vilma_mt

I would have done the same. You were cautious without with causing undue delay in treatment.

The usual problem with Safe-T-Vue I've experienced are (1) Techs not attaching the indicator to the bag properly. The cooler leaves the BB as it starts turning red. If you know ahead of time, attach indicators to the units and check for color prior to placing units in the cooler. (2) you may have validated the best cooler and use the best indicator available, once it leaves BB, the units are out of your control, anybody (Nursing staff) can take the units out of the cooler with the intent of transfusing, often leaving the units on a countertop for extended amount of time. Goodluck solving that. Safe-T-Vue is simple to use and would recommend it as well as HemoTempII. HemoTempII is bigger than Safe-T-Vue, with all the labels/stickers it would be a challenge to attach directly on the bag, it wouldn't hurt to ask for samples for you to try.

True...You can have the take it or leave approach when it comes to any Guidance, but, they are based on current regulations. A facility make take AABB's instead which in a lot of cases is more stringent than FDA's. Per FDA "You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations."

For a patient with current ABO and Negative Ab Screen (current/previous), it seems cumbersome to issue blood by emergency release than waiting few mins to perform IS XM. That said, if it can't be helped, I would be cautious giving Type Specific blood if there's only 1 ABO type on record either current or historical. Never assume the previous tech performed ABO type correctly! Emergency released blood does not necessarily mean it has to be "O" PRBC. It's compatibilty testing is incomplete.

Although a requirement only for electronic crossmatches (for now anyways), I think it's a good idea to have 2 blood types prior to issuing blood on patients without historical data.

"Patient background: Hx of a strong cold agglutinin that causes an ABO discrepancy. The patient forward types as B+ and reverses as Group O. According to the reference lab report, the ABO discrepancy could not be resolved by any of the techniques that were used. The transfusion recommendation is to crossmatch for compatibility with group O positive RBCs. The patient is frequently transfused on an outpatient basis. The antibody screen is consistently negative with Ortho gel, but a comment in the patient notes says to use prewarm technique. I'm not sure why the note is there, but I've used both methods.)" In your case, I see no reason performing pre-warming techniques for AB Screens when you consistently have negative Gel AB Screens. I would look more at the cause of ABO discrepancy and try to resolve it, is it weak or missing reactivity in the forward typing or extra reactivity in reverse typing. Performing prewarm techniques "to get rid of weak antibodies" is not an acceptable practice, clinically significant antibodies can easily be "prewarmed away". Prewarm techniques can be a powerful tool but never assume what you're detecting is merely cold reacting clinically insignificant antibody without first trying to determine if a clinically significant antibody is present. If a technologist suspects a cold antibody, he/she must prove a cold is present, not necessarily identify it. The technique should be used with caution especially on patients with recent transfusion and not used to eliminate unidentified reactivity.

Computer crossmatches do not apply to those patients with Antibody (current/previous) or ABO typing discrepancies, use serologic crossmatch techniques for compatibility testing.

Here's a copy of FDA and CLIA transcript regarding this topic...hope it helps Question 4: We perform all routine testing using gel technology. We also perform electronic crossmatches. For patients in whom clinically significant antibodies have been identified, is it sufficient to perform only a gel antiglobulin crossmatch? Does this satisfy the CLIA requirement to perform a test to detect ABO incompatibility? MS. MEYERS: For this question, before I start, I would like to just make the comment that the answers that I will be giving to the questions today are based on the CLIA regulations. However, I would like to remind the audience that many laboratories choose to obtain their CLIA certification through a CMS-approved accreditation organization, of which there are six. One of which is AABB. These laboratories must follow all the requirements of their chosen accreditation organization which may be more stringent than the CLIA requirements. Now back to the question. Actually, these CLIA requirements for crossmatching are based on the FDA requirements for crossmatching, and FDA and CMS have collaborated in preparing the answer to this question. The simple answer is that the IgG gel card does not fulfill the requirement to demonstrate ABO incompatibility. There are two issues involved here. First, the labeling clearly indicates that the IgG gel card is for direct and indirect antiglobulin tests. In other words, detection of cell-bound IgG antibodies. While the limitation section of the package insert states that some IgM antibodies may react, this limitation should not be interpreted to mean that the card is capable of detecting all IgM antibodies, particularly ABO antibodies. Secondly, the IgG gel card is a low ionic test system and there have been reports that ABO incompatibilities, due to IgM antibodies, can be missed when the antibodies are weak and the test is low ionic strength. While we acknowledge that there is continuing debate on this topic, but with the knowledge of these reports and in the absence of data from the reagent manufacturer to support the use of a low ionic strength system for detection of ABO incompatibility due to IgM antibodies, we believe it is not appropriate for users to omit some kind of test to detect these incompatibilities. And for eligible patients, an electronic crossmatch would fulfill the requirements. An immediate spin crossmatch, of course, is an acceptable method for all patients. MODERATOR: Thank you, Penny. Can I ask, because I could not hear everything that you just said, but did you respond to the part about sufficient to perform only the gel antiglobulin crossmatch, that first part? MS. MEYERS: No, it is not sufficient to perform only the gel antiglobulin crossmatch because that does not fulfill the requirement to detect ABO incompatibilities.

I agree with the citation. In Blood Bank "everything" must be documented. If Meditech does not give you the option, you may have to document results on paper and final result/interpretation in Meditech. A generic form with: IS / 37C / AHG or IgG / check cells Method used example tube vs gel Incubation time Controls used Remember document who did what when etc...... Goodluck

The AABB and CAP most likely prefer having a secondary armband. I haven't checked current AABB standards but CAP's TRM.30575 "mechanical barrier" or electronic verification system" was given as an option to reduce misidentification. The 21 CFR states..... "(a) A method of collecting and identifying the blood samples of recipients to ensure positive identification"

I don't think there's any change... here's a copy of the standard Standard QSA.05.07.01 for 2011 The organization labels blood specimens drawn from a recipient for typing and crossmatching. 1. The organization has written policies and procedures addressing specimen collection for typing and crossmatching. 2. Policies and procedures addressing specimen collection for typing and crossmatching include the requirement that the recipient be positively identified at the time of collection using two unique identifiers (neither of which is the patient room number). 3. Policies and procedures addressing specimen collection for typing and crossmatching include the requirement to label specimens legibly and immediately upon collection, in the presence of the recipient. 4. The request forms and the specimen label for typing and crossmatching include the following: - The recipient’s full name - The unique identifying number - The specimen collection date 5. Policies and procedures addressing specimen collection for typing and crossmatching include a consistent approach to identify recipients who are unknown, incoherent, or unconscious. 6. The organization identifies the individuals who draw blood for typing and crossmatching. 7. The organization follows its policies and procedures addressing specimen collection for typing and crossmatching.

CAP's definitions of Minor / Substantial revision...... Minor revision: A revision that does not affect the nature of a policy or the way in which a procedure is conducted. The revision would not affect patient results or patient outcomes. For example, a spelling or grammatical correction would be a minor revision. Substantial revision: A change that affects the nature of a policy or the way in which a procedure is conducted that could impact patient test results or patient outcome.

I suggest find out what brand of blood bags your blood supplier uses and call the company. From my understanding blood bags are also highly regulated surely they've done a lot of studies. I'm more concerned with the mold issue, maybe have a temporary storage solution for the blood until the cleansing agent dissipate.

Irradiation "kills" the wbcs but does not remove it from the blood. CMV lives in white blood cells and the virus is transmitted thru wbcs. I have yet to find a literature that says irradiation kills the virus. Leukoreduction does not prevent GVHD since there is still a small amount of "viable" wbcs and this small amount of wbc can wreak havoc in an immunocompromised patient.

Part of the Circular states.... "No medications or solutions may be routinely added to or infused through the same tubing with blood or components with the exception of 0.9% Sodium Chloride, Injection (USP), unless a) they have been approved for this use by the FDA or there is documentation available to show that the addition is safe and does not adversely affect the blood or component." I went to OHSU's website it does state "Approved for rinsing IV tubing".