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Standards for Immunohematology Reference Laboratories 6th and proposed 7th edition


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I have a question about the process that other reference laboratories use to comply with standard 5.1.6.1 The laboratory should have a process to ensure that test results and reports are acceptable before distribution, issue, or delivery. The 7th edition proposed standard 5.1.6.1 says "reviewed for acceptability". We are reviewing our process and would like to hear what others are doing during off hours.

Thanks for all your input!! :D

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I take it that by "during off hours" you mean the same as we do in the UK by being "on-call"? If I am correct in that assumption, we only have one person working in Red Cell Immunohaematology during such periods (be they at night, at weekends and on Bank Holidays - such as Christmas Day) and herein lies a problem.

Yes, you can review acceptability, but the person has to, by definition, review their own work - and they may be "unable to see the wood for the trees", particularly if they are exhausted after performing tests on several complex cases.

The trouble is that, again by definition, they would not be working on cases at this time unless the results (or cross-matched blood come to that) were not required urgently, and to a certain extent, under these conditions, the quality control is to see if the in vivo cross-match (as a result of their work - with all the best intentions) kills the patient or not!!!!!!!!!

As long as they stick strictly to SOPs, AND telephone for help (either another person physically coming in to help when they are overwhelmed, or for serological advice), I'm not too certain what else can be done.

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Thanks for the responses! Yes I mean on call hours. We have been reviewing our own work as well. The next day it gets reviewed by the supervisor. Of course we can always call for help when we are all by our lonesome and have questions or want to talk it over!

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