Tuesday, November 30, 2010

Assessing the Assessors

A number of years ago (2000-2001) I was invited to give a presentation about my proficiency testing program.  When I finished, I invited the audience for questions and comments.  A technologist stood and angrily complained that proficiency testing and accreditation bodies set themselves up as authorities, but were not required to meet any requirements or expectations.  She was absolutely right.   

So in 2001 I decided that we had to fix this, and in 2002 we were thoroughly assessed and our organization was certified has having a quality management system that served us well.  We have continued the process of external assessment and re certification ever since.  In 2010 a new ISO standard for Proficiency Testing bodies was developed (ISO17043:2010).  We are considering that recognition process as well.

My biggest regret was that I didn’t get the name or contact information of the technologist  who woke me up to the critical importance of demonstrating commitment to quality.

I tell the story for two reasons: the first to brag, and the second to make the point that despite my regularly raising the issue accreditation bodies in Canada have been much slower off the mark.  Indeed my above story could be almost as relevant today as it was 9 years ago.  

To be fair, in Canada we have a distributed responsibility health system with each province responsible for its own health oversight, so  there is no single oversight body that demands provincial accreditation bodies have themselves external assessed for quality and/or competence.  But it is not a matter of requirement.  It is a matter of obligation and commitment.

But now 2 provincial medical laboratory accreditation bodies (plus 1 more) have stepped up to the plate and achieved international recognition.

In 2004 the province of Ontario decided that it was time to get into laboratory inspections.  It was timely because the new international standard ISO15189 as a standard for quality and competence of medical laboratories had just been published.  The newly minted OLA (Ontario Laboratory Accreditation) arm of QMP-LS (Quality Management Program – Laboratory Services) created a standard that incorporated the new standard and others, to ensure that medical laboratories were implementing quality management systems (and other measures of competence).  They have become world leaders in ISO15189 accreditation.  ISO Accreditation in Canada is done officially under the authority of Standard Council of Canada, through its signatory relationship with the International Laboratory Accreditation Cooperation (ILAC).   

In 2010, my province of British Columbia, going a different route has none the less achieved international recognition through accreditation of its laboratory accreditation standards by the International Society for Quality in Health-care (ISQuA).  This is a complex process similar to the certification process that I underwent with ISO9001.  

There is a third organization which is not a provincial program, but a not-for-profit, independent organization known as Accreditation Canada which has for a long time run a voluntary program of accreditation of all (or nearly all) hospitals in Canada. A truly remarkable job.  Recently it has been working under contract in one province to assess its laboratories.  Accreditation Canada’s standards have also been accredited by ISQuA.   
To have standards accredited they have to be externally assessed and demonstrate the 6 principles of Quality Improvement , Patient/Service User Focus, Organizational Planning and Performance, Safety, Standards Development , and Standards Measurement (reference: www.ISQua.org).

The other provinces either don’t have a provincial accreditation body, or they have one that has not yet taken the step forward for external assessment and recognition.

There clearly are differences between the ILAC process and the ISQuA process, and their strengths and benefits for the clinical and laboratory settings can be debated for a long time.  It is similar to the discussion that sees value in differentiating between the accreditation process and the certification process. I’m not going to get into that at this point, largely because I see the argument is all too often driven by bias and competitive commercialism.   What is important is undergoing external assessment demands discipline and rigor and demonstrates a commitment  to quality improvement

So in Canada, we are fulfilling a process that I have been promoting for near a decade.  If Canadian oversight bodies want respect, they need to demonstrate they deserve it, and to do it by independent external assessment.

And so, congratulations to the province of Ontario OLA program, and to the province of British Columbia Diagnostic Accreditation Program and to Accreditation Canada (and to CMPT!) for allowing the external light of audit and assessment to be shone on their programs. 

And my heart-felt thanks to my anonymous friend who got me to get the ball rolling.

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  1. HI Mike! Thanks for the nice comments about the OLA program. More good news: earlier this year, our EQA program was accredited to ISO 17043 by A2LA.

    Kind regards,
    Julie Coffey

  2. Stringent Standard procedures and compliance to the predefined standards will help in improving the existing System.

  3. RIQAS is the largest international proficiency testing scheme in the world with over 16,000 participants, this large number of participants ensures a large database of results for a wide range of analytical methods thus increasing statistical validity. We are currently internationally accredited to ILAC G13:2007 by UKAS which covers quality management, programme design, sample manufacture, data handling, reporting and communications. In 2011 we are set to complete our accreditation to ISO/IEC 17043 giving laboratories even more confidence in RIQAS as an EQA provider.


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