Lcsmrz

Same here ...

We've never had a similar problem using glass 12x75 tubes. Plastic tubes are a different story.

Some cell washers add AHG for you. These cells washers need more extensive function checking. We used ours for washing only, so we did the daily fill check and the weekly dispense voiume verification -- that is, until it started smoking and it was taken out of service. If check cells worked after washing, we said it was working well ...

We blood bankers tend to use the term "validate" very loosely. Most of what we call do is not really validation at all, but everyone knows what we are talking about when we say that. Obviously, I do not repeat lot-release studies when accepting a new shipment of a reagent. Nor do I repeat a clinical trial when changing vendors. But I also don't exchange reagents from different vendors as if they were interchangeable. In addition to qualifying the vendor, I review the product insert, SOP and forms to see if any changes are required, then notify staff that we are changing vendors and that no modification is required for use. And of course, I document the decision.

If the patient has not been transfused recently, autoabsorbtion in the refrigerator would be a good thing, reducing the titer of a cold autoantibody that I don't want to detect in the first place. We recentrifuge previoius samples to remove particulates that may form durng storage and to make sure the sample is still platelet-poor.

Serum becomes anti-complementary when stored on cells; it is traditional to remove serum from cells to preserve adequate complement levels. I use EDTA plasma, so this issue is obviously moot. Also, serum/plasma that remains on the cells may become "absorbed serum/plasma" if the patient was recently transfused. I think the chances of mislabeling the pour-off tube far exceeds the possibility of missing a weak allo-antibody. I ask my techs not to separate patient samples.

Assuming the platelets will survive normally and you're transfusing them for an incidental low count (<100?), anytime the day of surgery should be fine. If the patient is actively destroying them or is refractory, I like the one hour limit. If it's a patient undergoing splenectomy, I wonder if it's necessary, since the count should rebound post-Op.

Once we confirm that an antibody is clinically insigificant, we usually prewarm it away and give crossmatch compatible blood. Antibodies like Cw, Lu(a), etc, we give gel crossmatch compatible units.

We would have no knowledge of any change in the "keep ahead" order. Nursing informs us of a Keep Ahead order, and as a coutesy, we say "thanks". But it's up to them to do the ordering ...

Daily QC of ABO reagents is not required, since the results of the forward and reverse serve as their own check of each other. I probably wouldn't do it either, although it is an added cost. If you use the reagents for any other purpose, through, QC should be documented.

The UltraCE does not add AHG reagent, so I calibrate my saline volume to ensure proper filling. Check cells tell me if the wash is sufficieint. If used for something other than just washing, you have to calibrate it just like any other serological centrifuge. Tech Mmanual p.828-32

The standard means that the software cannot be furnished "pre-validated" on a disc. It must be loaded on the actual hardware on which it will be used and tested. A third-party can test it for you and give you the documentation, but the plan must be acceptable to you, and the final packet must be reviewed and approved. Some of the "fun" of validating a computer system is learning the in's and out's of the software and its configuration during the validation process. I always have a problem with sites that had no plan, no documentation that they executed it, and no final review and acceptance documented. Merely doing what the vendor gives you may not be sufficient - someone must review it and augment it with additional testing, if the original plan is not sufficient for your liking. And if you think it is sufficient, it still must be reviewed and approved in writing. If you are adding to an exisiting and validated enterprise system, my thinking is that is is not sufficient to add a terminal and a printer to the system and call your job done. Each workstation must be configured and tested to confirm that essential processes will work the way all the other wrokstations do. That includes when something breaks and must be replaced. But that's what it takes for me to sleep at night ...

I look at "rare" antisera as those you can't readily obtain. While my outdated Anti-S and Anti-Fya won't be replaced, I would not use something like expired Anti-E, Anti-C or Anti-K, except for training students and new employees. I obtain antigen-negative units from the blood center, rather than use expired antisera that passed my QC to select units for transfusion. I gave up years ago attempting to think of a proper QC scheme for testing the sensitivity, specificity and potency of expired antisera. One heterozygous postiive cell (Sorry, Dr Judd, if you're still lurking) and one negative cell doesn't do it for me, when dealing with an expired antisera. And I rarely do anything for the sole purpose of saving money ...

JohnD: Please stay in touch with this board and educate us! Most blood bankers have never heard of Metrology and think a certificate of accuracy and NIST traceability from the manufacturer means the thermometer is accurate to one-third of the scale division -- that's what we were taught years ago. Uncertainty and uncertainty budgets are meaningless topics, and we can't figure out how two brand new NIST traceable thermometers could differ by 2 C inside the same temperature-controlled device, life a refrigerator. My life was changed years ago after eating lunch with a Metrologist ...

I would research why they are higher than others: higher acuity patients, prev bad experience with BB, multiple lawsuits, etc. In the age of eXM, the C/T should approach 1. With ISXM, our C/T runs ~1.3, mainly because of GI Bleeders.

Being a capitalist pig, I'm a firm believer in "what the market will bear", as long as the government doesn't mandate that I have to buy something. Raise prices high enough, other competitors will appear, and I start shopping for a less expensive option. Actually, sounds more like our future auto industry, with the government designing the type of cars it wants, then making sure there are no imports to compete with them ...

Spin times is a major factor in TAT. Ask anyone working in a Stat Lab! Sample centrifugation is a function of the centrifuge model and the tube manufacturer. The former's manufacturer rarely specifies how to use their device, but the tubes come with a product insert that usually specifies the recommended settings ("at least" xxx times G at xx Mins) for separation. G has to be converted into your model's RPM for the installed rotor. I always verify the manufacturer's recommendation, and re-verify them preriodically if assay critical (like coag). There are a few centrifuges that are specifically marketed for spinning clinical samples, and their manual talks about recommended settings by tube type (Gel tubes, plasma tubes, clot tubes, etc). You still should verify the settings for your brand of tubes. I've found the greatest determinates in reducing spin times are using a swing-bucket rotor instead of a fixed angle one, and a high-speed motor (>5000 RPM).

Temperatures can vary significantly in refrigerators and freezers. For all of my calibrations, I rubber band them together and immerse them to the line on the stem in some appropriate solution for a sufficient time to approximate temperature equilibrium. Lately, I've been busy (read: lazy) and have been sending mine to a ISO calibration lab once a year.

Computer quotes are going to vary alot, depending on number of workstations needed, patient acuity level, need for ISBT printing, existing network infrastructure, level of support, etc. Your best bet is to research vendors and submit an RFP. You'll have more options, since you are a small blood bank.

You can classify your disasters any way that works best for you. The trick is to exercize your plan occasionally, so everyone is familiar with it when something does happen. We have one disaster plan that is activated by an administrator, plus downtime procedures for utilities, analyzer, computer, etc. Homeland Security alert levels don't correlate well with hospital disaster plans.

With only two players in the BB reagent business, it's easy for a third party to call something unfair ...

I can't think of any regulations forbiding the practice. We are a small site and store reagents,etc in both our refrigerator and freezer. But be aware that the temp ranges for reagents are sometimes different for blood products and non-blood products.

I have a smalll inventory, so I just move the untis on the side to wipe down the racks. The hardest is the bottom, which is difficult to get to and always the dirtiest.

We follow the Tech Manual for retypes: just recheck Rh type on RhPos units with no WeakD testing. We use Anti-A,B on Group O units, instead of Anti-A and Anti-B -- local tradition, more than necesssity. You should follow your change control procedure for making any changes. For us, this involves getting the MD approval, validating any computer modifications, revising the SOPs, retraining staff, implementing the change, and writing an after-action report.

I worked at two places that had on-line manuals. Both were large facilities that used PDF's in read-only diretories for security. They were easy to read, relatively easy to update, and had great complaince with tracking software. The only thing I missed was a meta-search: being able to search all documents for the word "platelet" or "Anti-A", and the like. It would be interesting to see what happens if the medical director changed ...