Page 435 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-106 SOP Title: Research Infusions
IP is in a bag or syringe. This is usually based on the amount of the IP that is to be administered. The syringe can accommodate a maximum volume of 60 mL. Volumes greater than 60 mL requires the use of a bag. The syringe unit is the Alaris 8110 Syringe Module. The bag unit, a.k.a. large volume, is the Alaris 8100 Infusion Pump Module. Refer to the Alaris System User Manual for more information. The User Manual should be available where you are infusing the patient or online at https://www.bd.com/en-us.
4.4 Verification
Research IP must be verified as all other medications. Verification indicates the rights of medication administration have been confirmed. The Rights of medication administration include; right patient, right medication, right dose, right route, and right time. Portable scanning devices should be used when available. Specific training must be completed and access granted by CMC to use the portable scanning devices, contact Research Education for this request. If unavailable, manual administration of start and stop times must be added to the electronic medication administration record (eMAR). Some IP may require dual verification with another registered nurse.
Prior to starting the medication, the following steps must occur:
• Identify the patient with name and DOB at minimum
• Scan the medication (when available)
• Assure the 3 C’s are verified:
1. The medication is connected to the correct IV.
2. Ensure that all clamps are unclamped.
3. Confirm programmed information is correct per order.
4.5 Documentation
Documentation of the medication administration required may vary per sponsor requirements. Hospital policy requires all medication administration to be documented in Epic. A general rule is to document in the electronic health record (i.e., Epic) in the same manner as the other nursing staff in the clinic/unit where you are infusing. Verify with the sponsor if there are any specific requirements for documenting in EPIC versus the study source documentation. This should be discussed with the sponsor dung study start-up. Most of the infusion documentation will be completed in the eMAR and Flowsheet sections of the patient’s EPIC chart.
4.6 Disposal
Disposal of empty IP bag/syringe and tubing may vary. The sponsor should let you know if the empty IP bag/syringe and tubing will need to be returned to the IDS Pharmacy or can be disposed of per hospital policy. This should be discussed with the sponsor during study start-up.
SOP No. R121, Date: 06/16/2020