ar_confederate

I have to apologize. I went back and reread the variances and you are absolutely correct. I'm sorry to have given the wrong information here.

Having dealt with all of the "stuff" that government sends out for us peasants to deal with, specifically an irradiator; I would STRONGLY advise you to avoid gamma irradiators like the plague. We looked at replacing ours with X-ray but the cost of maintenance was prohibitive. I would suggest that you look into Co based irradiators. The source lasts longer than X-ray tubes and it doesn't come with the security headaches of Cs. If your blood supplier is close enough and has an irradiator, they would probably be able to handle your irradiation needs. UVblood, if a device isn't approved by the FDA for a specific use, in this case irradiation of blood, we can't use it.

Actually if I'm not mistaken, the FDA changed the rules slightly a couple of years ago about HH donors. You no longer have to have a variance from them to use their blood, IF they meet all other blood donor requirements and the testing is all negative. This only applies to HH patients and as stated earlier, all other therapuetic phlebotomies have to be done at no charge. I don't remember exactly when this came out but look at the FDA website under approved variances and there is a statement attached to a HH variance that says it's no longer required.

We use our weights in all aspects of collection but to answer your question; yes, we would recertify.

We send our weights to our state Department of Agriculture's metrology lab. I think that they charge $20 to recertify them. If you can't find anyone, I'll post the address for the metrology lab. I think that they'd do this for anyone who is willing to pay, whether in-state or not.

I have a question for ya'll about mapping. It's not been a requirement here in the US but as a blood center, we've decided to start temperature mapping when we validate or revalidate storage units. What is the purpose of the temp mapping? Is it to show air temps or the internal temps of the components? From a novice's viewpoint, it seems that the air temps would be too easliy affected by transient events, such as opening a door or defrost cycles, to really give a good idea of areas that are unsafe for the components. If we are looking for internal component temps, could you not put your probes or thermometers into a liquid solution that simulates your smallest component volume? Thanks! Emmett

I have two that fit many situations. "Perfect is the enemy of good" and when I'm wishing things were different, "It is what it is"

I guess this might fit here. It's not something spontaneous but was rather planned. I don't know if practical jokes are the rule in other parts of the world on April 1st but they are kind of expected here in the US. On April 1, one of my co-workers in the cytogenetics lab had a message to call Dr. Byrd about obtaining blood for chromosomes on Baby Katz. In and of itself, not very unusual since we frequently received chromosome analysis requests for newborns with ambiguous genitalia. The part that he didn't catch was that the phone number wasn't one of the usual in-hospital numbers. In fact, it was the phone number for a local pet shop. The entire lab had contrived reasons to be near the phone when he made the call. The conversation was great. Something along the lines of: Shop: Cantrell pet shop Lab: May I speak to Dr. Byrd? Shop: Sorry there's no doctor here. Lab: Sorry, must have dialed the wrong number Lab: Looks again at the note and dials the number again Shop: Cantrell pet shop Lab: May I speak to Dr Byrd Shop: Look, there's no Dr Byrd here Lab: (Confused and looking again at the note) Are you sure? Dr Byrd wants to get some blood from Baby Katz. Shop: Do you know who you just called? We have birds and we have baby cats but you're not getting any blood from any kitten! Lab: (in a rather excited voice) What in the world are you talking about? Who said anything about kittens? Shop: (Laughing) Let's think about this. You called a pet shop and it's April Fool's Day.... About this time, the light dawned, the lab feel apart in laughter and the victim joined in the laughter. He's a great sport and later plotted and executed well deserved revenge on another day! I wish everyone a very happy and prosperous New Year. Thanks for some great laughs and really good information on this board.

We also obtain the consent on the Therapeutic Blood Donation Record. Our consent reads, " The therapeutic process has been explained to me. All of my questions have been answered to my satisfaction. I have answered all questions truthfully and to the best of my knowledge. I understand that my blood will be disposed of in accordance with the blood center policies and procedures. I have read and understand the "Blood Donor Educational Material" and the "Privacy Notice." One significant difference from your situation of course, is that we are a community blood center and a good bit of the information that we tell the donor is in the educational material we provide to each donor; allogenic, auto and therapeutic. From the donor's side of it, we require a prescription from the physician, our medical director approves the procedure and the prescription has to be renewed every 6 months. Hope this helps. Happy New Year to all of ya'll.

We use wet ice for RBCs. The ice is placed into sealed bags and then a layer of foam sheets is placed between the blood and the ice bag. The box and ice combination has been validated for 24 hours. For local (in town) deliveries, we use a validated ice chest and ice bags. For platelet products we use gel packs that have been conditioned at 20-24C for 24 hours. Obviously, for plasma, we use dry ice. Another blood center I know of used conditioned gel packs that were placed in the refrigerator for a minimum of 24 hours in the place of the ice bags for the RBCs.

We validate the type rather than each cooler and determined the longest time that we could maintain the temperature for the worst case semario (1 unit, packed correctly, iced correctly). For us, it was 8 hours. We inspect and clean each cooler on a regular basis and replace any with damage. The cooler can ONLY be replaced with the same brand and model. We do a quarterly QC check for our shipping of components. Coolers are only used for in-town deliveries but these are checked as well to confirm that the coolers are still providing the proper environment for the components. As for the question about longer times than validated, we take the temperature of each unit in the cooler and quarantine the units. A product reveiw board evaluates the components and makes the decision to release or discard.

I want to thank all of the participants in this thread! It has been a most helpful thread and I have read a lot of good posts. Ya'll demonstrate a lot of wisdom, even to this QA who tries to use some common sense and humor, how successfully, you'd have to ask operations! I've learned a lot from ya'll.

To answer your questions: 1. We don't indicate collection sites in the DIN. Our computer system allows us to "allocate" number sets to our various centers. In addition, our system assigns drive codes that tell the computer where the unit was collected, in addition of course to the demographic information entered manually at data entry. 2. We purchase commercially printed numbers, in large part for better control of them. 3. We do all of the labelling ourselves 4. In ISBT, the splits are indicated in the product codes. You'd be welcome to come see how we do things but we're a ways from Atlanta, in Louisiana. Let me know if you'd like to visit.

We also perform the calculation using the weight. It's quick, easy and all of the inspectors have accepted it without a problem.

I've used the 5 Whys and the fishbone for our RCAs. Of the two, I think that the fishbone works better for us since it is visual. I've started using a flowchart of the process for some of the RCAs and it has also worked pretty well. It often will show a gap in the process flow that might not be recognized as readily with some of the other tools.