Mo. Code Regs. tit. 19 § 30-40.760
Current through Register Vol. 49, No. 18, September 16, 2024
Section 19 CSR 30-40.760 - Standards for ST-Segment Elevation Myocardial Infarction (STEMI) Center DesignationPURPOSE: This amendment changes continuing education hours to be consistent with required continuing education requirements by national designating or verifying bodies of STEMI centers, removes continuing medical education requirements for physicians who are emergency medicine board certified or board eligible through the American Board of Emergency Medicine or the American Osteopathic Board of Emergency Medicine and who are practicing in the emergency department of a STEMI center, removes requirements relating to the operation or construction of a helipad at STEMI centers, and adds an option for STEMI centers to enter STEMI data into a national data registry or databank that will allow the STEMI center to perform its performance improvement, and patient safety program requirements.
(1) General Standards for STEMI Center Designation.(A) The STEMI center board of directors, administration, medical staff, and nursing staff shall demonstrate a commitment to quality STEMI care. Methods of demonstrating the commitment shall include, but not be limited to, a board resolution that the hospital governing body agrees to establish policy and procedures for the maintenance of services essential for a STEMI center; assure that all STEMI patients will receive medical care at the level of the hospital's designation; commit the institution's financial, human, and physical resources as needed for the STEMI program; and establish a priority admission for the STEMI patient to the full services of the institution. (I-R, II-R, III-R, IV-R)(B) STEMI centers shall agree to accept all STEMI patients appropriate for the level of care provided at the hospital, regardless of race, sex, creed, or ability to pay. (I-R, II-R, III-R, IV-R)(C) The STEMI center shall demonstrate evidence of a STEMI program. The STEMI program shall be available twenty-four (24) hours a day, seven (7) days a week to treat and evaluate STEMI patients. (I-R, II-R, III-R, IV-R) 1. The STEMI center shall maintain a STEMI team that at a minimum consists of- A. A core team which provides administrative oversight and includes the following: (I) A physician experienced in diagnosing and treating cardiovascular disease and STEMI (usually the STEMI medical director); and (I-R, II-R, III-R, IV-R)(II) At least one (1) other health care professional or qualified individual credentialed in STEMI care (usually the STEMI program manager/coordinator); (I-R, II-R, III-R, IV-R)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) (I) Level I and II STEMI centers shall have this coverage promptly available from notification of STEMI patients. (I-R, II-R)(II) Level III and IV STEMI centers shall have a regional networking agreement with a level I or level II STEMI center for telephone consult or telemedicine consultation promptly available from notification of STEMI patients; and (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)2. The STEMI center shall have a peer review system to review STEMI cases respective of the STEMI center's designation. (I-R, II-R, III-R, IV-R)3. The STEMI team shall have appropriate experience to maintain skill and proficiency to care for STEMI patients. The STEMI center shall maintain evidence that it meets the following requirements by documenting the following: 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)4. The STEMI center shall maintain a multidisciplinary team, in addition to the STEMI team, to support the care of STEMI patients. (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)(D) The STEMI center shall provide the services of a cardiac catheterization laboratory staffed twenty-four (24) hours a day, seven (7) days a week. The staff of the cardiac catheterization laboratory, referred to as the cardiac catheterization laboratory team, shall consist of at least the following: 1. An interventional cardiologist. The STEMI center credentialing committee shall document that the interventional cardiologist has completed appropriate training and conducted sufficient coronary interventional procedures. In addition, the interventional cardiologist shall annually conduct a sufficient number of percutaneous coronary interventions (PCIs). It is recommended that interventional cardiologist(s) perform seventy-five (75) or more elective percutaneous coronary interventions per interventional cardiologist per year and eleven (11) or more primary percutaneous coronary interventions per interventional cardiologist per year; and (I-R/PA, II-R/PA)2. Other healthcare professionals as deemed necessary. (I-R/PA, II-R/PA)(E) A level I STEMI center shall meet the following criteria:1. It is recommended that the cardiac catheterization laboratory perform- 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; andB. 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; and2. On-site emergency cardiothoracic surgical services as needed twenty-four (24) hours a day, seven (7) days a week. (I-R/PA)(F) A level II STEMI center shall meet one (1) of the two (2) options outlined below to qualify for a level II STEMI center designation- 1. Option one- A. It is recommended that the cardiac catheterization laboratory perform- (I) An average of two hundred (200) or more elective percutaneous coronary interventions per year over three (3) consecutive preceding years per STEMI center; and(II) An average of thirty-six (36) or more primary percutaneous coronary interventions per year over three (3) consecutive preceding years per STEMI center; andB. 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)2. Option two is a level II STEMI center that performs less than a recommended average of two hundred (200) elective percutaneous coronary interventions per year and a recommended average of thirty-six (36) or more primary percutaneous coronary interventions per year over three (3) consecutive preceding years or a recommended average of two hundred (200) elective percutaneous coronary interventions per year or more and less than a recommended average of thirty-six (36) primary percutaneous coronary interventions per year over three (3) consecutive preceding years. The following requirements for option two shall be met to qualify for a level II center designation: 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; orB. 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; andC. 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:(I) The STEMI center's average time from the STEMI center door to percutaneous coronary interventions device inflation time (i.e., door-to-balloon (D2B) times) is no more than ninety (90) minutes at least seventy-five percent (75%) of the time; and (II-R)(II) The STEMI center tracks and compares the time from the first medical contact to balloon times; and (II-R)G. The STEMI center shall document that it collects and trends its past and current risk-adjusted outcome and process measures. (II-R)(G) The STEMI center shall appoint a physician to serve as the STEMI medical director with appropriate qualifications, experience, and training. A STEMI medical director shall be appointed at all times with no lapses. (I-R, II-R, III-R, IV-R) 1. Level I and II STEMI center medical directors shall be cardiologists or interventional cardiologists. It is recommended that the cardiologist or interventional cardiologist be board-certified or board-admissible in interventional cardiology or cardiology. (I-R, II-R)2. Level III and IV STEMI center medical directors shall be physicians. A board-certified or board-admissible physician is recommended. (III-R, IV-R)3. The STEMI center shall have a job description and organization chart depicting the relationship between the STEMI medical director and other services. (I-R, II-R, III-R, IV-R)4. Level I and II STEMI medical directors are recommended to be members of the catheterization lab team call roster. (I-R, II-R)5. The STEMI medical director shall meet the continuing medical education (CME) requirements as described in section (4) of this rule. (I-R)6. The STEMI medical director shall be responsible for oversight of the education and training of the medical and clinical staff in STEMI care. This includes a review of the appropriateness of the education and training for the practitioner's level of responsibility. (I-R, II-R, III-R, IV-R)7. Level I STEMI medical directors shall participate in the STEMI center's research and publication projects. (I-R)(H) The STEMI center shall have a STEMI program coordinator/ manager who is a registered nurse, other clinical staff, or qualified individual. The STEMI center shall have a STEMI program coordinator/manager at all times with no lapses. (I-R, II-R, III-R, IV-R)1. The STEMI center shall have a job description and organization chart depicting the relationship between the STEMI program coordinator/manager and other services. (I-R, II-R, III-R, IV-R)2. The STEMI coordinator/manager shall meet continuing education requirements as described in section (4) of this rule. (I-R)3. The STEMI program coordinator/manager shall participate in the formal STEMI center performance improvement and patient safety program. (I-R, II-R, III-R, IV-R)(I) The STEMI center shall document a plan for and utilization of a specific and well-organized system as appropriate to center level designation for the emergency department to rapidly notify and activate the STEMI team or STEMI/cardiac catheterization lab team at the time the emergency department identifies STEMI on electrocardiogram (ECG) or verifies emergency medical services (EMS) STEMI electrocardiogram identification. (I-R, II-R, III-R, IV-R)(J) The STEMI center shall have a protocol detailing a one- (1-) call cardiac catheterization lab activation by emergency medical services at the time emergency medical services identifies a STEMI patient and as appropriate to the hospital's process. (I-R, II-R)(K) The STEMI center shall have a one-(1-) call STEMI team activation protocol or a STEMI/cardiac catheterization lab team activation protocol as appropriate for center level designation that establishes the following: 1. The criteria used to triage STEMI patients; (I-R, II-R, III-R, IV-R)2. The person authorized to notify STEMI team or STEMI team/cardiac catheterization lab team members when a suspected STEMI patient is in route or when a suspected STEMI patient has arrived at the STEMI center; and (I-R, II-R, III-R, IV-R)3. The method for immediate notification and the response requirements for STEMI team or STEMI/cardiac catheterization lab team members when a suspected STEMI patient is in route to the STEMI center. (I-R, II-R, III-R, IV-R).(L) All members of the STEMI team or STEMI/cardiac catheterization lab team call roster shall comply with the availability and response requirements. If not on STEMI center premises, then STEMI/cardiac catheterization lab team members who are on call shall carry electronic communication devices at all times to permit contact by the STEMI center and shall be promptly available. (I-R, II-R, III-R, IV-R)(M) The STEMI centers shall have a fibrinolysis protocol for instances when percutaneous coronary intervention is not achievable within an appropriate designated time frame and for when fibrinolysis is achievable within an appropriate designated time frame. It is recommended that the designated time frame follow nationally acceptable standards, for example as set forth in Appendix A number eight (8) entitled "Time to Fibrinolytic Therapy" included in the article entitled "ACC/AHA Clinical Performance Measures for Adults with ST-Elevation and Non-ST-Elevation Myocardial Infarction: A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures (Writing Committee to Develop Performance Measures on ST-Elevation and Non-ST-Elevation Myocardial Infarction)" as published by the Journal of the American College of Cardiology in 2006, volume 47, pages 236-265 which is incorporated by reference in this rule and is available at the Journal of the American College of Cardiology, Reprint Department Elsevier Inc., 360 Park Avenue South, New York, NY 10010-1710 or on the Journal of the American College of Cardiology website at http://content.onlineJACC.org. This rule does not incorporate any subsequent amendments or additions. (I-R, II-R, III-R, IV-R)(N) STEMI centers shall have transfer agreements between referring and receiving facilities. (II-R, III-R, IV-R)1. The STEMI center shall have a one-(1-) call transfer protocol to a level I or level II designated STEMI center that establishes the criteria used to triage STEMI patients and identifies the persons authorized to notify the designated STEMI center. (II-R, III-R, IV-R)2. The STEMI center shall have a rapid transfer process in place to transport a STEMI patient to a higher level of STEMI care when needed. (II-R, III-R, IV-R)(O) STEMI centers shall have cardiac rehabilitation services directed by a physician experienced in cardiac rehabilitation. (I-R, II-R)(P) The STEMI centers shall demonstrate that there is a plan for adequate post-discharge and post-transfer follow-up on STEMI patients, including cardiac rehabilitation and repatriation if indicated. (I-R, II-R, III-R, IV-R)(Q) The STEMI center shall maintain a STEMI patient log, keep this log for a period of five (5) years, and make this log readily retrievable during a review by the department. This patient log shall include all STEMI patients and shall contain the following information: 1. Response times; (I-R, II-R, III-R, I V-R)2. Patient diagnosis; (I-R, II-R, III-R, IV-R)3. Treatment/actions; (I-R, II-R, III-R, IV-R)4. Outcomes; (I-R, II-R, III-R, IV-R)5. Number of patients; and (I-R, II-R, III-R, IV-R)6. Benchmark indicators. (I-R, II-R, III-R, IV-R)(R) The STEMI center shall have a helicopter landing area. (I-R, II-R, III-R, IV-R)(S) STEMI centers shall enter data into a STEMI registry as follows: 1. STEMI centers shall submit data into the department's Missouri STEMI registry on each STEMI patient who is admitted to the STEMI center, transferred out of the STEMI center, or dies as a result of the STEMI (independent of hospital admission or hospital transfer status). The data required to be submitted into the Missouri STEMI registry by the STEMI centers is listed and explained 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. The data shall be submitted electronically into the Missouri STEMI registry via the department's website at www.health.mo.gov; or (I-R, II-R, III-R, IV-R)
2. STEMI centers shall submit data into a national data registry or data bank capable of being used by the STEMI center to perform its ongoing performance improvement and patient safety program requirements for its STEMI patients. STEMI centers shall submit data for each data element included in the national data registry or data bank's data system; (I-R, II-R, III-R, IV-R)3. This data required in paragraphs (1)(T)1. and 2. above shall be submitted electronically into the STEMI registry on at least a quarterly basis for that calendar year. STEMI centers have ninety (90) days after the quarter ends to submit the data electronically into the STEMI registry; (I-R, II-R, III-R, IV-R)4. The data submitted by the STEMI centers shall be complete and current; and (I-R, II-R, III-R, IV-R)5. The data submitted by the STEMI centers shall be managed in compliance with the confidentiality requirements and procedures contained in section 192.067, RSMo. (I-R, II-R, III-R, IV-R)(T) A STEMI center shall maintain a diversion protocol for the STEMI center that is designed to allow best resource management within a given area. The STEMI center shall create criteria for diversion in this diversion protocol and shall detail a performance improvement and patient safety process in the diversion protocol to review and validate the criteria for diversion created by the STEMI center. The STEMI center shall also collect, document, and maintain diversion information that includes at least the date, length of time, and reason for diversion. This diversion information shall be readily retrievable by the STEMI center during a review by the department and shall be kept by the STEMI center for a period of five (5) years. (I-R, II-R, III-R, IV-R)(2) Medical Staffing Standards for STEMI Center Designation. (A) There shall be a delineation of privileges for the cardiologists, cardiothoracic surgeons, and interventional cardiologists made by the medical staff credentialing committee in each STEMI center. (I-R, II-R)(B) The STEMI center shall credential and have different types of physicians available as listed below- 1. A cardiologist; (I-R/PA, II-R/PA)2. An interventional cardiologist; (I-R/PA, II-R/PA)3. A cardiothoracic surgeon as follows: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)4. An emergency department physician; (I-R/IH, II-R/IH, III-R/IH, IV-R/IA)5. An internal medicine physician; (I-R/PA, II-R/PA, III-R/PA)6. A diagnostic radiologist; and (I-R/IA, II-R/IA, III-R/IA, IV-R/PA)7. An anesthesiologist. (I-PA, II-PA) A. Anesthesiology staffing requirements may be fulfilled by anesthesiology residents or certified registered nurse anesthetists (CRNA), or anesthesia assistants capable of assessing emergent situations in STEMI patients and of providing any indicated treatment including induction of anesthesia. When anesthesiology residents or CRNAs are used to fulfill availability requirements, the staff anesthesiologist on call will be advised and be promptly available and present for all operative interventions and emergency airway conditions. The CRNA may proceed with life preserving therapy while the anesthesiologist is in route under the direction of the cardiologist/cardiovascular surgeon, including induction of anesthesia. An anesthesiologist assistant shall practice only under the direct supervision of an anesthesiologist who is physically present or immediately available as this term is defined in section 334.400, RSMo. (I-PA, II-PA)(3) Standards for Hospital Resources and Capabilities for STEMI Center Designation. (A) The STEMI center shall meet emergency department standards listed below. 1. The emergency department staffing shall meet the following requirements: 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)2. Nursing documentation for the STEMI patient shall be on a STEMI flow sheet approved by the STEMI medical director and the STEMI program manager/coordinator. (I-R, II-R, III-R, IV-R)3. The emergency department shall have at least the following equipment for resuscitation and life support available to the unit:A. Airway control and ventilation equipment including: (I) Laryngoscopes; (I-R, II-R, III-R, IV-R)(II) Endotracheal tubes; (I-R, II-R, III-R, IV-R)(III) Bag-mask resuscitator; (I-R, II-R, III-R, IV-R)(IV) Sources of oxygen; and (I-R, II-R, III-R, IV-R)(V) Mechanical ventilator; (I-R, II-R, III-R)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)4. The STEMI center emergency department shall maintain all equipment according to the hospital preventive maintenance schedule and document when the equipment is checked. (I-R, II-R, III-R, IV-R)(B) The STEMI center shall have a designated intensive care unit (ICU). (I-R, II-R) 1. The STEMI center intensive care unit shall ensure staffing to provide appropriate care of the STEMI patient. (I-R, II-R) 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)2. The STEMI center intensive care unit shall have written care protocols for identification and treatment of acute STEMI patients which are available to intensive care unit personnel, reviewed annually, and revised as needed. (I-R, II-R)3. The STEMI center intensive care unit shall have intensive care unit beds for STEMI patients or, if space is not available in the intensive care unit, the STEMI center shall make arrangements to provide the comparable level of care until space is available in the intensive care unit. (I-R, II-R)4. The STEMI center intensive care unit shall have equipment available for resuscitation and to provide life support for the STEMI patient. This equipment shall include at least the following: 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: (I) External pacemaker; and (I-R, II-R)(II) Transvenous pacemaker; (I-R, II-R)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)5. The STEMI center intensive care unit shall check all equipment according to the hospital preventive maintenance schedule and document when it is checked. (I-R, II-R)(C) The STEMI center shall have a cardiac catheterization lab. (I-R, II-R) 1. The STEMI center cardiac catheterization lab shall have angiography with interventional capability available twenty-four (24) hours a day, seven (7) days a week. (I-R/PA, II-R/PA)2. All members of the STEMI center catheterization lab and team shall maintain core competencies annually as required by the STEMI center. (I-R, II-R)3. Resuscitation equipment shall be readily available in the STEMI center catheterization lab. (I-R, II-R)4. The following diagnostic equipment shall be readily available in the STEMI center cardiac catheterization lab: 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)5. The following interventional equipment shall be readily available in the STEMI center cardiac catheterization lab: B. Interventional guide wires; (I-R, II-R)C. Interventional guide catheters; (I-R, II-R)D. Balloon catheters- (I) Compliant; and (I-R, II-R)(II) Non-compliant; (I-R, II-R)E. Stents- (I) Bare metal stents; and (I-R, II-R)(II) Drug eluting stents; (I-R, II-R)F. Balloon pump catheters; and (I-R, II-R)G. Thrombectomy aspiration catheters or mechanical thrombectomy device. (I-R, II-R)6. The following equipment shall be readily available to the STEMI center cardiac catheterization lab: 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)7. The cardiac catheterization laboratory shall maintain equipment according to the STEMI center's preventive maintenance schedule and document when the equipment is checked. (I-R, II-R)(D) The STEMI center shall have an intermediate care unit (e.g., step down unit). (I-R, II-R, III-R)1. The STEMI center shall have a designated medical director for the STEMI center intermediate care unit who has access to a physician knowledgeable in STEMI care and who meets the STEMI call roster continuing medical education requirements as set forth in section (4) of this rule. (I-R, II-R, III-R)2. The STEMI center intermediate care unit shall have a physician on duty or available twenty-four (24) hours a day, seven (7) days a week who is not the emergency department physician. This physician shall have access to a physician on the STEMI call roster. (I-R/IA, II-R/IA, III-R/IA)3. The STEMI center intermediate care unit shall have registered nurses and other essential personnel on duty twenty-four (24) hours a day, seven (7) days a week. (I-R, II-R, III-R)4. The STEMI center intermediate care unit registered nurses shall remain current in continuing education requirements as set forth in section (4) of this rule. (I-R)5. The STEMI centers shall annually credential registered nurses that work in the intermediate care unit. (I-R, II-R, III-R)6. The STEMI center intermediate care unit shall have written care protocols for identification and treatment of STEMI patients which are available to the cardiac unit personnel, reviewed annually, and revised as needed. (I-R, II-R, III-R)7. The STEMI center intermediate care unit shall have equipment to support the care and resuscitation of the STEMI patient that includes at least the following: A. Airway control and ventilation equipment including: (I) Laryngoscopes, endotracheal tubes of all sizes; (I-R, II-R, III-R)(II) Bag-mask resuscitator and sources of oxygen; and (I-R, II-R, III-R)(III) Suction devices; and (I-R, II-R, III-R)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)8. The STEMI center intermediate care unit shall maintain equipment according to the STEMI center's preventive maintenance schedule and document when the equipment is checked. (I-R, II-R, III-R)(E) The STEMI center shall have the following radiological and diagnostic capabilities: 1. The STEMI center radiological and diagnostic capabilities shall include a mechanism for timely interpretation to aid in the management of STEMI patients; (I-R, II-R, III-R, IV-R)2. Resuscitation equipment shall be readily available in the radiology department; (I-R, II-R, III-R, IV-R)3. The STEMI center radiology department shall have adequate physician and nursing personnel available with monitoring equipment to fully support the STEMI patient and provide documentation of care during the time the patient is physically present in the radiology department and during transportation to and from the radiology department; (I-R, II-R, III-R, IV-R)4. The STEMI center radiology department shall have x-ray capability with twenty-four (24) hours a day, seven (7) days a week coverage; (I-R/IH, II-R/IH, III-R/IA, IV-R/PA)5. The STEMI center radiology department shall have a radiological technician; (I-R/IH, II-R/IH, III-R/IA, IV-R/PA)6. The STEMI center radiology department shall have in-house computerized tomography; (I-R, II-R)7. The STEMI center radiology department shall have a computerized tomography technician; and (I-R/IH, II-R/IA)8. The STEMI center shall maintain all radiology and diagnostic equipment according to the hospital's preventive maintenance schedule and document when the equipment is checked. (I-R, II-R, III-R, IV-R)(F) All level I STEMI centers and level II STEMI centers with cardiothoracic surgery capability shall have operating room personnel, equipment, and procedures that meet the following requirements: 1. The STEMI center operating room staff shall be available twenty-four (24) hours a day, seven (7) days a week; (I-R/PA, II-R/PA with cardiothoracic surgery capability)2. Registered nurses in the STEMI center operating room shall maintain core competencies annually as required by the STEMI center; (I-R/PA, II-R/PA with cardiothoracic surgery capability)3. The STEMI center shall provide twenty-four (24) hours a day, seven (7) days a week heart team coverage. This heart team includes physicians, perfusionists, and qualified individuals on call and available to provide cardiothoracic surgery; (I-R/PA, II-R/PA with cardiothoracic surgery capability)4. The STEMI center operating rooms shall have at least the following equipment: 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)
5. The STEMI center operating room shall maintain all equipment according to the STEMI center's preventive maintenance schedule and document when the equipment is checked. (I-R/PA, II-R/PA with cardiothoracic surgery capability)(G) All level I STEMI centers shall meet post-anesthesia recovery room (PAR) requirements as set out below. Those level II STEMI centers with cardiothoracic surgery capability shall also have a post-anesthesia recovery room and meet the requirements as set out below. (I-R/PA, II-R/PA with cardiothoracic surgery capability) 1. The STEMI center post-anesthesia recovery rooms shall have registered nurses and other essential personnel on call and available within sixty (60) minutes twenty-four (24) hours a day, seven (7) days a week. (I-R, II-R with cardiothoracic surgery capability)2. Registered nurses who work in the STEMI center post-anesthesia recovery room shall maintain core competencies annually as required by the STEMI center. (I-R, II-R with cardiothoracic surgery capability)3. The STEMI center post-anesthesia recovery rooms shall have at least the following equipment for resuscitation and to provide life support for the STEMI patient: 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)4. Drugs and supplies necessary for emergency care. (I-R/PA, II-R/PA with cardiothoracic surgery capability)5. The STEMI center post-anesthesia recovery room shall maintain all equipment according to the STEMI center's preventive maintenance schedule and document when the equipment is checked. (I-R, II-R with cardiothoracic surgery capability)(H) The STEMI center shall have clinical laboratory services available twenty-four (24) hours a day, seven (7) days a week. (I-R, II-R, III-R, IV-R) 1. The STEMI center's clinical laboratory services shall have a written protocol to provide timely availability of results. (I-R, II-R, III-R, IV-R)2. The STEMI center's clinical laboratory services shall be able to conduct standard analyses of blood, urine, and other body fluids. (I-R, II-R, III-R, IV-R)3. The STEMI center's clinical laboratory services shall be able to conduct blood typing and cross-matching. (I-R, II-R, III-R)4. The STEMI center's clinical laboratory services shall be able to conduct coagulation studies. (I-R, II-R, III-R, IV-R)5. Clinical laboratory services at level I, II, and III STEMI centers shall include a comprehensive blood bank or access to a community central blood bank and adequate hospital blood storage facilities. (I-R, II-R, III-R)6. Clinical laboratory services at level IV STEMI centers shall include a blood bank or access to a community central blood bank and adequate hospital blood storage facilities. (IV-R)7. The STEMI center's clinical laboratory services shall be able to perform blood gases and pH determinations. (I-R, II-R, III-R, IV-R)8. The STEMI center's clinical laboratory services shall be able to perform blood chemistries. (I-R, II-R, III-R, IV-R)9. The STEMI center's clinical laboratory services shall have a written protocol for prioritization of the STEMI patient in comparison to other time critical patients. (I-R, II-R, III-R, IV-R)(I) The STEMI center shall have support services to assist the STEMI patient's family from the time of entry into the facility to the time of discharge or transfer, and the support services that were provided shall be documented. (I-R, II-R, III-R, IV-R)(J) The STEMI center shall have cardiac rehabilitation or a written network agreement for the provision of cardiac rehabilitation. (I-R, II-R, III-R) 1. Level I and level II STEMI centers shall have Phase I cardiac rehabilitation on site. (I-R, II-R)(4) Continuing Medical Education (CME) and Continuing Education Standards for STEMI Center Designation. (A) The STEMI center shall ensure that staff providing services to STEMI patients receive continued medical education and continuing education as set forth in section (4) of this rule and document this education for each staff member. The department shall allow up to one (1) year from the date of the STEMI center's initial STEMI center designation for STEMI center staff members to complete all of the required continuing medical education and/or continuing education requirements if the STEMI center staff documents that at least half of the required continuing medical education and continuing education hours have been completed for each STEMI center staff at the time of the on-site initial application review. The STEMI center shall submit documentation to the department within one (1) year of the initial designation date that all continued medical education and continuing education requirements for STEMI center staff members have been met in order to maintain the STEMI center's designation. (I-R)(B) The STEMI call roster members shall complete the following continuing education requirements: 1. Core team members of the STEMI call roster in level I STEMI centers shall document a minimum of eight (8) hours every year of continuing education in the area of acute coronary syndrome. All other members of the STEMI call roster shall document a minimum of eight (8) hours every year of continuing 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. This continuing education shall be reviewed by the STEMI center medical director for appropriateness to the practitioner's level of responsibility. (I-R)(C) The STEMI center medical director shall complete the following continuing medical education requirements: 1. Level I STEMI medical directors shall document a minimum average of eight (8) hours every year in the area of acute coronary syndrome. (I-R)(D) The STEMI center's STEMI program manager/coordinator shall complete the following continuing education requirements:1. A level I STEMI program coordinator/manager shall complete and document the following: 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)(E) STEMI center emergency department personnel shall complete the continuing education requirements for STEMI centers that are detailed below. 1. The emergency department physician(s) shall be current in cardiovascular continuing medical education. (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) 2. Registered nurses assigned to the emergency department shall complete the following requirements: 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)(F) Registered nurses assigned to the intensive care unit who provide care to STEMI patients shall complete the following continuing education requirements: 1. Registered nurses in the intensive care unit shall complete and document a minimum 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 practitioner's level of responsibility. (I-R)(G) Registered nurses and clinical staff assigned to the cardiac catheterization lab shall complete the following continuing education requirements:1. Registered nurses and clinical staff shall complete and document a minimum of eight (8) hours of continuing education every year in the area of acute coronary syndrome. This continuing education shall be reviewed for appropriateness by the STEMI center medical director to the practitioner's level of responsibility. (I-R)(H) Registered nurses assigned to the intermediate care unit shall complete the following continuing education requirements: 1. Intermediate care unit registered nurses in level I STEMI centers shall complete and document a minimum 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 practitioner's level of responsibility. (I-R)(5) Standards for Hospital Performance Improvement, Patient Safety, Outreach, Public Education, and Training Programs for STEMI Center Designation. (A) The STEMI center shall maintain an ongoing performance improvement and patient safety program designed to objectively and systematically monitor, review, and evaluate the quality, timeliness, and appropriateness of patient care, to resolve problems, and to improve patient care. (I-R, II-R, III-R, IV-R) 1. The STEMI center shall collect, document, trend, maintain for at least five (5) years, and make available for review by the department at least the following data elements: 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)2. The STEMI center shall at least quarterly conduct a regular morbidity and mortality review. (I-R, II-R, III-R, IV-R)3. The STEMI center shall conduct a review of the reports generated by the department from the Missouri STEMI registry. (I-R, II-R, III-R, IV-R)4. The STEMI center shall conduct a monthly review of its pre-hospital STEMI care including inter-facility transfers. (I-R, II-R, III-R, IV-R)5. The STEMI center shall participate in the emergency medical services regional system of STEMI care. (I-R, II-R, III-R, IV-R)6. The STEMI center shall review cases of STEMI patients remaining greater than thirty (30) minutes at the referring hospital prior to transfer as a part of its performance improvement and patient safety program. (I-R, II-R, III-R, IV-R)7. The STEMI center shall review and monitor the core competencies of its physicians, practitioners, and nurses. (I-R, II-R, III-R, IV-R)(B) It is recommended that level I and II STEMI centers establish a cardiology outreach program that provides physicians in the outlying areas with telephone access to the cardiology program. (I-R, II-R)(C) STEMI centers shall establish a patient and public education program to promote STEMI prevention and awareness of signs and symptoms. (I-R, II-R, III-R, IV-R)(D) Level I, II, and III STEMI centers shall establish a professional education outreach program in catchment areas to provide training and other supports to improve care of STEMI patients. (I-R, II-R, III-R)(E) Each STEMI center shall establish a training program on caring for STEMI patients for professionals in the STEMI center that includes at least the following: 1. A procedure for training nurses and clinical staff to be credentialed in STEMI care; (I-R, II-R, III-R, IV-R)2. A mechanism to assure that all nurses providing care to STEMI patients complete a minimum of required continuing education to become credentialed in STEMI care; and (I-R, II-R, III-R, IV-R)3. The content and format of any STEMI continuing education courses developed and offered by the STEMI center shall be developed with the oversight of the STEMI center medical director. (I-R, II-R, II-R, IV-R)(F) STEMI centers shall provide and monitor timely feedback to the emergency medical services providers and referring hospital(s), if involved. This feedback shall include, at least, diagnosis, treatment, and referring hospital, if involved. It is recommended that the feedback be provided within seventy-two (72) hours of admission to the hospital. When emergency medical services does not provide patient care data on patient arrival or in a timely fashion (recommended within three (3) hours of patient delivery), this time frame shall not apply. (I-R, II-R, III-R, IV-R)(G) The STEMI centers shall be actively involved in local and regional emergency medical services systems by providing training and clinical educational resources. (I-R, II-R, III-R, IV-R)(6) Standards for the Programs in STEMI Research for STEMI Center Designation. (A) The STEMI center and its staff shall support an ongoing research program in STEMI as evidenced by any of the following:1. Production of evidence based reviews of the STEMI program's process and clinical outcomes; (I-R)2. Publications in peer-reviewed journals; (I-R)3. Reports of findings presented at regional or national meetings; (I-R)4. Receipt of grants for study of STEMI care; (I-R)5. Participation in multi-center studies; or (I-R)6. Epidemiological studies and individual case studies. (I-R)(B) The STEMI center shall agree to cooperate and participate with the department for the purpose of developing prevention programs. (I-R, II-R, III-R, IV-R) AUTHORITY: sections 190.185 and 190.241, RSMo Supp. 2012.* Original rule filed Nov. 15, 2012, effective June 30, 2013. Amended by Missouri Register January 3, 2023/Volume 48, Number 1, effective 12/7/2022Amended by Missouri Register May 1, 2023/Volume 48, Number 9, effective 6/30/2023*Original authority: 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002 and 190.241, RSMo 1987, amended 1998, 2008.