Effective 28 Aug 2017

190.241. Trauma, STEMI, or stroke centers, designation by department — on-site reviews — grounds for suspension or revocation of designation — data submission and analysis — fees — administrative hearing commission to hear persons aggrieved by designation. — 1. The department shall designate a hospital as an adult, pediatric or adult and pediatric trauma center when a hospital, upon proper application submitted by the hospital and site review, has been found by the department to meet the applicable level of trauma center criteria for designation in accordance with rules adopted by the department as prescribed by section 190.185. Such rules shall include designation as a trauma center without site review if such hospital is verified by a national verifying or designating body at the level which corresponds to a level approved in rule.

2. Except as provided for in subsection 5 of this section, the department shall designate a hospital as a STEMI or stroke center when such hospital, upon proper application and site review, has been found by the department to meet the applicable level of STEMI or stroke center criteria for designation in accordance with rules adopted by the department as prescribed by section 190.185. In developing STEMI center and stroke center designation criteria, the department shall use, as it deems practicable, appropriate peer-reviewed or evidence-based research on such topics including, but not limited to, the most recent guidelines of the American College of Cardiology and American Heart Association for STEMI centers, or the Joint Commission's Primary Stroke Center Certification program criteria for stroke centers, or Primary and Comprehensive Stroke Center Recommendations as published by the American Stroke Association. Such rules shall include designation as a STEMI center without site review if such hospital is certified by a national body.

3. The department of health and senior services shall, not less than once every five years, conduct an on-site review of every trauma, STEMI, and stroke center through appropriate department personnel or a qualified contractor, with the exception of stroke centers designated pursuant to subsection 5 of this section; however, this provision is not intended to limit the department's ability to conduct a complaint investigation pursuant to subdivision (3) of subsection 2 of section 197.080 of any trauma, STEMI, or stroke center. On-site reviews shall be coordinated for the different types of centers to the extent practicable with hospital licensure inspections conducted under chapter 197. No person shall be a qualified contractor for purposes of this subsection who has a substantial conflict of interest in the operation of any trauma, STEMI, or stroke center under review. The department may deny, place on probation, suspend or revoke such designation in any case in which it has reasonable cause to believe that there has been a substantial failure to comply with the provisions of this chapter or any rules or regulations promulgated pursuant to this chapter. If the department of health and senior services has reasonable cause to believe 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 trauma, STEMI, or stroke center fails two consecutive on-site reviews because of substantial noncompliance with standards prescribed by sections 190.001 to 190.245 or rules adopted by the department pursuant to sections 190.001 to 190.245, its center designation shall be revoked.

4. Instead of applying for STEMI center designation under subsection 2 of this section, a hospital may apply for STEMI center designation under this subsection. Upon receipt of an application from a hospital on a form prescribed by the department, the department shall designate such hospital:

(1) A level I STEMI center if such hospital has been certified as a Joint Commission comprehensive cardiac center or another department-approved nationally recognized organization that provides comparable STEMI center accreditation; or

(2) A level II STEMI center if such hospital has been accredited as a Mission: Lifeline STEMI receiving center by the American Heart Association accreditation process or another department-approved nationally recognized organization that provides STEMI receiving center accreditation.

5. Instead of applying for stroke center designation pursuant to the provisions of subsection 2 of this section, a hospital may apply for stroke center designation pursuant to this subsection. Upon receipt of an application from a hospital on a form prescribed by the department, the department shall designate such hospital:

(1) A level I stroke center if such hospital has been certified as a comprehensive stroke center by the Joint Commission or any other certifying organization designated by the department when such certification is in accordance with the American Heart Association/American Stroke Association guidelines;

(2) A level II stroke center if such hospital has been certified as a primary stroke center by the Joint Commission or any other certifying organization designated by the department when such certification is in accordance with the American Heart Association/American Stroke Association guidelines; or

(3) A level III stroke center if such hospital has been certified as an acute stroke-ready hospital by the Joint Commission or any other certifying organization designated by the department when such certification is in accordance with the American Heart Association/American Stroke Association guidelines.

­­Except as provided by subsection 6 of this section, the department shall not require compliance with any additional standards for establishing or renewing stroke designations. The designation shall continue if such hospital remains certified. The department may remove a hospital's designation as a stroke center if the hospital requests removal of the designation or the department determines that the certificate recognizing the hospital as a stroke center has been suspended or revoked. Any decision made by the department to withdraw its designation of a stroke center pursuant to this subsection that is based on the revocation or suspension of a certification by a certifying organization shall not be subject to judicial review. The department shall report to the certifying organization any complaint it receives related to the stroke center certification of a stroke center designated pursuant to this subsection. The department shall also advise the complainant which organization certified the stroke center and provide the necessary contact information should the complainant wish to pursue a complaint with the certifying organization.

6. Any hospital receiving designation as a stroke center pursuant to subsection 5 of this section shall:

(1) Annually and within thirty days of any changes submit to the department proof of stroke certification and the names and contact information of the medical director and the program manager of the stroke center;

(2) Submit to the department a copy of the certifying organization's final stroke certification survey results within thirty days of receiving such results;

(3) Submit every four years an application on a form prescribed by the department for stroke center review and designation;

(4) Participate in the emergency medical services regional system of stroke care in its respective emergency medical services region as defined in rules promulgated by the department;

(5) Participate in local and regional emergency medical services systems by reviewing and sharing outcome data and providing training and clinical educational resources.

­­Any hospital receiving designation as a level III stroke center pursuant to subsection 5 of this section shall have a formal agreement with a level I or level II stroke center for physician consultative services for evaluation of stroke patients for thrombolytic therapy and the care of the patient post-thrombolytic therapy.

7. Hospitals designated as a STEMI or stroke center by the department, including those designated pursuant to subsection 5 of this section, shall submit data to meet the data submission requirements specified by rules promulgated by the department. Such submission of data may be done by the following methods:

(1) Entering hospital data directly into a state registry by direct data entry;

(2) Downloading hospital data from a nationally recognized registry or data bank and importing the data files into a state registry; or

(3) Authorizing a nationally recognized registry or data bank to disclose or grant access to the department facility-specific data held by the registry or data bank.

­­A hospital submitting data pursuant to subdivision (2) or (3) of this subsection shall not be required to collect and submit any additional STEMI or stroke center data elements.

8. When collecting and analyzing data pursuant to the provisions of this section, the department shall comply with the following requirements:

(1) Names of any health care professionals, as defined in section 376.1350, shall not be subject to disclosure;

(2) The data shall not be disclosed in a manner that permits the identification of an individual patient or encounter;

(3) The data shall be used for the evaluation and improvement of hospital and emergency medical services' trauma, stroke, and STEMI care;

(4) The data collection system shall be capable of accepting file transfers of data entered into any national recognized trauma, stroke, or STEMI registry or data bank to fulfill trauma, stroke, or STEMI certification reporting requirements; and

(5) STEMI and stroke center data elements shall conform to nationally recognized performance measures, such as the American Heart Association's Get With the Guidelines, and include published detailed measure specifications, data coding instructions, and patient population inclusion and exclusion criteria to ensure data reliability and validity.

9. The board of registration for the healing arts shall have sole authority to establish education requirements for physicians who practice in an emergency department of a facility designated as a trauma, STEMI, or stroke center by the department under this section. The department shall deem such education requirements promulgated by the board of registration for the healing arts sufficient to meet the standards for designations under this section.

10. The department of health and senior services may establish appropriate fees to offset the costs of trauma, STEMI, and stroke center reviews.

11. No hospital shall hold itself out to the public as a STEMI center, stroke center, adult trauma center, pediatric trauma center, or an adult and pediatric trauma center unless it is designated as such by the department of health and senior services.

12. Any person aggrieved by an action of the department of health and senior services affecting the trauma, STEMI, or stroke center designation pursuant to this chapter, 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. It shall not be a condition to such determination that the person aggrieved seek a reconsideration, a rehearing, or exhaust any other procedure within the department.

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(L. 1987 S.B. 31 & 29 § 4, A.L. 1998 S.B. 743, A.L. 2008 H.B. 1790, A.L. 2016 S.B. 635 merged with S.B. 732 merged with S.B. 988, A.L. 2017 S.B. 50)