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Advisor
Posts: 39
Registered: ‎05-17-2016
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TPA at bedside

Question about the immediate use provision. TPA is historically mixed at bedside typically in the ED. IF we have enough notice, we try and mix it in the cleanroom, but sometimes this is not an option. Trying to keep this a low-risk level CSP to be compliant with immedaite use CSPs.

 

Here is the question. If i use a dispensing pin on the 100mg TPA vial, and then access the dispsensing pin once to reconstitutue, once to pull out the bolus dose and again to pull more solution to make desired  dose in the vial (to leave the patient dose in the bottle and then hang the bottle), is this considered low-risk because I have only penetrated the vial once with the dispsensing pin. Or, does accessing the dispening pin count as an "entry" into the vial (as described in <797> low-risk level compounding, no more than 2 entries into any one container).