dmpollock

Note to Brush: There is an email address on the website for site-specific questions. We can't use the BloodBankTalk forum for that, with the no-advertising policy. On a more general topic, it sounds like you might be using Sunquest or some other system which generates pool numbers. Until Sunquest becomes more ISBT compliant, my inclination would be to label depending on how the source units are labeled. If they were codabar, I would label the pool with a codabar style label. If they were ISBT-128, I would label the pool with an ISBT-128 label. While it wouldn't be ISBT-128 compliant, I would use the pool number generated by the computer. A pool number like "P1234" can't be printed with a codabar font since codabar does not support characters like "P." Although some people might not consider this the "right" answer, I would be inclined to print the system-generated pool number using an eye-readable number as well as a code 128 barcode of that number. If your scanners can read ISBT-128 labels, they will be able to read code 128, since that is the barcode font that ISBT-128 uses. Rather than deal with all these issues, a lot of facilities simply quit making pools or aliquots. If they can't get their blood provider to pool or aliquot, they issue the product as-is. For example, instead of pooling 6 random platelets, they will issue 6 individually tagged products. I am curious how people are labeling their blood with the expiration dates if they are using preprinted ISBT labels. Are they hand writing the date on the ISBT label where the expiration date barcode would be, or using some other method?

The Circular of Information is approved by FDA as far as I know. Here is what it says (from page 19): Do not use the frozen component if there is evidence of container breakage or of thawing during storage. Plasma must be thawed in a waterbath at 30-37 C or in an FDA-cleared device. If a waterbath is used, thaw FFP in a protective plastic overwrap using gentle agitation. Thawed FFP should be infused immediately or stored at 1-6 C for up to 24 hours. If stored greater than 24 hours, the words “fresh frozen†must be removed.

Here is a copy of the Daily Maintenance form for the ECHO. It is redone as a word document. GalileoEchoMaintenanceRecord.doc

Would anyone be interested in sharing procedures, training checklists, competency checklists, etc. for the ECHO instrument? The instrument comes with "recommended procedures" on a CD. Are people rewriting these or using them as-is? So far I have modified the daily startup procedure. The bulk of it is copied from the Immucor procedure, but I added a lot of specifics. A copy is attached. (I write the procedures in HTML, but the attachment is printed to a PDF file.) Galileo Echo Daily Startup.pdf

When you get your echo you will get a pre-written validation book which will be very helpful. They will not give you guidelines on how many samples for correlation. We chose 40 as the minimum, but ran more. You need to decide how you are going to use the instrument to know what tests to validate. We use it for ABO/Rh, antibody screens, and panels. We will not use it for DAT's since the method is IgG only and DAT's should be run with polyspecific AHG. We will not use it for crossmatching units since the method will not pick up ABO incompatibility reliably (IgG only). We will not use it for cord blood testing because we don't want to clog it up with clots. Are you planning to interface to a lab system? We set up our interface in the test system. We set up fake patients with all 8 blood types, and ran them all on the ECHO to ensure they all transmit properly. We also test samples with pos and neg antibody screens. We then switched the interface to live, and are testing 100 samples currently. Under "general options" I changed the facility name so that instead of just having our hospital's name it says "History_____ Interface transfer OK_______ Hospital name" For the first 100 interfaced patients we are printing out the report after the Echo runs the test. Then we document the history check on the report. Last step we accept the interfaced results. If the LIS matches the Echo report, we mark "yes" on the "Interface transfer OK block" Since about half of the interface validation samples already a historical type, I will be able to add the 50 or so samples results to the initial correlation data.

You might want to switch to 3-4% cells instead of prediluted, and make them up fresh every day. It is very easy. Where I used to work we used to do this and never had problems. We used plastic screwtop tubes for the cells (the same as sendout samples) Preparation of 0.8% Screen Cells I and II (prepared daily) Label two test tubes "I" and "II," and label both with the date prepared. Pipette 300 µl of corresponding 3% screen cells into each. Add 300 µl MTS Diluent 2 to each Centrifuge 60 seconds. Decant supernatant. Pipette 900 µl MTS Diluent 2 into each tube. Mix before each use.

I use an online procedure manual. All files are HTML. The procedures are more concise, since you can say "Specimens: see specimen acceptance procedure" with a hyperlink to the specimen acceptance. Paper copies are no longer kept. You need a good backup process if you get rid of the paper copies. Annual review: I send myself an email with a list of procedures I reviewed, then save it is a PDF which is linked to from those procedures.

I have not used any commercial systems, but I have received samples of labels from LabelClinic and they meet ISBT specifications. I tested them with our SunQuest system and they worked perfectly.

The attached is a copy of the current FDA and CLIA regulations pertinent to blood banks. These were all downloaded today from http://www.gpoaccess.gov/cfr/index.html and combined into one file for reference. 21CFR600-800-1270_42CFR493.pdf

I have attached a copy of the current Circular for reference. Also I assembled all the FDA blood-related regs (21 CFR 600, 800, 1270 series and CLIA (42 CFR 493) into one file, which is attached. 21CFR600-800-1270_42CFR493.pdf coiwnv0702.pdf

The 16th edition has a bit more on this: Compatible IV Solutions No medications or solutions other than 0.9% sodium chloride injection (USP) should be administered simultaneously with blood components through the same tubing. Solutions containing dextrose alone may cause red cells to swell and lyse. Lactated Ringer's solution or other solutions containing high levels of calcium may overcome the buffering capacity of the citrate anticoagulant in the blood preservative solution and cause clotting of the component. AABB Standards allows exceptions to the above restrictions when 1) the drug or solution has been approved by the FDA for use with blood administration or 2) there is documentation available to show that the addition is safe and does not adversely affect the blood or component. Acceptable solutions according to these criteria include ABO compatible plasma, 5% albumin, or plasma protein fraction. Certain solutions are compatible with blood or blood components as noted on the package inserts reviewed by the FDA, including Normosol-R pH 7.4 (Hospira, Inc, Lake Forest, IL) and Plasma-Lyte-A injection pH 7.4 (Baxter Healthcare, Deerfield, IL). There are several formulations of Plasma-Lyte that are not isotonic or that contain calcium; package inserts must be checked to confirm compatibility with components. The literature reports the safe use of morphine, hydromorphone [Dilaudid (Abbott Laboratories, North Chicago, IL)], and meperidine administered as a bolus in the same tubing as red cells. However, high doses of meperidine added to the RBC bag have caused hemolysis. The literature is not extensive, so this practice should be used with caution and only when there is no other venous access available to allow separate administration.

I am aware of a case which may have contributed to a neonatal demise. Surgery ran epinephrine through the same line as platelets. If you remember your coagulation testing, epinephrine is one of the platelet activators used in platelet aggregation testing, so this mix could cause DIC. The anaesthesiologist said there is nothing in their training or literature prohibiting this practice. The anaesthesiologist also polled other anaesthesiologists who said they also will run blood products through the same line as other IV fluids when there is limited access. I would guess this is more common than blood bankers think. The platelet + epinephrine mix is a bad one. I don't recall ever seeing this reported in the literature. It might be worth warning your ER and OR staff.

The requirement for fingerprinting comes from NRC is mentioned in excerpt below from the AABB website. I would recommend compliance. You might be able to go during working hours when you get fingerprinted, since it is a job requirement. You also can find a reference at http://www.nrc.gov/security/byproduct/fingerprinting-workshop-slides.pdf Issue 4 – Additional Requirements for Enhanced Security of CsCl Sources It was noted during the workshop that the NRC has mandated increased security measures to reduce homeland security risk. The increased security measures include, but are not limited to, performing a trustworthy and reliability review and fingerprinting for unescorted access to secure areas. In addition, information technology personnel must undergo the same security measures because they are the staff that controls access to secure areas. The NRC has been collaborating with several manufacturers on hardening efforts that would increase the amount of time for unauthorized access to the source material; a pilot program to achieve a goal of greater than 60 minutes is currently under way. A representative from FDA/CDRH indicated that the proposed device hardening efforts would not impact the device’s 510(k) status.

I would like someone to print the ABO/Rh labels I have posted to see if they work OK. See ABO/Rh Full Sheet labels on http://freeisbt.googlepages.com

There are labels available for testing at http://freeisbt.googlepages.com/home and more will be posted soon.

"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)." Clinical Laboratory Improvement Amendments (CLIA) - Interpretive Guidelines for Laboratories - Appendix C http://www.cms.hhs.gov/CLIA/downloads/apcsubj.pdf

I have created a new website for free ISBT labels: http://freeisbt.googlepages.com/ Validation labels are currently available.

On my website for free Codabar blood labels at http://www.geocities.com/dmpollock I am planning to start building ISBT labels. It will all take some time. I would like to know whether there is any interest and what would be most desirable. I have barcodes for testing I can load soon (expiration dates, test DINs, product codes). These are designed for testing and validation, not for labeling. I am planning to make ABO/Rh quadrant labels. Then components. These will be standard size and suitable for labeling units. Does anyone need any of this? If so, what would you like to see first? Does anyone need a reduced size label that is smaller than ISBT standards, but will still scan?