Step 1: Designate an Authorized Representative to complete the certification process and oversee implementation and compliance with the HEPZATO KIT REMS on behalf of the Healthcare Setting.

Step 2: Have the Authorized Representative review the following materials:

• Product’s Prescribing Information including Instructions for Use,
• Program Overview, and
• Didactic Modules

Step 3: Have the Authorized Representative complete the Healthcare Setting Enrollment Form and submit to the REMS Program

• Online
• By e-mail

Step 4: The Authorized Representative must ensure oversight and compliance with the HEPZATO KIT REMS by:

• Ensuring that the percutaneous hepatic perfusion procedure team(s) that must include healthcare providers with expertise in interventional radiology, anesthesiology, and perfusion as described in the Instructions for Use.
• Ensuring that the HCPs in the PHP procedure team have completed the required training. If a new HCP is going to be added to the PHP procedure team, ensuring that they undergo the training requirements in the REMS training program.
• Ensuring that the percutaneous hepatic perfusion procedure team members have each performed one procedure in the first six months following completion of training, a second procedure in the next six months, and at least two procedures annually thereafter.
• Ensuring that there is an on-site interventional radiology suite or operating room with fluoroscopy and with resuscitation personnel, equipment, and medications.
• Maintaining records of each percutaneous hepatic perfusion procedure team member’s training.
• Maintaining records of the percutaneous hepatic perfusion procedures performed with HEPZATO KIT and the associated percutaneous hepatic perfusion procedure team members’ participation.
• Maintaining records that processes and procedures are in place and are being followed.
• Complying with audits carried out by Delcath Systems, Inc., or a third party acting on behalf of Delcath Systems, Inc., to ensure that all training, processes, and procedures are in place and are being followed.

If the Hospital designates a new Authorized Representative, the new Authorized Representative must review the REMS Training Program and complete a new Healthcare Setting Enrollment Form.

Step 1: Have percutaneous hepatic perfusion procedure team(s) that must include healthcare providers with expertise in interventional radiology, anesthesiology, and perfusion as described in the Instructions for Use.

Step 2: Ensure that the HCPs in the procedural team have completed the required training. If a new HCP is going to be added to the procedural team, ensure that they undergo the training requirements in the REMS training program.

Step 3: Have percutaneous hepatic perfusion procedure team members who have each performed one procedure in the first six months following completion of training, a second procedure in the next six months, and at least two procedures annually thereafter.

Step 4: Have an on-site interventional radiology suite or operating room with fluoroscopy and with resuscitation personnel, equipment, and medications.

Step 5: If there is a change in Authorized Representative, have a new Authorized Representative enroll in the REMS Program by completing the Healthcare Setting Enrollment Form.

Step 1: Before administering, obtain an authorization to dispense a HEPZATO KIT for each procedure by completing the Procedure Team Qualification Status Form and submitting it to the HEPZATO KIT REMS Coordinating Center.

Step 2: Upon receipt of the Procedure Team Qualification Status Form, by the REMS Coordinating Center, verification of the healthcare setting’s certification will occur. Once verified, the REMS Coordinating Center will provide authorization to dispense to the Authorized Representative via e-mail.

Step 3: Assess the patient for severe peri-procedural complications associated with HEPZATO KIT during and after the procedure for at least 72 hours. Document severe peri-procedural complication using the Severe Peri-Procedure-related Complications Adverse Events Documentation Form and submit to the REMS Coordinating Center.

For more information on HEPZATO KIT REMS requirements contact the REMS Coordinating Center at 1-833-632-0457.