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Please could you tell me your views behind performing a crossmatch by IAT if your computer system didn't have an 'electronic issue' function? Thanks!

Thanks scubasammy & adiescast, I am sure I still get my CAs and PAs confused...just something I need to work on. On our annual Blood Compliance Report, (BCR), our regulators last year asked how many CAPAs were still open after 1 mth, 3mths etc. I understand now that some folk close the CAs quickly, but does the definition of CAPA not include the PAs too?

Another useful forum to begin discussions on the various UK Guidelines we have for Blood bank practices. This would be a very good area for more junior staff in our depts to begin to familiarise themselves with these documents. Each time I go back to have another look at various BCSH guidelines etc, I am amazed at how much information these contain . I am very grateful to the folk who have spent many hours researching and writing these docs, and consider these the key to helping us standardise and improve our practices.

Many thanks again Cliff for arranging these additional forums. We are hoping to get folk discussing UK Haemovigilance issues here and would also welcome input on how the US Biovigilance program is coming along too.

Thanks Tim, I'll try your description on senior management.......may I should add some 'hairy bits' and teeth to my diagram too???

Thanks Eoin, I found this template on the internet- but looks a bit complicated, so will need to simplify and just concentrate on the issues surrounding the Capacity for the lab to continue with building and maintaining quality practices. This would involve issues around timely training, validation, equipment handling, deviations and CAPA handling etc. to maintain BSQR compliance. A colleague of mine from another hospital mentioned that when trying to calculate capacity needs youmust take into consideration that issues such as training need double time (if 1:1 training) or multiply by 6x if training is 1:5. eplc_capacity_planning_template.doc

Thanks for the docs. This is my current view on how I see the quality system ...in my head!! QS overview.doc

Having further thoughts about this, surely CAs and PAs are all really corrective actions so should the deviation not remain open until both are complete. Could these then be closed and trended for the effectiveness check? -I am sure there are many ways we could do this, i'm just trying to find a simple one that works for my lab. I think that our regulators expect CAPA ( unsure if this is just corrective actions or preventive too???) to be completed within 30days ( or sooner for more critical incidents/ later for more complex ones as long as this is justified). So as Malcolm has mentioned...this may well be too late to save me from insanity!

I agree with all you have said Eoin, the only thing is that lab folk are being told that there is 'no money in the pot' and labs will have to maintain compliance anyway regardless of what the regulators say about staffing levels.

Today I was asked by a colleague to describe what I thought a Quality System was/ looked like. I can draw what I think it should be, but find it difficult to explain in simple words. How would you describe this - specifically to your staff but also to ordinary folk? Thanks

Thanks scubasammy that makes a lot of sense, will definitely help with my Quality metrics....and possibly my sanity!! Are other folk doing this too? Thanks

Hi Hutch, I would say the same principle needs to be applied to your antisera. As TimOz nicely put this in a thread (EQUIPMENT- pipette verification tips on BBT) when he was discussing control reagents: "I have had a bit to do with designing controls and many blood bankers really do not understand their test performance, so they do not understand using controls in red cell serology. Here is a classic example: Someting as robust and simple as a vial of monoclonal Anti-A can be damaged by a whole range of things like bacterial and reagent contamination, poor transport and poor storage. What do we QC it with? an A2 cell (or an A2B cell if we are diligent). The reality is that a good brand of Anti-A can loose 95 to 97% of its activity and still give a score 4 with an A2 cells but fail to detect an A3 cell. This is not really controlling the test at all." Your reagents will be under a lot more stress in the lab than the testing performed by the manufactuer. If you decide to carry on using these reagents up to the 2-year expiry, then state this to the MHRA with reasons and evidence of acceptable controls. Get additional clarification from the manufacturer and submit this too. Personally I wouldn't use my most critical, open vial reagents (ABO/D typing) for more than a couple of weeks on analysers. The use of rare antisera for longer periods would need to be justified. I am sure that sometimes the MHRA want you to comment on why you are doing/ not doing something and state this formally in your procedures, it doesn't always require a change of practice. How was your citation worded for this event?

I get the feeling that folks are closing their CAPA at different stages of the process. Currently we review our incidents and hopefully the initial actions (remedial) will have been completed within a few days (or sooner) depending on severity. At review, further corrective actions are assigned if needed, some of which may take many weeks to complete. Is it acceptable to close a CAPA after the initial corrective actions have been performed and call the further actions needed 'quality improvements' which can then be assigned a different time line? I would really appreciate ideas and suggestions of how your lab manages this process, many thanks.

Hi FRahman, I presume you mean the PBS, in which case as this is used for washing the Capture-R plates you need to be very careful . If you failed to detect an antibody that subsequently caused problems it would be difficult to prove the fault was with anything other than the expired saline that you knowingly used, and the company would wash their hands of any responsibility (just as any company would), so it would be down to negligence by the laboratory. This is regardless of how well your controls worked. If you are willing to take this responsibility then you need to document the reasons- and possibly check pH daily as a minimum?

Hi ABBwalker, I know many Pharmacy depts map their fridges within their actual location, but do they map every medicine fridge within the hospital ? Nearly every ward has one of these.

Hi Eoin, I know what you mean, definitely need a few drinks after one, but if folk are being pressurised even further by their management having unrealistic expectations........they probably feel battered and bruised permanently. It's not good or safe to work in an environment like that.

Thanks Marilyn-I keep forgetting this isn't a hospital setting!

Why ( just showing lack of any Biochem knowledge here) can't you measure the total protein in each cycle of removed wash solution by running through an analyser. if an additional cycle is then run (that you would not normally perform), the difference between this and the previous wash would show how much protein was still around in the volume of blood washed?...........this may be totally wrong-i'm just brainstorming!!

Malcolm, i'm sure throughout the world there are 'diificult' inspectors, but there are also many really good ones whose purpose is to help us reach acceptable standards- and this does affect patient safety. The first few inspection years were always going to be difficult for some labs with non-existent quality systems.

Even though this isn't the correct thread for this topic, I would say that there is nothing wrong with that comment. Some reagents ( e.g screening cells) may deteriorate faster even though you are storing at the correct temperature. If you repeatedly movie these from room temp to the fridge you could 'stress' the cells and affect the more fragile antigens. We have seen this with reagent storage on our analysers. Once a bottle is in use -you should justify the time period you are going to use it for. If you decide this is as stated for expiry of the reagent, state this in the sop, and respond accordingly to the inspectors.

Hi Emmett, I think the purpose of mapping is To show temperature stability of the equipment. Highlight any hot/ cold spots that it may not be a good idea to store some components Show equipment performance. To show that your chart temperatures/ digital readouts are reflecting the temperatures in the cabinet- ie that the probes for these are located in the correct positions. Somewhere along the line there needs to be a comparison using mapping probes in water or whatever, to show how the internal cabinet 'air' temperatures (especially in the hot/ cold spots) are affecting the 'core' temperature of the simulated component. The volume used for this test should be based on possibly maximum and minimum size of components/ products stored in the fridge (worst case scenarios). In the UK we map with components in -situ - for annual or after servicing mapping. For new equipment these are mapped empty and then Full prior to routine use.

OK ,I like the comments so far, so will ditch this idea for the time being. Following on from what Malcolm has said, I have to admit I think I've forgotton how to use a pipette, been off the bench too long doing 'Quality stuff'!!!!!.

Thanks Tim and Lcsmrz, I'll try and find out some more details from my QA in the next few weeks. I suppose I could mark a batch of my own tips using a newly calibrated pipette, and then check all my pipettes weekly to see if they are still in range....but a bit of hassle doing this. Of course if we perfomed quarterly in-house calibrations, and these did not show a significant change between calibrations that would be ok. However, if one of your pipettes failed calibration how would you deal with all the testing performed prior to the failed pipette calibration (I suppose the controls run would justify the results??), Just thoughts!!!

Thanks ABBWalker, as you say this is very much open to interpretation, and as we discussed earlier (privately), I do have concerns about the 200-250ml volumes used for core readings. Whatever validations/ testing is being performed should always be based on looking at the 'worst case' scenario, in this case if paediatric blood units are being stored, then the core readings should be performed in 50ml liquid. If a paediatric pack is constantly exposed to air temps above 6'C, then it is possible that the actual component itself will reflect this temperature and not the required one core one. How do we know to what level of harm this may cause a neonate? If small vial products such as anti-D Ig is being stored (?3ml vol), how long would the internal core temperature of this volume remain at 2-8'C (which is different to red cells in uk= 2-6'C), if the air temp of the unit fluctuates regularly. Does air temperature of a cabinet= the core temperature of small volume products?.....this is something that may need to be addressed by the mapping. I am very surprised that pharmaceuticals/ hospital pharmacy dept etc have not addressed this. Some medications can be severly affected by temperature variations such that they may not be of optimum benefit to a patient if stored incorrectly........about time hospitals mapped all their medicines fridges????

I was informed that pipette verification tips -which are pre-marked with dispense volumes could be used to perform a quick (rough?) daily/weekly check, in between the quarterly/ annual verification performed by the weight based assessments. This would just highlight any pipettes that could be losing calibration sooner so they could be re-calibrated prior to the scheduled date.