Ellen Zeigler
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Everything posted by Ellen Zeigler
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We're a large university center. The OR has 3 refrigerators that are monitored on the blood bank system. There is also a large cooler on wheels for liver transplants that has been validated. The blood bank and the OR are 3 floors apart. Overall our blood wastage is low for the size and complexity of the facility, however, it appears to be creeping up. A large number of the products wasted are a result of apheresis platelets or cryo being thrown into bags with red cells to return to the blood bank. We end up with cold cryo and platelets and warm RBCs. For room temp products (not expecting the product labeling to be sufficient) we put a green fluorescent 2" X 3/4" on each product that says DO NOT REFRIGERATE . Any suggestions? Thanks
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This surfaced about 9 months ago here (university center) from a different aspect in that the Orthopaedic Clinical practice is making their own in their office setting. After a bit of heartburn, I wrote their initial SOP so they could track supplies, etc. There are several FDA-approved devices that appear to be very simple (although I'll acknowledge that I have a blood center background). If you don't have any luck with moving the production to the office setting, the AABB Technical manual does have good instructions for making PRP. Good Luck
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Once you're firm on the requirements, I would suggest that you contact the nearest donor center and talk to their [laboratory] education person to determine if you can audit the required sections. The donor center then provides [to you I believer]the necessary documentation.
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You may want to search the FDA web site (devices) for Platelet rich plasma. We don't make it but there are some equipment systems that prepare it for the specifics of orthopaedics' practices (some of our sports medicine physicians do) that are FDA approved. They're making autolgous product not intended for coagulation correction, but for materials found in platelet granules
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24 hour samples for clinically significant antibodies
Ellen Zeigler replied to geni's topic in Transfusion Services
You may want to look at the package insert for the AHG that you use. Some have limitations that are specifically addressed to antibody screening, although there may be others that have/had limitations that would impact compatibility testing. -
Blood Specimen for Plasma/Platelet transfusion
Ellen Zeigler replied to khalidm3's topic in Transfusion Services
There are a couple of items that may be used to justify a blood type once each admission in addition to some of the others presented - it is a way to identify potential wrong blood in tube situations - in the current economy, patients are sharing their identities and this would be a way of at least knowing what type person you're transfusing - some Platletpheresis products and most FFP are larger volume products than they once were depending upon your supplier -
I pulled the Immucor Anti-Human Globulin (Anti-IgG, -C3d; Polyspecific), Isnert Code 3002-1; 10/2007. A crossmatch is an indirect antiglobulin test (you just don't know the RBC antigen profile when you start). In the secion under Specimen Collection and PReparation, it refers to regulatory agencies, if yours has a limit and for red blood cells from donor units, you may go throughout the dating period of the red cells. The other issue to keep in mind is that evacuated tubes are medical devices and for most - 14 days is the limit. You can always chose to go shorter. We do all in patients as 3 days and up to 14 days for pre admit testing (with no transfusion or pregnancy history)
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who's your antisera vendor?
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As long as you have an accurate pretransfusion history, the issue becomes the licensure of your AHG antisera. Those with Antibody require the an AHG x-match so its in the hands of the Cooms sera package instert
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I would stay away from putting labels on the bags. Adhesive would have to be FDA approved. at the moment my brain has gone blank as to its name but the vendors of BB labels would knw.
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The ASQ.org web site has a section on certifications. Within that section are outlines referred to as "Body of Knowledge" for each certification that ASQ has. Ifyou are auditing the CQA is the way to go. If you want a braoder base, you may also want to look at the CMQ/OE - the long way of saying certified quality manager.
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This is reportable to the FDA. This issue is not purity, etc, but the ability to track a product years from now if there is a lookback, recall or market withdrawal. The code is QC-97-19 The best way to get an idea of what is and is not reportable, is to look at the coding scheme. Obviously a lot are collection related issues, but not exclusively. If your crossmatch tags that are attached to the product are wrong, or you send out the wrong product, or patient. here's the link to the coding http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ReportaProblem/BiologicalProductDeviations/ucm129721.htm and the specifics for the failure to electronically release that is under QC and distribution: QC-97-19 Product not documented or incorrectly documented as issued in the computer (computer documentation is final check of issue process)
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One of our hospitals washes but only for limited situations. The typical product infused is CPD/CPDA-1, group O, leukoreduced, CMV neg, irradiated. For exchange transfusions or if blood less than 14 days old is not available, cells are washed. The intent is to remove K+ and metabolytes
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The probability of the collecting organization collecting a donor that is not eligible is slim. QC is performed with that procedures as with all others. More likely is the size of the patient, a patient who is on a diuretic, one who is actively bleeding and the hgb/hct is drawn prior to equilibration, or incorrect collection of the first specimen. /COLOR]
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I haven't looked at them in a long time, but preiously the only difference between a red cell (standard set ~ 170 u) and a component set was the length of the tubing.
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Accepting RBCs with alloantibodies
Ellen Zeigler replied to dcharland's topic in Transfusion Services
If the red cells have been prepared using an additive solution (adenine-saline, eg AS-1, AS-3, etc) there is minimal residual plasma left on the red cell. As the second approach - In the US they should be labeling with the antibody specificity. There are a lot of O negs out there with anti-D, C that you might readily be able to use. -
To back up - the refrigerator needs to be "off limits" during the mapping process. The intent is to get an idea of what the normal (without stress) limits and cycles are for the compressors and fans. Do you have hot spots, or cold spots? It gives you the background that you can then [potentially] make more educated guesses on excursions out of range, i.e., normal for the refrigerator, or not.
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In my former life with a large blood supplier, we were required to map our refrigerators. The brain is a bit rusty after 7-8 years but it was not 20 days. It was a continuous process that if memory serves logged temps every 10 minutes for at least 24 (maybe 48 )hours. If we had walk-in coolers with dual compressors we were mapping each compressor (and they really are different). The temperature mapping equipement had multiple probes and the storage equipment had to have a certain level of materials (sometimes we refrigerated carboys of saline to get the volume up) becasue refrigerators/freezers that are "full" operate more consistently. The four hours may have grown out of the AABB 5.1.8.2 "For storage of blood products. the temperatures hall be continuously mmonitored or the temperature shall be recorded at least every 4 hours." Hope this helps.
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UPDATE: Pre-Pooled Cryo. Expiration
Ellen Zeigler replied to Brenda K Hutson's topic in Transfusion Services
I would suggest you ask your supplier if they are sterile docking the cryos and if they add saline, if they've found a supplier's product that allows them to do that. If the answers are all yes - then you have yours - 6 hours; if not, it's an open system and no different from any room temperature stored open product - 4 hours -
A few questions about bone marrow aspirates
Ellen Zeigler replied to Hodag's topic in Tissue, stem cells, and bone marrow
Why not put some heparin in the syringe before the bone marrow? We mix Plasmalyte A with 50 IU/ml heparin for the marrow harvest and remove 1-2 ml of this into the syringes prior to collection. -
willing to share... we have several hospitals and have neonates & ortho speciality... we keep a thawed inventory of plasma so we found we needed forms to capture inventory thawing for unplanned downtimes and unit ABO/Rh confirmation. BB5100.05.FRM1Computer downtime Pretransfusion.doc BB5100.05.FRM2 Computer downtime Product Release.doc BB5100.05.FRM3 Computer downtime Unit Confirmation.doc BB5100.05.FRM4 Computer dowtime Phenotyping.doc BB5100.05.FRM5 Computer downtime Product modification.doc BB5100.05.FRM6 Computer downtime Prenatal.doc
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The manufacture's instructions provide the minimum required and even for those of us in the US it is sufficient for the FDA. The bottom line as previously stated: a positive and negative for each test. A cell can be the control for more than one test, e.g. group O cell for anti-A, Anti-B and -A,B (if you're using it) and negative for antibody screening if that is what the instrument is doing and the phenotype is correct. Frequency is more the issue. It is also generally specified in the manufacturer's instructions. Does your machine stop working if QC not performed... you can back into it that way, although it's a bit of a waste of time. Daily... or each shift which then becomes [potentially] more expensive but makes your techs take responsibility.
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10% glycerol provides a conductivity similar to liquid (RBC/WB) products. The quantity of liquid should be less than or equal to the smallest container stored in the refrigerator. For frozen products ( less than -18C) you can move to 40% grlycerol or antifreeze again in the smallest quantities. If you don't want to use liquid at miminum. your probes should be in a container to prevent drafts (fans, all door openings) from activating your alarms. 10% glycerol also works for room temperature monitoring (platelets). If you make up you quantities of solution in large amounts (1L or more) add a few drops of household bleach and it will delay mold. Only a small amount as not to corrode your temperature probes. Bring the solution(s) to whatever temperature you're going to monitor before you place the probes in to cut down on the alarming while the solutions come to temperature
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These two CAP proficiencies have been around for a while. While expensive, you need to consider what testing you perform and how you will accommodate regulations on proficiency testing without them. Elutions at minimum may be part of your antibody identification process and subject to CLIA requirements, i.e. 42 CFR 493.857, 493.865. Titers may be necessary for treatment or determination of organ transplant eligibility, eg, kidneys
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Alert:Expiration Date of Pre-Pooled Cryo
Ellen Zeigler replied to Brenda K Hutson's topic in Transfusion Services
A consideration if your cryo is made in a closed or open system... the individual units of cryoprecipitated AHF may be connected to the pooling system by a sterile connection devise, however, typically the saline used to rinse the individual bags is not. Most bags of saline are made for infusion and do not have tubing to connect. You may want to contact your supplier and ask the question or request a copy of the procedure that they use.