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Quality Control of Washed Cells


lindam923

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We have the Cobe 2991 Cell Washer and support 1 patient at our facility with washed red cells every 2-3 weeks. Our current Quality Control procedure is 80% red cell recovery using pre and post hematocrits on the unit that is washed. I can not find any literature stating the standard for acceptance. Our QC is running lower than 80% and we have had the machine serviced by Cobe. We

were trying to use protein removal as a standard however all samples we use are grossly hemolyzed.

Does anyone still use the Cobe 2991 Cell Washer and what do they use for a standard for their QC?

Thank you!!

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We use the 2991 for washed RBCs. We check for RBC recovery quarterly. We check for residual protein on all products. We have found the most success when fresh units are used -- older units tend to fail protein QC every time. We make a segment from the product tubing, spin the segment in a serofuge, then test the supernatant using a urinalysis dipstick. Because Standard 5.7.5.5 states that the process must remove "almost all of the plasma", we accept Negative and Trace values.

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Gross hemolysis sounds like a different issue than standard QC. Was the correct solution used? I've seen techs grab something other than normal saline when rushed. Was the unit contaminated? I'd do a culture. Did it get out of temperature somehow? What did it look like when you started washing? Our QC process is similar to heathervaught, but I would definitely investigate a grossly hemolyzed unit.

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We make a segment from the donut bag, spin the segment in a serofuge, then test for the protein. We don't use the waste line for this test (we do use it to QC other products).

I agree with Marilyn -- could be a solution issue. Not only the wrong solution (although all of the solutions that we stock for the 2991 should be compatible with RBCs, so I wouldn't suspect hemolysis even if the wrong one was used), but it could also be a manufacturing problem with the solutions. Maybe try a different lot of your 0.2% dextrose/0.9% saline.

Are you seeing the hemolysis on multiple units? Are they all coming from the same shelf in the refrigerator? Maybe you have a cold spot in the refrigerator that is causing the cells to lyse? Just trying to think outside of the box.

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My blood center also uses the 2991's. Since there is no standard defining what is or is not acceptable we don't perform any QC on this product. We do, however, on frozen/deglyced RBC and for those who don't know, these machines can be temperamental if not watched closely during runs.

I am also curious about those using protein levels. Did you determine a passing value through a validation of some kind?

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I am also curious about those using protein levels. Did you determine a passing value through a validation of some kind?

Not exactly. The Standard that I quoted before is quite vague and does not indicate how you determine that "almost all" of the plasma is removed. Our QA department and our Medical Director were both in agreement that Negative and Trace values indicated that "almost all" of the plasma was removed by the washing procedure.

We did perform a validation to qualify the urinalysis dipsticks for use.

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  • 9 years later...

Once a day, along with other daily reagent QC, we incubate at 37C for 15 minutes our anti-D reagent with D-negative QC cells.  We wash 3 times and test with anti-IgG.  Then check with Coombs control cells.  This simulates what we do with a tube screen.  If the reactions are negative and positive respectively, we say that that validates "QC" for the cell-washer.  JCAHO has not had a problem with this.

Scott

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