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Gary - Our staff also perform EQA on the POCT blood gas analysers exactly as you describe, for the same reasons. We haven't had an explicit non-conformance on this, but it has been raised at inspections and I've used the same explanation - ie it is not at all like a patient sample and therefore cannot be analysed in the same way. I've said that I agree that it is not ideal, and to some extent misses the point of EQA, but we know that clinical staff may not correctly mix the sample or understand the importance of analysing it immediately after breaking the vial. It would therefore be very difficult to assign any duff results to incorrect analytical procedure or analyser malfunction, or just an unmixed EQA sample. I agree with you that we are EQA-ing the analyser - a valid concern since POCT kit is not under our direct supervision for most of the time and may be misused or damaged by the occasional "rogue"/untrained user. We intend to continue doing this, and at the same time "quality assuring" the users by prioritising detailed training (covering pre- and post-analytical issues as well as the analytical procedure and data input), regular updates and unique passwords. Dr MJ Pearson Department of Clinical Biochemistry & Immunology Old Medical School Leeds General Infirmary (Leeds Teaching Hospitals NHS Trust) LEEDS LS1 3EX UK tel (44)-[0]113-392-3945 fax (44)-[0]113 392-3453. http://www.leedsth.nhs.uk >>> Gary Mascall <[log in to unmask]> 11/09/2007 10:34 >>> Following a recent CPA inspection, one of the non conformances was to do with EQA for POCT Blood Gas analysers. We were told that laboratory staff who service, maintain and IQC the analysers should not be analysing the EQA samples, this should be done by other staff. However, none of the EQA samples are actually whole blood in a syringe, so how could we possibly assess the ability of the users to correctly mix the EQA sample in a different way and matrix to how they would normally handle a patient sample? We feel that we are EQA ing the analyser and not the users, in the same way we perform EQA for our in laboratory analysers for other analytes, and intend to respond in this way. We would be grateful to hear how others handle this issue, and whether anyone else has been given the same non conformance following a CPA inspection. Thanks, Gary ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/ ------ACB discussion List Information-------- This is an open discussion list for the academic and clinical community working in clinical biochemistry. Please note, archived messages are public and can be viewed via the internet. Views expressed are those of the individual and they are responsible for all message content. ACB Web Site http://www.acb.org.uk List Archives http://www.jiscmail.ac.uk/lists/ACB-CLIN-CHEM-GEN.html List Instructions (How to leave etc.) http://www.jiscmail.ac.uk/