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".

You can always refer to .... http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm080296.pdf Every Transfusion Service should have a copy. I think anybody who would like to attempt deviating from the guidance will think twice when you refer them to this site. You might want to check if what your anesthesiologist is "doing" or "attempting to do" is FDA reportable.

I believe FDA allows up to 2 irradiations, not exceeding 5000 cGY. But must be documented as such indicating total dose. I have read this in one of the "ask the FDA" forums awhile back. I tried looking for the FDA Guidance/Regulation with no luck.

a lot of hospitals here in the US acknowledges that leukodepletion reduces risk of CMV infection. Irradiation on the other hand is still used to prevent GVHD. In the the event that there's an emergent need of transfusion and no available irradiated products available, no one should hesitate transfusing non-irradiated products. There are drugs available to prevent and treat GVHD. Here's a copy of AABB statement regarding Leukoreduced blood and CMV. STATEMENT OF THE AMERICAN ASSOCIATION OF BLOOD BANKS BEFORE THE BLOOD PRODUCTS ADVISORY COMMITTEE ON THE EFFECT OF LEUKOREDUCTION ON CMV TRANSMISSION THROUGH BLOOD TRANSFUSION SEPTEMBER 19, 1997 Presented by Roger Y. Dodd, PhD Mid-Atlantic District Representative to the AABB Board of Directors The AABB is the professional society for almost 8,500 individuals involved in blood banking and transfusion medicine. It also represents more than 2,200 institutional members including community and Red Cross blood collection centers, hospital based blood banks, and transfusion services as they collect, process, distribute, and transfuse blood and blood components. Our members are responsible for virtually all of the blood collected and more than 80 percent of the blood transfused in this country. Throughout its 50-year history, the AABB’s highest priority has been to maintain and enhance the safety of the nation’s blood supply. The AABB appreciates the opportunity to comment on the effect of leukoreduction on CMV transmission through blood transfusion. Over the past year, an ad hoc committee of the Association has reviewed the issue in detail and has reported that both retrospective and prospective data support the conclusion that the leukocyte reduction level currently accepted for the reduction of alloimunization to HLA molecules (that is, to fewer than 5 X 106 per transfused component) reduces transfusion-transmitted CMV to a level at least equivalent to that observed with the use of CMV-seronegative components. The data supporting this conclusion reflected a number of different studies, encompassing a variety of technical approaches to leukocyte reduction. These studies are reviewed in some detail in AABB’s Association Bulletin #97-2, dated April 23, 1997, and entitled “Leukocyte Reduction for the Prevention of Transfusion-Transmitted Cytomegalovirus (TT-CMV).†A copy of the Association bulletin has been provided to committee members. The AABB therefore endorses the use of leukoreduced components as a measure to reduce the risk of transmission of CMV to susceptible patients. The Association encourages the use of procedures which can be performed in a fashion which assures that current Standards for leukoreduction are consistently achieved.

I'm surprised nobody corrected me on second/third/fourth sentence of my post....I got my red cell/plasma/platelet transfusion all mixed up. May I redeem myself....Type specific platelets always first choice. When there is no available AB Platelet for AB type neonates, plasma volume reduction or platelet wash usually done.

I'm presuming the patient has not been recently transfused.

Now you got me confused...4 Patient AB Screens (3 Cell Screen cells each); 2 Patient ABO Type (3 tubes for Forward and 2 tubes for Reverse typing) with 2 extra positions.

With Manual method a tech can perform up to 4 AB Screens and 2 ABO Type because there are only 12 positions in the centrifuge. With Automation and other methods such as gel, a tech can perform a lot more than that. Attention to detail and a good process must be in place to avoid errors especially ABO typings. I would perform the number of AB Screen the incubator/centrifuge would allow BUT carefully perform my ABO Typing with caution and use the IS to confirm.

Not FDA reporable but it needs to be reported back to Physician at your facility and back to Stanford and I agree it needs internal review. GVHD can be treated/managed after the fact (i.e. steroids) but prevention is still the best. Leukoreduction has been accepted as CMV safe. As far I know it has not been accepted to replace Irradiation.

The first choice is always type specific. The only time AB platelets are preferred is when the neonate have a passive ABO antibodiies. Same goes for what plasma ABO type to give. Although for adults it's ok to give a type "O" platelet to a type "A" patient, we can't do it for neonates because of the blood volume. If there is no available AB platelets, some hospital perform plasma reduction or washed platelets (not sure if washing is still an acceptable practice)

I agree, I myself am not a big fan of separate armbands for blood bank. We have rejected samples because a phlebotomist mispells the name and on some occasions have accepted samples with pre-printed labels as long as the tube has a BB sticker without actually verifying what's written on the BB armband. Some nurses cut it off prematurely, some patients have 2 bands on. It's also an added expense. You'r right Pharmacy don't require a separate armband and if the hospital have a good process in place when it comes to patient identification why do we need a second armband. I prefer to have a policy to have a second typing on patients without historical data prior to issuing blood. All this second typing requirement is most likely from FDA's electronic crossmatch requirement. Two techs performing ABO typing or 2 samples or 2 ABO methods or 2 ABO data, to put it simply.