Showing posts with label standardization. Show all posts
Showing posts with label standardization. Show all posts

Wednesday, August 24, 2011

Quality that drives folks crazy

The other day I was part of a meeting reviewing a document intended to standardize Quality Standards.  The point was that was being put forward was that all Quality standards should use the same words and use them to mean the same thing.  That way regardless which quality standard you use you will immediately understand the document and be able to implement the requirement.  That makes sense.

But as the document continued, the devil in the details started to appear. 

Is the word “document” a verb or a noun, or can it be both?  Is “documented” an acceptable adjective?  The same applies to the word “record”.  And what about the words “goals”, “objectives”, “aim”, and “target”; are they the same of different? Is the term “goals and objectives” meaningful or redundant. 

The terms “continuous” and “continual” are raised as well.  Is the correct term “continuous improvement” or “continual improvement”?  Apparently the word “continuous” means “ongoing without interruption”, while “continual” means “ongoing but at regular intervals”.  Both of these terms need to be differentiated from “continued” because that term means “ongoing but after having stopped”.  And should we refer to “continuous education” or “continual education” or “continuing education”?  Apparently the term “continuing” can mean one or the other.   So perhaps the correct term for improvement is “continuing improvement”.  And where might “continuity” fit in?

In my own technical committee, we have struggled with a truly pointless convention.  When a “sample” is being collected from a patient (or is that a customer or a client) then we can that this is an action (procedure) in the “pre-examination phase”.  And if someone wants to refer to this as collecting a “specimen” as part of the pre-analytic phase” then they are wrong.    This is truly the stuff that some Qualitologists and Standardization people love, but which really drives most people crazy.
This is the stuff that gives quality a bad name as being deeply involved in minutiae rather on issues that are really important to organizations.  And I agree with that too. 

There are lots of drawbacks with this sort of discussion.  First and foremost, there must be hundreds of words that would need to be examined and discussed, and thousands of people who would be affected (should we call them “stakeholders” or “interested parties” or “affected parties”).  It would take years to work through with the likelihood of some sense of “consensus” or “agreement” or “general agreement” being very limited.  And even if we could come to some “common understanding” in English, would the subtleties translate into French or Spanish or Mandarin or Russian?  And third, it drives the "big-picture" advocates crazy, and even more importantly away from trying to improve Quality.

My solution to all this is to reduce the number of jargon words in what we try to convey.  And further to the point, reduce the number of words period.  Pictures are good.  More importantly, we should quit worrying about the trivial issues. 

Quality is about big principles of making sure people understand what they are supposed to do, thinking about a project before jumping in, checking what went right and learning from what went wrong.  Whether you used a red pen, or a blue pen, or white-out is a side issue. 

As this standards year soon comes full circle (World Standards Day is October 14th) we should resolve that next year our goal (objective) for Quality should be to keep it simple and effective.

Thursday, August 11, 2011

Better Reporting for Microbiology Samples

In clinical microbiology we have the same three-phase cycle as everyone else: the pre-examination phase, the examination phase and the post-examination phase. 
Microbiology samples have some unique characteristics that directly impact upon how we have to act in all three phases.  Because many (hopefully not all!) samples contain contamination from surface flora, they have to have a very brief interval before being processed in the laboratory.  Otherwise these contaminants overgrow and confuse the clinical interpretation of results.  At the other end of the cycle, because our results tend to be wordy and qualitative, often they need to be associated with interpretive or explanatory or cautionary text.  And that is sometimes a problem.  In 1996 we published an article about reporting variation.  Laboratories found 22 different ways to report the same quantity of bacteria in a urine sample.  You can call that a lack of standardization in reporting structure.

In a recent customer survey, CMPT asked the information that we provide around our samples.  Overall we found the responses quite elucidative and helpful.  Some examples: 

CMPT expectations for sample reporting, do not always agree with the policy and procedures of other institutions. It is sometimes difficult in knowing who is the best practice source.


The critiques should stick to the facts. There are many gray areas in Microbiology; many split opinions with no right or wrong answer.. The critiques often have the habit of stating these “gray” areas as clear cut, with the author’s opinion being presented as the only correct interpretation. It does not broaden anyone’s knowledge, by failing to represent the true dilemmas we face with cultures, and that there are no right or wrong answers in some situations.

I highlight these two results to make a few points.  First, I understand the feeling of challenge about sorting out who is and who is not a practical source of information.  I also disagree that with some consideration that the answer is difficult.  Second, I agree that Microbiology opinion can suffer because of the “gray” areas. 

In the olden days (like in the ‘50s and ‘60s and ‘70s) laboratorians were very comfortable with these gray areas because it meant that any answer was an OK answer.  Laboratorians were free to report results any way that they saw fit.  As I was told by a group of colleagues, "No one can infringe on my right to practice medicine the way I see fit".  

The problem with that approach was that it was predicated on the notion that laboratories exist for the benefit of the laboratory and not for the clinician and not for the patient.  Today the rules have changed and we understand that laboratory reports exist to provide information for the users.  When patients are tested in multiple laboratories there is some obligation to at least ensure that the information that they receive has some level of consistency.   Using the notion of  “gray areas” as a justification for inconsistent  reporting structure is not appropriate;  something more definitive is expected. 

In the absence of legislation and regulation or some other legally binding notion, at least we should make our decisions based on consensus within our community.  It is called standardization.

And that is where PT/EQA committees can and do play an important role. 

Take CMPT for example.  Our committee is a group of 13 medical microbiologists, scientists, technologists, with both clinical and laboratory expertise.  The group comes from across Canada and representing university hospitals, community hospitals and community laboratories.  The group collectively perceives the wording of reports as important and spends considerable time coming to conclusions about mutually agreeable decisions about meaningful clinical reports.     

If ever there is a group ideally designed to come to consensus opinion about the optimal way to report clinical samples, it would be a group just like this.  CMPT is not the only PT/EQA program in Canada, nor is it the only one that has a committee that assesses reports and determines optimal reporting patterns.

So with respect to the two comments mentioned above, I have to respectfully disagree.  There are better reports and poorer reports and there are community based PT/EQA committees well positioned to help define the better way to report.

Don’t agree?  That’s OK.  Submit an appeal with justifications.  The committee also  has the obligation to provide a second look.

But we will continue in our obligation to provide what we see is an important contribution to reporting standardization. 

It is one of the things that we do.