Kathy3171

Is there or will there be an ISBT128 label for thawed plasma?

You will be requesting a variance from 21 CFR 606.122(m)(3) in order to extend the storage time of thawed fresh frozen plasma at 1-6 C to 24 hours instead of 6 hours. Your request should consist of a letter stating the CFR reg as written and then how you want to deviate from it. You can state you want to align your hospital practice with the statement in the Circular, etc. You should state how you plan to label the product (new sticker, line through the word fresh...) and what you will do with the product after the 24 hours (discard, change to thawed plasma...) Also, print the form 356h from the FDA website and submit with your letter. Address your letter to: Dr Alan E Williams, HFM-370 Center for Biologics Evaluation and Research Food and Drug Administration Suite 200N 1401 Rockville Pike Rockville, MD 20852-1448 I got this information from our blood supplier and they were a great help in the 'how-to' department. Hope this helps. Kathy

I thought the issue of fraud was that you can't charge a patient for a test the doctorhas not orderd, if theyorder only an RH, you should not charge them for a complete type. Our computer is such that it will only record a full type in patient history so if the doctor only order an Rh, we perform the full type (which goes into computer history) but only charge for the Rh.

I was probably one of those that asked that question of the FDA at the last AABB conference in Miami and the response was that every institution is required to request a variance if they are going to issue thawed plasma up to 24 hours after thawing. I asked for the variance when I got back and just received the OK. I really don't understand why the FDA doesn't just issue a blanket approval so that it matches the Circular of Information and the Technical Manual. It would save everyone a lot of time.

We use the Bloodloc system which is a mechanical barrier. At the time the patient is drawn for transfusion, the nurse puts a three letter code on the patient's ID armband and the 3 letter code is written and underlined on the specimen. At the time of issue, we set the code in a plastic lock, lock the unit in a bag with this lock and it cannot be opened until the nurse is at the bedside and reads the code from the patient's armband. If they are at the wrong bedside, the lock will not open. It has worked very successfully at our facility for several years.

We use a Bloodloc system. A three letter code is attached to the patients ID bracelet. This code is handwritten and underlined on every specimen for Blood Bank. At the time of issue, we put the unit in a Bloodloc bag and lock a plastic lock that has been programmed with the three letter code. The nurse is unable to get to the unit unless she goes to the bedside, reads the code from the patient armband and opens the lock. If the lock won't open, there is a problem (this has happened when they go into the wrong room or have changed the code without telling us, etc.) Once the unit is out of the locked bag, they do the bedside checks for name and date of birth. They really objected to this extra step at first, but now they are not comfortable with anything else. The Bloodloc system is not a separate band as the code is placed on the patient's inpatient ID band. It is good for the patient's entire stay and does not have to be changed. We've used it for 4 years and have found it has prevented some identification problems.

At what point of time or after how many units does your institution switch an Rh negative child-bearing age female to Rh positive units in the case of a trauma. Our massive transfusion policy states to switch,after consulting with a pathologist, in order to not deplete our Rh negative supply, which is usually around 10 units, if we have them. This happened recently when we had a lacerated liver case and we used what we had and our supplier would not give us any more. I'm not sure I want to be so specific as to not give the technologist some discretion in managing the Rh negative inventory. Then, do you try to give Rhogam to compensate for the quantity of Rh positive units given? That could be a huge number of shots.

We had a JCAHO inspection recently for our point of care, and the inspector focused in on tissue storage. At our hospital, about 350 beds, the surgery department is responsible for tissue procurement, storage, handling and lookback. They have a tissue coordinator that handles all of these functions in addition to other duties. Because of the inspection, the lab was cited because according the JCAHO the lab is ultimately responsible. So.... I have written into the Blood Bank policy that states the Surgery department is responsible for Tissues with oversight by the Medical Director of the Blood Bank. I have been working with the coordinator in surgery to get their procedures written that comply with the standards. This is not an easy task, as we are on different wavelengths, but we are making progress.

We perform two types on every patient without a history regardless of transfusion requirements. Because we are small and only have one tech in the department at a time, the same tech retypes the patient using the same sample. We use two different methods, though, because our primary typing is performed on the gel and our retype is performed by tube.