Laboratory accreditation is getting increasingly popular, especially in resource-rich settings, and in some countries, such as United States, is a mandatory requirement for testing operations. This worldwide trend might represent a problem for laboratories in resource-limited settings, particularly when trying to get funding or sponsors to do clinical research.
What are your thoughts about accreditation in general?
Is it a good idea to promote the accreditation of all laboratories no matter the setting?
Do laboratories feel a lot of pressure to become accredited?
Which organisations do you think are better qualified to accredit a laboratory over any other?
Please share your thoughts and views about this interesting and controversial topic.
If you want to know a bit more about laboratory accreditation have a look at this article in the site: https://globalhealthlaboratories.tghn.org/articles/laboratory-accreditation/
I would think Accreditation of laboratories is a good idea as it helps in building the general capacity of the testing facilities, both in terms of the infrastructure and the human resource. However, It is important to take cognizance of the enormous amounts of funding that is usually required for such an undertaking. An equally important factor to consider is the sustainability of this exercise; to be accredited is one thing, to maintain the standards of accreditation year after year of assessments is a different ball game all together.
This may be a mandatory requirement for the labs in the developed nations but does it have to be mandatory for the developing nations testing facilities? I understand how important it is to conduct clinical trials in an accredited facility but I beg to differ with the notion that an entire lab has to be accredited in order to qualify to be involved in a trial. I am of the considered opinion that if a facility has to participate in a trial, the it should be allowed to accredit only the specific tests as required by the study protocol. This might just be what catapults the labs to improve on the other testing regimes and drive them up towards accreditation standards.
I also would like to hear opinions on the possibility of accrediting non trial research laboratories. What is the acceptable standard other than 17025? Research has expanded and it is no longer the traditional microbiology, chemistry or hematology that is at play. Global health demands that we look at health in totality since the emerging infectious diseases are not confined to humans; animals (domestic and wildlife) and arthropods (sandflies, mosquitoes, ticks etc) play a critical role as hosts and vectors of these diseases and as such have become an important sources of testing profile. Is it justified to separate the testing of non human specimen from human specimen? What standards would then one employ to accredit such facilities?
Accreditation as I said before requires funds; unfortunately until recently there has only been one recognized accreditation agency in Africa - SANAS. This has since been addressed with a few others coming up in other African countries.
I think it is important to develop this capacity at the national level in each country and then each national agency should be able to bench mark with other similar outfits internationally, this brings uniformity, acceptance in the procedures and practices and will reduce the financial burden associated with the exercise.
Thank you very much for your interesting and valuable contribution.
Like you say, Laboratories should bear in mind that once they have meet accreditation standards or have implemented a quality management system to be compliant with Good Clinical Laboratory Practice and other applicable standards, they need to keep up with the good work to maintain their level. It is because of this that training and involvement of staff, as well as the creation of a culture of quality in the everyday laboratory work, are so important. One person should be in charge and oversee the whole process of developing quality systems, but it also needs to be a team effort.
With respect to accreditation as mandatory requirement for laboratories to conduct clinical trials, perhaps not all laboratories need to have expensive companies to come and set them up as trial laboratories, if they have a good quality management system and create a compliant environment. Especially in resource-constrained settings. In fact the basic requirements for lab assays for clinical trials are reasonably straight forward and sensible: there needs to be training and records of it; the equipment need to be working, calibrated and have a service record; fridges and freezers need to have temperature monitoring; samples need tracking and labelling. None of this needs specialist equipment as long as documented and done properly.
The WHO AFRO has established a framework called Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) for improving the quality of public health laboratories in developing countries to achieve ISO 15189 standards. These free guidelines could also be used by laboratories with limited resources in locations outside Africa (https://globalhealthlaboratories.tghn.org/site_media/media/articles/SLIPTA_guide.pdf). It would be really good if similar support programmes could be implemented in other continents. However, like you suggested, perhaps the best approach would be for each country to establish their own public national accreditation agencies and standards that could be then harmonised with international ones.
Your question about accreditation and quality standards for non-trial research laboratories is a very interesting and relevant one. Does anyone have experience in this matter?
I think all laboratories should at least be working towards accreditation. Even if it is not going to be possible to achieve full accreditation for reasons of resource constraints or factors external to the laboratory, the process of working systematically towards some sort of standard such as ISO 15189 cannot fail to improve quality management. I have seen all too many laboratories that are wasting what few resources they have because of inadequate quality management systems, producing misleading results that may ultimately harm patients.
Members may find the LQSI approach that was launched by WHO last year useful. See https://extranet.who.int/lqsi
Hi David and thank you very much for your contribution.
I think the point you make about working towards raising laboratories to accreditation standards, even if the economic resources to get the actual accreditation are not available, is a very important one. Like you say, improving a laboratory's quality management could only be beneficial and actually help to stop waste and improve patients' care.
Thank you very much as well for the laboratory quality management system link form the WHO. It is a wonderful free resource for laboratories in resource-constrained settings.
Global Health Laboratories is working to develop some other LQSI training resources and an e-learning course, so watch this space.