I have been immersed in the arena of European laboratory quality over the last few days. It has been a very interesting and positive experience. I have had the opportunity to participate as a jury member for a candidate’s dissertation and defence of her PhD thesis on laboratory Quality. To my knowledge this was the first (maybe second) ever PhD based on research on medical laboratory Quality and Proficiency Testing (External Quality Assessment –EQA). Incredibly interesting and exciting. What I saw was a level of creative and innovative enquiry and a growing awareness in laboratory Quality as a valid subject of study. To my mind this is directly attributable to the development and dissemination of ISO 15189.
As we continue to see progress with new laboratory technologies and techniques that will expand the technical information we will also see growth in the tools that ensure that this new technology has a Quality foundation. Having gone through an era of too many tests that were fast, slickly packaged but complicated with poor sensitivity and even poorer specificity, the progress in studies on better quality monitoring will shine light on assay inadequacies and do much for continual diagnostic improvement.
I have invited the candidate to appear in this web-journal site as a guest and I look forward to her presentation and insights soon.
During the PhD dissertation and defense some key observations were presented and recommendations for change were offered. One recommendation suggested a role for a more uniform approach to quality for European laboratories. Over the last 5-7 years European countries have been changing their approach to accreditation by requiring that the number of accreditation bodies reduce to only one official one per country. That will be similar to the Canadian situation where there is only one provincial accreditor. For some countries this may be seen as a restriction because in the past some countries have had multiple accreditation bodies, but this will result in increased intra-country consistency and uniformity in quality assessment. There was also thoughts on the development of a over-arching role for EU policies for a more unified inter-country approach to Quality - something akin to the US CLIA.
Before that happens, I see an opportunity for some fundamental comparative study that could shed light on the modern value for supervening policies including mandatory accreditation.
In the United States there is a quality system that is driven centrally through the CLIA requirements under the authority of Health and Human Services (HHS) and the Center for Medicare and Medicaid Services (CMS). While states are allowed to have their own accreditation program, they must as a minimum meet the requirements of CLIA. In each state there is a 100 percent requirement for accreditation.
There is another model in Canada where we have a decentralized approach. Each province has the authority to decide on the role and necessity of laboratory accreditation. Most provinces have their own single accreditation program or use the accreditation program from another Canadian province. (Some provinces allow the intrusion of a foreign accreditation program, although the benefits or reasoning for this escapes me.) In almost every province where there is accreditation, the requirement is mandatory and there is 100 percent participation.
In Europe they have a system similar to Canada but different. If one considers each of the EU countries as an independent but integrated unit, then each country has a status similar to a US state or a Canadian province. In the EU, like Canada, there is no overarching “CLIA-like” structure. But in the EU countries, where there is accreditation, it is voluntary, so that the participation in most countries is only around 20 percent.
So we have 3 jurisdictions US, Canada, Europe; each with comparable development of medical laboratories, each with over 1000 medical laboratories, but with three different stable structures for Quality and Quality Assessment. I can’t imagine a model better suited for study and analysis.
quality is a must in drugs.ReplyDelete