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

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: 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; 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
2. 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; and
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)
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; 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:
(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)