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Everything posted by RR1
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So in a situation where a re-test was carried out on a sample with historical antibodies and this gave a positive screen compared to the result obtained 2 hrs ago- what would you do in this situation ? ( assume all weak antibody controls have worked ok). thanks
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These are great- thanks!
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Thanks Theresa.....i'm sure your presentation will be a great help. I want to create an access database for my incidents/ deviations too (once I figure out how to use access). I am currently placing these on an excel spreadsheet- in a workbook format on re-design this will include my audits on a separate tab and reference numbers to any incidents I may have escalated to senior management for actioning. I have attached a blank version + SOP + reporting template if of use to anyone. capa proc 100.doc QI Excel database.xls Quality incident report form BT-F-BT-002 v21.doc
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We re-test mainly to ensure our technique is working consistantly. Antibody levels can drop to sub-detectable levels- but it is very unusual for this to happen on samples taken within a few weeks of each other. You need to be able to explain why you arn't detecting the antibody on the current sample, if the patient has been multi-transfused with antigen neg blood- thats a possible reason . Regardless of the patient receiving antigen neg blood, we always need to ensure our basic critical test is working properly- and yes it does increase cost.
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This would be a good area for anyone to request help with specific BSQR/ GMP requirements, or if you are looking for specific sops, powerpoint presentations, help of any sort. ......you need to ask- i'm sure most of us would be willing to share these. So i'm going to ask.....does anyone have an sop / presentation for GMP training of cleaning staff or couriers they could share- we are all going to have to ensure this is performed - so it would be useful to have a consistant approach to it If you are not registered with BBT but have some info- please feel free to email me, and I could attach to this site..or not, as you wish. If no one really does have this- maybe we could collectively produce one on this thread, by giving ideas of what we need to include/ design etc. Many thanks!
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Hi David, As I have also previously said, the system must pick the antibody up in a repeatable way on the same sample. Hopefully correction of our saline storage might resolve this problem ...watch this space! However-I seem to have deviated from my original question which was, do labs retest their samples by same technique if the previously known antibody is not being detected on the current sample?
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While searching the internet- I have found a brilliant document produced by WHO on blood cold chain....am I the only person that didn't know this existed ?....it's very good see attached. Blood_Cold_Chain.pdf
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Hi Frahman, I have now been informed by the company that my missed antibodies were due to storing our phosphate buffered saline in a cold room (they were removed to room temp at least 3 days prior to use). Apprently cold storage of PBS causes PH stratification and therefore affects antibody detectability depending on where the PBS was drawn from for the wash phase (apparently we are the only UK site that does this). This effect is reversible by good mixing prior to use, however the moral of the story is to make sure all reagent storage conditions are strictly adhered to. All my controls have all been fine during the testing phases. Please could you tell me if you store your PBS like this too, would be very helpful to know.
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It was anti-K. However further information now given suggests it was due to our lab storing the Phosphate buffererd saline in a cold room (even though this was removed a good few days to room temp prior to use- and we are the only lab in UK who do this). Apparently when PBS is cooled it develops a stratified range of PHs in the container rather than being homogenous. Potentially depending onwhere in the container the PBS is drawn may adversely affect the antibody screen, hence the difference in reproducibility. The stratification is reversible if the containers are well mixed. Thoughts on this please.
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Since the introduction of new automation in my lab we have occassions when we come across samples that give a negative result on the antibody screen, but have historical antibody data on our computer system. Our normal procedure is to repeat test the sample. I would be really interested to know how other labs deal with this situation. a) Would you normally repeat test the sample ? Assume the patient may have been transfused/ antibody was weak etc. Also if a repeat test on the same sample then gave a 2+ to 3+ reaction- what further actions would you then take? Thanks
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Thanks- we currently use our National Blood Service produced Aneg and B+ controls that have weak anti-D and Anti-K antibodies respectively. Additionally we use weak anti-K, -Fya, -S run twice a day for our antibody screens (Solid phase). The manufacturers should recommend controls to use- and give this in writing, otherwise when these controls fail to work- you would get a response- probably from most manufactureres that your controls were not correct for the set-up ie wrong antibody subclass etc...you would have to justify your testing regime. It is expensive buying control material- but as we need assure ourselves (and everyone else- if there is a failure to interpret groups or detect antibodies ) that the testing is being performed optimally, this is the only real option.
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Thanks-do you know how long the initial phase is going to last?
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It would be nice to here from folk of the types of serious events they are currently reporting to SABRE, we know that most of us are under reporting events.....but this is probably due to not having clearer reporting guidelines- something which I am sure will improve soon. SABRE (serious adverse events and reactions) is the MHRA (FDA equivalent body) mandatory reporting system used in the UK, that all hospital blood banks and establishments have to report blood related problems to (since Nov 2005) I gather that in the U.S. an equivalent 'biovigilance system' has been introduced. It would be useful to know the type of data this system will be recording, and any information given to staff as to the type of reactions/ events required to be reported.
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If anyone has tips/ docs on how they are managing their CAPA system - or requires info, would be good to post it here. My main problems are trying to close the incidents in a timely way- it does become quite a challenge. it would also be interesting to know what databases/ systems folk are using for this function. I have had to produce an excel spreadsheet for this, but extracting the information required for the annual Blood Compliance Report- has been difficult....obviously I now need to improve the system ready for next years BCR!.
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If anyone has documents/ templates for change control.It would be good to have them posted in this area too. Thanks
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Hi Franklyn, Your documents look great- would you mind posting them on the ' UK Quality' part of this forum too - would really help. Many thanks!
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I am interested in knowing how often and what ABO and screen reagent controls labs are running on different analysers used. Are manufacturers supplying/ recommending the control reagents to use- and is this a formal statement given by them ...or just a passing remark. When we look at how Haem/ Biochem analysers are used- control reagents are all supplied as part of the set-up, these are not produced in-house. Thanks
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Anyone willing to share training docs/ competency sops etc... please add to this thread. some of mine attached- they may not be brilliant- if they are useful- thats great, if you have ones we could all view- that would help enormously. Thanks. transfusion specific training 2009 -staff assessment form.doc Training Matrix.doc
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Hi Folks, if we could use this thread to post documents you are willing to share on validation: SOPs, Templates, tips ...whatever you have would be good. This will help us all improve practices thanks! Apex validation template v1.0 complete.doc validation of cooler box.doc vmp 72a.doc
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Just to thank the BBT forum administrators for setting this area up. The BBT forum is an excellent resource that many lab staff in the UK are using to help with the Blood Safety Quality regulations. The sharing of ideas/ documents can only help improve practices and patient safety internationally. Many thanks!
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Hi lehooke, if you give me your email- I will forward the one I currently have, alternatively- if someone could tell me how to attach a word doc on this forum- would be appreciated.
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1. Did your analyser controls for Capture-R work ? (i'm presuming they did- or the results would have been invalidated) 2. Are you using 3 cell or4 cell screen? 3. Check your images- to ensure there is no excess saline in the wells. 4. Find out from your QC provider what IgG subclass the anti-D control was ( Immucor maintain that Capture-R does not detect IgG subclass 4 antibodies..which are designated as not being significant). 5. Did you repeat test the QC?...if you don't have any more sample- ask the QC provider if they can send a further sample to test. Answer to your question...yes.
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Hi Eoin, I know you posted this message ages ago- but would you be able to send me a copy of your checklists too. Due for MHRA re-inspection soon! Many Thanks Rashmi