Iowa Admin. Code r. 641-134.2

Current through Regsiter Vol. 46, No. 26, June 12, 2024
Rule 641-134.2 - Trauma care facility categorization and verification

Categorization and verification of trauma care facilities shall be made by the department based upon the trauma care facilities' resources available for providing trauma care services.

(1) Categorization.
a. Categorization as a trauma care facility shall be determined by the department from self-reported information provided to the department by a hospital or emergency care facility through a self-assessment categorization application provided by the department.
b. Categorization applications shall be submitted by all hospitals. New hospitals shall submit a categorization application no later than 90 days after licensing by the department of inspections and appeals, health facilities division. Categorization applications may be submitted by emergency care facilities. New emergency care facilities may submit a categorization application no later than 90 days after opening or reopening.
c. Categorization applications may be obtained from the department upon written request to: Iowa Department of Public Health, Bureau of Emergency and Trauma Services, Lucas State Office Building, Des Moines, Iowa 50319-0075.
(2) Categorization levels for trauma care facilities shall be identified as:
a. Level I.
b. Level II.
c. Level III.
d. Level IV.
(3) Adoption by reference.
a. Criteria specific to Level I trauma care facilities identified in the "Resources for Optimal Care of the Injured Patient 2014" (6th edition) published by the American College of Surgeons Committee on Trauma (ACS-COT) is incorporated and adopted by reference for Level I hospital and emergency care facility categorization criteria. Criteria specific to Level II trauma care facilities identified in the "Resources for Optimal Care of the Injured Patient 2014" (6th edition) published by the American College of Surgeons Committee on Trauma is incorporated and adopted by reference for Level II hospital and emergency care facility categorization criteria. Criteria specific to Level III trauma care facilities identified in the "Resources for Optimal Care of the Injured Patient 2014" (6th edition) published by the American College of Surgeons Committee on Trauma is incorporated and adopted by reference for Level III hospital and emergency care facility categorization criteria. Criteria specific to Level IV trauma care facilities identified in the "Resources for Optimal Care of the Injured Patient 2014" (6th edition) published by the American College of Surgeons Committee on Trauma is incorporated and adopted by reference for Level IV hospital and emergency care categorization criteria. For any differences which may occur between the adopted references and these administrative rules, the administrative rules shall prevail.
b. "Resources for Optimal Care of the Injured Patient 2014" (6th edition) published by the American College of Surgeons Committee on Trauma is available through the Iowa Department of Public Health, Bureau of Emergency and Trauma Services (BETS), Lucas State Office Building, Des Moines, Iowa 50319-0075, or the BETS website (idph.iowa.gov/BETS/Trauma).
c. Trauma care facilities shall transition to the criteria outlined in paragraph 134.2(3)"a."
(1) Level IV trauma care facilities shall transition to the criteria outlined in paragraph 134.2(3)"a" on or before October 1, 2017.
(2) Level III trauma care facilities shall maintain, at a minimum, the criteria requirements effective in 2013 until a transition to the criteria in paragraph 134.2(3) "a" at the next scheduled verification visit. Transition to paragraph 134.2(3)"a" criteria shall be completed on or before December 31, 2020.
(3) Level II trauma care facilities shall maintain, at a minimum, the criteria requirements effective in 2013 until American College of Surgeons Committee on Trauma verification on or before October 31, 2021.
d. The 2013 criteria for all levels of trauma care facilities are available through the Iowa Department of Public Health, Bureau of Emergency and Trauma Services, Lucas State Office Building, Des Moines, Iowa 50319-0075, or the BETS website (idph.iowa.gov/BETS/Trauma).
(4) Categorization shall not be construed to imply any guarantee on the part of the department as to the level of trauma care services available at a trauma care facility.
(5) A trauma care facility may apply to the department for a change in level of categorization through submission of a self-assessment categorization application. Hospitals, emergency care facilities, or trauma care facilities applying for initial verification or a change in level of categorization shall be verified based on the criteria outlined in paragraph 134.2(3)"a."
(6) Verification. Verification of a trauma care facility shall be determined by the department upon successful completion of the categorization application and completion of a verification survey. All categorized hospitals and emergency care facilities shall be verified.
a. Level I and Level II trauma care facilities shall be verified by the American College of Surgeons Committee on Trauma on or before October 31, 2021.
b. Trauma care facilities verified by the American College of Surgeons Committee on Trauma shall be accepted by the department as equivalent for categorization and verification as a trauma care facility in Iowa provided that all policy, reporting, and administrative rules have been met. The department may issue a certification of verification provided that the trauma care facility has been verified by the American College of Surgeons Committee on Trauma. The facility shall provide the department documentation including, but not limited to, a current copy of the ACS-COT verification.
c. A Level I or Level II trauma care facility which fails to attain American College of Surgeons Committee on Trauma verification shall submit an application to the department to be verified as a Level III or Level IV trauma care facility to ensure compliance with Iowa Code section 147A.23(2)"a."
d. Level III and Level IV trauma care facilities shall be verified by the department in consultation with the trauma survey team.
(7) The department shall conduct a verification survey for categorized hospitals or emergency care facilities.
a. A verification survey shall assess the ability of the hospital or emergency care facility to meet criteria for the level of categorization pursuant to 134.2(3).
b. Verification criteria are weighted by criteria types, Type I and Type II, as indicated in the "Resources for Optimal Care of the Injured Patient 2014" (6th edition) published by the American College of Surgeons Committee on Trauma and adopted in 134.2(3)"a."
c. Type II criteria deficiencies identified during the verification process may result in disciplinary action. Criteria deficiencies shall be resolved in accordance with the trauma care facility's final report. Failure to rectify deficiencies in accordance with the trauma care facility's final report shall result in disciplinary action.
d. Type I criteria deficiencies or persistently occurring Type II criteria deficiencies identified during the verification process shall result in disciplinary action. The department shall notify the trauma care facility's governing body of Type I or persistently occurring Type II criteria deficiencies. The trauma care facility shall implement a plan of correction within 45 days of issuance of the trauma facility's final report. Criteria deficiencies shall be resolved in accordance with the trauma care facility's final report and the implemented plan of correction. Failure to rectify deficiencies shall result in disciplinary action.
e. The department may conduct electronic review or on-site verification that criteria deficiencies have been resolved as outlined in final reports or disciplinary actions.
f. The department shall approve trauma care facility verification when the department is satisfied that the proposed facility will provide services and be operated in compliance with Iowa Code section 147A.23 and these administrative rules.
g. The department shall notify the applicant, in writing, as to the approval or denial of verification as a trauma care facility within 90 days after the completion of a verification survey.
h. Verification shall not be construed to imply any guarantee on the part of the department as to the level of trauma care services available at a hospital or emergency care facility.
i. Trauma care facility verification is valid for a period of three years from the effective date unless otherwise specified on the certificate of verification or unless sooner suspended or revoked.
j. Trauma care facilities shall be fully operational at their verified level upon the effective date specified on the certificate of verification. Trauma care facilities shall meet all requirements of Iowa Code section 147A.23 and these administrative rules.
k. As part of the verification and renewal process, the department or its designated trauma survey team may conduct periodic on-site reviews of the services and facilities of trauma care facilities including chart review at those facilities.
l. Trauma care facilities that are unable to maintain their categorization or verification, or both, shall notify the department within 48 hours.
m. The director, pursuant to 641-Chapter 178, may grant a waiver from the requirements of rules adopted under this chapter for any trauma care facility.
n. Proceedings, records, and reports developed pursuant to this chapter constitute peer review records under Iowa Code section 147.135, and are not subject to discovery by subpoena or admissible as evidence. All information and documents received from a hospital, emergency care facility, or trauma care facility under Iowa Code chapter 147A shall be confidential pursuant to Iowa Code section 272C.6(4).
(8) Prohibited acts. A hospital or emergency care facility that imparts or conveys, or causes to be imparted or conveyed, that it is a trauma care facility, or that uses any other term to indicate or imply that the hospital or emergency care facility is a trauma care facility without having obtained a certificate of verification by the department is subject to civil penalty not to exceed $100 per day for each offense. The director may apply to the district court for a writ of injunction to restrain the use of the term "trauma care facility."
(9) Nothing in Iowa Code section 147A.23 or these administrative rules shall be construed to restrict a hospital or emergency care facility from providing any services for which it is duly authorized.

Iowa Admin. Code r. 641-134.2

ARC 9445B, IAB 4/6/11, effective 5/11/11; ARC 1079C, IAB 10/2/2013, effective 1/6/2014
Amended by IAB August 2, 2017/Volume XL, Number 3, effective 9/6/2017
Amended by IAB March 24, 2021/Volume XLIII, Number 20, effective 4/28/2021