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Clear Biohazard bag inside an insulated bag https://www.hopkinsmedicalproducts.com/medical-specimen-transport-components/p/Insulated-Bio-Transport-Bag/

Our informed consent policy states that the practitioner, advanced mid-level provider, resident, or fellow performing a medical intervention or procedure which requires specific informed consent has primary responsibility for overseeing the informed consent process or verifying that appropriate informed consent is obtained. Additionally, these responsibilities may be delegated, after an order has been placed for the procedure, to a registered nurse (RN) or other allied health provider performing or providing the medical intervention, depending on the relative risk of the procedure and the training or experience of the health care team member, Informed consent is implied in emergency situations. A discussion and signed form is not required in these cases. The provider should document the emergent circumstances in the medical record and what reasonable attempts were made to reach a party with the power to consent.

https://www.fda.gov/OHRMS/DOCKETS/98fr/981218g2.pdf At no time should the total irradiation dose exceed 5000 cGy to any portion of the container.

How are facilities complying with the accreditation requirement to have a mechanism to ensure that fetal transfusion and fetal blood type ,when performed, is differentiated from that of the mother for intrauterine transfusions?

Are you sure its is a leukocyte reduction filter? That wouldn't seem to be of any benefit.

We perform quarterly alarm checks, setting the alarms off by manually warming the probes one quarter and the other three times we use the system to activate the alarm. We also compare the temperature reading to a NIST or NIST traceable temperature monitoring device at this time. Also the vendor comes and performs a temperature calibration annually. If the system has backup batteries it is also a good idea to periodically verify they still work. We still use charts as a backup monitoring system. The daily check is documented using the CTM and we also perform a daily comparison of the charts recorders to the CTM value. We do not routinely print any reports out.

Since there is a concern as to if the units are being transfused within 4 hours, it might be an opportunity to perform an audit to verify there is actually a problem. You have the time issued in the lab's LIS so you have that part tracked and there should be a mechanism to document when the nurses transfused the unit.

The maximum dose at any point in the container is 5000 rads or 50 Gy.

If there is a suspected transfusion reaction but when inspecting the post sample there is no hemolysis present is it necessary to compare the pre-transfusion sample to the post sample? This is in reference to AABB 7.4.2.1.

We had a policy approved stating that we would not be testing the low alarm value.

Does anyone use the ADAM-rWBC counter, if so do you like it.

The guidance is for donor centers that manufacture leukocyte reduced blood products. msdesoki your welcome

Here is the link to the guidance document http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/default.htm

There is a CBER Guidance document that provides the number of units to test based on a statistical method. Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion September 2012

It would be at a donor center.