Lcsmrz

While I've always felt more comfortable using a third, BB-specific identifier, many places I've recently worked go with just the Hospital ID band only. The thinking is that if the nurses can't get two identifiers right, a third one won't help either ...

The latest guidance from the FDA says that coolers not engaged in transport are indeed considered storage devices, and therefore to subject to the 1-6 C rule -- and probably the audio/visual alarm and recording graph requirement as well. Whether we agree with that ruling is immaterial at this point ... We've reduced our validated cooler storage time to 4 hours to stay within 1-6 C, and we still have plenty of takers! Our transfusion committee will take up compliance with the other requirements, but it looks like we're going to be forced to regress in getting an OR storage refrigerator, even though I think that's less safe of an alternative.

Your Quality Program should drive the annual review, and it should already be included in the plan: what's important every year to track? What focused studies were done, and what improvement was made? What audits/reviews were done, and what did they show? What's the plan for next year? Any training issues? What changes in service level are expected? Anything new on the BB horizon? etc, etc

I heard "what if someone was on fire and the computer was down ..." Personally, at that point, I wouldn't care what the MSDS sheet said, and I certainly wouldn't start looking for something made with flamable paper !!

Some labs have on-line network access to MSDS information, while others have 122 pounds of paper in 13 binders, requiring an FTE to maintain. What's the latest thinking on MSDS availability from AABB, CAP, JCAHO, etc?

This is one of those "risk assessment" type of question where the Medical Director gets to make the final decision after reviewing the evidence. Technically, anytime you can't prove by continuous monitoring that you've stored frozen plasma products at <-18 C, you're out of compliance and quarantining is warranted. Just showing that the products never thawed isn't good enough. But being able to show that the chart pen never travelled above -18 C, that the calibrated alarms never activated, and that every documented temp check was <-18 C is good evidence that the temp was always within range. But it's still his call -- he has to sleep at night!

I'm game for using any technique that helps define what you're concerned about and allow a good night's sleep. If an RT or cold panel can prove that it's just a clinically-insignificant, cold-reacting antibody giving you fits, prewarm it away and move on!!

We eliminated microfilters after going 100% leukodepleted.

The item is a response to the CAP's move to a Quality Management System; the AABB has been using quality systems for over 15 years. QMS is an approach to build quality into a final product or service by undestanding the processes used to build or deliver it and by controlling those processes for consistency. The CAP item has several implications. First, you have to understand what your customers' need from you. While that may sound intuitive, just try to record your customers' requirements and expectations for a product or service on a piece of paper! Next, you have to decide what material is critical. Test tubes used to perform bench work may be a commodity, but the reagents used definitely are critical material. Each facility has to decide for themselves what is a critical material, but generally things with a lot number, temperature requirements, and an expiration date are a critical material and need to be controlled to produce a quality product or service. How you control them is always facility-specific, but should track the storage, testing and usage of the material from receipt to final disposition/use. Third, you have to understand what you need from your supplier. Licensure, transportation, contracts, notifications, and the like play a part in determining whether a supplier can meet your needs. On-going evaluation should be part of your program. Finally, there should be a defined process for selecting and evaluating suppliers of critical material. Price should never be the only criteria! The inspector will look for your process for critical material, then check for documentation that you're following it. The days of only dating a vial when opened are gone !! Larry Smrz, MBA, MT(ASCP)SBB, CQA(ASQ) Indianapolis, IN AABB and CAP Assessor

I've used them all and personally love SoftBank. It seems to be a bit keytroke-heavy, but it gets the job done with eXM. But I'm only a user and don't have to maintain them or use them in other areas, such as Micro and AP. Sometimes a decision has to be made for the overall good of the lab, rather than one dept's preferences. Occasionally, the IS requirements drives the decision-making. You won't find one system that everyone likes ...

Our SOP states that drugs cannot be added to a blood bag and only Normal Saline can be used as a prime/flush solution for a blood infusion "Y" set. The nurses and anaesthesiologists routinely reuse the IV line after it's been flushed clear, though.

While we reconcile our inventory daily (start+in-out = end), we physically verify our inventory against the computer printout weekly. There is no regulation that I can think of regarding reconciliation, but you need to visually verify the condition of your stock daily and record it somewhere. Our daily inventory reconciliation makes sure no product has slipped throguh the cracks. It has to balance every day. And of course, you need to follow your own SOPs regarding inventry control.

I wonder if regualtions govern the transport of the patient's own blood in their own vehicle. What would happen if there was a spill or an accident? Would the patient have to undergo HazMat training?

Most regulations say that things need to be "segregated," so something doesn't get used inadvertantly. The segregated areas should be labeled, and everyone should know where and how to segregate things. There should no problems identified within your system. There are many ways of segregating things in the same refrig/freezer. We place quarantined items in the same refrigerator as the current lots and units, but on their own labeled shelf (bottom) with a prominent tag/sticker on each item. Since we have only one freezer where everything is stored together, quarantined items are tagged and overwrapped, and stored as much away from the other stuff as we can manage.

Our QA Plan says we will continuously monitor blood storage device temperatures. In the event of a chart failure, we would use our downtime process, which documents temperatures every 4 hrs.

Some type of barrier is a great idea when opening specimens! But as in all engineering-type controls, it should fit your work situation . I dislike being informed of only one type of barrier available -- and I hate face shields in normal lab conditions, unless absolutely necessary. We use HemoGard tubes, which, when used properly, offer significant protection against sprays. But we have a pull-down type face shield installed on every workstation that do not obstruct your arms and hands as much.

We did away with the micro dose ages ago, but it was partially due to our patient population and the lack of anticipated need. Our OB-GYNs agreed to give full-dose below 12 weeks.

I like to have a microscope available for those "special" occasions ... The real issue is how to interpret things you see under the scope. I don't want techs with a light shake-off overreading things, nor do I want the significant weak or mixed-field reaction missed.

Not much more blood banking for a T2 designation ... You may have to up your Oneg inventory a bit, and make sure you have a workable Emergency Release process in place !!

Sounds more of a cost problem than a regulatory one ... anything that gets you to answer will work. Cheaper to screen out the negatives with an inexpensive kit, or spend money running flow on all of them? Deciding between K-B vs Flow Cytometry is a harder question to answer.

4 hrs also here. The thinking is the retained clots & debris in the filter would be at 4 hrs at the end of the period. Since most units are given in about 2 hrs, they can get 2 units per tubing.

I would follow the recommendation of the product insert of the reagent mfr. Not sure what ours says. Some things are just hard to give up emotionally ...

This is a major problem for every blood banker I've talked to !! I wonder if we can get that "clarification" in writing from the FDA ...

We use our computer system statistics on cancels to determine rejection rate and the reason. Blood Bank should apply their rejection criteria the same as any other lab area -- it's not the tech's fault if a sample is unacceptable, unless he/she drew it !! Any visual hemolysis is a cause for rejection, unless your SOP states otherwise. Hemolysis is a psoitive reaction, and you can't see it if the sample is already hemolyzed. I'll do ABO/Rh testing on a hemolyzed sample, though, unless I think there's some contamination.

The techs have total discretion when to switch from Oneg to Opos in an emergency. Most give out 2 Onegs while waiting for a sample, but always keep at least 2 Onegs on the shelf for women < 50 yo. If we're low on Onegs, they switch immediately on males or older females.