Missouri Code of State Regulations
Title 19 - DEPARTMENT OF HEALTH AND SENIOR SERVICES
Division 30 - Division of Regulation and Licensure
Chapter 40 - Comprehensive Emergency Medical Services Systems Regulations
Section 19 CSR 30-40.760 - Standards for ST-Segment Elevation Myocardial Infarction (STEMI) Center Designation

A. A core team which provides administrative oversight and includes the following:

B. A STEMI call roster that provides twenty-four (24) hours a day, seven (7) days a week cardiology service coverage. The call roster identifies the physicians or qualified individuals on the schedule that are available to manage and coordinate emergent, urgent, and routine assessment, diagnosis, and treatment of the STEMI patients. A level I and level II STEMI call roster shall include, but not be limited to, the emergency department physician, interventional cardiologist, and others as appropriate. The level III STEMI center call roster shall include, but not be limited to, the emergency department physician and others as appropriate. A level IV STEMI center call roster shall include, but not be limited to, the emergency department physician and other qualified individuals as appropriate. (I-R, II-R, III-R, IV-R)

C. A clinical team appropriate to the center level designation that may include, but not be limited to, cardiologists, intervention-al cardiologists, clinical perfusionists, members of the STEMI call roster, members of the cardiac catheterization team, cardiothoracic surgeons, anesthesiologists, emergency department physicians, intensivists, and other STEMI center clinical staff as applicable. (I-R, II-R, III-R, IV-R)

A. A list of all STEMI team members; (I-R, II-R, III-R, IV-R)

B. Position qualifications and completion of continuing education requirements by STEMI team members as set forth in sections (1), (2), and (4) of this rule; (I-R, II-R, III-R, IV-R)

C. Management of sufficient numbers of STEMI patients by the STEMI team members in order to maintain their STEMI skills; (I-R, II-R, III-R, IV-R)

D. Participation by the core team and members of the STEMI call roster in at least half of the regular, ongoing STEMI program peer review system meetings as shown in meeting attendance documents. The STEMI medical director shall disseminate the information and findings from the peer review system meetings to the STEMI call roster members and the core team and document such dissemination; (I-R, II-R, III-R, IV-R)

E. Participation by STEMI team members in at least half of the regular ongoing STEMI program performance improvement and patient safety meetings and documentation of such attendance in the meeting minutes and/or meeting attendance documents. The STEMI medical director shall disseminate the information and findings from the performance improvement and patient safety meetings to the STEMI team members and document such dissemination. If a STEMI team member is unable to attend a STEMI program performance improvement and patient safety meeting, then the STEMI team member shall send an appropriate representative in his/her place; (I-R, II-R, III-R, IV-R)

F. Maintenance of skill levels in the management of STEMI patients by the STEMI team members as required by the STEMI center and the STEMI medical director and documentation of such continued experience; and (I-R, II-R, III-R, IV-R)

G. Review of regional outcome data on the quality of patient care by STEMI team members as part of the STEMI center's performance improvement and patient safety process. (I-R, II-R, III-R, IV-R)

A. The multidisciplinary team shall include a suitable representative from hospital units as appropriate for care of each STEMI patient. The units represented on the multidisciplinary team may include, but not be limited to: administration, emergency medical services, intensive care unit, cardiac catheterization lab, pharmacy, laboratory, intermediate care unit, cardiac rehabilitation, and discharge planning. (I-R, II-R, III-R, IV-R)

B. The multidisciplinary team members or their representatives shall attend at least half of the STEMI program performance improvement and patient safety meetings which shall be documented in meeting minutes and/or meeting attendance documents. (I-R, II-R, III-R, IV-R)

A. At least an average of four hundred (400) or more elective percutaneous coronary interventions per year over three (3) consecutive preceding years per STEMI center; and

B. At least an average of forty-nine (49) or more primary percutaneous coronary interventions per year over three (3) consecutive preceding years per STEMI center; and

A. It is recommended that the cardiac catheterization laboratory perform-

B. On-site emergency cardiothoracic surgical services or have a written plan that has been shown to be effective, a transfer agreement, and expedited transfer process for cardiothoracic surgery back-up in a nearby STEMI center with appropriate hemodynamic support capability for transfer. The written plan shall ensure that once a potential need for cardiothoracic intervention is identified, the STEMI patient can be evaluated by cardiothoracic surgery and in the operating room (OR) of the receiving hospital as expeditiously as possible; or (II-R)

A. If a STEMI center performs less than an annual recommended average of thirty-six (36) primary percutaneous coronary interventions over three (3) consecutive preceding years, it is recommended that the STEMI center perform an annual average of two hundred (200) or more elective percutaneous coronary interventions over three (3) consecutive preceding years, and it is recommended that all operators shall perform seventy-five (75) or more elective percutaneous coronary interventions and eleven (11) or more primary percutaneous coronary interventions per year. If an operator does not perform a recommended eleven (11) or more primary percutaneous coronary interventions per year, he or she shall have a mentoring relationship defined by written agreement with a highly experienced operator. This mentor may be a member of the same institution or belong to another institution. This relationship, established by a written agreement, may include, but not be limited to, on-site supervision and observation of performance during primary and elective percutaneous coronary interventions per year, review of mentee's patient encounters, review of mentee's outcomes, evaluation of mentee and hospital's process pertaining to elective and primary percutaneous coronary interventions, and guidance on methods to improve process, performance, and outcomes; or

B. If a STEMI center performs less than an annual recommended average of two hundred (200) elective percutaneous coronary interventions over three (3) consecutive preceding years, it is recommended that the STEMI center perform an annual average of thirty-six (36) primary percutaneous coronary interventions over three (3) consecutive preceding years, and it is recommended that all operators perform seventy-five (75) or more elective percutaneous coronary interventions and eleven (11) or more primary percutaneous coronary interventions per year or have a mentoring relationship defined by a written agreement with a highly experienced operator. This mentor may be a member of the same institution or belong to another institution. This relationship, established by a written agreement, may include, but not be limited to, on-site supervision and observation of performance during primary and elective percutaneous coronary interventions, review of mentee's patient encounters, review of mentee's outcomes, evaluation of mentee and hospital's process pertaining to elective and primary percutaneous coronary interventions, and guidance on methods to improve process, performance, and outcomes; and

C. Be able to provide on-site emergency cardiothoracic surgical services or have a written plan that has been shown to be effective, a transfer agreement, and expedited transfer process for cardiothoracic surgery back-up in a nearby STEMI center with appropriate hemodynamic support capability for transfer. The written plan shall ensure that once a potential need for cardiothoracic intervention is identified, the STEMI patient can be evaluated by cardiothoracic surgery and in the operating room of the receiving hospital as expeditiously as possible; and (II-R)

D. Provide cardiac intensive care capability; and (II-R)

E. Provide evidence of a written plan shown to be effective, a transfer agreement, and expedited transfer process for STEMI patients to higher level care in a nearby STEMI center with appropriate hemodynamic support capability for transfer; and (II-R)

F. The STEMI center shall collect, document, maintain for at least five (5) years, and make available for review by the department the following:

G. The STEMI center shall document that it collects and trends its past and current risk-adjusted outcome and process measures. (II-R)

A. A cardiothoracic surgeon and back-up coverage shall be available for level I STEMI centers and for those level II STEMI centers which provide cardiothoracic surgery; or (I-R/PA, II-R/PA)

B. A cardiothoracic surgeon and back-up coverage arrangements with a level I STEMI center or a level II STEMI center which provides cardiothoracic surgery shall be available for those level II STEMI centers that do not provide cardiothoracic surgery to ensure that the STEMI patient is in the operating room of the receiving STEMI center as expeditiously as possible, recommended within sixty (60) minutes of the time surgery is determined needed; (II-R)

A. The emergency department in the STEMI center shall provide immediate and appropriate care of the STEMI patient; (I-R, II-R, III-R, IV-R)

B. A level I STEMI center shall have a medical director of the emergency department who shall be a board-certified or board-admissible physician in emergency medicine by the American Board of Medical Specialties, the American Osteopathic Association Board of Osteopathic Specialists, or the Royal College of Physicians and Surgeons of Canada; (I-R)

C. A level II STEMI center shall have a medical director of the emergency department who shall be a board-certified or board-admissible physician; (II-R)

D. A level III and IV STEMI center shall have a medical director of the emergency department who is recommended to be a board-certified or board-admissible physician; (III-R, IV-R)

E. There shall be an emergency department physician credentialed for STEMI care covering the emergency department twenty-four (24) hours a day, seven (7) days a week; (I-R/IH, II-R/IH, III-R/IH, IV-R/IA)

F. The emergency department physician who provides coverage shall be current in continuing medical education (CME) in the area of cardiovascular disease as set forth in section (4) of this rule; (I-R)

G. There shall be a written policy defining the organizational relationship of the emergency department physicians to other physician members of the STEMI team; (I-R, II-R, III-R, IV-R)

H. Registered nurses in the emergency department shall be current in continuing education requirements as set forth in section (4) of this rule; (I-R)

I. At a minimum, all registered nurses assigned to the emergency department shall be determined to be credentialed in the care of the STEMI patient by the STEMI center within one (1) year of assignment in the emergency department, and these registered nurses shall remain current in continuing education requirements as set forth in section (4) of this rule; and (I-R, II-R, III-R, IV-R)

J. The emergency department in STEMI centers shall have written care protocols for identification, triage, and treatment of acute STEMI patients that are available to emergency department personnel, reviewed annually, and revised as needed. (I-R, II-R, III-R, IV-R)

A. Airway control and ventilation equipment including:

B. Suction devices; (I-R, II-R, III-R, IV-R)

C. Electrocardiograph, cardiac monitor, and defibrillator; (I-R, II-R, III-R, IV-R)

D. Central line insertion equipment; (I-R, II-R, III-R)

E. All standard intravenous fluids and administration devices including intravenous catheters and intraosseous devices; (I-R, II-R, III-R, IV-R)

F. Drugs and supplies necessary for STEMI emergency care; (I-R, II-R, III-R, IV-R)

G. Two- (2-) way communication link with emergency medical service (EMS) vehicles; (I-R, II-R, III-R, IV-R)

H. Equipment necessary to communicate with emergency medical services regarding pre-hospital ECG STEMI findings; (I-R, II-R, III-R, IV-R)

I. End-tidal carbon dioxide monitor; (I-R, II-R, III-R, IV-R)

J. Temperature control devices for patient and resuscitation fluids; (I-R, II-R, III-R, IV-R)

K. External pacemaker; and (I-R, II-R, III-R, IV-R)

L. Transvenous pacemaker. (I-R/IA, II-R/IA, III-R/IA)

A. The STEMI center intensive care unit shall have a designated medical director who has twenty-four (24) hours a day, seven (7) days a week access to a physician knowledgeable in STEMI care who meets the STEMI call roster continuing education requirements as set forth in section four (4) of this rule. (I-R, II-R)

B. The STEMI center intensive care unit shall have a physician on duty or available twenty-four (24) hours a day, seven (7) days a week in the STEMI center who is not the emergency department physician. This physician shall have access to a physician on the STEMI call roster. (I-R, II-R)

C. The STEMI center intensive care unit shall have a one to one (1:1) or one to two (1:2) registered nurse/patient ratio used for critically ill patients requiring intensive care unit level care. (I-R, II-R)

D. Registered nurses in the STEMI center intensive care unit shall annually maintain core competencies in the care of the STEMI patient and remain current in continuing education requirements as set forth in section (4) of this rule. (I-R, II-R)

A. Airway control and ventilation equipment including laryngoscopes, endotracheal tubes, bag-mask resuscitator, and a mechanical ventilator; (I-R, II-R)

B. Oxygen source with concentration controls; (I-R, II-R)

C. Cardiac emergency cart, including medications:

D. Telemetry, electrocardiograph, cardiac monitor, and defibrillator; (I-R, II-R)

E. Electronic pressure monitoring and pulse oximetry; (I-R, II-R)

F. End-tidal carbon dioxide monitor; (I-R, II-R)

G. Patient weighing devices; and (I-R, II-R)

H. Drugs, intravenous fluids, and supplies. (I-R, II-R)

A. Sheaths; (I-R, II-R)

B. Diagnostic wires; (I-R, II-R)

C. Diagnostic catheters; (I-R, II-R)

D. Manifold or contrast injector/delivery system; and (I-R, II-R)

E. Pressure tubing. (I-R, II-R)

A. Sheaths; (I-R, II-R)

B. Interventional guide wires; (I-R, II-R)

C. Interventional guide catheters; (I-R, II-R)

D. Balloon catheters-

E. Stents-

F. Balloon pump catheters; and (I-R, II-R)

G. Thrombectomy aspiration catheters or mechanical thrombectomy device. (I-R, II-R)

A. Balloon pump; (I-R, II-R)

B. The level I STEMI center cardiac catherization labs shall have percutaneous or surgically implanted circulatory assist devices (i.e., left ventricular assistive device (LVAD)). It is also recommended that the level II STEMI center cardiac catherization labs have left ventricular assistive devices; and (I-R)

C. Emboloic protection device. (I-R, II-R)

A. Airway control and ventilation equipment including:

B. Telemetry, electrocardiograph, cardiac monitor, and defibrillator; (I-R, II-R, III-R)

C. All standard intravenous fluids and administration devices and intravenous catheters; and (I-R, II-R, III-R)

D. Drugs and supplies necessary for emergency care. (I-R, II-R, III-R)

A. Thermal control equipment for patient and resuscitation fluids; (I-R/PA, II-R/PA with cardiothoracic surgery capability)

B. X-ray capability; (I-R/PA, II-R/PA with cardiothoracic surgery capability)

C. Instruments and equipment necessary for cardiothoracic surgical services; (I-R/PA, II-R/PA with cardiothoracic surgery capability)

D. Patient monitoring equipment; and (I-R/PA, II-R/PA with cardiothoracic surgery capability)

E. Resuscitation equipment readily available to the operating room; and (I-R/PA,

II-R/PA with cardiothoracic surgery capability)

A. Airway control and ventilation equipment including laryngoscopes, endotracheal tubes of all sizes, bag-mask resuscitator, sources of oxygen, and mechanical ventilator; (I-R, II-R with cardiothoracic surgery capability)

B. Suction devices; (I-R, II-R with cardiothoracic surgery capability)

C. Telemetry, electrocardiograph, cardiac monitor, and defibrillator; (I-R, II-R with cardiothoracic surgery capability)

D. All standard intravenous fluids and administration devices, including intravenous catheters; and (I-R, II-R with cardiothoracic surgery capability)

A. A minimum average of eight (8) hours every year of continuing education in the area of cardiovascular disease. This continuing education shall be reviewed for appropriateness by the STEMI center medical director to the STEMI program manager's/coordinator's level of responsibility; and (I-R)

B. Attend one (1) national, regional, or state meeting every two (2) years focused on cardiovascular disease. If the national, regional, or state meeting provides continuing education, that continuing education may count towards the annual requirement. (I-R)

A. Emergency department physicians in level I STEMI centers shall complete and document a minimum average of two (2) hours every year of continuing medical education in the area of cardiovascular disease, except for physicians who are emergency medicine board certified or board eligible through the American Board of Emergency Medicine (ABEM) or the American Osteopathic Board of Emergency Medicine (AOBEM) and who are practicing in the emergency department. (I-R)

A. Registered nurses assigned to the emergency department at level I STEMI centers shall complete and document a minimum of two (2) hours of continuing education every year in the area of cardiovascular disease; and (I-R)

B. Registered nurses assigned to the emergency department at STEMI centers shall maintain core competencies in the care of the STEMI patient annually as determined by the STEMI center. Continuing education earned in training to maintain these competencies may count toward continuing education requirements. (I-R, II-R, III-R, IV-R)

A. Any STEMI center that performs percutaneous coronary interventions shall report all percutaneous coronary intervention-related data, including the time from first medical contact or pre-hospital electrocardiogram STEMI identification to hospital door time and the time from first medical contact to balloon or device time. The percutaneous coronary intervention-related data is set forth and identified in the columns labeled "Level I & II STEMI Centers" and "Only for Level III STEMI Centers which are Performing Percutaneous Coronary Interventions (PCIs) (Only on Patients Receiving Percutaneous Coronary Interventions (PCIs))" in the document entitled "Time Critical Diagnosis ST-Segment Elevation Myocardial Infarction (STEMI) Center Registry Data Elements" dated March 1, 2012, which is incorporated by reference in this rule and is available at the Missouri Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570 or on the department's website at www.health.mo.gov. This rule does not incorporate any subsequent amendments or additions; (I-R, II-R, III-R)

B. Thrombolytic administration time which is the time from first medical contact or pre-hospital electrocardiogram STEMI identification to hospital door time and the time from hospital door to needle time; (I-R, II-R, III-R, IV-R)

C. Number of STEMI patients presenting within the treatment window for percutaneous coronary interventions and/or thrombolytic administration; (I-R, II-R, III-R, IV-R)

D. Number of eligible STEMI patients treated with percutaneous coronary intervention and/or thrombolytic administration; and (I-R, II-R, III-R, IV-R)

E. Time from when STEMI patient presents at the receiving STEMI center to time STEMI patient is in the operating room at the receiving STEMI center. (I-R, II-R if cardiac surgical capability)