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 10.24.05.01 - Definitions
Universal Citation: MD Code Reg 10.24.05.01
Current through Register Vol. 51, No. 19, September 20, 2024
A. In this chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) "Commission" means the Maryland Health
Care Commission.
(2) "C-PORT study"
means the randomized clinical research trial that was conducted by the Atlantic
Cardiovascular Patient Outcomes Team (C-PORT) to determine whether nonprimary
PCI performed in hospitals without on-site cardiac surgery services is as safe
and effective as nonprimary PCI performed in hospitals with on-site cardiac
surgery services.
(3) "Nonprimary
percutaneous coronary intervention" means PCI capable of relieving coronary
vessel narrowing associated with coronary artery disease unrelated to
ST-segment elevation myocardial infarction and includes elective PCI.
(4) "Percutaneous coronary intervention
(PCI)" means a variety of catheter-based techniques, including balloon
angioplasty, capable of relieving coronary vessel narrowing.
(5) "Primary PCI" means PCI capable of
relieving coronary vessel narrowing associated with ST-segment elevation
myocardial infarction (STEMI) and is also known as emergency PCI.
(6) "Regional service area" means the area
used for planning for cardiac surgery and PCI services, as provided in the
State Health Plan, COMAR 10.24.17.
(7) "Registry" means the C-PORT E Registry of
Non-Primary PCI that follows-on the C-PORT E Study of Non-Primary PCI and that
is:
(a) Maintained by the Principal
Investigator in the C-PORT E Study of Non-Primary PCI;
(b) Overseen by the Johns Hopkins
Institutional Review Board;
(c)
Overseen by a Data and Safety Monitoring Board.
(8) "STEMI" means coronary vessel narrowing
associated with ST-segment elevation myocardial infarction.
(9) "Waiver to perform nonprimary PCI" means
a time-limited exemption from the requirements of COMAR 10.24.17.04E, Policy
5.0, by which the Commission permitted an acute care hospital without on-site
cardiac surgery services to perform nonprimary PCI services within the C-PORT
study.
(10) "Waiver to perform
primary PCI" means a time-limited exemption from the requirements of COMAR
10.24.17.04E, Policy 5.0, by which the Commission permits an acute care
hospital without on-site cardiac surgery services to perform primary PCI
services.
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