Quality

It seems that the UK section of the site is doing well! Are there other forum categories you would like?

I've come across a new one so I thought I would ask you kind people for advice. I am working for a company that generates fit-to-work certifcates. What is the minimum information that would be acceptable in a footer for the template? I'm tempted by just document number and version but is that actually enough?

1. what to do if the QC of the components fails? 2. how to do the SPC for QC of components? do you use the percentage of failure or the number, e.g. hemolysis rate.

Does anyone have a calibration policy for equipment before I go off and write one from scratch? Sorry to be super cheeky...

Post it notes getting out of hand, losing track of pages in your notebook? Organise your to-do lists in here. Can anyone work out how to remove the completed tasks without actually deleting them (so they count in the numbers)? The 7-day thing seems to include complete stuff too and I can't make it stop To Do List Template.xlsx

So POCTs and clinical software are now classified as medical devices by the MHRA and subject to full validation - yay! We are OK in the labs as it's normal for us but it's going to be a steep learning curve in healthcare...

Hi, guys How are you? So, i'm doing a experiment where i'm testing two titration methods, the tube test and the column agglutination technique. Now i have to analyze to know if they have statistical difference and what is the correlacion of the two methods, but I found it difficult to decide which statistical test to use. Do you have any thoughts on which statistical test I should use? T teste? Pearson? Below is the table with the samples and their endpoints, for example: PLASMA TUBE A GEL A TUBE B GEL B 1 128 256 32 64 2…

Is there a benchmark for blood product wastage for each component and overall.

Dear all , I have question regarding the Q.C for the Red Cell Leukocyte depleted in additive solution (SAGAM) How can we do the sampling from the RBC unit to do the Hemolysis at the end of storage ? i need the procedure please if any one have it also the references if its available . Thanks a lot. Amer

Hope this is okay to post administrators, but I have been asked to publicise the MHRA Discussion Forum, especially for members of PathLabTalk who are either UK citizens, or who are working in a laboratory inspected by the MHRA. The address is forums.mhra.gov.uk/forumdisplay.php?60-Blood-Forum. You can go on there anonymously and ask virtually any questions you like concerning their inspections, quality, haemovigilance and SABRE, and a whole lot of other subjects. This will also help the UK TLC group (of which I am currently a member) formulate their standards. Lastly, you have to remember that despite both the MHRA and UK TLC being rather regarded as "stic…

Hello, We are seeing an increase of patients on the new oncology drug for multiple myeloma (DARALEX/DARATUMUMAB) and I was wondering if anyone had any useful tips to share. Currently our procedure states to do a baseline ABSC prior to initiating the drug and to antigen type for at least Kell. Additionally, if the ABSC is positive in Gel, to rerun it in tube and to do an immediate spin crossmatch on Kell negative units (provided of course that the patient is Kell negative). Just wondering if this is how other places are handling these patients. Thanks, Sue Arata

Hello, One of our smaller sites uses a specimen rocker to keep platelets agitated before being transfused. They do not routinely stock platelets which is why purchasing a platelet incubator/agitator is not on the agenda. On our last accreditation inspection we were cited for not performing a validation of the rocker for platelet storage. Has anyone done a validation of this type and could you share the details of how to set this up? Thanks!

my BTU is trying to do the validation and qualification program. one of the GMP auditor asked for the validation process for component making (focusing on RBC and FFP first). is there any example that I can use as a guide? thank you in advance.

Hi All Just wondering if anyone has applied the bowtie method of risk assessment in the context of transfusion labs and what significant 7 elements they have chosen as the basis ? Thanks

As some of you may know the UKTLC are reviewing the current 2014 standards. If you have any suggestions on what might be useful to include, please let me know many thanks Rashmi

Hi all, We are considering using our IH-1000 analysers to perform all antibody identifications, which we currently do manually. Has anyone undertaken this in their laboratory? What kind of validation processes did you cover? I have a million and one questions so just trying to get a feel for it at the moment! Any thought would be useful Thank you Nic

Hi! Was wondering if anyone had any advice and guidance on how to tackle uncertainty of measurement for testing using Diamed gelstation/IH system. We have been inspected by UKAS (last year) and one of our connected hospitals/labs have had their surveillance recently only to bring up UoM for transfusion testing. I don't know if I am just being a bit niave but I was under the assumption that UoM should be used for quantitative assays, and obviously we are using qualitative assays. Does anyone know how we would go about calculating UoM from this? We've again not been given any guidance from UKAS themselves (surprise?) and I am struggling to find a sensible way to w…

Hello Please help! I am wondering what the right setting would be for your low and high alarms for a blood fridge, if the calibration tolerance is +/- 0.5. For both the core and air Temperature. This is for my remote temperature monitoring systems. Thank you

Hi all, Wanted to let you know that there's a blog (one of a series) on Malcolm Needs on Canada's Canadian Society for Transfusion Medicine website. BloodBankTalk is also mentioned. http://www.transfusion.ca/Resources/CSTM-Blog/January-2017/I-will-remember-you-Malcolm-Needs

Can someone share their corrected result report policy for blood bank? will really appreciate any help.

All of our pipettes have been sent away for calibration and service for the first time this year and will go annually, I just wondered what everyone does with pipettes in between? We don't have any automated equipment so the pipettes aren't used for reagents (to my knowledge!) but mainly used for transfer of blood to the cards. Is there a usual interval of in-house maintenance required or is it ok to leave for a year between service and cal (current practise)? Thanks in advance

Can anyone help me with this. I'm relatively new in post at a new trust and I'm trying to pull together some documentation for Good Laboratory Practice. Over the past couple of months I've found myself pulling up staff on basic stuff like labelling tubes, writing down lot number etc. The most common comeback are 'well it's not in the SOP' or 'It didn't matter before when X was here'..... Are there any standards for GLP out there or is it something just drummed into you?? I don't remember it being part of my training as such, just how you do things. So my plan of action is a formal GLP document and to incorporate this into our next round of competencies. A…

Hi, does anyone use a NIBSC anti-D on their blood bank automation...to demonstrate metrological traecability...? Thanks

Hi would like to know how labs calculate uncertainty of measurement for quantitative methods ie fbc, coagulation tests, and how they calculate network uncertainty across their shared sites. Thanks!

Hi we are due to have a UKAS surveillance visit, and I believe one of the points that have been raised in other sites is regarding the use of a national standard for anti-D. Apparently after a PMI on an analyser we should be re validating the analyser with a primary standard of Anti-D. The basic QC which we use and which contains an anti-D of 0.05iu/ml is traceable back to a WHO standard. Any thoughts? Thanks