JLF

There is a transcript of the Ask the FDA and CLIA session from the 2017 AABB Annual Meeting that addresses this topic. It is available now at AABB.org. FDA defined that situation as storage.

Would anyone be willing to share procedures regarding preparation and testing stem cells for administration to include receipt, thawing, aliquoting, and testing of both a donor sample and the patient prior to administration?

I had never heard of it either.

Has anyone heard of running two positive and two negative controls with each test run of A1 Lectin and A2 Cells? I am told by a facility it was an AABB requirement. I have found no reference for it. They are running the current in-date positive and negative control reagents plus the last, expired positive and negative control reagents. I thought using expired controls would be in violation of CAP TRM.31250 (All reagents are used within their indicated expiration date).

I like the way you have explained it in your procedure. We may borrow that here.

I asked AABB to clarify and received this response: Please refer to AABB Blood Banks and Transfusion Services Standard 5.16 Crossmatch section (30th edition). Standard 5.16.1 states… “The crossmatch shall use methods that demonstrate ABO incompatibility and clinically significant antibodies to red cell antigens and shall include an antiglobulin test as described in Standard 5.14.3.” Standard 5.16.1.1 states “If no clinically significant antibodies were detected in tests performed in Standard 5.14.3 and there is no record of previous detection of such antibodies, at a minimum, detection of ABO incompatibility shall be performed.” Standard 5.16.2 states… “If a computer system is used as a method to detect ABO incompatibility, the following requirements shall be met:….” See standards 5.16.2.1 – 5.16.2.5. In summary, if you are doing an extended/Coombs crossmatch, you also need a method to demonstrate ABO incompatibility. This is most often done by an immediate spin crossmatch. Check your manufacturer’s instructions (Gel Cards, PeG, LISS, etc) to see if these reagents state that they also detect ABO incompatibility. Most of the time they do not, which is why an immediate crossmatch is performed along with the antiglobulin test. An electronic crossmatch can be done in lieu of the immediate spin phase if the requirements from Standards 5.16.2.1 – 5.16.2.5 have been met. Keep in mind that an electronic crossmatch can only detect ABO incompatibilities and does not include an antiglobulin test. So if the patient needs an extended/Coombs crossmatch, how is the ABO incompatibility being demonstrated? Is the LIS validated to combine an electronic crossmatch with an extended/Coombs crossmatch (this is usually no), does the antiglobulin test detect ABO incompatibility (this is usually no), or do you need to do an immediate spin crossmatch?

This actually has helped. I have been trying to implement Liquid Plasma and this may help.

That is true but patient identity is still occurring in the clinical area. It is possible for the Bloodsafe to be misused. More units can be removed than indicated, or blood for more than one patient can be removed once the door is open. If the process is set up to readily receive the information from the clinical area, it should work as a downtime process as well. I worked for many years at a Level 1 trauma center that could not have gotten blood out the door if it had to have a patient name and MRN applied to the labels. We had to issue coolers on demand within 1 minute. MTP blood first cooler had to be issued within 5 minutes. We had to label the units as uncrossmatched with no name assigned in a cooler storage device. We were told who the recipient was at the time of cooler pick-up. We did document that on an issue log. The patient's hospital chart labels were applied to all emergency paperwork. We were never cited by any regulatory agency for the process.

I am looking for a Softbank user who dispenses group A plasma during a Massive Transfusion Protocol (regardless of patient blood group). We are being told there is no way to restrict issuing group A plasma by patient type or location. We have a policy approved over a year ago that states we issue group A plasma for MTP but in essence we cannot do this in our computer system if the patient is type unknown or group B or AB. We cannot override and select the products either. The providers want the policy to work as written. I want the same, however, if there are no restrictions in non-emergency situations, the ability to dispense type incompatible products exists. If there is anyone out there who is familiar with Softbank, please respond. I am not familiar with Softbank tables but the other two systems I have helped build have tables that can accomplish this. Our IT folks tell us they are working with Softbank but it has been months. I find it hard to believe there is no other Softbank user already doing this.

If the blood is labeled as uncrossmatched and placed in a cooler or monitored refrigerator, it should be acceptable to apply the patient's name and MRN at the bedside just before transfusion, in an emergency situation. If anyone is using a Bloodsafe refrigerator to store emergency uncrossmatched blood in an ER, the patient identity is established in the clinical area by clinical personnel. I do not see how this is different. Having a made up dummy name complicates the process if the name is not being assigned by patient registration. In a true emergency situation or mass casualty situation occurs, the most accurate means of identifying who received what would be at the bedside, especially if there are multiple patients receiving transfusions. A patient chart label could be applied to the Transfusion tag prior to start of the unit.

Do you concentrate or dilute manufactured antibody screening cells for testing? If so, do you perform QC on the concentrated or diluted cells? Do you consider this an LDT since you are altering the manufacturer's product?

Anyone billing for incubation of crossmatch? If so, are you billing it in addition to the AHG crossmatch? I am trying to benchmark billing of incubation of crossmatch (cpt code 86921).

We use EPIC EHR and we have been working over one year on tweaking BB ordering. Order sets are the way to go, but each service has different rules and requires unique order sets. It is a lot of work but worth it. We get a printout of the prepare order not the transfused order. This is beneficial for pre-op patients. EPIC has a duplicate order screen pop-up that is large and obnoxious for duplicate type and screen orders. It has helped some but we still get duplicate orders. We are hoping this will continue to decrease as physicians are familiar with the system. We are also using medication style orders for derivatives and Rh Immune Globulin. We meet once a week with EPIC IS, nursing clinical services, various physician services, hospital IS, BB med director, and myself as Manager of Transfusion Service. It is well worth the time investment. For downtime, we use a back-up multi-copy requisition that is later scanned into EHR. It works well. Nursing is required to enter the collection date and time as well as the collector in the EPIC system for each BB specimen collection. If a lab phlebotomist collects, nurse can enter generic lab phleb as collector, and we collect phleb name in our BB system. The collection information stays on the nurse's worklist to remind them to complete the information. We have had problems with nurses defaulting their name instead of entering correct collector. It is a massive education issue. We are a large, metropolitan, level 1 trauma center so we have a lot of staff to educate. We are also trying to use EPIC to record transfusion data (vitals, rx evidence, etc). Is there anyone else with experience in this area?

I agree with FDA that temp is the critical issue, however, the AABB educational material for Nurses does state a time limit for return of 30 minutes. I asked AABB what was the basis for the time limit. I was told was it was arbitrary. I guess someone decided it takes a unit 30 minutes to reach 10 degrees. If anyone knows source, I have always been curious.

We actually have IS phase and AHG phase built into Coombs crossmatch test. We only assess one charge but cost per test takes into account cost of both phases.