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tbostock

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Posts posted by tbostock

  1. Ever try a FMEA (failure mode effect analysis)? Essentially you write every single step of a process, no matter how small. Then you grade each one according to:

    How easily/often is there a problem at that step?

    How severe would the consequences be to the patient at that step?

    You multiply these two numbers, and you pick the top few items that have the highest score to work on for corrective action. It's not hard to do, and works pretty well.

  2. "They told me that they had thought about putting the buffered saline in the kits but that it would not work because of the volume needed."

    Huh?? Have they thought about sending it outside the kit? I'm right there with you, phouck. I still believe that they should do the right thing and supply it to their customers...but only they have proven that it is the issue, and have updated their instructions to reflect this.

    We should all stand united and put our collective foot down! Oh, sorry, I'm feeling a little tough today.

  3. I believe one of the reasons is the Joint Commission's goal of involving patients in their own care. We now use DOB as our 2nd "official" identifier (we also use name, MR#, and Blood Bank ID band #), so that we can ask our patients to "please tell us your full name and DOB". Most patients don't know their MR number.

    I agree though that the DOB is not unique at all. But we used to think that our MR# was unique until we merged to another hospital, now we have duplicates...which explains why we go a little overboard using so many identifiers.

    By the way, my father and brother have the same exact name and DOB because my brother was born on the same day (different years of course)...what was my mom thinking???

  4. I'd never use that quantity in a month; what a waste. I have asked Immucor to provide a smaller quantity of pHix to its customers with each kit...no answer from them yet on that one.

    The name of the product is "pHix", Product # 005070 from Immucor. It comes in a box with 6 plastic bottles with 200 mL in each bottle. You add one 200 mL bottle of pHix to a 20-liter cube of unbuffered isotonic saline. Then you must test the ph and it should be between 6.5-7.5. (We use pH paper to test it, and we never have a problem with the pH being out of acceptable range.) It is then good of 31 days from the date prepared. Contact your Immucor rep for a price quote, but I suspect it will be around $100 for a box.

    As clmergen mentioned earlier, you should be able to pipette and measure to make up smaller batches at a time. It would be great if you could share a box (and the cost) with other institutions.

    What would be even better would be for Immucor to provide (or sell at a nominal cost.....HA!!!) small quantities since they are saying it is necessary for their FMH kit/procedure.

  5. I have always understood that when we take temperatures of a refrigerator, all temps (thermometer top shelf, thermometer bottom shelf, chart recorder and digital readout) must agree within 1 degree C, but I am unable to find a regulation for that...is it FDA? Or am I thinking of a certified thermometer matching another thermometer within 1 degree?

    And if they do not agree, the thermometer (that is calibrated annually against a NIST certified thermometer) is the "tiebreaker", correct? That is, the recording chart and/or digital reading should be changed to reflect the thermometer reading? Although it takes longer for the thermometer to react to sudden changes in temp...

  6. Totally agree with you, Brenda. You can't find a reference anywhere for "pre-pooled" cryo, so we went with the blood supplier's instructions, which said to use the "pooled" cryo regs of 4 hours. Hopefully the regs will be better clarified in the future.

  7. Yes, "hyperhemolytic syndrome" in the sickle cell patient. I saw it once many years ago; very frightening and you go crazy trying to find what you may have missed. Our patient did succumb to it, but she was very sick prior to the episode.

  8. I go strictly with the AABB Regulation 5.11.2.3; in summary, we should only accept what is complete, accurate and legible.

    So, when I quote that, I am then told that "complete" is relative; that is is just a guideline.

    That's a good one, Brenda. Complete doesn't really mean complete, does it? Jeez....

    All of the identifiers on our BB tube (name, MR#, DOB, and red band #) have to be perfect or it is rejected. Date, time and initials are required, but they can come and fix them; not my choice, but it was a decision made since they were not patient identifiers. Our mislabeled rate is 1-5% depending on the day and lack of focus...

  9. As per the Technical Manual "patients with warm autoantibodies have a higher rate of alloimmunization (12-40%)". And "in patients with active hemolysis, transfusion may increase hemolysis...". I always try to talk physicians out of transfusing these patients, and I hardly ever win the argument. So we get them to sign a scary statement about higher than normal risk. Sometimes that gets them to change their mind, usually not.

    So, yes, you will get better results with LISS, but since it is less sensitive, you may miss an allo.

  10. The ones that I have dealt with in the past were not quite as rude, but equally as misinformed about Blood Bank. Amazing to me that they don't have to be Clinical Laboratory Technologists...Sorry, sounds like you had a very stressful experience...I agree with David, have your Medical Director file a complaint.

  11. Here's the FDA's definition, found in a guidance document for Computer Validation on their website:

    Software validation means confirmation by examination and provision of objective evidence that the particular requirements for the software’s intended uses can be consistently fulfilled (Ref. 1). In other words, validation of BECS in the user’s facility should assure that the software is suitable for your specific operations and workload, and can accurately and repeatedly meet your needs as defined in your requirements document.

  12. And Immucor tells us that they are expecting to spend 6 or 7 million dollars for a Quality Improvement Project to correct the issues with the FDA. Translation = reagent costs will skyrocket again. Ugh

  13. I agree with Brenda that you cannot allow deviations from the labeling policy. There was a study in 1997 (published in Transfusion journal) that I love to quote:

    "The study found that specimens with any obvious labeling error were 40 times more likely to contain WBIT (wrong blood in tube)"

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