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Can 99mTc in vitro RBCs (UltraTag™) be prepared under the immediate-use exemption?
Yes, if a special standard operating procedure (SOP) is developed and followed whereby the number of needle puncture entries into the reaction vial is limited to two. Also remember that USP requires that blood manipulations be clearly separated from routine procedures and that they be controlled by specific SOPs to avoid cross contamination.
According to the manufacturer's documentation, the UltraTag™ preparation process involves the addition of 1–3 mL of a patient's blood to the reaction vial, which is allowed to react for 5 minutes. Contents from two syringes are then added sequentially, followed by up to 3 mL of a 99mTc-sodium pertechnetate solution after shielding the vial. The vial is incubated for another 20 minutes. The package insert preparation requires 4 puncture entries into the septum of the reaction vial. Some have argued that this described UltraTag™ labeling does not qualify for immediate-use or low-risk compounding because its preparation does not meet the requirement of "not more than two entries into any one container or package."
It appears that radiolabeling of RBCs using the UltraTag™ method can be performed "on the open bench" if the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standards (29 CFR 1910.1030) are followed. An important aspect of these standards is the use of personal protective equipment. Handling blood in a biological safety cabinet is desirable, but it appears that someone who is compounding could handle blood "on the bench-top" if they are supplied with and use "…appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices."