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Monday, January 30, 2012

In standards, every word is important.

I was in a conversation this week that reminded me of a conversation many years ago when I took freshman calculus.  My professor loved using the term “it is intuitively obvious that…” which was intend to mean that what he was about to say next should be immediately clear and obvious to anyone and everyone in the class. As it turned out, the only thing that became intuitively obvious was that neither mathematics nor engineering was going to become the path to my future career.

What I did learn however was that words are important and folks who write them have an obligation to create text that can be understood by the anticipated audience, and that the folks the read them have an obligation to read the text carefully in order to grasp the intended interpretation. 

Unfortunately when it comes to the creation and reading of guidance documents it may very well be “intuitively obvious” that commonly neither the writer nor the reader meets their obligation.

ISO 15189:2007 contains the phrase:  “The request form shall contain information sufficient to identify the patient”.  In an interpretive text I wrote the following:  “In North America, patient identification usually requires at least two unique identifiers, such as a name and a date of birth, recognizing that a name may not necessarily imply a traditional first name and surname. In certain situations, a coded number or word may be an acceptable substitute.”  Concern was raised because it was suggested that I had said that laboratories could rely on name and date of birth as sufficient identification.   
But that was not was said or implied.

OK, in retrospect I could have extended by my writing to be clearer and more illuminating.  What I could have written (and now in light of the discussion, should have written was something more akin to the following:

In North America, patient identification usually requires at least two unique identifiers, such as a name and a date of birth, recognizing that a name may not necessarily imply a traditional first name and surname. In certain situations, a coded number or word may be an acceptable substitute.  That being said the requirement states sufficient to identify the patient, and this may require using 3 or 4 or 5 or 10 pieces of information for example, one might consider adding, for example, a hospital number (if there is a hospital number) or a social security number (in Canada we call that a SIN number) plus an address.  But the organization will need to recognize that at a certain point the value of more input of information is offset by an increasing level of risk of information error or data entry error or the hazards associated with exposure of certain confidential information leading to the possibility of identification theft if the information gets into the wrong hands.

As mentioned, I could have written that, but I didn’t.  If I get a chance to write a third edition, I will include it.

My point here is that not seeing or misreading the phrase “at least” had a big impact on the readers reading and understanding.  And that can be a problem.

My take away message is that standards and guidance documents by necessity carry a lot of conditional phrases.  “National or regional requirements may apply”  or “including, but not limited to…” or “for example…” or “at least”  all are important words.  Readers trying to interpret and implement documents ignore them at their peril. 

Here is a suggestion (note that the word “suggestion” is also a conditional):  Reading of standards and guidelines is not something one can do casually.  In order to help focus on the text when reading a required standard in earnest, have two felt-tips.  Use a RED one to highlight wherever you see the word SHALL.  Use a YELLOW one to highlight wherever you see a conditional.   Then ask yourself, why did they use that here?  And how can I use that to my advantage?

I think you will find the exercise beneficial.   

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