# COMAR Title 30 — Maryland Institute for Emergency Medical Services Systems (MIEMSS) ## Subtitle 08 — Designation of Trauma and Specialty Referral Centers ### Chapter 16 — Cardiac Interventional Center Standards **Authority:** Education Article, §13-509, Annotated Code of Maryland **Administrative History:** Effective date: May 3, 2010 (37:9 Md. R. 674) #### Regulation .01 Definitions. *COMAR 30.08.16.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Cardiac Interventional Center” means: (a) An in-State hospital that meets the requirements in Regulation .02 of this chapter and is designated by MIEMSS and approved by the EMS Board to receive patients transported by ambulance with acute ST-segment elevation myocardial infarction (STEMI) who need Primary Percutaneous Coronary Intervention; or (b) An out-of-State hospital that has entered into an agreement with MIEMSS and has been approved by the EMS Board to receive patients with acute ST-segment elevation myocardial infarction who need Primary Percutaneous Coronary Intervention. (2) “Jurisdiction” means a state, commonwealth, or the District of Columbia. (3) “Percutaneous coronary intervention (PCI)” means a variety of catheter-based techniques, including balloon angioplasty, capable of relieving coronary vessel narrowing. (4) “Primary PCI” means PCI capable of relieving coronary vessel narrowing associated with acute ST-segment elevation myocardial infarction (STEMI). (5) “STEMI” means coronary vessel narrowing associated with ST-segment elevation myocardial infarction. #### Regulation .02 Cardiac Interventional Center. *COMAR 30.08.16.02* A. A Cardiac Interventional Center shall be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located. B. If located in Maryland, a Cardiac Interventional Center shall: (1) Have one of the following: (a) A Certificate of Need (CON) issued by the Maryland Health Care Commission for a cardiac surgery and percutaneous coronary intervention (PCI) program; or (b) A current waiver issued by the Maryland Health Care Commission to provide primary percutaneous coronary intervention (PCI) services to STEMI patients meeting certain criteria without on-site cardiac surgery; and (2) Be a base station approved under COMAR 30.03.06. C. If not located in Maryland, a Cardiac Interventional Center shall: (1) Possess all government approvals required to provide Primary PCI under the laws of the jurisdiction in which it is located including, if required, a CON; and (2) Satisfy one of the following: (a) Be a base station approved under COMAR 30.03.06; or (b) Have the equipment necessary to conduct a dual consult between EMS and a Maryland base station for each Maryland patient transported to the Cardiac Interventional Center. D. A Cardiac Interventional Center shall: (1) Provide primary PCI as soon as possible and not to exceed 90 minutes from patient arrival, that is, door to balloon time of less than 90 minutes, for 75% of appropriate STEMI patients; (2) Provide primary PCI for appropriate STEMI patients 24 hours per day, 7 day per week; (3) Have adequate physician, nursing, and technical staff to provide cardiac catheterization and coronary care unit services 24 hours per day, 7 days per week; (4) Have a single call access system for receiving patients with STEMI; (5) Participate in the County Hospital Alert Tracking System (CHATS) program; (6) Abide by the Maryland Emergency Medical Services Inter-Hospital Transfer Guidelines published by MIEMSS in addition to any applicable transfer requirements in COMAR 10.24.17; (7) Communicate as soon as possible with the STEMI patient's primary physician and cardiologist regarding patient outcome; (8) Establish a Cardiac Interventional Center medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which: (a) Meets at least three times a year; (b) Reviews practice patterns; and (c) Modifies practice patterns as appropriate; and (9) Comply with the requirements of COMAR 30.08.04, including participating in: (a) A Cardiovascular Data registry jointly approved by MHCC and MIEMSS, including any registry data reporting requirements established by either MIEMSS or MHCC; and (b) State specialty care quality management activities of MIEMSS or of MHCC that are approved by MIEMSS. #### Regulation .03 Catheterization Lab. *COMAR 30.08.16.03* A Cardiac Interventional Center may receive STEMI patients transported by ambulance directly to the catheterization lab when approved by the base station physician if the catheterization lab has a physician, appropriately credentialed to evaluate and stabilize an acute cardiac patient, a registered nurse, and a technician, capable of activating the catheterization lab, immediately available in house when: A. The 12 lead EKG in the field is interpreted by an advanced life support EMS provider as a high probability of a STEMI; or B. The 12 lead EKG in the field has been reviewed by an ED physician, a cardiologist, or both, and determined to be a STEMI. #### Regulation .04 Site Reviews. *COMAR 30.08.16.04* A. Notwithstanding COMAR 30.08.02.06, MIEMSS may designate any Cardiac Interventional Center without a site review. B. Notwithstanding §A of this regulation, MIEMSS staff may conduct an onsite review to verify compliance with this chapter, including: (1) Inspecting the hospital's physical plant; (2) Interviewing team members and management personnel; (3) Examining the hospital's Cardiac Interventional Center related documents, including patient care records; and (4) Reviewing other materials considered appropriate by MIEMSS. C. The Maryland Health Care Commission staff may participate in any review conducted by MIEMSS to verify compliance with COMAR 30.08.15, including reviewing application materials, and participating in any on-site review. D. MIEMSS staff may participate in any review conducted by the Maryland Health Care Commission to verify compliance with COMAR 10.24.17, including reviewing application materials, and participating in any on-site visits.