Tuesday, April 24, 2012

Assessing and improving quality in molecular genetic testing laboratories in Europe

Over the last few weeks I have referred to a person about to complete their PhD in medical laboratory Quality.  To my knowledge Sarah is the first person to have done this.  Congratulations, and here's to her being the start to a new trend.  

I have invited Sarah to prepare an entry for Making Medical Lab Quality Relevant.  I am pleased that she has contributed the following.  With that I am pleased to introduce Dr. Sarah Berwouts.

Only recently I defended my PhD dissertation and it was a pleasure to have Dr Michael Noble in the jury. I also feel honoured to get the opportunity to write a guest post on his entertaining blog. My research project mainly focussed on quality in Europe, so having input from Dr Noble on the Canadian situation was interesting and provided some food for thought. 

An intriguing discussion we had was about the difference between accreditation and certification. In Europe we believe that laboratory accreditation according standards such as ISO 17025 and ISO 15189 is the most efficient way to assure the quality in your laboratory. Certification, according to the ISO 9001 standard, is believed to imply a significant lower level of quality assurance, and not to assess, in general, the technical competence of the laboratory. Although I did not directly measure the difference in quality between accreditation and certification, I gathered information on the degree of implementation of certain quality aspects in both accredited and certified laboratories. These aspects involved, among others, having standard operating procedures, having a quality manual, and performing internal audits. I requested European molecular genetic testing laboratories to indicate the degree of implementation (fully implemented=score 3, advanced=score 2, just started=score 1 or not implemented=score 0) for these quality aspects and this degree of implementation was recalculated as a percentage. In the end, I got an overview of the implementation of the surveyed aspects in about 300 different laboratories. 

As I requested also the accreditation or certification status of the laboratories, I was able to compare the degree of implementation of quality aspects in both groups. Standard operating procedures were implemented very well in both groups (100% vs 99%). However, the availability of a quality manual in the laboratory, was implemented significantly less in the certified laboratories (96% vs 78%). A similar observation was true for performing internal audits (97% vs 68%).

These results supported the European view of certification being less stringent than accreditation. Nevertheless, it is surprising that a relatively high number of certified laboratories do not have a quality manual as this is a certification requirement. 

One could argue that there is a bias in the data, as the accreditation/certification status was collected through self-reporting and laboratories might have overestimated their accreditation/certification status. However, I validated the answers to the survey question ‘Is your laboratory accredited?’ and ‘Is your laboratory certified?’ by checking databases of accreditation and certification bodies. It is however possible that the person who filled out the survey was not aware of what is implemented in the laboratory and that this was more often the case in certified laboratories than in accredited laboratories. Or might it be possible that certification bodies certify laboratories even if they do not conform fully to the ISO 9001 standard?

I understood from Dr Noble that in Canada the situation is slightly different: certification and accreditation are closer to each other, and certification has been appreciated as a valuable tool to assure good quality in the laboratory. All depends of course also on the competence of the accreditation and certification bodies themselves. In Europe, recent efforts by the European co-operation for Accreditation (EA) lead to improved harmonisation among accreditation bodies: there can only be one accreditation body per country now, accredited according ISO 17011. Other European organisations and projects such as the European Society of Human Genetics and EuroGentest actively encourage and promote laboratory accreditation, more than certification. 
Although there might be slight differences in organisation of quality assurance in both Canada and Europe, we all aim for the release of correct and accurate test results and continued efforts are needed to assess and improve the quality in laboratories all over the world.

Sarah Berwouts (sarah.berwouts@med.kuleuven.be)

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