Lcsmrz

Not all hemolytic episodes are immune mediated, but that sure is suspicious. Any chance that the unit was hemolyzed due to mishandling, port problems, concurrent IV solution incompatiblity, etc? Also, were there intact RBCs in the urine, as in bleeding instead of hemoglobin clearance? You may find an antibody finally showing itself with the next crossamtch event.

We don't relabel the primary specimens or pour-off the plasma, but I hear it's a necessity for some automated equipment. In the General Lab, we leave the original name showing if relabeling is necssary, so each tech along the way can double-check it themselves -- and everyone double-checks labels routinely! While this is a good system, it's not perfect, since the wrong person can still be drawn, so we've been concentrating on the bedside ID and labeling process. Don't assume that once in 20 years is a good record -- you could have just been lucky or you have a low volume! Look closely at your system for weaknesses and see if they can be reduced or eliminated. JCAHO / equiv will require a Root Cause Analysis be performed, and there are several good techniques in the quality world for doing that.

CAP survey antibody samples are typically 3-4+. It would be difficult to believe that a properly working analyzer -- or for that matter, any other methodology -- would miss it without some human intervention or major malfunction. Sometimes with automated instrumentation, it's hard to mimmick a patient with a mock sample, and the analyzer could have gotten comfused.

We use the same cube for both the cell washer and the squirt bottle, and test for a neg DAT and the absence of hemolysis.

The same properties that make the bag flexible, strong, easy to manufacture, etc, makes it hard and brittle in the freezer. I train everyone how to handle the bags when cold and have few problems.

If I was laying in the trauma room coding, I think (assuming I could think at the time) that I would appreciate that the physician was focused on me, rather than on an emergency release form. There's always time to sign afterwards, and there's always ample documentation in the chart about how critical the patient's condition was.

I always interpreted this standard to apply to quantitative results only, between multiple analyzers or between the routine method and the backup method. For the same reason, we don't compare our automated UA dipstick results against the visual interpretation, and we watch our Rapid Streps vs cultures only to monitor the kit's sensitivity -- we had a problem previously. Comparing gel vs tube is comparing apples to oranges. Beyond your validation, exactly what information would you gain?

I eliminated splitting and pooling products from my SOP, so I wouldn't have to buy printers and register with ICCBBA. As I understand it, you have to go with ISBT, but you might be able to buy standard base label to make your own.

If your cabinet is for sterile processing, I can see doing sterility studies. But I wouldn't purposely infect it, just to see if you could kill it all. The disinfectant manufacturer may be able to provide you with their validation, which will be more extensive than what you would do. If your cabinet is being used for worker protection, I would certify the airflow and HEPA filter and make sure your procedures are being followed. You would do sterility studies to test your decontamination procedure, but it's nrmally not a sterile environment.

I can't believe so many of you Blood Bankers would consider the notion that we are capable of overdoing anything. Validation is such a critical part of our dotting-the-eyes-and-crossing-the-tee's mentality for so many years, that I am not able to sleep without killing at least one tree per month producing at least one doument just in case the inspector might ask to see something that I did not fully document. After all, it's for "the children" ...

Now THAT is an excellent point, John! I assumed that the transfusion was being ordered for symptomatic relief with a Hgb at around 8. But if the clinician is just chasing a number on a patient, then the transfusion was unwarranted, regardless of the Hgb. I found two references on normal Hgb variation in healthy adult males of 0.6 (bed, ambulatory). Throw in 75 years old, ASHD, COPD, diabetes, and who knows what else, and the 2 gm change does not seem that far out of the realm of possibilities. But I would throw in clinical symptoms to the transfusion trigger.

I plagerized mine from a site I inspected years ago. Three primes of 5% bleach, followed by 6 primes of DI water, followed by 3 primes of saline, then test with pH paper for 7.0. Even after this procedure is just completed, I bet we can grow something out of the line ...

I've seen patients with this type of Hgb variation before. Nursing home patients are usually drawn in the AM before they get out of bed. The clinician said there are fluid shifts that occur in the elderly outpatients after they get up, eat, and start moving around, whereas inpatients are usually in bed all day with little ambulation. Not sure how much of a variation would be seen, though.

This is a good question to ask the vendor. If studies have been performed to verify its perfromance with discontinuous storage on the analyzer, than they can send you a letter stating so. My guess is that they have not, given the problems with such a complicated validation. Some analyzers have a reagent timer, allowing you to start it on placement and stop it on removal.

I always ask the inspector to see the requirement, so I can "best assess our compliance with it." There are alot of inspectors that are only ciomfortable doing things their way ... At our facility, all patient specimens (any body fluid and blood bags) are transported in a biohazard bag, more out of tradition than anything else.

We run bleach through it monthly, rinse it excessively, then test with pH paper to make sure we got it all.

AABB also has a consulting service, with very knowledgeable people.

Per Fisher's Test, 2 pos / 5 neg equals 3 pos / 3 neg in statistical probability. The latter is just easier to remember.

The Fetal Screen is known to be a very sensitive screening test and somewhat subject to technique. We consider the K-B stain to be the gold standard in determining the extent of FMH and base our RhIg injecitons solely on it.

We are heading toward online transfusion documentation, including electronic bedside verification. Not quite there yet, though, but I'm not spending alot of time and effort on the manual form.

We strike the original (frozen) exp date and add a "Revised Exp Date" label above the bag label. The paperwork only reflects the thawed date and time.

One year sounds reasonable, depending on the resources you can throw at this project and the level of vendor support you get. Be careful of your client's documentation requirements, which may differ from what you think is reasonable -- there is alot of unreasonableness in the Blood Bank world!

We document the event and do at least a clerical check for anything, including hives. Our Medical Director might ask for cultures and a TRALI investigation, after talking with the clinician.

Using Fisher's method, you are getting a statistical probability that the pattern is the antibody specificity. Using less than 3 pos/3 neg just means you are altering your confidence to something other than 95%, maybe to the point that I would have trouble sleeping. At my facility, anything less than 3 pos/3 neg (with a few rare exceptions) leads to a search for more cells or sending the sample to the reference lab. But more important is eliminating all other significant possibilities from the mix, and we add the patient's antigen typing just to make sure I'm not fooled again. The AHG crossmatch confirms that a low freq isn't hiding in there somewhere. Panels and proper follow-up is a part of every educational opportunity here, to make sure everyone understands what is expected and why they are doing it. I purposely don't make them easy, to make sure everyone has to think before getting the right answer.

I vaguely remember years ago of someone being upset with our blood center when we leukodepleted several units Stat for them and immediately shipped them on ice, per their request. Turns out this close-by facility takes temps on arrival, and one was > 10 C. So much for customer service. Afterwards, we required the units be returned to the refrigerator for at least 1 hr after leukodepletion to make sure it didn't happen again. If returning issued FFP and meeting <10 C is important for you, do the same and let the patient bleed a little longer ...