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 30-40.420 - Definitions and Abbreviations Relating to Trauma Centers
Universal Citation: 19 MO Code of State Regs 30-40.420
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, adds honorarium and payment requirements for virtual reviews and on-site reviews, adds qualified contractor requirements, 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 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, changes the requirements for hospitals participating in the local and regional emergency medical services systems, 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, removes the data submission requirement for hospitals verified by American College of Surgeons, and removes American College of Surgeons level IV trauma centers as an alternate designation since the American College of Surgeons has recently eliminated the level IV trauma center verification. This amendment also makes changes to the application for trauma center designation form included herein in subsection (3)(A) by removing the American College of Surgeons level IV trauma centers as an alternate designation and 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 trauma center program is voluntary and no hospital shall be required to participate. No hospital shall in any way indicate to the public that it is a trauma center unless that hospital has been designated as such by the Department of Health and Senior Services (the department). Hospitals desiring trauma 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 in this chapter shall be designated by the department as trauma centers.
(2) Hospitals requesting to be reviewed and designated as a trauma center by the department shall meet the following requirements:
(A) The application required for trauma
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;
(B)
An application shall include the following information: designation level
requested; name, address, and telephone number of hospital; name of chief
executive officer, chairman/president of board of trustees, surgeon in charge
of trauma care, trauma nurse coordinator/program manager, director of emergency
medicine, and director of trauma intensive care; number of emergency department
trauma caseload, trauma team activations, computerized tomography scan
capability, magnetic resonance imaging capability, operating rooms, intensive
care unit/critical care unit beds, burn beds, rehabilitation beds, trauma
surgeons, neurosurgeons, orthopedists, emergency department physicians,
anesthesiologists, certified registered nurse anesthetists, pediatricians, and
pediatric surgeons; date of application; and signatures of the
chairman/president of board of trustees, hospital chief executive officer,
surgeon in charge of trauma, and director of emergency medicine. The trauma
center review and designation application form, included herein, is available
at the Health Standards and Licensure (HSL) office or may be obtained by
mailing a written request to Missouri Department of Health and Senior Services,
HSL, PO Box 570, Jefferson City, MO 65102-0570;
(C) The department shall notify the hospital
of any apparent omissions or errors in the completion of the application and
shall contact the hospital to arrange a date for the review;
(D) Failure of a hospital to cooperate in
arranging for a mutually suitable date for review shall constitute forfeiture
of application when a hospital's initial review is pending or suspension of
designation when a hospital's verification or validation review is
pending;
(E) Hospitals designated
as trauma centers under the previous designation system shall maintain their
designation until a review is conducted using the rules of this
chapter;
(F) The review of hospitals
for trauma center designation 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. The department may conduct an on-site review, a
virtual review, or a combination thereof on the hospitals/trauma centers. For
announced reviews that are scheduled with the hospitals/trauma centers, the
department will make the hospitals/trauma 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 on-site and/ or virtually less than ninety (90) days before the
announced review. The department will contact the hospitals/trauma centers to
make the hospitals/trauma 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 cost of any and all site reviews shall be paid by each
applicant hospital or renewing trauma center unless adequate funding is
available to the department to pay for reviews. Hospitals/trauma centers shall
be responsible for paying expenses related to the cost of the qualified
contractors to review their respective hospitals/trauma 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/trauma 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 trauma 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 trauma 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 beginning of the review 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/trauma 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;
(G) For the purpose of reviewing trauma
centers and hospitals applying for trauma center designation, the department
shall use review teams consisting of two (2) surgeons and one (1) emergency
physician who are experts in trauma care and one (1) trauma nurse
coordinator/trauma program manager experienced in trauma center review. The
team shall be disinterested politically and financially in the hospitals to be
reviewed. Out-of-state review teams shall conduct levels I and II reviews.
In-state reviewers may conduct level III reviews. In the event that
out-of-state reviewers are unavailable, level II reviews may be conducted by
in-state reviewers from emergency medical services (EMS) regions other than the
region being reviewed with approval of the director of the Department of Health
and Senior Services or his/her designee. When utilizing in-state review teams,
the level II trauma center shall have the right to refuse one (1) review team.
1. Any individual interested in becoming a
qualified contractor to conduct reviews shall-
A. Send the department a curriculum vitae
(CV) or résumé that includes his or her experience and expertise
in trauma 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;
(H) Any substantial deficiencies
cited in the initial review or the validation review regarding patient care
issues, especially those related to delivery of timely surgical intervention,
shall require a focused review to be conducted. When deficiencies involve
documentation or policy or equipment, the hospital's plan of correction shall
be submitted to the department and verified by department personnel;
(I) The verification review shall be
conducted in the same manner and detail as initial and validation reviews. A
review of the physical plant will not be necessary unless a deficiency was
cited in the physical plant in the preceding initial or validation review. If
deficiencies relate only to a limited number of areas of hospital operations, a
focused review shall be conducted. The review team for a focused review shall
be comprised of review team members with the required expertise to evaluate
corrections in the specified deficiency area;
(J) Validation reviews shall occur every
three (3) years;
(K)
Hospitals/trauma centers being reviewed through a virtual survey shall do the
following:
1. Provide a videoconferencing
platform to be used for the hospital/trauma 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
trauma 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 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 trauma program manager, the trauma program medical director,
the trauma 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 trauma
program medical director, the trauma 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. Any changes that
occur to this list may be communicated to the department during the review
meeting or before the virtual review;
(L) 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 trauma designation;
(M) Upon completion of a review, the reviewers shall
submit a report of their findings to the department. The report shall state
whether the specific standards for trauma center designation have or have not
been met; if not met, in what way they were not met. The report shall include
the patient chart audits and a narrative summary to include pre-hospital,
hospital, trauma service, emergency department, operating room, recovery room,
clinical lab, intensive care unit, blood bank, rehabilitation, performance
improvement and patient safety programs, education, outreach, research, chart
review, and interviews. The department has final authority to determine
compliance with the rules of this chapter;
(N) Within thirty (30) days after receiving a review
report, the department shall return a copy of the report in whole to the chief
executive officer of the hospital reviewed. Included with the report shall be
notification indicating that the hospital has met the criteria for trauma
center designation or has failed to meet the criteria for the designation level
for which it applied and options the hospital may pursue;
(O) If a verification review is required, the hospital
shall be allowed a period of six (6) months to correct deficiencies. A plan of
correction form shall be provided to the department and shall be completed by
the hospital and returned to the department within thirty (30) days after
notification of review findings;
(P) Once a review is completed, a final report shall
be prepared by the department. The final report shall be public record and
shall disclose the standards by which the reviews were conducted and whether
the standards were met. The reports filed by the reviewers shall be held
confidential and shall be disclosed only to the hospital's chief executive
officer or an authorized representative;
(Q) The department shall have the authority to put on
probation, suspend, revoke, or deny trauma center designation if the department
has determined that there has been a substantial failure to comply with the
requirements of the rules in this chapter. Once designated as a trauma center,
a hospital may voluntarily surrender the designation at any time without giving
cause, by contacting the department. In these cases, the application and review
process shall be completed again before the designation may be
reinstated;
(R) Trauma center
designation shall be valid for a period of three (3) years from the date the
trauma center is designated. Expiration of the designation shall occur unless
the trauma center applies for validation review within this three- (3-) year
period. Trauma center designation shall be site specific and not transferable
when a trauma center changes location;
(S) The department shall investigate complaints
against trauma centers. Failure of the hospital to cooperate in providing
documentation and interviews with appropriate staff may result in revocation of
trauma center designation. Any hospital which takes adverse action toward an
employee for cooperating with the department regarding a complaint is subject
to revocation of trauma center designation; and
(T) Failure of a hospital/trauma center to
provide all medical records and quality improvement documentation necessary for
the department to conduct a trauma review in order to determine if the
requirements of 19 CSR 3040.430 have been met shall result in the revocation of
the hospital/trauma center's designation as a trauma center.
(3) Hospitals seeking trauma center designation by the department based on their current verification as a trauma center by the American College of Surgeons shall meet the following requirements:
(A) An application for trauma
center designation by the department for hospitals that have been verified as a
trauma center by the American College of Surgeons 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 trauma verified 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 trauma 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) The
application for trauma verified hospital designation form, included herein,
shall be complete before the department designates a hospital/trauma center.
The department shall notify the hospital/trauma center of any apparent
omissions or errors in the completion of the application for trauma verified
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
as a level I trauma center if such hospital has been verified as a level I
trauma center (adult and pediatric) by the American College of
Surgeons;
2. The department shall
designate a hospital as a level II trauma center if such hospital has been
verified as a level II trauma center (adult and pediatric) by the American
College of Surgeons;
3. The
department shall designate a hospital as a level III trauma center if such
hospital has been verified as a level III trauma center (adult and pediatric)
by the American College of Surgeons;
4. The department shall designate a hospital
as a level IV trauma center if such hospital has been verified as a level IV
trauma center (adult and pediatric) by the American College of Surgeons;
5. The department shall designate
a hospital as a level I pediatric trauma center if such hospital has been
verified as a level I pediatric trauma center (only treats children) by the
American College of Surgeons;
6. The
department shall designate a hospital as a level II pediatric trauma center if
such hospital has been verified as a level II pediatric trauma center (only
treats children) by the American College of Surgeons;
7. The department shall designate a hospital
as a level I trauma center if such hospital has been verified as a level I
trauma center (only treats adults) by the American College of Surgeons; and
8. The department shall designate a
hospital as a level II trauma center if such hospital has been verified as a
level II trauma center (only treats adults) by the American College of
Surgeons
(C) Within
thirty (30) days of any changes or receipt of a verification, the hospital
shall submit to the department proof of verification as a trauma center by the
American College of Surgeons and the names and contact information of the
medical director of the trauma center and the program manager of the trauma
center. Verification as a trauma center by the American College of Surgeons
shall accompany the application for trauma verified hospital designation form.
A hospital shall report to the department in writing within thirty (30) days of
the date the hospital no longer is verified as a trauma center by the American
College of Surgeons for which the hospital used to receive its corresponding
designation with the department as a trauma center, whether because the
hospital voluntarily surrendered this verification or because the hospital's
verification was suspended or revoked by the American College of Surgeons or
expired;
(D) Participate in local
and regional emergency medical services systems for purposes of providing
training, sharing clinical educational resources, and collaborating on
improving patient outcomes;
(E)
The designation of a hospital as a trauma center pursuant to section (3) shall
continue if such hospital retains verification as a trauma center by the
American College of Surgeons; and
(F) The department may remove a hospital's designation
as a trauma center if requested by the hospital or if the department determines
that the verification by the American College of Surgeons has been suspended or
revoked. The department may also remove a hospital's designation as a trauma
center if the department determines the hospital's verification with the
American College of Surgeons has expired. Any decision made by the department
to withdraw the designation of a trauma center that is based on the revocation
or suspension of a verification by the American College of Surgeons shall not
be subject to judicial review.
(4) Hospitals that choose to apply to the department under sections (2) and (3) above and maintain a trauma designation with both the department and the American College of Surgeons may request either of the following two (2) options:
(A)
Hospitals may choose to apply to the department under section (2) above and
meet the requirements in section (2) above and
19 CSR
30-40.410 and
19 CSR
30-40.430. Hospitals may request a separate review by
only the department pursuant to section (2). Hospitals may choose to apply to
the department under section (3) above and meet the requirements set by the
American College of Surgeons. Hospitals may request a separate review by only
the American College of Surgeons; or
(B) Hospitals may choose to apply to the
department under section (2) above and meet the requirements in section (2)
above and 19 CSR 30-40.410 and
19 CSR
30-40.430. Hospitals may choose to apply to the
department under section (3) above and meet the requirements set by the
American College of Surgeons. Hospitals may request a joint review by both the
American College of Surgeons and the department. In a joint review, department
personnel shall be incorporated into these reviews upon the consent of the
American College of Surgeons. During these joint reviews, the trauma review
team chosen by the American College of Surgeons shall also include at least one
(1) emergency department physician and at least one (1) trauma program manager
(nurse). All costs for the review and review team shall be paid by the
hospitals. If a hospital successfully passes the joint review by the department
and the American College of Surgeons, then the hospital will be designated by
the department as a trauma center under both sections (2) and (3) above.
*Original authority: 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002 and 190.241, RSMo 1987, amended 1998, 2008.
Disclaimer: These regulations may not be the most recent version. Missouri may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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