Lcsmrz

Some facilities (mine included) have different specimen storage limits for different assays: ABO/Rh - either 2 or 14 days Abs - 2 days XM - either 3 or 10 days Ag Typing - varies by antisera etc

I think the AABB (www.aabb.org) has a publication on validation of pneumatic tube systems as blood delivery devices, but the site is down right now and I can't look it up.

RN tends to be a requirement for QA and Infectious Disease positions, since most of their time is spend educating other nurses about QA and Infectious Disease control. Despite our superior knowledge about these areas, MT's would simply lack the credability with nurses about clinical practices. Our Infectious Control nurse recently told me that, if she could just get physicians and nursing personnel to follow existing policies like handwashing, she'd be out of a job, and the lab have a third less work to do. I have no reason to doubt her. To their credit, I'm finally seeing RNs with quality credentials (ie, black belts) and advanced degrees in a non-nursing field. Maybe by the time I retire, we'll see some illumination in hospital-wide QA departments and real progress toward the goals of the IOM. In the meantime, I just hope the samples I get have the correct patient name on them ... Larry Smrz, MBA, MT(ASCP)SBB, CQA(ASQ) Indianapolis, IN

We perform weak D testing on all females <50 yo and all first-time Rh negs. Fetalscreens are done on problems >27 weeks.

Our policy is to give Rh Neg platelets to females <50 yo, and if none are available, to give 1 RhIg per 3 Rh Pos apheresis units transfused. We give very few platelets to females <50 yo, so I don't think this policy has ever been used.

We also issue antenatal RhIg on receipt of the specimen, but complete the testing on postpartum samples before giving it out. A few of our moms have residual RhIg (?) in their systems at delivery, and we use a 3-cell minipanel to rule out the other significant antibodies.

There are some special procedures in a lab where no QC exists -- autoabsorption sounds like one of them to me -- and interpretation is subject to the technologist's discretion, with respect to the other data from the patient sample. CAP comments that the Lab Director is charged with the responsibility to define such alternatives AS APPLICABLE. So, I would put the matter on the agenda of a BB or QA meeting and document the decision NOT to pursue alternative PT, based on "good clinical and laboratory practice."

I think it depends on what kind of volume you're encountering. A manual system works well up to a certain point, then computerization is almost a necessity. Many places use the BB computer system, since it's already validated and set up to track things easily. It would introduce yet another task for the BB staff, though. I haven't done tissues for years, but I suspect that the testing, tracking and tracing requirements apply to them, just like blood products. Using a spreadsheet for anything other than an automated clerk would introduce control functions that would make the system subject to the dreaded validation.

John: In their standards, both the AABB and CAP require some thought about acceptance testing of incoming supplies. CAP specifically comments that reagents and kits need to be checked before being placed into use, while the AABB verbage allows you to work it into your system. A brief look at ISO regs finds a requirement as well. Maybe we're talking about two different things ... Acceptance testing could be as little as a visual inspection of the container for leaks, or as much as parallel testing against the previous kit. It's whatever your facility defines as acceptable for that material. Both the criteria for acceptance and the incoming inspection need to be documented. For example, when a reagent shipment arrives, what do you do and how do you document it ??

Acceptance testing differs with every site and with every reagent, so it's important that your criteria be documented for each item defined as a critical material. We do this as part of our initial validation paperwork and add it to the receipt process. Since each item has its own acceptance criteria, every item in a shipment is verified on-reciept against these, and this is documented in the receipt log. We don't test each reagent in a shipment either, but we QC each reagent vial on opening and daily thereafter. Don't get me started on the usefulness of daily QC testing, though ...

Scheduling should not be an issue when deciding corrective action, nor should whether the units were actually Kell-negative. You could place yourself in jeopardy of a lawsuit for inconsistency or for placing your patients at risk for not dismissing a marginal employee. But you need to review the system and contributing factors to see if the system contributed to the error, and your HR department may be able to help. Did your computer detect the omission and issue a warning that was ignored? Is the midnight shift short-staffed and under workload or TAT stress? Is the employee error-prone, or is this the first serious error that the tech made in 20 years of otherwise exemplary service? Did the worker just work 13 straight nights, so you don't have to come in to give him a day off? Does the director have it in for midnight shift workers? On and on ... It's easy to say one big strike and you're out, but techs often struggle to make a bad system work, and an error of some magnitude is sometimes inevitable, given enough time. To me, ignoring a computer-generated warning would carry more weight, than missing a misfiled card in a manual system.

I understand that Ortho has an official prewarmed procedure that you could get from them, so there's a first step. We use prewarm technique only when we know what we're prewarming away. It works great for colder-reacting Ab's that we deem clinically insignificant and for attempting to ID another warmer-reacting Ab in the presence of a cold-reacting one. How you use it depends alot on your patient population ...

I've seen a veteran nurse do this once when a bag wouldn't flow and viscocity might have been a problem ... After priming the Y-tubing and spiking the blood bag, she shut the clamp below the drip chamber, took the unit off the IV pole and placed it low, then opened up the saline. It flowed into the bag without a problem. When she thought she had enough, she closed all the clamps, mixed it, and rehung the unit on the IV pole. After opening up the appropriate clamps, we found out that the unit had clots in it -- hence the flow problem -- and we exchanged it for one that did not. I'm pretty ignorant about nursing practices, but I was impressed!

We don't check the pH of our BB Saline any more. Since the advent of gel cards, we do little tube washing, mainly for Weak D or DAT testing. A note on the side of our box warns that a proper environment (15-30 C) is necessary for product stability. Perhaps the warehouse cannot maintain storage conditions ...

We consider the entire patient chart and all included reports to be confidential. No special statement is included.

We used a number-only wristband with our "John Doe" and multiple-trauma patient protocols. But I've always wanted to use it routinely. Getting and keeping the name and number correct on an ER wristband is more difficult than you think !! Actually, I don't care if the MRN or even the name is correct; if the patient was drawn and banded at the same time, whoever is wearing that wristband is compatible with the units I prepared ...

We document all reactions in the blood bank, as well as the physician response to the nurse's concern. The data are reviewed in transfusion committee. It never hurts to do a quick clerical check ...

Although we have both MTs and MLTs working in the blood bank, they undergo the same training, but have different job responsibilities. MTs have to sign-off on non-routine work (ABID, Ag typings, etc) that the MLTs perform, as well as the QC/PM.

We tag them when we get an "issue" order. Unless it's SPRCA- or HLA-matched, it's first-come, first-serve at our discretion. We send orders from the non-oncology physician who wants platelets "on hold at all times" to the Pathologist ...

In Indianapolis, several institutions have each BB patient double-ID'd and each BB specimen double-signed by the collector, plus one other nurse/phleb/etc. In the true nursing tradition, the collecting nurse gives the sample to another, who signs the first's name and approaches a third person to ask her to sign the tube, ..., and it arrives at the blood bank looking perfect !! NOTHING works better than consistently checking wristbands each and every event, even if it was just done 60 seconds ago. There is no adequate substitute short of inplantable RFID chips in the forehead or in the right hand (Rev 13:16) and appropriate automation.

True words of wisdom on validation. I remember in my early years on the bench -- when I had at least some hair -- that changes would be made based on what was presented as some seminar and on what the medical director would sign-off. We got off easy and learned the rest afterwards. Occasionally, it's because the mfr will no longer make the product or is having lot-release problems, as may be the case here. Things get sticky when time is a critical issue, and there is no other option, other than shutting down the transfusion service. In validation plans, I also like to see the (hopefully scientific) reasoning behind your choices: why 10,12,24,500 specimens? Makes me comfortable knowing you seriously thought out and researched what you're doing. Risk assessment information with the strengths/weaknesses of the new and the old methods/reagents allows customizing the validation plan, rather than relying on one SOP. I also would expect more from a 550-bed full-service community hospital, than a brand new 50-bed ortho-only specialty facility.

Nurses like the volume of the product, so they can set their infusion pumps. But unless you weigh each one and convert to volume, any ballpark figure may lead to large discrepancies with the one they have in their hand. We tell any nurse who calls that a packed cell is 325 mL +/- 10%, and they seem happy with it.

At that volume, why bother changing ????? I'm assuming that the Antibody Screen would also change to plasma and that we're not talking about a change in technology, such as from tubes to gel. I can't think of any required number of validation specimens, unless you get into automation. Because their volume is so low, a majority of the validation documentation could come from available research proving that the two methods are equivalent and detailing the strengths/weaknesses of the two and the reason for the change. You could also show that the new plasma tube is FDA-approved for BB work and use any training samples as part of the validation. Training for phlebs, tech and (if drawing blood) nurses needs to be documented, and SOP changes approved in advance. If the only change is the switch from serum to plasma, I would have my techs read the documentation I provided, maybe take a quiz, and perform one or two parallel tests drawn from the same person, just to see what the new tubes feel like and to document that they've been through it at least once.

Assuming your operation is quite small, it seems possible to develop a small in-house BB computer system from off-the-shelf software that performs no control functions, but you'd have to be very careful not to start relying on it in the future as your primary source of records in the future. It wouldn't be much more than an automated BB Clerk, and you couldn't start cross-checking blood types at XM or issue time, tracing and tracking things, or archiving data with it -- in other words, pretty useless ...

Reportable results are specific to your location and usually can be found on your state's Dept of Health website. In Indianapolis, I believe we still report anonymously, and the results are used for public health statistics only. Many states have a specific form for reporting results, which will also be available.