The applicant hospital must have, and maintain, a signed written agreement with a hospital providing on-site cardiac surgery. This agreement must include, at minimum, these provisions:

(1) The nonsurgical hospital shall coordinate with the backup surgical hospital about the availability of its surgical teams and operating rooms.

(2) The backup surgical hospital shall provide an attestation that it can perform cardiac surgery during the hours that elective PCIs are being performed at the applicant hospital.

(3) In the event of a patient transfer, the nonsurgical hospital shall provide access to all clinical data, including images and videos, to the backup surgical hospital.

(4) The physician(s) performing the elective PCI shall communicate to the backup surgical hospital cardiac surgeon(s) about the clinical reasons for urgent transfer and the patient's clinical condition.

(5) The backup surgical hospital shall accept all referred patients.

(6) The applicant hospital shall have a signed transportation agreement with a vendor who will transport by air or land all patients that require transfer to a backup surgical hospital.

(7) The transportation vendor shall provide an attestation that its emergency transport staff are advanced cardiac life support (ACLS) certified and have the skills, experience, and equipment to monitor and treat the patient en route.

(8) The applicant hospital shall maintain quality reporting of the total transportation time, calculated as the time that lapses from the decision to transfer the patient to arrival in the operating room of the backup surgical hospital. The total transportation time must be less than 120 minutes.

(9) The applicant hospital shall provide a patient consent form that communicates that the intervention is being performed without on-site surgical backup. The patient consent form shall address the risks and mitigations including, but not limited to, emergent patients transfer, surgery by a backup surgical hospital, and the established emergency transfer agreements.