Accreditation terminology does not fit comfortably in the cellular pathology lexicon, as many of its reports are subject to interpretation, so how can it satisfy ISO 15189 standards? Julie Terry reports on a positive assessment exercise, and provides some relevant guidance.
Following a United Kingdom Accreditation Service (UKAS) assessment visit last May, no findings were attributed to the immunohistochemistry (IHC) section of our laboratory. The assessors were very happy with all the quality procedures and I actually enjoyed the process. That’s not to say that I particularly enjoyed the period leading up to the big day – such a lot of work was required to bring our procedures up to standard. However, it was all worth it in the end and the service has certainly improved as a result. This short article highlights some experiences on the day of the assessment and also describes the principles of the validation and verification procedures that have been put in place in the IHC section of cellular pathology at the Calderdale Royal Hospital in Halifax. I thought it could be useful to describe a positive experience.
We all know that the terminology used in the ISO 15189 standards is not necessarily geared towards a cellular pathology laboratory. We do not deal with numbers, and many of our observations are subject to interpretation, so how can we satisfy the standards?
On the day of the assessment, the first question was “Do you have any antibodies that you have to make up?” If only I could have said no, and that they were all Ready to Use (RTU). There was just one, and once this was known then the remainder of the day’s questions focused on this aspect of the process, and answers to the following questions were sought:
* Do you use expired antibodies?
* How do you make the antibody? What dilution? Can I see the verification documentation?
* Which pipettes do you use? Can I see them and their UKAS calibration certificates?
* Who carries out this procedure? Can I see their pipette accuracy training records?
* Where is the antibody kept? Can I see evidence of temperature monitoring? Can you provide evidence that the measuring devices have been calibrated to UKAS standard?
* How is the batch logged on the instrument? How do you know who has made it? Which protocol is used for it?
* Can I see your full training records for IHC?
* What control tissue do you use for this antibody?
* How do you verify the control tissue? How do you store your controls? What are the expected staining patterns for the antibody?
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