1. A. In this chapter, the following terms have the meanings indicated.

2. B. Terms Defined.

   1. (1) “Commission” means the Maryland Health Care Commission.
   2. (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. (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. (4) “Percutaneous coronary intervention (PCI)” means a variety of catheter-based techniques, including balloon angioplasty, capable of relieving coronary vessel narrowing.
   5. (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. (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. (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:

      1. (a) Maintained by the Principal Investigator in the C-PORT E Study of Non-Primary PCI;
      2. (b) Overseen by the Johns Hopkins Institutional Review Board;
      3. (c) Overseen by a Data and Safety Monitoring Board.
   8. (8) “STEMI” means coronary vessel narrowing associated with ST-segment elevation myocardial infarction.
   9. (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. (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.

Authority: Health-General Article, §§19-101, 19-118, 19-120, and 19-120.1, Annotated Code of Maryland

Effective date: October 22, 2007 (34:21 Md. R. 1915)

Regulation .02C amended as an emergency provision effective April 11, 2009 (36:10 Md. R. 714); amended permanently effective July 16, 2009 (36:14 Md. R. 984)

Chapter revised as an emergency provision effective March 23, 2011 (38:8 Md. R. 504); revised permanently effective June 13, 2011 (38:12 Md. R. 705)

Regulation .04A amended effective October 17, 2011 (38:21 Md. R. 1278)

Chapter revised effective March 4, 2013 (40:4 Md. R. 346)