dmpollock

Also, the anticoagulant of the RBC is important for exchange transfusion to infants. Should be CPD or CPD-A1 (not AS-5 or other additive). We combine FFP with RBC that are irradiated, leukoreduced, CPD, CMV-neg, and sickle screen negative. We use O Neg RBC and AB FFP.

I have attached an abbreviated version of a procedure for preparing reconstituted whole blood for exchange transfusion for infants or for sickle cell patients. The calculations are slightly different than some references, but they yield more accurate results when you are trying to achieve a specific hematocrit. The formula is based on trial and error and actual measurements of specific gravity, donor bags, etc. rwb.pdf

Our nursing people have switched to a computer based reporting of transfusion reactions. Since it is a rare event for each nurse to ever have to fill out a report, they are not proficient at it. In auditing records, I find it takes them >5 HOURS to get the report to the blood bank. They get confused by the computer and end up re-reporting on paper. In 1/3 cases the report never even gets to the blood bank! I know it is a bit much to ask, but I am setting a standard of 15 minutes max to get the report to us. If we are to identify an ABO-incompatible error, time is important in order to start treatment. Does anyone else have a standard, or have you looked at your data? I plan to change our procedure to have the blood bank initiate the blood bank part of the investigation and test ordering based on a phone call from nursing, rather than wait for a report. Does anyone use this approach?

Since you are validating blood typing reagents, the easiest way, without doing any extra testing at all, would be to start using them at the same time as the old ones. During the validation period: If the sample is from a new patient with no historical blood type, test with the old reagents. If the sample is from a patient with a historical blood type, test with the new reagents. If the results match, then your new reagent is working. By the time you run out of old reagents you should have plenty of data. You would of course have to QC both set of reagents daily if you use this approach.

To clarify the issue. I am talking about specimens that have nothing to do with the blood bank. What is happening is that a hematology or other lab test value is dubious. The hematology tech wants to do a mini-"forensic" investigation to see if the phlebotomist mislabeled the tube or drew the wrong patient. They have been asked the blood bank to go so far as performing extensive (and expensive!) phenotypes on these samples. They have also asked the blood bank to scoop out red cells from the bottom of a heparinized sample with a gel barrier! The form I attached to my earlier message was a draft. It was intended solely for testing non-blood bank tubes. It has the statement "If the ABO/Rh types match, this does not mean that the samples were collected from the person indicated on the label" because I am not sure the hematology techs always interpret the results correctly. Our most recent case was there were two sets of samples with identical labels and accession numbers, but different collect times. In this case one tube was B Pos and the other A neg, so it was clear that a mislabeling occurred. But what would happen if both tubes are O Pos, which could easily occur by chance? Would they go ahead and report out the coag results? What if both tubes had been AB Neg? Would they understand the difference in probablity between the two situations? What I also don't want to happen is that this testing becomes part of the normal blood bank records. I would not want somebody in the blood bank to see these results, not knowing they came from a bad draw, to select platelets, for example, based on the blood type from that sample. I also would not want a situation where the bad tube is left in the blood bank, then a crossmatch is ordered and a blood bank tech uses the bad tube, not knowing it was a suspect mislabeled specimen. Also, I want good documentation of the incident because of the possibility of it being used as evidence in a legal issue. The CLIA issue of who can order the blood typing comes from the fact that this blood type has not been requested by the patient's physician. There could also be an issue of informed consent. Generally the patient is consenting to procedures and tests necessary for their diagnosis and treatment. The coag testing in my example would have been appropriate under the terms of consent. The ABO/Rh was not necessary for diagnosis or treatment. As far as routine blood bank work which is actually ordered by the patient's physician, there is not an issue for add-on testing appropriate to the order. If a crossmatch is ordered, it is expected that the patient's blood will be typed and have an antibody screen. It would also be expected for the antibody ID to be run when the screen is positive. A separate order would not be needed for the antibody ID. It would not be appropriate, however, to take the blood bank samples and start running glucoses, HIV testing, or whatever you want without an order.

There are a lot of potential problems with the practice. In the mean time, I have made a first draft of a request form (attached). If the hospital fires a phlebotomist based on these results, the blood bank tech could conceivably have to testify in a wrongful termination lawsuit. I have heard of a recent case where an allegedly terminated employee filed a case appealing denial of workman's comp. The results could also be involved in a malpractice suit if patient care was affected by wrong lab results. There might even be an issue of informed consent if the ABO/Rh was not necessary for diagnosis or treatment of the patient's condition. I also would be concerned to have a mechanism to prevent these results from accidentally becoming part of the Blood Bank record, or the specimen accidentally being used for a crossmatch later. BBT_Request For Blood Typing Of Suspected Misidentified Sample.pdf

These are cases where a hematology result is discrepant from what the expect: the tech thinks that the phlebotomist drew the wrong patient.

We occasionally are asked to do ABO/Rh testing on samples from outside the blood bank because the test results don't match what is expected. Does anyone have a policy or opinions on this? Is it a violation of the CLIA requirement for laboratory tests to be performed only at the request of an "authorized person?"

What kind of cooler is the one rated at 12 hours?

Our current policy follows (with reference). I would like someone from U Mich to verify, but I believe their practice is the same as below. Note, not applicable for warm autoantibodies. ------------------------------------- For patients who have a history of previously identified antibodies, it is not necessary to repeat the antibody ID when they come back for subsequent transfusions, provided that ALL of the following conditions are met: 1) The antibody screen fits the history. For example, if the patient previously had Anti-K and Anti-E, the screen cells that are positive for E or K are currently positive, and the screen cells that are E neg K neg are not reacting. 2) Donor units are phenotyped negative for the patient's antibodies. In the above example the donor units must be negative for both E and K. 3) The phenotyped donor units are crossmatch-compatible at the Coombs phase as well as immediate spin compatible. Reference: W J Judd, S H Butch, Repeat Antibody Identification Studies: How Much Is Enough?, Transfusion, 2002—Vol. 42, Supplement.

Hopefully most transfusion services are aware that they have to register with FDA, and thus will be inspected by FDA if they "manufacture" products. "Manufacturing" includes drawing donors and making components (other than splitting components). Even if the facility does not draw donors, but they leukoreduce products in the lab, or irradiate, they must be registered. I recently found that they require registration for preparing reconstituted whole blood. I am curious what people think of this and how they are handling it. From this page: http://www.aabb.org/Content/Programs_and_Services/Government_Regulatory_Issues/fdatranscripts2008.htm Question 37: I have a question regarding exchange transfusion. Can we issue AB plasma & RBCs in two separate bags that have been sterile docked together, but separated by use of a clamp so that the RNs can open the clamp and transfuse the product? Do we need FDA registration to do this? Response: If you sterile-dock plasma and RBC units together and issue it as a final product, you are performing a manufacturing step that is not covered by the exemption from registration in 21 CFR 607.65(f). You must register as a hospital blood bank. If you combine all or part of a red cell unit and a plasma unit and issue it as a final product, this is also manufacturing not covered by the exemption from registration, so you must register as a hospital blood bank. If you issue separate red cell and plasma units, the administration of these products is a practice of medicine for which we would not require registration. We encourage you to take a quality approach. Decide what process will minimize the risk and maximize the benefit to your patients, then determine the requirement for you to register with FDA.

I have loaded the 2009 version on a different message. Look for "2009 cfr (fda) "

Here is a free copy of the Code of Federal Regulations (CFR) pertinent to Blood Banks. All but the 493 part is from 2009. The 2009 493 won't be available until about Jan 2010. 21CFR600-800-1270_42CFR493.pdf

These armbands are intended for a barcoded sample to go to the lab. The barcode then would print on the paperwork, which can be compared at bedside to the armband. In Sunquest, for example, there is a field RN which can be used for this. Subsequent draws could use a new armband or write the number on the tube. If you don't see the barcodes, then the barcode font is not installed on your computer. I should have tested this out before uploading it. The source of the font is http://www.squaregear.net/fonts/free3of9.shtml I have attached a copy of the font. To install it: 1) Unzip the file and place the files ("FREE3OF9.TTF" and "FRE3OF9.TTF") somewhere on your computer. 2) Go to Control Panel -> Fonts 3) From the "File" menu, select "Install new fonts" and select the TTF files for installation. You may or may not have to reboot the computer for the fonts to be visible I also have attached a sample of what you should be seeing. Page1.pdf free3of9.zip

I didn't really like any of the commercial armbands, so I designed a set that would be easy to read, but with a barcode for scanning the sample into an LIS. The labels cost less than 2 cents each, not including the cost of the toner or the armbands. There are 67,600 unique, non-repeating armband numbers in the set. The barcode is Code 39, which should be readable by most scanners. The labels are designed to be printed on Avery 8195 label stock using a color laser printer. I have attached a starter set of 7,500 labels. If there is any interest, I can post the rest. ArmbandOutput001.pdf

As far as requirements go, the CLIA Interpretative guidelines state: There are no daily quality control requirements for reagent red cell panels used in antibody identification. Panel quality control is a combination of serological test results, such as: strength of reactions and patient phenotype; statistical probability, patient’s medical history; and laboratory standard of practice (i.e., how the laboratory handles compatibility testing for patients with unexpected antibodies). However, the QC requirements pertaining to new batch, lot, shipment of identification systems at §493.1256(e)(1) must be met. Reference: page 27 of: http://www.cms.hhs.gov/CLIA/downloads/apcsubk2.pdf

When dealing with random platelets we issue the whole unit and don't worry about splitting. If you are talking about pulling from an apheresis bag it depends on how you issue it. Other factors are whether you are using a sterile docking device, or whether you need leukoreduced product. With a syringe (which we won't make for plateletets) I would issue the amount required for transfusion plus 8-10 mL. Check with nursing staff to see what they need for dead space, if any, in their tubing. If given through a Y set we add 25 mL for the tubing. Watch for the volume ordered. Anything more than 15 mL/Kilo, or less than 10 mL/Kilo, might warrant double-checking. I once saw an order for 2000 mL for a premie!

I have used the Fisher thermometer (14-648-12) for everything from waterbath to blood warmers, including digital and glass thermometers. They cost less than $30. About 6 years ago when we last sent out the NIST glass thermometer for certification it was $100 every year plus shipping costs. I like the Fisher thermometer because the probe fit into the blood warmer where the IV tubing would go. The measuring part is at the tip of the probe. Here is a picture (the one at the bottom) is most like the real thing: https://fscimage.fishersci.com/images/F20378~wl.jpg

I have been using these thermometers for annually certifying all the other thermometers. They have a 2 year certification from manufacture. We usually have about a year and a half left when they arrive. When the certification is up I order a new one. Much cheaper than recertifying an old thermometer. Also no compaints from my FDA inspector, even though it is electronic. Thermometer (NIST digital), Fisher Scientific, 14-648-12

Here are some references, some of which are FDA 510k documents: http://www.fda.gov/CbER/510ksumm/k050036S.pdf http://www.fda.gov/cber/510ksumm/k980011S.pdf http://www.gbo.com/documents/Evaluation_K2_K3_Immunohematology_IDMTS_GelTest.pdf http://www.bd.com/vacutainer/faqs/

I got rid of the majority of the eluates, which were on cord blood from group O mothers. In the following situation we report out "Probable ABO" incompatibilty without doing an eluate: Mother = group O, antibody screen neg Baby = group A or B One rare situation where you can't figure out in advance is the case where the mother and the baby are ABO-compatible, and the mother's antibody screen is negative. This could be from an antibody against a low-frequency antigen that is present on the father's red cells. In this case the eluate would not react with your screen cells, but would be positive when tested with the father's red cells.

I am in favor of only testing cord blood of Rh neg mothers. Our hospital also tests the cord blood of group O mothers, which the doctors would not give up even when given documentation that it is not necessary. There is an ABC bulletin that states: "In a workup for anemia, there is no need to perform DATs on all infants of either Rh negative or group O mothers because the test often is positive (passive from RhoGam or anti-A, and has a very low predictive value for hemolytic disease of the newborn" Reference: http://www.americasblood.org/download/File/bulletin_v8_n3.pdf You can see all their bulletins at http://www.americasblood.org/go.cfm?do=Page.View&pid=74

I don't know of any data, but I remember years ago we had to use a serology rotator and monitor the room temp. I put the styrofoam lid from a shipping box on top of the serology rotator, then put the platelets on top of the styrofoam.

Mary, I tried opening it on a different computer than I used for uploading and had no problem. If Internet Explorer you right-click the "493.pdf" and do "Save target as" you will save a copy to your PC. Try opening from the PC. In Firefox the right click is "Save link as". The file probably requires acrobat reader 7 or higher. I tested it out with Acrobat Standard 8 and Acrobat Reader 9 and had no problems with either version. If you can be more specific about how you open the file and exact wording of the error message it would be helpful to troubleshoot.

The attached is a copy of the new 42 CFR 493 CLIA regulations (10-1-08). This edition was made available 1/27/09. There is a several month lag time for regulations. As far as I know, you can't find this anywhere else online other than right here on BloodBankTalk! I posted the current FDA regulations previously. If any one wants this merged into a single file with the FDA regulations, then post a message here and I will create and upload the file. 493.pdf