Avid1234

Adding more plasma than 25 micro liters to a gel card test would not be following manufacturer's directions. It would require a validation study in order to implement.

Are you a patient or a healthcare provider?

The rosette test or fetal cell screen is used to screen for Rh positive fetal red blood cells in the maternal circulation after the baby is delivered. It would only be used in a hospital setting. The Kleihauer-Betke test is used to detect and quantify the presence of fetal red blood cells in the maternal circulation. It can be used to detect any type of fetal to maternal bleed regardless of the baby's blood type. It is used to detect a bleed caused by trauma, such as the mom taking a fall or being in a car accident or to determine Rh Immune Globulin (Rho gam) dosage post delivery if the rosette test is positive.

Negative antibody screen means that no common clinically significant red blood cell antibodies were detected in the sample. This includes anti-D.

My facility is 6 upgrades behind for our bb software. Does anyone know of any regulatory body that requires that you are on the most current software version?

I think that this has a lot to do with intent. If the intent is to hold the blood until it can be transfused, then it is storage. If the intent is to move the product from one place to another, then it is transport.

CFR 606.60 has a listing for laboratory thermometers and electronic thermometers. Is it possible that the electronic therms refer to the ones used to check the donor's temp? This would be a good "Ask the FDA" question for the AABB annual meeting session.

I know of another hospital that just documents that the temperature indicator on the device was acceptable.

We had to modify the slips that we issue with the blood product to include a spot to record the ICD 10 infusion site info. The forms are reviewed by biller to document the infusion route. Bottom line is: If I want to get paid, I had to do the change. We made labels to put on the slips with the required info in check boxes until we could get the new forms through the required approval process. J

We have had our Tango for about 5 years and have seen this issue a few times. It is a known issue and the FDA approved the instrument without making them fix it. First time was with a CAP sample. We have made it a policy that when we get back to back positive antibody screens on the same strip, we have to rerun the second patient. We had a case where the specimen of the second position patient was actually contaminated with antibody from the first patient and carried over into the third patient. The first patient had 3 antibodies and an anti-D titer of 8092! We know the second specimen was contaminated because when repeated it was still positive. When we tested the CBC specimen it was negative. The third patient was negative on the repeat. And I still love my Tango. JL