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10.24.05.00.htm 10.24.05.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 24 MARYLAND HEALTH CARE COMMISSION Chapter 05 Continuation of Authority to Provide Non-Primary PCI Through Participation in the Follow-On C-PORT E Registry Authority: Health-General Article, §19-101, 19-118, 19-120, and 19-120.1, Annotated Code of Maryland
10.24.05.01.htm 10.24.05.01. 01 Definitions.. 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
10.24.05.02.htm 10.24.05.02. 02 Purpose and Scope.. A. In 2007, the Commission established a one-time process by which certain licensed acute general hospitals without on-site cardiac surgery services were awarded time-limited research waivers from the requirements of COMAR 10.24.17.04E, Policy 5.0, and were permitted to provide non-primary PCI services as part of the C-PORT E study to assess the safety and efficacy of providing non-primary PCI services for certain patient groups without on-site c
10.24.05.03.htm 10.24.05.03. 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; and2) A Registry hospital shall continue to satisfy the following requirements:. a) For institutional resources:.
10.24.05.04.htm 10.24.05.04. 04 Term.. A hospital’s ability to provide non-primary PCI [by virtue of the extension of its research waiver and entry into] in the Registry expires on the earlier of:A. The date upon which the Commission determines, through implementation in an update to COMAR 10.24.17 or other appropriate regulation, that the results of the C-PORT E study are sufficiently complete to guide public policy;B. A finding by the Commission that the C-PORT E study did not produce reli
10.24.05.05.htm 10.24.05.05. 05 Performance and Monitoring.. A. Each Registry hospital shall provide data to the Commission in a form and manner acceptable to the Commission.B. Each Registry hospital shall submit periodic progress reports in a format specified by the Commission and, at the conclusion of the research project and, if requested, at the end of the Registry, submit final reports in a form and manner acceptable to the Commission, as provided in COMAR 10.24.17.05D(2)d)C. Each Registry hospital
10.24.05.9999.htm 10.24.05.9999. Administrative History 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) ―.
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