exlimey

Interesting discussion. Yes, cardboard can carry dirt and/or insects, but to imply that the presence of such on supplies like saline cubes creates a risk to patients and staff is an extreme stretch. We don't live in a vacuum and most of us spend time outdoors with the dirt and bugs every day (potentially bringing them inside with us). A wipe with a damp paper towel should be sufficient to clean an obviously soiled outer container. If you talk to the manufacturer of the saline, I'm sure they would argue that the outer box is not merely a convenient shipping container, but also an integral part of the product itself, designed to support the flexible primary container and get the best performance from the product. After all, they've designed in a nice little tear-out section that creates a perfect hole for the spigot/tap.

But, but, but....you said "We QC the reagents". The equipment/instruments are qualified and deemed functional through calibration/certification/validation, and presumably, preventative maintenance.

Thank you, David. As I suspected. So why do two test systems using the same lot numbers of reagents need to be subjected to daily QC ? Let the debate begin.....

Very interesting, Sandra. I completely understand the intent of the regulations and I appreciate that first impressions of cleanliness of blood products are important. However, it appears that in an arguably overzealous attempt to keep everything "clean", the fact that the outside of any blood bag is not sterile is completely overlooked. The air to which the exterior of blood products are exposed (refrigerated or room temperature) is not sterile. But....this is not relevant because the product inside the bag is supposed to be sterile and appropriate precautions are used during infusion events. That being said, I like a clean, orderly and well-labeled refrigerator !

Please forgive my ignorance.....but do the regulations require facilities to "perform QC" on the reagents or the assay ?

Presumably predicted to be V-VS+ ? Might want to check on the hrB status, too.

My sympathies, Darren. That's a horrible situation. It's generally accepted that the best way to minimize HUMAN error is automation (with the proviso that the systems are well designed). If a LIS allows post-dated entries, it would seem logical that "scanning" would be the best option to back-fill the missing data. And, probably a lot quicker. If one is forced to perform manual data entry, the process should probably include a second check (verification), preferably by a second individual. Either way, not fun for anyone. Good luck.

Some caution may be appropriate. Most "colds" are indeed clinically insignificant and mere laboratory annoyances. Most of these are autoantibodies that can be avoided by pre-warming methods. However, some can be clinically important - there are examples of anti-Vel that behave exact as LaurieD describes, but are IgM, cold-reactive alloantibodies that can cause serious in vivo hemolysis. I think one case reported by Jill Storry was actually fatal. Another nasty beastie in this category is anti-P+P1+Pk (anti-Tja, in the old vernacular). I would suggest that a Reference Laboratory take a look at the sample (the Blood Bank of Hawaii is close ), just to give some assurance that the troublemaker is "just a cold auto". Pre-warming without an antibody ID may be dangerous. Just my two cents.

To paraphrase Malcolm: A proven responder may have "other stuff", too. A serological crossmatch is probably the best, and sometimes, the only way to detect it.

All of the above are excellent suggestions. I will have to get up earlier to contribute.

From reading the previous comments, both old and new, it appears that the manufacturer (Ortho) does not specifically require the bubble and therefore nothing is in writing (the Directions for Use). You may be out of luck trying to find something to reference.

I find it interesting that various users have been told/advised to use a pipette in a manner that may compromise the accuracy of the volume delivered. I'm sure the pipette instructions indicate to use vertically. Thankfully, the serological assays that are used by the Transfusion Medicine field have a wide range of tolerance. The "1-drop to 1-drop" concept is horrifying to many other pathology disciplines.

Agreed. The initial results using the Screening Cells still need to be resolved. "Non-specific" probably won't be acceptable. Please clarify - "Screening cell is positive with 2 lines(2+)". Does this mean that one, or two of the Screening Cells are reactive?

Agreed. Anything less than a full phenotype is useless. We don't even do that for Screening Cells, which are arguably a lot more important.

Excellent. It's not often that the IFU comes to our rescue.