15 years we have seen monumental progress in medical laboratory performance and quality in many African countries.  

I would like to delude that I had a tiny role to play in this, but that would be grandiose thinking.

 African physicians are now in a position that they can actually make clinical decisions based on laboratory test results.  That was not the case a mere 15 years ago.

There clearly is more work to be done, but I NEVER would have imagined that we would see the levels of success that we are seeing today.