Malcolm Needs

I'm afriad I don't (not without breaking Copyright Law).

If I may jump in here Rashmi, the answer is that you cc your Risk Assessments to a competent body, such as the MHRA, or the IBMS (who have an excellent legal department) so that, even if you are seen as a "whistle-blower" by your own CEO, you will be legally protected (as long as, of course, what you are writing is reasonable, even if, in the long run, it is proved to be unfounded). You have LEGAL protection, even if your "significant folk" don't like it. Indeed, if you know of a risk, and you do NOT report it, then you could be (almost certainly would be) legally in the wrong yourself. Ignore this bullying. You have powerful friends in the MHRA and the IBMS (and the BBTS come to that, and, possibly, the NHSBT[????????????]). :comfort::comfort:

Your first line is a point well made. How on Earth are we to tell? To be perfectly honest lateonenite, I am in absolute ignorance as to whether your Medicare is similar to our NHS in any respects! I literally do not have a clue! One thing where we do differ though, is that my staff will rarely ask me, let alone a Consultant (and certainly, under no circumstances a nurse, be they a physician's assistant or not), if they can use a selected panel, as they have a large amount of autonomy and, if you will forgive the language, I'm damned if I'm going to ask anyone if I can use, not only a selected panel, but also any of our selection of rare frozen red cells or reare frozen antisera. Within reason, I have total autonomy about the tests we perform (although if one of our own Consultants "demands" it, we do it [unless I can talk him/her out of it]), and do not have to answer to anyone except my direct line manager (and, if I get it wrong, my Consultant and, ultimately, the Law Courts). The individuals undertaking these investigations are all Fellows of the Institute of Biomedical Science specialising in Transfusion Medicine, and with a particular knowledge of Red Cell Immunohaematology, and so they are trusted. I doubt if I have to shout at them more than four times a day each!!!!!!!!!!!!!!!!!!!!!!!!!!!!! :D:D:D:D

I thought I did! Splendid plan, if I may say so, although I am foxed as to what the green could be! I will say this much. I am fully confident that you already cover paragraph 3.6, because only ever get genuine stuff from your hospital outside core hours. If we get telephoned from your hospital during on-call hours, we know that we have something worthwhile to look at (wish I could say the same for the other 49 odd hospitals!). Mind you, of course, if there is a rugby union international or test match cricket on the television, I (in any case) might not want to come in to work, but that's my fault for doing the rota wrongly!!!!!!!!! :D:D:D:D

Hi Shirley H, I do believe I know you, do I not! I would be heavy on the risks if I were you, with particular reference to who would be in deep trouble (the CEO) if the recommendations are ignored! :D:D:D

Hey, a lot of people already think I've got a big head. If you carry on like this, it will explode!!!!!!!!!!!!!!! :redface::redface: It's just that when I started out in Blood Transfusion, I had some fantastic mentors (such as Dr. Ken Goldsmith, Dr. Elizabeth [Jan] Ikin, Dr. Carolyn Giles, Joyce Poole, Ted Wheeler, to name but a few) and I feel that I owe it to them to try to help others.

I know exactly what you mean Rashmi, but in circumstances where CEO's do get a "talking to", particularly where extra finance for the Blood Transfusion Department is required, the MHRA are quite capable of taking things much further (and higher), and have recently done just that in one of their inspections. In the particulr case of which I am thinking (not public knowledge yet, so I can't name names) the BBM was given extra budget, extra powers and was promoted a KSF Grade (so it can work to our advantage). :D:D

Well, I do know of one Chief Executive who was asked by the MHRA how he was going to run his hospital without a Blood Transfusion Department (some "veiled" threat), so, as the MHRA are going to inspect against this, I would advise Chief Executives to take it very seriously! :eek::eek:

In the UK, the UK Transfusion Laboratory Collaborative, backed by the Institute of Biomedical Science (IBMS), Serious Hazards of Transfusion (SHOT), the Royal College of Pathologists (RCPath), the British Blood Transfusion Society (BBTS) and the Chief Medical Officer's National Blood Transfusion Committee (CMO's NBT) and equivalents in Scotland, Wales and Northern Ireland, has now published the "Recommended minimum standards for hospital transfusion laboratories" in various journals (two of which are Transfusion Science 2009; 19: 156-158 and The Biomedical Scientist 2009; 53: 744-745). The implimentation of these recommendations will be monitored, as appropriate, through current Medicines and Healthcare products Regulatory Agency (MHRA; where applicable to BSQR 2005) inspections. The impact of these recommendations on transfusion laboratory errors will be monitored by SHOT reporting via the MHRA Serious Adverse Blood Reactions and Events (SABRE) reporting system. This thing has teeth, and I suspect they will use them. I am wondering how people are getting on with implimenting these recommendations, and how much support they are receiving "from above"? :confused::confused:

Ditto in the NHSBT (and the rest of the NHS, as far as I am aware).

In such a case, we would always order a new sample. If this showed that a mistake had been made, we would immediately tell our Consultant, who would tell the patient's Consultant, and would contact our Quality Department to initiate a Root Cause Analysis. It may be no fault of the phlebotomy staff (doctor, nurse, phlebotomist); it may be someone who is using somebody else's identity (in which case, the police may become involved).

We do all sorts of tests on samples to identify the specificity of the antibody(ies) with no reference to a Consultant. This includes instigating such things as a DL test or tests for mixed cold and warm AIHA. However, if our findings suggest an unusual combination of antibodies, a combination that would give us problems supplying blood (say an anti-U+Jka), an antibody against a high incidence antigen, we would take our results to the Consultant for him or her to report to the hospital. The same applies if we find a DL positive or a mixed cold and warm AIHA, as these require medical input for correct treatment. We would also consult with a Consultant if we think that other tests, performed by other Departments, such as HLA or platelet antibodies in the case of multiple stillbirths, could be the answer, but again, the need medical input. In this way, we are very lucky, because we are "given our head", but have excellent Consultants to back us up (and to suggest other tests that we may have overlooked). :):)

My goodness Yanxia, I certainly wouldn't worry about your English! I should be ashamed of the fact that I can speak no other language than English (and often people tell me that I am not much good at speaking that!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!). :D

As a Reference Laboratory, we have access to plentiful supplies of R1Rz, and so would always rule out/in an anti-E accompanying an anti-c, but in 99.99% of cases (or more), clinically, it makes absoultely no difference whatsoever! If you are going to transfuse a patient who has anti-c, you would normally go for R1R1 anyway (I am accepting the fact that I am ignoring rare Rh patient types for now) and, in the case of a pregnant lady, the level of anti-c is usually far more important than the level of anti-E (and, if the level of anti-E is that high, and considered more important than the level of anti-c, the reactions will be noticably stronger with c+E+ red cells than with c+E- red cells). I do, therefore, see where you are coming from and agree. :)

Well, it is true that I am from a Reference Laboratory, but that having been said, the BCSH Guidelines in the UK strongly advise that an enzyme panel is run as well as an IAT panel, and so most Hospital Blood Banks will also run an enzyme panel. I do agree with you that, in the case of a warm auto (and many times in the case of a "cold" auto) the enzyme panel adds nothing. Yes, we run our enzyme panel in gels, but, unless there is an auto present, this panel is often extremely useful. :)

It is the word "punative" that worries me. This is exactly what these inspections should NOT be, but they seem to be like this on a regular basis in the UK too. Then, instead of you learning and improving the service as soon as possible, you spend a whole lot of time explaining things to your own Quality Department. :rage::rage:

I honestly can't remember if I've put this attachment on before. If I have, I apologise. If I haven't, it may, or may not, be of interest. You judge! :) Review of the current progress in developing universal red cell products and their potential to.doc

A very great pleasure.

What was her antibody(ies)? I know that we are not supposed to make moral judgments, but it seems to me that, if she had already lost 9 babies, anyet still had such disregard for the child she was carrying in her 11th pregnancy, the FDA should have looked at her and taken away her license!!!!!!!!!!!! :eek::eek:

We use an enzyme panel automatically, together with an IAT panel. Does this mean that you do not necessarily do the same? :confused::confused:

Yes, in extremis I would agree with this.

Hi David, I'm not saying you are wrong about the women of child-bearing age (I wouldn't dare!), but in my attachment I do make an arguement as to why I think this should be done. IT DOES NOT MEAN THAT YOU HAVE TO ACCEPT MY ARGUEMENT, I HASTEN TO ADD!

I must say, except in the circumstances I alluded to in my earlier posts, it does sound somewhat over the top to me too!!!

The case being that the patient was male, I honestly do not know why the supervisor was so worried, unless the patient was, or was likely to become transfusion dependent (in which case, I would also be wary of them making an anti-c; they had already shown themselves to be a responder by making anti-E+K).