Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 24 - MARYLAND HEALTH CARE COMMISSION
Chapter 10.24.05 - Continuation of Authority to Provide Non-Primary PCI Through Participation in the Follow-On C-PORT E Registry
Section 10.24.05.03 - Conditions for Maintaining Authority to Perform Nonprimary PCI and Participation in Registry
Universal Citation: MD Code Reg 10.24.05.03
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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