C Lumbert

We initially used the Cerner Emergency Dispense, but devised a simpler means to deal with uncrossmatched dispense. We created a patient named "Emergency, Uncrossmatched" and "assigned" two O Neg units to it. When the call and order comes for uncrossmatched RBCs, we document the dispense time and units dispensed on paper. After ABO specific units are ready to dispense, we back date/time the dispense of uncrossmtched units and dispense them to the patient who is now identified. This provides receipt of uncrossmatched blood in in the requesting service in seven or less minutes and all the information we need to back date the dispense is available in blood bank. Chuck Lumbert Lumbertc@trinity-health.org

I took part in a discussion on this issue this morning with our Lab Counsel group. One of the members stated that there is no standard requiring the transfusion to be initiated within a certain time from issue of the product, only that the transfusion be completed 4 hours from spiking the unit. This situation would appear to permit holding blood in the patient care area indefinitely before starting the transfusion. I noted that the Circular of Information for Blood and Blood Products from the ARC and AABB states: "It is undesirable for components that contain red cells to remain at room temperature longer than 4 hours." If we are required to follow manufacturer's recommendations, would this mean transfusion should be completed within 4 hours of issue from controlled storage?

I remember an article in the journal Immunohematology from 1994 titled: Misidentification of anti-Vel due to inappropriate use of prewarming and adsorption techniques Authors: J R Storry, D Mallory Immunohematology / American Red Cro.... 02/1994; 10(3):83-6. ...later. Retrospective testing in our laboratory detected anti-Vel in both pretransfusion... examples of anti- Vel at the IAT. The posttranshision serum was grossly hemolyzed and anti-Vel... hemolysis) was strongly reactive (3+s) with Vel+ RBCs but compatible with 10 examples of Vel- RBCs... The authors reported a fatal hemolytic reaction after the referring laboratory used the pre-warm technique in the rbc panel and crossmatches. Granted anti-Vel is uncommon, but it seems that sufficient examples showing missed clinically significant antibodies using the pre-warm technique should justify caution in any investigation.

We use Ortho Gel cards on the ProVue instrument and were getting repeated volume errors. On examining the cards, I observed what I thought might be sephadex gel in the well above the gel and liquid. The field engineer said that this will not spin down, so I called Ortho and they sent replacements. The replacements still seem to have droplets of gel on the sides of the wells above the liquid and we are still getting volume errors. If anyone else has observed this, I would appreciate learning what Ortho's response was. Chuck

Thank you all very much for your input and thanks to clmergen for the statement from AABB. i requested clarification from CAP last spring, since they list storage devices as refrigerators, freezers, and platelt chambers in one question and include coolers in another question. They have not responded. I do hope more clarification will be provided at the AABB in New Orleans this fall. If an FDA inspector is present, perhaps we might get a documented position to use as reference. Chuck Lumbert, Battle Creek, MI

But I thought that the FDA now considers blood in coolers, sitting in OR or an Outpatient transfusion location, Storage; not Shipment?? Thank you for opening this point Brenda. I have repeatedly read comments that FDA regards the coolers as storage in the patient care department, however, I have not been able to find a reference statement from FDA or from AABB or CAP with that definition. Can anyone help me locate the reference statement? I heard that the FDA representative clarified the point in an "Ask the Inspector" session a number of years ago. Chuck Lumbert Battle Creek, Michigan

After the installation validation, it is a good idea to perform maintenance according to the manufacturer's instructions (per FDA Regs). Our interpretation of the thermometer calibration requirement is that all thermometers should be calibrated against an NIST certified thermometer initially, then according to your company policy. ______________________ Chuck Lumbert, MT(ASCP)

I am aware that transfusionists must be trained and competent, but there I question whether in my state (Michigan) the transfusionist must be a physician or RN. The question arises when a service wants to transfer a patient by ambulance and transfusion is in progress or may take place enroute. Although the hospital policy states that a physician or RN must accompany the patient, this never happens. We are suggesting the hospital either change the policy or follow it. I have tried a search of Michigan Regs. but found nothing. Other than "trained and competent" has anyone encountered regulations governing who may transfuse blood products?

Has anyone considered the option permitted by FDA and CAP to use outdated rare typing sera as long as QC is acceptable? They do not permit this for easily obtainable reagents such as red cells, but list Anti-Jk-a, Le-a, etc as examples. We wondered if this exception would permit use of rare typing sera to exhaustion, rather than tossing it after the outdate.

John, We also do not get copies of transfusion records back in blood bank. Our hospital Quality Assurance Department monitors transfusions for appropriate documentation and compliance with procedure. This may be an unusual arrangement, but we are a free standing laboratory (half-owned by the hospital). We provide transfusion services, but the hospital does all their own quality assurance. Hope this is helpful. Chuck Lumbert