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 30-40.750 - ST-Segment Elevation Myocardial Infarction (STEMI) Center Designation Application and Review

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment adds virtual review
				  requirements, clarifies honorarium and payment requirements for virtual
				  reviews, updates language to be consistent with House Bill 2331 which made
				  changes to sections 190.241 and
				  190.245, RSMo, effective August
				  28, 2022, adds Comprehensive Heart Attack Center by the Joint Commission as a
				  type of certification or verification that hospitals may have in order for the
				  department to designate hospitals as level II STEMI centers, adds a requirement
				  that hospitals must provide the department with required medical records and
				  quality improvement documentation or be revoked, allows hospitals to continue
				  to be designated as long as the hospital has submitted an application and the
				  department has not yet been able to conduct a review before expiration, changes
				  the requirements for hospitals participating in local and regional emergency
				  medical services system, removes the data submission requirement for hospitals
				  verified or certified by department-approved national certifying bodies, and
				  updates what the hospitals have to submit to the department to confirm
				  verification or certification with national certifying bodies and when to
				  submit changes of this verification or certification. This amendment also makes
				  changes to the application for STEMI center designation form included herein in
				  subsection (3)(A) by adding Comprehensive Heart Attack Center, changing the
				  certification section to reflect the new requirements for notification of
				  changes and participation in local and regional emergency medical services
				  systems, and removing the data submission requirement.
(1) Participation in Missouri's STEMI center
				program is voluntary and no hospital shall be required to participate. No
				hospital shall hold itself out to the public as a state-designated STEMI center
				unless it is designated as such by the Department of Health and Senior Services
				(department). Hospitals desiring STEMI center designation shall apply to the
				department either through the option outlined in section (2) or section (3).
				Only those hospitals found to be in compliance with the requirements of the
				rules of this chapter shall be designated by the department as STEMI
				centers.
(2) Hospitals requesting
				to be reviewed and designated as a STEMI center by the department shall meet
				the following requirements:
(A) An application
				for STEMI center designation shall be made upon forms prepared or prescribed by
				the department and shall contain information the department deems necessary to
				make a fair determination of eligibility for review and designation in
				accordance with the rules of this chapter. The STEMI center review and
				designation application form, included herein, is available at the Health
				Standards and Licensure (HSL) office, online at the department's website at
www.health.mo.gov
, or may be
				obtained by mailing a written request to the Missouri Department of Health and
				Senior Services, HSL, PO Box 570, Jefferson City, MO 65102-0570. The
				application for STEMI center designation shall be submitted to the department
				no less than sixty (60) days and no more than one hundred twenty (120) days
				prior to the desired date of the initial designation or expiration of the
				current designation;
(B) Both
				sections A and B of the STEMI center review and designation application form,
				included herein, shall be complete before the department will arrange a date
				for the review. The department shall notify the hospital/STEMI center of any
				apparent omissions or errors in the completion of the STEMI center review and
				designation application form. When the STEMI center review and designation
				application form is complete, the department shall contact the hospital/STEMI
				center to arrange a date for the review;
(C) The hospital/STEMI center shall cooperate
				with the department in arranging for a mutually suitable date for any announced
				reviews;
(D) The department may
				conduct an on-site review, a virtual review, or a combination thereof on the
				hospitals/ STEMI centers. For announced reviews that are scheduled with the
				hospitals/STEMI centers, the department will make the hospitals/STEMI centers
				aware at least thirty (30) days prior to the scheduled review whether the
				department intends that the review will be conducted on-site and/or virtually.
				Due to unforeseen circumstances, the department may need to change whether the
				review is conducted on-site and/or virtually less than thirty (30) days before
				the announced review. The department will contact the hospitals/STEMI centers
				to make the hospitals/STEMI centers aware of any changes about how the review
				will be conducted, either on-site and/or virtually, prior to the date of the
				announced review. The different types of reviews to be conducted on
				hospitals/STEMI centers seeking STEMI center designation by the department
				include-
1. An initial review shall occur on
				a hospital applying to be initially designated as a STEMI center. An initial
				review shall include interviews with designated hospital staff, a review of the
				physical plant and equipment, and a review of records and documents as deemed
				necessary to assure compliance with the requirements of the rules of this
				chapter. This review may occur on-site and/or virtually;
2. A validation review shall occur on a
				designated STEMI center applying for renewal of its designation as a STEMI
				center. Validation reviews shall occur no less than every three (3) years. A
				validation review shall include interviews with designated STEMI center staff,
				a review of the physical plant and equipment, and a review of records and
				documents as deemed necessary to assure compliance with the requirements of the
				rules of this chapter. This review may occur on-site and/or virtually;
				and
3. A focus review shall occur
				on a designated STEMI center in which an initial or validation review was
				conducted and substantial deficiency(ies) were cited. A review of the physical
				plant will not be necessary unless a deficiency(ies) was cited in the physical
				plant in the preceding validation review. The focus review team shall be
				comprised of a representative from the department and may include a qualified
				contractor(s) with the required expertise to evaluate corrections in areas
				where deficiencies were cited. This review may occur on-site and/or
				virtually;
(E) STEMI
				center designation shall be valid for a period of three (3) years from the date
				the STEMI center/hospital is designated. Expiration of the designation shall
				occur unless the STEMI center applies for validation review within this three-
				(3-) year period and the department is unable to conduct a review before the
				designation expires.
1. STEMI center
				designation shall be site specific and non-transferable when a STEMI center
				changes location.
2. Once
				designated as a STEMI center, a STEMI center may voluntarily surrender the
				designation at any time without giving cause, by contacting the department in
				writing. In these cases, the application and review process shall be completed
				again before the designation may be reinstated;
(F) For the purpose of reviewing previously
				designated STEMI centers and hospitals applying for STEMI center designation,
				the department shall use review teams consisting of qualified contractors.
				These review teams shall consist of one (1) STEMI coordinator or STEMI program
				manager who has experience in STEMI care and one (1) emergency medicine
				physician experienced in STEMI care. The review team shall also consist of at
				least one (1) and no more than two (2) cardiologist(s)/interventional
				cardiologist(s) who are experts in STEMI care. One (1) representative from the
				department will also be a participant of the review team. This representative
				shall coordinate the review with the hospital/STEMI center and the other review
				team members.
1. Any individual interested in
				becoming a qualified contractor to conduct reviews shall-
A. Send the department a curriculum vitae
				(CV) or resume that includes his or her experience and expertise in STEMI care
				and whether an individual is in good standing with his or her licensing boards.
				A qualified contractor shall be in good standing with his or her respective
				licensing boards;
B. Provide the
				department evidence of his or her previous site survey experience (state and/or
				national designation survey process); and
C. Submit a list to the department that
				details any ownership he or she may have in a Missouri hospital(s), whether he
				or she has been terminated from any Missouri hospital(s), any lawsuits he or
				she has currently or had in the past with any Missouri hospital(s), and any
				Missouri hospital(s) for which his or her hospital privileges have been
				revoked.
2. Qualified
				contractors for the department shall enter into a written agreement with the
				department indicating, that among other things, they agree to abide by Chapter
				190, RSMo, and the rules in this chapter, during the review process;
(G) Out-of-state review team
				members shall conduct levels I and II hospital/STEMI center reviews. Review
				team members are considered out-of-state review team members if they work
				outside of the state of Missouri. In-state review team members may conduct
				levels III and IV hospital/STEMI center reviews. Review team members are
				considered in-state review team members if they work in the state of Missouri.
				In the event that out-of-state reviewers are unavailable, levels I and II STEMI
				center reviews may be conducted by in-state reviewers from Emergency Medical
				Services (EMS) regions as set forth in
				19 CSR
				30-40.302 other than the region being reviewed with
				the approval of the director of the department or his/her designee. When
				utilizing in-state review teams, levels I and II hospital/STEMI centers shall
				have the right to refuse one (1) in-state review team or certain members from
				one (1) in-state review team;
(H)
				Hospitals/STEMI centers shall be responsible for paying expenses related to the
				costs of the qualified contractors to review their respective hospitals/STEMI
				center during initial, validation, and focus reviews. The department shall be
				responsible for paying the expenses of its representative. Costs of the review
				to be paid by the hospital/STEMI center include-
1. An honorarium shall be paid to each
				qualified contractor of the review team whether the review occurs on-site or
				virtually. Qualified contractors of the review team for level I and II STEMI
				center reviews shall be paid one thousand four hundred fifty dollars ($1,450)
				per reviewer. Qualified contractors of the review team for level III and IV
				STEMI center reviews shall be paid one thousand dollars ($1,000) per reviewer.
				This honorarium shall be paid to each qualified contractor of the review team
				at the time the site survey begins if on-site or prior to the review beginning
				if the review is conducted virtually;
2. Airfare shall be paid for each qualified
				contractor of the review team, if applicable;
3. Lodging shall be paid for each qualified
				contractor of the review team, unless the review is conducted virtually. The
				hospital/STEMI center shall secure the appropriate number of hotel rooms for
				the qualified contractors and pay the hotel directly; and
4. Incidental expenses, if applicable, for
				each qualified contractor of the review team shall not exceed two hundred fifty
				dollars ($250) and may include the following:
A. Airport parking;
B. Checking bag charges;
C. Meals during the review; and
D. Mileage to and from the review if no
				airfare was charged by the reviewer. If the reviewer solely participated
				virtually in the review and did not travel by vehicle to the review, then no
				mileage shall be paid. Mileage shall be paid at the federal mileage rate for
				business miles as set by the Internal Revenue Service (IRS). Federal mileage
				rates can be found at the website
www.irs.gov
;
(I) Hospitals/STEMI centers being reviewed
				through a virtual survey shall do the following:
1. Provide a videoconferencing platform to be
				used for the hospital/STEMI center virtual review;
2. Provide a live tour of the
				hospital;
3. Ensure the
				videoconferencing platform used during the review is compliant with state and
				federal laws for protected health information;
4. Assign an on-site visit coordinator for
				the review. The on-site visit coordinator role cannot be fulfilled by the STEMI
				program manager. This on-site visit coordinator will be responsible for the
				logistical aspects of the virtual review. Responsibilities include, at least,
				the following:
A. Scheduling the
				videoconferencing meetings;
B.
				Sending out calendar invitations;
C. Providing electronic medical record (EMR)
				access to designated individuals;
D. Ensuring all required participants are on
				the videoconferencing line for the various parts of the review; and
E. Sending separate calendar invitations for
				each section of the virtual review to hospital staff, qualified contractors,
				and the department;
5.
				Assign one (1) staff navigator per qualified contractor to help remotely
				navigate the EMR, the patient performance improvement patient safety (PIPS)
				documentation, and supporting documentation. The staff navigator role cannot be
				fulfilled by the STEMI program manager, the STEMI program medical director, the
				STEMI program registrar, or the on-site visit coordinator for the review. The
				individuals designated as the staff navigators shall be familiar with
				navigating through the EMR;
6.
				Provide the department with requested patient care report information for the
				review no later than thirty (30) days prior to the virtual review;
7. Provide the department with requested
				medical records, PIPS documentation, registry report, and all supporting
				documentation at least seven (7) days prior to the virtual visit through a
				method that is compliant with state and federal laws for protected health
				information;
8. Schedule a
				pre-review call with the qualified contractors, the department, the STEMI
				program medical director, the STEMI program manager, the staff navigators and
				the on-site visit coordinator approximately one (1) week prior to the virtual
				review;
9. Test the functionality
				of the videoconferencing platform for the live tour of the hospital prior to
				the pre-review call; and
10.
				Provide a list of attendees for the review meeting and their roles to the
				review team and the department prior to the virtual review;
(J) The department may conduct an
				on-site review of the hospital prior to the virtual review process to ensure
				that the hospital meets the requirements for STEMI center
				designation;
(K) Upon completion
				of a review, the qualified contractors from the review team shall submit a
				report of their findings to the department. This report shall state whether the
				specific standards for STEMI center designation have or have not been met and
				if not met, in what way they were not met. This report shall detail the
				hospital/STEMI center's strengths, weaknesses, deficiencies, and
				recommendations for areas of improvement. This report shall also include
				findings from patient chart audits and a narrative summary of the following
				areas: prehospital, hospital, STEMI service, emergency department, operating
				room, angiography suites, recovery room, clinical lab, intensive care unit,
				rehabilitation, performance improvement and patient safety programs, education,
				outreach, research, chart review, and interviews. The department shall have the
				final authority to determine compliance with the rules of this
				chapter;
(L) The department shall
				return a copy of the report to the chief executive officer, the STEMI medical
				director, and the STEMI program manager/coordinator of the hospital/STEMI
				center reviewed. Included within the report shall be notification indicating
				whether the hospital/STEMI center has met the criteria for STEMI center
				designation or has failed to meet the criteria for STEMI center designation as
				requested. Also, if a focus review of the STEMI center is required, the time
				frame for this focus review will be shared with the chief executive officer,
				the STEMI medical director, and the STEMI program man-ager/coordinator of the
				STEMI center reviewed;
(M) When
				the hospital/STEMI center is found to have deficiencies, the hospital/STEMI
				center shall submit a plan of correction to the department. The plan of
				correction shall include identified deficiencies, actions to be taken to
				correct deficiencies, time frame in which the deficiencies are expected to be
				resolved, and the person responsible for the actions to resolve the
				deficiencies. A plan of correction form shall be completed by the hospital and
				returned to the department within thirty (30) days after notification of review
				findings and designation. If a focus review is required, the STEMI center shall
				be allowed a minimum period of six (6) months to correct
				deficiencies;
(N) No hospital
				shall hold itself out as a STEMI center designated by the department until
				given written approval by the department. The department shall give written
				approval to the hospitals to begin holding themselves out as designated STEMI
				centers by the department after all initial STEMI reviews have been completed
				for those hospitals which applied for STEMI review and designation with the
				department during the first round of applications and the time for plans of
				corrections have expired;
(O) A
				STEMI center shall make the department aware in writing within thirty (30) days
				if there are any changes in the STEMI center's name, address, contact
				information, chief executive officer, STEMI medical director, or STEMI program
				manager/coordinator;
(P) Failure of
				a hospital/STEMI center to provide all medical records and quality improvement
				documentation necessary for the department to conduct a STEMI review in order
				to determine if the requirements of
				19 CSR
				30-40.760 have been met shall result in the revocation
				of the hospital/ STEMI center's designation as a STEMI center;
(Q) Any person aggrieved by an action of the
				department affecting the STEMI center designation pursuant to Chapter 190,
				RSMo, including the revocation, the suspension, or the granting of, refusal to
				grant, or failure to renew a designation, may seek a determination by the
				Administrative Hearing Commission under Chapter 621, RSMo. It shall not be a
				condition to such determination that the person aggrieved seek reconsideration,
				a rehearing, or exhaust any other procedure within the department;
				and
(R) The department may deny,
				place on probation, suspend, or revoke such designation in any case in which it
				has determined that there has been a substantial failure to comply with the
				provisions of Chapter 190, RSMo, or any rules or regulations promulgated
				pursuant to this chapter. If the department has determined that a hospital is
				not in compliance with such provisions or regulations, it may conduct
				additional announced or unannounced site reviews of the hospital to verify
				compliance. If a STEMI center fails two (2) consecutive on-site reviews because
				of substantial noncompliance with standards prescribed by sections
				190.001 to
				190.245, RSMo, or rules adopted
				by the department pursuant to sections
				190.001 to
				190.245, RSMo, its center
				designation shall be revoked.