tcoyle

I don't know of any regs or accreditation standards, however your software vendor may have a stipulation about how many versions users can be behind before they stop supporting the software. You might check with them.

Hello, are you wanting to validate the actual printer (hardware) or all the labels coming out of Hematrax?

Hello, The people have spoken and thanks for the comments! I agree that the verification of a blood sample per CAP does not state how to do this. However, AABB is quite clear that determinations of ABO group be performed with the Anti-A and Anti-B reagents and with A1 and B reagent red cells. A question to consider: isn't it safer for the patient to do the full ABO group test when actual testing is required rather than performing only the front type? With the front and back type of testing you have a built in monitor to help discover discrepancies.

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."