presentation is part 2 of a series highlighting
Proficiency Testing as a Laboratory Quality Partner.
This series is put together by Dr. Michael A Noble
BA MD FRCP the material founder and now retired chair of CMPT – Canadian
(formerly Clinical) Microbiology Proficiency Testing Program. The content of the series iis based on
national and international experience and expertise in both providing and
teaching about Proficiency Testing (EQA).
Dr Noble continues to serve on the advisory committee of CMPT and collaborates with Oneworld Accuracy.
The International Organization for Standardization (ISO) includes in one of its essential standards ISO9001:2015 (Quality Management) a list of what is calls the Principles of Quality Management that includes: customer focus; leadership; engagement of people; process approach; improvement; evidence-based decision making; relationship management.
In my opinion citing of Principles should be an essential part of every standard. With disappointment, ISO does not include similar preambles to either ISO15189: 2012 (Medical Laboratories – Requirements for quality and competence) or ISO17043:2010 (Conformity Assessment – General Requirements for Proficiency Testing).
The later document, with particular interest in Proficiency Testing (PT/EQA) does however contain a preamble that speaks about a series of what it calls ten “typical purposes for interlaboratory comparisons”. I have not included the full list here, but I strongly encourage readers to check the Introduction section of the standard.
I agree that in the widely diverse universe of laboratory testing, PT/EQA can have a wide number of “purposes”. But within that list of purposes there are some that go beyond purpose and are core to what we do. I argue they could and indeed should be separated out as more than “purposes” and would be better defined as “guiding principles”, which I think are qualities based on key values that help businesses and customers make beneficial decisions and create a distinct culture.
I don’t know if this list is going to be seen in the next version of ISO17043 (2023), but in my opinion I think they are worth consideration, even if they are not included going forward. The list includes:.
A. Evaluation of the performance
· The evaluation
of processes including stability and reliability of reagents, supplies,
equipment and the environment is readily covered in the laboratory by Quality
Control and internal audits.
The external evaluation of performance can be done by direct observation by accreditation bodies but can only be done at scale through PT/EQA.
B. Identification of problems and initiation of actions for improvement
problems (non-conformances or opportunities-for-improvement)
is done, not in search of penalties, but to light errors that potentially can
PT/EQA clients and providers alike should understand that laboratories that have a perfect track record with EQA/PT may still have errors, but at a frequency below the detection limits of PT/EQA. More importantly, laboratories having even a few deficiencies in their PT/EQA challenges is making many more errors that are not being identified. Laboratories that investigate their EQA/PT including in clinical samples, often find the same errors have occurred before.
C. Provision of additional confidence to laboratory customers
· Let me tell
you a story. Increasingly laboratories
are putting their accreditation certificates out in the front lobby of their
institution where the public can see it, but their PT/EQA certificates hang on
the walls in the laboratory. We in the
laboratory know that we are doing well; what we need to do is share that
information with the clients that use the laboratories that we assess. It is the customers who benefit from knowing
that the laboratories are performing well.
D. Education of participating laboratories based on the outcomes of such comparisons
· Education is more than a purpose; without an educational foundation PT/EQA is only serves as an error detection system, which can prompt some facilities to finding opportunities to cheat and collude.
story… in our program we include an educational narrative in all our
reports. It is usually not more that 400
words but provides perspective and learning principles. In a number of surveys of clients over the
years, the smaller laboratories without access to journals and conferences identified our critiques as their most available
and most important educational information for continuing education.
E. Establishment of the effectiveness of test or measurement methods
· I include this within my list of PT/EQA principles, but I can concede that not all would agree. In fields where there are a variety of choices on measurement methods, PT/EQA can offer some unique opportunities for study. When samples are both homogeneous and stable, and there is a strong informatics foundation for analyzing performance, and there is a certain homogeneity in the testing laboratory pool, there can be value in looking at test methodology on side-by-side comparisons. Only PT/EQA studies can create information on studies done by multiple laboratories looking for a common answer. This can be an important part of the educational value-added through PT/EQA.
In summary I argue there are some guiding principles that should be central to every PT/EQA program. I applaud the original crafters of ISO17043 in identifying these. I only wish they had identified them as more than just “purposes”.
But while I am on the topic let me offer a sixth Principle which probably should not only be included, but should be first on the list… Quality First. I think this speaks for itself.