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Everything posted by heathervaught
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You are correct Richard, we are switching to SafeTrace and are in the process of developing and validating our processes. By the way, we are having our next ISBT meeting with our hospital customers on October 16th at noon. We will be serving a light lunch at 11:45 (RSVPs for lunch go to ngurney@indianablood.org). We will be handing out label samples and discussing some FAQs that have come up through our meetings, the ICCBA website, and other resources.
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Nitric Oxide in transfused red cells
heathervaught replied to Mabel Adams's topic in Transfusion Services
It seems to me that the lay press has sensationalized the risk of heart attack or stroke associated with blood transfusion. Does anyone know the actual rate? The http://www.time.com/time/health/article/0,8599,1669438,00.html?cnn=yes article on this just keeps referring to "many"... i.e. "...for many of the five million patients who receive blood transfusions every year" and "...many get sicker" How many of the five million? 10? 1,000? 1,000,000? If you use my rule of thumb, a couple = 2; a few = 3-4; several = 5-7; many = 8 or more. -
Nitric Oxide in transfused red cells
heathervaught replied to Mabel Adams's topic in Transfusion Services
I found these quotes: The "Stamler" is Dr. Jonathan Stamler of Duke University, leader of one of the research groups. I think (for what it's worth) that it is always safe to say to a patient or physician that Transfusion Medicine is a continuously evolving field, and we are always looking for ways to make blood transfusions safer and better. Just like we are always adding more infectious disease tests to our donated blood, scientists are also looking for other things that can be done to improve the safety, purity, and efficacy of transfused blood products. I would also add that transfusing blood in its current state is currently the safest thing that we can do until controled clinical trials on human subjects. There will always be risks, but as an industry we do everything that we can to mitigate and control those risks. -
When product storage units are moved a short distance within our facility, we allow for use immediately after the unit stabilizes at its required temperature. We use our remote temperature monitoring system to qualify that the temperature is OK after products are returned and would move them out if the temperature became unacceptable. If we have a longer distance or downtime, then we sometimes monitor the temperature ever 4 hours for 48 hours and compare it with our remote temperature monitoring system to ensure that everything is functioning. We picked these times because our QA department found them agreeable -- I don't think that we had any other logic than that. You should definitely have a plan stating how you will qualify the product storage units after the move.
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Bob, We have two 2991s -- one that is the old "peg board" style, but we also have a new one where the "pegs" have been replaced by a digital display (the knobs are still there). We bought the new one just a few years ago, and everyone who was trained on the old one still prefers that. We perform the following tests on the supernatant prior to release: Washed RBCs: supernatant for protein using a urinalysis dipstick; Deglyced RBCs: we also use the Haemonetics Color Comparator. We used to test the Refractive Index or Specific Gravity on the supernatant, but since our refractometer died we have had our reference lab do the "simulated" transfusion described in the Technical Manual. We also perform %RBC recovery for each procedure quarterly. Heather
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How much computer validation is enough?
heathervaught replied to Gerald's topic in Computer Systems / Software / ISBT128
I agree with a previos post -- first identify what the upgrades/improvements are and test those. Then, select a handfull of test cases from your original validation (why re-invent the wheel?) to prove that the upgrade did not impact those processes. It should definitely include one "normal" scenario and any/all "Control Point" scenarios. I feel your pain -- we are implementing a new computer system next year!