Wednesday, March 2, 2011

Oversight of the Quality Partners: survey results.

In a previous entry I raised that I created a survey of my proficiency testing program participants about their opinions about whether accreditation bodies, proficiency testing providers and medical device suppliers should seek official recognition either as a certification or accreditation process.
I picked these 3 because in each instance there is an ISO document that is used on a regular basis for establishing recognition.  Most Education providers, at the university or college level are accredited, but there is no single process for that and so I chose to not include them.  

An electronic survey went out and over a period of about 10 days I got back at response from about 40 percent of participants, which I think is a decent response.  Every province and region was represented.   Responders included laboratory directors, administrators, head technologists, supervisors, bench technologists, quality managers, and pathologists.  Responses included both the clinical laboratories and the water environmental laboratories.  From the clinical side, they included both hospital and non-hospital facilities. So while the responses were not random, they are well and representatively distributed.   
I intend to do a second response solicitation which will likely take the over-all result to to greater than 50 percent, but I suspect  there would be few changes or surprises in the collective results.  The only thing that might change is that some of the values might start to take on statistical significance.  But since this survey is not going to result in changes in regulation or legislation, I doubt a few p-values are going to have much of an impact.

First the mechanics.  The survey was designed using an on-line web-based electronic survey program.  The questions were of two categories: demographics and the specific challenges.  The questions were self-designed, but were vetted for clarity  through a reference group.  Most responses were through drop down tables or serial buttons.  There was sufficient space left of comments.  The time to completion was somewhere between 3-5 minutes.

There was one question that I blew entirely.  It was about laboratorians knowing that CMPT is certified to ISO9001:2008.  The question was so convoluted that when I looked at it myself, I wasn’t sure how to answer it.  So it got dropped.

There are 5 analyzable questions
Do you believe that Accreditation bodies should be accredited?
Do you believe that Equipment and Supplies providers should be accredited?
Do you believe that Proficiency Testing providers should be accredited?
Does knowing  that CMPT participates in regular voluntary oversight increase your confidence?
Does knowing  that CMPT participates in regular voluntary oversight increase program value?

Each question response was in the form of a 7 point Likert Scale from Strong Agreement to Indifferent to Strong Disagreement.

Strong or General Agreement
Somewhat Agree
Somewhat Disagree
Strong or General Disagreement
Accredit Accreditation Bodies
Accredit Suppliers
Accredit PT
Oversight increases
CMPT confidence
Oversight increases
CMPT value

When I looked at cross tabulations using demographic information (location, profession, whether the laboratory was in a hospital, whether the laboratory was accredited) there were no significant differences, although when we looked at the profession of the responder, our harshest critics were Microbiologists or Pathologists.  With respect to laboratories being accredited, it is important to note that only 3 percent of laboratories said they were not accredited.

Of interest, to me, in Canada we have stark regional differences with some provinces and regions strongly endorsing accreditation for clinical laboratories, while in others it is not mandated, or even recommended.  When I looked at the results of the questionnaire, I was surprised there was barely any impact of regional attitude.  In the same vein, most water laboratories are accredited to ISO17025, while clinical laboratories have a province level accreditation.  Despite that difference, their attitude towards accreditation of Quality Partners was essentially the same. 
If we had a larger representation from non-accredited laboratories it would be interesting to see how they would perceive the value of oversight.

Additionally, while none of the differences here are statistically significant, but the comments on the General and Strong Disagreements are interesting in that one person commented  that the oversight process needs to end somewhere and accrediting the accrediters is over the top.  
The most interesting was the comment “ISO accreditation is not a guarantee of quality but does indicate that the bearer is taking it seriously and is improving all the time.”  That shows really solid insight.

I was a little surprised by the results, although not flabbergasted.  I would have thought that laboratorians would be more demanding of their quality partners. While 85-90% expectation is high expectation, I would have guessed higher.  As in “if we have to go through this, then you sure are going to as well!”  From my personal point of view, I would be outraged if I thought that the bodies that could make decisions that impact on my reputation were not prepared to publicly demonstrate their own commitment to quality. 
The themes of "walking the walk" or "putting up or shutting up" come to the very front of my mind.

I am intrigued that around 15% (one in 8 laboratorians) are indifferent about having expectations for Quality Partners.  I don't know if that apathy or acceptance. Fodder for another series of questions. 

So memo to self: 
Most laboratories are pleased that I take the extra step to have voluntary oversight of my program.  For many it increases their confidence in my program, and increases their perception of our value.  Those are pretty powerful reasons for leaving those programs in place.  

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