Page 558 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Adm-002
SOP Title: Management of Medical Supplies & Devices | Storage Room & Cubicle Guidance
24-48 hours prior to the surgery and on the day of surgery, the CRC will check the temperature device to confirm whether any temperature excursions have occurred, report to the PI, Co-PI, CRCs, and sponsor and document and respond per protocol. If no significant excursions have occurred, the CRC will document the lot number and complete the device accounting log and scan and send to PI, Co-PI, CRCs, Delitra Houston, Rodneisha Powell, and sponsor. If a significant excursion had occurred, the CRC would coordinate an expedited shipment of new devices and return old devices (the surgeries may need to be rescheduled as appropriate). Chain of custody form will be signed, dated and timed.
On the day of the surgery, the ancillary staff under order of PI or CO-PI will take a device from Surgical Core to OR and complete the device accountability log; a copy will be scanned and efiled on the HC shared drive, and a copy emailed to the PI, Co-PI, CRCs, Delitra Houston, Rodneisha Powell, and sponsor. Chain of custody form will be signed, dated and timed.
Return Shipment of Devices:
CRC to coordinate with Xeltis Robert Kroslowitz on intended shipment and date of return of devices and
Rodneisha Powell and Delitra Houston, either at the end of the study or in the event of an unforeseen event. Upon mutual date of shipment, a calendar invite will be sent to Rodneisha and Delitra.
Accountability log will be completed, a copy scanned and efiled on the HC shared drive, and a copy emailed to the PI, Co-PI, CRCs, Delitra Houston, Rodneisha Powell, and sponsor.
Once the device accountability log was completed shipment is prepared from the Blood bank, the CRC will meet Rodneisha at Wayfinder: C3253 and confirm the contents with her presence, then taken to the mail room to be shipped out with security present. Chain of custody form will be signed, dated and timed.
Shipping label will be scanned, a copy efiled, and hard copy stored in the regulatory binder. Chain of custody form will be signed, dated and timed.