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

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, 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.