SMILLER

I just answered this question. My Score FAIL

Yeah, but once you had your fingers broken, you are back to not having a brake! Scott

Back in the last century we had a Coulter DACOS that seemed to break down every other specimen. It was very sensitive to temp and humidity changes. Probably due to it's age (like me). Scott

Here, a patient cannot be transfused without a BB armband, nor can blood be released from the BB without a paper requisition that has the patient's armband number (taken from the BB armband at bedside). Recently we had a nurse call up when they were ready to transfuse a patient in ER. She thought the T&S and XM was done, but the patient did not have a BB armband. This was a mistake by a phlebotomist. She had gone down to draw the T&S, was handed labels for more tests when she got down there, and drew the patient listed on the new labels. The problem here was that the patient on the new labels was not the same as the patient on the XM order. In the BB, because we will not transfuse a patient without a BB armband, we had the patient for the XM redrawn. That's when we realized the first draw was wrong, as the first specimen (the incorrectly labeled one) had atypical antibodies but the second did not (They were both O Pos). Without the strict BB armband policies, the first patient would have been transfused based on testing from another patient. Scott

We have a Hettich EBA-21 that seems to work OK. But we mostly use our Clay Adams sero-fuge 2001s . Not sure they still make the EBA-21s. Scott

Scott

I suppose if you are dealing with a cold-M (with positive reactions in gel) that you later successfully warm-away with tube testing, you could consider the antibody screen negative, when technically you would have a positive gel screen to begin with. But this is not the same as reporting a "positive" screen as negative! Scott

It's all electronic orders here, so the ER physician would be initially responsible; but the OR surgeon or anesthesiologist are responsible for any transfusions there, including uncrossmatched units. Scott

We have three electronic "uncrossmatched" orders that can be used: Emergency Release, Initial Resuscitation Cooler (2 RBCs and 2 plasmas), and a MTP initiation. These orders include physician documentation for uncrossed transfusions. Scott

That FDA press release caveat seems strange. Why don't you see if you can get a customer list from Sysmex and then call and ask how they are being used at similar facilities. You will want to talk to current users in any event. Scott

Our stuff is stored for 10 years, with a set of notebooks for each year. The patient's records are stored alphabetically within each year, with the current year's set is found in the Blood Bank. We do not collate individual patient's records from year-to-year. We do not search for expired patients in order to clean our printed records. We just toss a year's worth when it is 10 years old. Scott

At the end of the quoted policy above is this caveat: "Increase in temperature alone should not always constitute justification for a transfusion reaction work up. Nursing judgment should be used in evaluating symptoms and notification of physician." Here, we occasionally have problems with workups not being done, or direction from the blood bank to stop transfusions, against hospital policy. This is because there is sometimes a tendency to excuse reactions, such as a temp increase, to something other than an acute reaction to the transfusion. Now, every facility has to go by their own policy, but I would rephrase this as: "A significant increase in temperature, that may be attributable to some other cause, shall not constitute justification for ignoring what may be a life-threatening acute transfusion reaction. Nursing judgment should be used in evaluating symptoms only after consultation with the Laboratory Blood Bank, and attending physician." Scott

In the US we have been doing what you say is going to be the new policy for many years, except we only would do a DAT if the autocontrol was positive. I think that approach is pretty common. Orthos' panel A is for the ijnitial assessment. Most of the time, you will have a pretty good idea what you are dealing with with those results. Then, going by the 3 x 3 rule, w use other panels for rule-outs / rule-ins. Also, if there is no history, we antigen-type the patient for those antibodies that are being made. Scott

Ditto. For those of you who are still in evacuation areas, please get the hell out of there. Scott

It sounds like your SD is set too low. Try recalculating it based on recent results. Scott

Doesn't that analyzer run QC automatically? If it does, and there is a QC failure, it should not be sending those test results for patients to your LIS until the outlier is resolved. We run our PT and APTT QC every 8 hours like this but we have 500s. As a side note, we do run our Hema QC (manually of course!) every 8 hours +/- 1 hour. Inspectors do not have a problem with this so far. Scott

Do you then have a policy that references the References which describes where the references are referenced? Just wondering, Scott

For screen negative (currant and history) we do electronic crossmatches for trouble-free patients. We use blood bank specific armbands/specimen ID bracelets. When we do a repeat ABO/Rh it is done on the same specimen. Scott

A simple standard to go by would be to use the same acceptable limits for correlation that you use for QC. You cannot expect precision to be better for patient correlations than you get for QC, and it should be at least as good. Scott

TRM.30900 appears to apply to those situations that do not follow standard operating procedures and policies. However, if the hospital and blood bank HAS policies and procedures that cover release of uncrossed blood (approved by the Lab Medical Director -- just like every other P&P in the Lab), then the need for a "written authorization" would not be needed in those situations, as they are not "deviations from SOPs". Scott

Right, good point. The previously ID'd antibody does NOT need to be "reproved" (even if it is not showing up you will be screening units for it anyway). But any newly developed (i.e. de novo - Spanish for "not vocal" BTW) must be ruled out each time. Assuming they do not exist because a screen panel of 2 or 3 cells "matches' previous screen results just isn't adequate as far as appropriate "additional testing" that "must be performed". Scott

We have three "uncrossmatched" orders: uncrossed RBCs (which would include an indication of quantity), an "initial reforestation cooler" (of 2 unxm'd RBCs and 2 AB plasmas), and an order that initiates a Massive Transfusion Protocol. The MTP order stands until it is cancelled--we keep sending sets until then. Once a clean T&S is done, the MTP sets will be crossmatched product if at all possible. Scott

I think that originally in the US, (before a senator's wife endured a tragedy after a false-positive pap smear was reported by a 50-paps-per-hour histology aide causing the birth of CLIA) labs were sort of self-regulated compared to today. CAP and JCAHO for labs in general, AABB for blood banks, FDA for certian services, etc. So that the AABBs standards were, and still are, thought by many as de rigueur for any inspection organization as far as Immunohematology goes. But that doesn't mean they copy or follow AABB standards precisely -- US federal CLIA standard requirements are not as comprehensive as AABB (or CAP standards for that matter). Scott

Right. My sense is that the standards for a particular inspection agency, like JCAHO or CAP, are specific for that agency, and those are what your facility is inspected by. Having said that, I believe that when a Blood Bank area is inspected (in the US at least), the particular agency's standards are based on AABB guidelines. (Likewise ALL agencies must follow, at a minimum, CLIA legislative requirements for all areas of the clinical lab.) Scott

This is pretty much exactly what we do and neither the FDA or JCAHO inspectors have a problem with it. Scott