Sec. 10.24.05.03. Conditions for Maintaining Authority to Perform Nonprimary PCI and Participation in Registry

A. A Registry hospital shall maintain compliance with the following requirements:

(1) A Registry hospital shall meet the criteria established in the manual of operations of the C-PORT E Registry of Non-Primary PCI that follows-on the C-PORT E Study of Non-Primary PCI; and

(2) A Registry hospital shall continue to satisfy the following requirements:

(a) For institutional resources:

(i) Maintain a patient prioritization plan that guarantees that a patient who requires primary PCI for STEMI is given immediate preference for care in the cardiac catheterization laboratory;

(ii) Maintain a formal and properly executed written agreement with a tertiary care center that provides for the unconditional transfer of each non-primary PCI patient who requires additional care, including emergent or non-primary cardiac surgery or PCI, from the applicant hospital to the tertiary institution; and

(iii) Maintain its agreement with an advanced cardiac support emergency medical services provider that guarantees arrival of the air or ground ambulance at the applicant hospital within 30 minutes of a request for non-primary PCI patient transport by the applicant;

(b) For physician resources, A Registry hospital shall maintain adequate staff necessary for the provision of primary and non-primary PCI services, including a minimum of three interventional cardiologists who:

(i) Meet the requirements in the C-PORT E study research protocol and in COMAR 10.24.17, Table A-1;

(ii) Can be available on-site within 30 minutes when on call; and

(iii) Agree to abide by the Device Selection Criteria in the applicable Manual of Operations;

(c) For minimum volumes, A Registry hospital shall maintain a minimum volume of 200 PCI procedures during each year of its waiver;

(d) For follow-up of patients enrolled in the C-PORT E study, A Registry hospital shall maintain a patient follow-up rate of 98 percent; and

(e) For follow-up of patients enrolled in the Registry, A Registry hospital shall commit to patient follow-up through hospital discharge.

B. A Registry hospital shall notify the Commission in writing within 3 business days of the occurrence of any of the following:

(1) The hospital performs non-primary PCI on a patient not enrolled in the Registry;

(2) The hospital's primary PCI waiver expires, is relinquished, or is withdrawn;

(3) The hospital fails to notify the Commission of the death of or a coronary artery bypass surgery experienced by a patient participating in the Registry;

(4) The hospital fails to perform a minimum of 200 PCI procedures annually each year after it received a non-primary PCI research waiver from the Commission; or

(5) The hospital fails to meet and maintain the criteria required by the Commission for participation in the Registry, or its participation in the Registry ends for any reason.

C. A hospital required to give notice under §B of this regulation shall, on written notice from the Commission, immediately relinquish its authority to perform nonprimary PCI.