Meeting the Needs

It is remarkable that 2019 marks 40 years since Philip Crosby wrote his seminal book Quality is Free and his declaration of the Four Absolutes of Quality, the first of which was “Quality is defined as conformance to requirements” by which he meant that if the customer has certain requirements and expectations, such as defect free and durability, precision, and date of delivery, and all are met, then the product is meeting the customer’s requirements and can be fairly called a Quality product.   Meeting Requirements or Meeting the Needs of the Customer is not a cornerstone of modern quality, it is the cornerstone. 

As we think about meeting needs, it becomes clear that needs go a long way from purely “technical” considerations.  Yes, precision, and timeliness are still critical needs for medical laboratory testing, but so are clinical relevance, and interpretation, and context, and clear language and of course getting the right information to the right person and not infringing of confidentiality.  Satisfaction is essential, but is only the first step.  In our arena, our customers extend to cover health care personnel working with the “patient” as well as their family and friends and contacts and caregivers, and public health and the institutions of health.  It is not that meeting the needs has become more complicated; rather it is that we have become more aware of what people want, need and expect.  

So in November 2019 we are going to bring the discussion to the larger table.  On November 24-26 a conference will be held here in Vancouver BC Canada to look broadly at the theme of Meeting the Needs.

The conference will be an ideal forum for people interested in Quality in the Medical Laboratory field including technologists, Quality specialists, students, trainees, administrators, and pathologists from BC, across Canada and even beyond.

As we gear up you will see increasing information at https://polqm.med.ubc.ca/

This would be a good time to start thinking about your own poster presentations.

More to come!!!

Validation Verification and Vindication

Validation Verification and Vindication

We live in an era that loves to believe in logic and discipline as the basis of progress.  In near every discipline the clarion call to quality is that decisions must be evidence-based.  Evidence-based medicine is touted as the foundation for all diagnosis, investigation and treatment, based on the assumption that the overwhelming mass of studies performed and published provides us with all the information that we need.  

But it is pretty clear that many (most ?) of those studies are too small, too uncontrolled, and too biased and essentially not reliable, but we can do our best by combining studies and through meta-analysis can make the proverbial silk purse.  Despite this we generate tons of confusing and contradictory guidance in most things that are important, such as nutrition, vitamin usage, cardiac risk and anti-lipid therapy, and exercise, and on and on.  

For an interesting read on this subject, today I found an editorial in the Saudi Gazette written by Gary Taubes of the New York Times in which he talks about the “field of sort-of-science” in which “hypothesis is treated as facts”.   

The problem is not that we suffer from insufficient data or insufficient tools; indeed we live in the era of Big Data Analysis where thousands of databases with billions (and trillions) of points are available for picking and mining.  No it is not a problem of insufficient data; rather it is a problem of dirty data, poorly defined, incomplete, improperly gathered, and all too often inappropriately or insufficiently analyzed. 

Ultimately the problem is that we are left with the same lingering question “Who do you trust?”

To get on top of the solution we think in terms of Verification (is the analyzer capable of providing a repeatedly reproducible result within a narrow range of allowable error?) or Validation (do test results provide a result that is consistent with the gold standard and can they distinguish groups of subjects who are consistently “positive” from those that are consistently “negative” as measured by other parameters?).

But in addition I argue that we even more heavily rely on Vindication, which in this context I use to mean, “My approach must be right because I came to the same conclusion as noted in this other study”.  It’s a pretty soft measure, and a throwback to “evidence by authority” which predominated in the Dark Ages.  But it does have its compelling aspects.

 

I will give you an example.  In the Winter 2013 edition of Harvard Business Review Edward Hallowell wrote an article about a study published by Gilbert and Killingsworth in Science (Nov 2010) about people’s ability to focus on what they are doing and their sense of happiness.  What the study pointed out was that based on a pool of 2200 adults and over 250,000 observations, about 46 percent of people will commonly have their minds wander, even if they are enjoying what they are doing.  Hallowell, a psychiatrist and prolific writer on the subject of distraction writes, “Not only does such a lack of focus lead to unhappiness, it results in errors, wasted time, miscommunication, and misunderstanding, diminished productivity, and who knows how much global loss of income…”   

Now I am not a psychiatrist  (although I did a huge wack of training in psychiatry in my younger years), but in that sentence Hallowell summarizes the singular challenge for medical laboratory, and indeed all, Quality.  Recognizing that distraction occurs regularly is totally consistent with James Reason’s views on human error (slips and mistakes) and is consistent with Decker’s views on response to error, and is consistent with non-linearity of cause and effect in Chaos theory.   Lots of people (maybe most? maybe all?) lose concentration during work, and when that happens the opportunities for error and confusion arise.   Telling people to try harder is not an answer.  Telling people to Do it Right the First Time, is not an answer either.

Putting in systems to prevent the consequences of inattention and distraction (think Lean Poka Yoke) and putting in systems that will pick up on errors as early as possible, and putting in systems to reduce the repeating of error have a far more reasonable likelihood of success. 

I understand that my buying-in to this hypothesis is exactly what Taubes (sort-of-science) was concerned about (hypothesis becoming fact).  He would say that the linkage between distraction and error remains unproven.  But I have to say, without apology, that it works for me and I believe it.

Vindication.

Defining Quality

Paul Borawski, the CEO of the American Society for Quality and the writer of the blog A View from the Q has written a very interesting entry on the Definition of Quality.  It is worth a read [see: http://asq.org/blog/2013/01/how-do-you-define-quality/].

There are lots of definitions around that Paul was able to document in a Future of Quality report in 2011.

As I look at this list, I will tell you that in my opinion many, perhaps most, of the definitions presented are very unhelpful (The pursuit of perfect that never ends;  Quality is conscience, Excellence, Quality is the degree of feeling happiness, Quality is the intangible that makes a better world tangible,.).  These are phrases that contain nice but meaningless words. 

Then there were a few suggestions that were equally unhelpful, but didn’t even bother to include some feel good intention (Quality is what the customer says it is, I know it when I experience it, My total experience of the provider.)

The problem with all these phrases is that none of them express any sense of objective measurability, and as such don’t provide any support for progress for the science or discipline of Qualitology [see: They do nothing to advance study or progress in Qualitology [ see: http://www.medicallaboratoryquality.com/2010/12/science-of-qualitology.html ].

In 1979, Phillip Crosby created a pretty good working (excellent) definition that has by-and-large stood the test of time.  His Quality is the Conformance to Requirements has been reworked in a variety of ways, that all express the same concept (Quality is compliance to a specification, or Conformance to requirements, or Meeting customer requirements) 

This has proven to be a helpful place to start.  In my field, it starts to break down, for several reasons.  First, it implies that there is a uniform customer  or a common customer need.  It assumes that organizations has the flexibility to provide a unique service for each customer.  Second, it implies that customer requirements can always be met, and third it implies that we can capture and analyze the degree to which we have met the requirement (think customer satisfaction surveys).  I don’t think any of those are generally true statements.

I am not suggesting that the Crosby definition is wrong, or that it should be discard, or even denigrated, but I think in some fields it needs to be adjusted to fit the circumstance better.

With that in mind let me suggest: 

Quality is meeting the requirements and expectations in service or product that were committed to. 

Hold me responsible to what I commit to do.  If I do that then I can say I have Quality performance.  If I miss due to over-commitment  or under-performance I have detracted from my Quality.  

If I told you that I would get your dry-cleaning done by 10:00 AM, then Quality service requires me to have the job done without fault or damage and ready to go by 10:00 AM.  You can count on it. 

And if I told you it would be ready at 10:00 AM and you come at 09:00 AM and are angry because it is not ready yet, that may be a disappointment, but is not a reflection on the Quality of my service. 

If I told you that I would have that urine culture completed by Tuesday morning before 7:00 AM, that means that you can expect to have an accurate quality-controlled and quality-assured interpretable culture report with the appropriate antimicrobial susceptibility results on your computer screen for 07:00 hr rounds.

And if I told you that I would build a bridge for 3.3 Billion dollars that people can drive across safely, and what I provide within time, and under budget a bridge that nearly kills people in a predictable period of poor weather, that is called the Opposite of Quality. 

The value of my extension to Crosby’s definition is that it is predicated on to what I made a commitment.  If my commitment is not close to meeting customer needs  then we have a second issue (more on this later), but I can and should be held to what I commit to do.   If I have completed as committed then I can say I have performed a Quality task.  If I get it done well, but late, I can measure the degree of lateness (in the laboratory we call that turn-around time) and I can define the amount of Quality lost.  I can measure amount of conformance to commitment, and I can study the deviation and develop a specific strategy for improvement. 

So in summary my definition for quality is tied to the customer need, but is further refined based on my ability to perform based upon what I promised; it is stateable, and it is measureable, and it is studyable.  Mission accomplished.

Not bad, eh?

PS:  The planning for the UBC POLQM Quality Conference (October 16-18, 2013)  is coming along nicely.  The themes of World Standards in Health and Improving medical laboratory services for better consumer care are coming together are established.