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
Universal Citation: 19 MO Code of State Regs 30-40.720
Current through Register Vol. 49, No. 18, September 16, 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.
(3) Hospitals seeking stroke center designation by the depart- ment based on their current certification or verification as a stroke center by the Joint Commission, DNV-GL Healthcare or Healthcare Facilities Accreditation Program shall meet the following requirements:
(A) An application for stroke
center designation by the department for hospitals that have been certified or
verified as a stroke center by the Joint Commission, DNV-GL Healthcare or
Healthcare Facilities Accreditation Program shall be made upon forms prepared
or prescribed by the department and shall contain information the department
deems necessary to make a determination of eligibility for review and
designation in accordance with the rules of this chapter. The application for
stroke certified hospital designation 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;
(B) Both sections A and B of the application
for stroke certified hospital designation form, included herein, shall be
complete before the department designates a hospital/stroke center. The
department shall notify the hospital/stroke center of any apparent omissions or
errors in the completion of the application for stroke certified hospital
designation form. Upon receipt of a completed and approved application, the
department shall designate such hospital as follows:
1. The department shall designate a hospital
a level I stroke center if such hospital has been certified as a comprehensive
stroke center by the Joint Commission, DNV-GL Healthcare or Healthcare
Facilities Accreditation Program;
2. The department shall designate a hospital
a level II stroke center if such hospital has been certified as a primary
stroke center, thrombectomy-capable stroke center, thrombectomy ready stroke
center, or primary plus stroke center by either the Joint Commission, DNV-GL
Healthcare or Healthcare Facilities Accreditation Program; or
3. The department shall designate a hospital
a level III stroke center if such hospital has been certified as an acute
stroke-ready center by the Joint Commission, DNV-GL Healthcare or Healthcare
Facilities Accreditation Program;
(C) Within thirty (30) days of any changes or receipt
of a certificate or verification, the hospital shall submit to the department
proof of certification or verification as a stroke center by the Joint
Commission, DNV-GL Healthcare or Healthcare Facilities Accreditation Program
and the names and contact information of the medical director of the stroke
center and the program manager of the stroke center. A certificate or
verification as a stroke center by the Joint Commission, DNV-GL Healthcare or
Healthcare Facilities Accreditation Program shall accompany the application for
stroke certified hospital designation form. A hospital shall report to the
department in writing within thirty (30) days of the date the hospital no
longer is certified or verified as a stroke center by the Joint Commission,
DNV-GL Healthcare or Healthcare Facilities Accreditation Program for which the
hospital used to receive its corresponding designation with the department as a
stroke center, whether because the hospital voluntarily surrendered this
certificate or verification or because the hospital's certificate or
verification was suspended or revoked by the Joint Commission, DNV-GL
Healthcare or Healthcare Facilities Accreditation Program or expired;
(D) Any hospital designated as a
level III stroke center that is certified or verified by the Joint Commission,
DNV-GL Healthcare or Healthcare Facilities Accreditation Program as an acute
stroke-ready center shall have a formal agreement with a level I or level II
stroke center designated by the department for physician consultative services
for evaluation of stroke patients for thrombolytic therapy and the care of the
patient post-thrombolytic therapy;
(E) Participate in local and regional emergency
medical services systems for purposes of providing training, sharing clinical
educational resources, and collaborating on improving patient outcomes;
(F) The designation of a hospital
as a stroke center pursuant to section (3) shall continue if such hospital
retains certification as a stroke center by the Joint Commission, DNV-GL
Healthcare or Healthcare Facilities Accreditation Program; and
(G) The department may remove a hospital's
designation as a stroke center if requested by the hospital or the department
determines that the Joint Commission, DNV-GL Healthcare or Healthcare
Facilities Accreditation Program certification or verification has been
suspended or revoked. Any decision made by the department to withdraw the
designation of a stroke center that is based on the revocation or suspension of
a certification or revocation by the Joint Commission, DNV-GL Healthcare or
Healthcare Facilities Accreditation Program shall not be subject to judicial
review.
*Original authority: 192.006, RSMo 1993, amended 1995; 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002; and 190.241, RSMo 1987, amended 1998, 2008.
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