tcoyle

Agreed! From the 31st Edition of the BBTS Standards: Standard 5.14.5 Pretransfusion Testing requires two ABO group determinations and cites Standard 5.14.1 as the precursor. 5.14.1 states the ABO group shall be determined by testing the red cells with Anti-A and Anti-B reagents and by testing the serum or plasma for expected antibodies with A1 and B reagent red cells.... TRM.40550 Forward/Reverse Typing Phase II For each patient, red blood cells are tested with anti-A, anti-B, anti-D, and serum/plasma is tested using A1 and B reagent red cells. NOTE: The ABO/Rh type of the patient's red blood cells must be determined by an appropriate test procedure. Tests on each sample must include forward and reverse grouping. CAP and AABB are in agreement.

And then a comprehensive validation to show that it would work in all situations. Best to stick with what the manufacturer requires in their directions.

That is exactly what we have at the end of our documents. If there are validations or change controls associated with the document updates, we also include those in that revision history. When the history field becomes extra-long (and it can especially if you have an SOP that has been used for many years) we will archive that revision history for except the last 3 years or so and note that in the synopsis of change.

Hello paddleking: I'm curious if you are AABB accredited or inspected by CAP or ??? Does your hospital have a patient safety reporting program? Does your laboratory have a QA unit and/or event management system? Seems like there are many processes out of control...

Yikes. We don't use Meditech but how do you get DINs with same unit number? Unless they have different product codes because of divides or component manufacture (double red/red cell + FFP). If that is the case...e.g. an FFP with an RBC, then they should also be scanning the product code.

One way to document the persons non compliance is through event management and training. Part of the training should require documented competency before they start submitting patient test results on their own and direct observation should be a part of that. If this person cannot pass their competency then you have documented evidence. If you know this person is not following SOP, you should be able to document such in your event management system. Hopefully your SOPs also out line that concurrent documentation is required. Based on the Fair and Just Culture of event management, this sounds like the Reckless behavior where the person is making these conscious choices and disregarding the risk involved. This type of behavior should not be ignored and requires corrective action. Patient Safety and the "Just Culture."  A Primer for Health Care Executives Prepared by David Marx, JD

Can you imagine what a nightmare of logistics it would be if we had to be concerned about that? As long as you issued your product on that good specimen before it expired, you are fine. We have the same practice. Our day of draw is day 0 and then our specimens expire at midnight on day 3. We could issue products on that specimen up to the minute before it expired.

I would think you have a good argument against both. The AABB standard references the CFR which is also related to testing. (42CFR 493.1235 and 42 CFR 493.1451 (b)(8)(9)) from the CAP Lab General 55500 References Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Oct 1):1065-66 [42CFR493.1451(b)], 1053-54 [42CFR493.1413], 1992 (Feb 28) 7184 [42CFR493.1713]

I don't think its necessary to reinvent the wheel when the information is clearly displayed via another means.

Your blood product label should already have those. When labeled according to ISBT standards the product expiration date will be in the Q4 of the label. Time only needs to display if not equal to 2359. Special transfusion requirements such as irradiation or leukocytes reduced will be built into the product code. If antigen negative blood is required, we have a separate label that is applied with the specified antigen listed.

If it's an open system unit, according to the ICCBBA language you should have OPEN SYSTEM on the label. And, if you have a closed system for your aliquots the expiration date should be the same as your unit that the aliquot was taken from. Did CAP site you for the "A" added or only that the person couldn't tell if it was a closed system aliquot? (which seems odd...) Sorry I can't answer your question about Meditech, but it's strange that it adds something to your label.

The Circular of Information for the use of Human Blood and Blood Components has information regarding transfusion within 4 hours. Here is an excerpt: "Transfusion should be started before component expiration and completed within 4 hours." And another, "The initial portion of each unit transfused should be infused cautiously and with sufficient observation to detect onset of acute reactions. Thereafter, the rate of infusion can be more rapid, as tolerated by the patient’s circulatory system. It is undesirable for components that contain red cells to remain at room temperature longer than 4 hours. If the anticipated infusion rate must be so slow that the entire unit cannot be infused within 4 hours, it is appropriate to order smaller aliquots for transfusion."

We just moved to a new server for our donor system and we did a short validation to ensure that we could enter and receive all information end to end. That would include our connections to our donor questionnaire program, registration, draw information, manufacturing of the unit and exporting the unit to our transfusion system. We also tested our instrument interface that sends donor tests and the interface that we receive our tests that we send out for donor testing. It might seem like a lot to some, but when they are moving your whole application to a new piece of hardware, it would be prudent to ensure they did it correctly. We have a validation environment that they did the changes to first so that we could do our validation, (from which we did find some problems) then we performed a smoke test in the production side after the move as well. Considering that FDA states that you should validate your system...using the same software, hardware etc...I would recommend some type of documented validation.

Here is the article describing that incident that a colleague shared with us recently. An awful story, but worth reading and recognizing the importance of the checks that are put in place to keep patients safe. http://www.thecomet.net/news/nurse_from_stevenage_given_suspended_sentence_after_using_wrong_type_of_blood_in_transfusion_which_killed_patient_1_4883904

We do not require another tech to perform another verification of blood type just to use the computer for crossmatching. The computer is set up to require two ABORh's. Our policy is that we require two separate draws by two different phlebotomists when we have a patient that our computer system has never seen. The first ABORh is performed by our automated platform on one of the samples and then a technologist performs the second ABORh on the second sample. Our computer system, and I would hope yours too, keeps that historic information for the next time the same patient visits. The second time that patient arrives in our institution, we only draw one sample for testing and perform the ABORh. At this time, our computer recognizes the historic blood type and the current (i.e. Two ABORh's are present for computer crossmatching). If the patient meets our other criteria, then we are able to perform computer crossmatch. FDAEXM_Guidance.pdf I am not aware of any regulatory or accreditation requirements that state testing needs to be performed the way you describe your current process.

FDA Guidance for Computer Crossmatch states you should either perform or maintain a record of a second test, confirming the recipients ABO/Rh. Please see page 8. AABB standard 5.16.2.2 (30th edition) states that two determinations of the recipients ABO group...one on a current sample and the second by one of the following methods... FDAEXM_Guidance.pdf

We issue until the sample expiration. Our samples are good for 3 days with day 0 being the day of draw. Our computer expires the samples at midnight regardless of draw time.

I agree that you would use the first sample for subsequent transfusions until the sample expires. Your point that the person may have an unexpected antibody prior to the first transfusion that then explodes with a second unit could happen. If the patient does have a transfusion reaction because an unexpected antibody was present that could not be detected with the first antibody screen, it could result in a delayed reaction (>24 hours but less than 28 days after transfusion). It generally wouldn't be an immediate hemolytic...unless the wrong blood type is transfused. If the patient did have an unexpected, undetectable antibody and had a reaction; your transfusion reaction work up would discover this and moving forward, your transfusion service would have information to give antigen negative blood. As blood bankers we want to give the best product all the time. Following the rules/processes/procedures will help us stay on that course.

We also use a microwave which thaws a couple of units in about 7-8 minutes (not including the relabeling etc). Have you considered 5 day thawed plasma if your facility uses this product on a regular basis? This would allow you to have product readily available.

Here is a good AABB presentation from 2014 on competency. Hope it helps. AABB_2014_Competency_Assessment_a_toolbox.pdf

I'm not aware of any standard or regulation that requires a unit to have an ABO confirmation sticker displayed. That being said, maybe there is some history at your facility, perhaps this was a process improvement to ensure that all units would be confirmed prior to selection and crossmatching. I would also think that whoever wrote your SOP should be able to share why it is the way it is. And to address that the LIS will not allow a unit to be issued; I'm guessing you have a validation to show that if a unit is not ABO confirmed and crossmatched to a patient that it won't be allowed to be issued. With all that information you can make the correct decision for your facility.

Are you looking to add a blood dispensing machine? Do you have system a system engineer or someone skilled in the lean tools in your facility that could help with this?

Well, I'm glad to see that there are many using this...

All, Wondering if any other groups out there have experience with Aras Innovator as a platform for anything for perhaps, event management or ? Wondering what your experience with them has been, how you like the product, service, troubleshooting. Thanks.

Hey Mari, I was wondering how close you were to that area. Lots of prayers for the people of that region. Terri