RR1

I have recently heard of a situation where management apparently said that if staff don't follow procedures - then they should be disciplined, regardless that many staff were making the same error- and it was obviously a problem that required simplifying/ process improvement. So even though many of us try to make our systems non-punitive, there are unfortunately people in significant roles who don't want to understand what quality is all about and find it easier to cast blame.

Please can you tell me how haemovigilance reporting works in your organisation : What is the process and who is involved in deciding if an event is an SAE- and reportable to MHRA ? Thanks

Please can you give me some ideas on how you perform and document a CAPA effectiveness check. This was one of our non-conformances at a recent MHRA inspection. Also to consider: 1. Does the QI remain OPEN until the effectiveness check has been done and proved to have worked, or can the QI be closed and the effectiveness checked scheduled as a separate task? 2. What happens if you have ++++++ effectiveness checks to do- what is the easiest way to do all of these? Many thanks

We do an initial validation on one box only to see how extremes of external temperature and internal packing arrangements affects the internal box temperature.All other boxes are then checked for signs of damage etc, we do not validate each box, though a temperature logger is placed with every consignment. I have recently acquired some transport boxes that according to the manufacturer were meant to maintain temps between 2-6'C for upto 72hrs; however, when we tested this the best we could achieve was around 48hrs- quite a difference!

We have a temperature monitoring system that is only calibrated annually against UKAS standard by the supplier.

Hi HEP, Sounds as though the stuff on the wall is to do with the alarm connections- and they can be moved if needed. You are right about the small room -if there is poor ventilation then a small aircon unit would be needed, adding to the cost. If you are upfront with the MHRA inspector about this issue and tell them what you are planning a non-conformance may actually help you obtain resources, though you will need to show a risk assessment of the current status/use.

Could you not just make a simple checklist of the key/ critical points of the procedure and sign each point off once you have observed staff performing it as required?

The best thing would be to phone the fridge supplier and see if an electronic key pad could be fitted. I wouldn't consider a key lock safe to use on a blood fridge as the keys inevitably go missing or are left dangling in a visible unsecured location. You also want to be able to access the fridge should the lock fail- but with some sort of audible alarm. In the meantime you should raise a change control request and note down the options that have been considered. The small room idea sounds good as the external door could be fitted easily with a key pad; the fridge would need some sort of link to an external alarm, but as long as there is sufficient space in the room and the temperature is fairly stable, i'm not what other issues there would be regarding temperature control except mapping the fridge- which isn't really that difficult. If you decide to remove the fridge then don't forget the change control and risk assessment. Hope this helps

If anyone has experience of implementing a 5S / lean project throughout a hospital, any ideas on where to start would be appreciated. Thanks

We see a fair few of these (as well as anti-Jkb) using Capture-R.

Hi Elizabeth, Testing as below- Transfuse 10,000 Red cells / year With 100 group and screens/ day 500 each haem and Biochem samples/ day Thanks

Thanks Malcolm- I bet you use this slide regularly!!

I'm looking for ideas to include for various presentations around patient safety, particularly images to include to visually reinforce to folk that if we don't do things properly in the lab- can result in patient harm. The theme for this is the "cost of poor quality" So far ideas are to include: Picture of hydropic baby (though this may be a little too upsetting for some)? Description from a patient of what it feels like/ pain on receiving an incompatible transfusion Any more ideas would be great- thanks

"Remember" Rashmi? I didn't know that they knew in the first place. That's very true!!! Remember that there is no Blood Transfusion Specialist on the CPA's Inner Council (can't remember what they are actully called) by right. They are only allowed to attend when and if the other members think that there is something to discuss about the subject that they think they do not understand (so you can imagine how foten that happens), and the Blood Transfusion Reperesentative does not always even receive the minutes of the meetings, and so they only find out about some of the crass decisions after the event. Actually this statement seems to applies to a lot of what is going on in the UK with mergers. Pathology management seems to think you just tack on transfusion to any plan without consequesnces- and forget there are patients ultimately involved and who could be harmed if the structures aren't formed correctly at the start of these changes. Time for transfusion folk to stand up for what we really believe in and voice our concerns loudly...risk registers can be helpful tools.

Oh...it's going to be a very long document then??? I hope it also states that it is not worthwhile sending samples to a Reference Laboratory to find out whether or not a 98-year-old female is Weak D or Partial D too, but what about the 86 yr old M/F ? I suppose you could use an age range from 60- 115yrs, but I forgot- the guidelines include females of child-bearing potential are up to 60yrs- or has this now been increased to 98yrs (i'm sure i've read about someone in their 70's giving birth -not sure if male or female though) , so we would still need to send these then???

Thanks everyone else, do you folk see any particular, recurring errors with your cross-trained staff ? Also, is there any data being collected by the U.S Biovigilance program that shows the type of errors vs staff grade/transfusion experience ? "Being back in a small hospital has really opened my eyes to cross-trained staff inadequacies. They need to know so much information that they have lost the basics in so many areas. I saw a tech recently be confused on how to deal with a patient with a history of 2 antibodies but a current negative antibody screen. And antigen matched blood was already available. All he needed to do was crossmatch it..... He left it for me to do. And it isn't just in transfusion! The instruments in the other departments are sadly neglected" Regarding the above from Carrie, this is really scary but is happening in the UK too. Hopefully new developments will improve the UK situation and in 10yrs time we can be really proud of our training programs.

Hi Robina..nice not to have to call you fluffy anymore, Completely agree with everything you have said- seeing these things all the time. There is significant apathy with many staff who think this is just a 9-5 job, and responsibility for their own education lies with their place of work. I see the coming years are going to be a massive shock for many staff with new and more responsibilities given, for same pay, and accountability assigned.This is not necessarily a bad thing and could lead to a first class pathology service. With the formation of HUb/ Spoke models for Pathology services there is a need for high quality training departments to be formed, with dedicated staff (not just another role tacked onto someones JD) that could address these problems long term; Lets hope the "significant folk" in the DoH/ Networks who make these plans remember that Transfusion specifically requires highly skilled and knowledgeable staff to maintain patient safety - and listen to the discussions taking place about the loss of expertise.

Hi All, I have asked again and it appears that the draft will be submitted for review by the BCSH taskforce in June, but there is no definite date yet when the completed guideline will be published.

Ah, but if you worked in a hospital blood sciences lab, you would probably start to get cross, training staff, especially as comments made by certain folk is that there is nothing to transfusion, just adding some plasma to gel cards and centrifuging...even a trained monkey could do this! What specific training needs are there for a monkey?!!

Are majority of qualified technical staff around the Globe multidisciplinary trained in Haem, Biochem and Transfusion ? In the U.K most Biomedical Scientists (BMS) specialised early on in Haem/Transfusion and Biochemistry. As changes are now being discussed, we will probably need to develop a more multidisciplinary approach with lots of cross-training in the future. I'd be really interested to know how you handle cross-training and any specific problems/ useful tips. Many thanks

Thanks Tony, Yes, I see it can depend on findings of the investigation, but as we are required to report significant event /suspected events to MHRA as soon as possible, I would have thought that at least an initial notification report should be placed pending investigations, which can sometimes take weeks to resolve.

Hi Pluto, We use 2 bag thermogenesis thawers and have never mapped these. Our validation plan/ data was reviewed by the inspectors and no comments were made, though we had stated in the validation that there was no purpose in doing this. The water circulates and the temperature is monitored by in-built calibrated equipment and over-temp alarms in place. It may be useful to map much larger thawers (e.g 10 bag ones), but this would be to check that water circulation was adequate in all areas. If you are using a dry air thawer this may require mapping, but only because some of these thawers have rapid thaw programs that brings the internal temp to around 50'C (though these are not meant to affect the internal component temp- but I suppose these could be open to abuse). Regarding daily recording of Diamed incubators-we stopped daily recording of these as there seemed little purpose in taking a one point temperature. If your SOPs state that it is procedural to place your cards into the incubator, with the appropriate serological controls, when it is at the required temp- I personally think this is sufficient.

Hi Malcolm, Do you think then that temperature mapping is only really significant for lab areas where blood products (albumin) are being stored? Regardless of controls being run with tests, isn't it useful to know that you are not storing reagents directly in hot/cold spots ie under air con units or warm lab areas. I know the controls would show if these reagents had deteriorated, but surely you want to prevent this happening in the first place and minimise wastage? Regarding mapping small incubators, I suggest your quality folk reviews their risk asessment of the process and comes to the conclusion that as this equipment is calibrated according to manufacturers recommendations, that over/ under temp alarms are working and that controls are run routinely, this is very low risk and mapping is not required. Some of this stuff is just common sense- we all just all seem to be going over the top .

1.OK, so not a mega value adding activity unless this is just to check suitable environmental conditions to prevent any wastage if reagents were not optimally stored. 2. But this was just questioning what you do- or was this actually cited as a non-conformance? In any case a straight forward answer if the small incubator didn't have a logger or separate thermometer, would be to provide evidence of annual temperature calibration.

I see what you mean- thanks. After having a look at the Orange Book, mapping is only required in areas where blood products/ blood components are stored. Laboratory areas where critical supplies such as reagents are stored should be monitored but not necessarily mapped annually; this can be done every 2-3years. I certainly don't map our small incubators or plasma thawers, though this would be different for the Blood service where much larger equipment is used and there is a greater potential for hot/cold spots. Are you sure it isn't your quality folk going OTT with measuring/mapping etc too often, rather than MHRA stating that you have to do this?