FIRST REGULAR SESSION

HOUSE BILL NO. 1561 103RD GENERAL ASSEMBLY

INTRODUCED BY REPRESENTATIVE GALLICK.

3165H.01I JOSEPH ENGLER, Chief Clerk

AN ACT To repeal section 190.241, RSMo, and to enact in lieu thereof one new section relating to trauma center designations.

Be it enacted by the General Assembly of the state of Missouri, as follows:

Section A. Section 190.241, RSMo, is repealed and one new section enacted in lieu 2 thereof, to be known as section 190.241, to read as follows: 190.241. 1. Except as provided for in subsection 4 of this section, the department 2 shall designate a hospital as an adult, pediatric or adult and pediatric trauma center when a 3 hospital, upon proper application submitted by the hospital and site review, has been found by 4 the department to meet the applicable level of trauma center criteria for designation in 5 accordance with rules adopted by the department as prescribed by section 190.185. Site 6 review may occur on-site or by any reasonable means of communication, or by any 7 combination thereof. Such rules shall include designation as a trauma center without site 8 review if such hospital is verified by a national verifying or designating body at the level 9 which corresponds to a level approved in rule. In developing trauma center designation 10 criteria, the department shall use, as it deems practicable, peer-reviewed and evidence-based 11 clinical research and guidelines including, but not limited to, the most recent guidelines of the 12 American College of Surgeons. The department shall not deny a qualified hospital 13 designation as a level I, II, or III trauma center based solely on the distance or mileage 14 between trauma centers. 15 2. Except as provided for in subsection 4 of this section, the department shall 16 designate a hospital as a STEMI or stroke center when such hospital, upon proper application 17 and site review, has been found by the department to meet the applicable level of STEMI or

EXPLANATION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is intended to be omitted from the law. Matter in bold-face type in the above bill is proposed language. HB 1561 2

18 stroke center criteria for designation in accordance with rules adopted by the department as 19 prescribed by section 190.185. Site review may occur on-site or by any reasonable means of 20 communication, or by any combination thereof. In developing STEMI center and stroke 21 center designation criteria, the department shall use, as it deems practicable, peer-reviewed 22 and evidence-based clinical research and guidelines including, but not limited to, the most 23 recent guidelines of the American College of Cardiology, the American Heart Association, or 24 the American Stroke Association. Such rules shall include designation as a STEMI center or 25 stroke center without site review if such hospital is certified by a national body. 26 3. The department of health and senior services shall, not less than once every three 27 years, conduct a site review of every trauma, STEMI, and stroke center through appropriate 28 department personnel or a qualified contractor, with the exception of trauma centers, STEMI 29 centers, and stroke centers designated pursuant to subsection 4 of this section; however, this 30 provision is not intended to limit the department's ability to conduct a complaint investigation 31 pursuant to subdivision (3) of subsection 2 of section 197.080 of any trauma, STEMI, or 32 stroke center. Site reviews shall be coordinated for the different types of centers to the extent 33 practicable with hospital licensure inspections conducted under chapter 197. No person shall 34 be a qualified contractor for purposes of this subsection who has a substantial conflict of 35 interest in the operation of any trauma, STEMI, or stroke center under review. The 36 department may deny, place on probation, suspend or revoke such designation in any case in 37 which it has determined there has been a substantial failure to comply with the provisions of 38 this chapter or any rules or regulations promulgated pursuant to this chapter. Centers that are 39 placed on probationary status shall be required to demonstrate compliance with the provisions 40 of this chapter and any rules or regulations promulgated under this chapter within twelve 41 months of the date of the receipt of the notice of probationary status, unless otherwise 42 provided by a settlement agreement with a duration of a maximum of eighteen months 43 between the department and the designated center. If the department of health and senior 44 services has determined that a hospital is not in compliance with such provisions or 45 regulations, it may conduct additional announced or unannounced site reviews of the hospital 46 to verify compliance. If a trauma, STEMI, or stroke center fails two consecutive site reviews 47 because of substantial noncompliance with standards prescribed by sections 190.001 to 48 190.245 or rules adopted by the department pursuant to sections 190.001 to 190.245, its 49 center designation shall be revoked. 50 4. (1) Instead of applying for trauma, STEMI, or stroke center designation under 51 subsection 1 or 2 of this section, a hospital may apply for trauma, STEMI, or stroke center 52 designation under this subsection. Upon receipt of an application on a form prescribed by the 53 department, the department shall designate such hospital at a state level that corresponds to a 54 similar national designation as set forth in rules promulgated by the department. The rules HB 1561 3

55 shall be based on standards of nationally recognized organizations and the recommendations 56 of the time-critical diagnosis advisory committee. 57 (2) Except as provided by subsection 5 of this section, the department shall not 58 require compliance with any additional standards for establishing or renewing trauma, 59 STEMI, or stroke designations under this subsection. The designation shall continue if such 60 hospital remains certified or verified. The department may remove a hospital's designation as 61 a trauma center, STEMI center, or stroke center if the hospital requests removal of the 62 designation or the department determines that the certificate or verification that qualified the 63 hospital for the designation under this subsection has been suspended or revoked. Any 64 decision made by the department to withdraw its designation of a center pursuant to this 65 subsection that is based on the revocation or suspension of a certification or verification by a 66 certifying or verifying organization shall not be subject to judicial review. The department 67 shall report to the certifying or verifying organization any complaint it receives related to the 68 center designated pursuant to this subsection. The department shall also advise the 69 complainant which organization certified or verified the center and provide the necessary 70 contact information should the complainant wish to pursue a complaint with the certifying or 71 verifying organization. 72 5. Any hospital receiving designation as a trauma center, STEMI center, or stroke 73 center pursuant to subsection 4 of this section shall: 74 (1) Within thirty days of any changes or receipt of a certificate or verification, submit 75 to the department proof of certification or verification and the names and contact information 76 of the center's medical director and the program manager; and 77 (2) Participate in local and regional emergency medical services systems for purposes 78 of providing training, sharing clinical educational resources, and collaborating on improving 79 patient outcomes. 80 81 Any hospital receiving designation as a level III stroke center pursuant to subsection 4 of this 82 section shall have a formal agreement with a level I or level II stroke center for physician 83 consultative services for evaluation of stroke patients for thrombolytic therapy and the care of 84 the patient post-thrombolytic therapy. 85 6. Hospitals designated as a trauma center, STEMI center, or stroke center by the 86 department shall submit data by one of the following methods: 87 (1) Entering hospital data into a state registry; or 88 (2) Entering hospital data into a national registry or data bank. A hospital submitting 89 data pursuant to this subdivision shall not be required to collect and submit any additional 90 trauma, STEMI, or stroke center data elements. No hospital submitting data to a national data 91 registry or data bank under this subdivision shall withhold authorization for the department to HB 1561 4

92 access such data through such national data registry or data bank. Nothing in this subdivision 93 shall be construed as requiring duplicative data entry by a hospital that is otherwise 94 complying with the provisions of this subsection. Failure of the department to obtain access 95 to data submitted to a national data registry or data bank shall not be construed as hospital 96 noncompliance under this subsection. 97 7. When collecting and analyzing data pursuant to the provisions of this section, the 98 department shall comply with the following requirements: 99 (1) Names of any health care professionals, as defined in section 376.1350, shall not 100 be subject to disclosure; 101 (2) The data shall not be disclosed in a manner that permits the identification of an 102 individual patient or encounter; 103 (3) The data shall be used for the evaluation and improvement of hospital and 104 emergency medical services' trauma, stroke, and STEMI care; and 105 (4) Trauma, STEMI, and stroke center data elements shall conform to national 106 registry or data bank data elements, and include published detailed measure specifications, 107 data coding instructions, and patient population inclusion and exclusion criteria to ensure data 108 reliability and validity. 109 8. The department shall not have authority to establish additional education 110 requirements for physicians who are emergency medicine board-certified or board-eligible 111 through the American Board of Emergency Medicine (ABEM) or the American Osteopathic 112 Board of Emergency Medicine (AOBEM) and who are practicing in the emergency 113 department of a facility designated as a trauma center, STEMI center, or stroke center by the 114 department under this section. The department shall deem the education requirements 115 promulgated by ABEM or AOBEM to meet the standards for designations under this section. 116 Education requirements for non-ABEM or non-AOBEM certified physicians, nurses, and 117 other providers who provide care at a facility designated as a trauma center, STEMI center, or 118 stroke center by the department under this section shall mirror but not exceed those 119 established by national designating or verifying bodies of trauma centers, STEMI centers, or 120 stroke centers. 121 9. The department of health and senior services may establish appropriate fees to 122 offset only the costs of trauma, STEMI, and stroke center surveys. 123 10. No hospital shall hold itself out to the public as a STEMI center, stroke center, 124 adult trauma center, pediatric trauma center, or an adult and pediatric trauma center unless it 125 is designated as such by the department of health and senior services. 126 11. Any person aggrieved by an action of the department of health and senior services 127 affecting the trauma, STEMI, or stroke center designation pursuant to this chapter, including 128 the revocation, the suspension, or the granting of, refusal to grant, or failure to renew a HB 1561 5

129 designation, may seek a determination thereon by the administrative hearing commission 130 under chapter 621. It shall not be a condition to such determination that the person aggrieved 131 seek a reconsideration, a rehearing, or exhaust any other procedure within the department. ✔

Statutes affected:
Introduced (3165H.01): 190.241