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About nsfirm

  • Birthday 11/02/1976

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  1. Dear Sir, is it possible to share the 1. percentage of invalid test result 2. venipuncture failure please?
  2. Dear all, is it possible to share look-back and trace-back form and SOP? I'm still confused about how detail that it should be. thank you in advance.
  3. 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.
  4. dear Mam, could you please share more with me? really would like to hear it from you.
  5. question: is there a certain temperature and time as a limit before we way it has to be thrown away?
  6. dear Sir, what kind of sand? is it the sand for the cat or any sand will do?
  7. as far as I know, it's a model from a computer...
  8. nsfirm

    Hi again

    Hi again, I forgot whether I have introduced myself before, but I will just think about it as my first introduction. I'm Nova from Indonesia. Before I worked as a doctor in Hospital Transfusion Services so I asked a lot about blood transfusion reactions and blood administration. Not only in this forum, but also in other places, like ISBT congress, etc. But at the moment, I work for a Blood Transfusion Unit (where we do blood collection and blood processing). and we are in the middle of improving the quality, like implementing GMP, and as part of GMP do validation qualification. So I may ask more questions almost about anything. Thank you or in my country, Terima Kasih... Nova
  9. Dear all, I have to do validation process for the blood component making for each components that we made. But so many things still made me confused. 1. How many blood bags should be used for validation process? Is there any rules of how to calculate it? 2. Is it possible to do it more than one times? e.g. when I need to validate 60 blood bags, can we do it in three parts, each 20 blood bags? I asked the second question because in my country, the auditor said that we have to do it three times (because according to Pharmaceutical GMP, we have to do it three times). But when I ask about how many and how, it just answered by there is no certain rule about it. 3. Do we have to do it three times? e.g. when I need to validate 60 blood bags, do we have to do 3 x 60 blood bags instead of 1 x 60 blood bags or like question number two, 3 x 20 blood bags? So, how do you do it in your place? Thank you.
  10. 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.
  11. how about moving to my country, at least they still do it because they don't know... (trying to build a high hope, that they will change after they know)...
  12. just want to confirm using an example.... if one thalassemia patient needs one blood bag of FFP it needs a new informed consent? or one hemophiliac (in my hospital there are hemophiliacs who still get whether FFP or AHF/ Cryo), and he needs to be transfused with PRC, then a new informed consent needs to be made? and for inpatients, won't the same rule applied? I mean a new consent to be obtained when they require a transfusion for a different reason.
  13. in QPS 7 of JCI, there is a need of analysis conducted for: 1. all confirmed transfusion reactions, if applicable to the organization etc my questions: 1. what does it mean by if-applicable? 2. what is the meaning of confirmed transfusion reaction, because most of the transfusion reaction reported in my hospital, is just that, only reported, no further investigation done? 3. if what happens in my hospital can't be classified as confirmed, does it mean that my hospital doesn't have to do the analysis, because there is no confirmed transfusion reaction? 3. what are the numerator and denominator used for the indicator? 4. do you have samples of the analysis that has been done? just curious, what is the reason you put if the number of transfusion reaction is increased, when I don't think it's controllable. thank you.
  14. helppppp..... I'm trying to make sure that instead of using the waterbath which is already used for more than 10 years, it would be better to buy a new one of dry plasma thawer. when I said it has to be dry, someone said, ok put the blood bag in the plastic. when I said I don't know for sure if the temperature is still right, he said put a thermometer. at last I said it's not recommended anymore, he asked the literature. so, anyone, please help me with the standard, recommendation, or requirements of plasma thawer..... thank you before....
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