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 30-40.720 - Stroke Center Designation Application and Review

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment decreases validation reviews
				  to every three (3) years, adds virtual review requirements, clarifies
				  honorarium and payment requirements for virtual reviews, updates language to be
				  consistent with the House Bill 2331 amendment of sections
				  190.241 and
				  190.245, RSMo, that became
				  effective August 28, 2022, adds primary stroke center with thrombectomy
				  capability as a type of certification or verification that hospitals may have
				  in order for the department to designate hospitals as level II stroke 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,
				  changes the requirements for hospitals participating in local and regional
				  emergency medical services systems, removes the data submission requirement for
				  hospitals certified or verified by department-approved national 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 stroke center designation form included herein
				  in subsection (3)(A) by adding primary stroke center with thrombectomy
				  capability, changing the certification section to reflect the new requirements
				  for notification of changes and participation in the local and regional
				  emergency medical services systems, and removing the data submission
				  requirement.
(1)
				Participation in Missouri's stroke 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 stroke center unless it is designated as such by
				the Department of Health and Senior Services (department). Hospitals desiring
				stroke 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 stroke centers.
(2) Hospitals requesting to be reviewed and
				designated as a stroke center by the department shall meet the following
				requirements:
(A) An application for stroke
				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 stroke center review and designation
				application form, included herein, is available at the Health Standards and
				Licensure (HSL) office, or 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 stroke 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 stroke 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/stroke center of any
				apparent omissions or errors in the completion of the stroke center review and
				designation application form. When the stroke center review and designation
				application form is complete, the department shall contact the hospital/stroke
				center to arrange a date for the review;
(C) The hospital/stroke 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/stroke centers. For announced reviews that are
				scheduled with the hospitals/stroke centers, the department will make the
				hospitals/stroke centers aware at least ninety (90) 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 onsite and/or virtually less than ninety
				(90) days before the announced review. The department will contact the
				hospitals/stroke centers to make the hospitals/stroke centers aware of any
				changes about how the review will be conducted, either on-site and/or
				virtually, and/or when the review will be conducted with as much advance notice
				as possible prior to the date of the announced review. The different types of
				reviews to be conducted on hospitals/stroke centers seeking stroke center
				designation by the department include-
1. An
				initial review shall occur on a hospital applying to be initially designated as
				a stroke 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 stroke center applying for renewal of its
				designation as a stroke center. Validation reviews shall occur no less than
				every three (3) years. A validation review shall include interviews with
				designated stroke 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 require- ments 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 stroke 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) Stroke center designation shall be valid
				for a period of three (3) years from the date the stroke center/hospi-tal is
				designated. Expiration of the designation shall occur unless the stroke 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. Stroke center designation shall be site
				specific and non-transferable when a stroke center changes location.
2. Once designated as a stroke center, a
				stroke 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 stroke centers and hospitals
				applying for stroke center designation, the department shall use review teams
				consisting of qualified contractors. These review teams shall consist of one
				(1) stroke coordinator or stroke program manager who has experience in stroke
				care and one (1) emergency medicine physician also experienced in stroke care.
				The review team shall also consist of at least one (1) and no more than two (2)
				neurologist(s)/neuro-interventionalist(s) who are experts in stroke 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/stroke
				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
				stroke 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/stroke 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/stroke 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 stroke 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/stroke 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/stroke centers shall be responsible for paying expenses related to
				the cost of the qualified contractors to review their respective
				hospitals/stroke centers 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/stroke 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 levels I and II stroke
				center reviews shall be paid one thousand four hundred fifty dollars ($1,450)
				per reviewer. Qualified contractors of the review team for levels III and IV
				stroke 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/stroke 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/stroke centers being reviewed
				through a virtual survey shall do the following:
1. Provide an audio and videoconferencing
				platform to be used for the hospital/stroke center virtual review;
2. Provide a live tour of the
				hospital;
3. Ensure the video and
				audio conferencing service 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
				stroke 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 stroke program manager, the stroke program medical director,
				the stroke 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 through a method that is compliant with state and federal laws for
				protected health information 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
				stroke program medical director, the stroke 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 audio and videoconferencing service 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 to ensure that the hospital meets the requirements for stroke
				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 stroke 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/stroke 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, stroke 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 stroke medical
				director, and the stroke program manager/coordinator of the hospital/stroke
				center reviewed. Included within the report shall be notification indicating
				whether the hospital/stroke center has met the criteria for stroke center
				designation or has failed to meet the criteria for the stroke center
				designation requested. Also, if a focus review of the stroke center is
				required, the time frame for this focus review will be shared with the chief
				executive officer, the stroke medical director, and the stroke program
				manager/coordinator of the stroke center reviewed;
(M) When the hospital/stroke center is found to have
				deficiencies, the hospital/stroke 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, then the stroke center shall be allowed a minimum period of six
				(6) months to correct deficiencies;
(N) A stroke center shall make the department aware in
				writing within thirty (30) days if there are any changes in the stroke center's
				name, address, contact information, chief executive officer, stroke medical
				director, or stroke program manager/coordinator;
(O) Failure of a hospital/stroke center to
				provide all medical records and quality improvement documentation necessary for
				the department to conduct a stroke review in order to determine if the
				requirements of 19 CSR 30-40.730 have been met
				shall result in the revocation of the hospi-tal/stroke center's designation as
				a stroke center;
(P) Any person
				aggrieved by an action of the Department of Health and Senior Services
				affecting the stroke 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 thereon 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
(Q) 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 of Health and Senior Services 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 stroke 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.